[Title 21 CFR I]
[Code of Federal Regulations (annual edition) - April 1, 1996 Edition]
[Title 21 - FOOD AND DRUGS]
[Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--CONTINUED]
[From the U.S. Government Publishing Office]
21
FOOD AND DRUGS
2
1996-04-01
1996-04-01
false
FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--CONTINUED
I
CHAPTER I
FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--CONTINUED
(Parts 100 to 169)
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SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION
Part Page
100 General..................................... 5
101 Food labeling............................... 13
102 Common or usual name for nonstandardized
foods................................... 152
103 Quality standards for foods with no identity
standards............................... 159
104 Nutritional quality guidelines for foods.... 168
105 Foods for special dietary use............... 173
106 Infant formula quality control procedures... 175
107 Infant formula.............................. 181
108 Emergency permit control.................... 190
109 Unavoidable contaminants in food for human
consumption and food-packaging material. 200
110 Current good manufacturing practice in
manufacturing, packing, or holding human
food.................................... 206
113 Thermally processed low-acid foods packaged
in hermetically sealed containers....... 216
114 Acidified foods............................. 241
123 Fish and fishery products................... 247
129 Processing and bottling of bottled drinking
water................................... 255
130 Food standards: General..................... 260
131 Milk and cream.............................. 268
133 Cheeses and related cheese products......... 297
135 Frozen desserts............................. 349
136 Bakery products............................. 356
137 Cereal flours and related products.......... 360
139 Macaroni and noodle products................ 377
145 Canned fruits............................... 388
146 Canned fruit juices......................... 428
[[Page 4]]
150 Fruit butters, jellies, preserves, and
related products........................ 442
152 Fruit pies.................................. 450
155 Canned vegetables........................... 452
156 Vegetable juices............................ 474
158 Frozen vegetables........................... 477
160 Eggs and egg products....................... 480
161 Fish and shellfish.......................... 485
163 Cacao products.............................. 502
164 Tree nut and peanut products................ 510
165 Beverages................................... 513
166 Margarine................................... 531
168 Sweeteners and table sirups................. 534
169 Food dressings and flavorings............... 538
Editorial Note: For nomenclature changes to chapter I see 59 FR 14366,
Mar. 28, 1994.
[[Page 5]]
SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION
PART 100--GENERAL--Table of Contents
Subpart A--State and Local Requirements
Sec.
100.1 Petitions requesting exemption from preemption for State or local
requirements.
100.2 State enforcement of Federal regulations.
Subparts B-E [Reserved]
Subpart F--Misbranding for Reasons Other Than Labeling
100.100 Misleading containers.
Subpart G--Specific Administrative Rulings and Decisions
100.120 Artificially red-dyed yellow varieties of sweet potatoes.
100.130 Combinations of nutritive and nonnutritive sweeteners in ``diet
beverages.''
100.135 Disposition of incubator reject eggs.
100.140 Label declaration of salt in frozen vegetables.
100.145 Notice to packers of comminuted tomato products.
100.150 Notice to packers and shippers of shelled peanuts.
100.155 Salt and iodized salt.
100.160 Tolerances for moldy and insect-infected cocoa beans.
Authority: Secs. 201, 301, 307, 402, 403, 409, 701 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 337, 342, 343, 348,
371).
Source: 42 FR 14306, Mar. 15, 1977, unless otherwise noted.
Subpart A--State and Local Requirements
Sec. 100.1 Petitions requesting exemption from preemption for State or local requirements.
(a) Scope and purpose. (1) This subpart applies to the submission
and consideration of petitions under section 403A(b) of the Federal
Food, Drug, and Cosmetic Act (the act), by a State or a political
subdivision of a State, requesting exemption of a State requirement from
preemption under section 403A(a) of the act.
(2) Section 403A(b) of the act provides that where a State
requirement has been preempted under section 403A(a) of the act, the
State may petition the agency for an exemption. The agency may grant the
exemption, under such conditions as it may prescribe by regulation, if
the agency finds that the State requirement will not cause any food to
be in violation of any applicable requirement under Federal law, will
not unduly burden interstate commerce, and is designed to address a
particular need for information that is not met by the preemptive
Federal requirement.
(b) Definitions. (1) Act means the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 321 et seq.).
(2) Agency means the Food and Drug Administration.
(3) Commissioner means the Commissioner of Food and Drugs.
(4) State means a State as defined in section 201(a)(1) of the act
(which includes a territory of the United States, the District of
Columbia, and Puerto Rico) or any political subdivision of a State
having authority to issue food standards and food labeling regulations
having force of law.
(5) State requirement means any statute, standard, regulation, or
other requirement that is issued by a State.
(c) Prerequisites for petitions for exemption from preemption. The
Food and Drug Administration will consider a petition for exemption from
preemption on its merits only if the petition demonstrates that:
(1) The State requirement was enacted or was issued as a final rule
by an authorized official of the State and is in effect or would be in
effect but for the provisions of section 403A of the act.
(2) The State requirement is subject to preemption under section
403A(a) of the act because of a statutory provision listed in that
section or because of a Federal standard or other Federal regulation
that is in effect, or that has been published as a final rule with a
designated effective date, and that was issued under the authority of a
statutory provision listed in that section. For the purposes of this
subpart, all petitions seeking exemption from preemption under section
403A(a)(3)
[[Page 6]]
through (a)(5) of the act submitted before May 8, 1992, will be
considered timely even though the applicable statutory provisions or
regulations are not yet in effect.
(3) The petitioner is an official of a State having authority to act
for, or on behalf of, the Government in applying for an exemption of
State requirements from preemption.
(4) The State requirement is subject to preemption under section
403A(a) of the act because it is not identical to the requirement of the
preemptive Federal statutory provision or regulation including a
standard of identity, quality, and fill. ``Not identical to'' does not
refer to the specific words in the requirement but instead means that
the State requirement directly or indirectly imposes obligations or
contains provisions concerning the composition or labeling of food, or
concerning a food container, that:
(i) Are not imposed by or contained in the applicable provision
(including any implementing regulation) of section 401 or 403 of the
act; or
(ii) Differ from those specifically imposed by or contained in the
applicable provision (including any implementing regulation) of section
401 or 403 of the act.
(d) Form of petition. (1) All information included in the petition
should meet the general requirements of Sec. 10.20(c) of this chapter.
(2) An original and one copy of the petition shall be submitted, or
the petitioner may submit an original and a computer readable disk
containing the petition. Contents of the disk should be in a standard
format, such as ASCII format. (Petitioners interested in submitting a
disk should contact the Center for Food Safety and Applied Nutrition for
details.)
(3) Petitions for exemption from preemption for a State requirement
shall be submitted to the Dockets Management Branch in the following
form:
(Date) ----------------
Dockets Management Branch,
Food and Drug Administration,
Department of Health and Human Services,
rm. 1-23, 12420 Parklawn Dr.,
Rockville, MD 20857.
Petition Requesting Exemption from Preemption for State Requirement
The undersigned submits this petition under section 403A(b)of the
Federal Food, Drug, and Cosmetic Act to request that the Food and Drug
Administration exempt a State requirement from preemption.
The undersigned has authority to act for, or on behalf of, the
(identify State or political subdivision of the State) because (document
petitioner's authority to submit petition on behalf of the State).
A. Action Requested
1. Identify and give the exact wording of the State requirement and
give date it was enacted or issued in final form.
2. Identify the specific standard or regulation that is believed to
preempt the State requirement and the section and paragraph of the act
that the standard or regulation implements.
B. Documentation of State Requirement
Provide a copy of the State requirement that is the subject of the
application. Where available, the application should also include copies
of any legislative history or background materials used in issuing the
requirement, including hearing reports or studies concerning the
development or consideration of the requirement.
C. Statement of Grounds
A petition for an exemption from preemption should contain the
following:
1. An explanation of the State requirement and its rationale, and a
comparison of State and Federal requirements to show differences.
2. An explanation of why compliance with the State requirement would
not cause a food to be in violation of any applicable requirement under
Federal law.
3. Information on the effect that granting the State petition will
have on interstate commerce. The petition should contain information on
economic feasibility, i.e., whether the State and Federal requirements
have significantly different effects on the production and distribution
of the food product; comparison of the costs of compliance as shown by
data or information on the actual or anticipated effect of the State and
Federal requirements on the sale and price of the food product in
interstate commerce; and the effect of the State requirement on the
availability of the food product to consumers. To the extent possible,
the petition should include information showing that it is practical and
feasible for producers of food products to comply with the State
requirement. Such information may be submitted in the form of statements
from affected persons indicating their ability to comply.
[[Page 7]]
4. Identification of a particular need for information that the
State requirement is designed to meet, which need is not met by Federal
law. The petition should describe the conditions that require the State
to petition for an exemption, the information need that the State
requirement fulfills, the inadequacy of the Federal requirement in
addressing this need, and the geographical area or political subdivision
in which such need exists.
D. Environmental Impact
The petition shall contain a claim for categorical exclusion under
21 CFR 25.24 or an environmental assessment under 21 CFR 25.31.
E. Notification
Provide name and address of person, branch, department, or other
instrumentality of the State government that should be notified of the
Commissioner's action concerning the petition.
F. Certification
The undersigned certifies, that, to the best knowledge and belief of
the undersigned, this petition includes all information and views on
which the petition relies.
(Signature) ------------------------
(Name of petitioner) ----------------
(Mailing address) ------------------
(Telephone number) ----------------
(Information collection requirements in this section were approved
by the Office of Management and Budget (OMB) and assigned OMB number
0910-0277)
(e) Submission of petition for exemption; public disclosure. The
availability for public disclosure of a petition for exemption will be
governed by the rules specified in Sec. 10.20(j) of this chapter.
(f) Agency consideration of petitions. (1) Unless otherwise
specified in this section, all relevant provisions and requirements of
subpart B of part 10 of this chapter, are applicable to State petitions
requesting exemption from Federal preemption under section 403A(b) of
the act.
(2) If a petition does not meet the prerequisite requirements of
paragraph (c) of this section, the agency will issue a letter to the
petitioner denying the petition and stating in what respect the petition
does not meet these requirements.
(3) If a petition appears to meet the prerequisite requirements in
paragraph (c) of this section, it will be filed by the Dockets
Management Branch, stamped with the date of filing, and assigned a
docket number. The docket number identifies the file established by the
Dockets Management Branch for all submissions relating to the petition,
as provided in this part. Subsequent submissions relating to the matter
must refer to the docket number and will be filed in the docket file.
The Dockets Management Branch will promptly notify the petitioner in
writing of the filing and docket number of a petition.
(4) Any interested person may submit written comments to the Dockets
Management Branch on a filed petition as provided in Sec. 10.30(d) of
this chapter.
(5) Within 90 days of the date of filing the agency will furnish a
response to the petitioner. The response will either:
(i) State that the agency has tentatively determined that the
petition merits the granting of an exemption, and that it intends to
publish in the Federal Register a proposal to grant the exemption
through rulemaking;
(ii) Deny the petition and state the reasons for such denial; or
(iii) Provide a tentative response indicating why the agency has
been unable to reach a decision on the petition, e.g., because of other
agency priorities or a need for additional information.
(g) If a State submitted a petition for exemption of a State
requirement from preemption under section 403A(a)(3) through (a)(5) of
the act before May 8, 1992, that State requirement will not be subject
to preemption until:
(1) November 8, 1992; or
(2) Action on the petition, whichever occurs later.
[58 FR 2468, Jan. 6, 1993]
Sec. 100.2 State enforcement of Federal regulations.
(a) Under section 307 of the Federal Food, Drug, and Cosmetic Act
(the act), a State may bring, in its own name and within its own
jurisdiction, proceedings for the civil enforcement, or to restrain
violations, of sections 401, 403(b), 403(c), 403(d), 403(e), 403(f),
403(g), 403(h), 403(i), 403(k), 403(q), or 403(r) of the act if the food
that is the subject of the proceedings is located in the State.
[[Page 8]]
(b) No proceeding may be commenced by a State under paragraph (a) of
this section:
(1) Before 30 days after the State has given notice to the Food and
Drug Administration (FDA) that the State intends to bring such
proceeding.
(2) Before 90 days after the State has given notice to FDA of such
intent if FDA has, within such 30 days, commenced an informal or formal
enforcement action pertaining to the food which would be the subject of
such proceeding.
(3) If FDA is diligently prosecuting a proceeding in court
pertaining to such food, has settled such proceeding, or has settled the
informal or formal enforcement action pertaining to such food.
(c) A State may intervene as a matter of right, in any court
proceeding described in paragraph (b)(3) of this section.
(d) The notification that a State submits in accordance with
paragraph (b) of this section should include the following information
and be submitted in the following recommended format:
--------------------
(Date)
Name of State agency ------------
Post office address ------------
Street address ------------
City, State, and ZIP code ------------
Name of product(s) covered by the notification ------------
Reporting official, title, and telephone no. ------------
FAX No. ------------
Agency contact (if different from reporting official), title, and
telephone no. ------------
Director,
Division of Enforcement (HFS-605),
Center for Food Safety and Applied Nutrition,
Food and Drug Administration,
200 C St. SW.,
Washington, DC 20204.
To Whom It May Concern:
The undersigned, ------, submits this letter of notification
pursuant to section 307(b)(1) of the Federal Food, Drug, and Cosmetic
Act
(21 U.S.C. 337(b)(1)) with respect to --------. (name of products
covered by the notification and the enforcement action that is to be
initiated)
Attached hereto, and constituting a part of this letter of notification
are the following:
A. The name of the product.
B. The type and size of each product container.
C. Copy of the label and labeling of the product.
D. Manufacturing code (if applicable).
E. Name and address of firm believed to be responsible for
violations.
F. Name and address of parent firm (if known).
G. Reason for the anticipated State enforcement action (list
specific violations, including sections of the law violated).
H. Name of firm against which action is anticipated (if applicable).
I. Type of enforcement action.
Yours very truly,
Reporting Agency
By ------------
(Indicate authority)
(e) The letter of notification should be signed by a State official
authorized by the State to institute the contemplated enforcement
actions.
(f) The letter of notification should be sent to the Division of
Enforcement (HFS-605), Center for Food Safety and Applied Nutrition,
Food and Drug Administration, 200 C St. SW., Washington, DC 20204, FAX
number 202-205-4642.
(g) FDA will notify the State of the date in which its letter of
notification was received by FDA, Center for Food Safety and Applied
Nutrition, Division of Enforcement (HFS-605) (within 2 working days
after date of receipt). This date will be the date of notification for
the purposes of paragraph (b) of this section.
(h) The Director, Division of Enforcement, Office of Field Programs,
Center for Food Safety and Applied Nutrition, FDA, will respond to the
State's notification within 30 days of the date of notification by
advising:
(1) Whether FDA has commenced an informal or formal enforcement
action pertaining to the food that is the subject of the notification;
or
(2) Whether FDA is prosecuting a proceeding in court pertaining to
such food, has settled such proceeding, or has settled informal or
formal enforcement action pertaining to such food.
(i) Information contained in State notification letters shall be
exempt from public disclosure to the same extent to which such
information would be so exempt pursuant to Secs. 20.61, 20.64, and 20.88
of this chapter.
(j) Definitions. (1) Informal enforcement actions include warning
letters, recalls, detentions, or other administrative
[[Page 9]]
enforcement actions that pertain to the food in question.
(2) Formal enforcement actions include seizures, injunctions, or
other civil judicial enforcement actions that pertain to the food in
question. (Information collection requirements in this section were
approved by the Office of Management and Budget (OMB) and assigned OMB
control number 0910-0275.)
[58 FR 2460, Jan. 6, 1993; 58 FR 17097, Apr. 1, 1993]
Subparts B-E [Reserved]
Subpart F--Misbranding for Reasons Other Than Labeling
Sec. 100.100 Misleading containers.
In accordance with section 403(d) of the act, a food shall be deemed
to be misbranded if its container is so made, formed, or filled as to be
misleading.
(a) A container that does not allow the consumer to fully view its
contents shall be considered to be filled as to be misleading if it
contains nonfunctional slack-fill. Slack-fill is the difference between
the actual capacity of a container and the volume of product contained
therein. Nonfunctional slack-fill is the empty space in a package that
is filled to less than its capacity for reasons other than:
(1) Protection of the contents of the package;
(2) The requirements of the machines used for enclosing the contents
in such package;
(3) Unavoidable product settling during shipping and handling;
(4) The need for the package to perform a specific function (e.g.,
where packaging plays a role in the preparation or consumption of a
food), where such function is inherent to the nature of the food and is
clearly communicated to consumers;
(5) The fact that the product consists of a food packaged in a
reusable container where the container is part of the presentation of
the food and has value which is both significant in proportion to the
value of the product and independent of its function to hold the food,
e.g., a gift product consisting of a food or foods combined with a
container that is intended for further use after the food is consumed;
or durable commemorative or promotional packages; or
(6) Inability to increase level of fill or to further reduce the
size of the package (e.g., where some minimum package size is necessary
to accommodate required food labeling (excluding any vignettes or other
nonmandatory designs or label information), discourage pilfering,
facilitate handling, or accommodate tamper-resistant devices).
(b) [Reserved]
[59 FR 537, Jan. 5, 1994]
Subpart G--Specific Administrative Rulings and Decisions
Sec. 100.120 Artificially red-dyed yellow varieties of sweet potatoes.
(a) It has been the practice of some growers, packers, and
distributors of yellow varieties of sweet potatoes to artificially color
the skins of such potatoes with a red dye. Surveys made by the Food and
Drug Administration and letters received by the Administration from
consumers reveal that this practice can deceive those persons who prefer
the naturally red varieties of sweet potatoes. Also, representatives of
the red sweet potato industry have alleged that some consumers refuse to
purchase any red sweet potatoes since they cannot distinguish between
the naturally red ones and those artificially colored with red dye.
(b) The Food and Drug Administration concludes, therefore, that
yellow varieties of sweet potatoes artificially colored with a red dye
are adulterated within the meaning of section 402(b) of the Federal
Food, Drug, and Cosmetic Act.
(c) The Food and Drug Administration will consider appropriate
regulatory action regarding such adulterated sweet potatoes shipped in
interstate commerce if the act of adulterating the potatoes occurs after
90 days following the date of publication of this statement of policy in
the Federal Register.
Sec. 100.130 Combinations of nutritive and nonnutritive sweeteners in ``diet beverages.''
As a result of the removal of cyclamic acid and its salts from the
[[Page 10]]
list of substances generally recognized as safe (part 182 of this
chapter) by an order published in the Federal Register of October 21,
1969 (34 FR 17063), the Commissioner of Food and Drugs has received
inquiries as to the proper composition and labeling, from the standpoint
of application of the Federal Food, Drug, and Cosmetic Act, of so-called
``diet beverages'' that will be made from mixtures of nutritive
sweeteners and saccharin or its salts. The Commissioner concludes that:
(a) Any ``diet beverage'' or diet beverage base made with
combinations of nutritive and nonnutritive sweeteners must be so
formulated that each ingredient is one which is generally recognized as
safe and is not a food additive as defined in section 201(s) or a color
additive as defined in section 201(t) of the act, or if it is a food
additive or a color additive as so defined, is used in accordance with a
regulation established pursuant to section 409 or 721 of the act.
(b) The product is to be so formulated that its caloric value is at
least 50 percent less than the caloric value of the comparable product
made without artificial sweeteners. In no case shall the beverage
provide more than 6 calories per fluid ounce.
(c) If it is to be marketed under a name heretofore used on a
product represented to have no, or only a few, calories per serving, the
name shall be modified by the word ``new'' for at least 1 year following
the time such product is introduced in a given market.
(d) (1) The label must bear a complete statement of ingredients
except that spices, flavorings, and colorings may be designated as such
without naming each.
(2) The label must bear a statement of the caloric content per fluid
ounce, the carbohydrate content per fluid ounce, a statement of the
percentage of saccharin or saccharin salt used, and the statement
``Contains ------ mg saccharin (or saccharin salt, as the case may be)
per ounce, a nonnutritive artificial sweetener.''
(3) To further avoid injury through inadvertent use by diabetics in
the belief that the product does not contain carbohydrates, the label of
a beverage containing sugar(s) must bear the statement ``Contains
sugar(s); not for use by diabetics without advice of a physician.''
(4) To avoid confusion by diabetics, the label of a beverage
containing sorbitol, mannitol, or other hexitol, must bear the statement
``Contains carbohydrates, not for use by diabetics without advice of a
physician''. To further avoid confusion of these beverages with those
sweetened solely with nonnutritive artificial sweeteners which have been
marketed in containers bearing prominent statements such as ``sugar
free'', ``sugarless'', or ``no sugar'', the labels of beverages
containing hexitols must not bear these or similar statements.
(e) Bottlers of diet drinks have on hand large stocks of returnable
lithographed bottles bearing statements indicating that the beverages
contain cyclamates and/or declarations such as ``sugar free'', ``less
than 1 calorie per bottle'', or ``less than 2 calories per bottle''
which bottles were formerly used for artificially sweetened beverages
containing cyclamates. The Food and Drug Administration will not object
to continued use of these bottles under the following conditions:
(1) The bottles when filled with beverages made with combinations of
nutritive and nonnutritive sweeteners may be marketed only:
(i) In multiunit cartons labeled prominently on each principal
display panel with the information set forth in paragraphs (c) and (d)
of this section and with a prominent, forthright notice that any
information on bottles which is contrary to that on the cartons should
be disregarded because it is incorrect. To assure adequate prominence
and conspicuousness, the following statements should stand out in marked
contrast with other labeling: The statement of caloric content and
carbohydrate content per fluid ounce, the statement required by
paragraph (d) (3) or (4) of this section as applicable, and the notice
to disregard any information on bottles which is contrary to that on the
cartons. These statements may be made to stand out by means such as
setting them forth in boxes, printing in bold capitals on lines
[[Page 11]]
separated from other printed labeling, using colors that contrast with
those used for other label statements, or other similar means.
(ii) In vending machines bearing durable labeling which includes all
of the information required to appear on cartons set forth with the same
degree of prominence.
(2) In addition, the bottles must bear caps labeled prominently with
the words ``Contains Sugar'' or ``Contains Carbohydrates'', and accurate
statements of the caloric content and carbohydrate content per fluid
ounce.
Sec. 100.135 Disposition of incubator reject eggs.
(a) Investigations by the Food and Drug Administration and a number
of State regulatory agencies have revealed that incubator reject eggs,
removed as infertile or otherwise unhatchable during hatching
operations, are being diverted for human food use. Such eggs are
regarded as adulterated within the meaning of section 402(a)(3) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342(a)(3)) because they
are unfit for food.
(b) The introduction or delivery for introduction into interstate
commerce of adulterated eggs is prohibited under section 301(a) of the
aforesaid act (21 U.S.C. 331(a)) unless they have been broken, crushed,
or smashed and then denatured with kerosene, creolin, or other suitable
denaturant to preclude their diversion to human food channels.
Sec. 100.140 Label declaration of salt in frozen vegetables.
(a) In a number of diseases or disease conditions it is important to
restrict the intake of sodium. Sodium occurs in all natural foods, but
added salt makes the most important contribution to the total sodium
intake in the diet. Most fresh vegetables are of low sodium content and
consumers generally regard frozen vegetables as being free of added salt
and suitable for use in low-sodium diets. While salt may not be added
directly as a seasoning ingredient during the processing of frozen
vegetables, the use of salt brine in quality separation of such
vegetables as peas and lima beans preparatory to freezing may contribute
substantial amounts of salt to the finished article. The failure of the
labels of frozen vegetables to declare the presence of salt has been the
basis of complaints to the Food and Drug Administration.
(b) Section 403(i)(2) of the Federal Food, Drug, and Cosmetic Act
requires the label of a fabricated food to bear the common or usual name
of each ingredient present. The Department of Health and Human Services
regards any frozen vegetable containing salt, added directly or
indirectly, as misbranded in violation of section 403(i)(2) of the
Federal Food, Drug, and Cosmetic Act unless its label names salt as an
ingredient.
Sec. 100.145 Notice to packers of comminuted tomato products.
(a) It has long been known that tomato rot may be caused by one or
more of the following: Fungus diseases, bacterial diseases, virus
diseases, and certain nonparasitic diseases. Only the fungus rots are
characterized by the presence of mold filaments. Mold counts on
comminuted tomato products are not increased by incorporating within the
product tomato rot caused by bacteria, virus, or nonparasitic factors.
Although high mold counts on these products reveal that large amounts of
rotten material are present, low mold counts do not necessarily
demonstrate absence of the type of rot caused by the tomato diseases
that are not characterized by mold filaments.
(b) Inspections of canneries engaged in the packing of comminuted
tomato products show that most packers effectively trim, sort out, and
discard rotten tomatoes from the raw stock. Some packers, however, do
not properly eliminate rotten tomato material, and a few packers
deliberately use rotten tomatoes in these foods, provided the mold count
remains low. Some packers, on occasion, have mixed tomato products
having a high mold count with tomato products containing little or no
mold, so as to produce a blend with a low mold count.
(c) Packers of comminuted tomato products who rely upon the mold
count as the sole or primary control
[[Page 12]]
procedure, to the neglect of adequate sorting and trimming, may produce
products with low mold counts which contain substantial amounts of rot.
(d) It is the purpose of this announcement to advise all canners of
tomato products that:
(1) Although high mold count is conclusive evidence of inclusion of
substantial amounts of rot, mold count is not the only way of
establishing that comminuted tomato products contain decomposed tomato
material.
(2) Where factory observations or other evidence reveals that
comminuted tomato products contain rot not caused by mold, such rot, as
well as that caused by mold, will be taken into account in applying the
provisions of the Federal Food, Drug, and Cosmetic Act against
adulteration.
(3) The blending of tomato products adulterated with tomato rot, of
whatever kind, with tomato products made from sound tomatoes, or with
other sound food, renders the blend adulterated.
Sec. 100.150 Notice to packers and shippers of shelled peanuts.
(a) Investigations by the Food and Drug Administration have shown
that a number of interstate shipments of shelled peanuts in bags holding
from approximately 100 to 125 pounds each have failed to bear labeling
as required by the terms of the Federal Food, Drug, and Cosmetic Act.
(b) Shelled peanuts in sacks, whether or not shipped in carload
lots, should bear the following information required by the law on food
in package form:
(1) The name of the product.
(2) An accurate statement of net weight.
(3) The name and place of business of the packer or distributor.
(c) The information required by paragraph (b) of this section should
be conspicuously set forth. It may be printed or stenciled on each bag
or, if desired, placed on tags which are securely attached to each bag.
(d) The net weight marked on the bags must be the correct net weight
of the peanuts at the time they are delivered to the carrier for
interstate shipment. The tare weight of the bag should not be included
in the weight declaration.
Sec. 100.155 Salt and iodized salt.
(a) For the purposes of this section, the term ``iodized salt'' or
``iodized table salt'' is designated as the name of salt for human food
use to which iodide has been added in the form of cuprous iodide or
potassium iodide permitted by Secs. 184.1265 and 184.1634 of this
chapter. In the labeling of such products, all words in the name shall
be equal in prominence and type size. The statement ``This salt supplies
iodide, a necessary nutrient'' shall appear on the label immediately
following the name and shall be in letters which are not less in height
than those required for the declaration of the net quantity of contents
as specified in Sec. 101.105 of this chapter.
(b) Salt or table salt for human food use to which iodide has not
been added shall bear the statement, ``This salt does not supply iodide,
a necessary nutrient.'' This statement shall appear immediately
following the name of the food and shall be in letters which are not
less in height than those required for the declaration of the net
quantity of contents as specified in Sec. 101.105 of this chapter.
(c) Salt, table salt, iodized salt, or iodized table salt to which
anticaking agents have been added may bear in addition to the ingredient
statement designating the anticaking agent(s), a label statement
describing the characteristics imparted by such agent(s) (for example,
``free flowing''), providing such statement does not appear with greater
prominence or in type size larger than the statements which immediately
follow the name of the food as required by paragraphs (a) and (b) of
this section.
(d) Individual serving-sized packages containing less than \1/2\
ounce and packages containing more than 2\1/2\ pounds of a food
described in this section shall be exempt from declaration of the
statements which paragraphs (a) and (b) of this section require
immediately following the name of the food. Such exemption shall not
apply to the outer container or wrapper of a multiunit retail package.
[[Page 13]]
(e) All salt, table salt, iodized salt, or iodized table salt in
packages intended for retail sale shipped in interstate commerce 18
months after the date of publication of this statement of policy in the
Federal Register, shall be labeled as prescribed by this section; and if
not so labeled, the Food and Drug Administration will regard them as
misbranded within the meaning of sections 403 (a) and (f) of the Federal
Food, Drug, and Cosmetic Act.
[42 FR 14306, Mar. 15, 1977, as amended at 48 FR 10811, Mar. 15, 1983;
49 FR 24119, June 12, 1984]
Sec. 100.160 Tolerances for moldy and insect-infested cocoa beans.
On and after February 22, 1963, shipments of cocoa beans offered for
entry into the United States must meet a tolerance of 6 percent total
moldy and insect-infested, including insect-damaged, beans, but not more
than 4 percent of either moldy or insect-infested, including insect-
damaged, beans. This statement of policy supersedes the notice issued
August 27, 1931, addressed to shippers, importers, and dealers in cocoa
beans and manufacturers of chocolate and cocoa products and the
statement of policy issued June 22, 1961, in this section.
PART 101--FOOD LABELING--Table of Contents
Subpart A--General Provisions
Sec.
101.1 Principal display panel of package form food.
101.2 Information panel of package form food.
101.3 Identity labeling of food in packaged form.
101.4 Food; designation of ingredients.
101.5 Food; name and place of business of manufacturer, packer, or
distributor.
101.8 Labeling of food with number of servings.
101.9 Nutrition labeling of food.
101.10 Nutrition labeling of restaurant foods.
101.11 Saccharin and its salts; retail establishment notice.
101.12 Reference amounts customarily consumed per eating occasion.
101.13 Nutrient content claims--general principles.
101.14 Health claims: general requirements.
101.15 Food; prominence of required statements.
101.17 Food labeling warning and notice statements.
101.18 Misbranding of food.
Subpart B--Specific Food Labeling Requirements
101.22 Foods; labeling of spices, flavorings, colorings and chemical
preservatives.
101.29 Labeling of kosher and kosher-style foods.
101.30 Percentage juice declaration for foods purporting to be
beverages that contain fruit or vegetable juice.
101.33 Label declaration of D-erythroascorbic acid when it is an
ingredient of a fabricated food.
Subpart C--Specific Nutrition Labeling Requirements and Guidelines
101.36 Nutrition labeling of dietary supplements of vitamins and
minerals (eff. 7-5-95).
101.42 Nutrition labeling of raw fruit, vegetables, and fish.
101.43 Substantial compliance of food retailers with the guidelines for
the voluntary nutrition labeling of raw fruit, vegetables, and
fish.
101.44 Identification of the 20 most frequently consumed raw fruit,
vegetables, and fish in the United States.
101.45 Guidelines for the voluntary nutrition labeling of raw fruit,
vegetables, and fish.
Subpart D--Specific Requirements for Nutrient Content Claims
101.54 Nutrient content claims for ``good source,'' ``high,'' and
``more.''
101.56 Nutrient content claims for ``light'' or ``lite.''
101.60 Nutrient content claims for the calorie content of foods.
101.61 Nutrient content claims for the sodium content of foods.
101.62 Nutrient content claims for fat, fatty acid, and cholesterol
content of foods.
101.65 Implied nutrient content claims and related label statements.
101.67 Use of nutrient content claims for butter.
101.69 Petitions for nutrient content claims.
Subpart E--Specific Requirements for Health Claims
101.70 Petitions for health claims.
101.71 Health claims: claims not authorized.
101.72 Health claims: calcium and osteoporosis.
101.73 Health claims: dietary lipids and cancer.
101.74 Health claims: sodium and hypertension.
[[Page 14]]
101.75 Health claims: dietary saturated fat and cholesterol and risk of
coronary heart disease.
101.76 Health claims: fiber-containing grain products, fruits, and
vegetables and cancer.
101.77 Health claims: fruits, vegetables, and grain products that
contain fiber, particularly soluble fiber, and risk of
coronary heart disease.
101.78 Health claims: fruits and vegetables and cancer.
101.79 Health claims: folate and neural tube defects.
Subpart F--Specific Requirements for Descriptive Claims that are Neither
Nutrient Content Claims nor Health Claims
101.95 ``Fresh,'' ``freshly frozen,'' ``fresh frozen,'' ``frozen
fresh.''
Subpart G--Exemptions From Food Labeling Requirements
101.100 Food; exemptions from labeling.
101.103 Petitions requesting exemptions from or special requirements
for label declaration of ingredients.
101.105 Declaration of net quantity of contents when exempt.
101.108 Temporary exemptions for purposes of conducting authorized food
labeling experiments.
Appendix A to Part 101--Monier-Williams Procedure (With Modifications)
for Sulfites in Food, Center for Food Safety and Applied
Nutrition, Food and Drug Administration (November 1985)
Appendix B to Part 101--Graphic Enhancements Used by the FDA
Authority: Secs. 4, 5, 6 of the Fair Packaging and Labeling Act (15
U.S.C. 1453, 1454, 1455); secs. 201, 301, 402, 403, 409, 701 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 342, 343, 348,
371).
Source: 42 FR 14308, Mar. 15, 1977, unless otherwise noted.
Subpart A--General Provisions
Sec. 101.1 Principal display panel of package form food.
The term ``principal display panel'' as it applies to food in
package form and as used in this part, means the part of a label that is
most likely to be displayed, presented, shown, or examined under
customary conditions of display for retail sale. The principal display
panel shall be large enough to accommodate all the mandatory label
information required to be placed thereon by this part with clarity and
conspicuousness and without obscuring design, vignettes, or crowding.
Where packages bear alternate principal display panels, information
required to be placed on the principal display panel shall be duplicated
on each principal display panel. For the purpose of obtaining uniform
type size in declaring the quantity of contents for all packages of
substantially the same size, the term ``area of the principal display
panel'' means the area of the side or surface that bears the principal
display panel, which area shall be:
(a) In the case of a rectangular package where one entire side
properly can be considered to be the principal display panel side, the
product of the height times the width of that side;
(b) In the case of a cylindrical or nearly cylindrical container, 40
percent of the product of the height of the container times the
circumference;
(c) In the case of any otherwise shaped container, 40 percent of the
total surface of the container: Provided, however, That where such
container presents an obvious ``principal display panel'' such as the
top of a triangular or circular package of cheese, the area shall
consist of the entire top surface. In determining the area of the
principal display panel, exclude tops, bottoms, flanges at tops and
bottoms of cans, and shoulders and necks of bottles or jars. In the case
of cylindrical or nearly cylindrical containers, information required by
this part to appear on the principal display panel shall appear within
that 40 percent of the circumference which is most likely to be
displayed, presented, shown, or examined under customary conditions of
display for retail sale.
Sec. 101.2 Information panel of package form food.
(a) The term ``information panel'' as it applies to packaged food
means that part of the label immediately contiguous and to the right of
the principal display panel as observed by an individual facing the
principal display panel with the following exceptions:
(1) If the part of the label immediately contiguous and to the right
of the principal display panel is too small
[[Page 15]]
to accommodate the necessary information or is otherwise unusable label
space, e.g., folded flaps or can ends, the panel immediately contiguous
and to the right of this part of the label may be used.
(2) If the package has one or more alternate principal display
panels, the information panel is immediately contiguous and to the right
of any principal display panel.
(3) If the top of the container is the principal display panel and
the package has no alternate principal display panel, the information
panel is any panel adjacent to the principal display panel.
(b) All information required to appear on the label of any package
of food pursuant to Secs. 101.4, 101.5, 101.8, 101.9, 101.13, 101.17,
subpart D of part 101, and part 105 of this chapter shall appear either
on the principal display panel or on the information panel, unless
otherwise specified by regulations in this chapter.
(c) All information appearing on the principal display panel or the
information panel pursuant to this section shall appear prominently and
conspicuously, but in no case may the letters and/or numbers be less
than one-sixteenth inch in height unless an exemption pursuant to
paragraph (f) of this section is established. The requirements for
conspicuousness and legibility shall include the specifications of
Secs. 101.105(h) (1) and (2) and 101.15.
(1) Packaged foods are exempt from the type size requirements of
this paragraph: Provided, That:
(i) The package is designed such that it has a surface area that can
bear an information panel and/or an alternate principal display panel.
(ii) The area of surface available for labeling on the principal
display panel of the package as this term is defined in Sec. 101.1 is
less than 10 square inches.
(iii) The label information includes:
(a) Nutrition labeling in accordance with Sec. 101.9.
(b) A full list of ingredients in accordance with regulations in
this part and the policy expressed in Sec. 101.6.
(iv) The information required by paragraph (b) of this section
appears on the principal display panel or information panel label in
accordance with the provisions of this paragraph (c) except that the
type size is not less than three sixty-fourths inch in height.
(2) Packaged foods are exempt from the type size requirements of
this paragraph: Provided, That:
(i) The package is designed such that it has a single ``obvious
principal display panel'' as this term is defined in Sec. 101.1 and has
no other available surface area for an information panel or alternate
principal display panel.
(ii) The area of surface available for labeling on the principal
display panel of the package as this term is defined in Sec. 101.1 is
less than 12 square inches and bears all labeling appearing on the
package.
(iii) The label information includes:
(a) Nutrition labeling in accordance with Sec. 101.9.
(b) A full list of ingredients in accordance with regulations in
this part and the policy expressed in Sec. 101.6.
(iv) The information required by paragraph (b) of this section
appears on the single, obvious principal display panel in accordance
with the provisions of this paragraph (c) except that the type size is
not less than one thirty-second inch in height.
(3) Packaged foods are exempt from the type size requirements of
this paragraph: Provided, That:
(i) The package is designed such that it has a total surface area
available to bear labeling of less than 12 square inches.
(ii) The label information includes:
(a) Nutrition labeling in accordance with Sec. 101.9.
(b) A full list of ingredients in accordance with regulations in
this part and the policy expressed in Sec. 101.6.
(iii) The information required by paragraph (b) of this section
appears on the principal display panel or information panel label in
accordance with the provisions of this paragraph (c) except that the
type size is not less than one thirty-second inch in height.
(4)(i) Soft drinks packaged in bottles manufactured before October
31, 1975 shall be exempt from the requirements prescribed by this
section to the extent that information which is blown, lithographed, or
formed onto the surface of the bottle is exempt from the
[[Page 16]]
size and placement requirements of this section.
(ii) Soft drinks packaged in bottles shall be exempt from the size
and placement requirements prescribed by this section if all of the
following conditions are met:
(a) If the soft drink is packaged in a bottle bearing a paper,
plastic foam jacket, or foil label, or is packaged in a nonreusable
bottle bearing a label lithographed onto the surface of the bottle or is
packaged in metal cans, the product shall not be exempt from any
requirement of this section other than the exemptions created by
Sec. 1.24(a)(5) (ii) and (v) of this chapter and the label shall bear
all required information in the specified minimum type size, except the
label will not be required to bear the information required by
Sec. 101.5 if this information appears on the bottle closure or on the
lid of the can in a type size not less than one-sixteenth inch in
height, or if embossed on the lid of the can in a type size not less
than one-eighth inch in height.
(b) If the soft drink is packaged in a bottle which does not bear a
paper, plastic foam jacket or foil label, or is packaged in a reusable
bottle bearing a label lithographed onto the surface of the bottle:
(1) Neither the bottle nor the closure is required to bear nutrition
labeling in compliance with Sec. 101.9, except that any multiunit retail
package in which it is contained shall bear nutrition labeling if
required by Sec. 101.9; and any vending machine in which it is contained
shall bear nutrition labeling if nutrition labeling is not present on
the bottle or closure, if required by Sec. 101.9.
(2) All other information pursuant to this section shall appear on
the top of the bottle closure prominently and conspicuously in letters
and/or numbers no less than one thirty-second inch in height, except
that if the information required by Sec. 101.5 is placed on the side of
the closure in accordance with Sec. 1.24(a)(5)(ii) of this chapter, such
information shall appear in letters and/or numbers no less than one-
sixteenth inch in height.
(3) Upon the petition of any interested person demonstrating that
the bottle closure is too small to accommodate this information, the
Commissioner may by regulation establish an alternative method of
disseminating such information. Information appearing on the closure
shall appear in the following priority:
(i) The warning required by Sec. 100.130 of this chapter.
(ii) The statement of ingredients.
(iii) The name and address of the manufacturer, packer, or
distributor.
(iv) The statement of identity.
(5) Individual serving-size packages of food served with meals in
restaurants, institutions, and on board passenger carriers, and not
intended for sale at retail, are exempt from type-size requirements of
this paragraph, provided:
(i) The package has a total area of 3 square inches or less
available to bear labeling;
(ii) There is insufficient area on the package available to print
all required information in a type size of \1/16\ inch in height;
(iii) The label information includes a full list of ingredients in
accordance with regulations in this part and the policy expressed in
Sec. 101.6 of this chapter; and
(iv) The information required by paragraph (b) of this section
appears on the label in accordance with the provisions of this
paragraph, except that the type size is not less than \1/32\ inch in
height.
(d)(1) Except as provided by Sec. 101.9(j)(13) and (j)(17), all
information required to appear on the principal display panel or on the
information panel pursuant to this section shall appear on the same
panel unless there is insufficient space. In determining the sufficiency
of the available space, except as provided by Sec. 101.9(j)(17), any
vignettes, designs, and other nonmandatory label information shall not
be considered. If there is insufficient space for all of this
information to appear on a single panel, it may be divided between these
two panels except that the information required pursuant to any given
section or part shall all appear on the same panel. A food whose label
is required to bear the ingredient statement on the principal display
panel may bear all other information specified in paragraph (b) of this
section on the information panel.
[[Page 17]]
(2) Any food, not otherwise exempted in this section, if packaged in
a container consisting of a separate lid and body, and bearing nutrition
labeling pursuant to Sec. 101.9, and if the lid qualifies for and is
designed to serve as a principal display panel, shall be exempt from the
placement requirements of this section in the following respects:
(i) The name and place of business information required by
Sec. 101.5 shall not be required on the body of the container if this
information appears on the lid in accordance with this section.
(ii) The nutrition information required by Sec. 101.9 shall not be
required on the lid if this information appears on the container body in
accordance with this section.
(iii) The statement of ingredients required by Sec. 101.4 shall not
be required on the lid if this information appears on the container body
in accordance with this section. Further, the statement of ingredients
is not required on the container body if this information appears on the
lid in accordance with this section.
(e) All information appearing on the information panel pursuant to
this section shall appear in one place without other intervening
material.
(f) If the label of any package of food is too small to accommodate
all of the information required by Secs. 101.4, 101.5, 101.8, 101.9,
101.13, 101.17, subpart D of part 101, and part 105 of this chapter, the
Commissioner may establish by regulation an acceptable alternative
method of disseminating such information to the public, e.g., a type
size smaller than one-sixteenth inch in height, or labeling attached to
or inserted in the package or available at the point of purchase. A
petition requesting such a regulation, as an amendment to this paragraph
shall be submitted pursuant to part 10 of this chapter.
[42 FR 14308, Mar. 15, 1977, as amended at 42 FR 15673, Mar. 22, 1977;
42 FR 45905, Sept. 13, 1977; 42 FR 47191, Sept. 20, 1977; 44 FR 16006,
Mar. 16, 1979; 49 FR 13339, Apr. 4, 1984; 53 FR 16068, May 5, 1988; 58
FR 44030, Aug. 18, 1993; 60 FR 17205, Apr. 5, 1995]
Sec. 101.3 Identity labeling of food in packaged form.
(a) The principal display panel of a food in package form shall bear
as one of its principal features a statement of the identity of the
commodity.
(b) Such statement of identity shall be in terms of:
(1) The name now or hereafter specified in or required by any
applicable Federal law or regulation; or, in the absence thereof,
(2) The common or usual name of the food; or, in the absence
thereof,
(3) An appropriately descriptive term, or when the nature of the
food is obvious, a fanciful name commonly used by the public for such
food.
(c) Where a food is marketed in various optional forms (whole,
slices, diced, etc.), the particular form shall be considered to be a
necessary part of the statement of identity and shall be declared in
letters of a type size bearing a reasonable relation to the size of the
letters forming the other components of the statement of identity;
except that if the optional form is visible through the container or is
depicted by an appropriate vignette, the particular form need not be
included in the statement. This specification does not affect the
required declarations of identity under definitions and standards for
foods promulgated pursuant to section 401 of the act.
(d) This statement of identity shall be presented in bold type on
the principal display panel, shall be in a size reasonably related to
the most prominent printed matter on such panel, and shall be in lines
generally parallel to the base on which the package rests as it is
designed to be displayed.
(e) Under the provisions of section 403(c) of the Federal Food,
Drug, and Cosmetic Act, a food shall be deemed to be misbranded if it is
an imitation of another food unless its label bears, in type of uniform
size and prominence, the word ``imitation'' and, immediately thereafter,
the name of the food imitated.
(1) A food shall be deemed to be an imitation and thus subject to
the requirements of section 403(c) of the act if it is a substitute for
and resembles another food but is nutritionally inferior to that food.
[[Page 18]]
(2) A food that is a substitute for and resembles another food shall
not be deemed to be an imitation provided it meets each of the following
requirements:
(i) It is not nutritionally inferior to the food for which it
substitutes and which it resembles.
(ii) Its label bears a common or usual name that complies with the
provisions of Sec. 102.5 of this chapter and that is not false or
misleading, or in the absence of an existing common or usual name, an
appropriately descriptive term that is not false or misleading. The
label may, in addition, bear a fanciful name which is not false or
misleading.
(3) A food for which a common or usual name is established by
regulation (e.g., in a standard of identity pursuant to section 401 of
the act, in a common or usual name regulation pursuant to part 102 of
this chapter, or in a regulation establishing a nutritional quality
guideline pursuant to part 104 of this chapter), and which complies with
all of the applicable requirements of such regulation(s), shall not be
deemed to be an imitation.
(4) Nutritional inferiority includes: (i) Any reduction in the
content of an essential nutrient that is present in a measurable amount,
but does not include a reduction in the caloric or fat content provided
the food is labeled pursuant to the provisions of Sec. 101.9, and
provided the labeling with respect to any reduction in caloric content
complies with the provisions applicable to caloric content in part 105
of this chapter.
(ii) For the purpose of this section, a measurable amount of an
essential nutrient in a food shall be considered to be 2 percent or more
of the Daily Reference Value (DRV) of protein listed under
Sec. 101.9(c)(7)(iii) and of potassium listed under Sec. 101.9(c)(9) per
reference amount customarily consumed and 2 percent or more of the
Reference Daily Intake (RDI) of any vitamin or mineral listed under
Sec. 101.9(c)(8)(iv) per reference amount customarily consumed, except
that selenium, molybdenum, chromium, and chloride need not be
considered.
(iii) If the Commissioner concludes that a food is a substitute for
and resembles another food but is inferior to the food imitated for
reasons other than those set forth in this paragraph, he may propose
appropriate revisions to this regulation or he may propose a separate
regulation governing the particular food.
(f) A label may be required to bear the percentage(s) of a
characterizing ingredient(s) or information concerning the presence or
absence of an ingredient(s) or the need to add an ingredient(s) as part
of the common or usual name of the food pursuant to subpart B of part
102 of this chapter.
[42 FR 14308, Mar. 15, 1977, as amended at 48 FR 10811, Mar. 15, 1983;
58 FR 2227, Jan. 6, 1993; 60 FR 67174, Dec. 28, 1995]
Effective Date Note: At 60 FR 67174, Dec. 28, 1995, in Sec. 101.3,
paragraph (e)(4)(ii) was revised, effective January 1, 1997. For the
convenience of the reader, the superseded text is set forth below.
Sec. 101.3 Identity labeling of food in packaged form.
* * * * *
(e) * * *
(4) * * *
(ii) For the purpose of this section, a measurable amount of an
essential nutrient in a food shall be considered to be 2 percent or more
of the Daily Reference Value (DRV) of protein listed under
Sec. 101.9(c)(7)(iii) and of potassium listed under Sec. 101.9(c)(9) and
the Reference Daily Intake (RDI) of any vitamin or mineral listed under
Sec. 101.9(c)(8)(iv).
* * * * *
Sec. 101.4 Food; designation of ingredients.
(a)(1) Ingredients required to be declared on the label or labeling
of a food, including foods that comply with standards of identity,
except those ingredients exempted by Sec. 101.100, shall be listed by
common or usual name in descending order of predominance by weight on
either the principal display panel or the information panel in
accordance with the provisions of Sec. 101.2.
(2) The descending order of predominance requirements of paragraph
(a)(1) of this section do not apply to ingredients present in amounts of
2 percent or less by weight when a listing of these ingredients is
placed at the end of the ingredient statement following an appropriate
quantifying statement, e.g.,
[[Page 19]]
``Contains ______ percent or less of ______,'' or ``Less than ______
percent of ______.'' The blank percentage within the quantifying
statement shall be filled in with a threshold level of 2 percent, or, if
desired, 1.5 percent, 1.0 percent, or 0.5 percent, as appropriate. No
ingredient to which the quantifying phrase applies may be present in an
amount greater than the stated threshold.
(b) The name of an ingredient shall be a specific name and not a
collective (generic) name, except that:
(1) Spices, flavorings, colorings and chemical preservatives shall
be declared according to the provisions of Sec. 101.22.
(2) An ingredient which itself contains two or more ingredients and
which has an established common or usual name, conforms to a standard
established pursuant to the Meat Inspection or Poultry Products
Inspection Acts by the U.S. Department of Agriculture, or conforms to a
definition and standard of identity established pursuant to section 401
of the Federal Food, Drug, and Cosmetic Act, shall be designated in the
statement of ingredients on the label of such food by either of the
following alternatives:
(i) By declaring the established common or usual name of the
ingredient followed by a parenthetical listing of all ingredients
contained therein in descending order of predominance except that, if
the ingredient is a food subject to a definition and standard of
identity established in subchapter B of this chapter that has specific
labeling provisions for optional ingredients, optional ingredients may
be declared within the parenthetical listing in accordance with those
provisions.
(ii) By incorporating into the statement of ingredients in
descending order of predominance in the finished food, the common or
usual name of every component of the ingredient without listing the
ingredient itself.
(3) Skim milk, concentrated skim milk, reconstituted skim milk, and
nonfat dry milk may be declared as ``skim milk'' or ``nonfat milk''.
(4) Milk, concentrated milk, reconstituted milk, and dry whole milk
may be declared as ``milk''.
(5) Bacterial cultures may be declared by the word ``cultured''
followed by the name of the substrate, e.g., ``made from cultured skim
milk or cultured buttermilk''.
(6) Sweetcream buttermilk, concentrated sweetcream buttermilk,
reconstituted sweetcream buttermilk, and dried sweetcream buttermilk may
be declared as ``buttermilk''.
(7) Whey, concentrated whey, reconstituted whey, and dried whey may
be declared as ``whey''.
(8) Cream, reconstituted cream, dried cream, and plastic cream
(sometimes known as concentrated milk fat) may be declared as ``cream''.
(9) Butteroil and anhydrous butterfat may be declared as
``butterfat''.
(10) Dried whole eggs, frozen whole eggs, and liquid whole eggs may
be declared as ``eggs''.
(11) Dried egg whites, frozen egg whites, and liquid egg whites may
be declared as ``egg whites''.
(12) Dried egg yolks, frozen egg yolks, and liquid egg yolks may be
declared as ``egg yolks''.
(13) [Reserved]
(14) Each individual fat and/or oil ingredient of a food intended
for human consumption shall be declared by its specific common or usual
name (e.g., ``beef fat'', ``cottonseed oil'') in its order of
predominance in the food except that blends of fats and/or oils may be
designated in their order of predominance in the foods as ``----
shortening'' or ``blend of ---- oils'', the blank to be filled in with
the word ``vegetable'', ``animal'', ``marine'', with or without the
terms ``fat'' or ``oils'', or combination of these, whichever is
applicable if, immediately following the term, the common or usual name
of each individual vegetable, animal, or marine fat or oil is given in
parentheses, e.g., ``vegetable oil shortening (soybean and cottonseed
oil)''. For products that are blends of fats and/or oils and for foods
in which fats and/or oils constitute the predominant ingredient, i.e.,
in which the combined weight of all fat and/or oil ingredients equals or
exceeds the weight of the most predominant ingredient that is not a fat
or oil, the listing of the common or usual names of such fats and/or
oils in parentheses shall be in
[[Page 20]]
descending order of predominance. In all other foods in which a blend of
fats and/or oils is used as an ingredient, the listing of the common or
usual names in parentheses need not be in descending order of
predominance if the manufacturer, because of the use of varying
mixtures, is unable to adhere to a constant pattern of fats and/or oils
in the product. If the fat or oil is completely hydrogenated, the name
shall include the term ``hydrogenated'', or if partially hydrogenated,
the name shall include the term ``partially hydrogenated''. If each fat
and/or oil in a blend or the blend is completely hydrogenated, the term
``hydrogenated'' may precede the term(s) describing the blend, e.g.,
``hydrogenated vegetable oil (soybean, cottonseed, and palm oils)'',
rather than preceding the name of each individual fat and/or oil; if the
blend of fats and/or oils is partially hydrogenated, the term
``partially hydrogenated'' may be used in the same manner. Fat and/or
oil ingredients not present in the product may be listed if they may
sometimes be used in the product. Such ingredients shall be identified
by words indicating that they may not be present, such as ``or'', ``and/
or'', ``contains one or more of the following:'', e.g., ``vegetable oil
shortening (contains one or more of the following: cottonseed oil, palm
oil, soybean oil)''. No fat or oil ingredient shall be listed unless
actually present if the fats and/or oils constitute the predominant
ingredient of the product, as defined in this paragraph (b)(14).
(15) When all the ingredients of a wheat flour are declared in an
ingredient statement, the principal ingredient of the flour shall be
declared by the name(s) specified in Secs. 137.105, 137.200, 137.220 and
137.225 of this chapter, i.e., the first ingredient designated in the
ingredient list of flour, or bromated flour, or enriched flour, or self-
rising flour is ``flour'', ``white flour'', ``wheat flour'', or ``plain
flour''; the first ingredient designated in the ingredient list of durum
flour is ``durum flour''; the first ingredient designated in the
ingredient list of whole wheat flour, or bromated whole wheat flour is
``whole wheat flour'', ``graham flour'', or ``entire wheat flour''; and
the first ingredient designated in the ingredient list of whole durum
wheat flour is ``whole durum wheat flour''.
(16) Ingredients that act as leavening agents in food may be
declared in the ingredient statement by stating the specific common or
usual name of each individual leavening agent in parentheses following
the collective name ``leavening'', e.g., ``leavening (baking soda,
monocalcium phosphate, and calcium carbonate)''. The listing of the
common or usual name of each individual leavening agent in parentheses
shall be in descending order of predominance: Except, That if the
manufacturer is unable to adhere to a constant pattern of leavening
agents in the product, the listing of individual leavening agents need
not be in descending order of predominance. Leavening agents not present
in the product may be listed if they are sometimes used in the product.
Such ingredients shall be identified by words indicating that they may
not be present, such as ``or'', ``and/or'', ``contains one or more of
the following:''.
(17) Ingredients that act as yeast nutrients in foods may be
declared in the ingredient statement by stating the specific common or
usual name of each individual yeast nutrient in parentheses following
the collective name ``yeast nutrients'', e.g., ``yeast nutrients
(calcium sulfate and ammonium phosphate)''. The listing of the common or
usual name of each individual yeast nutrient in parentheses shall be in
descending order of predominance: Except, That if the manufacturer is
unable to adhere to a constant pattern of yeast nutrients in the
product, the listing of the common or usual names of individual yeast
nutrients need not be in descending order of predominance. Yeast
nutrients not present in the product may be listed if they are sometimes
used in the product. Such ingredients shall be identified by words
indicating that they may not be present, such as ``or'', ``and/or'', or
``contains one or more of the following:''.
(18) Ingredients that act as dough conditioners may be declared in
the ingredient statement by stating the specific common or usual name of
each individual dough conditioner in parentheses following the
collective name ``dough conditioner'', e.g., ``dough
[[Page 21]]
conditioners (L-cysteine, ammonium sulfate)''. The listing of the common
or usual name of each dough conditioner in parentheses shall be in
descending order of predominance: Except, That if the manufacturer is
unable to adhere to a constant pattern of dough conditioners in the
product, the listing of the common or usual names of individual dough
conditioners need not be in descending order of predominance. Dough
conditioners not present in the product may be listed if they are
sometimes used in the product. Such ingredients shall be identified by
words indicating that they may not be present, such as ``or'', ``and/
or'', or ``contains one or more of the following:''.
(19) Ingredients that act as firming agents in food (e.g., salts of
calcium and other safe and suitable salts in canned vegetables) may be
declared in the ingredient statement, in order of predominance
appropriate for the total of all firming agents in the food, by stating
the specific common or usual name of each individual firming agent in
descending order of predominance in parentheses following the collective
name ``firming agents''. If the manufacturer is unable to adhere to a
constant pattern of firming agents in the food, the listing of the
individual firming agents need not be in descending order of
predominance. Firming agents not present in the product may be listed if
they are sometimes used in the product. Such ingredients shall be
identified by words indicating that they may not be present, such as
``or'', ``and/or'', ``contains one or more of the following:''.
(20) For purposes of ingredient labeling, the term ``sugar'' shall
refer to sucrose, which is obtained from sugar cane or sugar beets in
accordance with the provisions of Sec. 184.1854 of this chapter.
(21) [Reserved]
(22) Wax and resin ingredients on fresh produce when such produce is
held for retail sale, or when held for other than retail sale by packers
or repackers shall be declared collectively by the phrase ``coated with
food-grade animal-based wax, to maintain freshness'' or the phrase
``coated with food-grade vegetable-, petroleum-, beeswax-, and/or
shellac-based wax or resin, to maintain freshness'' as appropriate. The
terms ``food-grade'' and ``to maintain freshness'' are optional. The
term ``lac-resin'' may be substituted for the term ``shellac.''
(c) When water is added to reconstitute, completely or partially, an
ingredient permitted by paragraph (b) of this section to be declared by
a class name, the position of the ingredient class name in the
ingredient statement shall be determined by the weight of the
unreconstituted ingredient plus the weight of the quantity of water
added to reconstitute that ingredient, up to the amount of water needed
to reconstitute the ingredient to single strength. Any water added in
excess of the amount of water needed to reconstitute the ingredient to
single strength shall be declared as ``water'' in the ingredient
statement.
(d) When foods characterized on the label as ``nondairy'' contain a
caseinate ingredient, the caseinate ingredient shall be followed by a
parenthetical statement identifying its source. For example, if the
manufacturer uses the term ``nondairy'' on a creamer that contains
sodium caseinate, it shall include a parenthetical term such as ``a milk
derivative'' after the listing of sodium caseinate in the ingredient
list.
(e) If the percentage of an ingredient is included in the statement
of ingredients, it shall be shown in parentheses following the name of
the ingredient and expressed in terms of percent by weight. Percentage
declarations shall be expressed to the nearest 1 percent, except that
where ingredients are present at levels of 2 percent or less, they may
be grouped together and expressed in accordance with the quantifying
guidance set forth in paragraph (a)(2) of this section.
(f) Except as provided in Sec. 101.100, ingredients that must be
declared on labeling because there is no label for the food, including
foods that comply with standards of identity, shall be listed
prominently and conspicuously by common or usual name in the manner
prescribed by paragraph (b) of this section.
[42 FR 14308, Mar. 15, 1977, as amended at 43 FR 12858, Mar. 28, 1978;
43 FR 24519, June 6, 1978; 48 FR 8054, Feb. 25, 1983; 55 FR 17433, Apr.
25, 1990; 58 FR 2875, Jan. 6, 1993]
[[Page 22]]
Sec. 101.5 Food; name and place of business of manufacturer, packer, or distributor.
(a) The label of a food in packaged form shall specify conspicuously
the name and place of business of the manufacturer, packer, or
distributor.
(b) The requirement for declaration of the name of the manufacturer,
packer, or distributor shall be deemed to be satisfied, in the case of a
corporation, only by the actual corporate name, which may be preceded or
followed by the name of the particular division of the corporation. In
the case of an individual, partnership, or association, the name under
which the business is conducted shall be used.
(c) Where the food is not manufactured by the person whose name
appears on the label, the name shall be qualified by a phrase that
reveals the connection such person has with such food; such as
``Manufactured for --------------'', ``Distributed by --------------'',
or any other wording that expresses the facts.
(d) The statement of the place of business shall include the street
address, city, State, and ZIP code; however, the street address may be
omitted if it is shown in a current city directory or telephone
directory. The requirement for inclusion of the ZIP code shall apply
only to consumer commodity labels developed or revised after the
effective date of this section. In the case of nonconsumer packages, the
ZIP code shall appear either on the label or the labeling (including
invoice).
(e) If a person manufactures, packs, or distributes a food at a
place other than his principal place of business, the label may state
the principal place of business in lieu of the actual place where such
food was manufactured or packed or is to be distributed, unless such
statement would be misleading.
Sec. 101.8 Labeling of food with number of servings.
(a) The label of any package of a food that bears a representation
as to the number of servings contained in such package shall bear in
immediate conjunction with such statement, and in the same size type as
is used for such statement, a statement of the net quantity (in terms of
weight, measure, or numerical count) of each such serving; however, such
statement may be expressed in terms that differ from the terms used in
the required statement of net quantity of contents (for example cups,
tablespoons) when such differing term is common to cookery and describes
a constant quantity. Such statement shall not be misleading in any
particular. Where nutrition labeling information is required in
accordance with the provisions of Sec. 101.9, however, the statement of
the net quantity of each serving shall be consistent with the
requirements for serving size expression set forth in that section
(e.g., 10 1-cup (240 milliliters) servings). A statement of the number
of units in a package is not in itself a statement of the number of
servings.
(b) If there exists a voluntary product standard promulgated
pursuant to the procedures found in 15 CFR part 10 by the Department of
Commerce, quantitatively defining the meaning of the term ``serving''
with respect to a particular food, then any label representation as to
the number of servings in such packaged food shall correspond with such
quantitative definition. (Copies of published standards are available
upon request from the National Bureau of Standards, Department of
Commerce, Washington, DC 20234.)
[42 FR 14308, Mar. 15, 1977, as amended at 58 FR 2291, Jan. 6, 1993]
Sec. 101.9 Nutrition labeling of food.
(a) Nutrition information relating to food shall be provided for all
products intended for human consumption and offered for sale unless an
exemption is provided for the product in paragraph (j) of this section.
(1) When food is in package form, the required nutrition labeling
information shall appear on the label in the format specified in this
section.
(2) When food is not in package form, the required nutrition
labeling information shall be displayed clearly at the point of purchase
(e.g., on a counter card, sign, tag affixed to the product, or some
other appropriate device). Alternatively, the required information may
be placed in a booklet, looseleaf binder, or other appropriate
[[Page 23]]
format that is available at the point of purchase.
(3) Solicitation of requests for nutrition information by a
statement ``For nutrition information write to ________________'' on the
label or in the labeling or advertising for a food, or providing such
information in a direct written reply to a solicited or unsolicited
request, does not subject the label or the labeling of a food exempted
under paragraph (j) of this section to the requirements of this section
if the reply to the request conforms to the requirements of this
section.
(4) If any vitamin or mineral is added to a food so that a single
serving provides 50 percent or more of the Reference Daily Intake (RDI)
for the age group for which the product is intended, as specified in
paragraph (c)(8)(iv) of this section, of any one of the added vitamins
or minerals, unless such addition is permitted or required in other
regulations, e.g., a standard of identity or nutritional quality
guideline, or is otherwise exempted by the Commissioner, the food shall
be considered a food for special dietary use within the meaning of
Sec. 105.3(a)(1)(iii) of this chapter.
(b) Except as provided in Sec. 101.9(h)(3), all nutrient and food
component quantities shall be declared in relation to a serving as
defined in this section.
(1) The term ``serving'' or ``serving size'' means an amount of food
customarily consumed per eating occasion by persons 4 years of age or
older which is expressed in a common household measure that is
appropriate to the food. When the food is specially formulated or
processed for use by infants or by toddlers, a serving or serving size
means an amount of food customarily consumed per eating occasion by
infants up to 12 months of age or by children 1 through 3 years of age,
respectively.
(2) Except as provided in paragraphs (b)(3), (b)(4), and (b)(6) of
this section and for products that are intended for weight control and
are available only through a weight-control or weight-maintenance
program, serving size declared on a product label shall be determined
from the ``Reference Amounts Customarily Consumed Per Eating Occasion *
* *'' (reference amounts) that appear in Sec. 101.12(b) using the
procedures described below. For products that are both intended for
weight control and available only through a weight-control program, a
manufacturer may determine the serving size that is consistent with the
meal plan of the program. Such products must bear a statement, ``for
sale only through the -------- program'' (fill in the blank with the
name of the appropriate weight-control program, e.g., Smith's Weight
Control), on the principal display panel. However, the reference amounts
in Sec. 101.12(b) shall be used for purposes of evaluating whether
weight-control products that are available only through a weight-control
program qualify for nutrient content claims or health claims.
(i) For products in discrete units (e.g., muffins, sliced products,
such as sliced bread, or individually packaged products within a
multiserving package) and for products which consist of two or more
foods packaged and presented to be consumed together where the
ingredient represented as the main ingredient is in discrete units
(e.g., pancakes and syrup), the serving size shall be declared as
follows:
(A) If a unit weighs 50 percent or less of the reference amount, the
serving size shall be the number of whole units that most closely
approximates the reference amount for the product category;
(B) If a unit weighs more than 50 percent, but less than 67 percent
of the reference amount, the manufacturer may declare one unit or two
units as the serving size;
(C) If a unit weighs 67 percent or more, but less than 200 percent
of the reference amount, the serving size shall be one unit;
(D) If a unit weighs 200 percent or more of the reference amount,
the manufacturer may declare one unit as the serving size if the whole
unit can reasonably be consumed at a single-eating occasion.
(E) For products that have reference amounts of 100 grams (g) (or
milliliter (mL)) or larger and are individual units within a
multiserving package, if a unit contains more than 150 percent but less
than 200 percent of the reference amount, the manufacturer may
[[Page 24]]
decide whether to declare the individual unit as 1 or 2 servings.
(F) The serving size for maraschino cherries shall be expressed as 1
cherry with the parenthetical metric measure equal to the average weight
of a medium size cherry.
(G) The serving size for products that naturally vary in size (e.g.,
pickles, shellfish, whole fish, and fillet of fish) may be the amount in
ounces that most closely approximates the reference amount for the
product category. Manufacturers shall adhere to the requirements in
paragraph (b)(5)(vi) of this section for expressing the serving size in
ounces.
(H) For products which consist of two or more foods packaged and
presented to be consumed together where the ingredient represented as
the main ingredient is in discrete units (e.g., pancakes and syrup), the
serving size may be the number of discrete units represented as the main
ingredient plus proportioned minor ingredients used to make the
reference amount for the combined product determined in Sec. 101.12(f).
(I) For packages containing several individual single-serving
containers, each of which is labeled with all required information
including nutrition labeling as specified in Sec. 101.9 (that is, are
labeled appropriately for individual sale as single-serving containers),
the serving size shall be 1 unit.
(ii) For products in large discrete units that are usually divided
for consumption (e.g., cake, pie, pizza, melon, cabbage), for unprepared
products where the entire contents of the package is used to prepare
large discrete units that are usually divided for consumption (e.g.,
cake mix, pizza kit), and for products which consist of two or more
foods packaged and presented to be consumed together where the
ingredient represented as the main ingredient is a large discrete unit
usually divided for consumption (e.g., prepared cake packaged with a can
of frosting), the serving size shall be the fractional slice of the
ready-to-eat product (e.g., 1/12 cake, 1/8 pie, 1/4 pizza, 1/4 melon, 1/
6 cabbage) that most closely approximates the reference amount for the
product category, and may be the fraction of the package used to make
the reference amount for the unprepared product determined in
Sec. 101.12(c) or the fraction of the large discrete unit represented as
the main ingredient plus proportioned minor ingredients used to make the
reference amount for the combined product determined in Sec. 101.12(f).
In expressing the fractional slice, manufacturers shall use 1/2, 1/3, 1/
4, 1/5, 1/6, or smaller fractions that can be generated by further
division by 2 or 3.
(iii) For nondiscrete bulk products (e.g., breakfast cereal, flour,
sugar, dry mixes, concentrates, pancake mixes, macaroni and cheese
kits), and for products which consist of two or more foods packaged and
presented to be consumed together where the ingredient represented as
the main ingredient is a bulk product (e.g., peanut butter and jelly),
the serving size shall be the amount in household measure that most
closely approximates the reference amount for the product category and
may be the amount of the bulk product represented as the main ingredient
plus proportioned minor ingredients used to make the reference amount
for the combined product determined in Sec. 101.12(f).
(3) The serving size for meal products and main dish products as
defined in Sec. 101.13(l) and (m) that comes in single-serving
containers as defined in paragraph (b)(6) of this section shall be the
entire content (edible portion only) of the package. Serving size for
meal products and main dish products in multiserving containers shall be
based on the reference amount applicable to the product in
Sec. 101.12(b) if the product is listed in Sec. 101.12(b). Serving size
for meal products and main dish products in multiserving containers that
are not listed in Sec. 101.12(b) shall be based on the reference amount
according to Sec. 101.12(f).
(4) A variety pack, such as a package containing several varieties
of single-serving units as defined in paragraph (b)(2)(i) of this
section, and a product having two or more compartments with each
compartment containing a different food, shall provide nutrition
information for each variety or food per serving size that is derived
from the reference amount in Sec. 101.12(b) applicable for each variety
or food and
[[Page 25]]
the procedures to convert the reference amount to serving size in
paragraph (b)(2) of this section.
(5) For labeling purposes, the term ``common household measure'' or
``common household unit'' means cup, tablespoon, teaspoon, piece, slice,
fraction (e.g., 1/4 pizza), ounce (oz), fluid ounce (fl oz), or other
common household equipment used to package food products (e.g., jar,
tray). In expressing serving size in household measures, except as
specified in paragraphs (b)(5)(iv), (b)(5)(v), (b)(5)(vi), and
(b)(5)(vii) of this section, the following rules shall be used:
(i) Cups, tablespoons, or teaspoons shall be used wherever possible
and appropriate except for beverages. For beverages, a manufacturer may
use fluid ounces. Cups shall be expressed in 1/4-or 1/3-cup increments,
tablespoons in whole number of tablespoons for quantities less than 1/4
cup but greater than or equal to 2 tablespoons (tbsp), 1, 1 1/3, 1 1/2,
or 1 2/3 tbsp for quantities less than 2 tbsp but greater than or equal
to 1 tbsp, and teaspoons in whole number of teaspoons for quantities
less than 1 tbsp but greater than or equal to 1 teaspoon (tsp), and in
1/4-tsp increments for quantities less than 1 tsp.
(ii) If cups, tablespoons or teaspoons are not applicable, units
such as piece, slice, tray, jar, and fraction shall be used.
(iii) If paragraphs (b)(5)(i) and (b)(5)(ii) of this section are not
applicable, ounces may be used with an appropriate visual unit of
measure such as a dimension of a piece, e.g., 1 oz (28 g/about 1/2
pickle). Ounce measurements shall be expressed in 0.5 oz increments most
closely approximating the reference amount.
(iv) A description of the individual container or package shall be
used for single serving containers and for individually packaged
products within multiserving containers (e.g., can, box, package). A
description of the individual unit shall be used for other products in
discrete units (e.g., piece, slice, cracker, bar).
(v) For unprepared products where the entire contents of the package
is used to prepare large discrete units that are usually divided for
consumption (e.g., cake mix, pizza kit), the fraction or portion of the
package may be used.
(vi) Ounces with an appropriate visual unit of measure, as described
in paragraph (b)(5)(iii) of this section, may be used for products that
naturally vary in size as provided for in paragraph (b)(2)(i)(G) of this
section.
(vii) As provided for in Sec. 101.9(h)(1), for products that consist
of two or more distinct ingredients or components packaged and presented
to be consumed together (e.g. dry macaroni and cheese mix, cake and
muffin mixes with separate ingredient packages, pancakes and syrup),
nutrition information may be declared for each component or as a
composite. The serving size may be provided in accordance with the
provisions of paragraphs (b)(2)(i), (b)(2)(ii), and (b)(2)(iii) of this
section, or alternatively in ounces with an appropriate visual unit of
measure, as described in paragraph (b)(5)(iii) of this section (e.g.,
declared as separate components: ``3 oz dry macaroni (84 g/about 2/3
cup)'' and ``1 oz dry cheese mix (28 g/about 2 tbsp);'' declared as a
composite value: ``4 oz (112 g/about 2/3 cup macaroni and 2 tbsp dry
cheese mix)'').
(viii) For nutrition labeling purposes, a teaspoon means 5
milliliters (mL), a tablespoon means 15 mL, a cup means 240 mL, 1 fl oz
means 30 mL, and 1 oz in weight means 28 g.
(ix) When a serving size, determined from the reference amount in
Sec. 101.12(b) and the procedures described in this section, falls
exactly half way between two serving sizes, e.g., 2.5 tbsp,
manufacturers shall round the serving size up to the next incremental
size.
(6) A product that is packaged and sold individually and that
contains less than 200 percent of the applicable reference amount shall
be considered to be a single-serving container, and the entire content
of the product shall be labeled as one serving except for products that
have reference amounts of 100 g (or mL) or larger, manufacturers may
decide whether a package that contains more than 150 percent but less
than 200 percent of the reference amount is 1 or 2 servings. Packages
sold individually that contain 200 percent or more of the applicable
reference amount may be labeled as a single-serving if the entire
[[Page 26]]
content of the package can reasonably be consumed at a single-eating
occasion.
(7) A label statement regarding a serving shall be the serving size
expressed in common household measures as set forth in paragraphs (b)(2)
through (b)(6) of this section and shall be followed by the equivalent
metric quantity in parenthesis (fluids in milliliters and all other
foods in grams) except for single-serving containers.
(i) For a single-serving container, the parenthetical metric
quantity, which will be presented as part of the net weight statement on
the principal display panel, is not required except where nutrition
information is required on a drained weight basis according to
Sec. 101.9(b)(9). However, if a manufacturer voluntarily provides the
metric quantity on products that can be sold as single servings, then
the numerical value provided as part of the serving size declaration
must be identical to the metric quantity declaration provided as part of
the net quantity of contents statement.
(ii) The gram or milliliter quantity equivalent to the household
measure should be rounded to the nearest whole number except for
quantities that are less than 5 g (mL). The gram (mL) quantity between 2
and 5 g (mL) should be rounded to the nearest 0.5 g (mL) and the g (mL)
quantity less than 2 g (mL) should be expressed in 0.1-g (mL)
increments.
(iii) In addition, serving size may be declared in ounce and fluid
ounce, in parenthesis, following the metric measure separated by a slash
where other common household measures are used as the primary unit for
serving size, e.g., 1 slice (28 g/1 oz) for sliced bread. The ounce
quantity equivalent to the metric quantity should be expressed in 0.1 oz
increments.
(iv) If a manufacturer elects to use abbreviations for units, the
following abbreviations shall be used: tbsp for tablespoon, tsp for
teaspoon, g for gram, mL for milliliter, oz for ounce, and fl oz for
fluid ounce.
(v) For products that only require the addition of water or another
ingredient that contains insignificant amounts of nutrients in the
amount added and that are prepared in such a way that there are no
significant changes to the nutrient profile, the amount of the finished
product may be declared in parentheses at the end of the serving size
declaration (e.g., 1/2 cup (120 mL) concentrated soup (makes 1 cup
prepared)).
(vi) To promote uniformity in label serving sizes in household
measures declared by different manufacturers, FDA has provided a
guideline entitled, ``Guidelines for Determining the Gram Weight of the
Household Measure.'' The guideline can be obtained from the Office of
Food Labeling (HFS-150), Center for Food Safety and Applied Nutrition,
Food and Drug Administration, 200 C St. SW., Washington, DC 20204.
(8) Determination of the number of servings per container shall be
based on the serving size of the product determined by following the
procedures described in this section.
(i) The number of servings shall be rounded to the nearest whole
number except for the number of servings between 2 and 5 servings and
random weight products. The number of servings between 2 and 5 servings
shall be rounded to the nearest 0.5 serving. Rounding should be
indicated by the use of the term ``about'' (e.g., about 2 servings,
about 3.5 servings).
(ii) When the serving size is required to be expressed on a drained
solids basis and the number of servings varies because of a natural
variation in unit size (e.g., maraschino cherries, pickles), the
manufacturer may state the typical number of servings per container
(e.g., usually 5 servings).
(iii) For random weight products, a manufacturer may declare
``varied'' for the number of servings per container provided the
nutrition information is based on the reference amount expressed in
ounces. The manufacturer may provide the typical number of servings in
parenthesis following the ``varied'' statement.
(iv) For packages containing several individual single-serving
containers, each of which is labeled with all required information
including nutrition labeling as specified in Sec. 101.9 (that is, are
labeled appropriately for individual sale as single-serving containers),
the number of servings shall be the number
[[Page 27]]
of individual packages within the total package.
(v) For packages containing several individually packaged
multiserving units, the number of servings shall be determined by
multiplying the number of individual multiserving units in the total
package by the number of servings in each individual unit.
(9) The declaration of nutrient and food component content shall be
on the basis of food as packaged or purchased with the exception of raw
fish covered under Sec. 101.42 (see 101.44), packaged single-ingredient
products that consist of fish or game meat as provided for in paragraph
(j)(11) of this section, and of foods that are packed or canned in
water, brine, or oil but whose liquid packing medium is not customarily
consumed (e.g., canned fish, maraschino cherries, pickled fruits, and
pickled vegetables). Declaration of nutrient and food component content
of raw fish shall follow the provisions in Sec. 101.45. Declaration of
the nutrient and food component content of foods that are packed in
liquid which is not customarily consumed shall be based on the drained
solids.
(10) Another column of figures may be used to declare the nutrient
and food component information:
(i) Per 100 g or 100 mL, or per 1 oz or 1 fl oz of the food as
packaged or purchased;
(ii) Per one unit if the serving size of a product in discrete units
in a multiserving container is more than 1 unit;
(iii) Per cup popped for popcorn in a multiserving container.
(11) If a product is promoted on the label, labeling, or advertising
for a use that differs in quantity by twofold or greater from the use
upon which the reference amount in Sec. 101.12(b) was based (e.g.,
liquid cream substitutes promoted for use with breakfast cereals), the
manufacturer shall provide a second column of nutrition information
based on the amount customarily consumed in the promoted use, in
addition to the nutrition information per serving derived from the
reference amount in Sec. 101.12(b), except that nondiscrete bulk
products that are used primarily as ingredients (e.g., flour,
sweeteners, shortenings, oils), or traditionally used for multipurposes
(e.g., eggs, butter, margarine), and multipurpose baking mixes are
exempt from this requirement.
(c) The declaration of nutrition information on the label and in
labeling of a food shall contain information about the level of the
following nutrients, except for those nutrients whose inclusion, and the
declaration of amounts, is voluntary as set forth in this paragraph. No
nutrients or food components other than those listed in this paragraph
as either mandatory or voluntary may be included within the nutrition
label. Except as provided for in paragraphs (f) or (j) of this section,
nutrient information shall be presented using the nutrient names
specified and in the following order in the formats specified in
paragraphs (d) or (e) of this section.
(1) ``Calories, total,'' ``Total calories,'' or ``Calories'': A
statement of the caloric content per serving, expressed to the nearest
5-calorie increment up to and including 50 calories, and 10-calorie
increment above 50 calories, except that amounts less than 5 calories
may be expressed as zero. Energy content per serving may also be
expressed in kilojoule units, added in parentheses immediately following
the statement of the caloric content.
(i) Caloric content may be calculated by the following methods.
Where either specific or general food factors are used, the factors
shall be applied to the actual amount (i.e., before rounding) of food
components (e.g., fat, carbohydrate, protein, or ingredients with
specific food factors) present per serving.
(A) Using specific Atwater factors (i. e., the Atwater method) given
in Table 13, ``Energy Value of Foods--Basis and Derivation,'' by A. L.
Merrill and B. K. Watt, United States Department of Agriculture (USDA)
Handbook No. 74 (slightly revised, 1973), which is incorporated by
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 and is
available from the Office of Food Labeling (HFS-150), Center for Food
Safety and Applied Nutrition, Food and Drug Administration, 200 C St.
SW., Washington, DC 20204, or may be inspected at the Office of the
Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC.;
[[Page 28]]
(B) Using the general factors of 4, 4, and 9 calories per gram for
protein, total carbohydrate, and total fat, respectively, as described
in USDA Handbook No. 74 (slightly revised 1973) pp. 9-11, which is
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51 (the availability of this incorporation by reference is given in
paragraph (c)(1)(i)(A) of this section);
(C) Using the general factors of 4, 4, and 9 calories per gram for
protein, total carbohydrate less the amount of insoluble dietary fiber,
and total fat, respectively, as described in USDA Handbook No. 74
(slightly revised 1973) pp. 9-11, which is incorporated by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51 (the availability of
this incorporation by reference is given in paragraph (c)(1)(i)(A) of
this section;
(D) Using data for specific food factors for particular foods or
ingredients approved by the Food and Drug Administration (FDA) and
provided in parts 172 or 184 of this chapter, or by other means, as
appropriate; or
(E) Using bomb calorimetry data subtracting 1.25 calories per gram
protein to correct for incomplete digestibility, as described in USDA
Handbook No. 74 (slightly revised 1973) p. 10, which is incorporated by
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 (the
availability of this incorporation by reference is given in paragraph
(c)(1)(i)(A) of this section).
(ii) ``Calories from fat'': A statement of the caloric content
derived from total fat as defined in paragraph (c)(2) of this section in
a serving, expressed to the nearest 5-calorie increment, up to and
including 50 calories, and the nearest 10-calorie increment above 50
calories, except that label declaration of ``calories from fat'' is not
required on products that contain less than 0.5 gram of fat in a serving
and amounts less than 5 calories may be expressed as zero. This
statement shall be declared as provided in paragraph (d)(5) of this
section. Except as provided for in paragraph (f) of this section, if
``Calories from fat'' is not required and, as a result, not declared,
the statement ``Not a significant source of calories from fat'' shall be
placed at the bottom of the table of nutrient values in the same type
size.
(iii) ``Calories from saturated fat'' or ``Calories from saturated''
(VOLUNTARY): A statement of the caloric content derived from saturated
fat as defined in paragraph (c)(2)(i) of this section in a serving may
be declared voluntarily, expressed to the nearest 5-calorie increment,
up to and including 50 calories, and the nearest 10-calorie increment
above 50 calories, except that amounts less than 5 calories may be
expressed as zero. This statement shall be indented under the statement
of calories from fat as provided in paragraph (d)(5) of this section.
(2) ``Fat, total'' or ``Total fat'': A statement of the number of
grams of total fat in a serving defined as total lipid fatty acids and
expressed as triglycerides. Amounts shall be expressed to the nearest
0.5 (1/2) gram increment below 5 grams and to the nearest gram increment
above 5 grams. If the serving contains less than 0.5 gram, the content
shall be expressed as zero.
(i) ``Saturated fat,'' or ``Saturated'': A statement of the number
of grams of saturated fat in a serving defined as the sum of all fatty
acids containing no double bonds, except that label declaration of
saturated fat content information is not required for products that
contain less than 0.5 gram of total fat in a serving if no claims are
made about fat or cholesterol content, and if ``calories from saturated
fat'' is not declared. Except as provided for in paragraph (f) of this
section, if a statement of the saturated fat content is not required
and, as a result, not declared, the statement ``Not a significant source
of saturated fat'' shall be placed at the bottom of the table of
nutrient values in the same type size. Saturated fat content shall be
indented and expressed as grams per serving to the nearest 0.5 (1/2)
gram increment below 5 grams and to the nearest gram increment above 5
grams. If the serving contains less than 0.5 gram, the content shall be
expressed as zero.
(ii) ``Polyunsaturated fat'' or ``Polyunsaturated'' (VOLUNTARY): A
statement of the number of grams of polyunsaturated fat in a serving
defined as cis,cis-methylene-interrupted
[[Page 29]]
polyunsaturated fatty acids may be declared voluntarily, except that
when monounsaturated fat is declared, or when a claim about fatty acids
or cholesterol is made on the label or in labeling of a food other than
one that meets the criteria in Sec. 101.62(b)(1) for a claim for ``fat
free,'' label declaration of polyunsaturated fat is required.
Polyunsaturated fat content shall be indented and expressed as grams per
serving to the nearest 0.5 (1/2) gram increment below 5 grams and to the
nearest gram increment above 5 grams. If the serving contains less than
0.5 gram, the content shall be expressed as zero.
(iii) ``Monounsaturated fat'' or ``Monounsaturated'' (VOLUNTARY): A
statement of the number of grams of monounsaturated fat in a serving
defined as cis-monounsaturated fatty acids may be declared voluntarily
except that when polyunsaturated fat is declared, or when a claim about
fatty acids or cholesterol is made on the label or in labeling of a food
other than one that meets the criteria in Sec. 101.62(b)(1) for a claim
for ``fat free,'' label declaration of monounsaturated fat is required.
Monounsaturated fat content shall be indented and expressed as grams per
serving to the nearest 0.5 (1/2) gram increment below 5 grams and to the
nearest gram increment above 5 grams. If the serving contains less than
0.5 gram, the content shall be expressed as zero.
(3) ``Cholesterol'': A statement of the cholesterol content in a
serving expressed in milligrams to the nearest 5-milligram increment,
except that label declaration of cholesterol information is not required
for products that contain less than 2 milligrams cholesterol in a
serving and make no claim about fat, fatty acids, or cholesterol
content, or such products may state the cholesterol content as zero.
Except as provided for in paragraph (f) of this section, if cholesterol
content is not required and, as a result, not declared, the statement
``Not a significant source of cholesterol'' shall be placed at the
bottom of the table of nutrient values in the same type size. If the
food contains 2 to 5 milligrams of cholesterol per serving, the content
may be stated as ``less than 5 milligrams.''
(4) ``Sodium'': A statement of the number of milligrams of sodium in
a specified serving of food expressed as zero when the serving contains
less than 5 milligrams of sodium, to the nearest 5-milligram increment
when the serving contains 5 to 140 milligrams of sodium, and to the
nearest 10-milligram increment when the serving contains greater than
140 milligrams.
(5) ``Potassium'' (VOLUNTARY): A statement of the number of
milligrams of potassium in a specified serving of food may be declared
voluntarily, except that when a claim is made about potassium content,
label declaration shall be required. Potassium content shall be
expressed as zero when the serving contains less than 5 milligrams of
potassium, to the nearest 5-milligram increment when the serving
contains less than or equal to 140 milligrams of potassium, and to the
nearest 10-milligram increment when the serving contains more than 140
milligrams.
(6) ``Carbohydrate, total'' or ``Total carbohydrate'': A statement
of the number of grams of total carbohydrate in a serving expressed to
the nearest gram, except that if a serving contains less than 1 gram,
the statement ``Contains less than 1 gram'' or ``less than 1 gram'' may
be used as an alternative, or if the serving contains less than 0.5
gram, the content may be expressed as zero. Total carbohydrate content
shall be calculated by subtraction of the sum of the crude protein,
total fat, moisture, and ash from the total weight of the food. This
calculation method is described in A. L. Merrill and B. K. Watt,
``Energy Value of Foods--Basis and Derivation,'' USDA Handbook 74
(slightly revised 1973) pp. 2 and 3, which is incorporated by reference
in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 (the availability
of this incorporation by reference is given in paragraph (c)(1)(i)(A) of
this section).
(i) ``Dietary fiber'': A statement of the number of grams of total
dietary fiber in a serving, indented and expressed to the nearest gram,
except that if a serving contains less than 1 gram, declaration of
dietary fiber is not required or, alternatively, the statement
``Contains less than 1 gram'' or ``less than 1 gram'' may be used, and
if the serving contains less than 0.5
[[Page 30]]
gram, the content may be expressed as zero. Except as provided for in
paragraph (f) of this section, if dietary fiber content is not required
and as a result, not declared, the statement ``Not a significant source
of dietary fiber'' shall be placed at the bottom of the table of
nutrient values in the same type size.
(A) ``Soluble fiber'' (VOLUNTARY): A statement of the number of
grams of soluble dietary fiber in a serving may be declared voluntarily
except when a claim is made on the label or in labeling about soluble
fiber, label declaration shall be required. Soluble fiber content shall
be indented under dietary fiber and expressed to the nearest gram,
except that if a serving contains less than 1 gram, the statement
``Contains less than 1 gram'' or ``less than 1 gram'' may be used as an
alternative, and if the serving contains less than 0.5 gram, the content
may be expressed as zero.
(B) ``Insoluble fiber'' (VOLUNTARY): A statement of the number of
grams of insoluble dietary fiber in a serving may be declared
voluntarily except that when a claim is made on the label or in labeling
about insoluble fiber, label declaration shall be required. Insoluble
fiber content shall be indented under dietary fiber and expressed to the
nearest gram except that if a serving contains less than 1 gram, the
statement ``Contains less than 1 gram'' or ``less than 1 gram'' may be
used as an alternative, and if the serving contains less than 0.5 gram,
the content may be expressed as zero.
(ii) ``Sugars'': A statement of the number of grams of sugars in a
serving, except that label declaration of sugars content is not required
for products that contain less than 1 gram of sugars in a serving if no
claims are made about sweeteners, sugars, or sugar alcohol content.
Except as provided for in paragraph (f) of this section, if a statement
of the sugars content is not required and, as a result, not declared,
the statement ``Not a significant source of sugars'' shall be placed at
the bottom of the table of nutrient values in the same type size. Sugars
shall be defined as the sum of all free mono- and disaccharides (such as
glucose, fructose, lactose, and sucrose). Sugars content shall be
indented and expressed to the nearest gram, except that if a serving
contains less than 1 gram, the statement ``Contains less then 1 gram''
or ``less than 1 gram'' may be used as an alternative, and if the
serving contains less than 0.5 gram, the content may be expressed as
zero.
(iii) ``Sugar alcohol'' (VOLUNTARY): A statement of the number of
grams of sugar alcohols in a serving may be declared voluntarily on the
label, except that when a claim is made on the label or in labeling
about sugar alcohol or sugars when sugar alcohols are present in the
food, sugar alcohol content shall be declared. For nutrition labeling
purposes, sugar alcohols are defined as the sum of saccharide
derivatives in which a hydroxyl group replaces a ketone or aldehyde
group and whose use in the food is listed by FDA (e.g., mannitol or
xylitol) or is generally recognized as safe (e.g., sorbitol). In lieu of
the term ``sugar alcohol,'' the name of the specific sugar alcohol
(e.g., ``xylitol'') present in the food may be used in the nutrition
label provided that only one sugar alcohol is present in the food. Sugar
alcohol content shall be indented and expressed to the nearest gram,
except that if a serving contains less than 1 gram, the statement
``Contains less then 1 gram'' or ``less than 1 gram'' may be used as an
alternative, and if the serving contains less than 0.5 gram, the content
may be expressed as zero.
(iv) ``Other carbohydrate'' (VOLUNTARY): A statement of the number
of grams of other carbohydrates may be declared voluntarily. Other
carbohydrates shall be defined as the difference between total
carbohydrate and the sum of dietary fiber, sugars, and sugar alcohol,
except that if sugar alcohol is not declared (even if present), it shall
be defined as the difference between total carbohydrate and the sum of
dietary fiber and sugars. Other carbohydrate content shall be indented
and expressed to the nearest gram, except that if a serving contains
less than 1 gram, the statement ``Contains less than 1 gram'' or ``less
than 1 gram'' may be used as an alternative, and if the serving contains
less than 0.5 gram, the content may be expressed as zero.
[[Page 31]]
(7) ``Protein'': A statement of the number of grams of protein in a
serving, expressed to the nearest gram, except that if a serving
contains less than 1 gram, the statement ``Contains less than 1 gram''
or ``less than 1 gram'' may be used as an alternative, and if the
serving contains less than 0.5 gram, the content may be expressed as
zero. When the protein in foods represented or purported to be for
adults and children 4 or more years of age has a protein quality value
that is a protein digestibility-corrected amino acid score of less than
20 expressed as a percent, or when the protein in a food represented or
purported to be for children greater than 1 but less than 4 years of age
has a protein quality value that is a protein digestibility-corrected
amino acid score of less than 40 expressed as a percent, either of the
following shall be placed adjacent to the declaration of protein content
by weight: The statement ``not a significant source of protein,'' or a
listing aligned under the column headed ``Percent Daily Value'' of the
corrected amount of protein per serving, as determined in paragraph
(c)(7)(ii) of this section, calculated as a percentage of the Daily
Reference Value (DRV) or Reference Daily Intake (RDI), as appropriate,
for protein and expressed as Percent of Daily Value. When the protein
quality in a food as measured by the Protein Efficiency Ratio (PER) is
less than 40 percent of the reference standard (casein) for a food
represented or purported to be for infants, the statement ``not a
significant source of protein'' shall be placed adjacent to the
declaration of protein content. Protein content may be calculated on the
basis of the factor of 6.25 times the nitrogen content of the food as
determined by the appropriate method of analysis as given in the
``Official Methods of Analysis of the AOAC International'' (formerly the
Association of Official Analytical Chemists), 15th Ed. (1990), which is
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51, except when the official procedure for a specific food requires
another factor. Copies may be obtained from AOAC, 2200 Wilson Blvd.,
suite 400, Arlington, VA 22201-3301, or may be inspected at the Office
of the Federal Register, 800 North Capitol St. NW., suite 700,
Washington, DC.
(i) A statement of the corrected amount of protein per serving, as
determined in paragraph (c)(7)(ii) of this section, calculated as a
percentage of the RDI or DRV for protein, as appropriate, and expressed
as Percent of Daily Value, may be placed on the label, except that such
a statement shall be given if a protein claim is made for the product,
or if the product is represented or purported to be for use by infants
or children under 4 years of age. When such a declaration is provided,
it shall be placed on the label adjacent to the statement of grams of
protein and aligned under the column headed ``Percent Daily Value,'' and
expressed to the nearest whole percent. However, the percentage of the
RDI for protein shall not be declared if the food is represented or
purported to be for use by infants and the protein quality value is less
than 40 percent of the reference standard.
(ii) The ``corrected amount of protein (gram) per serving'' for
foods represented or purported for adults and children 1 or more years
of age is equal to the actual amount of protein (gram) per serving
multiplied by the amino acid score corrected for protein digestibility.
If the corrected score is above 1.00, then it shall be set at 1.00. The
protein digestibility-corrected amino acid score shall be determined by
methods given in sections 5.4.1, 7.2.1, and 8.00 in ``Protein Quality
Evaluation, Report of the Joint FAO/WHO Expert Consultation on Protein
Quality Evaluation,'' Rome, 1990, except that when official AOAC
procedures described in section (c)(7) of this paragraph require a
specific food factor other than 6.25, that specific factor shall be
used. The ``Report of the Joint FAO/WHO Expert Consultation on Protein
Quality Evaluation'' as published by the Food and Agriculture
Organization of the United Nations/World Health Organization is
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. Copies are available from the Center for Food Safety and
Applied Nutrition (HFS-150), Food and Drug Administration, 200 C St.
SW., Washington, DC 20204, or may be inspected at the Office of the
[[Page 32]]
Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC.
For foods represented or purported for infants, the corrected amount of
protein (grams) per serving is equal to the actual amount of protein
(grams) per serving multiplied by the relative protein quality value.
The relative protein quality value shall be determined by dividing the
subject food protein PER value by the PER value for casein. If the
relative protein value is above 1.00, it shall be set at 1.00.
(iii) For the purpose of labeling with a percent of the Daily
Reference Value (DRV) or RDI, a value of 50 grams of protein shall be
the DRV for adults and children 4 or more years of age, and the RDI for
protein for children less than 4 years of age, infants, pregnant women,
and lactating women shall be 16 grams, 14 grams, 60 grams, and 65 grams,
respectively.
(8) Vitamins and minerals: A statement of the amount per serving of
the vitamins and minerals as described in this paragraph, calculated as
a percent of the RDI and expressed as percent of Daily Value.
(i) For purposes of declaration of percent of Daily Value as
provided for in paragraphs (d), (e), and (f) of this section, foods
represented or purported to be for use by infants, children less than 4
years of age, pregnant women, or lactating women shall use the RDI's
that are specified for the intended group. For foods represented or
purported to be for use by both infants and children under 4 years of
age, the percent of Daily Value shall be presented by separate
declarations according to paragraph (e) of this section based on the RDI
values for infants from birth to 12 months of age and for children under
4 years of age. Similarly, the percent of Daily Value based on both the
RDI values for pregnant women and for lactating women shall be declared
separately on foods represented or purported to be for use by both
pregnant and lactating women. When such dual declaration is used on any
label, it shall be included in all labeling, and equal prominence shall
be given to both values in all such labeling. All other foods shall use
the RDI for adults and children 4 or more years of age.
(ii) The declaration of vitamins and minerals as a percent of the
RDI shall include vitamin A, vitamin C, calcium, and iron, in that
order, and shall include any of the other vitamins and minerals listed
in paragraph (c)(8)(iv) of this section when they are added as a
nutrient supplement, or when a claim is made about them. Other vitamins
and minerals need not be declared if neither the nutrient nor the
component is otherwise referred to on the label or in labeling or
advertising and the vitamins and minerals are:
(A) Required or permitted in a standardized food (e.g., thiamin,
riboflavin, and niacin in enriched flour) and that standardized food is
included as an ingredient (i.e., component) in another food; or
(B) Included in a food solely for technological purposes and
declared only in the ingredient statement. The declaration may also
include any of the other vitamins and minerals listed in paragraph
(c)(8)(iv) of this section when they are naturally occurring in the
food. The additional vitamins and minerals shall be listed in the order
established in paragraph (c)(8)(iv) of this section.
(iii) The percentages for vitamins and minerals shall be expressed
to the nearest 2-percent increment up to and including the 10-percent
level, the nearest 5-percent increment above 10 percent and up to and
including the 50-percent level, and the nearest 10-percent increment
above the 50-percent level. Amounts of vitamins and minerals present at
less than 2 percent of the RDI are not required to be declared in
nutrition labeling but may be declared by a zero or by the use of an
asterisk (or other symbol) that refers to another asterisk (or symbol)
that is placed at the bottom of the table and that is followed by the
statement ``Contains less than 2 percent of the Daily Value of this
(these) nutrient (nutrients).'' Alternatively, except as provided for in
paragraph (f) of this section, if vitamin A, vitamin C, calcium, or iron
is present in amounts less than 2 percent of the RDI, label declaration
of the nutrient(s) is not required if the statement ``Not a significant
source of __________ (listing the vitamins or minerals omitted)'' is
placed
[[Page 33]]
at the bottom of the table of nutrient values. Either statement shall be
in the same type size as nutrients that are indented.
(iv) The following RDI's and nomenclature are established for the
following vitamins and minerals which are essential in human nutrition:
Vitamin A, 5,000 International Units
Vitamin C, 60 milligrams
Calcium, 1,000 milligrams
Iron, 18 milligrams
Vitamin D, 400 International Units
Vitamin E, 30 International Units
Vitamin K, 80 micrograms
Thiamin, 1.5 milligrams
Riboflavin, 1.7 milligrams
Niacin, 20 milligrams
Vitamin B6, 2.0 milligrams
Folate, 400 micrograms
Vitamin B12, 6 micrograms
Biotin, 300 micrograms
Pantothenic acid, 10 milligrams
Phosphorus, 1,000 milligrams
Iodine, 150 micrograms
Magnesium, 400 milligrams
Zinc, 15 milligrams
Selenium, 70 micrograms
Copper, 2.0 milligrams
Manganese, 2.0 milligrams
Chromium, 120 micrograms
Molybdenum, 75 micrograms
Chloride, 3,400 milligrams
(v) The following synonyms may be added in parentheses immediately
following the name of the nutrient or dietary component:
Vitamin C--Ascorbic acid
Thiamin--Vitamin B1
Riboflavin--Vitamin B2
Folate--either Folic acid or Folacin may be used.
Calories--Energy
(vi) A statement of the percent of vitamin A that is present as
beta-carotene may be declared voluntarily. When the vitamins and
minerals are listed in a single column, the statement shall be indented
under the information on vitamin A. When vitamins and minerals are
arrayed horizontally, the statement of percent shall be presented in
parenthesis following the declaration of vitamin A and the percent DV of
vitamin A in the food (e.g., ``Percent Daily Value: Vitamin A 50 (90
percent as beta-carotene)''). When declared, the percentages shall be
expressed in the same increments as are provided for vitamins and
minerals in paragraph (c)(8)(iii) of this section.
(9) For the purpose of labeling with a percent of the DRV, the
following DRV's are established for the following food components based
on the reference caloric intake of 2,000 calories:
------------------------------------------------------------------------
Unit of
Food component measurement DRV
------------------------------------------------------------------------
Fat............................. gram (g).......... 65
Saturated fatty acids........... do................ 20
Cholesterol..................... milligrams (mg)... 300
Total carbohydrate.............. grams (g)......... 300
Fiber........................... do................ 25
Sodium.......................... milligrams (mg)... 2,400
Potassium....................... do................ 3,500
Protein......................... grams (g)......... 50
------------------------------------------------------------------------
(d)(1) Nutrient information specified in paragraph (c) of this
section shall be presented on foods in the following format, as shown in
paragraph (d)(12) of this section, except on foods on which dual columns
of nutrition information are declared as provided for in paragraph (e)
of this section, on those food products on which the simplified format
is required to be used as provided for in paragraph (f) of this section,
on foods for infants and children less than 4 years of age as provided
for in paragraph (j)(5) of this section, and on foods in small or
intermediate-sized packages as provided for in paragraph (j)(13) of this
section. In the interest of uniformity of presentation, FDA urges that
the nutrition information be presented using the graphic specifications
set forth in appendix B to part 101.
(i) The nutrition information shall be set off in a box by use of
hairlines and shall be all black or one color type, printed on a white
or other neutral contrasting background whenever practical.
(ii) All information within the nutrition label shall utilize:
(A) A single easy-to-read type style,
(B) Upper and lower case letters,
(C) At least one point leading (i.e., space between two lines of
text) except that at least four points leading shall be utilized for the
information required by paragraphs (d)(7) and (d)(8) of this section as
shown in paragraph (d)(12), and
(D) Letters should never touch.
(iii) Information required in paragraphs (d)(3), (d)(5), (d)(7), and
(d)(8) of this section shall be in type size no smaller than 8 point.
Except for the
[[Page 34]]
heading ``Nutrition Facts,'' the information required in paragraphs
(d)(4), (d)(6), and (d)(9) of this section and all other information
contained within the nutrition label shall be in type size no smaller
than 6 point. When provided, the information described in paragraph
(d)(10) of this section shall also be in type no smaller than 6 point.
(iv) The headings required by paragraphs (d)(2), (d)(4), and (d)(6)
of this section (i.e., ``Nutrition Facts,'' ``Amount per Serving,'' and
``% Daily Value*''), the names of all nutrients that are not indented
according to requirements of paragraph (c) of this section (i.e.,
``Calories,'' ``Total Fat,'' ``Cholesterol,'' ``Sodium,'' ``Total
Carbohydrate,'' and ``Protein''), and the percentage amounts required by
paragraph (d)(7)(ii) of this section shall be highlighted by bold or
extra bold type or other highlighting (reverse printing is not permitted
as a form of highlighting) that prominently distinguishes it from other
information. No other information shall be highlighted.
(v) A hairline rule that is centered between the lines of text shall
separate ``Amount Per Serving'' from the calorie statements required in
paragraph (d)(5) of this section and shall separate each nutrient and
its corresponding percent Daily Value required in paragraphs (d)(7)(i)
and (d)(7)(ii) of this section from the nutrient and percent Daily Value
above and below it, as shown in paragraph (d)(12) of this section.
(2) The information shall be presented under the identifying heading
of ``Nutrition Facts'' which shall be set in a type size larger than all
other print size in the nutrition label and, except for labels presented
according to the format provided for in paragraph (d)(11) of this
section, unless impractical, shall be set the full width of the
information provided under paragraph (d)(7) of this section, as shown in
paragraph (d)(12) of this section.
(3) Information on serving size shall immediately follow the heading
as shown in paragraph (d)(12) of this section. Such information shall
include:
(i) ``Serving Size'': A statement of the serving size as specified
in paragraph (b)(7) of this section.
(ii) ``Servings Per Container'': The number of servings per
container, except that this statement is not required on single serving
containers as defined in paragraph (b)(6) of this section or on other
food containers when this information is stated in the net quantity of
contents declaration.
(4) A subheading ``Amount Per Serving'' shall be separated from
serving size information by a bar as shown in paragraph (d)(12) of this
section.
(5) Information on calories shall immediately follow the heading
``Amount Per Serving'' and shall be declared in one line, leaving
sufficient space between the declaration of ``Calories'' and ``Calories
from fat'' to allow clear differentiation, or, if ``Calories from
saturated fat'' is declared, in a column with total ``Calories'' at the
top, followed by ``Calories from fat'' (indented), and ``Calories from
saturated fat'' (indented).
(6) The column heading ``% Daily Value,'' followed by an asterisk
(e.g., ``% Daily Value*''), shall be separated from information on
calories by a bar as shown in paragraph (d)(12) of this section. The
position of this column heading shall allow for a list of nutrient names
and amounts as described in paragraph (d)(7) of this section to be to
the left of, and below, this column heading. The column headings
``Percent Daily Value,'' ``Percent DV,'' or ``% DV'' may be substituted
for ``% Daily Value.''
(7) Except as provided for in paragraph (j)(13) of this section,
nutrient information for both mandatory and any voluntary nutrients
listed in paragraph (c) of this section that are to be declared in the
nutrition label, except vitamins and minerals, shall be declared as
follows:
(i) The name of each nutrient, as specified in paragraph (c) of this
section, shall be given in a column and followed immediately by the
quantitative amount by weight for that nutrient appended with a ``g''
for grams or ``mg'' for milligrams as shown in paragraph (d)(12) of this
section.
(ii) A listing of the percent of the DRV as established in
paragraphs (c)(7)(iii) and (c)(9) of this section shall be given in a
column aligned under the heading ``% Daily Value'' established
[[Page 35]]
in paragraph (d)(6) of this section with the percent expressed to the
nearest whole percent for each nutrient declared in the column described
in paragraph (d)(7)(i) of this section for which a DRV has been
established, except that the percent for protein may be omitted as
provided in paragraph (c)(7) of this section. The percent shall be
calculated by dividing either the amount declared on the label for each
nutrient or the actual amount of each nutrient (i.e., before rounding)
by the DRV for the nutrient, except that the percent for protein shall
be calculated as specified in paragraph (c)(7)(ii) of this section. The
numerical value shall be followed by the symbol for percent (i.e., %).
(8) Nutrient information for vitamins and minerals shall be
separated from information on other nutrients by a bar and shall be
arrayed horizontally (e.g., Vitamin A 4%, Vitamin C 2%, Calcium 15%,
Iron 4%) or may be listed in two columns as shown in paragraph (d)(12)
of this section, except that when more than four vitamins and minerals
are declared, they may be declared vertically with percentages listed
under the column headed ``% Daily Value.''
(9) A footnote, preceded by an asterisk, shall be placed beneath the
list of vitamins and minerals and shall be separated from that list by a
hairline.
(i) The footnote shall state:
Percent Daily Values are based on a 2,000 calorie diet.
Your daily values may be higher or lower depending on your calorie
needs.
------------------------------------------------------------------------
Calories: 2,000 2,500
------------------------------------------------------------------------
Total fat..................... Less than..... 65 g 80 g
Saturated fat................. Less than..... 20 g 25 g
Cholesterol................... Less than..... 300 mg 300 mg
Sodium........................ Less than..... 2,400 mg 2,400 mg
Total carbohydrate............ .............. 300 g 375 g
Dietary fiber................. .............. 25 g 30 g
------------------------------------------------------------------------
(ii) If the percent of Daily Value is given for protein in the
Percent of Daily Value column as provided in paragraph (d)(7)(ii) of
this section, protein shall be listed under dietary fiber, and a value
of 50 g shall be inserted on the same line in the column headed
``2,000'' and a value of 65 g in the column headed ``2,500''.
(iii) If potassium is declared in the column described in paragraph
(d)(7)(i) of this section, potassium shall be listed under sodium and
the DRV established in paragraph (c)(9) of this section shall be
inserted on the same line in the numeric columns.
(iv) The abbreviations established in paragraph (j)(13)(ii)(B) of
this section may be used within the footnote.
(10) Caloric conversion information on a per gram basis for fat,
carbohydrate, and protein may be presented beneath the information
required in paragraph (d)(9) of this section, separated from that
information by a hairline. This information may be presented
horizontally as shown in paragraph (d)(12) of this section (i.e.,
``Calories per gram: fat 9, carbohydrate 4, protein 4'') or vertically
in columns.
(11)(i) If the space beneath the information on vitamins and
minerals is not adequate to accommodate the information required in
paragraph (d)(9) of this section, the information required in paragraph
(d)(9) may be moved to the right of the column required in paragraph
(d)(7)(ii) of this section and set off by a line that distinguishes it
and sets it apart from the percent Daily Value information. The caloric
conversion information provided for in paragraph (d)(10) of this section
may be presented beneath either side or along the full length of the
nutrition label.
(ii) If the space beneath the mandatory declaration of iron is not
adequate to accommodate any remaining vitamins and minerals to be
declared or the information required in paragraph (d)(9) of this
section, the remaining information may be moved to the right and set off
by a line that distinguishes it and sets it apart from the nutrients and
the percent DV information given to the left. The caloric conversion
information provided for in paragraph (d)(10) of this section may be
presented beneath either side or along the full length of the nutrition
label.
(iii) If there is not sufficient continuous vertical space (i.e.,
approximately 3 in) to accommodate the required components of the
nutrition label up to and including the mandatory declaration of iron,
the nutrition label may be presented in a tabular display as shown
below.
[[Page 36]]
[GRAPHIC] [TIFF OMITTED] TR01JA93.351
[[Page 37]]
(12) The following sample label illustrates the provisions of
paragraph (d) of this section.
[GRAPHIC] [TIFF OMITTED] TR01JA93.352
[[Page 38]]
(13)(i) Nutrition labels on the outer label of packages of products
that contain two or more separately packaged foods that are intended to
be eaten individually (e.g., variety packs of cereals or snack foods) or
of packages that are used interchangeably for the same type of food
(e.g., round ice cream containers) may use an aggregate display.
(ii) Aggregate displays shall comply with the format requirements of
paragraph (d) of this section to the maximum extent possible, except
that the identity of each food shall be specified immediately under the
``Nutrition Facts'' title, and both the quantitative amount by weight
(i.e., g/mg amounts) and the percent Daily Value for each nutrient shall
be listed in separate columns under the name of each food. The following
sample label illustrates an aggregate display.
[GRAPHIC] [TIFF OMITTED] TR01JA93.353
(14) In accordance with Sec. 101.15(c)(2), when nutrition labeling
must appear in a second language, the nutrition information may be
presented in a separate nutrition label for each language or in one
nutrition label with the information in the second language following
that in English. Numeric characters that are identical in both languages
need not be repeated (e.g., ``Protein/Proteinas 2 g''). All required
information must be included in both languages.
(e) Nutrition information may be presented for two or more forms of
the same food (e.g., both ``as purchased'' and ``as prepared'') or for
common combinations of food as provided for in paragraph (h)(4) of this
section, for different units (e.g., slices of bread or per
[[Page 39]]
100 grams) as provided for in paragraph (b) of this section, or for two
or more groups for which RDI's are established (e.g., both infants and
children less than 4 years of age) as shown in paragraph (e)(5) of this
section. When such dual labeling is provided, equal prominence shall be
given to both sets of values. Information shall be presented in a format
consistent with paragraph (d) of this section, except that:
(1) Following the subheading of ``Amount Per Serving,'' there shall
be two or more column headings accurately describing the forms of the
same food (e.g., ``Mix'' and ``Baked''), the combinations of food, the
units, or the RDI groups that are being declared. The column
representing the product as packaged and according to the label serving
size based on the reference amount in Sec. 101.12(b) shall be to the
left of the numeric columns.
(2) When the dual labeling is presented for two or more forms of the
same food, for combinations of food, or for different units, total
calories and calories from fat (and calories from saturated fat, when
declared) shall be listed in a column and indented as specified in
paragraph (d)(5) of this section with quantitative amounts declared in
columns aligned under the column headings set forth in paragraph (e)(1)
of this section.
(3) Quantitative information by weight required in paragraph
(d)(7)(i) of this section shall be specified for the form of the product
as packaged and according to the label serving size based on the
reference amount in Sec. 101.12(b).
(i) Quantitative information by weight may be included for other
forms of the product represented by the additional column(s) either
immediately adjacent to the required quantitative information by weight
for the product as packaged and according to the label serving size
based on the reference amount in Sec. 101.12(b) or as a footnote.
(A) If such additional quantitative information is given immediately
adjacent to the required quantitative information, it shall be declared
for all nutrients listed and placed immediately following and
differentiated from the required quantitative information (e.g.,
separated by a comma). Such information shall not be put in a separate
column.
(B) If such additional quantitative information is given in a
footnote, it shall be declared in the same order as the nutrients are
listed in the nutrition label. The additional quantitative information
may state the total nutrient content of the product identified in the
second column or the nutrient amounts added to the product as packaged
for only those nutrients that are present in different amounts than the
amounts declared in the required quantitative information. The footnote
shall clearly identify which amounts are declared. Any subcomponents
declared shall be listed parenthetically after principal components
(e.g., 1/2 cup skim milk contributes an additional 40 calories, 65 mg
sodium, 6 g total carbohydrate (6 g sugars), and 4 g protein).
(ii) Total fat and its quantitative amount by weight shall be
followed by an asterisk (or other symbol) (e.g., ``Total fat (2 g)*'')
referring to another asterisk (or symbol) at the bottom of the nutrition
label identifying the form(s) of the product for which quantitative
information is presented.
(4) Information required in paragraphs (d)(7)(ii) and (d)(8) of this
section shall be presented under the subheading ``% DAILY VALUE'' and in
columns directly under the column headings set forth in paragraph (e)(1)
of this section.
(5) The following sample label illustrates the provisions of
paragraph (e) of this section:
[[Page 40]]
[GRAPHIC] [TIFF OMITTED] TR01JA93.354
(f) The declaration of nutrition information may be presented in the
simplified format set forth herein when a food product contains
insignificant amounts of seven or more of the following: Calories, total
fat, saturated fat, cholesterol, sodium, total carbohydrate, dietary
fiber, sugars, protein,
[[Page 41]]
vitamin A, vitamin C, calcium, and iron; except that for foods intended
for children less than 2 years of age to which Sec. 101.9(j)(5)(i)
applies, nutrition information may be presented in the simplified format
when a food product contains insignificant amounts of six or more of the
following: Calories, total fat, sodium, total carbohydrate, dietary
fiber, sugars, protein, vitamin A, vitamin C, calcium, and iron.
(1) An ``insignificant amount'' shall be defined as that amount that
allows a declaration of zero in nutrition labeling, except that for
total carbohydrate, dietary fiber, and protein, it shall be an amount
that allows a declaration of ``less than 1 gram.''
(2) The simplified format shall include information on the following
nutrients:
(i) Total calories, total fat, total carbohydrate, protein, and
sodium;
(ii) Calories from fat and any other nutrients identified in
paragraph (f) of this section that are present in the food in more than
insignificant amounts; and
(iii) Any vitamins and minerals listed in paragraph (c)(8)(iv) of
this section when they are required to be added as a nutrient supplement
to foods for which a standard of identity exists.
(iv) Any vitamins or minerals listed in paragraph (c)(8)(iv) of this
section voluntarily added to the food as nutrient supplements.
(3) Other nutrients that are naturally present in the food in more
than insignificant amounts may be voluntarily declared as part of the
simplified format.
(4) If any nutrients are declared as provided in paragraphs
(f)(2)(iii), (f)(2)(iv), or (f)(3) of this section as part of the
simplified format or if any nutrition claims are made on the label or in
labeling, the statement ``Not a significant source of ----------'' (with
the blank filled in with the name(s) of any nutrient(s) identified in
Sec. 101.9(f) and calories from fat that are present in insignificant
amounts) shall be included at the bottom of the nutrition label.
(5) Except as provided for in paragraphs (j)(5) and (j)(13) of this
section, nutrient information declared in the simplified format shall be
presented in the same manner as specified in paragraphs (d) or (e) of
this section, except that the footnote required in paragraph (d)(9) of
this section is not required. When the footnote is omitted, an asterisk
shall be placed at the bottom of the label followed by the statement
``Percent Daily Values are based on a 2,000 calorie diet'' and, if the
term ``Daily Value'' is not spelled out in the heading, a statement that
``DV'' represents ``Daily Value.''
(g) Compliance with this section shall be determined as follows:
(1) A collection of primary containers or units of the same size,
type, and style produced under conditions as nearly uniform as possible,
designated by a common container code or marking, or in the absence of
any common container code or marking, a day's production, constitutes a
``lot.''
(2) The sample for nutrient analysis shall consist of a composite of
12 subsamples (consumer units), taken 1 from each of 12 different
randomly chosenshipping cases, to be representative of a lot. Unless a
particular method of analysis is specified in paragraph (c) of this
section, composites shall be analyzed by appropriate methods as given in
the ``Official Methods of Analysis of the AOAC International,'' 15th Ed.
(1990), which is incorporated by reference in accordance with 5 U.S.C.
552(a) or 1 CFR part 51 or, if no AOAC method is available or
appropriate, by other reliable and appropriate analytical procedures.
The availability of this incorporation by reference is given in
paragraph (c)(7) of this section.
(3) Two classes of nutrients are defined for purposes of compliance:
(i) Class I. Added nutrients in fortified or fabricated foods; and
(ii) Class II. Naturally occurring (indigenous) nutrients. If any
ingredient which contains a naturally occurring (indigenous) nutrient is
added to a food, the total amount of such nutrient in the final food
product is subject to class II requirements unless the same nutrient is
also added.
(4) A food with a label declaration of a vitamin, mineral, protein,
total carbohydrate, dietary fiber, other carbohydrate, polyunsaturated
or monounsaturated fat, or potassium shall be deemed to be misbranded
under section 403(a) of the Federal
[[Page 42]]
Food, Drug, and Cosmetic Act (the act) unless it meets the following
requirements:
(i) Class I vitamin, mineral, protein, dietary fiber, or potassium.
The nutrient content of the composite is at least equal to the value for
that nutrient declared on the label.
(ii) Class II vitamin, mineral, protein, total carbohydrate, dietary
fiber, other carbohydrate, polyunsaturated or monounsaturated fat, or
potassium. The nutrient content of the composite is at least equal to 80
percent of the value for that nutrient declared on the label.
Provided, That no regulatory action will be based on a determination
of a nutrient value that falls below this level by a factor less than
the variability generally recognized for the analytical method used in
that food at the level involved.
(5) A food with a label declaration of calories, sugars, total fat,
saturated fat, cholesterol, or sodium shall be deemed to be misbranded
under section 403(a) of the act if the nutrient content of the composite
is greater than 20 percent in excess of the value for that nutrient
declared on the label. Provided, That no regulatory action will be based
on a determination of a nutrient value that falls above this level by a
factor less than the variability generally recognized for the analytical
method used in that food at the level involved.
(6) Reasonable excesses of a vitamin, mineral, protein, total
carbohydrate, dietary fiber, other carbohydrate, polyunsaturated or
monounsaturated fat, or potassium over labeled amounts are acceptable
within current good manufacturing practice. Reasonable deficiencies of
calories, sugars, total fat, saturated fat, cholesterol, or sodium under
labeled amounts are acceptable within current good manufacturing
practice.
(7) Compliance will be based on the metric measure specified in the
label statement of serving size.
(8) Compliance with the provisions set forth in paragraphs (g)(1)
through (g)(6) of this section may be provided by use of an FDA approved
data base that has been computed following FDA guideline procedures and
where food samples have been handled in accordance with current good
manufacturing practice to prevent nutrition loss. FDA approval of a data
base shall not be considered granted until the Center for Food Safety
and Applied Nutrition has agreed to all aspects of the data base in
writing. The approval will be granted where a clear need is presented
(e.g., raw produce and seafood). Approvals will be in effect for a
limited time, e.g., 10 years, and will be eligible for renewal in the
absence of significant changes in agricultural or industry practices.
Approval requests shall be submitted in accordance with the provisions
of Sec. 10.30 of this chapter. Guidance in the use of data bases may be
found in the ``FDA Nutrition Labeling Manual--A Guide for Developing and
Using Data Bases,'' available from the Office of Food Labeling (HFS-
150), Center for Food Safety and Applied Nutrition, Food and Drug
Administration, 200 C St. SW., Washington, DC 20204.
(9) When it is not technologically feasible, or some other
circumstance makes it impracticable, for firms to comply with the
requirements of this section (e.g., to develop adequate nutrient
profiles to comply with the requirements of paragraph (c) of this
section), FDA may permit alternative means of compliance or additional
exemptions to deal with the situation. Firms in need of such special
allowances shall make their request in writing to the Center for Food
Safety and Applied Nutrition (HFS-150), Food and Drug Administration,
200 C St. SW., Washington, DC 20204.
(h) Products with separately packaged ingredients or foods, with
assortments of food, or to which other ingredients are added by the user
may be labeled as follows:
(1) If a product consists of two or more separately packaged
ingredients enclosed in an outer container or of assortments of the same
type of food (e.g., assorted nuts or candy mixtures) in the same retail
package, nutrition labeling shall be located on the outer container or
retail package (as the case may be) to provide information for the
consumer at the point of purchase. However, when two or more food
products are simply combined together in such a manner that no outer
container is used, or no outer label is available,
[[Page 43]]
each product shall have its own nutrition information, e.g., two boxes
taped together or two cans combined in a clear plastic overwrap. When
separately packaged ingredients or assortments of the same type of food
are intended to be eaten at the same time, the nutrition information may
be specified per serving for each component or as a composite value.
(2) If a product consists of two or more separately packaged foods
that are intended to be eaten individually and that are enclosed in an
outer container (e.g., variety packs of cereals or snack foods), the
nutrition information shall:
(i) Be specified per serving for each food in a location that is
clearly visible to the consumer at the point of purchase; and
(ii) Be presented in separate nutrition labels or in one aggregate
nutrition label with separate columns for the quantitative amount by
weight and the percent Daily Value for each food.
(3) If a package contains a variety of foods, or an assortment of
foods, and is in a form intended to be used as a gift, the nutrition
labeling shall be in the form required by paragraphs (a) through (f) of
this section, but it may be modified as follows:
(i) Nutrition information may be presented on the label of the outer
package or in labeling within or attached to the outer package.
(ii) In the absence of a reference amount customarily consumed in
Sec. 101.12(b) that is appropriate for the variety or assortment of
foods in a gift package, 1 ounce for solid foods, 2 fluid ounces for
nonbeverage liquids (e.g., syrups), and 8 fluid ounces for beverages may
be used as the standard serving size for purposes of nutrition labeling
of foods subject to this paragraph. However, the reference amounts
customarily consumed in Sec. 101.12(b) shall be used for purposes of
evaluating whether individual foods in a gift package qualify for
nutrient content claims or health claims.
(iii) The number of servings per container may be stated as
``varied.''
(iv) Nutrition information may be provided per serving for
individual foods in the package, or, alternatively, as a composite per
serving for reasonable categories of foods in the package having similar
dietary uses and similar significant nutritional characteristics.
Reasonable categories of foods may be used only if accepted by FDA. In
determining whether a proposed category is reasonable, FDA will consider
whether the values of the characterizing nutrients in the foods proposed
to be in the category meet the compliance criteria set forth in
paragraphs (g)(3) through (g)(6) of this section. Proposals for such
categories may be submitted in writing to the Office of Food Labeling
(HFS-150), Center for Food Safety and Applied Nutrition, Food and Drug
Administration, 200 C St. SW., Washington, DC 20204.
(v) If a food subject to paragraph (j)(13) of this section because
of its small size is contained in a gift package, the food need not be
included in the determination of nutrition information under paragraph
(h) of this section if it is not specifically listed in a promotional
catalogue as being present in the gift package, and:
(A) It is used in small quantities primarily to enhance the
appearance of the gift package; or
(B) It is included in the gift package as a free gift or promotional
item.
(4) If a food is commonly combined with other ingredients or is
cooked or otherwise prepared before eating, and directions for such
combination or preparations are provided, another column of figures may
be used to declare nutrition information on the basis of the food as
consumed in the format required in paragraph (e) of this section (e.g.,
a dry ready-to-eat cereal may be described with one set of Percent Daily
Values for the cereal as sold (e.g., per ounce), and another set for the
cereal and milk as suggested in the label (e.g., per ounce of cereal and
1/2 cup of vitamin D fortified skim milk); and a cake mix may be labeled
with one set of Percent Daily Values for the dry mix (per serving) and
another set for the serving of the final cake when prepared): Provided,
That, the type and quantity of the other ingredients to be added to the
product by the user and the specific method of cooking and other
preparation shall be specified prominently on the label.
[[Page 44]]
(i) Except as provided in paragraphs (j)(13) and (j)(17) of this
section, the location of nutrition information on a label shall be in
compliance with Sec. 101.2.
(j) The following foods are exempt from this section or are subject
to special labeling requirements:
(1)(i) Food offered for sale by a manufacturer, packer, or
distributor who has annual gross sales made or business done in sales to
consumers that is not more than $500,000 or has annual gross sales made
or business done in sales of food to consumers of not more than $50,000,
Provided, That the food bears no nutrition claims or other nutrition
information in any context on the label or in labeling or advertising.
Claims or other nutrition information subject the food to the provisions
of this section.
(ii) For purposes of this paragraph, calculation of the amount of
sales shall be based on the most recent 2-year average of business
activity. Where firms have been in business less than 2 years,
reasonable estimates must indicate that annual sales will not exceed the
amounts specified. For foreign firms that ship foods into the United
States, the business activities to be included shall be the total amount
of food sales, as well as other sales to consumers, by the firm in the
United States.
(2) Food products which are:
(i) Served in restaurants, Provided, That the food bears no
nutrition claims or other nutrition information in any context on the
label or in labeling or advertising. Claims or other nutrition
information subject the food to the provisions of this section;
(ii) Served in other establishments in which food is served for
immediate human consumption (e.g., institutional food service
establishments, such as schools, hospitals, and cafeterias;
transportation carriers, such as trains and airplanes; bakeries,
delicatessens, and retail confectionery stores where there are
facilities for immediate consumption on the premises; food service
vendors, such as lunch wagons, ice cream shops, mall cookie counters,
vending machines, and sidewalk carts where foods are generally consumed
immediately where purchased or while the consumer is walking away,
including similar foods sold from convenience stores; and food delivery
systems or establishments where ready-to-eat foods are delivered to
homes or offices), Provided, That the food bears no nutrition claims or
other nutrition information in any context on the label or in labeling
or advertising. Claims or other nutrition information subject the food
to the provisions of this section;
(iii) Sold only in such facilities, Provided, That the food bears no
nutrition claims or other nutrition information in any context on the
label or in labeling or advertising. Claims or other nutrition
information subject the food to the provisions of this section;
(iv) Used only in such facilities and not served to the consumer in
the package in which they are received (e.g., foods that are not
packaged in individual serving containers); or
(v) Sold by a distributor who principally sells food to such
facilities: Provided, That:
(A) This exemption shall not be available for those foods that are
manufactured, processed, or repackaged by that distributor for sale to
any persons other than restaurants or other establishments that serve
food for immediate human consumption, and
(B) The manufacturer of such products is responsible for providing
the nutrition information on the products if there is a reasonable
possibility that the product will be purchased directly by consumers.
(3) Food products that are:
(i) Of the type of food described in paragraphs (j)(2)(i) and
(j)(2)(ii) of this section,
(ii) Ready for human consumption,
(iii) Offered for sale to consumers but not for immediate human
consumption,
(iv) Processed and prepared primarily in a retail establishment, and
(v) Not offered for sale outside of that establishment (e.g., ready-
to-eat foods that are processed and prepared on-site and sold by
independent delicatessens, bakeries, or retail confectionery stores
where there are no facilities for immediate human consumption; by in-
store delicatessen, bakery, or candy departments; or at self-service
food bars such as salad bars), Provided, That the food bears no
nutrition
[[Page 45]]
claims or other nutrition information in any context on the label or in
labeling or advertising. Claims or other nutrition information subject
the food to the provisions of this section.
(4) Foods that contain insignificant amounts of all of the nutrients
and food components required to be included in the declaration of
nutrition information under paragraph (c) of this section, Provided,
That the food bears no nutrition claims or other nutrition information
in any context on the label or in labeling or advertising. Claims or
other nutrition information subject the food to the provisions of this
section. An insignificant amount of a nutrient or food component shall
be that amount that allows a declaration of zero in nutrition labeling,
except that for total carbohydrate, dietary fiber, and protein, it shall
be an amount that allows a declaration of ``less than 1 gram.'' Foods
that are exempt under this paragraph include coffee beans (whole or
ground), tea leaves, plain unsweetened instant coffee and tea,
condiment-type dehydrated vegetables, flavor extracts, and food colors.
(5)(i) Foods, other than infant formula, represented or purported to
be specifically for infants and children less than 2 years of age shall
bear nutrition labeling, except as provided in paragraph (j)(5)(ii) and
except that such labeling shall not include calories from fat (paragraph
(c)(1)(ii) of this section), calories from saturated fat ((c)(1)(iii)),
saturated fat ((c)(2)(i)), polyunsaturated fat ((c)(2)(ii)),
monounsaturated fat ((c)(2)(iii)), and cholesterol ((c)(3)).
(ii) Foods, other than infant formula, represented or purported to
be specifically for infants and children less than 4 years of age shall
bear nutrition labeling, except that:
(A) Such labeling shall not include declarations of percent of Daily
Value for total fat, saturated fat, cholesterol, sodium, potassium,
total carbohydrate, and dietary fiber;
(B) Nutrient names and quantitative amounts by weight shall be
presented in two separate columns.
(C) The heading ``Percent Daily Value'' required in paragraph (d)(6)
of this section shall be placed immediately below the quantitative
information by weight for protein;
(D) Percent of Daily Value for protein, vitamins, and minerals shall
be listed immediately below the heading ``Percent Daily Value''; and
(E) Such labeling shall not include the footnote specified in
paragraph (d)(9) of this section.
(6) Dietary supplements of vitamins or minerals that have an RDI as
established in paragraph (c)(8)(iv) of this section or a DRV as
established in paragraph (c)(9) of this section shall be labeled in
compliance with Sec. 101.36, except that dietary supplements of vitamins
or minerals in food in conventional form (e.g., breakfast cereals), of
herbs, and of other similar nutritional substances shall conform to the
labeling of this section.
(7) Infant formula subject to section 412 of the act, as amended,
except that such foods shall be labeled in compliance with part 107 of
this chapter.
(8) Medical foods as defined in section 5(b) of the Orphan Drug Act
(21 U.S.C. 360ee(b)(3)). A medical food is a food which is formulated to
be consumed or administered enterally under the supervision of a
physician and which is intended for the specific dietary management of a
disease or condition for which distinctive nutritional requirements,
based on recognized scientific principles, are established by medical
evaluation. A food is subject to this exemption only if:
(i) It is a specially formulated and processed product (as opposed
to a naturally occurring foodstuff used in its natural state) for the
partial or exclusive feeding of a patient by means of oral intake or
enteral feeding by tube;
(ii) It is intended for the dietary management of a patient who,
because of therapeutic or chronic medical needs, has limited or impaired
capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or
certain nutrients, or who has other special medically determined
nutrient requirements, the dietary management of which cannot be
achieved by the modification of the normal diet alone;
(iii) It provides nutritional support specifically modified for the
management of the unique nutrient needs that
[[Page 46]]
result from the specific disease or condition, as determined by medical
evaluation;
(iv) It is intended to be used under medical supervision; and
(v) It is intended only for a patient receiving active and ongoing
medical supervision wherein the patient requires medical care on a
recurring basis for, among other things, instructions on the use of the
medical food.
(9) Food products shipped in bulk form that are not for distribution
to consumers in such form and that are for use solely in the manufacture
of other foods or that are to be processed, labeled, or repacked at a
site other than where originally processed or packed.
(10) Raw fruits, vegetables, and fish subject to section 403(q)(4)
of the act, except that the labeling of such foods should adhere to
guidelines in Sec. 101.45. This exemption is contingent on the food
bearing no nutrition claims or other nutrition information in any
context on the label or in labeling or advertising. Claims or other
nutrition information subject the food to nutrition labeling in
accordance with Sec. 101.45. The term ``fish'' includes freshwater or
marine fin fish, crustaceans, and mollusks, including shellfish,
amphibians, and other forms of aquatic animal life.
(11) Packaged single-ingredient products that consist of fish or
game meat (i.e., animal products not covered under the Federal Meat
Inspection Act or the Poultry Products Inspection Act, such as flesh
products from deer, bison, rabbit, quail, wild turkey, or ostrich)
subject to this section may provide required nutrition information for a
3-ounce cooked edible portion (i.e., on an ``as prepared'' basis),
except that:
(i) Such products that make claims that are based on values as
packaged must provide nutrition information on an as packaged basis, and
(ii) Nutrition information is not required for custom processed fish
or game meats.
(12) Game meats (i.e., animal products not covered under the Federal
Meat Inspection Act or the Poultry Products Inspection Act, such as
flesh products from deer, bison, rabbit, quail, wild turkey, or ostrich)
may provide required nutrition information on labeling in accordance
with the provisions of paragraph (a)(2) of this section.
(13)(i) Foods in small packages that have a total surface area
available to bear labeling of less than 12 square inches, Provided, That
the labels for these foods bear no nutrition claims or other nutrition
information in any context on the label or in labeling or advertising.
Claims or other nutrition information subject the food to the provisions
of this section.
(A) The manufacturer, packer, or distributor shall provide on the
label of packages that qualify for and use this exemption an address or
telephone number that a consumer can use to obtain the required
nutrition information (e.g., ``For nutrition information, call 1-800-
123-4567'').
(B) When such products bear nutrition labeling, either voluntarily
or because nutrition claims or other nutrition information is provided,
all required information shall be in type size no smaller than 6 point
or all uppercase type of 1/16 inches minimum height, except that
individual serving-size packages of food served with meals in
restaurants, institutions, and on board passenger carriers, and not
intended for sale at retail, may comply with Sec. 101.2(c)(5).
(ii) Foods in packages that have a total surface area available to
bear labeling of 40 or less square inches may modify the requirements of
paragraphs (c) through (f) and (i) of this section by one or more of the
following means:
(A) Presenting the required nutrition information in a tabular or,
as provided below, linear (i.e., string) fashion rather than in vertical
columns if the product has a total surface area available to bear
labeling of less than 12 square inches, or if the product has a total
surface area available to bear labeling of 40 or less square inches and
the package shape or size cannot accommodate a standard vertical column
or tabular display on any label panel. Nutrition information may be
given in a linear fashion only if the label will not accommodate a
tabular display.
(1) The following sample label illustrates the tabular display.
[[Page 47]]
[GRAPHIC] [TIFF OMITTED] TR01JA93.355
(2) The following sample label illustrates the linear display. When
nutrition information is given in a linear fashion, bolding is required
only on the title ``Nutrition Facts`` and is allowed voluntarily for the
nutrient names for ``Calories,'' ``Total fat,'' ``Cholesterol,''
``Sodium,'' ``Total carbohydrate,'' and ``Protein.''
[GRAPHIC] [TIFF OMITTED] TR01JA93.356
(B) Using any of the following abbreviations:
Serving size--Serv size
Servings per container--Servings
Calories from fat--Fat cal
Calories from saturated fat--Sat fat cal
Saturated fat--Sat fat
Monounsaturated fat--Monounsat fat
Polyunsaturated fat--Polyunsat fat
Cholesterol--Cholest
Total carbohydrate--Total carb
Dietary fiber--Fiber
Soluble fiber--Sol fiber
Insoluble fiber--Insol fiber
Sugar alcohol--Sugar alc
Other carbohydrate--Other carb
(C) Omitting the footnote required in paragraph (d)(9) of this
section and placing another asterisk at the bottom of the label followed
by the statement ``Percent Daily Values are based on a 2,000 calorie
diet`` and, if the term ``Daily Value'' is not spelled out in the
heading, a statement that ``DV'' represents ``Daily Value.''
(D) Presenting the required nutrition information on any label
panel.
(14) Shell eggs packaged in a carton that has a top lid designed to
conform to the shape of the eggs are exempt from outer carton label
requirements where the required nutrition information is clearly
presented immediately beneath the carton lid or in an insert that can be
clearly seen when the carton is opened.
(15) The unit containers in a multiunit retail food package where:
(i) The multiunit retail food package labeling contains all
nutrition information in accordance with the requirements of this
section;
(ii) The unit containers are securely enclosed within and not
intended to be separated from the retail package under conditions of
retail sale; and
(iii) Each unit container is labeled with the statement ``This Unit
Not Labeled For Retail Sale'' in type size not less than 1/16-inch in
height, except that this statement shall not be required when the inner
unit containers
[[Page 48]]
bear no labeling at all. The word ``individual'' may be used in lieu of
or immediately preceding the word ``Retail'' in the statement.
(16) Food products sold from bulk containers: Provided, That
nutrition information required by this section be displayed to consumers
either on the labeling of the bulk container plainly in view or in
accordance with the provisions of paragraph (a)(2) of this section.
(17) Foods in packages that have a total surface area available to
bear labeling greater than 40 square inches but whose principal display
panel and information panel do not provide sufficient space to
accommodate all required information may use any alternate panel that
can be readily seen by consumers for the nutrition label. The space
needed for vignettes, designs, and other nonmandatory label information
on the principal display panel may be considered in determining the
sufficiency of available space on the principal display panel for the
placement of the nutrition label. Nonmandatory label information on the
information panel shall not be considered in determining the sufficiency
of available space for the placement of the nutrition label.
(k) A food labeled under the provisions of this section shall be
deemed to be misbranded under sections 201(n) and 403(a) of the act if
its label or labeling represents, suggests, or implies:
(1) That the food, because of the presence or absence of certain
dietary properties, is adequate or effective in the prevention, cure,
mitigation, or treatment of any disease or symptom. Information about
the relationship of a dietary property to a disease or health-related
condition may only be provided in conformance with the requirements of
Sec. 101.14 and part 101, subpart E.
(2) That a balanced diet of ordinary foods cannot supply adequate
amounts of nutrients.
(3) That the lack of optimum nutritive quality of a food, by reason
of the soil on which that food was grown, is or may be responsible for
an inadequacy or deficiency in the quality of the daily diet.
(4) That the storage, transportation, processing, or cooking of a
food is or may be responsible for an inadequacy or deficiency in the
quality of the daily diet.
(5) That the food has dietary properties when such properties are of
no significant value or need in human nutrition.
(6) That a natural vitamin in a food is superior to an added or
synthetic vitamin or to differentiate in any way between vitamins
naturally present from those added.
[58 FR 2175, Jan. 6, 1993, as amended at 58 FR 2227, 2533, Jan. 6, 1993;
58 FR 17104, Apr. 1, 1993; 58 FR 17328-17331, Apr. 2, 1993; 58 FR 44048,
44076, Aug. 18, 1993; 58 FR 59363, Nov. 9, 1993; 58 FR 60109, Nov. 15,
1993; 59 FR 371, Jan. 4, 1994; 59 FR 62317, Dec. 5, 1994; 60 FR 17205,
Apr. 5, 1995; 60 FR 30788, June 12, 1995; 60 FR 67174, Dec. 28, 1995; 61
FR 8779, Mar. 5, 1996; 61 FR 14479, Apr. 2, 1996]
Effective Date Notes: 1. At 60 FR 67174, Dec. 28, 1995, in
Sec. 101.9, paragraph (c)(8)(iv) was revised, effective January 1, 1997.
For the convenience of the reader, the superseded text is set forth
below.
Sec. 101.9 Nutrition labeling of food.
* * * * *
(c) * * *
(8) * * *
(iv) The following RDI's and nomenclature are established for the
following vitamins and minerals which are essential in human nutrition:
Vitamin A, 5,000 International Units.
Vitamin C, 60 milligrams.
Calcium, 1.0 gram.
Iron, 18 milligrams.
Vitamin D, 400 International Units.
Vitamin E, 30 International Units.
Thiamin, 1.5 milligrams.
Riboflavin, 1.7 milligrams.
Niacin, 20 milligrams.
Vitamin B6, 2.0 milligrams.
Folate, 0.4 milligrams.
Vitamin B12, 6.0 micrograms.
Biotin, 0.3 milligram.
Pantothenic acid, 10 milligrams.
Phosphorus, 1.0 gram.
Iodine, 150 micrograms.
Magnesium, 400 milligrams.
Zinc, 15 milligrams.
Copper, 2.0 milligrams.
* * * * *
2. At 61 FR 8779, Mar. 5, 1996, in Sec. 101.9, in paragraph
(c)(8)(v) the entry which read ``Folate--Folacin'' was revised to read
as set forth above in the text, effective April 19, 1996.
[[Page 49]]
Sec. 101.10 Nutrition labeling of restaurant foods.
Nutrition labeling in accordance with Sec. 101.9 shall be provided
upon request for any restaurant food or meal for which a nutrient
content claim (as defined in Sec. 101.13 or in subpart D of this part)
or a health claim (as defined in Sec. 101.14 and permitted by a
regulation in subpart E of this part) is made (except on menus). Except:
That information on the nutrient amounts that are the basis for the
claim (e.g., ``low fat,'' this meal provides less than 10 grams of fat)
may serve as the functional equivalent of complete nutrition information
as described in Sec. 101.9. Nutrient levels may be determined by
nutrient data bases, cookbooks, or analyses or by other reasonable bases
that provide assurance that the food or meal meets the nutrient
requirements for the claim. Presentation of nutrition labeling may be in
various forms, including those provided in Sec. 101.45 and other
reasonable means.
[58 FR 2410, Jan. 6, 1993; 58 FR 17341, Apr. 2, 1993]
Sec. 101.11 Saccharin and its salts; retail establishment notice.
Each retail establishment (except restaurants) that sells food that
contains saccharin shall display the following notice in the locations
set forth in paragraph (b) of this section:
[GRAPHIC] [TIFF OMITTED] TR01JA93.357
Each notice shall be displayed prominently, in a manner highly visible
to consumers (e.g., not shielded by other store signs or merchandise
displays) and set up to reduce the likelihood
[[Page 50]]
that a notice will be torn, defaced, or removed.
(a) The notice shall be printed in a combination of red and black
ink on white card stock and be at least 11 by 14 inches. The background
of the bold heading, ``Saccharin Notice,'' and the boxed warning
statement shall be bright red and the lettering, white. The remaining
background shall be white with black ink. All lettering shall be in
gothic typeface.
(b) Except as provided in paragraph (c) of this section, each retail
establishment that sells food that contains saccharin shall display a
notice in each of the following three locations:
(1) Near the entrance to the retail establishment and arranged so
that consumers are likely to see the notice upon entering.
(2) Centrally located in the area of the retail establishment in
which soft drinks containing saccharin are displayed. If there is more
than one such place, then in the area where the greatest quantity of
diet soft drinks are displayed.
(3) In the area in the establishment in which the largest quantity
of saccharin-containing foods (including saccharin sold in package form
as a sugar substitute) are displayed, other than the area where diet
soft drinks are displayed.
(c) The following are exceptions to the requirements set forth in
paragraph (b) of this section:
(1) A retail establishment with 3,200 square feet or less of floor
space shall display at least one notice. The notice shall be located
near the entrance to the retail establishment and arranged so that
consumers are likely to see the notice upon entering.
(2) A retail establishment with more than 3,200 but less than 10,000
square feet of floor space shall display at least two notices. The first
notice shall be located near the entrance to the retail establishment
and arranged so that consumers are likely to see the notice upon
entering. The second notice shall be centrally located in the area of
the retail establishment in which soft drinks containing saccharin are
displayed. If there is more than one such place, then in the area where
the greatest quantity of diet soft drinks are displayed. If diet soft
drinks are not sold, then in the area of the establishment in which the
largest quantity of saccharin-containing foods (including saccharin sold
in package form as a sugar substitute) are displayed.
(3) A large retail establishment, e.g., department store, whose
primary business consists of selling nonfood items (i.e., the proportion
of food sold is extremely small compared to other items) shall display
at least one notice. The notice shall be located in the area of the
establishment in which foods containing saccharin are displayed. If
there is more than one such area, then a notice shall be displayed in
each area.
(d) Each manufacturer of saccharin-containing food who customarily
delivers his products directly to retail establishments shall make
available at least three notices to each retail establishment in which
his products are sold. Each manufacturer shall also arrange to supply
additional notices to a retail establishment that asks for them.
(e) Manufacturers who do not customarily deliver their saccharin-
containing food products directly to retail establishments may fulfill
their obligation to provide notices either in the manner set forth in
paragraph (d) of this section or by participating in, and performing the
actions required by, a trade association coordinated program that meets
the following requirements:
(1) The coordinating association shall have filed notice of the
program with the Food and Drug Administration, including the
association's name, mailing address, telephone number, and contact
person.
(2) Each manufacturer participating in the program shall file notice
of its participation with the coordinating association, including its
name, mailing address, telephone number, and contact person.
(3) The association shall ensure that retail establishment notices,
in the form specified in this section, are readily available to
participating manufacturers.
(4) The association shall take affirmative steps to coordinate with
retail establishments, their trade associations,
[[Page 51]]
and the trade press to disseminate information about the applicable
requirements of the Saccharin Study and Labeling Act and these
regulations, the existence of the association coordinated program, and
the availability of notices through the program.
(5) Each manufacturer shall, in consultation with the association,
communicate with its contacts in the distributional chain to inform them
of the applicable requirements of the Saccharin Study and Labeling Act
and these regulations, and the continued availability of notices.
(6) Each manufacturer shall ensure that notices are promptly
provided on request to any retail establishment carrying its products.
(7) The association shall consult with participating manufacturers
concerning the implementation and progress of the program and shall
disseminate information to facilitate the conduct of the program based
on such consultations or consultation with the Food and Drug
Administration.
(8) The association shall, on request, permit the Food and Drug
Administration to have access to the participation notices filed by
manufacturers, samples showing the form of retail establishment notices
made available, and typical communication materials used by the
association in the course of the program.
[43 FR 8795, Mar. 3, 1978]
Sec. 101.12 Reference amounts customarily consumed per eating occasion.
(a) The general principles and factors that the Food and Drug
Administration (FDA) considered in arriving at the reference amounts
customarily consumed per eating occasion (reference amounts) which are
set forth in paragraph (b) of this section, are that:
(1) FDA calculated the reference amounts for persons 4 years of age
or older to reflect the amount of food customarily consumed per eating
occasion by persons in this population group. These reference amounts
are based on data set forth in appropriate national food consumption
surveys.
(2) FDA calculated the reference amounts for an infant or child
under 4 years of age to reflect the amount of food customarily consumed
per eating occasion by infants up to 12 months of age or by children 1
through 3 years of age, respectively. These reference amounts are based
on data set forth in appropriate national food consumption surveys. Such
reference amounts are to be used only when the food is specially
formulated or processed for use by an infant or by a child under 4 years
of age.
(3) An appropriate national food consumption survey includes a large
sample size representative of the demographic and socioeconomic
characteristics of the relevant population group and must be based on
consumption data under actual conditions of use.
(4) To determine the amount of food customarily consumed per eating
occasion, FDA considered the mean, median, and mode of the consumed
amount per eating occasion.
(5) When survey data were insufficient, FDA took various other
sources of information on serving sizes of food into consideration.
These other sources of information included:
(i) Serving sizes used in dietary guidance recommendations or
recommended by other authoritative systems or organizations;
(ii) Serving sizes recommended in comments;
(iii) Serving sizes used by manufacturers and grocers; and
(iv) Serving sizes used by other countries.
(6) Because they reflect the amount customarily consumed, the
reference amount and, in turn, the serving size declared on the product
label are based on only the edible portion of food, and not bone, seed,
shell, or other inedible components.
(7) The reference amount is based on the major intended use of the
food (e.g., milk as a beverage and not as an addition to cereal).
(8) The reference amounts for products that are consumed as an
ingredient of other foods, but that may also be consumed in the form in
which they are purchased (e.g., butter), are based on use in the form
purchased.
(9) FDA sought to ensure that foods that have similar dietary usage,
product characteristics, and customarily consumed amounts have a uniform
reference amount.
[[Page 52]]
(b) The following reference amounts shall be used as the basis for
determining serving sizes for specific products:
Table 1.--Reference Amounts Customarily Consumed Per Eating Occasion:
Infant and Toddler Foods 1,2,3,4
------------------------------------------------------------------------
Product category Reference amount Label statement5
------------------------------------------------------------------------
Cereals, dry instant........ 15 g................ ------ cup (------
g)
Cereals, prepared, ready-to- 110 g............... ------ cup(s) (------
serve. g)
Other cereal and grain 7 g for infants and ------ cup(s) (------
products, dry ready-to-eat, 20 g for toddlers g) for ready-to-
e.g., ready-to-eat cereals, for ready-to-eat eat cereals; ------
cookies, teething biscuits, cereals; 7 g for piece(s) (------ g)
and toasts. all others. for others
Dinners, desserts, fruits, 15 g................ ------ tbsp(s)
vegetables or soups, dry (------ g); ------
mix. cup(s) (------ g)
Dinners, desserts, fruits, 110 g............... ------ cup(s) (------
vegetables or soups, ready- g); ------ cup(s)
to-serve, junior type. (------ mL)
Dinners, desserts, fruits, 60 g................ ------ cup(s) (------
vegetables or soups, ready- g); ------ cup(s)
to-serve, strained type. (------ mL)
Dinners, stews or soups for 170 g............... ------ cup(s) (------
toddlers, ready-to-serve. g); ------ cup(s)
(------ mL)
Fruits for toddlers, ready- 125 g............... ------ cup(s) (------
to-serve. g)
Vegetables for toddlers, 70 g................ ------ cup(s) (------
ready-to- serve. g)
Eggs/egg yolks, ready-to- 55 g................ ------ cup(s) (------
serve. g)
Juices, all varieties....... 120 mL.............. 4 fl oz (120 mL)
------------------------------------------------------------------------
\1\ These values represent the amount of food customarily consumed per
eating occasion and were primarily derived from the 1977-1978 and the
1987-1988 Nationwide Food Consumption Surveys conducted by the U.S.
Department of Agriculture.
\2\ Unless otherwise noted in the Reference amount column, the reference
amounts are for the ready-to-serve or almost ready-to-serve form of
the product (i.e., heat and serve, brown and serve). If not listed
separately, the reference amount for the unprepared form (e.g., dry
cereal) is the amount required to make the reference amount of the
prepared form. Prepared means prepared for consumption (e.g., cooked).
\3\ Manufacturers are required to convert the reference amount to the
label serving size in a household measure most appropriate to their
specific product using the procedures in 21 CFR 101.9(b).
\4\Copies of the list of products for each product category are
available from the Office of Food Labeling (HFS-150), Center for Food
Safety and Applied Nutrition, Food and Drug Administration, 200 C St.
SW., Washington, DC 20204.
\5\ The label statements are meant to provide guidance to manufacturers
on the presentation of serving size information on the label, but they
are not required. The term ``piece'' is used as a generic description
of a discrete unit. Manufacturers should use the description of a unit
that is most appropriate for the specific product (e.g., sandwich for
sandwiches, cookie for cookies, and bar for frozen novelties).
Table 2.--Reference Amounts Customarily Consumed Per Eating Occasion:
General Food Supply1,2,3,4
------------------------------------------------------------------------
Product category Reference amount Label statement5
------------------------------------------------------------------------
Bakery products:
Biscuits, croissants, 55 g................ ------ piece(s) (----
bagels, tortillas, soft -- g)
bread sticks, soft
pretzels, corn bread,
hush puppies.
Breads (excluding sweet 50 g................ ------ piece(s) (----
quick type), rolls. -- g) for sliced
bread and distinct
pieces (e.g.,
rolls); 2 oz (56 g/
------ inch slice)
for unsliced bread
Bread sticks--see .................... ....................
crackers.
Toaster pastries--see .................... ....................
coffee cakes.
Brownies................ 40 g................ ------ piece(s) (----
-- g) for distinct
pieces; fractional
slice (------ g)
for bulk
Cakes, heavy weight 125 g............... ------ piece(s) (----
(cheese cake; pineapple -- g) for distinct
upside-down cake; pieces (e.g.,
fruit, nut, and sliced or
vegetable cakes with individually
more than or equal to packaged products);
35 percent of the ------ fractional
finished weight as slice (------ g)
fruit, nuts, or for large discrete
vegetables or any of units
these combined)6.
Cakes, medium weight 80 g................ ------ piece(s) (----
(chemically leavened -- g) for distinct
cake with or without pieces (e.g.,
icing or filling except cupcake); ------
those classified as fractional slice (--
light weight cake; ---- g) for large
fruit, nut, and discrete units
vegetable cake with
less than 35 percent of
the finished weight as
fruit, nuts, or
vegetables or any of
these combined; light
weight cake with icing;
Boston cream pie;
cupcake; eclair; cream
puff)7.
[[Page 53]]
Cakes, light weight 55 g................ ------ piece(s) (----
(angel food, chiffon, -- g) for distinct
or sponge cake without pieces (e.g.,
icing or filling)8. sliced or
individually
packaged products);
------ fractional
slice (------ g)
for large discrete
units
Coffee cakes, crumb 55 g................ ------ piece(s) (----
cakes, doughnuts, -- g) for sliced
Danish, sweet rolls, bread and distinct
sweet quick type pieces (e.g.,
breads, muffins, doughnut); 2 oz (56
toaster pastries. g/visual unit of
measure) for bulk
products (e.g.,
unsliced bread)
Cookies................. 30 g................ ------ piece(s) (----
-- g)
Crackers that are 15 g................ ------ piece(s) (----
usually not used as -- g)
snack, melba toast,
hard bread sticks, ice
cream cones9.
Crackers that are 30 g................ ------ piece(s) (----
usually used as snacks. -- g)
Croutons................ 7 g................. ------ tbsp(s)
(------ g); ------
cup(s) (------ g);
------ piece(s)
(------ g) for
large pieces
French toast, pancakes, 110 g prepared for ------ piece(s) (----
variety mixes. french toast and -- g); ------
pancakes; 40 g dry cup(s) (------ g)
mix for variety for dry mix
mixes.
Grain-based bars with or 40 g................ ------ piece(s) (----
without filling or -- g)
coating, e.g.,
breakfast bars, granola
bars, rice cereal bars.
Ice cream cones--see .................... ....................
crackers.
Pies, cobblers, fruit 125 g............... ------ piece(s) (----
crisps, turnovers, --g) for distinct
other pastries. pieces; ------
fractional slice (--
---- g) for large
discrete units
Pie crust............... 1/6 of 8 inch crust; 1/6 of 8 inch crust
1/8 of 9 inch crust. (------ g); 1/8 of
9 inch crust (------
g)
Pizza crust............. 55 g................ ------ fractional
slice (------ g)
Taco shells, hard....... 30 g................ ------ shell(s) (----
-- g)
Waffles................. 85 g................ ------ piece(s) (----
-- g)
Beverages:
Carbonated and 240 mL.............. 8 fl oz (240 mL)
noncarbonated
beverages, wine
coolers, water.
Coffee or tea, flavored 240 mL prepared..... 8 fl oz (240 mL)
and sweetened.
Cereal and Other Grain
Products:
Breakfast cereals (hot 1 cup prepared; 40 g ------ cup(s) (------
cereal type), hominy plain dry cereal; g)
grits. 55 g flavored,
sweetened dry
cereal.
Breakfast cereals, ready- 15 g................ ------ cup(s) (------
to-eat, weighing less g)
than 20 g per cup,
e.g., plain puffed
cereal grains.
Breakfast cereals, ready- 30 g................ ------ cup(s) (------
to-eat weighing 20 g or g)
more but less than 43 g
per cup; high fiber
cereals containing 28 g
or more of fiber per
100 g.
Breakfast cereals, ready- 55 g................ ------ piece(s) (----
to-eat, weighing 43 g -- g) for large
or more per cup; distinct pieces
biscuit types. (e.g., biscuit
type);------ cup(s)
(------ g) for all
others
Bran or wheat germ...... 15 g................ ------ tbsp(s)
(------ g); ------
cup(s) (------ g)
Flours or cornmeal...... 30 g................ ------ tbsp(s)
(------ g); ------
cup(s) (------ g)
Grains, e.g., rice, 140 g prepared; 45 g ------ cup(s) (------
barley, plain. dry. g)
Pastas, plain........... 140 g prepared; 55 g ------ cup(s) (------
dry. g); ------
piece(s) (------ g)
for large pieces
(e.g., large shells
or lasagna noodles)
or 2 oz (56 g/
visual unit of
measure) for dry
bulk products
(e.g., spaghetti)
Pastas, dry, ready-to- 25 g................ ------ cup(s) (------
eat, e.g., fried canned g)
chow mein noodles.
Starches, e.g., 10 g................ ------ tbsp (------
cornstarch, potato g)
starch, tapioca, etc..
Stuffing................ 100 g............... ------ cup(s) (------
g)
Dairy Products and
Substitutes:
Cheese, cottage......... 110 g............... ------ cup (------
g)
Cheese used primarily as 55 g................ ------ cup (------
ingredients, e.g., dry g)
cottage cheese, ricotta
cheese.
[[Page 54]]
Cheese, grated hard, 5 g................. ------ tbsp (------
e.g., Parmesan, Romano. g)
Cheese, all others 30 g................ ------ piece(s) (----
except those listed as -- g) for distinct
separate categories-- pieces;------
includes cream cheese tbsp(s) (------ g)
and cheese spread. for cream cheese
and cheese spread;
1 oz (28 g/visual
unit of measure)
for bulk
Cheese sauce--see sauce
category.
Cream or cream 15 mL............... 1 tbsp (15 mL)
substitutes, fluid.
Cream or cream 2 g................. ------ tsp (------
substitutes, powder. g)
Cream, half & half...... 30 mL............... 2 tbsp (30 mL)
Eggnog.................. 120 mL.............. 1/2 cup (120 mL); 4
fl oz (120 mL)
Milk, condensed, 30 mL............... 2 tbsp (30 mL)
undiluted.
Milk, evaporated, 30 mL............... 2 tbsp (30 mL)
undiluted.
Milk, milk-based drinks, 240 mL.............. 1 cup (240 mL); 8 fl
e.g., instant oz (240 mL)
breakfast, meal
replacement, cocoa.
Shakes or shake 240 mL.............. 1 cup (240 mL); 8 fl
substitutes, e.g., oz (240 mL)
dairy shake mixes,
fruit frost mixes.
Sour cream.............. 30 g................ ------ tbsp (------
g)
Yogurt.................. 225 g............... ------ cup (------
g)
Desserts:
Ice cream, ice milk, 1/2 cup-includes the ------ piece(s) (----
frozen yogurt, sherbet: volume for coatings -- g) for
all types, bulk and and wafers for the individually
novelties (e.g., bars, novelty type wrapped or packaged
sandwiches, cones). varieties. products; 1/2 cup
(------ g) for
others
Frozen flavored and 85 g................ ------ piece(s) (----
sweetened ice and pops, -- g) for
frozen fruit juices: individually
all types, bulk and wrapped or packaged
novelties (e.g., bars, products; ------
cups). cup(s) (------ g)
for others
Sundae.................. 1 cup............... 1 cup (------ g)
Custards, gelatin or 1/2 cup............. ------ piece(s) (----
pudding. -- g) for distinct
unit (e.g.,
individually
packaged products);
1/2 cup (------ g)
for bulk
Dessert Toppings and
Fillings:
Cake frostings or icings 35 g................ ------ tbsp(s)
(------ g)
Other dessert toppings, 2 tbsp.............. 2 tbsp (------ g); 2
e.g., fruits, syrups, tbsp (30 mL)
spreads, marshmallow
cream, nuts, dairy and
nondairy whipped
toppings.
Pie fillings............ 85 g................ ------ cup(s) (------
g)
Egg and Egg Sustitutes:
Egg mixtures, e.g., egg 110 g............... ------ piece(s) (----
foo young, scrambled -- g) for discrete
eggs, omelets. pieces; ------
cup(s) (------ g)
Eggs (all sizes)9....... 50 g................ 1 large, medium,
etc. (------ g)
Egg substitutes......... An amount to make 1 ------ cup(s) (------
large (50 g) egg. g); ------ cup(s)
(------ mL)
Fats and Oils:
Butter, margarine, oil, 1 tbsp.............. 1 tbsp (------ g); 1
shortening. tbsp (15 mL)
Butter replacement, 2 g................. ------ tsp(s) (------
powder. g)
Dressings for salads.... 30 g................ ------ tbsp (------
g); ------ tbsp
(------ mL)
Mayonnaise, sandwich 15 g................ ------ tbsp (------
spreads, mayonnaise- g)
type dressings.
Spray types............. 0.25 g.............. About ------ seconds
spray (------ g)
Fish, Shellfish, Game
Meats10, and Meat or
Poultry Substitutes:
Bacon substitutes, 15 g................ ------ piece(s) (----
canned anchovies,11 -- g) for discrete
anchovy pastes, caviar. pieces; ------
tbsp(s) (------ g)
for others
Dried, e.g., jerky...... 30 g................ ------ piece(s) (----
-- g)
Entrees with sauce, 140 g cooked........ ------ cup(s) (------
e.g., fish with cream g); 5 oz (140 g/
sauce, shrimp with visual unit of
lobster sauce. measure) if not
measurable by cup
Entrees without sauce, 85 g cooked; 110 g ------ piece(s) (----
e.g., plain or fried uncooked12. -- g) for discrete
fish and shellfish, pieces; ------
fish and shellfish cake. cup(s) (------ g);
------ oz (------ g/
visual unit of
measure) if not
measurable by cup13
[[Page 55]]
Fish, shellfish or game 55 g................ ------ piece(s) (----
meat10, canned11. -- g) for discrete
pieces; ------
cup(s) (------ g);
2 oz (56 g/------
cup) for products
that are difficult
to measure the g
weight of cup
measure (e.g.,
tuna); 2 oz (56 g/--
---- pieces) for
products that
naturally vary in
size (e.g.,
sardines)
Substitute for luncheon 55 g................ ------ piece(s) (----
meat, meat spreads, -- g) for distinct
Canadian bacon, pieces (e.g.,
sausages and slices, links); ----
frankfurters. -- cup(s) (------
g); 2 oz (56 g/
visual unit of
measure) for
nondiscrete bulk
product
Smoked or pickled11 55 g................ ------ piece(s) (----
fish, shellfish, or -- g) for distinct
game meat10; fish or pieces (e.g.,
shellfish spread. slices, links) or --
---- cup(s) (------
g); 2 oz (56 g/
visual unit of
measure) for
nondiscrete bulk
product
Substitutes for bacon
bits--see miscellaneous
category.
Fruits and Fruit Juices:
Candied or pickled11.... 30 g................ ------ piece(s) (----
-- g)
Dehydrated fruits--see .................... ....................
snacks category.
Dried................... 40 g................ ------ piece(s) (----
-- g) for large
pieces (e.g.,
dates, figs,
prunes); ------
cup(s) (------ g)
for small pieces
(e.g., raisins)
Fruits for garnish or 4 g................. 1 cherry (------ g)
flavor, e.g.,
maraschino cherries11.
Fruit relishes, e.g., 70 g................ ------ cup(s) (------
cranberry sauce, g)
cranberry relish.
Fruits used primarily as 30 g................ See footnote 13
ingredients, avocado.
Fruits used primarily as 55 g................ ------ piece(s) (----
ingredients, others -- g) for large
(cranberries, lemon, fruits; ------
lime). cup(s) (------ g)
for small fruits
measurable by cup13
Watermelon.............. 280 g............... See footnote 13
All other fruits (except 140 g............... ------ piece(s) (----
those listed as -- g) for large
separate categories), pieces (e.g.,
fresh, canned, or strawberries,
frozen. prunes, apricots,
etc.); ------
cup(s) (------ g)
for small pieces
(e.g., blueberries,
raspberries,
etc.)13
Juices, nectars, fruit 240 mL.............. 8 fl oz (240 mL)
drinks.
Juices used as 5 mL................ 1 tsp (5 mL)
ingredients, e.g.,
lemon juice, lime juice.
Legumes:
Bean cake (tofu)11, 85 g................ ------ piece(s) (----
tempeh. -- g) for discrete
pieces; 3 oz (84 g/
visual unit of
measure) for bulk
products
Beans, plain or in sauce 130 g for beans in ------ cup (------
sauce or canned in g)
liquid and refried
beans prepared; 90
g for others
prepared; 35 g dry.
Miscellaneous Category:
Baking powder, baking 1 g................. ------ tsp (------
soda, pectin. g)
Baking decorations, 1 tsp or 4 g if not ------ piece(s) (----
e.g., colored sugars measurable by -- g) for discrete
and sprinkles for teaspoon. pieces;1 tsp (------
cookies, cake g)
decorations.
Batter mixes, bread 30 g................ ------ tbsp(s)
crumbs. (------ g);------
cup(s) (------ g)
Cooking wine............ 30 mL............... 2 tbsp (30 mL)
Dietary supplements not The maximum amount ------ tablet(s),
in conventional food recommended, as ------ capsule(s),
form.. appropriate, on the ------ packet(s), --
label for ---- tsp(s) (------
consumption per g), etc.
eating occasion or,
in the absence of
recommendations, 1
unit, e.g., tablet,
capsule, packet,
teaspoonful, etc..
Drink mixers (without Amount to make 240 ------ fl oz (------
alcohol). mL drink (without mL)
ice).
Chewing gum9............ 3 g................. ------ piece(s) (----
-- g)
[[Page 56]]
Meat, poultry and fish Amount to make one ------ tsp(s) (------
coating mixes, dry; reference amount of g); ------ tbsp(s)
seasoning mixes, dry, final dish. (------ g)
e.g., chili seasoning
mixes, pasta salad
seasoning mixes.
Salad and potato 7 g................. ------ tbsp(s)
toppers, e.g., salad (------ g)
crunchies, salad
crispins, substitutes
for bacon bits.
Salt, salt substitutes, 1 g................. ------ tsp(s) (------
seasoning salts (e.g., g);------ piece(s)
garlic salt). (------ g) for
discrete pieces
(e.g., individually
packaged products)
Spices, herbs (other 1/4 tsp or 0.5 g if 1/4 tsp (------ g);
than dietary not measurable by ------ piece(s)
supplements). teaspoon. (------ g) if not
measurable by
teaspoons (e.g.,
bay leaf)
Mixed Dishes:
Measurable with cup, 1 cup.............. 1 cup (------ g)
e.g., casseroles, hash,
macaroni and cheese,
pot pies, spaghetti
with sauce, stews, etc..
Not measurable with cup, 140 g, add 55 g for ------ piece(s) (----
e.g., burritos, egg products with gravy -- g) for discrete
rolls, enchiladas, or sauce topping, pieces; ------
pizza, pizza rolls, e.g., enchilada fractional slice (--
quiche, all types of with cheese sauce, ---- g) for large
sandwiches. crepe with white discrete units
sauce14.
Nuts and Seeds:
Nuts, seeds, and 30 g................ ------ piece(s) (----
mixtures, all types: -- g) for large
sliced, chopped, pieces (e.g.,
slivered, and whole. unshelled nuts);----
-- tbsp(s) (------
g) ;------ cup(s)
(------ g) for
small pieces (e.g.,
peanuts, sunflower
seeds)
Nut and seed butters, 2 tbsp.............. 2 tbsp (------ g)
pastes, or creams.
Coconut, nut and seed 15 g................ ------ tbsp(s)
flours. (------ g); ------
cup (------ g)
Potatoes and Sweet Potatoes/
Yams:
French fries, hash 70 g prepared; 85 g ------ piece(s) (----
browns, skins, or for frozen -- g) for large
pancakes. unprepared french distinct pieces
fries. (e.g., patties,
skins); 2.5 oz (70
g/------ pieces)
for prepared fries;
3 oz (84 g/------
pieces) for
unprepared fries
Mashed, candied, 140 g............... ------ piece(s) (----
stuffed, or with sauce. -- g) for discrete
pieces (e.g.,
stuffed potato);
------ cup(s)
(------ g)
Plain, fresh, canned, or 110 g for fresh or ------ piece(s) (----
frozen. frozen; 125 g for -- g) for discrete
vacuum packed; 160 pieces;------
g for canned in cup(s) (------ g)
liquid. for sliced or
chopped products
Salads:
Gelatin salad........... 120 g............... ------ cup (------
g)
Pasta or potato salad... 140 g............... ------ cup(s) (------
g)
All other salads, e.g., 100 g............... ------ cup(s) (------
egg, fish, shellfish, g)
bean, fruit, or
vegetable salads.
Sauces, Dips, Gravies and
Condiments:
Barbecue sauce, 2 tbsp.............. 2 tbsp (------ g); 2
hollandaise sauce, tbsp (30 mL)
tartar sauce, other
sauces for dipping
(e.g., mustard sauce,
sweet and sour sauce),
all dips (e.g., bean
dips, dairy-based dips,
salsa).
Major main entree 125 g............... ------ cup (------
sauces, e.g., spaghetti g); ------ cup (----
sauce. -- mL)
Minor main entree sauces 1/4 cup............. 1/4 cup (------ g);
(e.g., pizza sauce, 1/4 cup (60 mL)
pesto sauce), other
sauces used as toppings
(e.g., gravy, white
sauce, cheese sauce),
cocktail sauce.
Major condiments, e.g., 1 tbsp.............. 1 tbsp (------ g); 1
catsup, steak sauce, tbsp (15 mL)
soy sauce, vinegar,
teriyaki sauce,
marinades.
Minor condiments, e.g., 1 tsp............... 1 tsp (------ g); 1
horseradish, hot tsp (5 mL)
sauces, mustards,
worcestershire sauce.
[[Page 57]]
Snacks:
All varieties, chips, 30 g................ ------ cup(s) (------
pretzels, popcorns, g) for small
extruded snacks, fruit- pieces (e.g.,
based snacks (e.g., popcorn) ------
fruit chips,) grain- piece(s) (------ g)
based snack mixes. for large pieces
(e.g., large
pretzels; pressed
dried fruit sheet);
1 oz (28 g/visual
unit of measure)
for bulk products
(e.g., potato
chips)
Soups:
All varieties........... 245 g............... ------ cup (------
g); ------ cup (----
-- mL)
Sugars and Sweets:
Baking candies (e.g., 15 g................ ------ piece(s) (----
chips). -- g) for large
pieces; ------
tbsp(s) (------ g)
for small pieces; 1/
2 oz (14 g/visual
unit of measure)
for bulk products
Hard candies, breath 2 g................. ------ piece(s) (----
mints. -- g)
Hard candies, roll-type, 5 g................. ------ piece(s) (----
mini-size in dispenser -- g)
packages.
Hard candies, others.... 15 g................ ------ piece(s) (----
-- g) for large
pieces;------
tbsp(s) (------ g)
for ``mini-size''
candies measurable
by tablespoon; 1/2
oz (14 g/visual
unit of measure)
for bulk products
All other candies....... 40 g................ ------ piece(s) (----
-- g); 1 1/2 oz (42
g/visual unit of
measure) for bulk
products
Confectioner's sugar.... 30 g................ ------ cup (------
g)
Honey, jams, jellies, 1 tbsp.............. 1 tbsp (------ g); 1
fruit butter, molasses. tbsp (15 mL)
Marshmallows............ 30 g................ ------ cup(s) (------
g) for small
pieces; ------
piece(s) (------ g)
for large pieces
Sugar................... 4 g................. ------ tsp (------
g) ; ------
piece(s) (------ g)
for discrete pieces
(e.g., sugar cubes,
individually
packaged products)
Sugar substitutes....... An amount equivalent ------ tsp(s) (------
to one reference g) for solids; ----
amount for sugar in -- drop(s) (------
sweetness. g) for liquid;
------ piece(s)
(------ g) (e.g.,
individually
packaged products)
Syrups.................. 30 mL for syrups 2 tbsp (30 mL) for
used primarily as syrups used
an ingredient primarily as an
(e.g., light or ingredient; 1/4 cup
dark corn syrup); (60 mL) for all
60 mL for all others
others.
Vegetables:
Vegetables primarily 4 g................. ------ piece(s) (----
used for garnish or -- g); ------
flavor, e.g., pimento, tbsp(s) (------ g)
parsley. for chopped
products
Chili pepper, green 30 g................ ------ piece(s) (----
onion. -- g)13; ------
tbsp(s) (------ g);
------ cup(s)
(------ g) for
sliced or chopped
products
All other vegetables 85 g for fresh or ------ piece(s) (----
without sauce: fresh, frozen; 95 g for -- g) for large
canned, or frozen. vacuum packed; 130 pieces (e.g.,
g for canned in brussel sprouts); --
liquid, cream-style ---- cup(s) (------
corn, canned or g) for small pieces
stewed tomatoes, (e.g., cut corn,
pumpkin, or winter green peas); 3 oz
squash. (84 g/visual unit
of measure) if not
measurable by cup13
All other vegetables 110 g............... ------ piece(s) (----
with sauce: fresh, -- g) for large
canned, or frozen. pieces (e.g.,
brussel sprouts); --
---- cup(s) (------
g) for small pieces
(e.g., cut corn,
green peas); 4 oz
(112 g/visual unit
of measure) if not
measurable by cup
Vegetable juice......... 240 mL.............. 8 fl oz (240 mL)
Olives11................ 15 g................ ------ piece(s) (----
-- g); ------
tbsp(s) (------ g)
for sliced products
Pickles, all types11.... 30 g................ 1 oz (28 g/visual
unit of measure)
Pickle relishes......... 15 g................ ------ tbsp (------
g)
Vegetable pastes, e.g., 30 g................ ------ tbsp (------
tomato paste. g)
[[Page 58]]
Vegetable sauces or 60 g................ ------ cup (------
purees, e.g, tomato g); ------ cup (----
sauce, tomato puree. -- mL)
------------------------------------------------------------------------
\1\ These values represent the amount (edible portion) of food
customarily consumed per eating occasion and were primarily derived
from the 1977-1978 and the 1987-1988 Nationwide Food Consumption
Surveys conducted by the U.S. Department of Argiculture.
\2\ Unless otherwise noted in the Reference Amount column, the reference
amounts are for the ready-to-serve or almost ready-to-serve form of
the product (i.e., heat and serve, brown and serve). If not listed
separately, the reference amount for the unprepared form (e.g., dry
mixes; concentrates; dough; batter; fresh and frozen pasta) is the
amount required to make the reference amount of the prepared form.
Prepared means prepared for consumption (e.g., cooked).
\3\ Manufacturers are required to convert the reference amount to the
label serving size in a household measure most appropriate to their
specific product using the procedures in 21 CFR 101.9(b).
\4\ Copies of the list of products for each product category are
available from the Office of Food Labeling (HFS-150), Center for Food
Safety and Applied Nutrition, Food and Drug Administration, 200 C St.
SW., Washington, DC 20204.
\5\ The label statements are meant to provide guidance to manufacturers
on the presentation of serving size information on the label, but they
are not required. The term ``piece'' is used as a generic description
of a discrete unit. Manufacturers should use the description of a unit
that is most appropriate for the specific product (e.g., sandwich for
sandwiches, cookie for cookies, and bar for ice cream bars). The
guidance provided is for the label statement of products in ready-to-
serve or almost ready-to-serve form. The guidance does not apply to
the products which require further preparation for consumption (e.g.,
dry mixes, concentrates) unless specifically stated in the product
category, reference amount, or label statement column that it is for
these forms of the product. For products that require further
preparation, manufacturers must determine the label statement
following the rules in Sec. 101.9(b) using the reference amount
determined according to Sec. 101.12(c).
\6\ Includes cakes that weigh 10 g or more per cubic inch.
\7\ Includes cakes that weigh 4 g or more per cubic inch but less than
10 g per cubic inch.
\8\ Includes cakes that weigh less than 4 g per cubic inch.
\9\ Label serving size for ice cream cones and eggs of all sizes will be
1 unit. Label serving size of all chewing gums that weigh more than
the reference amount that can reasonably be consumed at a single-
eating occasion will be 1 unit.
\10\ Animal products not covered under the Federal Meat Inspection Act
or the Poultry Products Inspection Act, such as flesh products from
deer, bison, rabbit, quail, wild turkey, geese, ostrich, etc.
\11\ If packed or canned in liquid, the reference amount is for the
drained solids, except for products in which both the solids and
liquids are customarily consumed (e.g., canned chopped clam in juice).
\12\ The reference amount for the uncooked form does not apply to raw
fish in Sec. 101.45 or to single-ingredient products that consist of
fish or game meat as provided for in Sec. 101.9(b)(j)(11).
\13\ For raw fruit, vegetables, and fish, manufacturers should follow
the label statement for the serving size specified in Appendices A and
B to the regulation entitled ``Food Labeling; Guidelines for Voluntary
Nutrition Labeling; and Identification of the 20 Most Frequently
Consumed Raw Fruits, Vegetables, and Fish; Definition of Substantial
Compliance; Correction'' (56 FR 60880 as amended 57 FR 8174, March 6,
1992).
\14\ Pizza sauce is part of the pizza and is not considered to be sauce
topping.
(c) If a product requires further preparation, e.g., cooking or the
addition of water or other ingredients, and if paragraph (b) of this
section provides a reference amount for the product in the prepared but
not the unprepared form, then the reference amount for the unprepared
product shall be determined using the following rules:
(1) Except as provided for in paragraph (c)(2) of this section, the
reference amount for the unprepared product shall be the amount of the
unprepared product required to make the reference amount for the
prepared product as established in paragraph (b) of this section.
(2) For products where the entire contents of the package is used to
prepare one large discrete unit usually divided for consumption, the
reference amount for the unprepared product shall be the amount of the
unprepared product required to make the fraction of the large discrete
unit closest to the reference amount for the prepared product as
established in paragraph (b) of this section.
(d) The reference amount for an imitation or substitute food or
altered food, such as a ``low calorie'' version, shall be the same as
for the food for which it is offered as a substitute.
(e) If a food is modified by incorporating air (aerated), and
thereby the density of the food is lowered by 25 percent or more in
weight than that of an appropriate reference regular food as described
in Sec. 101.13(j)(1)(ii)(A), and the reference amount of the regular
food is in grams, the manufacturer may determine the reference amount of
the aerated food by adjusting for the difference in density of the
aerated food relative to the density of the appropriate reference food
provided that the manufacturer will show FDA detailed protocol and
records of all data that were used to determine the density-adjusted
reference amount for the aerated food. The reference amount for the
aerated food shall be rounded to
[[Page 59]]
the nearest 5-g increment. Such products shall bear a descriptive term
indicating that extra air has been incorporated (e.g., whipped,
aerated). The density-adjusted reference amounts described in paragraph
(b) of this section may not be used for cakes except for cheese cake.
The differences in the densities of different types of cakes having
different degrees of air incorporation have already been taken into
consideration in determining the reference amounts for cakes in
Sec. 101.12(b). In determining the difference in density of the aerated
and the regular food, the manufacturer shall adhere to the following:
(1) The regular and the aerated product must be the same in size,
shape, and volume. To compare the densities of products having nonsmooth
surfaces (e.g., waffles), manufacturers shall use a device or method
that ensures that the volumes of the regular and the aerated products
are the same.
(2) Sample selections for the density measurements shall be done in
accordance with the provisions in Sec. 101.9(e).
(3) Density measurements of the regular and the aerated products
shall be conducted by the same trained operator using the same
methodology (e.g., the same equipment, procedures, and techniques) under
the same conditions.
(4) Density measurements shall be replicated a sufficient number of
times to ensure that the average of the measurements is representative
of the true differences in the densities of the regular and the
``aerated'' products.
(f) For products that have no reference amount listed in paragraph
(b) of this section for the unprepared or the prepared form of the
product and that consist of two or more foods packaged and presented to
be consumed together (e.g., peanut putter and jelly, cracker and cheese
pack, pancakes and syrup, cake and frosting), the reference amount for
the combined product shall be determined using the following rules:
(1) For bulk products (e.g., peanut butter and jelly), the reference
amount for the combined product shall be the reference amount, as
established in paragraph (b) of this section, for the ingredient that is
represented as the main ingredient plus proportioned amounts of all
minor ingredients.
(2) For products where the ingredient represented as the main
ingredient is one or more discrete units (e.g., cracker and cheese pack,
pancakes and syrup, cake and frosting), the reference amount for the
combined product shall be either the number of small discrete units or
the fraction of the large discrete unit that is represented as the main
ingredient that is closest to the reference amount for that ingredient
as established in paragraph (b) of this section plus proportioned
amounts of all minor ingredients.
(3) If the reference amounts are in compatible units, they shall be
summed (e.g., the reference amount for equal volumes of peanut butter
and jelly for which peanut butter is represented as the main ingredient
would be 4 tablespoons (tbsp) (2 tbsp peanut butter plus 2 tbsp jelly).
If the reference amounts are in incompatible units, the weights of the
appropriate volumes should be used (e.g., 110 grams (g) pancakes plus
the gram weight of the proportioned amount of syrup).
(g) The reference amounts set forth in paragraphs (b) through (f) of
this section shall be used in determining whether a product meets the
criteria for nutrient content claims, such as ``low calorie,'' and for
health claims. If the serving size declared on the product label differs
from the reference amount, and the product meets the criteria for the
claim only on the basis of the reference amount, the claim shall be
followed by a statement that sets forth the basis on which the claim is
made. That statement shall include the reference amount as it appears in
paragraph (b) of this section followed, in parenthesis, by the amount in
common household measure if the reference amount is expressed in
measures other than common household measures (e.g., for a beverage,
``Very low sodium, 35 mg or less per 240 mL (8 fl oz)'').
(h) The Commissioner of Food and Drugs, either on his or her own
initiative or in response to a petition submitted pursuant to part 10 of
this chapter, may issue a proposal to establish or amend a reference
amount in paragraph (b) of this section. A petition to
[[Page 60]]
establish or amend a reference amount shall include:
(1) Objective of the petition;
(2) A description of the product;
(3) A complete sample product label including nutrition label, using
the format established by regulation;
(4) A description of the form (e.g., dry mix, frozen dough) in which
the product will be marketed;
(5) The intended dietary uses of the product with the major use
identified (e.g., milk as a beverage and chips as a snack);
(6) If the intended use is primarily as an ingredient in other
foods, list of foods or food categories in which the product will be
used as an ingredient with information on the prioritization of the use;
(7) The population group for which the product will be offered for
use (e.g., infants, children under 4 years of age);
(8) The names of the most closely related products (or in the case
of foods for special dietary use and imitation or substitute foods, the
names of the products for which they are offered as substitutes);
(9) The suggested reference amount (the amount of edible portion of
food as consumed, excluding bone, seed, shell, or other inedible
components) for the population group for which the product is intended
with full description of the methodology and procedures that were used
to determine the suggested reference amount. In determining the
reference amount, general principles and factors in paragraph (a) of
this section should be followed.
(10) The suggested reference amount shall be expressed in metric
units. Reference amounts for fluids shall be expressed in milliliters.
Reference amounts for other foods shall be expressed in grams except
when common household units such as cups, tablespoons, and teaspoons,
are more appropriate or are more likely to promote uniformity in serving
sizes declared on product labels. For example, common household measures
would be more appropriate if products within the same category differ
substantially in density, such as frozen desserts.
(i) In expressing the reference amounts in milliliters, the
following rules shall be followed:
(A) For volumes greater than 30 milliliters (mL), the volume shall
be expressed in multiples of 30 mL.
(B) For volumes less than 30 mL, the volume shall be expressed in
milliliters equivalent to a whole number of teaspoons or 1 tbsp, i.e.,
5, 10, or 15 mL.
(ii) In expressing the reference amounts in grams, the following
general rules shall be followed:
(A) For quantities greater than 10 g, the quantity shall be
expressed in the nearest 5-g increment.
(B) For quantities less than 10 g, exact gram weights shall be used.
(11) A petition to create a new subcategory of food with its own
reference amount shall include the following additional information:
(i) Data that demonstrate that the new subcategory of food will be
consumed in amounts that differ enough from the reference amount for the
parent category to warrant a separate reference amount. Data must
include sample size; and the mean, standard deviation, median, and modal
consumed amount per eating occasion for the petitioned product and for
other products in the category, excluding the petitioned product. All
data must be derived from the same survey data.
(ii) Documentation supporting the difference in dietary usage and
product characteristics that affect the consumption size that
distinguishes the petitioned product from the rest of the products in
the category.
(12) A claim for categorical exclusion under Sec. 25.24 of this
chapter or an environmental assessment under Sec. 25.31 of this chapter;
and
(13) In conducting research to collect or process food consumption
data in support of the petition, the following general guidelines should
be followed.
(i) Sampled population selected should be representative of the
demographic and socioeconomic characteristics of the target population
group for which the food is intended.
(ii) Sample size (i.e., number of eaters) should be large enough to
give reliable estimates for customarily consumed amounts.
(iii) The study protocol should identify potential biases and
describe how potential biases are controlled for or, if
[[Page 61]]
not possible to control, how they affect interpretation of results.
(iv) The methodology used to collect or process data should be fully
documented and should include: study design, sampling procedures,
materials used (e.g., questionnaire, and interviewer's manual),
procedures used to collect or process data, methods or procedures used
to control for unbiased estimates, and procedures used to correct for
nonresponse.
(14) A statement concerning the feasibility of convening
associations, corporations, consumers, and other interested parties to
engage in negotiated rulemaking to develop a proposed rule consistent
with the Negotiated Rulemaking Act (5 U.S.C. 561).
[58 FR 44051, Aug. 18, 1993; 58 FR 60109, Nov. 15, 1993, as amended at
59 FR 371, Jan. 4, 1994; 59 FR 24039, May 10, 1994]
Sec. 101.13 Nutrient content claims--general principles.
(a) This section and the regulations in subpart D of this part apply
to foods that are intended for human consumption and that are offered
for sale, including foods in conventional food form and dietary
supplements of vitamins, minerals, herbs, and other similar nutritional
substances (dietary supplements).
(b) A claim that expressly or implicitly characterizes the level of
a nutrient (nutrient content claim) of the type required in nutrition
labeling under Sec. 101.9, with the exception of such claims on
restaurant menus, may not be made on the label or in labeling of foods
unless the claim is made in accordance with this regulation and with the
applicable regulations in subpart D of this part or in part 105 or part
107 of this chapter.
(1) An expressed nutrient content claim is any direct statement
about the level (or range) of a nutrient in the food, e.g., ``low
sodium'' or ``contains 100 calories.''
(2) An implied nutrient content claim is any claim that:
(i) Describes the food or an ingredient therein in a manner that
suggests that a nutrient is absent or present in a certain amount (e.g.,
``high in oat bran''); or
(ii) Suggests that the food, because of its nutrient content, may be
useful in maintaining healthy dietary practices and is made in
association with an explicit claim or statement about a nutrient (e.g.,
``healthy, contains 3 grams (g) of fat'').
(3) Except for claims regarding vitamins and minerals described in
paragraph (q)(3) of this section, no nutrient content claims may be made
on food intended specifically for use by infants and children less than
2 years of age unless the claim is specifically provided for in parts
101, 105, or 107 of this chapter.
(4) Reasonable variations in the spelling of the terms defined in
part 101 and their synonyms are permitted provided these variations are
not misleading (e.g., ``hi'' or ``lo'').
(5) For dietary supplements, claims for calories, fat, saturated
fat, and cholesterol may not be made on products that meet the criteria
in Sec. 101.60(b)(1) or (b)(2) for ``calorie free'' or ``low calorie''
claims, except, in the case of calorie claims, when an equivalent amount
of a similar dietary supplement (e.g., another protein supplement) that
the labeled food resembles and for which it substitutes, normally
exceeds the definition for ``low calorie'' in Sec. 101.60(b)(2).
(c) Information that is required or permitted by Sec. 101.9 or
Sec. 101.36, as applicable, to be declared in nutrition labeling, and
that appears as part of the nutrition label, is not a nutrient content
claim and is not subject to the requirements of this section. If such
information is declared elsewhere on the label or in labeling, it is a
nutrient content claim and is subject to the requirements for nutrient
content claims.
(d) A ``substitute'' food is one that may be used interchangeably
with another food that it resembles, i.e., that it is organoleptically,
physically, and functionally (including shelf life) similar to, and that
it is not nutritionally inferior to unless it is labeled as an
``imitation.''
(1) If there is a difference in performance characteristics that
materially limits the use of the food, the food may still be considered
a substitute if the label includes a disclaimer adjacent to the most
prominent claim as defined in
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paragraph (j)(2)(iii) of this section, informing the consumer of such
difference (e.g., ``not recommended for frying'').
(2) This disclaimer shall be in easily legible print or type and in
a size no less than that required by Sec. 101.105(i) for the net
quantity of contents statement, except where the size of the claim is
less than two times the required size of the net quantity of contents
statement, in which case the disclaimer shall be no less than one-half
the size of the claim but no smaller than one-sixteenth of an inch,
unless the package complies with Sec. 101.2(c)(5), in which case the
disclaimer may be in type of not less than one thirty-second of an inch.
(e)(1) Because the use of a ``free'' or ``low'' claim before the
name of a food implies that the food differs from other foods of the
same type by virtue of its having a lower amount of the nutrient, only
foods that have been specially processed, altered, formulated, or
reformulated so as to lower the amount of the nutrient in the food,
remove the nutrient from the food, or not include the nutrient in the
food, may bear such a claim (e.g., ``low sodium potato chips'').
(2) Any claim for the absence of a nutrient in a food, or that a
food is low in a nutrient when the food has not been specially
processed, altered, formulated, or reformulated to qualify for that
claim shall indicate that the food inherently meets the criteria and
shall clearly refer to all foods of that type and not merely to the
particular brand to which the labeling attaches (e.g., ``corn oil, a
sodium-free food'').
(f) A nutrient content claim shall be in type size no larger than
two times the statement of identity and shall not be unduly prominent in
type style compared to the statement of identity.
(g) The label or labeling of a food for which a nutrient content
claim is made shall contain prominently and in immediate proximity to
such claim, the following referral statement: ``See --------------------
------------ for nutrition information'' with the blank filled in with
the identity of the panel on which nutrition labeling is located, except
that when such a claim appears on the panel that bears nutrition
information the referral statement may be omitted.
(1) The referral statement ``See [appropriate panel] for nutrition
information'' shall be in easily legible boldface print or type, in
distinct contrast to other printed or graphic matter, and in a size no
less than that required by Sec. 101.105(i) for the net quantity of
contents statement, except where the size of the claim is less than two
times the required size of the net quantity of contents statement, in
which case the referral statement shall be no less than one-half the
size of the claim but no smaller than one-sixteenth of an inch, unless
the package complies with Sec. 101.2(c)(5), in which case the referral
statement may be in type of not less than one thirty-second of an inch.
(2) The referral statement shall be immediately adjacent to the
nutrient content claim and may have no intervening material other than,
if applicable, other information in the statement of identity or any
other information that is required to be presented with the claim under
this section (e.g., see paragraph (j)(2) of this section) or under a
regulation in subpart D of this part (e.g., see Secs. 101.54 and
101.62). If the nutrient content claim appears on more than one panel of
the label, the referral statement shall be adjacent to the claim on each
panel except for the panel that bears the nutrition information where it
may be omitted.
(3) If a single panel of a food label or labeling contains multiple
nutrient content claims or a single claim repeated several times, a
single referral statement may be made. The statement shall be adjacent
to the claim that is printed in the largest type on that panel.
(h) In place of the referral statement described in paragraph (g) of
this section,
(1) If a food, except a meal product as defined in Sec. 101.13(l), a
main dish product as defined in Sec. 101.13(m), or food intended
specifically for use by infants and children less than 2 years of age,
contains more than 13.0 g of fat, 4.0 g of saturated fat, 60 milligrams
(mg) of cholesterol, or 480 mg of sodium per reference amount
customarily consumed, per labeled serving, or, for a
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food with a reference amount customarily consumed of 30 g or less or 2
tablespoons or less, per 50 g (for dehydrated foods that must be
reconstituted before typical consumption with water or a diluent
containing an insignificant amount, as defined in Sec. 101.9(f)(1), of
all nutrients per reference amount customarily consumed, the per 50 g
criterion refers to the ``as prepared'' form), then that food must
disclose, as part of the referral statement, that the nutrient exceeding
the specified level is present in the food as follows: ``See
[appropriate panel] for information about [nutrient requiring
disclosure] and other nutrients,'' e.g., ``See side panel for
information about total fat and other nutrients.''
(2) If a food is a meal product as defined in Sec. 101.13(l), and
contains more than 26 g of fat, 8.0 g of saturated fat, 120 mg of
cholesterol, or 960 mg of sodium per labeled serving, then that food
must disclose, in accordance with the requirements as provided in
paragraph (h)(1) of this section, that the nutrient exceeding the
specified level is present in the food.
(3) If a food is a main dish product as defined in Sec. 101.13(m),
and contains more than 19.5 g of fat, 6.0 g of saturated fat, 90 mg of
cholesterol, or 720 mg of sodium per labeled serving, then that food
must disclose, in accordance with the requirements as provided in
paragraph (h)(1) of this section, that the nutrient exceeding the
specified level is present in the food.
(i) Except as provided in Sec. 101.9 or Sec. 101.36, as applicable,
or in paragraph (q)(3) of this section, the label or labeling of a
product may contain a statement about the amount or percentage of a
nutrient if:
(1) The use of the statement on the food implicitly characterizes
the level of the nutrient in the food and is consistent with a
definition for a claim, as provided in subpart D of this part, for the
nutrient that the label addresses. Such a claim might be, ``less than 3
g of fat per serving;''
(2) The use of the statement on the food implicitly characterizes
the level of the nutrient in the food and is not consistent with such a
definition, but the label carries a disclaimer adjacent to the statement
that the food is not ``low'' in or a ``good source'' of the nutrient,
such as ``only 200 mg sodium per serving, not a low sodium food.'' The
disclaimer must be in easily legible print or type and in a size no less
than that required by Sec. 101.105(i) for the net quantity of contents
statement except where the size of the claim is less than two times the
required size of the net quantity of contents statement, in which case
the disclaimer shall be no less than one-half the size of the claim but
no smaller than one-sixteenth of an inch unless the package complies
with Sec. 101.2(c)(5), in which case the disclaimer may be in type of
not less less than one thirty-second of an inch, or
(3) The statement does not in any way implicitly characterize the
level of the nutrient in the food and it is not false or misleading in
any respect (e.g., ``100 calories'' or ``5 grams of fat''), in which
case no disclaimer is required.
(4) ``Percent fat free'' claims are not authorized by this
paragraph. Such claims shall comply with Sec. 101.62(b)(6).
(j) A food may bear a statement that compares the level of a
nutrient in the food with the level of a nutrient in a reference food.
These statements shall be known as ``relative claims'' and include
``light,'' ``reduced,'' ``less'' (or ``fewer''), and ``more'' claims.
(1) To bear a relative claim about the level of a nutrient, the
amount of that nutrient in the food must be compared to an amount of
nutrient in an appropriate reference food as specified below.
(i)(A) For ``less'' (or ``fewer'') and ``more'' claims, the
reference food may be a dissimilar food within a product category that
can generally be substituted for one another in the diet (e.g., potato
chips as reference for pretzels, orange juice as a reference for vitamin
C tablets) or a similar food (e.g., potato chips as reference for potato
chips, one brand of multivitamin as reference for another brand of
multivitamin).
(B) For ``light,'' ``reduced,'' ``added,'' ``extra,'' ``fortified,''
and ``enriched'' claims, the reference food shall be a similar food
(e.g., potato chips as a reference for potato chips, one brand of
multivitamin for another brand of multivitamin), and
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(ii)(A) For ``light'' claims, the reference food shall be
representative of the type of food that includes the product that bears
the claim. The nutrient value for the reference food shall be
representative of a broad base of foods of that type; e.g., a value in a
representative, valid data base; an average value determined from the
top three national (or regional) brands, a market basket norm; or, where
its nutrient value is representative of the food type, a market leader.
Firms using such a reference nutrient value as a basis for a claim, are
required to provide specific information upon which the nutrient value
was derived, on request, to consumers and appropriate regulatory
officials.
(B) For relative claims other than ``light,'' including ``less'' and
``more'' claims, the reference food may be the same as that provided for
``light'' in paragraph (j)(1)(ii)(A) of this section, or it may be the
manufacturer's regular product, or that of another manufacturer, that
has been offered for sale to the public on a regular basis for a
substantial period of time in the same geographic area by the same
business entity or by one entitled to use its trade name. The nutrient
values used to determine the claim when comparing a single
manufacturer's product to the labeled product shall be either the values
declared in nutrition labeling or the actual nutrient values, provided
that the resulting label is internally consistent to (i.e., that the
values stated in the nutrition information, the nutrient values in the
accompanying information and the declaration of the percentage of
nutrient by which the food has been modified are consistent and will not
cause consumer confusion when compared), and that the actual
modification is at least equal to the percentage specified in the
definition of the claim.
(2) For foods bearing relative claims:
(i) The label or labeling must state the identity of the reference
food and the percentage (or fraction) of the amount of the nutrient in
the reference food by which the nutrient in the labeled food differs
(e.g., ``50 percent less fat than (reference food)'' or ``1/3 fewer
calories than (reference food)''),
(ii) This information shall be immediately adjacent to the most
prominent claim. The type size shall be in accordance with paragraph
(g)(1) of this section.
(iii) The determination of which use of the claim is in the most
prominent location on the label or labeling will be made based on the
following factors, considered in order:
(A) A claim on the principal display panel adjacent to the statement
of identity;
(B) A claim elsewhere on the principal display panel;
(C) A claim on the information panel; or
(D) A claim elsewhere on the label or labeling.
(iv) The label or labeling must also bear:
(A) Clear and concise quantitative information comparing the amount
of the subject nutrient in the product per labeled serving with that in
the reference food; and
(B) This statement shall appear adjacent to the most prominent claim
or to the nutrition label, except that if the nutrition label is on the
information panel, the quantitative information may be located elsewhere
on the information panel in accordance with Sec. 101.2.
(3) A relative claim for decreased levels of a nutrient may not be
made on the label or in labeling of a food if the nutrient content of
the reference food meets the requirement for a ``low'' claim for that
nutrient (e.g., 3 g fat or less).
(k) The term ``modified'' may be used in the statement of identity
of a food that bears a relative claim that complies with the
requirements of this part, followed immediately by the name of the
nutrient whose content has been altered (e.g., ``Modified fat
cheesecake''). This statement of identity must be immediately followed
by the comparative statement such as ``Contains 35 percent less fat than
----------.'' The label or labeling must also bear the information
required by paragraph (j)(2) of this section in the manner prescribed.
(l) For purposes of making a claim, a ``meal product shall be
defined as a food that:
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(1) Makes a major contribution to the total diet by:
(i) Weighing at least 10 ounces (oz) per labeled serving; and
(ii) Containing not less than three 40-g portions of food, or
combinations of foods, from two or more of the following four food
groups, except as noted in paragraph (l)(1)(ii)(E) of this section.
(A) Bread, cereal, rice, and pasta group;
(B) Fruits and vegetables group;
(C) Milk, yogurt, and cheese group;
(D) Meat, poultry, fish, dry beans, eggs, and nuts group; except
that;
(E) These foods shall not be sauces (except for foods in the above
four food groups that are in the sauces), gravies, condiments, relishes,
pickles, olives, jams, jellies, syrups, breadings or garnishes; and
(2) Is represented as, or is in a form commonly understood to be, a
breakfast, lunch, dinner, or meal. Such representations may be made
either by statements, photographs, or vignettes.
(m) For purposes of making a claim, a ``main dish product'' shall be
defined as a food that:
(1) Makes a major contribution to a meal by
(i) Weighing at least 6 oz per labeled serving; and
(ii) Containing not less than 40 g of food, or combinations of
foods, from each of at least two of the following four food groups,
except as noted in paragraph (m)(1)(ii)(E) of this section.
(A) Bread, cereal, rice, and pasta group;
(B) Fruits and vegetables group;
(C) Milk, yogurt, and cheese group;
(D) Meat, poultry, fish, dry beans, eggs, and nuts groups; except
that:
(E) These foods shall not be sauces (except for foods in the above
four food groups that are in the sauces) gravies, condiments, relishes,
pickles, olives, jams, jellies, syrups, breadings, or garnishes; and
(2) Is represented as, or is in a form commonly understood to be, a
main dish (e.g, not a beverage or a dessert). Such representations may
be made either by statements, photographs, or vignettes.
(n) Nutrition labeling in accordance with Sec. 101.9, Sec. 101.10,
or Sec. 101.36, as applicable, shall be provided for any food for which
a nutrient content claim is made.
(o) Except as provided in Sec. 101.10, compliance with requirements
for nutrient content claims in this section and in the regulations in
subpart D of this part, will be determined using the analytical
methodology prescribed for determining compliance with nutrition
labeling in Sec. 101.9.
(p)(1) Unless otherwise specified, the reference amount customarily
consumed set forth in Sec. 101.12(b) through (f) shall be used in
determining whether a product meets the criteria for a nutrient content
claim. If the serving size declared on the product label differs from
the reference amount customarily consumed, and the amount of the
nutrient contained in the labeled serving does not meet the maximum or
minimum amount criterion in the definition for the descriptor for that
nutrient, the claim shall be followed by the criteria for the claim as
required by Sec. 101.12(g) (e.g., ``very low sodium, 35 mg or less per
240 milliliters (8 fl oz.)'').
(2) The criteria for the claim shall be immediately adjacent to the
most prominent claim in easily legible print or type and in a size in
accordance with paragraph (g)(1) of this section.
(q) The following exemptions apply:
(1) Nutrient content claims that have not been defined by regulation
and that are contained in the brand name of a specific food product that
was the brand name in use on such food before October 25, 1989, may
continue to be used as part of that brand name for such product,
provided that they are not false or misleading under section 403(a) of
the Federal Food, Drug, and Cosmetic Act (the act). However, foods
bearing such claims must comply with section 403(f), (g), and (h) of the
act;
(2) A soft drink that used the term ``diet'' as part of its brand
name before October 25, 1989, and whose use of that term was in
compliance with Sec. 105.66 of this chapter as that regulation appeared
in the Code of Federal Regulations on that date, may continue to use
that term as part of its brand name, provided that its use of the term
is not false or misleading under section 403(a) of the act. Such claims
are exempt from the requirements of section
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403(r)(2) of the act (e.g., the referral statement also required by
Sec. 101.13(g) and the disclosure statement also required by
Sec. 101.13(h)). Soft drinks marketed after October 25, 1989, may use
the term ``diet'' provided they are in compliance with the current
Sec. 105.66 of this chapter and the requirements of Sec. 101.13.
(3) A statement that describes the percentage of a vitamin or
mineral in the food, including foods intended specifically for use by
infants and children less than 2 years of age, in relation to a
Reference Daily Intake (RDI) as defined in Sec. 101.9 may be made on the
label or in labeling of a food without a regulation authorizing such a
claim for a specific vitamin or mineral unless such claim is expressly
prohibited by regulation under section 403(r)(2)(A)(vi) of the act.
(4) The requirements of this section do not apply to:
(i) Infant formulas subject to section 412(h) of the act; and
(ii) Medical foods defined by section 5(b) of the Orphan Drug Act.
(5) A nutrient content claim used on food that is served in
restaurants (except on menus) or other establishments in which food is
served for immediate human consumption or which is sold for sale or use
in such establishments shall comply with the requirements of this
section and the appropriate definition in subpart D of this part, except
that:
(i) Such claim is exempt from the requirements for disclosure
statements in paragraphs (g) and (h) of this section and
Secs. 101.54(d), 101.62(c), (d)(1)(ii)(D), (d)(2)(iii)(C), (d)(3),
(d)(4)(ii)(C), and (d)(5)(ii)(C); and
(ii) In lieu of analytical testing, compliance may be determined
using a reasonable basis for concluding that the food that bears the
claim meets the definition for the claim. This reasonable basis may
derive from recognized data bases for raw and processed foods, recipes,
and other means to compute nutrient levels in the foods or meals and may
be used provided reasonable steps are taken to ensure that the method of
preparation adheres to the factors on which the reasonable basis was
determined (e.g., types and amounts of ingredients, cooking
temperatures, etc.). Firms making claims on foods based on this
reasonable basis criterion are required to provide to appropriate
regulatory officials on request the specific information on which their
determination is based and reasonable assurance of operational adherence
to the preparation methods or other basis for the claim; and
(iii) A term or symbol that may in some contexts constitute a claim
under this section may be used, provided that the use of the term or
symbol does not characterize the level of a nutrient, and a statement
that clearly explains the basis for the use of the term or symbol is
prominently displayed and does not characterize the level of a nutrient.
For example, a term such as ``lite fare'' followed by an asterisk
referring to a note that makes clear that in this restaurant ``lite
fare'' means smaller portion sizes than normal; or an item bearing a
symbol referring to a note that makes clear that this item meets the
criteria for the dietary guidance established by a recognized dietary
authority would not be considered a nutrient content claim under
Sec. 101.13.
(6) Nutrient content claims that were part of the common or usual
names of foods that were subject to a standard of identity on November
8, 1990, are not subject to the requirements of paragraphs (b), (g), and
(h) of this section or to definitions in subpart D of this part.
(7) Implied nutrient content claims may be used as part of a brand
name, provided that the use of the claim has been authorized by the Food
and Drug Administration. Petitions requesting approval of such a claim
may be submitted under Sec. 101.69(o).
(8) The term ``fluoridated,'' ``fluoride added'' or ``with added
fluoride'' may be used on the label or in labeling of bottled water that
contains added fluoride.
[58 FR 2410, Jan. 6, 1993; 58 FR 17341, 17342, Apr. 2, 1993, as amended
at 58 FR 44030, Aug. 18, 1993; 59 FR 393, Jan. 4, 1994; 59 FR 15051,
Mar. 31, 1994; 60 FR 17205, Apr. 5, 1995; 61 FR 11731, Mar. 22, 1996]
Sec. 101.14 Health claims: general requirements.
(a) Definitions. For purposes of this section, the following
definitions apply:
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(1) Health claim means any claim made on the label or in labeling of
a food, including a dietary supplement, that expressly or by
implication, including ``third party'' references, written statements
(e.g., a brand name including a term such as ``heart''), symbols (e.g.,
a heart symbol), or vignettes, characterizes the relationship of any
substance to a disease or health-related condition. Implied health
claims include those statements, symbols, vignettes, or other forms of
communication that suggest, within the context in which they are
presented, that a relationship exists between the presence or level of a
substance in the food and a disease or health-related condition.
(2) Substance means a specific food or component of food, regardless
of whether the food is in conventional food form or a dietary supplement
that includes vitamins, minerals, herbs, or other similar nutritional
substances.
(3) Nutritive value means a value in sustaining human existence by
such processes as promoting growth, replacing loss of essential
nutrients, or providing energy.
(4) Dietary supplement means a food, not in conventional food form,
that supplies a component to supplement the diet by increasing the total
dietary intake of that component.
(5) Disqualifying nutrient levels means the levels of total fat,
saturated fat, cholesterol, or sodium in a food above which the food
will be disqualified from making a health claim. These levels are 13.0
grams (g) of fat, 4.0 g of saturated fat, 60 milligrams (mg) of
cholesterol, or 480 mg of sodium, per reference amount customarily
consumed, per label serving size, and, only for foods with reference
amounts customarily consumed of 30 g or less or 2 tablespoons or less,
per 50 g. For dehydrated foods that must have water added to them prior
to typical consumption, the per 50-g criterion refers to the as prepared
form. Any one of the levels, on a per reference amount customarily
consumed, a per label serving size or, when applicable, a per 50 g
basis, will disqualify a food from making a health claim unless an
exception is provided in subpart E of this part, except that:
(i) The levels for a meal product as defined in Sec. 101.13(l) are
26.0 g of fat, 8.0 g of saturated fat, 120 mg of cholesterol, or 960 mg
of sodium per label serving size, and
(ii) The levels for a main dish product as defined in
Sec. 101.13(m) are 19.5 g of fat, 6.0 g of saturated fat, 90 mg of
cholesterol, or 720 mg of sodium per label serving size.
(6) Disease or health-related condition means damage to an organ,
part, structure, or system of the body such that it does not function
properly (e.g., cardiovascular disease), or a state of health leading to
such dysfunctioning (e.g., hypertension); except that diseases resulting
from essential nutrient deficiencies (e.g., scurvy, pellagra) are not
included in this definition (claims pertaining to such diseases are
thereby not subject to Sec. 101.14 or Sec. 101.70).
(b) Eligibility. For a substance to be eligible for a health claim:
(1) The substance must be associated with a disease or health-
related condition for which the general U.S. population, or an
identified U.S. population subgroup (e.g., the elderly) is at risk, or,
alternatively, the petition submitted by the proponent of the claim
otherwise explains the prevalence of the disease or health-related
condition in the U.S. population and the relevance of the claim in the
context of the total daily diet and satisfies the other requirements of
this section.
(2) If the substance is to be consumed as a component of a
conventional food at decreased dietary levels, the substance must be a
nutrient listed in 21 U.S.C. 343(q)(1)(C) or (q)(1)(D), or one that the
Food and Drug Administration (FDA) has required to be included in the
label or labeling under 21 U.S.C. 343(q)(2)(A); or
(3) If the substance is to be consumed at other than decreased
dietary levels:
(i) The substance must, regardless of whether the food is in
conventional food form or dietary supplement form, contribute taste,
aroma, or nutritive value, or any other technical effect listed in
Sec. 170.3(o) of this chapter, to the food and must retain that
attribute when consumed at levels that are necessary to justify a claim;
and
(ii) The substance must be a food or a food ingredient or a
component of a
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food ingredient whose use at the levels necessary to justify a claim has
been demonstrated by the proponent of the claim, to FDA's satisfaction,
to be safe and lawful under the applicable food safety provisions of the
Federal Food, Drug, and Cosmetic Act.
(c) Validity requirement. FDA will promulgate regulations
authorizing a health claim only when it determines, based on the
totality of publicly available scientific evidence (including evidence
from well-designed studies conducted in a manner which is consistent
with generally recognized scientific procedures and principles), that
there is significant scientific agreement, among experts qualified by
scientific training and experience to evaluate such claims, that the
claim is supported by such evidence.
(d) General health claim labeling requirements. (1) When FDA
determines that a health claim meets the validity requirements of
paragraph (c) of this section, FDA will propose a regulation in subpart
E of this part to authorize the use of that claim. If the claim pertains
to a substance not provided for in Sec. 101.9 or Sec. 101.36, FDA will
propose amending that regulation to include declaration of the
substance.
(2) When FDA has adopted a regulation in subpart E of this part
providing for a health claim, firms may make claims based on the
regulation in subpart E of this part, provided that:
(i) All label or labeling statements about the substance-disease
relationship that is the subject of the claim are based on, and
consistent with, the conclusions set forth in the regulations in subpart
E of this part;
(ii) The claim is limited to describing the value that ingestion (or
reduced ingestion) of the substance, as part of a total dietary pattern,
may have on a particular disease or health-related condition;
(iii) The claim is complete, truthful, and not misleading. Where
factors other than dietary intake of the substance affect the
relationship between the substance and the disease or health-related
condition, such factors may be required to be addressed in the claim by
a specific regulation in subpart E of this part;
(iv) All information required to be included in the claim appears in
one place without other intervening material, except that the principal
display panel of the label or labeling may bear the reference statement,
``See -------------- for information about the relationship between ----
---------- and ------------,'' with the blanks filled in with the
location of the labeling containing the health claim, the name of the
substance, and the disease or health-related condition (e.g., ``See
attached pamphlet for information about calcium and osteoporosis''),
with the entire claim appearing elsewhere on the other labeling,
Provided that, where any graphic material (e.g., a heart symbol)
constituting an explicit or implied health claim appears on the label or
labeling, the reference statement or the complete claim shall appear in
immediate proximity to such graphic material;
(v) The claim enables the public to comprehend the information
provided and to understand the relative significance of such information
in the context of a total daily diet; and
(vi) If the claim is about the effects of consuming the substance at
decreased dietary levels, the level of the substance in the food is
sufficiently low to justify the claim. To meet this requirement, if a
definition for use of the term ``low'' has been established for that
substance under this part, the substance must be present at a level that
meets the requirements for use of that term, unless a specific
alternative level has been established for the substance in subpart E of
this part. If no definition for ``low'' has been established, the level
of the substance must meet the level established in the regulation
authorizing the claim; or
(vii) If the claim is about the effects of consuming the substance
at other than decreased dietary levels, the level of the substance is
sufficiently high and in an appropriate form to justify the claim. To
meet this requirement, if a definition for use of the term ``high'' for
that substance has been established under this part, the substance must
be present at a level that meets the requirements for use of that term,
unless a specific alternative level has been established for the
substance in subpart
[[Page 69]]
E of this part. If no definition for ``high'' has been established
(e.g., where the claim pertains to a food either as a whole food or as
an ingredient in another food), the claim must specify the daily dietary
intake necessary to achieve the claimed effect, as established in the
regulation authorizing the claim; Provided That:
(A) Where the food that bears the claim meets the requirements of
paragraphs (d)(2)(vi) or (d)(2)(vii) of this section based on its
reference amount customarily consumed, and the labeled serving size
differs from that amount, the claim shall be followed by a statement
explaining that the claim is based on the reference amount rather than
the labeled serving size (e.g., ``Diets low in sodium may reduce the
risk of high blood pressure, a disease associated with many factors. A
serving of -------- ounces of this product conforms to such a diet.'').
(B) Where the food that bears the claim is sold in a restaurant
(except if the claim is made on a menu) or in other establishments in
which food that is ready for human consumption is sold, the food can
meet the requirements of paragraphs (d)(2)(vi) or (d)(2)(vii) of this
section if the firm that sells the food has a reasonable basis on which
to believe that the food that bears the claim meets the requirements of
paragraphs (d)(2)(vi) and (d)(2)(vii) of this section and provides that
basis upon request.
(3) Nutrition labeling shall be provided in the label or labeling of
any food for which a health claim is made in accordance with Sec. 101.9;
for restaurant foods, in accordance with Sec. 101.10; or for dietary
supplements of vitamins or minerals, in accordance with Sec. 101.36. The
requirements of the introductory text of paragraph (d)(3) of this
section are effective as of May 8, 1993, except:
(i)--(ii) [Reserved]
(iii) For dietary supplements of vitamins, minerals, herbs, or other
similar nutritional substances for which the requirements of paragraph
(d)(3) of this section will be effective July 5, 1994.
(e) Prohibited health claims. No expressed or implied health claim
may be made on the label or in labeling for a food, regardless of
whether the food is in conventional food form or dietary supplement
form, unless:
(1) The claim is specifically provided for in subpart E of this
part; and
(2) The claim conforms to all general provisions of this section as
well as to all specific provisions in the appropriate section of subpart
E of this part;
(3) None of the disqualifying levels identified in paragraph (a)(5)
of this section is exceeded in the food, unless specific alternative
levels have been established for the substance in subpart E of this
part; or unless FDA has permitted a claim despite the fact that a
disqualifying level of a nutrient is present in the food based on a
finding that such a claim will assist consumers in maintaining healthy
dietary practices, and, in accordance with the regulation in subpart E
of this part that makes such a finding, the label bears a referral
statement that complies with Sec. 101.13(h), highlighting the nutrient
that exceeds the disqualifying level;
(4) Except as provided in paragraph (e)(3) of this section, no
substance is present at an inappropriate level as determined in the
specific provision authorizing the claim in subpart E of this part;
(5) The label does not represent or purport that the food is for
infants and toddlers less than 2 years of age except if the claim is
specifically provided for in subpart E of this part; and
(6) Except for dietary supplements or where provided for in other
regulations in part 101, subpart E, the food contains 10 percent or more
of the Reference Daily Intake or the Daily Reference Value for vitamin
A, vitamin C, iron, calcium, protein, or fiber per reference amount
customarily consumed prior to any nutrient addition.
(f) The requirements of this section do not apply to:
(1) Infant formulas subject to section 412(h) of the Federal Food,
Drug, and Cosmetic Act, and
(2) Medical foods defined by section 5(b) of the Orphan Drug Act.
(g) Applicability. The requirements of this section apply to foods
intended for human consumption that are offered for sale, regardless of
whether the
[[Page 70]]
foods are in conventional food form or dietary supplement form.
[58 FR 2533, Jan. 6, 1993; 58 FR 17097, Apr. 1, 1993, as amended at 58
FR 44038, Aug. 18, 1993; 59 FR 425, Jan. 4, 1994; 59 FR 15050, Mar. 31,
1994]
Sec. 101.15 Food; prominence of required statements.
(a) A word, statement, or other information required by or under
authority of the act to appear on the label may lack that prominence and
conspicuousness required by section 403(f) of the act by reason (among
other reasons) of:
(1) The failure of such word, statement, or information to appear on
the part or panel of the label which is presented or displayed under
customary conditions of purchase;
(2) The failure of such word, statement, or information to appear on
two or more parts or panels of the label, each of which has sufficient
space therefor, and each of which is so designed as to render it likely
to be, under customary conditions of purchase, the part or panel
displayed;
(3) The failure of the label to extend over the area of the
container or package available for such extension, so as to provide
sufficient label space for the prominent placing of such word,
statement, or information;
(4) Insufficiency of label space (for the prominent placing of such
word, statement, or information) resulting from the use of label space
for any word, statement, design, or device which is not required by or
under authority of the act to appear on the label;
(5) Insufficiency of label space (for the prominent placing of such
word, statement, or information) resulting from the use of label space
to give materially greater conspicuousness to any other word, statement,
or information, or to any design or device; or
(6) Smallness or style of type in which such word, statement, or
information appears, insufficient background contrast, obscuring designs
or vignettes, or crowding with other written, printed, or graphic
matter.
(b) No exemption depending on insufficiency of label space, as
prescribed in regulations promulgated under section 403 (e) or (i) of
the act, shall apply if such insufficiency is caused by:
(1) The use of label space for any word, statement, design, or
device which is not required by or under authority of the act to appear
on the label;
(2) The use of label space to give greater conspicuousness to any
word, statement, or other information than is required by section 403(f)
of the act; or
(3) The use of label space for any representation in a foreign
language.
(c)(1) All words, statements, and other information required by or
under authority of the act to appear on the label or labeling shall
appear thereon in the English language: Provided, however, That in the
case of articles distributed solely in the Commonwealth of Puerto Rico
or in a Territory where the predominant language is one other than
English, the predominant language may be substituted for English.
(2) If the label contains any representation in a foreign language,
all words, statements, and other information required by or under
authority of the act to appear on the label shall appear thereon in the
foreign language: Provided, however, That individual serving-size
packages of foods containing no more than 1\1/2\ avoirdupois ounces or
no more than 1\1/2\ fluid ounces served with meals in restaurants,
institutions, and passenger carriers and not intended for sale at retail
are exempt from the requirements of this paragraph (c)(2), if the only
representation in the foreign language(s) is the name of the food.
(3) If any article of labeling (other than a label) contains any
representation in a foreign language, all words, statements, and other
information required by or under authority of the act to appear on the
label or labeling shall appear on such article of labeling.
Sec. 101.17 Food labeling warning and notice statements.
(a) Self-pressurized containers. (1) The label of a food packaged in
a self-pressurized container and intended to be expelled from the
package under pressure shall bear the following warning:
[[Page 71]]
Warning--Avoid spraying in eyes. Contents under pressure. Do not
puncture or incinerate. Do not store at temperature above 120 deg. F.
Keep out of reach of children.
(2) In the case of products intended for use by children, the phrase
``except under adult supervision'' may be added at the end of the last
sentence in the warning required by paragraph (a)(1) of this section.
(3) In the case of products packaged in glass containers, the word
``break'' may be substituted for the word ``puncture'' in the warning
required by paragraph (a)(1) of this section.
(4) The words ``Avoid spraying in eyes'' may be deleted from the
warning required by paragraph (a)(1) of this section in the case of a
product not expelled as a spray.
(b) Self-pressurized containers with halocarbon or hydrocarbon
propellants. (1) In addition to the warning required by paragraph (a) of
this section, the label of a food packaged in a self-pressurized
container in which the propellant consists in whole or in part of a
halocarbon or a hydrocarbon shall bear the following warning:
Warning--Use only as directed. Intentional misuse by deliberately
concentrating and inhaling the contents can be harmful or fatal.
(2) The warning required by paragraph (b)(1) of this section is not
required for the following products:
(i) Products expelled in the form of a foam or cream, which contain
less than 10 percent propellant in the container.
(ii) Products in a container with a physical barrier that prevents
escape of the propellant at the time of use.
(iii) Products of a net quantity of contents of less than 2 ounces
that are designed to release a measured amount of product with each
valve actuation.
(iv) Products of a net quantity of contents of less than one-half
ounce.
(c) Self-pressurized containers with a chlorofluorocarbon
propellant. (1) In addition to the warning required by paragraphs (a)
and (b) of this section, the label on each package of a food in a self-
pressurized container in which the propellant consists in whole or in
part of a fully halogenated chlorofluoroalkane (chlorofluorocarbon)
shall bear the following warning:
Warning--Contains a chlorofluorocarbon that may harm the public
health and environment by reducing ozone in the upper atmosphere.
(2) The warning required by paragraph (c)(1) of this section shall
appear on an appropriate panel with such prominence and conspicuousness
as to render it likely to be read and understood by ordinary individuals
under normal conditions of purchase. The warning may appear on a firmly
affixed tag, tape, card, or sticker or similar overlabeling attached to
the package. The warning shall comply in all other respects with
Sec. 101.2, e.g., type-size requirements.
(3) The warning required by paragraph (c)(1) of this section is
applicable only to self-pressurized containers that use
chlorofluorocarbons in whole or in part as a propellant to expel from
the container liquid or solid material different from the propellant,
but the warning is not applicable to the use of chlorofluorocarbon as a
stabilizer in food toppings and spreads.
(d) Protein products. (1) The label and labeling of any food product
in liquid, powdered, tablet, capsule, or similar forms that derives more
than 50 percent of its total caloric value from either whole protein,
protein hydrolysates, amino acid mixtures, or a combination of these,
and that is represented for use in reducing weight shall bear the
following warning:
Warning: Very low calorie protein diets (below 400 Calories per day)
may cause serious illness or death. Do Not Use for Weight Reduction in
Such Diets Without Medical Supervision. Not for use by infants,
children, or pregnant or nursing women.
(2) Products described in paragraph (d)(1) of this section are
exempt from the labeling requirements of that paragraph if the protein
products are represented as part of a nutritionally balanced diet plan
providing 400 or more Calories (kilocalories) per day and the label or
labeling of the product specifies the diet plan in detail or provides a
brief description of that diet plan and adequate information describing
where
[[Page 72]]
the detailed diet plan may be obtained and the label and labeling bear
the following statement:
Notice: For weight reduction, use only as directed in the
accompanying diet plan (the name and specific location in labeling of
the diet plan may be included in this statement in place of
``accompanying diet plan''). Do not use in diets supplying less than 400
Calories per day without medical supervision.
(3) The label and labeling of food products represented or intended
for dietery (food) supplementation that derive more than 50 percent of
their total caloric value from either whole protein, protein
hydrolysates, amino acid mixtures, or a combination of these, that are
represented specifically for purposes other than weight reduction; and
that are not covered by the requirements of paragraph (d) (1) and (2) of
this section; shall bear the following statement:
Notice: Use this product as a food supplement only. Do not use for
weight reduction.
(4) The provisions of this paragraph are separate from and in
addition to any labeling requirements promulgated by the Federal Trade
Commission for protein supplements.
(5) Protein products shipped in bulk form for use solely in the
manufacture of other foods and not for distribution to consumers in such
container are exempt from the labeling requirements of this paragraph.
(6) The warning and notice statements required by paragraphs (d)
(1), (2), and (3) of this section shall appear prominently and
conspicuously on the principal display panel of the package label and
any other labeling.
[42 FR 14308, Mar. 15, 1977, as amended at 42 FR 22033, Apr. 29, 1977;
49 FR 13690, Apr. 6, 1984; 49 FR 28548, July 13, 1984]
Sec. 101.18 Misbranding of food.
(a) Among representations in the labeling of a food which render
such food misbranded is a false or misleading representation with
respect to another food or a drug, device, or cosmetic.
(b) The labeling of a food which contains two or more ingredients
may be misleading by reason (among other reasons) of the designation of
such food in such labeling by a name which includes or suggests the name
of one or more but not all such ingredients, even though the names of
all such ingredients are stated elsewhere in the labeling.
(c) Among representations in the labeling of a food which render
such food misbranded is any representation that expresses or implies a
geographical origin of the food or any ingredient of the food except
when such representation is either:
(1) A truthful representation of geographical origin.
(2) A trademark or trade name provided that as applied to the
article in question its use is not deceptively misdescriptive. A
trademark or trade name composed in whole or in part of geographical
words shall not be considered deceptively misdescriptive if it:
(i) Has been so long and exclusively used by a manufacturer or
distributor that it is generally understood by the consumer to mean the
product of a particular manufacturer or distributor; or
(ii) Is so arbitrary or fanciful that it is not generally understood
by the consumer to suggest geographic origin.
(3) A part of the name required by applicable Federal law or
regulation.
(4) A name whose market significance is generally understood by the
consumer to connote a particular class, kind, type, or style of food
rather than to indicate geographical origin.
Subpart B--Specific Food Labeling Requirements
Sec. 101.22 Foods; labeling of spices, flavorings, colorings and chemical preservatives.
(a)(1) The term ``artificial flavor'' or ``artificial flavoring''
means any substance, the function of which is to impart flavor, which is
not derived from a spice, fruit or fruit juice, vegetable or vegetable
juice, edible yeast, herb, bark, bud, root, leaf or similar plant
material, meat, fish, poultry, eggs, dairy products, or fermentation
products thereof. Artificial flavor includes the substances listed in
Secs. 172.515(b) and 182.60 of this chapter except where these are
derived from natural sources.
[[Page 73]]
(2) The term ``spice'' means any aromatic vegetable substance in the
whole, broken, or ground form, except for those substances which have
been traditionally regarded as foods, such as onions, garlic and celery;
whose significant function in food is seasoning rather than nutritional;
that is true to name; and from which no portion of any volatile oil or
other flavoring principle has been removed. Spices include the spices
listed in Sec. 182.10 and Part 184 of this chapter, such as the
following:
Allspice, Anise, Basil, Bay leaves, Caraway seed, Cardamon, Celery seed,
Chervil, Cinnamon, Cloves, Coriander, Cumin seed, Dill seed, Fennel
seed, Fenugreek, Ginger, Horseradish, Mace, Marjoram, Mustard flour,
Nutmeg, Oregano, Paprika, Parsley, Pepper, black; Pepper, white; Pepper,
red; Rosemary, Saffron, Sage, Savory, Star aniseed, Tarragon, Thyme,
Turmeric.
Paprika, turmeric, and saffron or other spices which are also colors,
shall be declared as ``spice and coloring'' unless declared by their
common or usual name.
(3) The term ``natural flavor'' or ``natural flavoring'' means the
essential oil, oleoresin, essence or extractive, protein hydrolysate,
distillate, or any product of roasting, heating or enzymolysis, which
contains the flavoring constituents derived from a spice, fruit or fruit
juice, vegetable or vegetable juice, edible yeast, herb, bark, bud,
root, leaf or similar plant material, meat, seafood, poultry, eggs,
dairy products, or fermentation products thereof, whose significant
function in food is flavoring rather than nutritional. Natural flavors
include the natural essence or extractives obtained from plants listed
in Secs. 182.10, 182.20, 182.40, and 182.50 and part 184 of this
chapter, and the substances listed in Sec. 172.510 of this chapter.
(4) The term ``artificial color'' or ``artificial coloring'' means
any ``color additive'' as defined in Sec. 70.3(f) of this chapter.
(5) The term ``chemical preservative'' means any chemical that, when
added to food, tends to prevent or retard deterioration thereof, but
does not include common salt, sugars, vinegars, spices, or oils
extracted from spices, substances added to food by direct exposure
thereof to wood smoke, or chemicals applied for their insecticidal or
herbicidal properties.
(b) A food which is subject to the requirements of section 403(k) of
the act shall bear labeling, even though such food is not in package
form.
(c) A statement of artificial flavoring, artificial coloring, or
chemical preservative shall be placed on the food or on its container or
wrapper, or on any two or all three of these, as may be necessary to
render such statement likely to be read by the ordinary person under
customary conditions of purchase and use of such food. The specific
artificial color used in a food shall be identified on the labeling when
so required by regulation in part 74 of this chapter to assure safe
conditions of use for the color additive.
(d) A food shall be exempt from compliance with the requirements of
section 403(k) of the act if it is not in package form and the units
thereof are so small that a statement of artificial flavoring,
artificial coloring, or chemical preservative, as the case may be,
cannot be placed on such units with such conspicuousness as to render it
likely to be read by the ordinary individual under customary conditions
of purchase and use.
(e) A food shall be exempt while held for sale from the requirements
of section 403(k) of the act (requiring label statement of any
artificial flavoring, artificial coloring, or chemical preservatives) if
said food, having been received in bulk containers at a retail
establishment, is displayed to the purchaser with either (1) the
labeling of the bulk container plainly in view or (2) a counter card,
sign, or other appropriate device bearing prominently and conspicuously
the information required to be stated on the label pursuant to section
403(k).
(f) A fruit or vegetable shall be exempt from compliance with the
requirements of section 403(k) of the act with respect to a chemical
preservative applied to the fruit or vegetable as a pesticide chemical
prior to harvest.
(g) A flavor shall be labeled in the following way when shipped to a
food manufacturer or processor (but not a consumer) for use in the
manufacture of a fabricated food, unless it is a flavor for which a
standard of identity
[[Page 74]]
has been promulgated, in which case it shall be labeled as provided in
the standard:
(1) If the flavor consists of one ingredient, it shall be declared
by its common or usual name.
(2) If the flavor consists of two or more ingredients, the label
either may declare each ingredient by its common or usual name or may
state ``All flavor ingredients contained in this product are approved
for use in a regulation of the Food and Drug Administration.'' Any
flavor ingredient not contained in one of these regulations, and any
nonflavor ingredient, shall be separately listed on the label.
(3) In cases where the flavor contains a solely natural flavor(s),
the flavor shall be so labeled, e.g., ``strawberry flavor'', ``banana
flavor'', or ``natural strawberry flavor''. In cases where the flavor
contains both a natural flavor and an artificial flavor, the flavor
shall be so labeled, e.g., ``natural and artificial strawberry flavor''.
In cases where the flavor contains a solely artificial flavor(s), the
flavor shall be so labeled, e.g., ``artificial strawberry flavor''.
(h) The label of a food to which flavor is added shall declare the
flavor in the statement of ingredients in the following way:
(1) Spice, natural flavor, and artificial flavor may be declared as
``spice'', ``natural flavor'', or ``artificial flavor'', or any
combination thereof, as the case may be.
(2) An incidental additive in a food, originating in a spice or
flavor used in the manufacture of the food, need not be declared in the
statement of ingredients if it meets the requirements of
Sec. 101.100(a)(3).
(3) Substances obtained by cutting, grinding, drying, pulping, or
similar processing of tissues derived from fruit, vegetable, meat, fish,
or poultry, e.g., powdered or granulated onions, garlic powder, and
celery powder, are commonly understood by consumers to be food rather
than flavor and shall be declared by their common or usual name.
(4) Any salt (sodium chloride) used as an ingredient in food shall
be declared by its common or usual name ``salt.''
(5) Any monosodium glutamate used as an ingredient in food shall be
declared by its common or usual name ``monosodium glutamate.''
(6) Any pyroligneous acid or other artificial smoke flavors used as
an ingredient in a food may be declared as artificial flavor or
artificial smoke flavor. No representation may be made, either directly
or implied, that a food flavored with pyroligneous acid or other
artificial smoke flavor has been smoked or has a true smoked flavor, or
that a seasoning sauce or similar product containing pyroligneous acid
or other artificial smoke flavor and used to season or flavor other
foods will result in a smoked product or one having a true smoked
flavor.
(7) Because protein hydrolysates function in foods as both
flavorings and flavor enhancers, no protein hydrolysate used in food for
its effects on flavor may be declared simply as ``flavor,'' ``natural
flavor,'' or ``flavoring.'' The ingredient shall be declared by its
specific common or usual name as provided in Sec. 102.22 of this
chapter.
(i) If the label, labeling, or advertising of a food makes any
direct or indirect representations with respect to the primary
recognizable flavor(s), by word, vignette, e.g., depiction of a fruit,
or other means, or if for any other reason the manufacturer or
distributor of a food wishes to designate the type of flavor in the food
other than through the statement of ingredients, such flavor shall be
considered the characterizing flavor and shall be declared in the
following way:
(1) If the food contains no artificial flavor which simulates,
resembles or reinforces the characterizing flavor, the name of the food
on the principal display panel or panels of the label shall be
accompanied by the common or usual name of the characterizing flavor,
e.g., ``vanilla'', in letters not less than one-half the height of the
letters used in the name of the food, except that:
(i) If the food is one that is commonly expected to contain a
characterizing food ingredient, e.g., strawberries in ``strawberry
shortcake'', and the food contains natural flavor derived from such
ingredient and an amount of characterizing ingredient insufficient to
independently characterize the food,
[[Page 75]]
or the food contains no such ingredient, the name of the characterizing
flavor may be immediately preceded by the word ``natural'' and shall be
immediately followed by the word ``flavored'' in letters not less than
one-half the height of the letters in the name of the characterizing
flavor, e.g., ``natural strawberry flavored shortcake,'' or ``strawberry
flavored shortcake''.
(ii) If none of the natural flavor used in the food is derived from
the product whose flavor is simulated, the food in which the flavor is
used shall be labeled either with the flavor of the product from which
the flavor is derived or as ``artificially flavored.''
(iii) If the food contains both a characterizing flavor from the
product whose flavor is simulated and other natural flavor which
simulates, resembles or reinforces the characterizing flavor, the food
shall be labeled in accordance with the introductory text and paragraph
(i)(1)(i) of this section and the name of the food shall be immediately
followed by the words ``with other natural flavor'' in letters not less
than one-half the height of the letters used in the name of the
characterizing flavor.
(2) If the food contains any artificial flavor which simulates,
resembles or reinforces the characterizing flavor, the name of the food
on the principal display panel or panels of the label shall be
accompanied by the common or usual name(s) of the characterizing flavor,
in letters not less than one-half the height of the letters used in the
name of the food and the name of the characterizing flavor shall be
accompanied by the word(s) ``artificial'' or ``artificially flavored'',
in letters not less than one-half the height of the letters in the name
of the characterizing flavor, e.g., ``artificial vanilla'',
``artificially flavored strawberry'', or ``grape artificially
flavored''.
(3) Wherever the name of the characterizing flavor appears on the
label (other than in the statement of ingredients) so conspicuously as
to be easily seen under customary conditions of purchase, the words
prescribed by this paragraph shall immediately and conspicuously precede
or follow such name, without any intervening written, printed, or
graphic matter, except:
(i) Where the characterizing flavor and a trademark or brand are
presented together, other written, printed, or graphic matter that is a
part of or is associated with the trademark or brand may intervene if
the required words are in such relationship with the trademark or brand
as to be clearly related to the characterizing flavor; and
(ii) If the finished product contains more than one flavor subject
to the requirements of this paragraph, the statements required by this
paragraph need appear only once in each statement of characterizing
flavors present in such food, e.g., ``artificially flavored vanilla and
strawberry''.
(iii) If the finished product contains three or more distinguishable
characterizing flavors, or a blend of flavors with no primary
recognizable flavor, the flavor may be declared by an appropriately
descriptive generic term in lieu of naming each flavor, e.g.,
``artificially flavored fruit punch''.
(4) A flavor supplier shall certify, in writing, that any flavor he
supplies which is designated as containing no artificial flavor does
not, to the best of his knowledge and belief, contain any artificial
flavor, and that he has added no artificial flavor to it. The
requirement for such certification may be satisfied by a guarantee under
section 303(c)(2) of the act which contains such a specific statement. A
flavor used shall be required to make such a written certification only
where he adds to or combines another flavor with a flavor which has been
certified by a flavor supplier as containing no artificial flavor, but
otherwise such user may rely upon the supplier's certification and need
make no separate certification. All such certifications shall be
retained by the certifying party throughout the period in which the
flavor is supplied and for a minimum of three years thereafter, and
shall be subject to the following conditions:
(i) The certifying party shall make such certifications available
upon request at all reasonable hours to any duly authorized office or
employee of the Food and Drug Administration or any other employee
acting on behalf of the Secretary of Health and Human
[[Page 76]]
Services. Such certifications are regarded by the Food and Drug
Administration as reports to the government and as guarantees or other
undertakings within the meaning of section 301(h) of the act and subject
the certifying party to the penalties for making any false report to the
government under 18 U.S.C. 1001 and any false guarantee or undertaking
under section 303(a) of the act. The defenses provided under section
303(c)(2) of the act shall be applicable to the certifications provided
for in this section.
(ii) Wherever possible, the Food and Drug Administration shall
verify the accuracy of a reasonable number of certifications made
pursuant to this section, constituting a representative sample of such
certifications, and shall not request all such certifications.
(iii) Where no person authorized to provide such information is
reasonably available at the time of inspection, the certifying party
shall arrange to have such person and the relevant materials and records
ready for verification as soon as practicable: Provided, That, whenever
the Food and Drug Administration has reason to believe that the supplier
or user may utilize this period to alter inventories or records, such
additional time shall not be permitted. Where such additional time is
provided, the Food and Drug Administration may require the certifying
party to certify that relevant inventories have not been materially
disturbed and relevant records have not been altered or concealed during
such period.
(iv) The certifying party shall provide, to an officer or
representative duly designated by the Secretary, such qualitative
statement of the composition of the flavor or product covered by the
certification as may be reasonably expected to enable the Secretary's
representatives to determine which relevant raw and finished materials
and flavor ingredient records are reasonably necessary to verify the
certifications. The examination conducted by the Secretary's
representative shall be limited to inspection and review of inventories
and ingredient records for those certifications which are to be
verified.
(v) Review of flavor ingredient records shall be limited to the
qualitative formula and shall not include the quantitative formula. The
person verifying the certifications may make only such notes as are
necessary to enable him to verify such certification. Only such notes or
such flavor ingredient records as are necessary to verify such
certification or to show a potential or actual violation may be removed
or transmitted from the certifying party's place of business: Provided,
That, where such removal or transmittal is necessary for such purposes
the relevant records and notes shall be retained as separate documents
in Food and Drug Administration files, shall not be copied in other
reports, and shall not be disclosed publicly other than in a judicial
proceeding brought pursuant to the act or 18 U.S.C. 1001.
(j) A food to which a chemical preservative(s) is added shall,
except when exempt pursuant to Sec. 101.100 bear a label declaration
stating both the common or usual name of the ingredient(s) and a
separate description of its function, e.g., ``preservative'', ``to
retard spoilage'', ``a mold inhibitor'', ``to help protect flavor'' or
``to promote color retention''.
(k) The label of a food to which any coloring has been added shall
declare the coloring in the statement of ingredients in the manner
specified in paragraphs (k)(1) and (k)(2) of this section, except that
colorings added to butter, cheese, and ice cream, if declared, may be
declared in the manner specified in paragraph (k)(3) of this section,
and colorings added to foods subject to Secs. 105.62 and 105.65 of this
chapter shall be declared in accordance with the requirements of those
sections.
(1) A color additive or the lake of a color additive subject to
certification under 721(c) of the act shall be declared by the name of
the color additive listed in the applicable regulation in part 74 or
part 82 of this chapter, except that it is not necessary to include the
``FD&C'' prefix or the term ``No.'' in the declaration, but the term
``Lake'' shall be included in the declaration of the lake of the
certified color additive (e.g., Blue 1 Lake). Manufacturers may
parenthetically declare an appropriate alternative name of the certified
color additive following its common or usual
[[Page 77]]
name as specified in part 74 or part 82 of this chapter.
(2) Color additives not subject to certification may be declared as
``Artificial Color,'' ``Artificial Color Added,'' or ``Color Added'' (or
by an equally informative term that makes clear that a color additive
has been used in the food). Alternatively, such color additives may be
declared as ``Colored with --------------'' or ``------------ color'',
the blank to be filled with the name of the color additive listed in the
applicable regulation in part 73 of this chapter.
(3) When a coloring has been added to butter, cheese, or ice cream,
it need not be declared in the ingredient list unless such declaration
is required by a regulation in part 73 or part 74 of this chapter to
ensure safe conditions of use for the color additive. Voluntary
declaration of all colorings added to butter, cheese, and ice cream,
however, is recommended.
[42 FR 14308, Mar. 15, 1977, as amended at 44 FR 3963, Jan. 19, 1979; 44
FR 37220, June 26, 1979; 54 FR 24891, June 12, 1989; 58 FR 2875, Jan. 6,
1993]
Sec. 101.29 Labeling of kosher and kosher-style foods.
The term ``kosher'' should be used only on food products that meet
certain religious dietary requirements. The precise significance of the
phrase ``kosher style'' as applied to any particular product by the
public has not been determined. There is a likelihood that the use of
the term may cause the prospective purchaser to think that the product
is ``kosher.'' Accordingly, the Food and Drug Administration believes
that use of the phrase should be discouraged on products that do not
meet the religious dietary requirements.
Sec. 101.30 Percentage juice declaration for foods purporting to be beverages that contain fruit or vegetable juice.
(a) This section applies to any food that purports to be a beverage
that contains any fruit or vegetable juice (i.e., the product's
advertising, label, or labeling bears the name of, or variation on the
name of, or makes any other direct or indirect representation with
respect to, any fruit or vegetable juice), or the label or labeling
bears any vignette (i.e., depiction of a fruit or vegetable) or other
pictorial representation of any fruit or vegetable, or the product
contains color and flavor that gives the beverage the appearance and
taste of containing a fruit or vegetable juice. The beverage may be
carbonated or noncarbonated, concentrated, full-strength, diluted, or
contain no juice. For example, a soft drink (soda) that does not
represent or suggest by its physical characteristics, name, labeling,
ingredient statement, or advertising that it contains fruit or vegetable
juice does not purport to contain juice and therefore does not require a
percent juice declaration.
(b)(1) If the beverage contains fruit or vegetable juice, the
percentage shall be declared by the words ``Contains --------------
percent (or %) ------------ juice'' or `` ------------ percent (or %)
juice,'' or a similar phrase, with the first blank filled in with the
percentage expressed as a whole number not greater than the actual
percentage of the juice and the second blank (if used) filled in with
the name of the particular fruit or vegetable (e.g., ``Contains 50
percent apple juice'' or ``50 percent juice'').
(2) If the beverage contains less than 1 percent juice, the total
percentage juice shall be declared as ``less than 1 percent juice'' or
``less than 1 percent ------------ juice'' with the blank filled in with
the name of the particular fruit or vegetable.
(3) If the beverage contains 100 percent juice and also contains
non-juice ingredients that do not result in a diminution of the juice
soluble solids or, in the case of expressed juice, in a change in the
volume, when the 100 percent juice declaration appears on a panel of the
label that does not also bear the ingredient statement, it must be
accompanied by the phrase ``with added ----------,'' the blank filled in
with a term such as ``ingredient(s),'' ``preservative,'' or
``sweetener,'' as appropriate (e.g., ``100% juice with added
sweetener''), except that when the presence of the non-juice
ingredient(s) is declared as a part of the statement of identity of the
product, this phrase need not accompany the 100 percent juice
declaration.
[[Page 78]]
(c) If a beverage contains minor amounts of juice for flavoring and
is labeled with a flavor description using terms such as ``flavor'',
``flavored'', or ``flavoring'' with a fruit or vegetable name and does
not bear:
(1) The term ``juice'' on the label other than in the ingredient
statement; or
(2) An explicit vignette depicting the fruit or vegetable from which
the flavor derives, such as juice exuding from a fruit or vegetable; or
(3) Specific physical resemblance to a juice or distinctive juice
characteristic such as pulp then total percentage juice declaration is
not required.
(d) If the beverage does not meet the criteria for exemption from
total juice percentage declaration as described in paragraph (c) of this
section and contains no fruit or vegetable juice, but the labeling or
color and flavor of the beverage represents, suggests, or implies that
fruit or vegetable juice may be present (e.g., the product advertising
or labeling bears the name, a variation of the name, or a pictorial
representation of any fruit or vegetable, or the product contains color
and flavor that give the beverage the appearance and taste of containing
a fruit or vegetable juice), then the label shall declare ``contains
zero (0) percent (or %) juice''. Alternatively, the label may declare
``Containing (or contains) no ---------- juice'', or ``no ----------
juice'', or ``does not contain ------------ juice'', the blank to be
filled in with the name of the fruits or vegetables represented,
suggested, or implied, but if there is a general suggestion that the
product contains fruit or vegetable juice, such as the presence of fruit
pulp, the blank shall be filled in with the word ``fruit'' or
``vegetable'' as applicable (e.g., ``contains no fruit juice'', or
``does not contain fruit juice'').
(e) If the beverage is sold in a package with an information panel
as defined in Sec. 101.2, the declaration of amount of juice shall be
prominently placed on the information panel in lines generally parallel
to other required information, appearing:
(1) Near the top of the information panel, with no other printed
label information appearing above the statement except the brand name,
product name, logo, or universal product code; and
(2) In easily legible boldface print or type in distinct contrast to
other printed or graphic matter, in a height not less than the largest
type found on the information panel except that used for the brand name,
product name, logo, universal product code, or the title phrase
``Nutrition Facts'' appearing in the nutrition information as required
by Sec. 101.9.
(f) The percentage juice declaration may also be placed on the
principal display panel, provided that the declaration is consistent
with that presented on the information panel.
(g) If the beverage is sold in a package that does not bear an
information panel as defined in Sec. 101.2, the percentage juice
declaration shall be placed on the principal display panel, in type size
not less than that required for the declaration of net quantity of
contents statement in Sec. 101.105(i), and be placed near the name of
the food.
(h)(1) In enforcing these regulations, the Food and Drug
Administration will calculate the labeled percentage of juice from
concentrate found in a juice or juice beverage using the minimum Brix
levels listed below where single-strength (100 percent) juice has at
least the specified minimum Brix listed below:
------------------------------------------------------------------------
100
Juice percent
juice1
------------------------------------------------------------------------
Acerola........................................................ 6.0
Apple.......................................................... 11.5
Apricot........................................................ 11.7
Banana......................................................... 22.0
Blackberry..................................................... 10.0
Blueberry...................................................... 10.0
Boysenberry.................................................... 10.0
Cantaloupe Melon............................................... 9.6
Carambola...................................................... 7.8
Carrot......................................................... 8.0
Casaba Melon................................................... 7.5
Cashew (Caju).................................................. 12.0
Celery......................................................... 3.1
Cherry, dark, sweet............................................ 20.0
Cherry, red, sour.............................................. 14.0
Crabapple...................................................... 15.4
Cranberry...................................................... 7.5
Currant (Black)................................................ 11.0
Currant (Red).................................................. 10.5
Date........................................................... 18.5
Dewberry....................................................... 10.0
Elderberry..................................................... 11.0
Fig............................................................ 18.2
Gooseberry..................................................... 8.3
Grape.......................................................... 16.0
[[Page 79]]
Grapefruit..................................................... 310.0
Guanabana (soursop)............................................ 16.0
Guava.......................................................... 7.7
Honeydew melon................................................. 9.6
Kiwi........................................................... 15.4
Lemon.......................................................... 2 4.5
Lime........................................................... 2 4.5
Loganberry..................................................... 10.5
Mango.......................................................... 13.0
Nectarine...................................................... 11.8
Orange......................................................... 311.8
Papaya......................................................... 11.5
Passion Fruit.................................................. 14.0
Peach.......................................................... 10.5
Pear........................................................... 12.0
Pineapple...................................................... 12.8
Plum........................................................... 14.3
Pomegranate.................................................... 16.0
Prune.......................................................... 18.5
Quince......................................................... 13.3
Raspberry (Black).............................................. 11.1
Raspberry (Red)................................................ 9.2
Rhubarb........................................................ 5.7
Strawberry..................................................... 8.0
Tangerine...................................................... 311.8
Tomato......................................................... 5.0
Watermelon..................................................... 7.8
Youngberry..................................................... 10.0
------------------------------------------------------------------------
\1\ Indicates Brix value unless other value specified.
\2\ Indicates anhydrous citrus acid percent by weight.
\3\ Brix values determined by refractometer for citrus juices may be
corrected for citric acid.
(2) If there is no Brix level specified in paragraph (h)(1) of this
section, the labeled percentage of that juice from concentrate in a
juice or juice beverage will be calculated on the basis of the soluble
solids content of the single-strength (unconcentrated) juice used to
produce such concentrated juice.
(i) Juices directly expressed from a fruit or vegetable (i.e., not
concentrated and reconstituted) shall be considered to be 100 percent
juice and shall be declared as ``100 percent juice.''
(j) Calculations of the percentage of juice in a juice blend or a
diluted juice product made directly from expressed juice (i.e., not from
concentrate) shall be based on the percentage of the expressed juice in
the product computed on a volume/volume basis.
(k) If the product is a beverage that contains a juice whose color,
taste, or other organoleptic properties have been modified to the extent
that the original juice is no longer recognizable at the time processing
is complete, or if its nutrient profile has been diminished to a level
below the normal nutrient range for the juice, then that juice to which
such a major modification has been made shall not be included in the
total percentage juice declaration.
(l) A beverage required to bear a percentage juice declaration on
its label, that contains less than 100 percent juice, shall not bear any
other percentage declaration that describes the juice content of the
beverage in its label or in its labeling (e.g., ``100 percent natural''
or ``100 percent pure''). However, the label or labeling may bear
percentage statements clearly unrelated to juice content (e.g.,
``provides 100 percent of U.S. RDA of vitamin C'').
(m) Products purporting to be beverages that contain fruit or
vegetable juices are exempted from the provisions of this section until
May 8, 1994. All products that are labeled on or after that date shall
comply with this section.
[58 FR 2925, Jan. 6, 1993, as amended at 58 FR 44063, Aug. 18, 1993; 58
FR 49192, Sept. 22, 1993]
Sec. 101.33 Label declaration of D-erythroascorbic acid when it is an ingredient of a fabricated food.
(a) The article d-erythroascorbic acid (d-araboascorbic acid, d-
erythro-3-keto-hexonic acid lactone) has sometimes been designated as d-
isoascorbic acid. However, this designation is capable of misleading
purchasers of food in which it is used as an ingredient because of the
similarity of such designation to the chemical name and the common name
of vitamin C, which is ascorbic acid. Ascorbic acid (vitamin C) is
capable of preventing the deficiency disease scurvy, but d-isoascorbc
acid is ineffective for this purpose.
(b) The Joint Committee on Nomenclature of the American Institute of
Nutrition and the Society of Biological Chemists has considered this
matter, and pursuant to the Committee's recommendation the respective
scientific organizations approved a resolution to drop the use of the
designation d-isoascorbic acid and to adopt as a common name the name
erythorbic acid for d-erythroascorbic acid.
(c) The compound d-erythroascorbic acid is not specified as an
ingredient of any food for which a standard has been established. For
foods other than those for which standards have been established,
section 403(i)(2) of the Federal Food, Drug, and Cosmetic Act requires
[[Page 80]]
that ingredients be listed on labels by their common or usual names. If
the label on a food that contains d-erythroascorbic acid designates that
ingredient by the name erythorbic acid, the requirement that the label
bear the common or usual name of the ingredient will be regarded as
having been met.
Subpart C--Specific Nutrition Labeling Requirements and Guidelines
Source: 55 FR 60890, Nov. 27, 1991, unless otherwise noted.
Sec. 101.36 Nutrition labeling of dietary supplements of vitamins and minerals.
(a) The label of a dietary supplement of a vitamin or mineral that
has a Reference Daily Intake (RDI) as established in
Sec. 101.9(c)(8)(iv) or a Daily Reference Value (DRV) as established in
Sec. 101.9(c)(9), shall bear nutrition labeling in accordance with this
regulation, as illustrated in paragraph (c)(9) of this section, unless
an exemption is provided for the product in paragraph (f) of this
section. Dietary supplements of herbs or other similar nutritional
substances shall bear nutrition labeling in accordance with Sec. 101.9.
(b) The declaration of nutrition information on the label and in
labeling shall contain the following information, using the headings and
format specified, under the heading of ``Nutrition Facts''. The
nutrition information shall be enclosed in a box by use of lines, shall
be all black or one color type, and shall be printed on a white or other
neutral contrasting background whenever practical.
(1) The subheading ``Serving Size'' shall be placed under the
heading and aligned on the left side of the nutrition label. The serving
size shall be determined in accordance with Sec. 101.9(b) and
Sec. 101.12(b), Table 2. Serving size shall be expressed using a term
that is appropriate for the form of the supplement, such as ``tablets,''
``capsules,'' ``packets,'' or ``teaspoonfuls.''
(2) The subheading ``Servings Per Container'' shall be placed under
the subheading ``Serving Size'' and aligned on the left side of the
nutrition label, except that this information need not be provided when
it is stated in the net quantity of contents declaration.
(3) A listing of all nutrients required in Sec. 101.9(c) that are
present in the dietary supplement in quantitative amounts by weight that
exceed the amount that can be declared as zero in Sec. 101.9(c). Those
nutrients that are not present, or present in amounts that would be
declared as zero, shall not be declared. In addition, potassium shall be
declared except when present in quantitative amounts by weight that
allow a declaration of zero. The name of each nutrient listed shall be
immediately followed by the quantitative amount by weight of the
nutrient. Nutrient names and quantitative amounts shall be presented in
a column under the heading ``Amount Per Serving'' and aligned on the
left side of the nutrition label. The heading ``Amount Per Serving''
shall be separated from other information on the label by a bar above
and beneath it, except that when calories are listed, the bar shall be
placed beneath the calorie declaration. When the serving size of the
product is one unit (e.g., 1 tablet), a heading consistent with the
declaration of serving size, such as ``Amount per Tablet'' or ``Each
Tablet Contains,'' may be used in place of the heading ``Amount per
Serving.'' Other appropriate terms, such as capsule, packet, or
teaspoonful, may be used in place of the term ``Serving.''
(i) These amounts shall be expressed in the increments specified in
Sec. 101.9(c), except that the amounts of vitamins and minerals,
excluding sodium and potassium, declared on the nutrition label shall be
the actual amount of the vitamin or mineral included in the dietary
supplement, using the units of measure and the levels of significance
given in Sec. 101.9(c). In declaring the amounts of vitamins and
minerals, zeros following decimal points may be dropped, and additional
levels of significance may be used when the number of decimal places
indicated is not sufficient to express lower amounts (e.g., the RDI for
copper is given in whole milligrams, but the quantitative amount may be
declared in tenths of a milligram). Amounts for chloride and manganese
shall be expressed in mg,
[[Page 81]]
and, amounts for chromium, molybdenum, selenium, and vitamin K shall be
expressed in micrograms. These values shall be expressed in whole
numbers.
(ii) Nutrients that are present shall be listed in the order
specified in Sec. 101.9(c); except that, when present, vitamin K shall
follow vitamin E; calcium and iron shall follow pantothenic acid;
selenium shall follow zinc; and manganese, chromium, molybdenum,
chloride, sodium, and potassium shall follow copper. This results in the
following order for vitamins and minerals: Vitamin A, vitamin C, vitamin
D, vitamin E, vitamin K, thiamin, riboflavin, niacin, vitamin B6,
folate, vitamin B12, biotin, pantothenic acid, calcium, iron,
phosphorus, iodine, magnesium, zinc, selenium, copper, manganese,
chromium, molybdenum, chloride, sodium, and potassium. A bar shall
separate the last nutrient to be listed from the bottom of the nutrition
label, as shown in the sample labels in paragraph (c)(9) of this
section.
(iii) If the product contains two or more separately packaged
dietary supplements of vitamins and minerals (e.g., the product has a
packet of supplements to be taken in the morning and a different packet
to be taken in the afternoon), the quantitative amounts may be presented
as specified in this paragraph in individual nutrition labels or in one
aggregate nutrition label with separate columns declaring the
quantitative amounts for each package as illustrated in paragraph
(c)(9)(iii) of this section.
(iv) The percent of vitamin A that is present as beta-carotene may
be declared, to the nearest whole percent, immediately adjacent to or
beneath the nutrient name (e.g., ``Vitamin A 5000 IU (90 percent as
beta-carotene)''), except that the declaration is required when a claim
is made about beta-carotene. The amount of beta-carotene in terms of
international units (IU) may be included in parentheses following the
percent statement (e.g., ``Vitamin A 5000 IU (90 percent (4500 IU) as
beta-carotene)'').
(v) The following synonyms may be added in parenthesis immediately
following the name of these nutrients: Vitamin C (ascorbic acid),
thiamin (vitamin B1), riboflavin (vitamin B2), folate--either folic acid
or folacin may be used, and calories (energy). Energy content per
serving may be expressed in kilojoules units, added in parentheses
immediately following the statement of caloric content.
(vi) All nutrients shall be displayed with uniform type size, style,
color, and prominence.
(4) A listing of the percent of the Daily Value (i.e., the percent
of the RDI as established in Sec. 101.9(c)(8)(iv) or DRV as established
in Sec. 101.9(c)(9)), where appropriate, of all nutrients listed in the
nutrition label, except that the percent for protein may be omitted as
provided in Sec. 101.9(c)(7), no percent shall be given for sugars, and
for labels of dietary supplements of vitamins and minerals that are
represented or purported to be for use by infants, children less than 4
years of age, or pregnant or lactating women, no percent shall be given
for vitamin K, selenium, manganese, chromium, molybdenum, or chloride.
This information shall be presented in one column aligned under the
heading of ``% Daily Value'' and to the right of the column of nutrient
names and amounts. The headings ``% Daily Value (DV),'' ``% DV,''
``Percent Daily Value,'' or ``Percent DV'' may be substituted for ``%
Daily Value.'' The heading ``% Daily Value'' shall be placed on the same
line as the heading ``Amount per Serving'' or placed beneath this
heading and the bar underneath it, except that ``% Daily Value'' shall
be placed beneath this bar when calorie information is required to be
declared. Calorie information shall be placed beneath ``Amount Per
Serving'' and above the bar.
(i) The percent of Daily Value shall be calculated by dividing
either the amount declared on the label for each nutrient or the actual
amount of each nutrient (i.e., before rounding) by the RDI or DRV for
the specified nutrient and multiplying by 100, except that the percent
for protein shall be calculated as specified in Sec. 101.9(c)(7)(ii).
The numerical value shall be followed by the symbol for percent (i.e.,
%).
(ii) The percentages based on RDI's and on DRV's shall be expressed
to the nearest whole percent, except that ``Less than 1%'' may be used
in place of
[[Page 82]]
``0%'' when the declaration of the quantitative amount by weight is a
value greater than zero.
(iii) The percent of Daily Value for vitamins and minerals shall be
based on RDI values for adults and children 4 or more years of age
unless the product is represented or purported to be for use by infants,
children less than 4 years of age, pregnant women, or lactating women,
in which case the column heading shall clearly state the intended group.
If the product is for persons within more than one group, the percent of
daily value for each group shall be presented in separate columns as
shown in paragraph (c)(9)(ii) of this section.
(iv) If the product contains two or more separately packaged dietary
supplements of vitamins and minerals (e.g., the product has a packet of
supplements to be taken in the morning and a different packet to be
taken in the afternoon), the percent of Daily Value may be presented as
specified in paragraph (b)(4) of this section in individual nutrition
labels or in one aggregate nutrition label with separate columns
declaring the percent of Daily Value for each package as illustrated in
paragraph (c)(9)(iii) of this section.
(v) If the percent of Daily Value is declared for total fat,
saturated fat, total carbohydrate, dietary fiber, or protein, the value
shall be followed by an asterisk that refers to another asterisk at the
bottom of the nutrition label that states ``Percent Daily Values are
based on a 2,000 calorie diet.''
(vi) When no percent is given for sugars, or for labels of dietary
supplements of vitamins and minerals that are represented or purported
to be for use by infants, children less than 4 years of age, or pregnant
or lactating women, when no percent is given for vitamin K, selenium,
manganese, chromium, molybdenum, or chloride, an asterisk shall be
placed in the ``Percent Daily Value'' column that shall refer to another
asterisk that is placed at the bottom of the nutrition label and
followed by the statement ``Daily Value not established.''
(c) Nutrition information specified in this section shall be
presented as follows:
(1) The title of ``Nutrition Facts'' shall be set in a type size
larger than all other print size in the nutrition label and, unless
impractical, shall be set full width of the nutrition label. The title
and all headings shall be highlighted (reverse printing is not permitted
as a form of highlighting) to distinguish them from other information.
(2) All information within the nutrition label shall utilize a
single easy-to-read type style.
(3) All information within the nutrition label shall utilize upper
and lower case letters, except that all uppercase lettering may be
utilized for packages that have a total surface area available to bear
labeling of less than 12 square inches.
(4) All information within the nutrition label shall have at least
one point leading (i.e., space between two lines of text).
(5) Letters should never touch.
(6) All information within the nutrition label on packages that have
a total surface area available to bear labeling of less than 12 square
inches shall have type size no smaller than 4.5 point; packages that
have from 12 to 40 square inches of surface area available to bear
labeling shall have type size no smaller than 6 point; and packages with
more than 40 square inches of surface area available to bear labeling
shall have type size no smaller than 8 point, except that on packages
with more than 40 square inches of available surface area, type size no
smaller than 6 point may be used for the listing of information on beta-
carotene, as specified in paragraph (b)(3)(iv) of this section, for the
headings required by paragraphs (b)(3) and (b)(4) of this section (i.e.,
``Amount Per Serving'' and ``% Daily Value''), and for the footnote
required by paragraph (b)(4)(v) of this section.
(7) A hairline rule that is centered between the lines of text shall
separate each nutrient and its corresponding percent Daily Value
required in paragraph (b)(4) of this section from the nutrient and
percent Daily Value above and beneath it, as shown in paragraph (c)(9)
of this section, and shall separate
[[Page 83]]
``Amount Per Serving'' from the calorie statement, when the listing of
calories is required.
(8) In the interest of uniformity of presentation, FDA urges that
the information be presented using the graphic specifications set forth
in appendix B to part 101, as applicable.
(9) The following sample labels are presented for the purpose of
illustration:
(i) Multiple vitamin.
[GRAPHIC] [TIFF OMITTED] TR01JA93.358
[[Page 84]]
(ii) Multiple vitamin for children and adults.
[GRAPHIC] [TIFF OMITTED] TR01JA93.359
[[Page 85]]
(iii) Multiple vitamins in packets.
[GRAPHIC] [TIFF OMITTED] TR01JA93.360
(10) If space is not adequate to list the required information as
shown in the sample labels in paragraph (c)(9) of this section, the list
may be split and continued to the right, as long as the headings are
repeated. The list to the right shall be set off by a line that
distinguishes it and sets it apart from the nutrients and percent of
Daily Value information given to the left. The following sample label
illustrates this display:
[[Page 86]]
[GRAPHIC] [TIFF OMITTED] TR01JA93.361
(d)(1) Compliance with this section shall be determined in
accordance with Sec. 101.9(g)(1) through (g)(8).
(2) When it is not technologically feasible, or some other
circumstance makes it impracticable, for firms to comply with the
requirements of this section, FDA may permit alternative means of
compliance or additional exemptions to deal with the situation in
accordance with Sec. 101.9(g)(9). Firms in need of such special
allowances shall make their request in writing to the Office of Food
Labeling (HFS-150), Food and Drug Administration, 200 C St. SW.,
Washington, DC 20204.
(e) Except as provided in paragraph (g) of this section, the
location of nutrition information on a label shall be in compliance with
Sec. 101.2.
(f)(1) Dietary supplements of vitamins or minerals are exempt from
this section when they are offered for sale by a manufacturer, packer,
or distributor who has annual gross sales made or business done in sales
to consumers that is not more than $500,000 or has annual gross sales
made or business done in sales of food to consumers of not more than
$50,000, Provided, That the food bears no nutrition claims or other
nutrition information on a label or labeling or in advertising.
(2) For purposes of the paragraph, calculation of the amount of
sales shall be based on the most recent 2-year average of business
activity. Where firms have been in business less than 2 years,
reasonable estimates must indicate that annual sales will not exceed the
amounts specified. For foreign firms that ship foods into the United
States, the business activities to be included shall be the total amount
of food sales, as well as other sales to consumers, by the firm in the
United States.
(g) Dietary supplements of vitamins and minerals shall be subject to
the special labeling conditions specified in Sec. 101.9(j)(5)(i) and
(j)(5)(ii) for food, other than infant formula, represented or purported
to be specifically for infants and children less than 2 years of age and
4 years of age, respectively; in Sec. 101.9(j)(9) for food products
shipped in bulk form that are not for distribution
[[Page 87]]
to consumers; in Sec. 101.9(j)(13) for foods in small or intermediate-
sized packages; in Sec. 101.9(j)(15) for foods in multiunit food
containers; and, in Sec. 101.9(j)(16) for foods sold in bulk containers.
(h) Dietary supplements of vitamins and minerals shall be subject to
the misbranding provisions of Sec. 101.9(k).
[59 FR 373, Jan. 4, 1994; 59 FR 24039, May 10, 1994, as amended at 60 FR
67175, Dec. 28, 1995; 61 FR 8779, Mar. 5, 1996; 61 FR 10280, Mar. 13,
1996]
Effective Date Notes: 1. At 60 FR 67175, Dec. 28, 1995, in
Sec. 101.36, paragraphs (b)(3) introductory text, (i), (ii), (b)(4)
introductory text, and (vi) were revised, effective January 1, 1997. At
61 FR 10280, Mar. 13, 1996, in Sec. 101.36(b)(3)(ii) the terms ``vitamin
B6'' and ``vitamin B12'' was corrected to make the numbers subscript,
effective January 1, 1997. For the convenience of the reader, the
superseded text is set forth below.
Sec. 101.35 Nutrition labeling of dietary supplements of vitamins and
minerals.
* * * * *
(b) * * *
(3) A listing of all nutrients required in Sec. 101.9(c) that are
present in the dietary supplement in quantitative amounts by weight that
exceed the amount that can be declared as zero in Sec. 101.9(c). Those
nutrients that are not present, or that are present in amounts that
would be declared as zero, shall not be declared. In addition,
potassium, vitamin K, chloride, chromium, fluoride, manganese,
molybdenum, and selenium shall be declared, except when present in
quantitative amounts by weight that allow a declaration of zero. The
name of each nutrient listed shall be immediately followed by the
quantitative amount by weight of the nutrient. Nutrient names and
quantitative amounts shall be presented in a column under the heading of
``Amount Per Serving'' and aligned on the left side of the nutrition
label. The heading ``Amount Per Serving'' shall be separated from other
information on the label by a bar above and beneath it, except that when
calories are listed, the bar shall be placed beneath the calorie
declaration. When the serving size of the product is one unit (e.g., one
tablet), a heading consistent with the declaration of the serving size,
such as ``Amount Per Tablet'' or ``Each Tablet Contains,'' may be used
in place of the heading ``Amount Per Serving.'' Other appropriate terms,
such as capsule, packet, or teaspoonful, may be used in place of the
term ``Serving.''
(i) These amounts shall be expressed in the increments specified in
Sec. 101.9(c), except that the amounts of vitamins and minerals,
excluding sodium and potassium, declared on the nutrition label shall be
the actual amount of the vitamin or mineral included in the dietary
supplement, using the units of measure and the levels of significance
given in Sec. 101.9(c). In declaring the amounts of vitamins and
minerals, zeros following decimal points may be dropped, and additional
levels of significance may be used when the number of decimal places
indicated is not sufficient to express lower amounts (e.g., the RDI for
copper is given in whole milligrams (mg), but the quantitative amount
may be declared in tenths of a mg). Amounts for chloride, fluoride, and
manganese shall be expressed in mg, and, amounts for chromium,
molybdenum, selenium, and vitamin K shall be expressed in micrograms.
These values shall be expressed in whole numbers, except that tenths may
be used for fluoride.
(ii) Nutrients that are present shall be listed in the order
specified in Sec. 101.9(c); except that, when present, vitamin K shall
follow vitamin E; calcium and iron shall follow pantothenic acid;
selenium shall follow zinc; and manganese, fluoride, chromium,
molybdenum, chloride, sodium, and potassium shall follow copper. This
results in the following order for vitamins and minerals: Vitamin A,
vitamin C, vitamin D, vitamin E, vitamin K, thiamin, riboflavin, niacin,
vitamin B6, folate, vitamin B12, biotin, pantothenic acid, calcium,
iron, phosphorus, iodine, magnesium, zinc, selenium, copper, manganese,
fluoride, chromium, molybdenum, chloride, sodium, and potassium. A bar
shall separate the last nutrient to be listed from the bottom of the
nutrition label, as shown in the sample labels in paragraph (c)(9) of
this section.
* * * * *
(4) A listing of the percent of the Daily Value (i.e., the percent
of the RDI as established in Sec. 101.9(c)(8)(iv) or DRV as established
in Sec. 101.9(c)(9)), where appropriate, of all nutrients listed in the
nutrition label, except that the percent for protein may be omitted as
provided in Sec. 101.9(c)(7) and no percent shall be given for sugars,
vitamin K, chloride, chromium, fluoride, manganese, molybdenum, and
selenium. This information shall be presented in one column aligned
under the heading of``% Daily Value'' and to the right of the column of
nutrient names and amounts. The headings ``% Daily Value (DV),'' ``%
DV,'' ``Percent Daily Value,'' or ``Percent DV'' may be substituted for
``% Daily Value.'' The heading ``% Daily Value'' shall be placed on the
same line as the heading ``Amount Per Serving'' or placed beneath this
heading and the bar underneath it, except that ``% Daily Value'' shall
be placed beneath this bar when calorie information is required to be
declared. Calorie information
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shall be placed beneath ``Amount Per Serving'' and above the bar.
* * * * *
(vi) When no percent is given for sugars, vitamin K, chloride,
chromium, fluoride, manganese, molybdenum, or selenium, an asterisk
shall be placed in the ``% Daily Value'' column that shall refer to
another asterisk that is placed at the bottom of the nutrition label and
is followed by the statement ``Daily Value not established.''
* * * * *
2. At 61 FR 8779, Mar. 5, 1996, in Sec. 101.36, paragraph (b)(3)(v)
was amended by removing the words ``folate (folacin)'' and by adding in
their place the words ``folate--either folic acid or folacin may be
used'', effective April 19, 1996.
Sec. 101.42 Nutrition labeling of raw fruit, vegetables, and fish.
(a) The Food and Drug Administration (FDA) urges food retailers to
provide nutrition information, as provided in Sec. 101.9(c), for raw
fruit, vegetables, and fish at the point-of-purchase. If retailers
choose to provide such information, they should do so in a manner that
conforms to the guidelines in Sec. 101.45.
(b) In Sec. 101.44, FDA has listed the 20 varieties of raw fruit,
vegetables, and fish that are most frequently consumed during a year and
to which the guidelines apply.
(c) FDA has also defined in Sec. 101.43, the circumstances that
constitute substantial compliance by food retailers with the guidelines.
(d) By May 8, 1993, FDA will issue a report on actions taken by food
retailers to provide consumers with nutrition information for raw fruit,
vegetables, and fish under the guidelines established in Sec. 101.45.
(1) The report will include a determination of whether there is
substantial compliance, as defined in Sec. 101.43, with the guidelines.
(2) In evaluating substantial compliance, FDA will consider only the
20 varieties of raw fruit, vegetables, and fish most frequently consumed
as identified in Sec. 101.44.
(e) If FDA finds that there is substantial compliance with the
guidelines for the nutrition labeling of raw fruit and vegetables or of
fish, the agency will so state in the report, and the guidelines will
remain in effect. FDA will reevaluate the market place for substantial
compliance every 2 years.
(f) If FDA determines that there is not substantial compliance with
the guidelines for raw fruit and vegetables or for raw fish, the agency
will at that time issue proposed regulations requiring that any person
who offers raw fruit and vegetables or fish to consumers provide, in a
manner prescribed by regulations, the nutrition information required by
Sec. 101.9. Final regulations would have to be issued 6 months after
issuance of proposed regulations, and they would become effective 6
months after the date of their promulgation.
Sec. 101.43 Substantial compliance of food retailers with the guidelines for the voluntary nutrition labeling of raw fruit, vegetables, and fish.
(a) The Food and Drug Administration (FDA) will judge a food
retailer who sells raw agricultural commodities or raw fish to be in
compliance with the guidelines in Sec. 101.45 with respect to raw
agricultural commodities if the retailer displays or provides nutrition
labeling for at least 90 percent of the raw agricultural commodities
listed in Sec. 101.44 that it sells, and with respect to raw fish if the
retailer displays or provides nutrition labeling for at least 90 percent
of the types of raw fish listed in Sec. 101.44 that it sells. To be in
compliance, the nutrition labeling shall:
(1) Be presented in the store or other type of establishment in a
manner that is consistent with Sec. 101.45(a);
(2) Be presented in content and format that are consistent with
Sec. 101.45(b); and
(3) Include data that have been provided by FDA (see
Sec. 101.45(i)), that have been accepted by FDA (see Sec. 101.45 (c),
(f), and (g)), or that are consistent with Sec. 101.45 (d) and (e) and
have not been found to be out of compliance after a review under
Sec. 101.9(e) (see Sec. 101.45(h)).
(b) To determine whether there is substantial compliance by food
retailers with the guidelines in Sec. 101.45 for the voluntary nutrition
labeling of raw fruit and vegetables and of raw fish, FDA will select a
representative sample of 2,000 stores, allocated by store
[[Page 89]]
type and size, for raw fruit and vegetables and for raw fish.
(c) FDA will find that there is substantial compliance with the
guidelines in Sec. 101.45 if it finds based on paragraph (a) of this
section that at least 60 percent of all stores that are evaluated are in
compliance.
(d) FDA will evaluate substantial compliance separately for raw
agricultural commodities and for raw fish.
Sec. 101.44 Identification of the 20 most frequently consumed raw fruit, vegetables, and fish in the United States.
(a) The 20 most frequently consumed raw fruit are: Banana, apple,
watermelon, orange, cantaloupe, grape, grapefruit, strawberry, peach,
pear, nectarine, honeydew melon, plum, avocado, lemon, pineapple,
tangerine, sweet cherry, kiwifruit, and lime.
(b) The 20 most frequently consumed raw vegetables are: Potato,
iceberg lettuce, tomato, onion, carrot, celery, sweet corn, broccoli,
green cabbage, cucumber, bell pepper, cauliflower, leaf lettuce, sweet
potato, mushroom, green onion, green (snap) bean, radish, summer squash,
and asparagus.
(c) The 20 most frequently consumed raw fish are: Shrimp, cod,
pollack, catfish, scallop, Atlantic/coho salmon, flounder, sole, oyster,
orange roughy, Atlantic/Pacific and jack mackerel, ocean perch,
rockfish, whiting, clam, haddock, blue crab, rainbow trout, halibut, and
lobster.
Sec. 101.45 Guidelines for the voluntary nutrition labeling of raw fruit, vegetables, and fish.
Nutrition labeling for raw fruit, vegetables, and fish listed in
Sec. 101.44 should be presented to the public in the following manner:
(a) Nutrition labeling information should be displayed at the point
of purchase by an appropriate means, including by affixing it to the
food, by posting a sign, or by making the information readily available
in brochure, notebook, or leaflet form in close proximity to the foods.
The nutrition labeling information may also be supplemented by a video,
live demonstration, or other media.
(b) Nutrition information should be provided on the label or in
labeling in accordance with Sec. 101.9, as modified by the following
guidelines:
(1) The percent U.S. RDA for protein, thiamin, riboflavin, and
niacin may be declared in the nutrition labeling. Declaration of complex
carbohydrates, sugars, dietary fiber, saturated fat, and cholesterol is
also voluntary.
(2) Nutrition labeling information may be presented on individual
labels or in charts in vertical columns or in lines. When lines are
used, any subcomponents declared should be listed parenthetically after
principal components (e.g., saturated fat should be parenthetically
listed after fat).
(3) Declaration of the number of servings per container need not be
included in nutrition labeling of raw fruit, vegetables, and fish.
(4) The nutrition label data should be based on raw edible portion
for fruit and vegetables and on a cooked edible portion for fish. The
methods used to cook fish should be those that do not add fat, breading,
or seasoning (e.g., salt or spices).
(c) Nutrient data and proposed nutrient values for nutrition
labeling for raw fruit, vegetables, and fish may be submitted to the
Center for Food Safety and Applied Nutrition (HFS-150), Food and Drug
Administration, 200 C St. SW., Washington, DC 20204, for review and
evaluation. The data and nutrient values for nutrition labeling are
appropriate for use if they are accepted by the Food and Drug
Administration (FDA). The submission to FDA should include information
on the source of the data (names of investigators, name of organization,
place of analysis, dates of analyses), number of samples, sampling
scheme, analytical methods, statistical treatment of the data, and
proposed quantitative label declarations. The nutrient values for the
nutrition labeling should be determined in accordance with FDA guidance.
(d) Composite data that reflect representative nutrient levels for
various varieties, species, cultivars; seasons; and geographic regions
may be used to label raw fruit, vegetables, and fish. Alternatively,
data that reflect a specific variety, species, cultivar; season; or
geographic region may be used to label raw fruit, vegetables, and fish;
the nutrition labeling information for such
[[Page 90]]
variety, etc., should provide food names and descriptions for the fruit,
vegetables, and fish that appropriately reflect the samples analyzed for
nutrient values.
(e) The FDA manual ``Compliance Procedures for Nutrition Labeling''
(or subsequent revisions of this manual) should be used to develop
nutrition label values from data base values. The manual is available
from the Division of Nutrition.
(f) If the agency's Center for Food Safety and Applied Nutrition
agrees to all aspects of a submitted data base, FDA will notify a
submitter in writing of its acceptance of the nutrient data and nutrient
values for nutrition labeling. FDA's acceptance will be for a period of
10 years or until other data for the same food are submitted to FDA and
found to be superior. Those obtaining data base and nutrient value
acceptance from FDA are responsible for continued maintenance of the
data base. FDA will renew its acceptance of a data base upon request
after 10 years unless the data have been superseded by other data on the
same food or there have been demonstrated changes in agricultural or
industry practices. When agricultural or industry practices change
(e.g., a change occurs in a predominant variety produced), or when FDA
monitoring suggests that the data base or nutrient values are no longer
representative of the item sold in this country, FDA will take steps to
revoke its acceptance of the data base and nutrient values. A revised
data base and proposed nutrient values may be submitted to FDA for
acceptance.
(g) If the nutrition information is in accordance with an FDA-
accepted data base, the nutrient values have been computed following FDA
guidelines, and the food has been handled in accordance with current
good manufacturing practices to prevent nutrient loss, a nutrition label
will not be subject to the agency compliance review under Sec. 101.9(e).
(h) Organizations may use data bases that they believe validly
reflect the nutrient content of raw fruit, vegetables, and fish;
however, labeling computed from data bases not reviewed, evaluated, and
accepted by the agency is subject to the compliance procedures of
Sec. 101.9(e).
(i) FDA will publish, and provide an opportunity for comment on,
updates of the nutrition labeling data for the 20 most frequently
consumed raw fruit, vegetables, and fish (or a notice that the data sets
have not changed from the previous publication) at least every 2 years
in the Federal Register. FDA accepted data for other raw fruit,
vegetables, and fish, or for other nutrients, are available from the
Center for Food Safety and Applied Nutrition (HFS-150), 200 C St. SW.,
Washington, DC 20204.
[55 FR 60890, Nov. 27, 1991, as amended at 61 FR 14479, Apr. 2, 1996]
Subpart D--Specific Requirements for Nutrient Content Claims
Source: 58 FR 2413, Jan. 6, 1993, unless otherwise noted.
Sec. 101.54 Nutrient content claims for ``good source,'' ``high,'' and ``more.''
(a) General requirements. Except as provided in paragraph (e) of
this section, a claim about the level of a nutrient in a food in
relation to the Reference Daily Intake (RDI) established for that
nutrient in Sec. 101.9(c)(8)(iv) or Daily Reference Value (DRV)
established for that nutrient in Sec. 101.9(c)(9), (excluding total
carbohydrates) may only be made on the label or in labeling of the food
if:
(1) The claim uses one of the terms defined in this section in
accordance with the definition for that term;
(2) The claim is made in accordance with the general requirements
for nutrient content claims in Sec. 101.13; and
(3) The food for which the claim is made is labeled in accordance
with Sec. 101.9, Sec. 101.10, or Sec. 101.36, as applicable.
(b) ``High'' claims. (1) The terms ``high,'' ``rich in,'' or
``excellent source of'' may be used on the label or in the labeling of
foods except meal products as defined in Sec. 101.13(l), main dish
products as defined in Sec. 101.13(m), and dietary supplements of
vitamins or minerals to characterize the level of any substance that is
not a vitamin or mineral, provided that the food contains 20 percent or
more of the RDI or the DRV
[[Page 91]]
per reference amount customarily consumed.
(2) The terms defined in paragraph (b)(1) of this section may be
used on the label and in the labeling of meal products as defined in
Sec. 101.13(l) and main dish products as defined in Sec. 101.13(m),
provided that:
(i) The product contains a food that meets the definition of
``high'' in paragraph (b)(1) of this section; and
(ii) The label or labeling clearly identifies the food that is the
subject of the claim (e.g., the serving of broccoli in this product is
high in vitamin C).
(c) ``Good Source'' claims. (1) The terms ``good source,''
``contains,'' or ``provides'' may be used on the label or in labeling of
foods except meal products as described in Sec. 101.13(l) main dish
products as described in Sec. 101.13(m), and dietary supplements of
vitamins or minerals to characterize the level of any substance that is
not a vitamin or mineral, provided that the food contains 10 to 19
percent of the RDI or the DRV per reference amount customarily consumed.
(2) The terms defined in paragraph (c)(1) of this section may be
used on the label and in the labeling of meal products as defined in
Sec. 101.13(l) and main dish products as defined in 101.13(m), provided
that:
(i) The product contains a food that meets the definition of ``good
source'' in paragraph (c)(1) of this section; and
(ii) The label or labeling clearly identifies the food that is the
subject of the claim (e.g., the serving of sweet potatoes in this
product is a ``good source'' of fiber).
(d) ``Fiber'' claims. (1) If a nutrient content claim is made with
respect to the level of dietary fiber, that is, that the product is high
in fiber, a good source of fiber, or that the food contains ``more''
fiber, and the food is not ``low'' in total fat as defined in
Sec. 101.62(b)(2) or, in the case of a meal product, as defined in
Sec. 101.13(l), or main dish product, as defined in Sec. 101.13(m), is
not ``low'' in total fat as defined in Sec. 101.62(b)(3), then the label
shall disclose the level of total fat per labeled serving.
(2) The disclosure shall appear in immediate proximity to such
claim, be in a type size no less than one-half the size of the claim and
precede the referral statement required in Sec. 101.13(g) (e.g.,
``contains [x amount] of total fat per serving. See [appropriate panel]
for nutrition information'').
(e) ``More'' claims. (1) A relative claim using the terms ``more,''
``fortified,'' ``enriched,'' ``added,'' and ``extra'' may be used on the
label or in labeling of foods to describe the level of protein,
vitamins, minerals,
[[Page 92]]
dietary fiber, or potassium except as limited by Sec. 101.13(j)(1)(i)
and except meal products as defined in Sec. 101.13(l), main dish
products as defined in Sec. 101.13(m), and dietary supplements of
vitamins or minerals to characterize the level of any substance that is
not a vitamin or mineral, provided that:
(i) The food contains at least 10 percent more of the RDI for
vitamins or minerals or of the DRV for protein, dietary fiber, or
potassium (expressed as a percent of the Daily Value) per reference
amount customarily consumed than an appropriate reference food; and
(ii) Where the claim is based on a nutrient that has been added to
the food, that fortification is in accordance with the policy on
fortification of foods in Sec. 104.20 of this chapter; and
(iii) As required in Sec. 101.13(j)(2) for relative claims:
(A) The identity of the reference food and the percentage (or
fraction) that the nutrient is greater relative to the RDI or DRV are
declared in immediate proximity to the most prominent such claim (e.g.,
``contains 10 percent more of the Daily Value for fiber than white
bread''); and
(B) Quantitative information comparing the level of the nutrient in
the product per labeled serving with that of the reference food that it
replaces (e.g., ``Fiber content of white bread is 1 gram (g) per
serving; (this product) 3.5 g per serving'') is declared adjacent to the
most prominent claim or to the nutrition label, except that if the
nutrition label is on the information panel, the quantitative
information may be located elsewhere on the information panel in
accordance with Sec. 101.2.
(2) A relative claim using the terms ``more,'' ``fortified,''
``enriched,'' ``added,'' and ``extra'' may be used on the label or in
labeling to describe the level of protein, vitamins, minerals, dietary
fiber or potassium, except as limited in Sec. 101.13(j)(1)(i), in meal
products as defined in Sec. 101.13(l) or main dish products as defined
in Sec. 101.13(m), provided that:
(i) The food contains at least 10 percent more of the RDI for
vitamins or minerals or of the DRV for protein, dietary fiber, or
potassium (expressed as a percent of the Daily Value) per 100 g of food
than an appropriate reference food.
(ii) Where the claim is based on a nutrient that has been added to
the food, that fortification is in accordance with the policy on
fortification of foods in Sec. 104.20 of this chapter; and
(iii) As required in Sec. 101.13(j)(2) for relative claims:
(A) The identity of the reference food and the percentage (or
fraction) that the nutrient was increased relative to the RDI or DRV are
declared in immediate proximity to the most prominent such claim (e.g.,
``contains 10 percent more of the Daily Value for fiber per 3 oz than
does `X brand of product'''), and
(B) Quantitative information comparing the level of the nutrient in
the product per specified weight with that of the reference food that it
replaces (e.g., ``The fiber content of `X brand of product' is 2 g per 3
oz. This product contains 4.5 g per 3 oz.'') is declared adjacent to the
most prominent claim or to the nutrition label, except that if the
nutrition label is on the information panel, the quantitative
information may be located elsewhere on the information panel in
accordance with Sec. 101.2.
[58 FR 2413, Jan. 6, 1993; 58 FR 17342, Apr. 2, 1993, as amended at 59
FR 394, Jan. 4, 1994; 59 FR 15051, Mar. 31, 1994; 60 FR 17206, Apr. 5,
1995; 61 FR 11731, Mar. 22, 1996]
Sec. 101.56 Nutrient content claims for ``light'' or ``lite.''
(a) General requirements. A claim using the term ``light'' or
``lite'' to describe a food may only be made on the label or in labeling
of the food if:
(1) The claim uses one of the terms defined in this section in
accordance with the definition for that term;
(2) The claim is made in accordance with the general requirements
for nutrient content claims in Sec. 101.13; and
(3) The food is labeled in accordance with Sec. 101.9 or
Sec. 101.10, where applicable.
(b) ``Light'' claims. The terms ``light'' or ``lite'' may be used on
the label or in the labeling of foods, except meal products as defined
in Sec. 101.13(l) and main dish products as defined in Sec. 101.13(m),
without further qualification, provided that:
(1) If the food derives 50 percent or more of its calories from fat,
its fat content is reduced by 50 percent or more per reference amount
customarily consumed compared to an appropriate reference food as
specified in Sec. 101.13(j)(1); or
(2) If the food derives less than 50 percent of its calories from
fat:
(i) The number of calories is reduced by at least one-third (33 1/3
percent) per reference amount customarily consumed compared to an
appropriate reference food; or
(ii) Its fat content is reduced by 50 percent or more per reference
amount customarily consumed compared to the reference food that it
resembles or for which it substitutes as specified in Sec. 101.13(j)(1);
and
(3) As required in Sec. 101.13(j)(2) for relative claims:
(i) The identity of the reference food and the percent (or fraction)
that the calories and the fat were reduced are declared in immediate
proximity to the most prominent such claim, (e.g., ``1/3 fewer calories
and 50 percent less fat than our regular cheese cake'');
(ii) Quantitative information comparing the level of calories and
fat content in the product per labeled serving size with that of the
reference food that it replaces (e.g., ``lite cheesecake--200 calories,
4 grams (g) fat per serving; regular cheesecake--300 calories, 8 g fat
per serving'') is declared adjacent to the most prominent claim or to
the nutrition label, except that if the nutrition label is on the
information panel, the quantitative information may be located elsewhere
on the information panel in accordance with Sec. 101.2; and
(iii) If the labeled food contains less than 40 calories or less
than 3 g fat per reference amount customarily consumed, the percentage
reduction for that nutrient need not be declared.
[[Page 93]]
(4) A ``light'' claim may not be made on a food for which the
reference food meets the definition of ``low fat'' and ``low calorie.''
(c)(1)(i) A product for which the reference food contains 40
calories or less and 3 g fat or less per reference amount customarily
consumed may use the term ``light'' or ``lite'' without further
qualification if it is reduced by 50 percent or more in sodium content
compared to the reference food; and
(ii) As required in Sec. 101.13(j)(2) for relative claims:
(A) The identity of the reference food and the percent (or fraction)
that the sodium was reduced shall be declared in immediate proximity to
the most prominent such claim (e.g., 50 percent less sodium than our
regular soy sauce); and
(B) Quantitative information comparing the level of sodium per
labeled serving size with that of the reference food that it replaces
(e.g., ``lite soy sauce 500 milligrams (mg) sodium per serving; regular
soy sauce 1,000 mg per serving'') is declared adjacent to the most
prominent claim or to the nutrition label, except that if the nutrition
label is on the information panel, the quantitative information may be
located elsewhere on the information panel in accordance with
Sec. 101.2.
(2)(i) A product for which the reference food contains more than 40
calories or more than 3 g fat per reference amount customarily consumed
may use the term ``light in sodium'' or ``lite in sodium'' if it is
reduced by 50 percent or more in sodium content compared to the
reference food, provided that ``light'' or ``lite'' is presented in
immediate proximity with ``in sodium'' and the entire term is presented
in uniform type size, style, color, and prominence; and
(ii) As required in Sec. 101.13(j)(2) for relative claims:
(A) The identity of the reference food and the percent (or fraction)
that the sodium was reduced shall be declared in immediate proximity to
the most prominent such claim (e.g., 50 percent less sodium than our
regular canned peas); and
(B) Quantitative information comparing the level of sodium per
labeled serving size with that of the reference food that it replaces
(e.g., ``lite canned peas, 175 mg sodium per serving; regular canned
peas 350 mg per serving'') is declared adjacent to the most prominent
claim or to the nutrition label, except that if the nutrition label is
on the information panel, the quantitative information may be located
elsewhere on the information panel in accordance with Sec. 101.2.
(iii) Except for meal products as defined in Sec. 101.13(l) and main
dish products as defined in Sec. 101.13(m), a ``light in sodium'' claim
may not be made on a food for which the reference food meets the
definition of ``low in sodium''.
(d)(1) The terms ``light'' or ``lite'' may be used on the label or
in the labeling of a meal product as defined in Sec. 101.13(l) and a
main dish product as defined in Sec. 101.13(m), provided that:
(i) The food meets the definition of:
(A) ``Low in calories'' as defined in Sec. 101.60(b)(3); or
(B) ``Low in fat'' as defined in Sec. 101.62(b)(3); and
(ii)(A) A statement appears on the principal display panel that
explains whether ``light'' is used to mean ``low fat,'' ``low
calories,'' or both (e.g., ``Light Delight, a low fat meal''); and
(B) The accompanying statement is no less than one-half the type
size of the ``light'' or ``lite'' claim.
(2)(i) The term ``light in sodium'' or ``lite in sodium'' may be
used on the label or in the labeling of a meal product as defined in
Sec. 101.13(l) and a main dish product as defined in Sec. 101.13(m),
provided that the food meets the definition of ``low in sodium'' as
defined in Sec. 101.61(b)(5)(i); and
(ii) ``Light'' or ``lite'' and ``in sodium'' are presented in
uniform type size, style, color, and prominence.
(e) Except as provided in paragraphs (b) through (d) of this
section, the term ``light'' or ``lite'' may not be used to refer to a
food that is not reduced in fat by 50 percent, or, if applicable, in
calories by 1/3 or, when properly qualified, in sodium by 50 percent
unless:
(1) It describes some physical or organoleptic attribute of the food
such as texture or color and the information (e.g., ``light in color''
or ``light in texture'') so stated, clearly conveys the nature of the
product; and
[[Page 94]]
(2) The attribute (e.g., ``color'' or ``texture'') is in the same
style, color, and at least one-half the type size as the word ``light''
and in immediate proximity thereto.
(f) If a manufacturer can demonstrate that the word ``light'' has
been associated, through common use, with a particular food to reflect a
physical or organoleptic attribute (e.g., light brown sugar, light corn
syrup, or light molasses) to the point where it has become part of the
statement of identity, such use of the term ``light'' shall not be
considered a nutrient content claim subject to the requirements in this
part.
(g) The term ``lightly salted'' may be used on a product to which
has been added 50 percent less sodium than is normally added to the
reference food as described in Sec. 101.13(j)(1)(i)(B) and
(j)(1)(ii)(B), provided that if the product is not ``low in sodium'' as
defined in Sec. 101.61(b)(4), the statement ``not a low sodium food,''
shall appear adjacent to the nutrition label of the food bearing the
claim, or, if the nutrition label is on the information panel, it may
appear elsewhere on the information panel in accordance with Sec. 101.2
and the information required to accompany a relative claim shall appear
on the label or labeling as specified in Sec. 101.13(j)(2).
[58 FR 2413, Jan. 6, 1993; 58 FR 17342, Apr. 2, 1993, as amended at 60
FR 17206, Apr. 5, 1995]
Sec. 101.60 Nutrient content claims for the calorie content of foods.
(a) General requirements. A claim about the calorie or sugar content
of a food may only be made on the label or in the labeling of a food if:
(1) The claim uses one of the terms defined in this section in
accordance with the definition for that term;
(2) The claim is made in accordance with the general requirements
for nutrient content claims in Sec. 101.13;
(3) The food for which the claim is made is labeled in accordance
with Sec. 101.9, Sec. 101.10, or Sec. 101.36, as applicable; and
(4) For dietary supplements, claims regarding calories may not be
made on products that meet the criteria in Sec. 101.60(b)(1) or (b)(2)
for ``calorie free'' or ``low calorie'' claims except when an equivalent
amount of a similar dietary supplement (e.g., another protein
supplement) that the labeled food resembles and for which it
substitutes, normally exceeds the definition for ``low calorie'' in
Sec. 101.60(b)(2).
(b) ``Calorie content claims.'' (1) The terms ``calorie free,''
``free of calories,'' ``no calories,'' ``zero calories,'' ``without
calories,'' ``trivial source of calories,'' ``negligible source of
calories,'' or ``dietarily insignificant source of calories'' may be
used on the label or in the labeling of foods, provided that:
(i) The food contains less than 5 calories per reference amount
customarily consumed and per labeled serving.
(ii) As required in Sec. 101.13(e)(2), if the food meets this
condition without the benefit of special processing, alteration,
formulation, or reformulation to lower the caloric content, it is
labeled to disclose that calories are not usually present in the food
(e.g., ``cider vinegar, a calorie free food'').
(2) The terms ``low calorie,'' ``few calories,'' ``contains a small
amount of calories,'' ``low source of calories,'' or ``low in calories''
may be used on the label or in labeling of foods, except meal products
as defined in Sec. 101.13(l) and main dish products as defined in
Sec. 101.13(m), provided that:
(i)(A) The food has a reference amount customarily consumed greater
than 30 grams (g) or greater than 2 tablespoons and does not provide
more than 40 calories per reference amount customarily consumed; or
(B) The food has a reference amount customarily consumed of 30 g or
less or 2 tablespoons or less and does not provide more than 40 calories
per reference amount customarily consumed and, except for sugar
substitutes, per 50 g (for dehydrated foods that must be reconstituted
before typical consumption with water or a diluent containing an
insignificant amount, as defined in Sec. 101.9(f)(1), of all nutrients
per reference amount customarily consumed, the per 50 g criterion refers
to the ``as prepared'' form).
(ii) If a food meets these conditions without the benefit of special
processing, alteration, formulation, or reformulation to vary the
caloric content, it is labeled to clearly refer to all foods of its type
and not merely to the
[[Page 95]]
particular brand to which the label attaches (e.g., ``celery, a low
calorie food'').
(3) The terms defined in paragraph (b)(2) of this section may be
used on the label or in labeling of meal products as defined in
Sec. 101.13(l) or main dish products as defined in Sec. 101.13(m),
provided that:
(i) The product contains 120 calories or less per 100 g; and
(ii) If the product meets this condition without the benefit of
special processing, alteration, formulation, or reformulation to lower
the calorie content, it is labeled to clearly refer to all foods of its
type and not merely to the particular brand to which it attaches.
(4) The terms ``reduced calorie,'' ``reduced in calories,''
``calorie reduced,'' ``fewer calories,'' ``lower calorie,'' or ``lower
in calories'' may be used on the label or in the labeling of foods,
except as limited by Sec. 101.13(j)(1)(i) and except meal products as
defined in Sec. 101.13(l) and main dish products as defined in
Sec. 101.13(m), provided that:
(i) The food contains at least 25 percent fewer calories per
reference amount customarily
[[Page 96]]
consumed than an appropriate reference food as described in
Sec. 101.13(j)(1); and
(ii) As required in Sec. 101.13(j)(2) for relative claims:
(A) The identity of the reference food and the percent (or fraction)
that the calories differ between the two foods are declared in immediate
proximity to the most prominent such claim (e.g., reduced calorie
cupcakes ``33 1/3 percent fewer calories than regular cupcakes''); and
(B) Quantitative information comparing the level of the nutrient per
labeled serving size with that of the reference food that it replaces
(e.g., ``Calorie content has been reduced from 150 to 100 calories per
serving.'') is declared adjacent to the most prominent claim or to the
nutrition label, except that if the nutrition label is on the
information panel, the quantitative information may be located elsewhere
on the information panel in accordance with Sec. 101.2.
(iii) Claims described in paragraph (b)(4) of this section may not
be made on the label or labeling of foods if the reference food meets
the definition for ``low calorie.''
(5) The terms defined in paragraph (b)(4) of this section may be
used on the label or in the labeling of meal products as defined in
Sec. 101.13(l) and main dish products as defined in Sec. 101.13(m),
provided that:
(i) The food contains at least 25 percent fewer calories per 100 g
of food than
[[Page 97]]
an appropriate reference food as described in Sec. 101.13(j)(1); and
(ii) As required in Sec. 101.13(j)(2) for relative claims:
(A) The identity of the reference food and the percent (or fraction)
that the calories differ between the two foods are declared in immediate
proximity to the most prominent such claim (e.g., Larry's Reduced
Calorie Lasagna, ``25 percent fewer calories per oz (or 3 oz) than our
regular Lasagna''); and
(B) Quantitative information comparing the level of the nutrient in
the product per specified weight with that of the reference food that it
replaces (e.g., ``Calorie content has been reduced from 108 calories per
3 oz to 83 calories per 3 oz.'') is declared adjacent to the most
prominent claim or to the nutrition label, except that if the nutrition
label is on the information panel, the quantitative information may be
located elsewhere on the information panel in accordance with
Sec. 101.2.
(iii) Claims described in paragraph (b)(5) of this section may not
be made on the label or labeling of food if the reference food meets the
definition for ``low calorie.''
(c) Sugar content claims--(1) Use of terms such as ``sugar free,''
``free of sugar,'' ``no sugar,'' ``zero sugar,'' ``without sugar,''
``sugarless,'' ``trivial source of sugar,'' ``negligible source of
sugar,'' or ``dietarily insignificant source of sugar.'' Consumers may
reasonably be expected to regard terms that represent that the food
contains no sugars or sweeteners e.g., ``sugar free,'' or ``no sugar,''
as indicating a product which is low in calories or significantly
reduced in calories. Consequently, except as provided in paragraph
(c)(2) of this section, a food may not be labeled with such terms
unless:
(i) The food contains less than 0.5 g of sugars, as defined in
Sec. 101.9(c)(6)(ii), per reference amount customarily consumed and per
labeled serving or, in the case of a meal product or main dish product,
less than 0.5 g of sugars per labeled serving; and
(ii) The food contains no ingredient that is a sugar or that is
generally understood by consumers to contain sugars unless the listing
of the ingredient in the ingredient statement is followed by an asterisk
that refers to the statement below the list of ingredients, which states
``adds a trivial amount of sugar,'' ``adds a negligible amount of
sugar,'' or ``adds a dietarily insignificant amount of sugar;'' and
(iii)(A) It is labeled ``low calorie'' or ``reduced calorie'' or
bears a relative claim of special dietary usefulness labeled in
compliance with paragraphs (b)(2), (b)(3), (b)(4), or (b)(5) of this
section; or
(B) Such term is immediately accompanied, each time it is used, by
either the statement ``not a reduced calorie food,'' ``not a low calorie
food,'' or ``not for weight control.''
(2) The terms ``no added sugar,'' ``without added sugar,'' or ``no
sugar added'' may be used only if:
(i) No amount of sugars, as defined in Sec. 101.9(c)(6)(ii), or any
other ingredient that contains sugars that functionally substitute for
added sugars is added during processing or packaging; and
(ii) The product does not contain an ingredient containing added
sugars such as jam, jelly, or concentrated fruit juice; and
(iii) The sugars content has not been increased above the amount
present in the ingredients by some means such as the use of enzymes,
except where the intended functional effect of the process is not to
increase the sugars content of a food, and a functionally insignificant
increase in sugars results; and
(iv) The food that it resembles and for which it substitutes
normally contains added sugars; and
(v) The product bears a statement that the food is not ``low
calorie'' or ``calorie reduced'' (unless the food meets the requirements
for a ``low'' or ``reduced calorie'' food) and that directs consumers'
attention to the nutrition panel for further information on sugar and
calorie content.
(3) Paragraph (c)(1) of this section shall not apply to a factual
statement that a food, including foods intended specifically for infants
and children less than 2 years of age, is unsweetened or contains no
added sweeteners in the case of a food that contains apparent
substantial inherent sugar content, e.g., juices.
(4) The claims provided for in paragraph (c)(1) and (c)(2) of this
section may be used on labels or in labeling of dietary supplements of
vitamins or minerals that are intended specifically for use by infants
and children less than 2 years of age.
(5) The terms ``reduced sugar,'' ``reduced in sugar,'' ``sugar
reduced,'' ``less sugar,'' ``lower sugar'' or ``lower in sugar'' may be
used on the label or in labeling of foods, except meal products as
defined in Sec. 101.13(l), main dish products as defined in
Sec. 101.13(m), and dietary supplements of vitamins or minerals,
provided that:
(i) The food contains at least 25 percent less sugar per reference
amount customarily consumed than an appropriate reference food as
described in Sec. 101.13(j)(1); and
(ii) As required in Sec. 101.13(j)(2) for relative claims:
(A) The identity of the reference food and the percent (or fraction)
that the sugar differs between the two foods are declared in immediate
proximity to the most prominent such claim (e.g., ``these corn flakes
contain 25 percent less sugar than our sugar coated corn flakes''); and
(B) Quantitative information comparing the level of the sugar in the
product per labeled serving with that of the reference food that it
replaces (e.g., ``Sugar content has been lowered from 8 g to 6 g per
serving.'') is declared adjacent to the most prominent claim or to the
nutrition label, except that if the nutrition label is on the
information panel, the quantitative information may be located elsewhere
on the information panel in accordance with Sec. 101.2.
(6) The terms defined in paragraph (c)(4) of this section may be
used on the label or in the labeling of a meal product as defined in
Sec. 101.13(l) and a main dish product as defined in Sec. 101.13(m),
provided that:
(i) The food contains at least 25 percent less sugars per 100 g of
food than an appropriate reference food as described in
Sec. 101.13(j)(1), and
(ii) As required in Sec. 101.13(j)(2) for relative claims:
(A) The identity of the reference food and the percent (or fraction)
that the sugars differ between the two foods are declared in immediate
proximity to the most prominent such claim (e.g., reduced sweet and sour
shrimp dinner, ``25 percent less sugar per 3 oz than our regular sweet
and sour shrimp dinner''); and
(B) Quantitative information comparing the level of the nutrient in
the product per specified weight with that of the reference food that it
replaces (e.g., ``Sugar content has been reduced from 17 g per 3 oz to
13 g per 3 oz.'') is declared adjacent to the most prominent claim or to
the nutrition label, except that if the nutrition label is on the
information panel, the quantitative information may be located elsewhere
on the information panel in accordance with Sec. 101.2.
[58 FR 2413, Jan. 6, 1993; 58 FR 17342, Apr. 2, 1993, as amended at 58
FR 44031, Aug. 18, 1993; 59 FR 394, Jan. 4, 1994; 60 FR 17206, Apr. 5,
1995]
Sec. 101.61 Nutrient content claims for the sodium content of foods.
(a) General requirements. A claim about the level of sodium or salt
in a food may only be made on the label or in the labeling of the food
if:
(1) The claim uses one of the terms defined in this section in
accordance with the definition for that term;
(2) The claim is made in accordance with the general requirements
for nutrient content claims in Sec. 101.13; and
(3) The food for which the claim is made is labeled in accordance
with Sec. 101.9, Sec. 101.10, or Sec. 101.36, as applicable.
(b) ``Sodium content claims.'' (1) The terms ``sodium free,'' ``free
of sodium,'' ``no sodium,'' ``zero sodium,'' ``without sodium,''
``trivial source of sodium,'' ``negligible source of sodium,'' or
``dietary insignificant source of sodium'' may be used on the label or
in the labeling of foods, provided that:
(i) The food contains less than 5 milligrams (mg) of sodium per
reference amount customarily consumed and per labeled serving or, in the
case of a meal product or a main dish product, less than 5 mg of sodium
per labeled serving; and
(ii) The food contains no ingredient that is sodium chloride or is
generally understood by consumers to contain sodium, unless the listing
of the ingredient in the ingredient statement is followed by an asterisk
that refers to the statement below the list of ingredients, which
states: ``Adds a trivial amount of sodium,'' ``adds a negligible amount
of sodium'' or ``adds a dietarily insignificant amount of sodium;'' and
(iii) As required in Sec. 101.13(e)(2) if the food meets these
conditions without the benefit of special processing, alteration,
formulation, or reformulation to lower the sodium content, it is labeled
to disclose that sodium is not usually present in the food (e.g., ``leaf
lettuce, a sodium free food'').
(2) The terms ``very low sodium,'' or ``very low in sodium,'' may be
used on the label or in labeling of foods, except meal products as
defined in Sec. 101.13(l) and main
[[Page 98]]
dish products as defined in Sec. 101.13(m), provided that:
(i)(A) The food has a reference amount customarily consumed greater
than 30 grams (g) or greater than 2 tablespoons and contains 35 mg or
less sodium per reference amount customarily consumed; or
(B) The food has a reference amount customarily consumed of 30 g or
less or 2 tablespoons or less and contains 35 mg or less sodium per
reference amount customarily consumed and per 50 g (for dehydrated foods
that must be reconstituted before typical consumption with water or a
diluent containing an insignificant amount, as defined in
Sec. 101.9(f)(1), of all nutrients per reference amount customarily
consumed, the per 50-g criterion refers to the ``as prepared'' form);
(ii) If the food meets these conditions without the benefit of
special processing, alteration, formulation, or reformulation to vary
the sodium content, it is labeled to clearly refer to all foods of its
type and not merely to the particular brand to which the label attaches
(e.g., ``potatoes, a very low-sodium food'').
(3) The terms defined in paragraph (b)(2) of this section may be
used on the label or in labeling of meal products as defined in
Sec. 101.13(l) and main dish products as defined in Sec. 101.13(m),
provided that:
(i) The product contains 35 mg or less of sodium per 100 g of
product; and
(ii) If the product meets this condition without the benefit of
special processing, alteration, formulation, or reformulation to lower
the sodium content, it is labeled to clearly refer to all foods of its
type and not merely to the particular brand to which the label attaches.
(4) The terms ``low sodium,'' or ``low in sodium,'' ``little
sodium,'' ``contains a small amount of sodium,'' or ``low source of
sodium'' may be used on the label or in the labeling of foods, except
meal products as defined in Sec. 101.13(l) and main dish products as
defined in Sec. 101.13(m), provided that:
(i)(A) The food has a reference amount customarily consumed greater
than 30 g or greater than 2 tablespoons and contains 140 mg or less
sodium per reference amount customarily consumed; or
(B) The food has a reference amount customarily consumed of 30 g or
less or 2 tablespoons or less and contains 140 mg or less sodium per
reference amount customarily consumed and per 50 g (for dehydrated foods
that must be reconstituted before typical consumption with water or a
diluent containing an insignificant amount, as defined in
Sec. 101.9(f)(1), of all nutrients per reference amount customarily
consumed, the per 50-g criterion refers to the ``as prepared'' form);
and
(ii) If the food meets these conditions without the benefit of
special processing, alteration, formulation, or reformulation to vary
the sodium content, it is labeled to clearly refer to all foods of its
type and not merely to the particular brand to which the label attaches
(e.g., ``fresh spinach, a low sodium food''); and
(5) The terms defined in paragraph (b)(4) of this section may be
used on the label or in labeling of meal products as defined in
Sec. 101.13(l) and main dish products as defined in Sec. 101.13(m),
provided that:
(i) The product contains 140 mg or less sodium per 100 g; and
(ii) If the product meets these conditions without the benefit of
special processing, alteration, formulation, or reformulation to lower
the sodium content, it is labeled to clearly refer to all foods of its
type and not merely to the particular brand to which the label attaches.
(6) The terms ``reduced sodium,'' ``reduced in sodium,'' ``sodium
reduced,'' ``less sodium,'' ``lower sodium,'' or ``lower in sodium'' may
be used on the label or in labeling of foods, except meal products as
defined in Sec. 101.13(l) and main dish products as defined in
Sec. 101.13(m), provided that:
(i) The food contains at least 25 percent less sodium per reference
amount customarily consumed than an appropriate reference food as
described in Sec. 101.13(j)(1).
(ii) As required for Sec. 101.13(j)(2) for relative claims:
[[Page 99]]
(A) The identity of the reference food and the percent (or fraction)
that the sodium differs from the labeled food are declared in immediate
proximity to the most prominent such claim (e.g., ``reduced sodium ----
------, 50 percent less sodium than regular ----------''); and
(B) Quantitative information comparing the level of the sodium in
the product per labeled serving with that of the reference food that it
replaces (e.g., ``Sodium content has been lowered from 300 to 150 mg per
serving.'') is declared adjacent to the most prominent claim or to the
nutrition label, except that if the nutrition label is on the
information panel, the quantitative information may be located elsewhere
on the information panel in accordance with Sec. 101.2.
(iii) Claims described in paragraph (b)(6) of this section may not
be made on the label or in the labeling of a food if the nutrient
content of the reference food meets the definition for ``low sodium.''
(7) The terms defined in paragraph (b)(6) of this section may be
used on the label or in the labeling of meal products as defined in
Sec. 101.13(l) and main dish products as defined in Sec. 101.13(m),
provided that:
(i) The food contains at least 25 percent less sodium per 100 g of
food than an appropriate reference food as described in
Sec. 101.13(j)(1), and
(ii) As required in Sec. 101.13(j)(2) for relative claims:
(A) The identity of the reference food and the percent (or fraction)
that the sodium differs from the reference food are declared in
immediate proximity to the most prominent such claim (e.g., reduced
sodium eggplant parmigiana dinner ``30 percent less sodium per oz (or 3
oz) than our regular eggplant parmigiana dinner'').
(B) Quantitative information comparing the level of sodium in the
product per specified weight with that of the reference food that it
replaces (e.g., ``Sodium content has been reduced from 217 mg per 3 oz
to 150 mg per 3 oz.'') is declared adjacent to the most prominent claim
or to the nutrition label, except that if the nutrition label is on the
information panel, the quantitative information may be located elsewhere
on the information panel in accordance with Sec. 101.2.
(iii) Claims described in paragraph (b)(7) of this section may not
be made on the label or in the labeling of a food if the nutrient
content of the reference food meets the definition for ``low sodium.''
(c) The term ``salt'' is not synonymous with ``sodium.'' Salt refers
to sodium chloride. However, references to salt content such as
``unsalted,'' ``no salt,'' ``no salt added'' are potentially misleading.
(1) The term ``salt free'' may be used on the label or in labeling
of foods only if the food is ``sodium free'' as defined in paragraph
(b)(1) of this section.
(2) The terms ``unsalted,'' ``without added salt,'' and ``no salt
added'' may be used on the label or in labeling of foods only if:
(i) No salt is added during processing;
(ii) The food that it resembles and for which it substitutes is
normally processed with salt; and
(iii) If the food is not sodium free, the statement, ``not a sodium
free food'' or ``not for control of sodium in the diet'' appears
adjacent to the nutrition label of the food bearing the claim, or, if
the nutrition label is on the information panel, it may appear elsewhere
on the information panel in accordance with Sec. 101.2.
(3) Paragraph (c)(2) of this section shall not apply to a factual
statement that a food intended specifically for infants and children
less than 2 years of age is unsalted, provided such statement refers to
the taste of the food and is not otherwise false and misleading.
[58 FR 2413, Jan. 6, 1993; 58 FR 17342, Apr. 2, 1993, as amended at 58
FR 44032, Aug. 18, 1993; 59 FR 394, Jan. 4, 1994; 60 FR 17206, Apr. 5,
1995]
Sec. 101.62 Nutrient content claims for fat, fatty acid, and cholesterol content of foods.
(a) General requirements. A claim about the level of fat, fatty
acid, and cholesterol in a food may only be made on the label or in the
labeling of foods if:
(1) The claim uses one of the terms defined in this section in
accordance with the definition for that term;
(2) The claim is made in accordance with the general requirements
for nutrient content claims in Sec. 101.13;
(3) The food for which the claim is made is labeled in accordance
with Sec. 101.9, Sec. 101.10, or Sec. 101.36, as applicable; and
(4) For dietary supplements, claims for fat, saturated fat, and
cholesterol may not be made on products that meet the criteria in
Sec. 101.60(b)(1) or (b)(2) for ``calorie free'' or ``low calorie''
claims.
(b) ``Fat content claims.'' (1) The terms ``fat free,'' ``free of
fat,'' ``no fat,'' ``zero fat,'' ``without fat,'' ``nonfat,'' ``trivial
source of fat,'' ``negligible source of fat,'' or ``dietarily
insignificant source of fat'' may be used on the label or in labeling of
foods, provided that:
(i) The food contains less than 0.5 gram (g) of fat per reference
amount customarily consumed and per labeled serving or, in the case of a
meal product or main dish product, less than 0.5 g of fat per labeled
serving; and
(ii) The food contains no added ingredient that is a fat or is
generally understood by consumers to contain fat unless the listing of
the ingredient in the ingredient statement is followed by an asterisk
that refers to the statement below the list of ingredients, which states
``adds a trivial amount of fat,'' ``adds a negligible amount of fat,''
or ``adds a dietarily insignificant amount of fat;'' and
(iii) As required in Sec. 101.13(e)(2), if the food meets these
conditions without
[[Page 100]]
the benefit of special processing, alteration, formulation, or
reformulation to lower fat content, it is labeled to disclose that fat
is not usually present in the food (e.g., ``broccoli, a fat free
food'').
(2) The terms ``low fat,'' ``low in fat,'' ``contains a small amount
of fat,'' ``low source of fat,'' or ``little fat'' may be used on the
label or in labeling of foods, except meal products as defined in
Sec. 101.13(l) and main dish products as defined in Sec. 101.13(m),
provided that:
(i)(A) The food has a reference amount customarily consumed greater
than 30 g or greater than 2 tablespoons and contains 3 g or less of fat
per reference amount customarily consumed; or
(B) The food has a reference amount customarily consumed of 30 g or
less or 2 tablespoons or less and contains 3 g or less of fat per
reference amount customarily consumed and per 50 g of food (for
dehydrated foods that must be reconstituted before typical consumption
with water or a diluent containing an insignificant amount, as defined
in Sec. 101.9(f)(1), of all nutrients per reference amount customarily
consumed, the per 50-g criterion refers to the ``as prepared'' form);
and
(ii) If the food meets these conditions without the benefit of
special processing, alteration, formulation, or reformulation to lower
fat content, it is labeled to clearly refer to all foods of its type and
not merely to the particular brand to which the label attaches (e.g.,
``frozen perch, a low fat food'').
(3) The terms defined in paragraph (b)(2) of this section may be
used on the label or in labeling of meal products as defined in
Sec. 101.13(l) or main dish products as defined in Sec. 101.13(m),
provided that:
(i) The product contains 3 g or less of total fat per 100 g and not
more than 30 percent of calories from fat; and
(ii) If the product meets these conditions without the benefit of
special processing, alteration, formulation, or reformulation to lower
fat content, it is labeled to clearly refer to all foods of its type and
not merely to the particular brand to which the label attaches.
(4) The terms ``reduced fat,'' ``reduced in fat,'' ``fat reduced,''
``less fat,'' ``lower fat,'' or ``lower in fat'' may be used on the
label or in the labeling of foods, except meal products as defined in
Sec. 101.13(l) and main dish products as defined in Sec. 101.13(m),
provided that:
(i) The food contains at least 25 percent less fat per reference
amount customarily consumed than an appropriate reference food as
described in Sec. 101.13(j)(1); and
(ii) As required in Sec. 101.13(j)(2) for relative claims:
(A) The identity of the reference food and the percent (or fraction)
that the fat differs between the two foods and are declared in immediate
proximity to the most prominent such claim (e.g., ``reduced fat--50
percent less fat than our regular brownies''); and
(B) Quantitative information comparing the level of fat in the
product per labeled serving with that of the reference food that it
replaces (e.g.,
[[Page 101]]
``Fat content has been reduced from 8 g to 4 g per serving.'') is
declared adjacent to the most prominent claim or to the nutrition label,
except that if the nutrition label is on the information panel, the
quantitative information may be located elsewhere on the information
panel in accordance with Sec. 101.2.
(iii) Claims described in paragraph (b)(4) of this section may not
be made on the label or in the labeling of a food if the nutrient
content of the reference food meets the definition for ``low fat.''
(5) The terms defined in paragraph (b)(4) of this section may be
used on the label or in the labeling of meal products as defined in
Sec. 101.13(l) and main dish products as defined in Sec. 101.13(m),
provided that:
(i) The food contains at least 25 percent less fat per 100 g of food
than an appropriate reference food as described in Sec. 101.13(j)(1);
and
(ii) As required in Sec. 101.13(j)(2) for relative claims:
(A) The identity of the reference food and the percent (or fraction)
that the fat differs between the two foods are declared in immediate
proximity to the most prominent such claim (e.g., reduced fat spinach
souffle, ``33 percent less fat per 3 oz than our regular spinach
souffle''); and
(B) Quantitative information comparing the level of fat in the
product per specified weight with that of the reference food that it
replaces (e.g., ``Fat content has been reduced from 7.5 g per 3 oz to 5
g per 3 oz.'') is declared adjacent to the most prominent claim, to the
nutrition label, or, if the nutrition label is located on the
information panel, it may appear elsewhere on the information panel in
accordance with Sec. 101.2.
(iii) Claims described in paragraph (b)(5) of this section may not
be made on the label or in the labeling of a food if the nutrient
content of the reference food meets the definition for ``low fat.''
(6) The term ``------ percent fat free'' may be used on the label or
in the labeling of foods, provided that:
(i) The food meets the criteria for ``low fat'' in paragraph (b)(2)
or (b)(3) of this section;
(ii) The percent declared and the words ``fat free'' are in uniform
type size; and
(iii) A ``100 percent fat free'' claim may be made only on foods
that meet the criteria for ``fat free'' in paragraph (b)(1) of this
section, that contain less than 0.5 g of fat per 100 g, and that contain
no added fat.
(c) ``Fatty acid content claims.'' The label or labeling of foods
that bear claims with respect to the level of saturated fat shall
disclose the level of total fat and cholesterol in the food in immediate
proximity to such claim each time the claim is made and in type that
shall be no less than one-half the size of the type used for the claim
with respect to the level of saturated fat. Declaration of cholesterol
content may be omitted when the food contains less than 2 milligrams
(mg) of cholesterol per reference amount customarily consumed or in the
case of a meal or main dish product less than 2 mg of cholesterol per
labeled serving. Declaration of total fat may be omitted with the term
defined in paragraph (c)(1) of this section when the food contains less
than 0.5 g of total fat per reference amount customarily consumed or, in
the case of a meal product or a main dish product, when the product
contains less than 0.5 g of total fat per labeled serving. The
declaration of total fat may be omitted with the terms defined in
paragraphs (c)(2) through (c)(5) of this section when the food contains
3 g or less of total fat per reference amount customarily consumed or in
the case of a meal product or a main dish product, when the product
contains 3 g or less of total fat per 100 g and not more than 30 percent
calories from fat.
(1) The terms ``saturated fat free,'' ``free of saturated fat,''
``no saturated fat,'' ``zero saturated fat,'' ``without saturated fat,''
``trivial source of saturated fat,'' ``negligible source of saturated
fat,'' or ``dietarily insignificant source of saturated fat'' may be
used on the label or in the labeling of foods, provided that:
(i) The food contains less than 0.5 g of saturated fat and less than
0.5 g trans fatty acid per reference amount customarily consumed and per
labeled serving, or in the case of a meal product or main dish product,
less than 0.5 g of saturated fat and less than 0.5 g trans fatty acid
per labeled serving; and
(ii) The food contains no ingredient that is generally understood by
consumers to contain saturated fat unless the listing of the ingredient
in the ingredient statement is followed by an asterisk that refers to
the statement below the list of ingredients which states, ``adds a
trivial amount of saturated fat,'' ``adds a negligible amount of
saturated fat,'' or ``adds a dietarily insignificant amount of saturated
fat;'' and
(iii) As required in Sec. 101.13(e)(2), if the food meets these
conditions without the benefit of special processing, alteration,
formulation, or reformulation to lower saturated fat content, it
[[Page 102]]
is labeled to disclose that saturated fat is not usually present in the
food.
(2) The terms ``low in saturated fat,'' ``low saturated fat,''
``contains a small amount of saturated fat,'' ``low source of saturated
fat,'' or ``a little saturated fat'' may be used on the label or in the
labeling of foods, except meal products as defined in Sec. 101.13(l) and
main dish products as defined in Sec. 101.13(m), provided that:
(i) The food contains 1 g or less of saturated fatty acids per
reference amount
[[Page 103]]
customarily consumed and not more than 15 percent of calories from
saturated fatty acids; and
(ii) If a food meets these conditions without benefit of special
processing, alteration, formulation, or reformulation to lower saturated
fat content, it is labeled to clearly refer to all foods of its type and
not merely to the particular brand to which the label attaches (e.g.,
``raspberries, a low saturated fat food'').
(3) The terms defined in paragraph (c)(2) of this section may be
used on the label or in the labeling of meal products as defined in
Sec. 101.13(l) and main dish products as defined in Sec. 101.13(m),
provided that:
(i) The product contains 1 g or less of saturated fatty acids per
100 g and less than 10 percent calories from saturated fat; and
(ii) If the product meets these conditions without the benefit of
special processing, alteration, formulation, or reformulation to lower
saturated fat content, it is labeled to clearly refer to all foods of
its type and not merely to the particular brand to which the label
attaches.
(4) The terms ``reduced saturated fat,'' ``reduced in saturated
fat,'' ``saturated fat reduced,'' ``less saturated fat,'' ``lower
saturated fat,'' or ``lower in saturated fat'' may be used on the label
or in the labeling of foods, except as limited by Sec. 101.13(j)(1)(i)
and except meal products as defined in Sec. 101.13(l) and main dish
products as defined in Sec. 101.13(m), provided that:
(i) The food contains at least 25 percent less saturated fat per
reference amount customarily consumed than an appropriate reference food
as described in Sec. 101.13(j)(1); and
(ii) As required in Sec. 101.13(j)(2) for relative claims:
(A) The identity of the reference food and the percent (or fraction)
that the saturated fat differs between the two foods are declared in
immediate proximity to the most prominent such claim (e.g., ``reduced
saturated fat. Contains 50 percent less saturated fat than the national
average for nondairy creamers''); and
(B) Quantitative information comparing the level of saturated fat in
the product per labeled serving with that of the reference food that it
replaces (e.g., ``Saturated fat reduced from 3 g to 1.5 g per serving'')
is declared adjacent to the most prominent claim or to the nutrition
label, except that if the nutrition label is on the information panel,
the quantitative information may be located elsewhere on the information
panel in accordance with Sec. 101.2.
(iii) Claims described in paragraph (c)(4) of this section may not
be made on the label or in the labeling of a food if the nutrient
content of the reference food meets the definition for ``low saturated
fat.''
(5) The terms defined in paragraph (c)(4) of this section may be
used on the label or in the labeling of meal products as defined in
Sec. 101.13(l) and main dish products as defined in Sec. 101.13(m),
provided that:
(i) The food contains at least 25 percent less saturated fat per 100
g of food than an appropriate reference food as described in
Sec. 101.13(j)(1), and
(ii) As required in Sec. 101.13(j)(2) for relative claims:
(A) The identity of the reference food, and the percent (or
fraction) that the fat differs between the two foods are declared in
immediate proximity to the most prominent such claim (e.g., reduced
saturated fat Macaroni and Cheese, ``33 percent less saturated fat per 3
oz than our regular Macaroni and Cheese'').
(B) Quantitative information comparing the level of saturated fat in
the product per specified weight with that of the reference food that it
replaces (e.g., ``Saturated fat content has been reduced from 2.5 g per
3 oz to 1.7 g per 3 oz.'') is declared adjacent to the most prominent
claim or to the nutrition label, except that if the nutrition label in
on the information panel, the quantitative information may be located
elsewhere on the information panel in accordance with Sec. 101.2.
(iii) Claims described in paragraph (c)(5) of this section may not
be made on the label or in the labeling of a food if the nutrient
content of the reference food meets the definition for ``low saturated
fat.''
(d) ``Cholesterol content claims.'' (1) The terms ``cholesterol
free,'' ``free of cholesterol,'' ``zero cholesterol,'' ``without
cholesterol,'' ``no cholesterol,'' ``trivial source of cholesterol,''
``negligible source of cholesterol,'' or ``dietarily insignificant
source of cholesterol'' may be used on the label or in the labeling of
foods, provided that:
(i) For foods that contain 13 g or less of total fat per reference
amount cutomarily consumed, per labeled serving, and per 50 g if the
reference amount customarily consumed is 30 g or less or 2 tablespoons
or less (for dehydrated foods that must be reconstituted before typical
consumption with water or a diluent containing an insignificant amount,
as defined in Sec. 101.9(f)(1), of all nutrients per reference amount
customarily consumed, the per 50-g criterion refers to the ``as
prepared'' form), or, in the case of meal products, 26.0 g or less total
fat per labeled serving, or, in the case of main dish products, 19.5 g
or less total fat per labeled serving:
(A) The food contains less than 2 mg of cholesterol per reference
amount customarily consumed and per labeling serving or, in the case of
a meal product or main dish product, less than 2 mg of cholesterol per
labeled serving; and
(B) The food contains no ingredient that is generally understood by
consumers to contain cholesterol, unless the listing of the ingredient
in the ingredient statement is followed by an asterisk that refers to
the statement below the list of ingredients, which states ``adds a
trivial amount of cholesterol,'' ``adds a negligible amount of
cholesterol,'' or ``adds a dietarily insignificant amount of
cholesterol;'' and
(C) The food contains 2 g or less of saturated fatty acids per
reference amount customarily consumed or, in the case of a meal product
or main dish product, 2 g or less of saturated fatty acids per labeled
serving; and
(D) As required in Sec. 101.13(e)(2), if the food contains less than
2 mg of cholesterol per reference amount customarily consumed or in the
case of a meal product or main dish product, less than 2 mg of
cholesterol per labeled serving without the benefit of special
processing, alteration, formulation, or reformulation to lower
cholesterol content, it is labeled to disclose that cholesterol is not
usually present in the food (e.g., ``applesauce, a cholesterol-free
food'').
(ii) For food that contain more than 13 g of total fat per reference
amount customarily consumed, per labeling serving, or per 50 g if the
reference amount customarily consumed is 30 g or less or 2 tablespoons
or less (for dehydrated foods that must be reconstituted before typical
consumption with water or a diluent containing an insignificant amount,
as defined in Sec. 101.9(f)(1), of all nutrients per reference amount
customarily consumed, the per 50-g criterion refers to the ``as
prepared'' form), or in the case of a meal product, more than 26 g of
total fat per labeled serving, or, in the case of a main dish product
more than 19.5 g of total fat per labeled serving:
(A) The food contains less than 2 mg of cholesterol per reference
amount customarily consumed and per labeling serving or, in the case of
a meal product or main dish product, less than 2 mg of cholesterol per
labeled serving; and
(B) The food contains no ingredient that is generally understood by
consumers to contain cholesterol, unless the listing of the ingredient
in the ingredient statement is followed by an asterisk that refers to
the statement below the list of ingredients, which states ``adds a
trivial amount of cholesterol,'' ``adds a negligible amount of
cholesterol,'' or ``adds a dietarily insignificant amount of
cholesterol;'' and
(C) The food contains 2 g or less of saturated fatty acids per
reference amount cutomarily consumed or, in the case of a meal product
or main dish product less than 2 g of saturated fatty acids per labeled
serving; and
(D) The label or labeling discloses the level of total fat in a
serving (as declared on the label) of the food. Such disclosure shall
appear in immediate proximity to such claim preceding the referral
statement required in Sec. 101.13(g) in type that shall be no less than
one-half the size of the type used for such claim. If the claim appears
on more than one panel, the disclosure shall be made on each panel
except for the panel that bears nutrition labeling. If the claim appears
more than once on a panel, the disclosure shall be made in immediate
proximity to the claim that is printed in the largest type; and
(E) As required in Sec. 101.13(e)(2), if the food contains less than
2 mg of cholesterol per reference amount customarily consumed or in the
case of a meal product or main dish product less than 2 mg of
cholesterol per labeled serving without the benefit of special
processing, alteration, formulation, or
[[Page 104]]
reformulation to lower cholesterol content, it is labeled to disclose
that cholesterol is not usually present in the food (e.g., ``canola oil,
a cholesterol-free food, contains 14 g of fat per serving''); or
(F) If the food contains less than 2 mg of cholesterol per reference
amount customarily consumed or in the case of a meal product or main
dish product less than 2 mg of cholesterol per labeled serving only as a
result of special processing, alteration, formulation, or reformulation,
the amount of cholesterol is substantially less (i.e., meets
requirements of paragraph (d)(4)(ii)(A) of this section) than the food
for which it substitutes as specified in Sec. 101.13(d) that has a
significant (e.g., 5 percent or more of a national or regional market)
market share. As required in Sec. 101.13(j)(2) for relative claims:
(1) The identity of the reference food and the percent (or fraction)
that the cholesterol was reduced are declared in immediate proximity to
the most prominent such claim (e.g., ``cholesterol-free margarine,
contains 100 percent less cholesterol than butter''); and
(2) Quantitative information comparing the level of cholesterol in
the product per labeled serving with that of the reference food that it
replaces (e.g., ``Contains no cholesterol compared with 30 mg
cholesterol in one serving of butter. Contains 13 g of fat per
serving.'') is declared adjacent to the most prominent claim or to the
nutrition label, except that if the nutrition label is on the
information panel, the quantitative information may be located elsewhere
on the information panel in accordance with Sec. 101.2.
(2) The terms ``low in cholesterol,'' ``low cholesterol,''
``contains a small amount of cholesterol,'' ``low source of
cholesterol,'' or ``little cholesterol'' may be used on the label or in
the labeling of foods, except meal products as defined in Sec. 101.13(l)
and main dish products as defined in Sec. 101.13(m), provided that:
(i) For foods that have a reference amount customarily consumed
greater than 30 g or greater than 2 tablespoons and contain 13 g or less
of total fat per reference amount customarily consumed and per labeled
serving:
(A) The food contains 20 mg or less of cholesterol per reference
amount customarily consumed;
(B) The food contains 2 g or less of saturated fatty acids per
reference amount customarily consumed; and
(C) As required in Sec. 101.13(e)(2), if the food meets these
conditions without the benefit of special processing, alteration,
formulation, or reformulation to lower cholesterol content, it is
labeled to clearly refer to all foods of that type and not merely to the
particular brand to which the label attaches (e.g., ``low fat cottage
cheese, a low cholesterol food.'').
(ii) For foods that have a reference amount customarily consumed of
30 g or less or 2 tablespoons or less and contain 13 g or less of total
fat per reference amount customarily consumed, per labeled serving, and
per 50 g (for dehydrated foods that must be reconstituted before typical
consumption with water or a diluent containing an insignificant amount,
as defined in Sec. 101.9(f)(1), of all nutrients per reference amount
customarily consumed, the per 50-g criterion refers to the ``as
prepared'' form);
(A) The food contains 20 mg or less of cholesterol per reference
amount customarily consumed and per 50 g (for dehydrated foods that must
be reconstituted before typical consumption with water or a diluent
containing an insignificant amount, as defined in Sec. 101.9(f)(1), of
all nutrients per reference amount customarily consumed, the per 50-g
criterion refers to the ``as prepared'' form);
(B) The food contains 2 g or less of saturated fatty acids per
reference amount customarily consumed; and
(C) As required in Sec. 101.13(e)(2), if the food meets these
conditions without the benefit of special processing, alteration,
formulation, or reformulation to lower cholesterol content, it is
labeled to clearly refer to all foods of that type and not merely to the
particular brand to which the label attaches (e.g., ``low fat cottage
cheese, a low cholesterol food'').
(iii) For foods that have a reference amount customarily consumed
greater than 30 g or greater than 2 tablespoons and contain more than 13
g of total fat
[[Page 105]]
per reference amount customarily consumed or per labeled serving,
(A) The food contains 20 mg or less of cholesterol per reference
amount customarily consumed;
(B) The food contains 2 g or less of saturated fatty acids per
reference amount customarily consumed;
(C) The label or labeling discloses the level of total fat in a
serving (as declared on the label) of the food. Such disclosure shall
appear in immediate proximity to such claim preceding the referral
statement required in Sec. 101.13(g) in type that shall be no less than
one-half the size of the type used for such claim. If the claim appears
on more than one panel, the disclosure shall be made on each panel
except for the panel that bears nutrition labeling. If the claim is made
more than once on a panel, the disclosure shall be made in immediate
proximity to the claim that is printed in the largest type; and
(D) As required in Sec. 101.13(e)(2), if the food meets these
conditions without the benefit of special processing, alteration,
formulation, or reformulation to lower cholesterol content, it is
labeled to clearly refer to all foods of that type
[[Page 106]]
and not merely to the particular brand to which the label attaches; or
(E) If the food contains 20 mg or less of cholesterol only as a
result of special processing, alteration, formulation, or reformulation,
the amount of cholesterol is substantially less (i.e., meets
requirements of paragraph (d)(4)(ii)(A) of this section) than the food
for which it substitutes as specified in Sec. 101.13(d) that has a
significant (e.g., 5 percent or more of a national or regional market)
market share. As required in Sec. 101.13(j)(2) for relative claims:
(1) The identity of the reference food and the percent (or fraction)
that the cholesterol has been reduced are declared in immediate
proximity to the most prominent such claim (e.g., ``low-cholesterol
peanut butter sandwich crackers, contains 83 percent less cholesterol
than our regular peanut butter sandwich crackers''); and
(2) Quantitative information comparing the level of cholesterol in
the product per labeled serving with that of the reference food that it
replaces (e.g., ``Cholesterol lowered from 30 mg to 5 mg per serving;
contains 13 g of fat per serving.'') is declared adjacent to the most
prominent claim or to the nutrition label, except that if the nutrition
label is on the information panel, the quantitative information may be
located elsewhere on the information panel in accordance with
Sec. 101.2.
(iv) For foods that have a reference amount customarily consumed of
30 g or less or 2 tablespoons or less and contain more than 13 g of
total fat per reference amount customarily consumed, per labeled
serving, or per 50 g (for dehydrated foods that must be reconstituted
before typical consumption with water or a diluent containing an
insignificant amount, as defined in Sec. 101.9(f)(1), of all nutrients
per reference amount customarily consumed, the per 50-g criterion refers
to the ``as prepared'' form),
(A) The food contains 20 mg or less of cholesterol per reference
amount customarily consumed and per 50 g (for dehydrated foods that must
be reconstituted before typical consumption with water or a diluent
containing an insignificant amount, as defined in Sec. 101.9(f)(1), of
all nutrients per reference amount customarily consumed, the per 50-g
criterion refers to the ``as prepared'' form),
(B) The food contains 2 g or less of saturated fatty acids per
reference amount customarily consumed;
(C) The label or labeling discloses the level of total fat in a
serving (as declared on the label) of the food. Such disclosure shall
appear in immediate proximity to such claim preceding the referral
statement required in Sec. 101.13(g) in type that shall be no less than
one-half the size of the type used for such claim. If the claim appears
on more than one panel, the disclosure shall be made on each panel
except for the panel that bears nutrition labeling. If the claim is made
more than once on a panel, the disclosure shall be made in immediate
proximity to the claim that is printed in the largest type; and
(D) As required in Sec. 101.13(e)(2), if the food meets these
conditions without the benefit of special processing, alteration,
formulation, or reformulation to lower cholesterol content, it is
labeled to clearly refer to all foods of that type and not merely to the
particular brand to which the label attaches; or
(E) If the food contains 20 mg or less of cholesterol only as a
result of special processing, alteration, formulation, or reformulation,
the amount of cholesterol is substantially less (i.e., meets
requirements of paragraph (d)(4)(ii)(A) of this section) than the food
for which it substitutes as specified in Sec. 101.13(d) that has a
significant (i.e., 5 percent or more of a national or regional market)
market share. As required in Sec. 101.13(j)(2) for relative claims:
(1) The identity of the reference food and the percent (or fraction)
that the cholesterol has been reduced are declared in immediate
proximity to the most prominent such claim (e.g., ``low-cholesterol
peanut butter sandwich crackers, contains 83 percent less cholesterol
than our regular peanut butter sandwich crackers''); and
(2) Quantitative information comparing the level of cholesterol in
the product per labeled serving with that of the reference food that it
replaces (e.g., ``Cholesterol lowered from 30 mg to 5 mg per serving;
contains 13 g of fat per serving.'') is declared adjacent to the most
prominent claim or to the nutrition label, except that if the nutrition
label is on the information panel, the quantitative information may be
located elsewhere on the information panel in accordance with
Sec. 101.2.
(3) The terms defined in paragraph (d)(2) of this section may be
used on the label and in labeling of meal products as defined in
Sec. 101.13(l) or a main dish product as defined in Sec. 101.13(m)
provided that the product meets the requirements of paragraph (d)(2) of
this section except that the determination as to whether paragraph
(d)(2)(i) or (d)(2)(iii) of this section applies to the product will be
made only on the basis of whether the meal product contains 26 g or less
of total fat per labeled serving or the main dish product contain 19.5 g
or less of total fat per labeled serving, the requirement in paragraphs
(d)(2)(i)(A) and (d)(2)(iii)(A) of this section shall be limited to 20
mg of cholesterol per 100 g, and the requirement in paragraphs
(d)(2)(i)(B) and (d)(2)(iii)(B) of this section shall be modified to
require that the food contain 2 g or less of saturated fat per 100 g
rather than per reference amount customarily consumed.
(4) The terms ``reduced cholesterol,'' ``reduced in cholesterol,''
``cholesterol reduced,'' ``less cholesterol,'' ``lower cholesterol,'' or
``lower in cholesterol'' except as limited by Sec. 101.13(j)(1)(i) may
be used on the label or in labeling of foods or foods that substitute
for those foods as specified in Sec. 101.13(d), excluding meal products
as defined in Sec. 101.13(l) and main dish products as defined in
Sec. 101.13(m), provided that:
(i) For foods that contain 13 g or less of total fat per reference
amount customarily consumed, per labeled serving, and per 50 g if the
reference amount customarily consumed is 30 g or less or 2 tablespoons
or less (for dehydrated foods that must be reconstituted before typical
consumption with water or a diluent containing an insignificant amount,
as defined in Sec. 101.9(f)(1), of all nutrients per reference amount
customarily consumed, the per 50-g criterion refers to the ``as
prepared'' form):
(A) The food has been specifically formulated, altered, or processed
to reduce its cholesterol by 25 percent or more from the reference food
it resembles as defined in Sec. 101.13(j)(1) and for which it
substitutes as specified in Sec. 101.13(d) that has a significant (i.e.,
5 percent or more) market share; and
(B) The food contains 2 g or less of saturated fatty acids per
reference amount customarily consumed; and
(C) As required in Sec. 101.13(j)(2) for relative claims:
(1) The identity of the reference food and the percent (or fraction)
that the cholesterol has been reduced are declared in immediate
proximity to the most prominent such claim; and
(2) Quantitative information comparing the level of cholesterol in
the product per labeled serving with that of the reference food that it
replaces (e.g., ``[labeled product] 50 mg cholesterol per serving;
[reference product] 30 mg cholesterol per serving'') is declared
adjacent to the most prominent claim or to the nutrition label, except
that if the nutrition label is on the information panel, the
quantitative information may be located elsewhere on the
[[Page 107]]
information panel in accordance with Sec. 101.2.
(ii) For foods that contain more than 13 g of total fat per
reference amount customarily consumed, per labeled serving, or per 50 g
if the reference amount customarily consumed is 30 g or less or 2
tablespoons or less (for dehydrated foods that must be reconstituted
before typical consumption with water or a diluent containing an
insignificant amount, as defined in Sec. 101.9(f)(1), of all nutrients
per reference amount customarily consumed, the per 50-g criterion refers
to the ``as prepared'' form):
(A) The food has been specifically formulated, altered, or processed
to reduce its cholesterol by 25 percent or more from the reference food
it resembles as defined in Sec. 101.13(j)(1) and for which it
substitutes as specified in Sec. 101.13(d) that has a significant (i.e.,
5 percent or more of a national or regional market) market share;
(B) The food contains 2 g or less of saturated fatty acids per
reference amount customarily consumed;
(C) The label or labeling discloses the level of total fat in a
serving (as declared on the label) of the food. Such disclosure shall
appear in immediate proximity to such claim preceding the referral
statement required in Sec. 101.13(g) in type that shall be no less than
one-half the size of the type used for such claim. If the claim appears
on more than one panel, the disclosure shall be made on each panel
except for the panel that bears nutrition labeling. If the claim is made
more than once on a panel, the disclosure shall be made in immediate
proximity to the claim that is printed in the largest type; and
(D) As required in Sec. 101.13(j)(2) for relative claims:
(1) The identity of the reference food and the percent (or fraction)
that the cholesterol has been reduced are declared in immediate
proximity to the most prominent such claim (e.g., 25 percent less
cholesterol than ----------------); and
(2) Quantitative information comparing the level of cholesterol in
the product per labeled serving with that of the reference food that it
replaces (e.g., ``Cholesterol lowered from 55 mg to 30 mg per serving.
Contains 13 g of fat per serving.'') is declared adjacent to the most
prominent claim or to the nutrition label, except that if the nutrition
label is on the information panel, the quantitative information may be
located elsewhere on the information panel in accordance with
Sec. 101.2.
(iii) Claims described in paragraph (d)(4) of this section may not
be made on the label or in labeling of a food if the nutrient content of
the reference food meets the definition for ``low cholesterol.''
(5) The terms defined in paragraph (d)(4) of this section may be
used on the label or in the labeling of meal products as defined in
Sec. 101.13(l) and main dish products as defined in Sec. 101.13(m),
provided that:
(i) For meal products that contain 26.0 g or less of total fat per
labeled serving or for main dish products that contain 19.5 g or less of
total fat per labeled serving;
(A) The food has been specifically formulated, altered, or processed
to reduce its cholesterol by 25 percent or more from the reference food
it resembles as defined in Sec. 101.13(j)(1) and for which it
substitutes as specified in Sec. 101.13(d) that has a significant (e.g.,
5 percent or more of a national or regional market) market share;
(B) The food contains 2 g or less of saturated fatty acids per 100
g; and
(C) As required in Sec. 101.13(j)(2) for relative claims:
(1) The identity of the reference food, and the percent (or
fraction) that the cholesterol has been reduced are declared in
immediate proximity to the most prominent such claim (e.g., ``25% less
cholesterol per 3 oz than --------.''); and
(2) Quantitative information comparing the level of cholesterol in
the product per specified weight with that of the reference food that it
replaces (e.g., ``Cholesterol content has been reduced from 35 mg per 3
oz to 25 mg per 3 oz.'') is declared adjacent to the most prominent
claim or to the nutrition label, except that if the nutrition label is
on the information panel, the quantitative information may be located
elsewhere on the information panel in accordance with Sec. 101.2.
(ii) For meal products that contain more than 26.0 g of total fat
per labeled
[[Page 108]]
serving or for main dish products that contain more than 19.5 g of total
fat per labeled serving:
(A) The food has been specifically formulated, altered, or processed
to reduce its cholesterol by 25 percent or more from the reference food
it resembles as defined in Sec. 101.13(j)(1) and for which it
substitutes as specified in Sec. 101.13(d) that has a significant (e.g.,
5 percent or more of a national or regional market) market share.
(B) The food contains 2 g or less of saturated fatty acids per 100
g;
(C) The label or labeling discloses the level of total fat in a
serving (as declared on the label) of the food. Such disclosure shall
appear in immediate proximity to such claim preceding the referral
statement required in Sec. 101.13(g) in type that shall be no less than
one-half the size of the type used for such claim. If the claim appears
on more than one panel the disclosure shall be made on each panel except
for the panel that bears nutrition labeling. If the claim is made more
than once on a panel, the disclosure shall be made in immediate
proximity to the claim that is printed in the largest type; and
(D) As required in Sec. 101.13(j)(2) for relative claims:
(1) The identity of the reference food and the percent (or fraction)
that the cholesterol has been reduced are declared in immediate
proximity to the most prominent such claim (e.g., 25 percent less
cholesterol than ------------); and
(2) Quantitative information comparing the level of cholesterol in
the product per specified weight with that of the reference food that it
replaces (e.g., ``Cholesterol lowered from 30 mg to 22 mg per 3 oz of
product.'') is declared adjacent to the most prominent claim or to the
nutrition label, except that if the nutrition label is on the
information panel, the quantitative information may be located elsewhere
on the information panel in accordance with Sec. 101.2.
(iii) Claims described in paragraph (d)(5) of this section may not
be made on the label or in the labeling of a food if the nutrient
content of the reference food meets the definition for ``low
cholesterol.''
(e) ``Lean'' and ``extra lean'' claims. (1) The term ``lean'' may be
used on the label or in labeling of foods except meal products as
defined in Sec. 101.13(l) and main dish products as defined in
Sec. 101.13(m) provided that the food is a seafood or game meat product
and as packaged contains less than 10 g total fat, 4.5 g or less
saturated fat, and less than 95 mg cholesterol per reference amount
customarily consumed and per 100 g;
(2) The term defined in paragraph (e)(1) of this section may be used
on the label or in the labeling of meal products as defined in
Sec. 101.13(l) or main dish products as defined in Sec. 101.13(m)
provided that the food contains less than 10 g total fat, 4.5 g or less
saturated fat, and less than 95 mg cholesterol per 100 g and per labeled
serving;
(3) The term ``extra lean'' may be used on the label or in the
labeling of foods except meal products as defined in Sec. 101.13(l) and
main dish products as defined in Sec. 101.13(m) provided that the food
is a discrete seafood or game meat product and as packaged contains less
than 5 g total fat, less than 2 g saturated fat, and less than 95 mg
cholesterol per reference amount customarily consumed and per 100 g; and
(4) The term defined in paragraph (e)(3) of this section may be used
on the label or in labeling of meal products as defined in
Sec. 101.13(l) and main dish products as defined in Sec. 101.13(m)
provided that the food contains less than 5 g of fat, less than 2 g of
saturated fat, and less than 95 mg of cholesterol per 100 g and per
labeled serving.
(f) Misbranding. Any label or labeling containing any statement
concerning fat, fatty acids, or cholesterol that is not in conformity
with this section shall be deemed to be misbranded under sections
201(n), 403(a), and 403(r) of the Federal Food, Drug, and Cosmetic Act.
[58 FR 2413, Jan. 6, 1993; 58 FR 17342, 17343, Apr. 2, 1993, as amended
at 58 FR 44032, Aug. 18, 1993; 58 FR 60105, Nov. 15, 1993; 59 FR 394,
Jan. 4, 1994; 60 FR 17207, Apr. 5, 1995]
Sec. 101.65 Implied nutrient content claims and related label statements.
(a) General requirements. An implied nutrient content claim can only
be
[[Page 109]]
made on the label and in labeling of the food if:
(1) The claim uses one of the terms described in this section in
accordance with the definition for that term;
(2) The claim is made in accordance with the general requirements
for nutrient content claims in Sec. 101.13; and
(3) The food for which the claim is made is labeled in accordance
with Sec. 101.9, Sec. 101.10, or Sec. 101.36, as applicable.
(b) Label statements that are not implied claims. Certain label
statements about the nature of a product are not nutrient content claims
unless such statements are made in a context that would make them an
implied claim under Sec. 101.13(b)(2). The following types of label
statements are generally not implied nutrient content claims and, as
such, are not subject to the requirements of Sec. 101.13 and this
section:
(1) A claim that a specific ingredient or food component is absent
from a product, provided that the purpose of such claim is to facilitate
avoidance of the substances because of food allergies (see Sec. 105.62
of this chapter), food intolerance, religious beliefs, or dietary
practices such as vegetarianism or other nonnutrition related reason,
e.g., ``100 percent milk free;''
(2) A claim about a substance that is nonnutritive or that does not
have a nutritive function, e.g., ``contains no preservatives,'' ``no
artificial colors;''
(3) A claim about the presence of an ingredient that is perceived to
add value to the product, e.g., ``made with real butter,'' ``made with
whole fruit,'' or ``contains honey,'' except that claims about the
presence of ingredients other than vitamins or minerals or that are
represented as a source of vitamins and minerals are not allowed on
labels or in labeling of dietary supplements of vitamins and minerals
that are not in conventional food form.
(4) A statement of identity for a food in which an ingredient
constitutes essentially 100 percent of a food (e.g., ``corn oil,'' ``oat
bran,'' ``vitamin C 60 mg tablet'').
(5) A statement of identity that names as a characterizing
ingredient, an ingredient associated with a nutrient benefit (e.g.,
``corn oil margarine,'' ``oat bran muffins,'' or ``whole wheat
bagels''), unless such claim is made in a context in which label or
labeling statements, symbols, vignettes, or other forms of communication
suggest that a nutrient is absent or present in a certain amount; and
(6) A label statement made in compliance with a specific provision
of part 105 of this chapter, solely to note that a food has special
dietary usefulness relative to a physical, physiological, pathological,
or other condition, where the claim identifies the special diet of which
the food is intended to be a part.
(c) Particular implied nutrient content claims. (1) Claims about the
food or an ingredient therein that suggest that a nutrient or an
ingredient is absent or present in a certain amount (e.g., ``high in oat
bran'') are implied nutrient content claims and must comply with
paragraph (a) of this section.
(2) The phrases ``contains the same amount of [nutrient] as a
[food]'' and ``as much [nutrient] as a [food]'' may be used on the label
or in the labeling of foods, provided that the amount of the nutrient in
the reference food is enough to qualify that food as a ``good source''
of that nutrient, and the labeled food, on a per serving basis, is an
equivalent, good source of that nutrient (e.g., ``as much fiber as an
apple,'' ``Contains the same amount of Vitamin C as an 8 oz glass of
orange juice.'').
(3) Claims may be made that a food contains or is made with an
ingredient that is known to contain a particular nutrient, or is
prepared in a way that affects the content of a particular nutrient in
the food, if the finished food is either ``low'' in or a ``good source''
of the nutrient that is associated with the ingredient or type of
preparation. If a more specific level is claimed (e.g., ``high in ------
----''), that level of the nutrient must be present in the food. For
example, a claim that a food contains oat bran is a claim that it is a
good source of dietary fiber; that a food is made only with vegetable
oil is a claim that it is low in saturated fat; and that a food contains
no oil is a claim that it is fat free.
(d) General nutritional claims. (1) Claims about a food that suggest
that the food because of its nutrient content may be useful in
maintaining healthy dietary practices and that are made in association
with an explicit claim or
[[Page 110]]
statement about a nutrient (e.g., ``healthy, contains 3 grams of fat'')
are implied nutrient content claims covered by this paragraph.
(2) The term ``healthy'' or any derivative of the term ``healthy,''
such as ``health,'' ``healthful,'' ``healthfully,'' ``healthfulness,''
``healthier,'' ``healthiest,'' ``healthily,'' and ``healthiness'' may be
used on the label or in labeling of a food, other than raw, single
ingredient seafood or game meat products, main dish products as defined
in Sec. 101.13(m), and meal products as defined in Sec. 101.13(l), as an
implied nutrient content claim to denote foods that are useful in
constructing a diet that is consistent with dietary recommendations
provided that:
(i) The food meets the definition of ``low'' for fat and saturated
fat;
(ii)(A) The food has a reference amount customarily consumed greater
than 30 grams (g) or greater than 2 tablespoons and, before January 1,
1998, contains 480 milligrams (mg) sodium or less per reference amount
customarily consumed, and per labeled serving; or
(B) The food has a reference amount customarily consumed of 30 g or
less or 2 tablespoons or less and, before January 1, 1998, contains 480
mg sodium or less per 50 g (for dehydrated foods that must be
reconstituted before typical consumption with water or a diluent
containing an insignificant amount as defined in Sec. 101.9(f)(1), of
all nutrients per reference amount customarily consumed, the per 50 g
criterion refers to the ``as prepared'' form);
(C)(1) The food has a reference amount customarily consumed greater
than 30 g or greater than 2 tablespoons and, after January 1, 1998,
contains 360 mg sodium or less per reference amount customarily
consumed, and per labeled serving; or
(2) The food has a reference amount customarily consumed of 30 g or
less or 2 tablespoons or less and, after January 1, 1998, contains 360
mg sodium or less per 50 g (for dehydrated foods that must be
reconstituted before typical consumption with water or a diluent
containing an insignificant amount as defined in Sec. 101.9(f)(1), of
all nutrients per reference amount customarily consumed, the per 50 g
criterion refers to the ``as prepared'' form);
(iii) Cholesterol is not present at a level exceeding the disclosure
level as described in Sec. 101.13(h);
(iv) The food, other than a raw fruit or vegetable, contains at
least 10 percent of the Reference Daily Intake (RDI) or Daily Reference
Value (DRV) per reference amount customarily consumed of vitamin A,
vitamin C, calcium, iron, protein, or fiber;
(v) Where compliance with paragraph (d)(2)(iv) of this section is
based on a nutrient that has been added to the food, that fortification
is in accordance with the policy on fortification of foods in
Sec. 104.20 of this chapter; and
(vi) The food complies with definitions and declaration requirements
established in part 101 of this chapter for any specific nutrient
content claim on the label or in labeling.
(3) The term ``healthy'' or its derivatives may be used on the label
or in labeling of raw, single ingredient seafood or game meat as an
implied nutrient content claim provided that:
(i) The food contains less than 5 g total fat, less than 2 g
saturated fat, and less than 95 mg cholesterol per reference amount
customarily consumed and per 100 g;
(ii)(A) The food has a reference amount customarily consumed greater
than 30 g or greater than 2 tablespoons and, before January 1, 1998,
contains 480 mg sodium or less per reference amount customarily
consumed, and per labeled serving; or
(B) The food has a reference amount customarily consumed of 30 g or
less or 2 tablespoons or less and, before January 1, 1998, contains 480
mg sodium or less per 50 g (for dehydrated foods that must be
reconstituted before typical consumption with water or a diluent
containing an insignificant amount as defined in Sec. 101.9(f)(1), of
all nutrients per reference amount customarily consumed, the per 50 g
criterion refers to the ``as prepared'' form);
(C)(1) The food has a reference amount customarily consumed greater
than 30 g or greater than 2 tablespoons and, after January 1, 1998,
contains 360 mg sodium or less per reference amount customarily
consumed, and per labeled serving; or
(2) The food has a reference amount customarily consumed of 30 g or
less or
[[Page 111]]
2 tablespoons or less and, after January 1, 1998, contains 360 mg sodium
or less per 50 g (for dehydrated foods that must be reconstituted before
typical consumption with water or a diluent containing an insignificant
amount as defined in Sec. 101.9(f)(1), of all nutrients per reference
amount customarily consumed, the per 50 g criterion refers to the ``as
prepared'' form);
(iii) The food contains at least 10 percent of the RDI or DRV per
reference amount customarily consumed of vitamin A, vitamin C, calcium,
iron, protein, or fiber;
(iv) Where compliance with paragraph (d)(3)(iii) of this section is
based on a nutrient that has been added to the food, that fortification
is in accordance with the policy on fortification of foods in
Sec. 104.20 of this chapter; and
(v) The food complies with definitions and declaration requirements
established in this part for any specific nutrient content claim on the
label or in labeling.
(4) The term ``healthy'' or its derivatives may be used on the label
or in labeling of main dish products, as defined in Sec. 101.13(m), and
meal products, as defined in Sec. 101.13(l) as an implied nutrient
content claim provided that:
(i) The food meets the definition of ``low'' for fat and saturated
fat;
(ii)(A) Before January 1, 1998, sodium is not present at a level
exceeding 600 mg per labeled serving, or
(B) After January 1, 1998, sodium is not present at a level
exceeding 480 mg per labeled serving;
(iii) Cholesterol is not present at a level exceeding 90 mg per
labeled serving;
(iv) The food contains at least 10 percent of the RDI or DRV per
labeled serving of two (for main dish products) or three (for meal
products) of the following nutrients--vitamin A, vitamin C, calcium,
iron, protein, or fiber;
(v) Where compliance with paragraph (d)(4)(iv) of this section is
based on a nutrient that has been added to the food, that fortification
is in accordance with the policy on fortification of foods in
Sec. 104.20 of this chapter; and
(vi) The food complies with definitions and declaration requirements
established in this part for any specific nutrient content claim on the
label or in labeling.
[58 FR 2413, Jan. 6, 1993; 58 FR 17343, Apr. 2, 1993, as amended at 59
FR 394, Jan. 4, 1994; 59 FR 24249, May 10, 1994; 59 FR 50828, Oct. 6,
1994]
Sec. 101.67 Use of nutrient content claims for butter.
(a) Claims may be made to characterize the level of nutrients,
including fat, in butter if:
(1) The claim complies with the requirements of Sec. 101.13 and with
the requirements of the regulations in this subpart that define the
particular nutrient content claim that is used and how it is to be
presented. In determining whether a claim is appropriate, the
calculation of the percent fat reduction in milkfat shall be based on
the 80 percent milkfat requirement provided by the statutory standard
for butter (21 U.S.C. 321a);
(2) The product contains cream or milk, including milk constituents
(including, but not limited to, whey, casein, modified whey, and salts
of casein), or both, with or without added salt, with or without safe
and suitable colorings, with or without nutrients added to comply with
paragraph (a)(3) of this section, and with or without safe and suitable
bacterial cultures. The product may contain safe and suitable
ingredients to improve texture, prevent syneresis, add flavor, extend
shelf life, improve appearance, and add sweetness. The product may
contain water to replace milkfat although the amount of water in the
product shall be less than the amount of cream, milk, or milk
constituents;
(3) The product is not nutritionally inferior, as defined in
Sec. 101.3(e)(4), to butter as produced under 21 U.S.C. 321a; and
(4) If the product would violate 21 U.S.C. 321a but for the nutrient
content claim that characterizes the level of nutrients, that claim
shall be an explicit claim that is included as part of the common or
usual name of the product.
(b) Deviations from the ingredient provisions of 21 U.S.C. 321a must
be the minimum necessary to achieve similar performance characteristics
as butter as produced under 21 U.S.C. 321a, or the
[[Page 112]]
food will be deemed to be adulterated under section 402(b) of the act.
The performance characteristics (e.g., physical properties, organoleptic
characteristics, functional properties, shelf life) of the product shall
be similar to butter as produced under 21 U.S.C. 321a. If there is a
significant difference in performance characteristics (that materially
limits the uses of the product compared to butter,) the label shall
include a statement informing the consumer of such difference (e.g., if
appropriate, ``not recommended for baking purposes''). Such statement
shall comply with the requirements of Sec. 101.13(d). The modified
product shall perform at least one of the principal functions of butter
substantially as well as butter as produced under 21 U.S.C. 321a.
(c)(1) Each of the ingredients used in the food shall be declared on
the label as required by the applicable sections of this part.
(2) Safe and suitable ingredients added to improve texture, prevent
syneresis, add flavor, extend shelf life, improve appearance, or add
sweetness and water added to replace milkfat shall be identified with an
asterisk in the ingredient statement. The statement ``*Ingredients not
in regular butter'' shall immediately follow the ingredient statement in
the same type size.
[58 FR 2455, Jan. 6, 1993]
Sec. 101.69 Petitions for nutrient content claims.
(a) This section pertains to petitions for claims, expressed or
implied, that:
(1) Characterize the level of any nutrient which is of the type
required to be in the label or labeling of food by section 403(q)(1) or
(q)(2) of the Federal Food, Drug, and Cosmetic Act (the act); and
(2) That are not exempted under section 403(r)(5)(A) through
(r)(5)(C) of the act from the requirements for such claims in section
403(r)(2).
(b) Petitions included in this section are:
(1) Petitions for a new (heretofore unauthorized) nutrient content
claim;
(2) Petitions for a synonymous term (i.e., one that is consistent
with a term defined by regulation) for characterizing the level of a
nutrient; and
(3) Petitions for the use of an implied claim in a brand name.
(c) An original and one copy of the petition to be filed under the
provisions of section 403(r)(4) of the act shall be submitted, or the
petitioner may submit an original and a computer readable disk
containing the petition. Contents of the disk should be in a standard
format, such as ASCII format. Petitioners interested in submitting a
disk should contact FDA's Center for Food Safety and Applied Nutrition
for details. If any part of the material submitted is in a foreign
language, it shall be accompanied by an accurate and complete English
translation. The petition shall state the petitioner's post office
address to which published notices as required by section 403 of the act
may be sent.
(d) Pertinent information may be incorporated in, and will be
considered as part of, a petition on the basis of specific reference to
such information submitted to and retained in the files of the Food and
Drug Administration. However, any reference to unpublished information
furnished by a person other than the applicant will not be considered
unless use of such information is authorized (with the understanding
that such information may in whole or part be subject to release to the
public) in a written statement signed by the person who submitted it.
Any reference to published information should be accompanied by reprints
or photostatic copies of such references.
(e) If nonclinical laboratory studies are included in a petition
submitted under section 403(r)(4) of the act, the petition shall
include, with respect to each nonclinical study contained in the
petition, either a statement that the study has been, or will be,
conducted in compliance with the good laboratory practice regulations as
set forth in part 58 of this chapter or, if any such study was not
conducted in compliance with such regulations, a brief statement of the
reason for the noncompliance.
(f) If clinical investigations are included in a petition submitted
under section 403(r)(4) of the act, the petition shall include a
statement regarding each such clinical investigation relied upon in the
petition that the study either was conducted in compliance with
[[Page 113]]
the requirements for institutional review set forth in part 56 of this
chapter or was not subject to such requirements in accordance with
Sec. 56.104 or Sec. 56.105 of this chapter, and that it was conducted in
compliance with the requirements for informed consent set forth in part
50 of this chapter.
(g) The availability for public disclosure of petitions submitted to
the agency under this section will be governed by the rules specified in
Sec. 10.20(j) of this chapter.
(h) All petitions submitted under this section shall include either
a claim for a categorical exclusion under Sec. 25.24 of this chapter or
an environmental assessment under Sec. 25.31 of this chapter.
(i) The data specified under the several lettered headings should be
submitted on separate sheets or sets of sheets, suitably identified. If
such data have already been submitted with an earlier application from
the petitioner, the present petition may incorporate it by specific
reference to the earlier petition.
(j) The petition must be signed by the petitioner or by his attorney
or agent, or (if a corporation) by an authorized official.
(k) The petition shall include a statement signed by the person
responsible for the petition, that to the best of his knowledge, it is a
representative and balanced submission that includes unfavorable
information, as well as favorable information, known to him pertinent to
the evaluation of the petition.
(l) All applicable provisions of part 10--Administrative Practices
and Procedures, may be used by the Commissioner of Food and Drugs, the
petitioner or any outside party with respect to any agency action on the
petition.
(m)(1) Petitions for a new nutrient content claim shall include the
following data and be submitted in the following form.
------------
(Date)
Name of petitioner ------------
Post office address ------------
Subject of the petition ------------
Office of Food Labeling (HFS-150)
Food and Drug Administration,
Department of Health and Human Services,
Washington, DC 20204.
To Whom It May Concern:
The undersigned, -- submits this petition under section 403(r)(4) of
the Federal Food, Drug, and Cosmetic Act (the act) with respect to
(statement of the claim and its proposed use).
Attached hereto and constituting a part of this petition, are the
following:
A. A statement identifying the descriptive term and the nutrient
that the term is intended to characterize with respect to the level of
such nutrient. The statement should address why the use of the term as
proposed will not be misleading. The statement should provide examples
of the nutrient content claim as it will be used on labels or labeling,
as well as the types of foods on which the claim will be used. The
statement shall specify the level at which the nutrient must be present
or what other conditions concerning the food must be met for the use of
the term in labels or labeling to be appropriate, as well as any factors
that would make the use of the term inappropriate.
B. A detailed explanation, supported by any necessary data, of why
use of the food component characterized by the claim is of importance in
human nutrition by virtue of its presence or absence at the levels that
such claim would describe. This explanation shall also state what
nutritional benefit to the public will derive from use of the claim as
proposed, and why such benefit is not available through the use of
existing terms defined by regulation under section 403(r)(2)(A)(i) of
the act. If the claim is intended for a specific group within the
population, the analysis should specifically address nutritional needs
of such group, and should include scientific data sufficient for such
purpose.
C. Analytical data that shows the amount of the nutrient that is the
subject of the claim and that is present in the types of foods for which
the claim is intended. The assays should be performed on representative
samples using the Association of Official Analytical Chemists
International (AOAC International) methods where available. If no AOAC
International method is available, the petitioner shall submit the assay
method used, and data establishing the validity of the method for
assaying the nutrient in the particular food. The validation data should
include a statistical analysis of the analytical and product
variability.
D. A detailed analysis of the potential effect of the use of the
proposed claim on food consumption and of any corresponding changes in
nutrient intake. The latter item shall specifically address the intake
of nutrients that have beneficial and negative consequences in the total
diet. If the claim is intended for a specific group within the
population, the above analysis shall specifically address the dietary
practices of such group and shall include data sufficient to
[[Page 114]]
demonstrate that the dietary analysis is representative of such group.
E. The petitioner is required to submit either a claim for
categorical exclusion under Sec. 25.24 of this chapter or an
environmental assessment under Sec. 25.31 of this chapter.
Yours very truly,
Petitioner ------------
By ------------
(Indicate authority)
(2) Within 15 days of receipt of the petition, the petitioner will
be notified by letter of the date on which the petition was received by
the agency. Such notice will inform the petitioner:
(i) That the petition is undergoing agency review (in which case a
docket number will be assigned to the petition), and the petitioner will
subsequently be notified of the agency's decision to file or deny the
petition; or
(ii) That the petition is incomplete, e.g., it lacks any of the data
required by this part, it presents such data in a manner that is not
readily understood, or it has not been submitted in quadruplicate, in
which case the petition will be denied, and the petitioner will be
notified as to what respect the petition is incomplete.
(3) Within 100 days of the date of receipt of the petition, the
Commissioner of Food and Drugs will notify the petitioner by letter that
the petition has either been filed or denied. If denied, the
notification shall state the reasons therefor. If filed, the date of the
notification letter becomes the date of filing for the purposes of
section 403(r)(4)(A)(i) of the act. A petition that has been denied
shall not be made available to the public. A filed petition shall be
available to the public as provided under paragraph (g) of this section.
(4) Within 90 days of the date of filing the Commissioner of Food
and Drugs will by letter of notification to the petitioner:
(i) Deny the petition; or
(ii) Inform the petitioner that a proposed regulation to provide for
the requested use of the new term will be published in the Federal
Register. The Commissioner of Food and Drugs will publish the proposal
to amend the regulations to provide for the requested use of the
nutrient content claim in the Federal Register within 90 days of the
date of filing. The proposal will also announce the availability of the
petition for public disclosure.
(n)(1) Petitions for a synonymous term shall include the following
data and be submitted in the following form.
------------
(Date)
Name of petitioner ------------
Post office address ------------
Subject of the petition ------------
Office of Food Labeling (HFS-150)
Food and Drug Administration,
Department of Health and Human Services,
Washington, DC 20204.
To Whom It May Concern:
The undersigned, ------------ submits this petition under section
403(r)(4) of the Federal Food, Drug, and Cosmetic Act (the act) with
respect to (statement of the synonymous term and its proposed use in a
nutrient content claim that is consistent with an existing term that has
been defined under section 403(r)(2) of the act).
Attached hereto and constituting a part of this petition, are the
following:
A. A statement identifying the synonymous descriptive term, the
existing term defined by a regulation under section 403(r)(2)(A)(i) of
the act with which the synonymous term is claimed to be consistent. The
statement should address why the proposed synonymous term is consistent
with the term already defined by the agency, and why the use of the
synonymous term as proposed will not be misleading. The statement should
provide examples of the nutrient content claim as it will be used on
labels or labeling, as well as the types of foods on which the claim
will be used. The statement shall specify whether any limitations not
applicable to the use of the defined term are intended to apply to the
use of the synonymous term.
B. A detailed explanation, supported by any necessary data, of why
use of the proposed term is requested, including an explanation of
whether the existing defined term is inadequate for the purpose of
effectively characterizing the level of a nutrient. This item shall also
state what nutritional benefit to the public will derive from use of the
claim as proposed, and why such benefit is not available through the use
of existing term defined by regulation. If the claim is intended for a
specific group within the population, the analysis should specifically
address nutritional needs of such group, and should include scientific
data sufficient for such purpose.
C. The petitioner is required to submit either a claim for
categorical exclusion under Sec. 25.24 of this chapter or an
environmental assessment under Sec. 25.31 of this chapter.
Yours very truly,
Petitioner ------------
By ------------
[[Page 115]]
(Indicate authority)
(2) Within 15 days of receipt of the petition the petitioner will be
notified by letter of the date on which the petition
[[Page 116]]
was received. Such notice will inform the petitioner:
(i) That the petition is undergoing agency review (in which case a
docket number will be assigned to the petition) and the petitioner will
subsequently be notified of the agency's decision to grant the
petitioner permission to use the proposed term or to deny the petition;
or
(ii) That the petition is incomplete, e.g., it lacks any of the data
required by this part, it presents such data in a manner that is not
readily understood, or it has not been submitted in quadruplicate, in
which case the petition will be denied, and the petitioner will be
notified as to what respect the petition is incomplete.
(3) Within 90 days of the date of receipt of the petition that is
accepted for review (i.e., that has not been found to be incomplete and
consequently denied, the Commissioner of Food and Drugs will notify the
petitioner by letter of the agency's decision to grant the petitioner
permission to use the proposed term, with any conditions or limitations
on such use specified, or to deny the petition, in which case the letter
shall state the reasons therefor. Failure of the petition to fully
address the requirements of this section shall be grounds for denial of
the petition.
(4) As soon as practicable following the agency's decision to either
grant or deny the petition, the Commissioner of Food and Drugs will
publish a notice in the Federal Register informing the public of his
decision. If the petition is granted the Food and Drug Administration
will list, the approved synonymous term in the regulations listing terms
permitted for use in nutrient content claims.
(o)(1) Petitions for the use of an implied nutrient content claim in
a brand name shall include the following data and be submitted in the
following form:
------------
(Date)
Name of petitioner ------------
Post office address ------------
Subject of the petition ------------
Office of Food Labeling (HFS-150)
Food and Drug Administration,
Department of Health and Human Services,
Washington, DC 20204.
To Whom It May Concern:
The undersigned, -------------------------------- submits this
petition under section 403(r)(4) of the Federal Food, Drug, and Cosmetic
Act (the act) with respect to (statement of the implied nutrient content
claim and its proposed use in a brand name).
Attached hereto and constituting a part of this petition, are the
following:
A. A statement identifying the implied nutrient content claim, the
nutrient the claim is intended to characterize, the corresponding term
for characterizing the level of such nutrient as defined by a regulation
under section 403(r)(2)(A)(i) of the act, and the brand name of which
the implied claim is intended to be a part. The statement should address
why the use of the brandname as proposed will not be misleading. It
should address in particular what information is required to accompany
the claim or other ways in which the claim meets the requirements of
sections 201(n) and 403(a) of the act. The statement should provide
examples of the types of foods on which the brand name will appear. It
shall also include data showing that the actual level of the nutrient in
the food qualifies the food to bear the corresponding term defined by
regulation. Assay methods used to determine the level of a nutrient
should meet the requirements stated under petition format item C in
paragraph (k)(1) of this section.
B. A detailed explanation, supported by any necessary data, of why
use of the proposed brand name is requested. This item shall also state
what nutritional benefit to the public will derive from use of the brand
name as proposed. If the branded product is intended for a specific
group within the population, the analysis should specifically address
nutritional needs of such group and should include scientific data
sufficient for such purpose.
C. The petitioner is required to submit either a claim for
categorical exclusion under Sec. 25.24 of this chapter or an
environmental assessment under Sec. 25.31 of this chapter.
Yours very truly,
Petitioner ------------
By ------------
(2) Within 15 days of receipt of the petition the petitioner will be
notified by letter of the date on which the petition was received. Such
notice will inform the petitioner:
(i) That the petition is undergoing agency review (in which case a
docket number will be assigned to the petition); or
(ii) That the petition is incomplete, e.g., it lacks any of the data
required by this part, it presents such data in a manner that is not
readily understood, or it has not been submitted in quadruplicate, in
which case the petition will be denied, and the petitioner will be
notified as to what respect the petition is incomplete.
(3) The Commissioner of Food and Drugs will publish a notice of the
petition in the Federal Register announcing its availability to the
public and seeking comment on the petition. The petition shall be
available to the public to the extent provided under paragraph (g) of
this section. The notice shall allow 30 days for comments.
(4) Within 100 days of the date of receipt of the petition that is
accepted for review (i.e., that has not been found to be incomplete and
subsequently returned to the petitioner), the Commissioner of Food and
Drugs will:
(i) Notify the petitioner by letter of the agency's decision to
grant the petitioner permission to use the proposed brand name if such
use is not misleading, with any conditions or limitations on such use
specified; or
(ii) Deny the petition, in which case the letter shall state the
reasons therefor. Failure of the petition to fully address the
requirements of this section shall be grounds for denial of the
petition. Should the Commissioner of Food and Drugs not notify the
petitioner of his decision on the petition within 100 days, the petition
shall be considered to be granted.
(5) As soon as practicable following the granting of a petition, the
Commissioner of Food and Drugs will publish a notice in the Federal
Register informing the public of such fact.
(Information collection requirements in this section were approved by
the Office of Management and Budget (OMB) and assigned OMB control
number ------------)
[58 FR 2413, Jan. 6, 1993; 58 FR 17343, Apr. 2, 1993, as amended at 58
FR 44033, Aug. 18, 1993]
Subpart E--Specific Requirements for Health Claims
Sec. 101.70 Petitions for health claims.
(a) Any interested person may petition the Food and Drug
Administration (FDA) to issue a regulation regarding a health claim. An
original and one copy of the petition shall be submitted, or the
petitioner may submit an original and a computer readable disk
containing the petition. Contents of the disk should be in a standard
format, such as ASCII format. (Petitioners interested in submitting a
disk should contact the Center for Food Safety and Applied Nutrition for
details.) If any part of the material submitted is in a foreign
language, it shall be accompanied by an accurate and complete English
translation. The petition shall state the petitioner's post office
address to which any correspondence required by section 403 of the
Federal Food, Drug, and Cosmetic Act may be sent.
(b) Pertinent information may be incorporated in, and will be
considered as part of, a petition on the basis of specific reference to
such information submitted to and retained in the files of FDA. Such
information may include any findings, along with the basis of the
findings, of an outside panel with expertise in the subject area. Any
reference to published information shall be accompanied by reprints, or
easily readable copies of such information.
(c) If nonclinical laboratory studies are included in a petition,
the petition shall include, with respect to each nonclinical study
contained in the petition, either a statement that the study has been
conducted in compliance with the good laboratory practice regulations as
set forth in part 58 of this chapter, or, if any such study was not
conducted in compliance with such regulations, a brief statement of the
reason for the noncompliance.
(d) If clinical or other human investigations are included in a
petition, the petition shall include a statement that they were either
conducted in compliance with the
[[Page 117]]
requirements for institutional review set forth in part 56 of this
chapter, or were not subject to such requirements in accordance with
Sec. 56.104 or Sec. 56.105, and a statement that they were conducted in
compliance with the requirements for informed consent set forth in part
50 of this chapter.
(e) All data and information in a health claim petition are
available for public disclosure after the notice of filing of petition
is issued to the petitioner, except that clinical investigation reports,
adverse reaction reports, product experience reports, consumer
complaints, and other similar data and information shall only be
available after deletion of:
(1) Names and any information that would identify the person using
the product.
(2) Names and any information that would identify any third party
involved with the report, such as a physician or hospital or other
institution.
(f) Petitions for a health claim shall include the following data
and be submitted in the following form:
--------------
(Date)
Name of petitioner ------------
Post office address ------------
Subject of the petition ------------
Food and Drug Administration,
Office of Food Labeling (HFS-150),
200 C St. SW.,
Washington, DC 20204,
The undersigned, -------------------- submits this petition pursuant
to section 403(r)(4) or 403(r)(5)(D) of the Federal Food, Drug, and
Cosmetic Act with respect to (statement of the substance and its health
claim).
Attached hereto, and constituting a part of this petition, are the
following:
A. Preliminary requirements. A complete explanation of how the
substance conforms to the requirements of Sec. 101.14(b) (21 CFR
101.14(b)). For petitions where the subject substance is a food
ingredient or a component of a food ingredient, the petitioner should
compile a comprehensive list of the specific ingredients that will be
added to the food to supply the substance in the food bearing the health
claim. For each such ingredient listed, the petitioner should state how
the ingredient complies with the requirements of Sec. 101.14(b)(3)(ii),
e.g., that its use is generally recognized as safe (GRAS), listed as a
food additive, or authorized by a prior sanction issued by the agency,
and what the basis is for the GRAS claim, the food additive status, or
prior sanctioned status.
B. Summary of scientific data. The summary of scientific data
provides the basis upon which authorizing a health claim can be
justified as providing the health benefit. The summary must establish
that, based on the totality of publicly available scientific evidence
(including evidence from well-designed studies conducted in a manner
which is consistent with generally recognized scientific procedures and
principles), there is significant scientific agreement among experts
qualified by scientific training and experience to evaluate such claims,
that the claim is supported by such evidence.
The summary shall state what public health benefit will derive from
use of the claim as proposed. If the claim is intended for a specific
group within the population, the summary shall specifically address
nutritional needs of such group and shall include scientific data
showing how the claim is likely to assist in meeting such needs.
The summary shall concentrate on the findings of appropriate review
articles, National Institutes of Health consensus development
conferences, and other appropriate resource materials. Issues addressed
in the summary shall include answers to such questions as:
1. Is there an optimum level of the particular substance to be
consumed beyond which no benefit would be expected?
2. Is there any level at which an adverse effect from the substance
or from foods containing the substance occurs for any segment of the
population?
3. Are there certain populations that must receive special
consideration?
4. What other nutritional or health factors (both positive and
negative) are important to consider when consuming the substance?
In addition, the summary of scientific data shall include a detailed
analysis of the potential effect of the use of the proposed claim on
food consumption, specifically any change due to significant alterations
in eating habits and corresponding changes in nutrient intake resulting
from such changes in food consumption. The latter item shall
specifically address the effect on the intake of nutrients that have
beneficial and negative consequences in the total diet.
If the claim is intended for a significant subpopulation within the
general U.S. population, the analysis shall specifically address the
dietary practices of such group, and shall include data sufficient to
demonstrate that the dietary analysis is representative of such group
(e.g., adolescents or the elderly).
If appropriate, the petition shall explain the prevalence of the
disease or health-related condition in the U.S. population and the
relevance of the claim in the context of the total daily diet.
Also, the summary shall demonstrate that the substance that is the
subject of the proposed claim conforms to the definition of the term
``substance'' in Sec. 101.14(a)(2).
C. Analytical data that show the amount of the substance that is
present in representative foods that would be candidates to bear the
claim should be obtained from
[[Page 118]]
representative samples using methods from the Association of Official
Analytical Chemists (AOAC), where available. If no AOAC method is
available, the petitioner shall submit the assay method used and data
establishing the validity of the method for assaying the substance in
food. The validation data should include a statistical analysis of the
analytical and product variability.
D. Model health claim. One or more model health claims that
represent label statements that may be used on a food label or in
labeling for a food to characterize the relationship between the
substance in a food to a disease or health-related condition that is
justified by the summary of scientific data provided in section C of the
petition. The model health claim shall include:
1. A brief capsulized statement of the relevant conclusions of the
summary, and
2. A statement of how this substance helps the consumer to attain a
total dietary pattern or goal associated with the health benefit that is
provided.
E. The petition shall include the following attachments:
1. Copies of any computer literature searches done by the petitioner
(e.g., Medline).
2. Copies of articles cited in the literature searches and other
information as follows:
a. All information relied upon for the support of the health claim,
including copies of publications or other information cited in review
articles and used to perform meta-analyses.
b. All information concerning adverse consequences to any segment of
the population (e.g., sensitivity to the substance).
c. All information pertaining to the U.S. population.
F. The petitioner is required to submit either a claim for
categorical exclusion under Sec. 25.24 of this chapter or an
environmental assessment under Sec. 25.31 of this chapter.
Yours very truly,
Petitioner ------------
By ------------
(Indicate authority)
(g) The data specified under the several lettered headings should be
submitted on separate pages or sets of pages, suitably identified. If
such data have already been submitted with an earlier application from
the petitioner or any other final petition, the present petition may
incorporate it by specific reference to the earlier petition.
(h) The petition shall include a statement signed by the person
responsible for the petition that, to the best of his/her knowledge, it
is a representative and balanced submission that includes unfavorable
information as well as favorable information, known to him/her to be
pertinent to the evaluation of the proposed health claim.
(i) The petition shall be signed by the petitioner or by his/her
attorney or agent, or (if a corporation) by an authorized official.
(j) Agency action on the petition. (1) Within 15 days of receipt of
the petition, the petitioner will be notified by letter of the date on
which the petition was received. Such notice will inform the petitioner
that the petition is undergoing agency review and that the petitioner
will subsequently be notified of the agency's decision to file for
comprehensive review or deny the petition.
(2) Within 100 days of the date of receipt of the petition, FDA will
notify the petitioner by letter that the petition has either been filed
for comprehensive review or denied. The agency will deny a petition
without reviewing the information contained in B. Summary of Scientific
Data if the information in A. Preliminary Requirements is inadequate in
explaining how the substance conforms to the requirements of
Sec. 101.14(b). If the petition is denied, the notification will state
the reasons therefor, including justification of the rejection of any
report from an authoritative scientific body of the U.S. Government. If
filed, the date of the notification letter becomes the date of filing
for the purposes of this regulation. A petition that has been denied
without filing will not be made available to the public. A filed
petition will be available to the public to the extent provided under
paragraph (e) of this section.
(3) Within 90 days of the date of filing, FDA will by letter of
notification to the petitioner:
(i) Deny the petition, or
(ii) Inform the petitioner that a proposed regulation to provide for
the requested use of the health claim will be published in the Federal
Register. If the petition is denied, the notification will state the
reasons therefor, including justification for the rejection of any
report from an authoritative scientific body of the U.S. Government. FDA
will publish the proposal to amend the regulations to provide for the
requested use of the health claim in the Federal Register within 90
[[Page 119]]
days of the date of filing. The proposal will also announce the
availability of the petition for public review.
[58 FR 2534, Jan. 6, 1993; 58 FR 17097, Apr. 1, 1993, as amended at 59
FR 425, Jan. 4, 1994]
Sec. 101.71 Health claims: claims not authorized.
Health claims not authorized for foods in conventional food form or
for dietary supplements of vitamins, minerals, herbs, or other similar
substances:
(a) Dietary fiber and cancer.
(b) Dietary fiber and cardiovascular disease.
(c) Antioxidant vitamins and cancer.
(d) Zinc and immune function in the elderly.
(e) Omega-3 fatty acids and coronary heart disease.
[58 FR 2534, Jan. 6, 1993, as amended at 58 FR 2548, 2578, 2620, 2639,
2664, 2714, Jan. 6, 1993; 58 FR 17100, Apr. 1, 1993; 59 FR 437, Jan. 4,
1994]
Sec. 101.72 Health claims: calcium and osteoporosis.
(a) Relationship between calcium and osteoporosis. An inadequate
calcium intake contributes to low peak bone mass and has been identified
as one of many risk factors in the development of osteoporosis. Peak
bone mass is the total quantity of bone present at maturity, and experts
believe that it has the greatest bearing on whether a person will be at
risk of developing osteoporosis and related bone fractures later in
life. Another factor that influences total bone mass and susceptibility
to osteoporosis is the rate of bone loss after skeletal maturity. An
adequate intake of calcium is thought to exert a positive effect during
adolescence and early adulthood in optimizing the amount of bone that is
laid down. However, the upper limit of peak bone mass is genetically
determined. The mechanism through which an adequate calcium intake and
optimal peak bone mass reduce the risk of osteoporosis is thought to be
as follows. All persons lose bone with age. Hence, those with higher
bone mass at maturity take longer to reach the critically reduced mass
at which bones can fracture easily. The rate of bone loss after skeletal
maturity also influences the amount of bone present at old age and can
influence an individual's risk of developing osteoporosis. Maintenance
of an adequate intake of calcium later in life is thought to be
important in reducing the rate of bone loss particularly in the elderly
and in women during the first decade following menopause.
(b) Significance of calcium. Calcium intake is not the only
recognized risk factor in the development of osteoporosis, a
multifactorial bone disease. Other factors including a person's sex,
race, hormonal status, family history, body stature, level of exercise,
general diet, and specific life style choices such as smoking and excess
alcohol consumption affect the risk of osteoporosis.
(1) Heredity and being female are two key factors identifying those
individuals at risk for the development of osteoporosis. Hereditary risk
factors include race: Notably, Caucasians and Asians are characterized
by low peak bone mass at maturity. Caucasian women, particularly those
of northern European ancestry, experience the highest incidence of
osteoporosis-related bone fracture. American women of African heritage
are characterized by the highest peak bone mass and lowest incidence of
osteoporotic fracture, despite the fact that they have low calcium
intake.
(2) Maintenance of an adequate intake of calcium throughout life is
particularly important for a subpopulation of individuals at greatest
risk of developing osteoporosis and for whom adequate dietary calcium
intake may have the most important beneficial effects on bone health.
This target subpopulation includes adolescent and young adult Caucasian
and Asian American women.
(c) Requirements. (1) All requirements set forth in Sec. 101.14
shall be met.
(2) Specific requirements. (i) Nature of the claim. A health claim
associating calcium with a reduced risk of osteoporosis may be made on
the label or lableing of a food describe in paragraph (c)(2)(ii) of this
section, provided that:
(A) The claim makes clear that adequate calcium intake throughout
life is not the only recognized risk factor in this multifactorial bone
disease by
[[Page 120]]
listing specific factors, including sex, race, and age that place
persons at risk of developing osteoporosis and stating that an adequate
level of exercise and a healthful diet are also needed;
(B) The claim does not state or imply that the risk of osteoporosis
is equally applicable to the general United States population. The claim
shall identify the populations at particular risk for the development of
osteoporosis. These populations include white (or the term
``Caucasian'') women and Asian women in their bone forming years
(approximately 11 to 35 years of age or the phrase ``during teen or
early adult years'' may be used). The claim may also identify menopausal
(or the term ``middle-aged'') women, persons with a family history of
the disease, and elderly (or ``older'') men and women as being at risk;
(C) The claim states that adequate calcium intake throughout life is
linked to reduced risk of osteoporosis through the mechanism of
optimizing peak bone mass during adolescence and early adulthood. The
phrase ``build and maintain good bone health'' may be used to convey the
concept of optimizing peak bone mass. When reference is made to persons
with a family history of the disease, menopausal women, and elderly men
and women, the claim may also state that adequate calcium intake is
linked to reduced risk of osteoporosis through the mechanism of slowing
the rate of bone loss;
(D) The claim does not attribute any degree of reduction in risk of
osteoporosis to maintaining an adequate calcium intake throughout life;
and
(E) The claim states that a total dietary intake greater than 200
percent of the recommended daily intake (2,000 milligrams (mg) of
calcium) has no further known benefit to bone health. This requirement
does not apply to foods that contain less than 40 percent of the
recommended daily intake of 1,000 mg of calcium per day or 400 mg of
calcium per reference amount customarily consumed as defined in
Sec. 101.12 (b) or per total daily recommended supplement intake.
(ii) Nature of the food. (A) The food shall meet or exceed the
requirements for a ``high'' level of calcium as defined in
Sec. 101.54(c);
(B) The calcium content of the product shall be assimilable;
(C) Dietary supplements shall meet the United States Pharmacopeia
(U.S.P.) standards for disintegration and dissolution applicable to
their component calcium salts, except that dietary supplements for which
no U.S.P. standards exist shall exhibit appropriate assimilability under
the conditions of use stated on the product label;
(D) A food or total daily recommended supplement intake shall not
contain more phosphorus than calcium on a weight per weight basis.
(d) Optional information. (1) The claim may include information from
paragraphs (a) and (b) of this section.
(2) The claim may include information on the number of people in the
United States who have osteoporosis. The sources of this information
must be identified, and it must be current information from the National
Center for Health Statistics, the National Institutes of Health, or
``Dietary Guidelines for Americans.''
(e) Model health claim. The following model health claims may be
used in food labeling to describe the relationship between calcium and
osteoporosis:
Model Health Claim Appropriate for Most Conventional Foods:
Regular exercise and a healthy diet with enough calcium helps teen
and young adult white and Asian women maintain good bone health and may
reduce their high risk of osteoporosis later in life.
Model Health Claim Appropriate for Foods Exceptionally High in Calcium
and Most Calcium Supplements:
Regular exercise and a healthy diet with enough calcium helps teen
and young adult white and Asian women maintain good bone health and may
reduce their high risk of osteoporosis later in life. Adequate calcium
intake is important, but daily intakes above about 2,000 mg are not
likely to provide any additional benefit.
[58 FR 2676, Jan. 6, 1993; 58 FR 17101, Apr. 1, 1993]
Sec. 101.73 Health claims: dietary lipids and cancer.
(a) Relationship between fat and cancer. (1) Cancer is a
constellation of
[[Page 121]]
more than 100 different diseases, each characterized by the uncontrolled
growth and spread of abnormal cells. Cancer has many causes and stages
in its development. Both genetic and environmental risk factors may
affect the risk of cancer. Risk factors include a family history of a
specific type of cancer, cigarette smoking, alcohol consumption,
overweight and obesity, ultraviolet or ionizing radiation, exposure to
cancer-causing chemicals, and dietary factors.
(2) Among dietary factors, the strongest positive association has
been found between total fat intake and risk of some types of cancer.
Based on the totality of the publicly available scientific evidence,
there is significant scientific agreement among experts, qualified by
training and experience to evaluate such evidence, that diets high in
total fat are associated with an increased cancer risk. Research to
date, although not conclusive, demonstrates that the total amount of
fats, rather than any specific type of fat, is positively associated
with cancer risk. The mechanism by which total fat affects cancer has
not yet been established.
(3) A question that has been the subject of considerable research
is whether the effect of fat on cancer is site-specific. Neither human
nor animal studies are consistent in the association of fat intake with
specific cancer sites.
(4) Another question that has been raised is whether the
association of total fat intake to cancer risk is independently
associated with energy intakes, or whether the association of fat with
cancer risk is the result of the higher energy (caloric) intake normally
associated with high fat intake. FDA has concluded that evidence from
both animal and human studies indicates that total fat intake alone,
independent of energy intake, is associated with cancer risk.
(b) Significance of the relationship between fat intake and risk of
cancer. (1) Cancer is ranked as a leading cause of death in the United
States. The overall economic costs of cancer, including direct health
care costs and losses due to morbidity and mortality, are very high.
(2) U.S. diets tend to be high in fat and high in calories. The
average U.S. diet is estimated to contain 36 to 37 percent of calories
from total fat. Current dietary guidelines from the Federal Government
and other national health professional organizations recommend that
dietary fat intake be reduced to a level of 30 percent or less of energy
(calories) from total fat. In order to reduce intake of total fat,
individuals should choose diets which are high in vegetables, fruits,
and grain products (particularly whole grain products), choose lean cuts
of meats, fish, and poultry, substitute low-fat dairy products for
higher fat products, and use fats and oils sparingly.
(c) Requirements. (1) All requirements set forth in Sec. 101.14
shall be met.
(2) Specific requirements. (i) Nature of the claim. A health claim
associating diets low in fat with reduced risk of cancer may be made on
the label or labeling of a food described in paragraph (c)(2)(ii) of
this section, provided that:
(A) The claim states that diets low in fat ``may'' or ``might''
reduce the risk of some cancers;
(B) In specifying the disease, the claim uses the following terms:
``some types of cancer'' or ``some cancers'';
(C) In specifying the nutrient, the claim uses the term ``total
fat'' or ``fat'';
(D) The claim does not specify types of fat or fatty acid that may
be related to the risk of cancer;
(E) The claim does not attribute any degree of cancer risk reduction
to diets low in fat; and
(F) The claim indicates that the development of cancer depends on
many factors.
(ii) Nature of the food. The food shall meet all of the nutrient
content requirements of Sec. 101.62 for a ``low fat'' food; except that
fish and game meats (i.e., deer, bison, rabbit, quail, wild turkey,
geese, ostrich) may meet the requirements for ``extra lean'' in
Sec. 101.62.
(d) Optional information. (1) The claim may identify one or more of
the following risk factors for development of cancer: Family history of
a specific type of cancer, cigarette smoking, alcohol consumption,
overweight and obesity, ultraviolet or ionizing radiation, exposure to
cancer-causing chemicals, and dietary factors.
[[Page 122]]
(2) The claim may include information from paragraphs (a) and (b) of
this section which summarize the relationship between dietary fat and
cancer and the significance of the relationship.
(3) The claim may indicate that it is consistent with ``Nutrition
and Your Health: Dietary Guidelines for Americans,'' U.S. Department of
Agriculture (USDA) and Department of Health and Human Services (DHHS),
Government Printing Office.
(4) The claim may include information on the number of people in the
United States who have cancer. The sources of this information must be
identified, and it must be current information from the National Center
for Health Statistics, the National Institutes of Health, or ``Nutrition
and Your Health: Dietary Guidelines for Americans,'' USDA and DHHS,
Government Printing Office.
(e) Model health claims. The following model health claims may be
used in food labeling to describe the relationship between dietary fat
and cancer:
(1) Development of cancer depends on many factors. A diet low in
total fat may reduce the risk of some cancers.
(2) Eating a healthful diet low in fat may help reduce the risk of
some types of cancers. Development of cancer is associated with many
factors, including a family history of the disease, cigarette smoking,
and what you eat.
[58 FR 2801, Jan. 6, 1993; 58 FR 17343, Apr. 2, 1993]
Sec. 101.74 Health claims: sodium and hypertension.
(a) Relationship between sodium and hypertension (high blood
pressure). (1) Hypertension, or high blood pressure, generally means a
systolic blood pressure of greater than 140 millimeters of mercury (mm
Hg) or a diastolic blood pressure of greater than 90 mm Hg.
Normotension, or normal blood pressure, is a systolic blood pressure
below 140 mm Hg and diastolic blood pressure below 90 mm Hg. Sodium is
specified here as the chemical entity or electrolyte ``sodium'' and is
distinguished from sodium chloride, or salt, which is 39 percent sodium
by weight.
(2) The scientific evidence establishes that diets high in sodium
are associated with a high prevalence of hypertension or high blood
pressure and with increases in blood pressure with age, and that diets
low in sodium are associated with a low prevalence of hypertension or
high blood pressure and with a low or no increase of blood pressure with
age.
(b) Significance of sodium in relation to high blood pressure. (1)
High blood pressure is a public health concern primarily because it is a
major risk factor for mortality from coronary heart disease and stroke.
Early management of high blood pressure is a major public health goal
that can assist in reducing mortality associated with coronary heart
disease and stroke. There is a continuum of mortality risk that
increases as blood pressures rise. Individuals with high blood pressure
are at greatest risk, and individuals with moderately high, high normal,
and normal blood pressure are at steadily decreasing risk. The
scientific evidence indicates that reducing sodium intake lowers blood
pressure and associated risks in many but not all hypertensive
individuals. There is also evidence that reducing sodium intake lowers
blood pressure and associated risks in many but not all normotensive
individuals as well.
(2) The populations at greatest risk for high blood pressure, and
those most likely to benefit from sodium reduction, include those with
family histories of high blood pressure, the elderly, males because they
develop hypertension earlier in life than females, and black males and
females. Although some population groups are at greater risk than
others, high blood-pressure is a disease of public health concern for
all population groups. Sodium intake, alcohol consumption, and obesity
are identified risk factors for high blood pressure.
(3) Sodium intakes exceed recommended levels in almost every group
in the United States. One of the major public health recommendations
relative to high blood pressure is to decrease consumption of salt. On a
population-wide basis, reducing the average sodium intake would have a
small but significant effect on reducing the average blood pressure,
and, consequently,
[[Page 123]]
reducing mortality from coronary heart disease and stroke.
(4) Sodium is an essential nutrient, and experts have recommended a
safe minimum level of 500 milligrams (mg) sodium per day and an upper
level of 2,400 mg sodium per day, the FDA Daily Value for sodium.
(c) Requirements. (1) All requirements set forth in Sec. 101.14
shall be met.
(2) Specific requirements. (i) Nature of the claim. A health claim
associating diets low in sodium with reduced risk of high blood pressure
may be made on the label or labeling of a food described in paragraph
(c)(2)(ii) of this section, provided that:
(A) The claim states that diets low in sodium ``may'' or ``might''
reduce the risk of high blood pressure;
(B) In specifying the disease, the claim uses the term ``high blood
pressure'';
(C) In specifying the nutrient, the claim uses the term ``sodium'';
(D) The claim does not attribute any degree of reduction in risk of
high blood pressure to diets low in sodium; and
(E) The claim indicates that development of high blood pressure
depends on many factors.
(ii) Nature of the food. The food shall meet all of the nutrient
content requirements of Sec. 101.61 for a ``low sodium'' food.
(d) Optional information. (1) The claim may identify one or more of
the following risk factors for development of high blood pressure in
addition to dietary sodium consumption: Family history of high blood
pressure, growing older, alcohol consumption, and excess weight.
(2) The claim may include information from paragraphs (a) and (b) of
this section, which summarizes the relationship between dietary sodium
and high blood pressure and the significance of the relationship.
(3) The claim may include information on the number of people in the
United States who have high blood pressure. The sources of this
information must be identified, and it must be current information from
the National Center for Health Statistics, the National Institutes of
Health, or ``Nutrition and Your Health: Dietary Guidelines for
Americans,'' U.S. Department of Health and Human Services (DHHS) and
U.S. Department of Argiculture (USDA), Government Printing Office.
(4) The claim may indicate that it is consistent with ``Nutrition
and Your Health: U.S. Dietary Guidelines for Americans, DHHS and USDA,
Government Printing Office.
(5) In specifying the nutrient, the claim may include the term
``salt'' in addition to the term ``sodium.''
(6) In specifying the disease, the claim may include the term
``hypertension'' in addition to the term ``high blood pressure.''
(7) The claim may state that individuals with high blood pressure
should consult their physicians for medical advice and treatment. If the
claim defines high or normal blood pressure, then the health claim must
state that individuals with high blood pressure should consult their
physicians for medical advice and treatment.
(e) Model health claims. The following are model health claims that
may be used in food labeling to describe the relationship between
dietary sodium and high blood pressure:
(1) Diets low in sodium may reduce the risk of high blood pressure,
a disease associated with many factors.
(2) Development of hypertension or high blood pressure depends on
many factors. [This product] can be part of a low sodium, low salt diet
that might reduce the risk of hypertension or high blood pressure.
[58 FR 2836, Jan. 6, 1993; 58 FR 17100, Apr. 1, 1993]
Sec. 101.75 Health claims: dietary saturated fat and cholesterol and risk of coronary heart disease.
(a) Relationship between dietary saturated fat and cholesterol and
risk of coronary heart disease. (1) Cardiovascular disease means
diseases of the heart and circulatory system. Coronary heart disease is
the most common and serious form of cardiovascular disease and refers to
diseases of the heart muscle and supporting blood vessels. High blood
total- and low density lipoprotein (LDL)- cholesterol levels are major
modifiable risk factors in the development of coronary heart disease.
High coronary heart disease rates
[[Page 124]]
occur among people with high blood cholesterol levels of 240 milligrams/
decaliter (mg/dL) (6.21 millimoles per liter (mmol/L)) or above and LDL-
cholesterol levels of 160 mg/dL (4.13 mmol/L) or above. Borderline high
risk blood cholesterol levels range from 200 to 239 mg/dL (5.17 to 6.18
mmol/L) and 130 to 159 mg/dL (3.36 to 4.11 mmol/L) of LDL-cholesterol.
Dietary lipids (fats) include fatty acids and cholesterol. Total fat,
commonly referred to as fat, is composed of saturated fat (fatty acids
containing no double bonds), and monounsaturated and polyunsaturated fat
(fatty acids containing one or more double bonds).
(2) The scientific evidence establishes that diets high in saturated
fat and cholesterol are associated with increased levels of blood total-
and LDL-cholesterol and, thus, with increased risk of coronary heart
disease. Diets low in saturated fat and cholesterol are associated with
decreased levels of blood total- and LDL-cholesterol, and thus, with
decreased risk of developing coronary heart disease.
(b) Significance of the relationship between dietary saturated fat
and cholesterol and risk of coronary heart disease. (1) Coronary heart
disease is a major public health concern in the United States, primarily
because it accounts for more deaths than any other disease or group of
diseases. Early management of risk factors for coronary heart disease is
a major public health goal that can assist in reducing risk of coronary
heart disease. There is a continuum of mortality risk from coronary
heart disease that increases with increasing levels of blood LDL-
cholesterol. Individuals with high blood LDL-cholesterol are at greatest
risk. A larger number of individuals with more moderately elevated
cholesterol also have increased risk of coronary events; such
individuals comprise a substantial proportion of the adult U.S.
population. The scientific evidence indicates that reducing saturated
fat and cholesterol intakes lowers blood LDL-cholesterol and risk of
heart disease in most individuals. There is also evidence that reducing
saturated fat and cholesterol intakes in persons with blood cholesterol
levels in the normal range also reduces risk of heart disease.
(2) Other risk factors for coronary heart disease include a family
history of heart disease, high blood pressure, diabetes, cigarette
smoking, obesity (body weight 30 percent greater than ideal body
weight), and lack of regular physical exercise.
(3) Intakes of saturated fat exceed recommended levels in many
people in the United States. Intakes of cholesterol are, on average, at
or above recommended levels. One of the major public health
recommendations relative to coronary heart disease risk is to consume
less than 10 percent of calories from saturated fat, and an average of
30 percent or less of total calories from all fat. Recommended daily
cholesterol intakes are 300 mg or less per day.
(c) Requirements. (1) All requirements set forth in Sec. 101.14
shall be met.
(2) Specific requirements. (i) Nature of the claim. A health claim
associating diets low in saturated fat and cholesterol with reduced risk
of coronary heart disease may be made on the label or labeling of a food
described in paragraph (c)(2)(ii) of this section provided that:
(A) The claim states that diets low in saturated fat and cholesterol
``may'' or ``might'' reduce the risk of heart disease;
(B) In specifying the disease, the claim uses the terms ``heart
disease'' or ``coronary heart disease;''
(C) In specifying the nutrient, the claim uses the terms ``saturated
fat'' and ``cholesterol'' and lists both;
(D) The claim does not attribute any degree of risk reduction for
coronary heart disease to diets low in dietary saturated fat and
cholesterol; and
(E) The claim states that coronary heart disease risk depends on
many factors.
(ii) Nature of the food. The food shall meet all of the nutrient
content requirements of Sec. 101.62 for a ``low saturated fat,'' ``low
cholesterol,'' and ``low fat'' food; except that fish and game meats
(i.e., deer, bison, rabbit, quail, wild turkey, geese, and ostrich) may
meet the requirements for ``extra lean'' in Sec. 101.62.
[[Page 125]]
(d) Optional information. (1) The claim may identify one or more of
the following risk factors in addition to saturated fat and cholesterol
about which there is general scientific agreement that they are major
risk factors for this disease: A family history of coronary heart
disease, elevated blood total and LDL-cholesterol, excess body weight,
high blood pressure, cigarette smoking, diabetes, and physical
inactivity.
(2) The claim may indicate that the relationship of saturated fat
and cholesterol to heart disease is through the intermediate link of
``blood cholesterol'' or ``blood total- and LDL cholesterol.''
(3) The claim may include information from paragraphs (a) and (b) of
this section, which summarize the relationship between dietary saturated
fat and cholesterol and risk of coronary heart disease, and the
significance of the relationship.
(4) In specifying the nutrients, the claim may include the term
``total fat'' in addition to the terms ``saturated fat'' and
``cholesterol''.
(5) The claim may include information on the number of people in the
United States who have coronary heart disease. The sources of this
information shall be identified, and it shall be current information
from the National Center for Health Statistics, the National Institutes
of Health, or ``Nutrition and Your Health: Dietary Guidelines for
Americans,'' U.S. Department of Health and Human Services (DHHS) and
U.S. Department of Agriculture (USDA), Government Printing Office.
(6) The claim may indicate that it is consistent with ``Nutrition
and Your Health: Dietary Guidelines for Americans,'' DHHS and USDA,
Government Printing Office.
(7) The claim may state that individuals with elevated blood total-
or LDL-cholesterol should consult their physicians for medical advice
and treatment. If the claim defines high or normal blood total- or LDL-
cholesterol levels, then the claim shall state that individuals with
high blood cholesterol should consult their physicians for medical
advice and treatment.
(e) Model health claims.The following are model health claims that
may be used in food labeling to describe the relationship between
dietary saturated fat and cholesterol and risk of heart disease:
(1) While many factors affect heart disease, diets low in saturated
fat and cholesterol may reduce the risk of this disease;
(2) Development of heart disease depends upon many factors, but its
risk may be reduced by diets low in saturated fat and cholesterol and
healthy lifestyles;
(3) Development of heart disease depends upon many factors,
including a family history of the disease, high blood LDL-cholesterol,
diabetes, high blood pressure, being overweight, cigarette smoking, lack
of exercise, and the type of dietary pattern. A healthful diet low in
saturated fat, total fat, and cholesterol, as part of a healthy
lifestyle, may lower blood cholesterol levels and may reduce the risk of
heart disease;
(4) Many factors, such as a family history of the disease, increased
blood- and LDL-cholesterol levels, high blood pressure, cigarette
smoking, diabetes, and being overweight, contribute to developing heart
disease. A diet low in saturated fat, cholesterol, and total fat may
help reduce the risk of heart disease; and
(5) Diets low in saturated fat, cholesterol, and total fat may
reduce the risk of heart disease. Heart disease is dependent upon many
factors, including diet, a family history of the disease, elevated blood
LDL-cholesterol levels, and physical inactivity.
[58 FR 2757, Jan. 6, 1993]
Sec. 101.76 Health claims: fiber-containing grain products, fruits, and vegetables and cancer.
(a) Relationship between diets low in fat and high in fiber-
containing grain products, fruits, and vegetables and cancer risk. (1)
Cancer is a constellation of more than 100 different diseases, each
characterized by the uncontrolled growth and spread of abnormal cells.
Cancer has many causes and stages in its development. Both genetic and
environmental risk factors may affect the risk of cancer. Risk factors
include: A family history of a specific type of cancer, cigarette
smoking, overweight
[[Page 126]]
and obesity, alcohol consumption, ultraviolet or ionizing radiation,
exposure to cancer-causing chemicals, and dietary factors.
(2) The scientific evidence establishes that diets low in fat and
high in fiber-containing grain products, fruits, and vegetables are
associated with a reduced risk of some types of cancer. Although the
specific role of total dietary fiber, fiber components, and the multiple
nutrients and other substances contained in these foods are not yet
fully understood, many studies have shown that diets low in fat and high
in fiber-containing foods are associated with reduced risk of some types
of cancer.
(b) Significance of the relationship between consumption of diets
low in fat and high in fiber-containing grain products, fruits, and
vegetables and risk of cancer. (1) Cancer is ranked as a leading cause
of death in the United States. The overall economic costs of cancer,
including direct health care costs and losses due to morbidity and
mortality, are very high.
(2) U.S. diets tend to be high in fat and low in grain products,
fruits, and vegetables. Studies in various parts of the world indicate
that populations who habitually consume a diet high in plant foods have
lower risks of some cancers. These diets generally are low in fat and
rich in many nutrients, including, but not limited to, dietary fiber.
Current dietary guidelines from Federal government agencies and
nationally recognized health professional organizations recommend
decreased consumption of fats (less than 30 percent of calories),
maintenance of desirable body weight, and increased consumption of
fruits and vegetables (five or more servings daily), and grain products
(six or more servings daily).
(c) Requirements. (1) All requirements set forth in Sec. 101.14
shall be met.
(2) Specific requirements. (i) Nature of the claim. A health claim
associating diets low in fat and high in fiber-containing grain
products, fruits, and vegetables with reduced risk of cancer may be made
on the label or labeling of a food described in paragraph (c)(2)(ii) of
this section, provided that:
(A) The claim states that diets low in fat and high in fiber-
containing grain products, fruits, and vegetables ``may'' or ``might''
reduce the risk of some cancers;
(B) In specifying the disease, the claim uses the following terms:
``some types of cancer,'' or ``some cancers'';
(C) The claim is limited to grain products, fruits, and vegetables
that contain dietary fiber;
(D) The claim indicates that development of cancer depends on many
factors;
(E) The claim does not attribute any degree of cancer risk reduction
to diets low in fat and high in fiber-containing grain products, fruits,
and vegetables;
(F) In specifying the dietary fiber component of the labeled food,
the claim uses the term ``fiber'', ``dietary fiber'' or ``total dietary
fiber''; and
(G) The claim does not specify types of dietary fiber that may be
related to risk of cancer.
(ii) Nature of the food. (A) The food shall be or shall contain a
grain product, fruit, or vegetable.
(B) The food shall meet the nutrient content requirements of
Sec. 101.62 for a ``low fat'' food.
(C) The food shall meet, without fortification, the nutrient content
requirements of Sec. 101.54 for a ``good source'' of dietary fiber.
(d) Optional information. (1) The claim may include information from
paragraphs (a) and (b) of this section, which summarize the relationship
between diets low in fat and high in fiber-containing grain products,
fruits, and vegetables, and some types of cancer and the significance of
the relationship.
(2) The claim may identify one or more of the following risk factors
for development of cancer: Family history of a specific type of cancer,
cigarette smoking, overweight and obesity, alcohol consumption,
ultraviolet or ionizing radiation, exposure to cancer causing chemicals,
and dietary factors.
(3) The claim may indicate that it is consistent with ``Nutrition
and Your Health: Dietary Guidelines for Americans,'' U.S. Department of
Agriculture (USDA) and Department of Health and Human Services (DHHS),
Government Printing Office.
(4) The claim may include information on the number of people in the
[[Page 127]]
United States who have cancer. The sources of this information must be
identified, and it must be current information from the National Center
for Health Statistics, the National Institutes of Health, or ``Nutrition
and Your Health: Dietary Guidelines for Americans,'' USDA and DHHS,
Government Printing Office.
(e) Model health claims. The following model health claims may be
used in food labeling to characterize the relationship between diets low
in fat and high in fiber-containing grain products, fruits, and
vegetables and cancer risk:
(1) Low fat diets rich in fiber-containing grain products, fruits,
and vegetables may reduce the risk of some types of cancer, a disease
associated with many factors.
(2) Development of cancer depends on many factors. Eating a diet low
in fat and high in grain products, fruits, and vegetables that contain
dietary fiber may reduce your risk of some cancers.
[58 FR 2548, Jan. 6, 1993]
Sec. 101.77 Health claims: fruits, vegetables, and grain products that contain fiber, particularly soluble fiber, and risk of coronary heart disease.
(a) Relationship between diets low in saturated fat and cholesterol
and high in fruits, vegetables, and grain products that contain fiber,
particularly soluble fiber, and risk of coronary heart disease. (1)
Cardiovascular disease means diseases of the heart and circulatory
system. Coronary heart disease is the most common and serious form of
cardiovascular disease and refers to diseases of the heart muscle and
supporting blood vessels. High blood total- and low density lipoprotein
(LDL)- cholesterol levels are major modifiable risk factors in the
development of coronary heart disease. High coronary heart disease rates
occur among people with high blood cholesterol levels of 240 milligrams
per deciliter (mg/dL) (6.21 (mmol/L)) or above and LDL-cholesterol
levels of 160 mg/dL (4.13 mmol/L) or above. Borderline high risk blood
cholesterol levels range from 200 to 239 mg/dL (5.17 to 6.18 mmol/L) and
130 to 159 mg/dL (3.36 to 4.11 mmol/L) of LDL-cholesterol. Dietary
lipids (fats) include fatty acids and cholesterol. Total fat, commonly
referred to as fat, is composed of saturated fat (fatty acids containing
no double bonds), and monounsaturated and polyunsaturated fat (fatty
acids containing one or more double bonds).
(2) The scientific evidence establishes that diets high in saturated
fat and cholesterol are associated with increased levels of blood total-
and LDL-cholesterol and, thus, with increased risk of coronary heart
disease. Diets low in saturated fat and cholesterol are associated with
decreased levels of blood total- and LDL-cholesterol, and thus, with
decreased risk of developing coronary heart disease.
(3) Populations with relatively low blood cholesterol levels tend to
have dietary patterns that are not only low in total fat, especially
saturated fat and cholesterol, but are also relatively high in fruits,
vegetables, and grain products. Although the specific roles of these
plant foods are not yet fully understood, many studies have shown that
diets high in plant foods are associated with reduced risk of coronary
heart disease. These studies correlate diets rich in fruits, vegetables,
and grain products and nutrients from these diets, such as some types of
fiber, with reduced coronary heart disease risk. Persons consuming these
diets frequently have high intakes of dietary fiber, particularly
soluble fibers. Currently, there is not scientific agreement as to
whether a particular type of soluble fiber is beneficial, or whether the
observed protective effects of fruits, vegetables, and grain products
against heart disease are due to other components, or a combination of
components, in these diets, including, but not necessarily limited to,
some types of soluble fiber, other fiber components, other
characteristics of the complex carbohydrate content of these foods,
other nutrients in these foods, or displacement of saturated fat and
cholesterol from the diet.
(b) Significance of the relationship between diets low in saturated
fat and cholesterol, and high in fruits, vegetables, and grain products
that contain fiber, particularly soluble fiber, and risk of coronary
heart disease. (1) Coronary heart disease is a major public health
concern in the United States, primarily because it accounts for more
deaths
[[Page 128]]
than any other disease or group of diseases. Early management of risk
factors for coronary heart disease is a major public health goal that
can assist in reducing risk of coronary heart disease. There is a
continuum of mortality risk from coronary heart disease that increases
with increasing levels of blood LDL-cholesterol. Individuals with high
blood LDL-cholesterol are at greatest risk. A larger number of
individuals with more moderately elevated cholesterol also have
increased risk of coronary events; such individuals comprise a
substantial proportion of the adult U.S. population. The scientific
evidence indicates that reducing saturated fat and cholesterol intakes
lowers blood LDL-cholesterol and risk of heart disease in most
individuals, including persons with blood cholesterol levels in the
normal range. Additionally, consuming diets high in fruits, vegetables,
and grain products, foods that contain soluble fiber, may be a useful
adjunct to a low saturated fat and low cholesterol diet.
(2) Other risk factors for coronary heart disease include a family
history of heart disease, high blood pressure, diabetes, cigarette
smoking, obesity (body weight 30 percent greater than ideal body
weight), and lack of regular physical exercise.
(3) Intakes of saturated fat exceed recommended levels in many
people in the United States. Intakes of cholesterol are, on average, at
or above recommended levels. Intakes of fiber-containing fruits,
vegetables, and grain products are about half of recommended intake
levels. One of the major public health recommendations relative to
coronary heart disease risk is to consume less than 10 percent of
calories from saturated fat, and an average of 30 percent or less of
total calories from all fat. Recommended daily cholesterol intakes are
300 mg or less per day. Recommended total dietary fiber intakes are
about 25 grams (g) daily, of which about 25 percent (about 6 g) should
be soluble fiber.
(4) Current dietary guidance recommendations encourage decreased
consumption of dietary fat, especially saturated fat and cholesterol,
and increased consumption of fiber-rich foods to help lower blood LDL-
cholesterol levels. Results of numerous studies have shown that fiber-
containing fruits, vegetables, and grain products can help lower blood
LDL-cholesterol.
(c) Requirements. (1) All requirements set forth in Sec. 101.14
shall be met.
(2) Specific requirements. (i) Nature of the claim. A health claim
associating diets low in saturated fat and cholesterol and high in
fruits, vegetables, and grain products that contain fiber, particularly
soluble fiber, with reduced risk of heart disease may be made on the
label or labeling of a food described in paragraph (c)(2)(ii) of this
section, provided that:
(A) The claim states that diets low in saturated fat and cholesterol
and high in fruits, vegetables, and grain products that contain fiber
``may'' or ``might'' reduce the risk of heart disease;
(B) In specifying the disease, the claim uses the following terms:
``heart disease'' or ``coronary heart disease;''
(C) The claim is limited to those fruits, vegetables, and grains
that contain fiber;
(D) In specifying the dietary fiber, the claim uses the term
``fiber,'' ``dietary fiber,'' ``some types of dietary fiber,'' ``some
dietary fibers,'' or ``some fibers;'' the term ``soluble fiber'' may be
used in addition to these terms;
(E) In specifying the fat component, the claims uses the terms
``saturated fat'' and ``cholesterol;'' and
(F) The claim indicates that development of heart disease depends on
many factors; and
(G) The claim does not attribute any degree of risk reduction for
coronary heart disease to diets low in saturated fat and cholesterol and
high in fruits, vegetables, and grain products that contain fiber.
(ii) Nature of the food. (A) The food shall be or shall contain a
fruit, vegetable, or grain product.
(B) The food shall meet the nutrient content requirements of
Sec. 101.62 for a ``low saturated fat,'' ``low cholesterol,'' and ``low
fat'' food.
(C) The food contains, without fortification, at least 0.6 g of
soluble fiber per reference amount customarily consumed;
(D) The content of soluble fiber shall be declared in the nutrition
[[Page 129]]
information panel, consistent with Sec. 101.9(c)(6)(i)(A).
(d) Optional information. (1) The claim may identify one or more of
the following risk factors for heart disease about which there is
general scientific agreement: A family history of coronary heart
disease, elevated blood-, total- and LDL-cholesterol, excess body
weight, high blood pressure, cigarette smoking, diabetes, and physical
inactivity.
(2) The claim may indicate that the relationship of diets low in
saturated fat and cholesterol, and high in fruits, vegetables, and grain
products that contain fiber to heart disease is through the intermediate
link of ``blood cholesterol'' or ``blood total- and LDL-cholesterol.''
(3) The claim may include information from paragraphs (a) and (b) of
this section, which summarize the relationship between diets low in
saturated fat and cholesterol and high in fruits, vegetables, and grain
products that contain fiber and coronary heart disease, and the
significance of the relationship.
(4) In specifying the nutrients, the claim may include the term
``total fat'' in addition to the terms ``saturated fat'' and
``cholesterol.''
(5) The claim may indicate that it is consistent with ``Nutrition
and Your Health: Dietary Guidelines for Americans,'' U.S. Department of
Agriculture (USDA) and Department of Health and Human Services (DHHS),
Government Printing Office (GPO).
(6) The claim may state that individuals with elevated blood total-
and LDL-cholesterol should consult their physicians for medical advice
and treatment. If the claim defines high or normal blood total- and LDL-
cholesterol levels, then the claim shall state that individuals with
high blood cholesterol should consult their physicians for medical
advice and treatment.
(7) The claim may include information on the number of people in the
United States who have heart disease. The sources of this information
shall be identified, and it shall be current information from the
National Center for Health Statistics, the National Institutes of
Health, or ``Nutrition and Your Health: Dietary Guidelines for
Americans,'' USDA and DHHS, GPO.
(e) Model health claims. The following model health claims may be
used in food labeling to characterize the relationship between diets low
in saturated fat and cholesterol and high in fruits, vegetables, and
grain products that contain soluble fiber:
(1) Diets low in saturated fat and cholesterol and rich in fruits,
vegetables, and grain products that contain some types of dietary fiber,
particularly soluble fiber, may reduce the risk of heart disease, a
disease associated with many factors.
(2) Development of heart disease depends on many factors. Eating a
diet low in saturated fat and cholesterol and high in fruits,
vegetables, and grain products that contain fiber may lower blood
cholesterol levels and reduce your risk of heart disease.
[58 FR 2578, Jan. 6, 1993]
Sec. 101.78 Health claims: fruits and vegetables and cancer.
(a) Relationship between substances in diets low in fat and high in
fruits and vegetables and cancer risk. (1) Cancer is a constellation of
more than 100 different diseases, each characterized by the uncontrolled
growth and spread of abnormal cells. Cancer has many causes and stages
in its development. Both genetic and environmental risk factors may
affect the risk of cancer. Risk factors include a family history of a
specific type of cancer, cigarette smoking, alcohol consumption,
overweight and obesity, ultraviolet or ionizing radiation, exposure to
cancer-causing chemicals, and dietary factors.
(2) Although the specific roles of the numerous potentially
protective substances in plant foods are not yet understood, many
studies have shown that diets high in plant foods are associated with
reduced risk of some types of cancers. These studies correlate diets
rich in fruits and vegetables and nutrients from these diets, such as
vitamin C, vitamin A, and dietary fiber, with reduced cancer risk.
Persons consuming these diets frequently have high intakes of these
nutrients. Currently, there is not scientific agreement as to whether
the observed protective effects of fruits and vegetables
[[Page 130]]
against cancer are due to a combination of the nutrient components of
diets rich in fruits and vegetables, including but not necessarily
limited to dietary fiber, vitamin A (as beta-carotene) and vitamin C, to
displacement of fat from such diets, or to intakes of other substances
in these foods which are not nutrients but may be protective against
cancer risk.
(b) Significance of the relationship between consumption of diets
low in fat and high in fruits and vegetables and risk of cancer. (1)
Cancer is ranked as a leading cause of death in the United States. The
overall economic costs of cancer, including direct health care costs and
losses due to morbidity and mortality, are very high.
(2) U.S. diets tend to be high in fat and low in fruits and
vegetables. Studies in various parts of the world indicate that
populations who habitually consume a diet high in plant foods have lower
risks of some cancers. These diets generally are low in fat and rich in
many nutrients, including, but not limited to, dietary fiber, vitamin A
(as beta-carotene), and vitamin C. Current dietary guidelines from
Federal Government agencies and nationally recognized health
professional organizations recommend decreased consumption of fats (less
than 30 percent of calories), maintenance of desirable body weight, and
increased consumption of fruits and vegetables (5 or more servings
daily), particularly those fruits and vegetables which contain dietary
fiber, vitamin A, and vitamin C.
(c) Requirements. (1) All requirements set forth in Sec. 101.14
shall be met.
(2) Specific requirements. (i) Nature of the claim. A health claim
associating substances in diets low in fat and high in fruits and
vegetables with reduced risk of cancer may be made on the label or
labeling of a food described in paragraph (c)(2)(ii) of this section,
provided that:
(A) The claim states that diets low in fat and high in fruits and
vegetables ``may'' or ``might'' reduce the risk of some cancers;
(B) In specifying the disease, the claim uses the following terms:
``some types of cancer'', or ``some cancers'';
(C) The claim characterizes fruits and vegetables as foods that are
low in fat and may contain vitamin A, vitamin C, and dietary fiber;
(D) The claim characterizes the food bearing the claim as containing
one or more of the following, for which the food is a good source under
Sec. 101.54: dietary fiber, vitamin A, or vitamin C;
(E) The claim does not attribute any degree of cancer risk reduction
to diets low in fat and high in fruits and vegetables;
(F) In specifying the fat component of the labeled food, the claim
uses the term ``total fat'' or ``fat'';
(G) The claim does not specify types of fats or fatty acids that may
be related to risk of cancer;
(H) In specifying the dietary fiber component of the labeled food,
the claim uses the term ``fiber'', ``dietary fiber'', or ``total dietary
fiber'';
(I) The claim does not specify types of dietary fiber that may be
related to risk of cancer; and
(J) The claim indicates that development of cancer depends on many
factors.
(ii) Nature of the food. (A) The food shall be or shall contain a
fruit or vegetable.
(B) The food shall meet the nutrient content requirements of
Sec. 101.62 for a ``low fat'' food.
(C) The food shall meet, without fortification, the nutrient content
requirements of Sec. 101.54 for a ``good source'' of at least one of the
following: vitamin A, vitamin C, or dietary fiber.
(d) Optional information. (1) The claim may include information from
paragraphs (a) and (b) of this section, which summarize the relationship
between diets low in fat and high in fruits and vegetables and some
types of cancer and the significance of the relationship.
(2) The claim may identify one or more of the following risk factors
for development of cancer: Family history of a specific type of cancer,
cigarette smoking, alcohol consumption, overweight and obesity,
ultraviolet or ionizing radiation, exposure to cancer-causing chemicals,
and dietary factors.
(3) The claim may use the word ``beta-carotene'' in parentheses
after the term vitamin A, provided that the vitamin A in the food
bearing the claim is beta-carotene.
[[Page 131]]
(4) The claim may indicate that it is consistent with ``Nutrition
and Your Health: Dietary Guidelines for Americans,'' U.S. Department of
Agriculture (USDA) and the Department of Health and Human Services
(DHHS), Government Printing Office.
(5) The claim may include information on the number of people in the
United States who have cancer. The sources of this information must be
identified, and it must be current information from the National Center
for Health Statistics, the National Institutes of Health, or ``Nutrition
and Your Health: Dietary Guidelines for Americans,'' USDA and DHHS,
Government Printing Office.
(e) Model health claims. The following model health claims may be
used in food labeling to characterize the relationship between
substances in diets low in fat and high in fruits and vegetables and
cancer:
(1) Low fat diets rich in fruits and vegetables (foods that are low
in fat and may contain dietary fiber, vitamin A, and vitamin C) may
reduce the risk of some types of cancer, a disease associated with many
factors. Broccoli is high in vitamins A and C, and it is a good source
of dietary fiber.
(2) Development of cancer depends on many factors. Eating a diet low
in fat and high in fruits and vegetables, foods that are low in fat and
may contain vitamin A, vitamin C, and dietary fiber, may reduce your
risk of some cancers. Oranges, a food low in fat, are a good source of
fiber and vitamin C.
[58 FR 2639, Jan. 6, 1993]
Sec. 101.79 Health claims: Folate and neural tube defects.
(a) Relationship between folate and neural tube defects--(1)
Definition. Neural tube defects are serious birth defects of the brain
or spinal cord that can result in infant mortality or serious
disability. The birth defects anencephaly and spina bifida are the most
common forms of neural tube defects and account for about 90 percent of
these defects. These defects result from failure of closure of the
covering of the brain or spinal cord during early embryonic development.
Because the neural tube forms and closes during early pregnancy, the
defect may occur before a woman realizes that she is pregnant.
(2) Relationship. The available data show that diets adequate in
folate may reduce the risk of neural tube defects. The strongest
evidence for this relationship comes from an intervention study by the
Medical Research Council of the United Kingdom that showed that women at
risk of recurrence of a neural tube defect pregnancy who consumed a
supplement containing 4 milligrams (mg)(4,000 micrograms (mcg)) folic
acid daily before conception and continuing into early pregnancy had a
reduced risk of having a child with a neural tube defect. (Products
containing this level of folic acid are drugs). In addition, based on
its review of a Hungarian intervention trial that reported
periconceptional use of a multivitamin and multimineral preparation
containing 800 mcg (0.8 mg) of folic acid, and its review of the
observational studies that reported periconceptional use of
multivitamins containing 0 to 1,000 mcg of folic acid, the Food and Drug
Administration concluded that most of these studies had results
consistent with the conclusion that folate, at levels attainable in
usual diets, may reduce the risk of neural tube defects.
(b) Significance of folate--(1) Public health concern. Neural tube
defects occur in approximately 0.6 of 1,000 live births in the United
States (i.e., approximately 6 of 10,000 live births; about 2,500 cases
among 4 million live births annually). Neural tube defects are believed
to be caused by many factors. The single greatest risk factor for a
neural tube defect-affected pregnancy is a personal or family history of
a pregnancy affected with a such a defect. However, about 90 percent of
infants with a neural tube defect are born to women who do not have a
family history of these defects. The available evidence shows that diets
adequate in folate may reduce the risk of neural tube defects but not of
other birth defects.
(2) Populations at risk. Prevalence rates for neural tube defects
have been reported to vary with a wide range of factors including
genetics, geography, socioeconomic status, maternal birth cohort, month
of conception, race,
[[Page 132]]
nutrition, and maternal health, including maternal age and reproductive
history. Women with a close relative (i.e., sibling, niece, nephew) with
a neural tube defect, those with insulin-dependent diabetes mellitus,
and women with seizure disorders who are being treated with valproic
acid or carbamazepine are at significantly increased risk compared with
women without these characteristics. Rates for neural tube defects vary
within the United States, with lower rates observed on the west coast
than on the east coast.
(3) Those who may benefit. Based on a synthesis of information from
several studies, including those which used multivitamins containing
folic acid at a daily dose level of 400 mcg (0.4
mg), the Public Health Service has inferred that folate alone at levels
of 400 mcg (0.4 mg) per day may reduce the risk of neural tube defects.
The protective effect found in studies of lower dose folate measured by
the reduction in neural tube defect incidence, ranges from none to
substantial; a reasonable estimate of the expected reduction in the
United States is 50 percent. It is expected that consumption of adequate
folate will avert some, but not all, neural tube defects. The underlying
causes of neural tube defects are not known. Thus, it is not known what
proportion of neural tube defects will be averted by adequate folate
consumption. From the available evidence, the Public Health Service
estimates that there is the potential for averting 50 percent of cases
that now occur (i.e., about 1,250 cases annually). However, until
further research is done, no firm estimate of this proportion will be
available.
(c) Requirements. The label or labeling of food may contain a
folate/neural tube defect health claim provided that:
(1) General requirements. The health claim for a food meets all of
the general requirements of Sec. 101.14 for health claims, except that a
food may qualify to bear the health claim if it meets the definition of
the term ``good source.''
(2) Specific requirements--(i) Nature of the claim--(A)
Relationship. A health claim that women who are capable of becoming
pregnant and who consume adequate amounts of folate daily during their
childbearing years may reduce their risk of having a pregnancy affected
by spina bifida or other neural tube defects may be made on the label or
labeling of food provided that:
(B) Specifying the nutrient. In specifying the nutrient, the claim
shall use the terms ``folate,'' ``folic acid,'' ``folacin,'' ``folate, a
B vitamin,'' ``folic acid, a B vitamin,'' or ``folacin, a B vitamin.''
(C) Specifying the condition. In specifying the health- related
condition, the claim shall identify the birth defects as ``neural tube
defects,'' ``birth defects spina bifida or anencephaly,'' ``birth
defects of the brain or spinal cord anencephaly or spina bifida,''
``spina bifida and anencephaly, birth defects of the brain or spinal
cord,'' ``birth defects of the brain or spinal cord;'' or ``brain or
spinal cord birth defects.''
(D) Multifactorial nature. The claim shall not imply that folate
intake is the only recognized risk factor for neural tube defects.
(E) Reduction in risk. The claim shall not attribute any specific
degree of reduction in risk of neural tube defects from maintaining an
adequate folate intake throughout the childbearing years. The claim
shall state that some women may reduce their risk of a neural tube
defect pregnancy by maintaining adequate intakes of folate during their
childbearing years. Optional statements about population-based estimates
of risk reduction may be made in accordance with paragraph (c)(3)(vi) of
this section.
(F) Safe upper limit of daily intake. Claims on foods that contain
more than 100 percent of the Daily Value (DV) (400 mcg) when labeled for
use by adults and children 4 or more years of age, or 800 mcg when
labeled for use by pregnant or lactating women) shall identify the safe
upper limit of daily intake with respect to the DV. The safe upper limit
of daily intake value of 1,000 mcg (1 mg) may be included in
parentheses.
(G) The claim. The claim shall not state that a specified amount of
folate per serving from one source is more effective in reducing the
risk of neural tube defects than a lower amount per serving from another
source.
(H) The claim shall state that folate needs to be consumed as part
of a healthful diet.
[[Page 133]]
(ii) Nature of the food--(A) Requirements. The food shall meet or
exceed the requirements for a ``good source'' of folate as defined in
Sec. 101.54;
(B) Dietary supplements. Dietary supplements shall meet the United
States Pharmacopeia (USP) standards for disintegration and dissolution,
except that if there are no applicable USP standards, the folate in the
dietary supplement shall be shown to be bioavailable under the
conditions of use stated on the product label.
(iii) Limitation. The claim shall not be made on foods that contain
more than 100 percent of the RDI for vitamin A as retinol or preformed
vitamin A or vitamin D per serving or per unit.
(iv) Nutrition labeling. The nutrition label shall include
information about the amount of folate in the food. This information
shall be declared after the declaration for iron if only the levels of
vitamin A, vitamin C, calcium, and iron are provided, or in accordance
with Sec. 101.9 (c)(8) and (c)(9) if other optional vitamins or minerals
are declared.
(3) Optional information--(i) Risk factors. The claim may
specifically identify risk factors for neural tube defects. Where such
information is provided, it may consist of statements from
Sec. 101.79(b)(1) or (b)(2) (e.g., Women at increased risk include those
with a personal history of a neural tube defect-affected pregnancy,
those with a close relative (i.e., sibling, niece, nephew) with a neural
tube defect; those with insulin-dependent diabetes mellitus; those with
seizure disorders who are being treated with valproic acid or
carbamazepine) or from other parts of this paragraph (c)(3)(i).
(ii) Relationship between folate and neural tube defects. The claim
may include statements from paragraphs (a) and (b) of this section that
summarize the relationship between folate and neural tube defects and
the significance of the relationship except for information specifically
prohibited from the claim.
(iii) Personal history of a neural tube defect-affected pregnancy.
The claim may state that women with a history of a neural tube defect
pregnancy should consult their physicians or health care providers
before becoming pregnant. If such a statement is provided, the claim
shall also state that all women should consult a health care provider
when planning a pregnancy.
(iv) Daily value. The claim may identify 100 percent of the DV (100%
DV; 400 mcg) for folate as the target intake goal.
(v) Prevalence. The claim may provide estimates, expressed on an
annual basis, of the number of neural tube defect-affected births among
live births in the United States. Current estimates are provided in
Sec. 101.79(b)(1), and are approximately 6 of 10,000 live births
annually (i.e., about 2,500 cases among 4 million live births annually).
Data provided in Sec. 101.79(b)(1) shall be used, unless more current
estimates from the U.S. Public Health Service are available, in which
case the latter may be cited.
(vi) Reduction in risk. An estimate of the reduction in the number
of neural tube defect-affected births that might occur in the United
States if all women consumed adequate folate throughout their
childbearing years may be included in the claim. Information contained
in paragraph (b)(3) of this section may be used. If such an estimate
(i.e., 50 percent) is provided, the estimate shall be accompanied by
additional information that states that the estimate is population-based
and that it does not reflect risk reduction that may be experienced by
individual women.
(vii) Diets adequate in folate. The claim may identify diets
adequate in folate by using phrases such as ``Sources of folate include
fruits, vegetables, whole grain products, fortified cereals, and dietary
supplements.'' or ``Adequate amounts of folate can be obtained from
diets rich in fruits, dark green leafy vegetables, legumes, whole grain
products, fortified cereals, or dietary supplements.'' or ``Adequate
amounts of folate can be obtained from diets rich in fruits, including
citrus fruits and juices, vegetables, including dark green leafy
vegetables, legumes, whole grain products, including breads, rice, and
pasta, fortified cereals, or a dietary supplement.''
(d) Model health claims. The following are examples of model health
claims that may be used in food labeling to
[[Page 134]]
describe the relationship between folate and neural tube defects:
(1) Examples 1 and 2. Model health claims appropriate for foods
containing 100 percent or less of the DV for folate per serving or per
unit (general population). The examples contain only the required
elements:
(i) Healthful diets with adequate folate may reduce a woman's risk
of having a child with a brain or spinal cord birth defect.
(ii) Adequate folate in healthful diets may reduce a woman's risk of
having a child with a brain or spinal cord birth defect.
(2) Example 3. Model health claim appropriate for foods containing
100 percent or less of the DV for folate per serving or per unit. The
example contains all required elements plus optional information: Women
who consume healthful diets with adequate folate throughout their
childbearing years may reduce their risk of having a child with a birth
defect of the brain or spinal cord. Sources of folate include fruits,
vegetables, whole grain products, fortified cereals, and dietary
supplements.
(3) Example 4. Model health claim appropriate for foods intended for
use by the general population and containing more than 100 percent of
the DV of folate per serving or per unit: Women who consume healthful
diets with adequate folate may reduce their risk of having a child with
birth defects of the brain or spinal cord. Folate intake should not
exceed 250% of the DV (1,000 mcg).
[61 FR 8779, Mar. 5, 1996]
Effective Date Note: At 61 FR 8779, Mar. 5, 1996, Sec. 101.79 was
revised, effective April 19, 1996. For the convenience of the reader,
the superseded text is set forth below.
Sec. 101.79 Health claims: folate and neural tube defects.
(a) Relationship between folate and neural tube defects--(1)
Definition. Neural tube defects are serious birth defects of the brain
or spinal cord that can result in infant mortality or serious
disability. The birth defects anencephaly and spina bifida are the most
common forms of neural tube defects and account for about 90 percent of
these defects. These defects result from failure of closure of the
covering of the brain or spinal cord during early embryonic development.
Because the neural tube forms and closes during early pregnancy, the
defect may occur before a woman realizes that she is pregnant.
(2) Relationship. The available data show that diets adequate in
folate may reduce the risk of neural tube defects. The strongest
evidence for this relationship comes from an intervention study by the
Medical Research Council of the United Kingdom that showed that women at
risk of recurrence of a neural tube defect pregnancy who consumed a
supplement containing 4 milligrams (mg) (4,000 micrograms (g))
folic acid daily had a reduced risk of having a child with a neural tube
defect. (Products that contain this level of folic acid are drugs.) In
addition, based on its review of a Hungarian intervention trial that
used a multivitamin and multimineral preparation containing 800
g (0.8 mg) of folic acid, and its review of the observational
studies that reported use of multivitamins containing 0 to 1,000
g of folic acid, the Food and Drug Administration concluded
that most of these studies had results consistent with the conclusion
that folate, at levels attainable in usual diets, may reduce the risk of
neural tube defects.
(b) Significance of folate--(1) Public health concern. Neural tube
defects occur in approximately 0.6 of 1,000 live births in the United
States (i.e., about 2,500 cases among 4 million live births annually).
Neural tube defects are believed to be caused by many factors. The
single greatest risk factor for a neural tube defect-affected pregnancy
is a personal or family history of a pregnancy affected with a such a
defect. However, about 90 percent of infants with a neural tube defect
are born to women who do not have a family history of these defects. The
available evidence shows that diets adequate in folate may reduce the
risk of neural tube defects but not of other birth defects.
(2) Populations at risk. Prevalence rates for neural tube defects
have been reported to vary with a wide range of factors, including
genetics, geography, socioeconomic status, maternal birth cohort, month
of conception, race, nutrition, and maternal health, including maternal
age and reproductive history. Women with a close relative (i.e.,
sibling, niece, nephew) with a neural tube defect, those with insulin-
dependent diabetes mellitus, and women with seizure disorders who are
being treated with valproic acid or carbamazepine are at significantly
increased risk compared with women without these characteristics. Rates
for neural tube defects vary within the United States, with lower rates
observed on the west coast than on the east coast.
(3) Those who may benefit. Based on a synthesis of the results of
several observational studies, the Public Health Service has estimated
that about 50 percent of neural tube defect-affected pregnancies in the
United
[[Page 135]]
States (e.g., about 1,250) may be averted annually if all women consume
adequate amounts of folate daily (i.e., 0.4 mg) throughout their
childbearing years.
(c) Requirements. The label or labeling of food in conventional food
form or dietary supplements may contain a folate/neural tube defect
health claim provided that:
(1) General requirements. The health claim for a food or supplement
meets all of the general requirements of Sec. 101.14 for health claims,
except that a food or dietary supplement may qualify to bear the health
claim if it meets the definition of the term ``good source.''
(2) Specific requirements--(i) Nature of the claim--(A)
Relationship. A health claim that women who are capable of becoming
pregnant and who consume adequate amounts of folate daily during their
childbearing years may reduce their risk of having a pregnancy affected
by spina bifida or other neural tube defects may be made on the label or
labeling of foods in conventional food form or of dietary supplements
provided that:
(B) Specifying the nutrient. In specifying the nutrient, the claim
shall use the terms ``folate,'' ``folic acid,'' ``folacin,'' ``folate, a
B vitamin,'' ``folic acid, a B vitamin,'' or ``folacin, a B vitamin.''
(C) Specifying the condition. In specifying the health-related
condition, the claim shall identify the birth defects as ``neural tube
defects,'' ``birth defects, spina bifida, or anencephaly,'' ``birth
defects of the brain or spinal cord anencephaly or spina bifida,'' or
``spina bifida or anencephaly, birth defects of the brain or spinal
cord;''
(D) Multifactorial nature. The claim shall state that neural tube
defects have many causes and shall not imply that folate intake is the
only recognized risk factor for neural tube defects.
(E) Prevalence. In specifying the prevalence of neural tube defects
among women in the general population, the claim shall state that such
birth defects ``which, while not widespread, are extremely significant''
or ``* * * birth defects * * * that, while not widespread, are extremely
significant.''
(F) Reduction in risk. The claim shall not attribute any specific
degree of reduction in risk of neural tube defects, including mention of
the Public Health Service estimate that 50 percent of neural tube
defects may be averted annually, to maintaining an adequate folate
intake throughout the childbearing years. The claim shall state that
some women may reduce their risk of a neural tube defect pregnancy by
maintaining adequate intakes of folic acid during their childbearing
years.
(G) Safe upper limit of daily intake. Claims on fortified foods in
conventional form and on dietary supplements that contain more than 25
percent of the RDI for folate (100 g per serving or per unit)
shall state that 1 mg folate per day is the safe upper limit of intake
(e.g., ``Folate consumption should be limited to 1,000 g per
day from all sources.'')
(H) The claim. The claim shall not state that a specified amount of
folate (e.g., 400 g in a dietary supplement) is more effective
in reducing the risk of neural tube defects than a lower amount (e.g.,
100 g in a breakfast cereal or from diets rich in fruits and
vegetables).
(ii) Nature of the food--(A) Requirements. The food or supplement
shall meet or exceed the requirements for a good source of folate as
defined in Sec. 101.54;
(B) Diets adequate in folate. The claim shall identify diets
adequate in folate by using phrases such as ``* * * diets that include 2
to 4 servings per day of fruits) including citrus fruits and juices), 3
to 5 servings of vegetables (including dark green leafy vegetables and
legumes), 6 to 11 servings of enriched grain products (such as breads,
rice, and pasta) and fortified cereals. Such diets provide many
essential minerals and vitamins, including folate. Women who do not eat
well-balanced diets or who may be concerned about their diets may choose
to obtain folate from dietary supplements.''; or ``Adequate amounts of
folate, a B vitamin, can be obtained from diets rich in fruits,
including citrus fruits and juices, vegetables, including dark green
leafy vegetables and legumes, enriched grain products, including breads,
rice, and pasta, fortified cereals, or a dietary supplement.''; or
``Adequate amounts of folate, a B vitamin, can be obtained from diets
rich in fruits, dark green leafy vegetables and legumes, enriched grain
products, fortified cereals, or from dietary supplements.''
(C) Dietary supplements. Dietary supplements shall meet the United
States Pharmacopeia (U.S.P.) standards for disintegration and
dissolution, except that if there are no applicable U.S.P. standards,
the folate in the dietary supplement shall be shown to be bioavailable
under the conditions of use stated on the product label.
(iii) Limitation. The claim shall not be made on foods in
conventional food form or dietary supplements that contain more than 100
percent of the RDI for vitamin A as retinol or preformed vitamin A or
vitamin D.
(iv) Nutrition labeling. The nutrition label shall include
information about the amount of folate in the food. This information
shall be declared after the declaration for iron if only the levels of
vitamin A, vitamin C, calcium, and iron are provided, or in accordance
with Sec. 101.9(c)(8) and (c)(9) if other optional vitamins or minerals
are declared.
(3) Optional information--(i) Risk factors. The claim may
specifically identify risk factors for neural tube defects;
(ii) Relationship between folate and neural tube defects. The claim
may include statements from paragraphs (a) and (b) of this
[[Page 136]]
section that summarize the relationship between folate and neural tube
defects and the significance of the relationship except for information
specifically prohibited from the claim.
(iii) Personal history of a neural tube defect-affected pregnancy.
The claim may state that women with a history of a neural tube defect
pregnancy should consult their physicians or health care providers
before becoming pregnant.
(iv) Daily value. The claim may identify the daily value level of
400 g of folate per day as the target intake goal.
(d) Model health claims. The following are examples of model health
claims that may be used in food labeling to describe the relationship
between folate and neural tube defects:
(1) Example 1. Women who consume adequate amounts of folate, a B
vitamin, daily throughout their childbearing years may reduce their risk
of having a child with a neural tube birth defect. Such birth defects,
while not widespread, are very serious. They can have many causes.
Adequate amounts of folate can be obtained from diets rich in fruits,
dark green leafy vegetables and legumes, enriched grain products,
fortified cereals, or a supplement. Folate consumption should be limited
to 1,000 g per day from all sources.
(2) Example 2. Women who consume adequate amounts of folate daily
throughout their childbearing years may reduce their risk of having a
child with a birth defect of the brain and spinal cord. Such birth
defects, while not widespread, are very serious. They can have many
causes. Adequate amounts of folate, a B vitamin, can be obtained from
diets rich in fruits, dark green leafy vegetables and legumes, enriched
grain products, fortified cereals, or a supplement. Women who have had a
child with a spinal cord birth defect should consult a physician before
becoming pregnant. Folate consumption should be limited to 1,000
g per day from all sources.
(3) Example 3. Women who take steps to ensure that their folate
intake is adequate throughout their childbearing years may reduce their
risk of having a child with a neural tube defect. Such birth defects,
while not widespread, are very serious. They can have many causes.
Adequate amounts of folate, a B vitamin, can be obtained from diets rich
in citrus fruits and juices, dark green leafy vegetables and legumes,
enriched grain products such as breads, rice, and pasta, fortified
cereal, or a supplement. Folate consumption should be limited to 1,000
g per day from all sources.
(4) Example 4. Women who take steps to ensure that their folate
intake is at least 400 g daily throughout their childbearing
years may reduce their risk of having a child with spina bifida or
anencephaly, birth defects of the brain or spinal cord that, while not
widespread, are very serious. These birth defects can have many causes.
Adequate amounts of folate, a B vitamin, can be obtained from diets rich
in fruits, including citrus fruits and juices, vegetables, including
dark green leafy vegetables and legumes, enriched grain products,
including breads, rice, and pasta, fortified cereals, or from a
supplement. Women who have had a pregnancy affected with a neural tube
defect should consult a physician before becoming pregnant. Folate
consumption should be limited to 1,000 g per day from all
sources.
(5) Example 5. Some women who consume the Daily Value of folate (400
g) throughout their childbearing years may reduce their risk of
having a child affected with spina bifida or anencephaly, birth defects
of the brain or spinal cord that, while not widespread, are very
serious. These birth defects can have many causes. Women of childbearing
age should choose well-balanced diets that include 2 to 4 servings per
day of fruits (including citrus fruits and juices), 3 to 5 servings of
vegetables (including dark green leafy vegetables and legumes), 6 to 11
servings of enriched grain products (such as breads, rice, and pasta) or
fortified cereals throughout their childbearing years. Such diets
provide many essential minerals and vitamins, including folate. Women
who may be concerned about their diets may choose to obtain folate from
a supplement. Folate consumption should be limited to 1,000 g
per day from all sources.
(e) Effective date. For fortified foods, this regulation is
effective on the date the food additive regulation on the use of folic
acid that was proposed on October 14, 1993, becomes effective.
[59 FR 434, Jan. 4, 1994]
Subpart F--Specific Requirements for Descriptive Claims that are Neither
Nutrient Content Claims nor Health Claims
Sec. 101.95 ``Fresh,'' ``freshly frozen,'' ``fresh frozen,'' ``frozen fresh.''
The terms defined in this section may be used on the label or in
labeling of a food in conformity with the provisions of this section.
The requirements of the section pertain to any use of the subject terms
as described in paragraphs (a) and (b) of this section that expressly or
implicitly refers to the food on labels or labeling, including use in a
brand name and use as a sensory modifier. However, the use of the term
``fresh'' on labels or labeling is not subject to the requirements of
[[Page 137]]
paragraph (a) of this section if the term does not suggest or imply that
a food is unprocessed or unpreserved. For example, the term ``fresh''
used to describe pasteurized whole milk is not subject to paragraph (a)
of this section because the term does not imply that the food is
unprocessed (consumers commonly understand that milk is nearly always
pasteurized). However, the term ``fresh'' to describe pasta sauce that
has been pasteurized or that contains pasteurized ingredients would be
subject to paragraph (a) of this section because the term implies that
the food is not processed or preserved. Uses of fresh not subject to
this regulation will be governed by the provisions of 403(a) of the
Federal Food, Drug, and Cosmetic Act (the act).
(a) The term ``fresh,'' when used on the label or in labeling of a
food in a manner that suggests or implies that the food is unprocessed,
means that the food is in its raw state and has not been frozen or
subjected to any form of thermal processing or any other form of
preservation, except as provided in paragraph (c) of this section.
(b) The terms ``fresh frozen'' and ``frozen fresh,'' when used on
the label or in labeling of a food, mean that the food was quickly
frozen while still fresh (i.e., the food had been recently harvested
when frozen). Blanching of the food before freezing will not preclude
use of the term ``fresh frozen'' to describe the food. ``Quickly
frozen'' means frozen by a freezing system such as blast-freezing (sub-
zero Fahrenheit temperature with fast moving air directed at the food)
that ensures the food is frozen, even to the center of the food, quickly
and that virtually no deterioration has taken place.
(c) Provisions and restrictions--(1) The following do not preclude
the food from use of the term ``fresh:''
(i) The addition of approved waxes or coatings;
(ii) The post-harvest use of approved pesticides;
(iii) The application of a mild chlorine wash or mild acid wash on
produce; or
(iv) The treatment of raw foods with ionizing radiation not to
exceed the maximum dose of 1 kiloGray in accordance with Sec. 179.26 of
this chapter.
(2) A food meeting the definition in paragraph (a) of this section
that is refrigerated is not precluded from use of ``fresh'' as provided
by this section.
[58 FR 2426, Jan. 6, 1993]
Subpart G--Exemptions From Food Labeling Requirements
Sec. 101.100 Food; exemptions from labeling.
(a) The following foods are exempt from compliance with the
requirements of section 403(i)(2) of the act (requiring a declaration on
the label of the common or usual name of each ingredient when the food
is fabricated from two or more ingredients).
(1) An assortment of different items of food, when variations in the
items that make up different packages packed from such assortment
normally occur in good packing practice and when such variations result
in variations in the ingredients in different packages, with respect to
any ingredient that is not common to all packages. Such exemption,
however, shall be on the condition that the label shall bear, in
conjunction with the names of such ingredients as are common to all
packages, a statement (in terms that are as informative as practicable
and that are not misleading) indicating by name other ingredients which
may be present.
(2) A food having been received in bulk containers at a retail
establishment, if displayed to the purchaser with either:
(i) The labeling of the bulk container plainly in view, provided
ingredient information appears prominently and conspicuously in
lettering of not less than one-fourth of an inch in height; or
(ii) A counter card, sign, or other appropriate device bearing
prominently and conspicuously, but in no case with lettering of less
than one-fourth of an inch in height, the information required to be
stated on the label pursuant to section 403(i)(2) of the Federal Food,
Drug, and Cosmetic Act (the act).
(3) Incidental additives that are present in a food at insignificant
levels and do not have any technical or functional effect in that food.
For the
[[Page 138]]
purposes of this paragraph (a)(3), incidental additives are:
(i) Substances that have no technical or functional effect but are
present in a food by reason of having been incorporated into the food as
an ingredient of another food, in which the substance did have a
functional or technical effect.
(ii) Processing aids, which are as follows:
(a) Substances that are added to a food during the processing of
such food but are removed in some manner from the food before it is
packaged in its finished form.
(b) Substances that are added to a food during processing, are
converted into constituents normally present in the food, and do not
significantly increase the amount of the constitutents naturally found
in the food.
(c) Substances that are added to a food for their technical or
functional effect in the processing but are present in the finished food
at insignificant levels and do not have any technical or functional
effect in that food.
(iii) Substances migrating to food from equipment or packaging or
otherwise affecting food that are not food additives as defined in
section 201(s) of the act; or if they are food additives as so defined,
they are used in conformity with regulations established pursuant to
section 409 of the act.
(4) For the purposes of paragraph (a)(3) of this section, any
sulfiting agent (sulfur dioxide, sodium sulfite, sodium bisulfite,
potasssium bisulfite, sodium metabisulfite, and potassium metabisulfite)
that has been added to any food or to any ingredient in any food and
that has no technical effect in that food will be considered to be
present in an insignificant amount only if no detectable amount of the
agent is present in the finished food. A detectable amount of sulfiting
agent is 10 parts per million or more of the sulfite in the finished
food. Compliance with this paragraph will be determined using sections
20.123-20.125, ``Total Sulfurous Acid,'' in ``Official Methods of
Analysis of the Association of Official Analytical Chemists,'' 14th Ed.
(1984), which is incorporated by reference and the refinements of the
``Total Sulfurous Acid'' procedure in the ``Monier-Williams Procedure
(with Modifications) for Sulfites in Foods,'' which is Appendix A to
Part 101. A copy of sections 20.123-20-125 of the Official Methods of
Analysis of the Association of Official Analytical Chemists'' is
available from the Association of Official Analytical Chemists, P.O. Box
540, Benjamin Franklin Station, Washington, DC 20044, or available for
inspection at the Office of the Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC.
(b) A food repackaged in a retail establishment is exempt from the
following provisions of the act if the conditions specified are met.
(1) Section 403(e)(1) of the act (requiring a statement on the label
of the name and place of business of the manufacturer, packer, or
distributor).
(2) Section 403(g)(2) of the act (requiring the label of a food
which purports to be or is represented as one for which a definition and
standard of identity has been prescribed to bear the name of the food
specified in the definition and standard and, insofar as may be required
by the regulation establishing the standard the common names of the
optional ingredients present in the food), if the food is displayed to
the purchaser with its interstate labeling clearly in view, or with a
counter card, sign, or other appropriate device bearing prominently and
conspicuously the information required by these provisions.
(3) Section 403(i)(1) of the act (requiring the label to bear the
common or usual name of the food), if the food is displayed to the
purchaser with its interstate labeling clearly in view, or with a
counter card, sign, or other appropriate device bearing prominently and
conspicuously the common or usual name of the food, or if the common or
usual name of the food is clearly revealed by its appearance.
(c) An open container (a container of rigid or semirigid
construction, which is not closed by lid, wrapper, or otherwise other
than by an uncolored transparent wrapper which does not obscure the
contents) of a fresh fruit or fresh vegetable, the quantity of contents
of which is not more than 1 dry quart, shall be exempt from the labeling
requirements of sections 403(e), (g)(2)
[[Page 139]]
(with respect to the name of the food specified in the definition and
standard), and (i)(1) of the act; but such exemption shall be on the
condition that if two or more such containers are enclosed in a crate or
other shipping package, such crate or package shall bear labeling
showing the number of such containers enclosed therein and the quantity
of the contents of each.
(d) Except as provided by paragraphs (e) and (f) of this section, a
shipment or other delivery of a food which is, in accordance with the
practice of the trade, to be processed, labeled, or repacked in
substantial quantity at an establishment other than that where
originally processed or packed, shall be exempt, during the time of
introduction into and movement in interstate commerce and the time of
holding in such establishment, from compliance with the labeling
requirements of section 403 (c), (e), (g), (h), (i), (k), and (q) of the
act if:
(1) The person who introduced such shipment or delivery into
interstate commerce is the operator of the establishment where such food
is to be processed, labeled, or repacked; or
(2) In case such person is not such operator, such shipment or
delivery is made to such establishment under a written agreement, signed
by and containing the post office addresses of such person and such
operator, and containing such specifications for the processing,
labeling, or repacking, as the case may be, of such food in such
establishment as will ensure, if such specifications are followed, that
such food will not be adulterated or misbranded within the meaning of
the act upon completion of such processing, labeling, or repacking. Such
person and such operator shall each keep a copy of such agreement until
2 years after the final shipment or delivery of such food from such
establishment, and shall make such copies available for inspection at
any reasonable hour to any officer or employee of the Department who
requests them.
(3) The article is an egg product subject to a standard of identity
promulgated in part 160 of this chapter, is to be shipped under the
conditions specified in paragraph (d) (1) or (2) of this section and for
the purpose of pasteurization or other treatment as required in such
standard, and each container of such egg product bears a conspicuous tag
or label reading ``Caution--This egg product has not been pasteurized or
otherwise treated to destroy viable Salmonella microorganisms''. In
addition to safe and suitable bactericidal processes designed
specifically for Salmonella destruction in egg products, the term
``other treatment'' in the first sentence of this paragraph shall
include use in acidic dressings in the processing of which the pH is not
above 4.1 and the acidity of the aqueous phase, expressed as acetic
acid, is not less than 1.4 percent, subject also to the conditions that:
(i) The agreement required in paragraph (d) (2) of this section
shall also state that the operator agrees to utilize such unpasteurized
egg products in the processing of acidic dressings according to the
specifications for pH and acidity set forth in this paragraph, agrees
not to deliver the acidic dressing to a user until at least 72 hours
after such egg product is incorporated in such acidic dressing, and
agrees to maintain for inspection adequate records covering such
processing for 2 years after such processing.
(ii) In addition to the caution statement referred to above, the
container of such egg product shall also bear the statement
``Unpasteurized ------ for use in acidic dressings only'', the blank
being filled in with the applicable name of the eggs or egg product.
(e) Conditions affecting expiration of exemptions: (1) An exemption
of a shipment or other delivery of a food under paragraph (d) (1) or (3)
of this section shall, at the beginning of the act of removing such
shipment or delivery, or any part thereof, from such establishment
become void ab initio if the food comprising such shipment, delivery, or
part is adulterated or misbranded within the meaning of the act when so
removed.
(2) An exemption of a shipment or other delivery of a food under
paragraph (d) (2) or (3) of this section shall become void ab initio
with respect to the person who introduced such shipment or delivery into
interstate commerce upon refusal by such person to make available for
inspection a copy of
[[Page 140]]
the agreement, as required by paragraph (d) (2) or (3) of this section.
(3) An exemption of a shipment or other delivery of a food under
paragraph (d) (2) or (3) of this section shall expire:
(i) At the beginning of the act of removing such shipment or
delivery, or any part thereof, from such establishment if the food
constituting such shipment, delivery, or part is adulterated or
misbranded within the meaning of the act when so removed; or
(ii) Upon refusal by the operator of the establishment where such
food is to be processed, labeled, or repacked, to make available for
inspection a copy of the agreement, as required by such paragraph.
(f) The word ``processed'' as used in this paragraph shall include
the holding of cheese in a suitable warehouse at a temperature of not
less than 35 deg. F for the purpose of aging or curing to bring the
cheese into compliance with requirements of an applicable definition and
standard of identity. The exemptions provided for in paragraph (d) of
this section shall apply to cheese which is, in accordance with the
practice of the trade, shipped to a warehouse for aging or curing, on
condition that the cheese is identified in the manner set forth in one
of the applicable following paragraphs, and in such case the provisions
of paragraph (e) of this section shall also apply:
(1) In the case of varieties of cheese for which definitions and
standards of identity require a period of aging whether or not they are
made from pasteurized milk, each such cheese shall bear on the cheese a
legible mark showing the date at which the preliminary manufacturing
process has been completed and at which date curing commences, and to
each cheese, on its wrapper or immediate container, shall be affixed a
removable tag bearing the statement ``Uncured ------ cheese for
completion of curing and proper labeling'', the blank being filled in
with the applicable name of the variety of cheese. In the case of swiss
cheese, the date at which the preliminary manufacturing process had been
completed and at which date curing commences is the date on which the
shaped curd is removed from immersion in saturated salt solution as
provided in the definition and standard of identity for swiss cheese,
and such cheese shall bear a removable tag reading, ``To be cured and
labeled as `swiss cheese,' but if eyes do not form, to be labeled as
`swiss cheese for manufacturing' ''.
(2) In the case of varieties of cheeses which when made from
unpasteurized milk are required to be aged for not less than 60 days,
each such cheese shall bear a legible mark on the cheese showing the
date at which the preliminary manufacturing process has been completed
and at which date curing commences, and to each such cheese or its
wrapper or immediate container shall be affixed a removable tag reading,
``------ cheese made from unpasteurized milk. For completion of curing
and proper labeling'', the blank being filled in with the applicable
name of the variety of cheese.
(3) In the case of cheddar cheese, washed curd cheese, colby cheese,
granular cheese, and brick cheese made from unpasteurized milk, each
such cheese shall bear a legible mark on the cheese showing the date at
which the preliminary manufacturing process has been completed and at
which date curing commences, and to each such cheese or its wrapper or
immediate container shall be affixed a removable tag reading ``------
cheese made from unpasteurized milk. For completion of curing and proper
labeling, or for labeling as ------ cheese for manufacturing'', the
blank being filled in with the applicable name of the variety of cheese.
(g) The label declaration of a harmless marker used to identify a
particular manufacturer's product may result in unfair competition
through revealing a trade secret. Exemption from the label declaration
of such a marker is granted, therefore, provided that the following
conditions are met:
(1) The person desiring to use the marker without label declaration
of its presence has submitted to the Commissioner of Food and Drugs full
information concerning the proposed usage and the reasons why he
believes label declaration of the marker should be subject to this
exemption; and
(2) The person requesting the exemption has received from the
[[Page 141]]
Commissioner of Food and Drugs a finding that the marker is harmless and
that the exemption has been granted.
(h) Wrapped fish fillets of nonuniform weight intended to be
unpacked and marked with the correct weight at or before the point of
retail sale in an establishment other than that where originally packed
shall be exempt from the requirement of section 403(e)(2) of the act
during introduction and movement in interstate commerce and while held
for sale prior to weighing and marking:
(1) Provided, That (i) The outside container bears a label
declaration of the total net weight; and
(ii) The individual packages bear a conspicuous statement ``To be
weighed at or before time of sale'' and a correct statement setting
forth the weight of the wrapper;
(2) Provided further, That it is the practice of the retail
establishment to weigh and mark the individual packages with a correct
net-weight statement prior to or at the point of retail sale. A
statement of the weight of the wrapper shall be set forth so as to be
readily read and understood, using such term as ``wrapper tare--ounce'',
the blank being filled in with the correct average weight of the wrapper
used.
(3) The act of delivering the wrapped fish fillets during the retail
sale without the correct net-weight statement shall be deemed an act
which results in the product's being misbranded while held for sale.
Nothing in this paragraph shall be construed as requiring net-weight
statements for wrapped fish fillets delivered into institutional trade
provided the outside container bears the required information.
(i) Wrapped clusters (consumer units) of bananas of nonuniform
weight intended to be unpacked from a master carton or container and
weighed at or before the point of retail sale in an establishment other
than that where originally packed shall be exempt from the requirements
of section 403(e)(2) of the act during introduction and movement in
interstate commerce and while held for sale prior to weighing:
(1) Provided, That (i) The master carton or container bears a label
declaration of the total net weight; and
(ii) The individual packages bear a conspicuous statement ``To be
weighed at or before the time of sale'' and a correct statement setting
forth the weight of the wrapper; using such term as ``wrapper tare ----
-- ounce'', the blank being filled in with the correct average weight of
the wrapper used;
(2) Provided further, That it is the practice of the retail
establishment to weigh the individual packages either prior to or at the
time of retail sale.
(3) The act of delivering the wrapped clusters (consumer units)
during the retail sale without an accurate net weight statement or
alternatively without weighing at the time of sale shall be deemed an
act which results in the product's being misbranded while held for sale.
Nothing in this paragraph shall be construed as requiring net-weight
statements for clusters (consumer units) delivered into institutional
trade, provided that the master container or carton bears the required
information.
[42 FR 14308, Mar. 15, 1977, as amended at 51 FR 25017, July 9, 1986; 58
FR 2188, 2876, Jan. 6, 1993]
Sec. 101.103 Petitions requesting exemptions from or special requirements for label declaration of ingredients.
The Commissioner of Food and Drugs, either on his own initiative or
on behalf of any interested person who has submitted a petition pursuant
to part 10 of this chapter may issue a proposal to amend Sec. 101.4 to
specify the manner in which an ingredient(s) shall be declared, i.e., by
specific or class name, or Sec. 101.100 to exempt an ingredient(s) from
the requirements for label declaration.
[42 FR 14308, Mar. 15, 1977, as amended at 42 FR 15673, Mar. 22, 1977]
Sec. 101.105 Declaration of net quantity of contents when exempt.
(a) The principal display panel of a food in package form shall bear
a declaration of the net quantity of contents. This shall be expressed
in the terms of weight, measure, numerical count, or a combination of
numerical count and weight or measure. The
[[Page 142]]
statement shall be in terms of fluid measure if the food is liquid, or
in terms of weight if the food is solid, semisolid, or viscous, or a
mixture of solid and liquid; except that such statement may be in terms
of dry measure if the food is a fresh fruit, fresh vegetable, or other
dry commodity that is customarily sold by dry measure. If there is a
firmly established general consumer usage and trade custom of declaring
the contents of a liquid by weight, or a solid, semisolid, or viscous
product by fluid measure, it may be used. Whenever the Commissioner
determines that an existing practice of declaring net quantity of
contents by weight, measure, numerical count, or a combination in the
case of a specific packaged food does not facilitate value comparisons
by consumers and offers opportunity for consumer confusion, he will by
regulation designate the appropriate term or terms to be used for such
commodity.
(b)(1) Statements of weight shall be in terms of avoirdupois pound
and ounce.
(2) Statements of fluid measure shall be in terms of the U.S. gallon
of 231 cubic inches and quart, pint, and fluid ounce subdivisions
thereof, and shall:
(i) In the case of frozen food that is sold and consumed in a frozen
state, express the volume at the frozen temperature.
(ii) In the case of refrigerated food that is sold in the
refrigerated state, express the volume at 40 deg. F (4 deg. C).
(iii) In the case of other foods, express the volume at 68 deg. F
(20 deg. C).
(3) Statements of dry measure shall be in terms of the U.S. bushel
of 2,150.42 cubic inches and peck, dry quart, and dry pint subdivisions
thereof.
(c) When the declaration of quantity of contents by numerical count
does not give adequate information as to the quantity of food in the
package, it shall be combined with such statement of weight, measure, or
size of the individual units of the foods as will provide such
information.
(d) The declaration may contain common or decimal fractions. A
common fraction shall be in terms of halves, quarters, eighths,
sixteenths, or thirty-seconds; except that if there exists a firmly
established general consumer usage and trade custom of employing
different common fractions in the net quantity declaration of a
particular commodity, they may be employed. A common fraction shall be
reduced to its lowest terms; a decimal fraction shall not be carried out
to more than two places. A statement that includes small fractions of an
ounce shall be deemed to permit smaller variations than one which does
not include such fractions.
(e) The declaration shall be located on the principal display panel
of the label, and with respect to packages bearing alternate principal
panels it shall be duplicated on each principal display panel.
(f) The declaration shall appear as a distinct item on the principal
display panel, shall be separated (by at least a space equal to the
height of the lettering used in the declaration) from other printed
label information appearing above or below the declaration and (by at
least a space equal to twice the width of the letter ``N'' of the style
of type used in the quantity of contents statement) from other printed
label information appearing to the left or right of the declaration. It
shall not include any term qualifying a unit of weight, measure, or
count (such as ``jumbo quart'' and ``full gallon'') that tends to
exaggerate the amount of the food in the container. It shall be placed
on the principal display panel within the bottom 30 percent of the area
of the label panel in lines generally parallel to the base on which the
package rests as it is designed to be displayed: Provided, That on
packages having a principal display panel of 5 square inches or less,
the requirement for placement within the bottom 30 percent of the area
of the label panel shall not apply when the declaration of net quantity
of contents meets the other requirements of this part.
(g) The declaration shall accurately reveal the quantity of food in
the package exclusive of wrappers and other material packed therewith:
Provided, That in the case of foods packed in containers designed to
deliver the food under pressure, the declaration shall state the net
quantity of the contents
[[Page 143]]
that will be expelled when the instructions for use as shown on the
container are followed. The propellant is included in the net quantity
declaration.
(h) The declaration shall appear in conspicuous and easily legible
boldface print or type in distinct contrast (by typography, layout,
color, embossing, or molding) to other matter on the package; except
that a declaration of net quantity blown, embossed, or molded on a glass
or plastic surface is permissible when all label information is so
formed on the surface. Requirements of conspicuousness and legibility
shall include the specifications that:
(1) The ratio of height to width (of the letter) shall not exceed a
differential of 3 units to 1 unit (no more than 3 times as high as it is
wide).
(2) Letter heights pertain to upper case or capital letters. When
upper and lower case or all lower case letters are used, it is the lower
case letter ``o'' or its equivalent that shall meet the minimum
standards.
(3) When fractions are used, each component numeral shall meet one-
half the minimum height standards.
(i) The declaration shall be in letters and numerals in a type size
established in relationship to the area of the principal display panel
of the package and shall be uniform for all packages of substantially
the same size by complying with the following type specifications:
(1) Not less than one-sixteenth inch in height on packages the
principal display panel of which has an area of 5 square inches or less.
(2) Not less than one-eighth inch in height on packages the
principal display panel of which has an area of more than 5 but not more
than 25 square inches.
(3) Not less than three-sixteenths inch in height on packages the
principal display panel of which has an area of more than 25 but not
more than 100 square inches.
(4) Not less than one-fourth inch in height on packages the
principal display panel of which has an area of more than 100 square
inches, except not less than \1/2\ inch in height if the area is more
than 400 square inches.
Where the declaration is blown, embossed, or molded on a glass or
plastic surface rather than by printing, typing, or coloring, the
lettering sizes specified in paragraphs (h)(1) through (4) of this
section shall be increased by one-sixteenth of an inch.
(j) On packages containing less than 4 pounds or 1 gallon and
labeled in terms of weight or fluid measure:
(1) The declaration shall be expressed both in ounces, with
identification by weight or by liquid measure and, if applicable (1
pound or 1 pint or more) followed in parentheses by a declaration in
pounds for weight units, with any remainder in terms of ounces or common
or decimal fractions of the pound (see examples set forth in paragraphs
(m) (1) and (2) of this section), or in the case of liquid measure, in
the largest whole units (quarts, quarts and pints, or pints, as
appropriate) with any remainder in terms of fluid ounces or common or
decimal fractions of the pint or quart (see examples in paragraphs (m)
(3) and (4) of this section).
(2) If the net quantity of contents declaration appears on a random
package, that is a package which is one of a lot, shipment, or delivery
of packages of the same consumer commodity with varying weights and with
no fixed weight pattern, it may, when the net weight exceeds 1 pound, be
expressed in terms of pounds and decimal fractions of the pound carried
out to not more than two decimal places. When the net weight does not
exceed 1 pound, the declaration on the random package may be in decimal
fractions of the pound in lieu of ounces (see example in paragraph
(m)(5) of this section).
(3) The declaration may appear in more than one line. The term ``net
weight'' shall be used when stating the net quantity of contents in
terms of weight. Use of the terms ``net'' or ``net contents'' in terms
of fluid measure or numerical count is optional. It is sufficient to
distinguish avoirdupois ounce from fluid ounce through association of
terms; for example, ``Net wt. 6 oz'' or ``6 oz Net wt.'' and ``6 fl oz''
or ``Net contents 6 fl oz''.
(k) On packages containing 4 pounds or 1 gallon or more and labeled
in terms of weight or fluid measure, the declaration shall be expressed
in pounds for weight units with any remainder in terms of ounces or
common
[[Page 144]]
or decimal fraction of the pound, or in the case of fluid measure, it
shall be expressed in the largest whole unit (gallons followed by common
or decimal fraction of a gallon or by the next smaller whole unit or
units (quarts, or quarts and pints)) with any remainder in terms of
fluid ounces or common or decimal fractions of the pint or quart (see
paragraph (m)(6) of this section).
(l) [Reserved]
(m) Examples:
(1) A declaration of 1\1/2\ pounds weight shall be expressed as
``Net Wt. 24 oz (1 lb 8 oz),'' ``Net Wt. 24 oz (1\1/2\ lb),'' or ``Net
Wt. 24 oz (1.5 lb)''.
(2) A declaration of three-fourths pound avoirdupois weight shall be
expressed as ``Net Wt. 12 oz''.
(3) A declaration of 1 quart liquid measure shall be expressed as
``Net 32 fl oz (1 qt)''.
(4) A declaration of 1\3/4\ quarts liquid measure shall be expressed
as ``Net contents 56 fluid ounces (1 quart 1\1/2\ pints)'' or as ``Net
56 fluid oz (1 qt 1 pt 8 oz)'', but not in terms of quart and ounce such
as ``Net 56 fluid oz (1 quart 24 ounces)''.
(5) On a random package, declaration of three-fourths pound
avoirdupois may be expressed as ``Net Wt. .75 lb''.
(6) A declaration of 2\1/2\ gallons liquid measure shall be
expressed as ``Net contents 2\1/2\ gallons,'' ``Net contents 2.5
gallons,'' or ``Net contents 2 gallons 2 quarts'' and not as ``2 gallons
4 pints''.
(n) For quantities, the following abbreviations and none other may
be employed (periods and plural forms are optional):
weight wt pint pt
ounce oz quart qt
pound lb fluid fl
gallon gal
(o) Nothing in this section shall prohibit supplemental statements
at locations other than the principal display panel(s) describing in
nondeceptive terms the net quantity of contents; Provided, that such
supplemental statements of net quantity of contents shall not include
any term qualifying a unit of weight, measure, or count that tends to
exaggerate the amount of the food contained in the package; for example,
``jumbo quart'' and ``full gallon''. Dual or combination declarations of
net quantity of contents as provided for in paragraphs (a), (c), and (j)
of this section (for example, a combination of net weight plus numerical
count, net contents plus dilution directions of a concentrate, etc.) are
not regarded as supplemental net quantity statements and may be located
on the principal display panel.
(p) A separate statement of the net quantity of contents in terms of
the metric system is not regarded as a supplemental statement and an
accurate statement of the net quantity of contents in terms of the
metric system of weight or measure may also appear on the principal
display panel or on other panels.
(q) The declaration of net quantity of contents shall express an
accurate statement of the quantity of contents of the package.
Reasonable variations caused by loss or gain of moisture during the
course of good distribution practice or by unavoidable deviations in
good manufacturing practice will be recognized. Variations from stated
quantity of contents shall not be unreasonably large.
(r) The declaration of net quantity of contents on pickles and
pickle products, including relishes but excluding one or two whole
pickles in clear plastic bags which may be declared by count, shall be
expressed in terms of the U.S. gallon of 231 cubic inches and quart,
pint, and fluid ounce subdivisions thereof.
(s) On a multiunit retail package, a statement of the quantity of
contents shall appear on the outside of the package and shall include
the number of individual units, the quantity of each individual unit,
and, in parentheses, the total quantity of contents of the multiunit
package in terms of avoirdupois or fluid ounces, except that such
declaration of total quantity need not be followed by an additional
parenthetical declaration in terms of the largest whole units and
subdivisions thereof, as required by paragraph (j)(1) of this section. A
multiunit retail package may thus be properly labeled: ``6-16 oz
bottles--(96 fl oz)'' or ``3-16 oz cans--(net wt. 48 oz)''. For the
purposes of this section, ``multiunit retail package'' means a package
containing two or more individually packaged units of the identical
commodity and in the
[[Page 145]]
same quantity, intended to be sold as part of the multiunit retail
package but capable of being individually sold in full compliance with
all requirements of the regulations in this part. Open multiunit retail
packages that do not obscure the number of units or prevent examination
of the labeling on each of the individual units are not subject to this
paragraph if the labeling of each individual unit complies with the
requirements of paragraphs (f) and (i) of this section. The provisions
of this section do not apply to that butter or margarine covered by the
exemptions in Sec. 1.24(a) (10) and (11) of this chapter.
(t) Where the declaration of net quantity of contents is in terms of
net weight and/or drained weight or volume and does not accurately
reflect the actual quantity of the contents or the product falls below
the applicable standard of fill of container because of equipment
malfunction or otherwise unintentional product variation, and the label
conforms in all other respects to the requirements of this chapter
(except the requirement that food falling below the applicable standard
of fill of container shall bear the general statement of substandard
fill specified in Sec. 130.14(b) of this chapter), the mislabeled food
product, including any food product that fails to bear the general
statement of substandard fill specified in Sec. 130.14(b) of this
chapter, may be sold by the manufacturer or processor directly to
institutions operated by Federal, State or local governments (schools,
prisons, hospitals, etc.): Provided, That:
(1) The purchaser shall sign a statement at the time of sale stating
that he is aware that the product is mislabeled to include
acknowledgment of the nature and extent of the mislabeling, (e.g.,
``Actual net weight may be as low as ----% below labeled quantity'') and
that any subsequent distribution by him of said product except for his
own institutional use is unlawful. This statement shall be kept on file
at the principal place of business of the manufacturer or processor for
2 years subsequent to the date of shipment of the product and shall be
available to the Food and Drug Administration upon request.
(2) The product shall be labeled on the outside of its shipping
container with the statement(s):
(i) When the variation concerns net weight and/or drained weight or
volume, ``Product Mislabeled. Actual net weight (drained weight or
volume where appropriate) may be as low as ----% below labeled quantity.
This Product Not for Retail Distribution'', the blank to be filled in
with the maximum percentage variance between the labeled and actual
weight or volume of contents of the individual packages in the shipping
container, and
(ii) When the variation is in regard to a fill of container
standard, ``Product Mislabeled. Actual fill may be as low as --% below
standard of fill. This Product Not for Retail Distribution''.
(3) The statements required by paragraphs (t)(2) (i) and (ii) of
this section, which may be consolidated where appropriate, shall appear
prominently and conspicuously as compared to other printed matter on the
shipping container and in boldface print or type on a clear, contrasting
background in order to render them likely to be read and understood by
the purchaser under ordinary conditions of purchase.
[42 FR 14308, Mar. 15, 1977, as amended at 42 FR 15673, Mar. 22, 1977]
Sec. 101.108 Temporary exemptions for purposes of conducting authorized food labeling experiments.
(a) The food industry is encouraged to experiment voluntarily, under
controlled conditions and in collaboration with the Food and Drug
Administration, with graphics and other formats for presenting nutrition
and other related food labeling information that is consistent with the
current quantitative system in Secs. 101.9 and 101.25 and with
Secs. 105.66, 105.67, and 105.69 of this chapter.
(b) Any firm that intends to undertake a labeling experiment that
requires exemptions from certain requirements of Secs. 101.9 and 101.25
and Secs. 105.66, 105.67, and 105.69 of this chapter should submit a
written proposal containing a thorough discussion of each of the
following information items that apply to the particular experiment:
[[Page 146]]
(1) A description of the labeling format to be tested;
(2) A statement of the criteria to be used in the experiment for
assigning foods to categories, e.g., nutrient or other values defining
``low'' and ``reduced'';
(3) A draft of the material to be used in the store, e.g., shelf
tags, booklets, posters, etc.;
(4) The dates on which the experiment will begin and end and on
which a written report of analysis of the experimental data will be
submitted to FDA, together with a commitment not to continue the
experiment beyond the proposed ending date without FDA approval;
(5) The geographic area or areas in which the experiment is to be
conducted;
(6) The mechanism to measure the effectiveness of the experiment;
(7) The method for conveying to consumers the required nutrition and
other labeling information that is exempted from the label during the
experiment;
(8) The method that will be or has been used to determine the actual
nutritional characteristics of foods for which a claim is made; and
(9) A statement of the sections of the regulations for which an
exemption is sought.
(c) The written proposal should be sent to the Dockets Management
Branch (HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn
Dr., Rockville, MD 20857. The proposal should be clearly identified as a
request for a temporary exemption for purposes of conducting authorized
food labeling experiments and submitted as a citizen petition under
Sec. 10.30 of this chapter.
(d) Approval for food labeling experiments will be given by FDA in
writing. Foods labeled in violation of existing regulations will be
subject to regulatory action unless an FDA-approved exemption to the
specific regulation has been granted for that specific product.
(e) Reporting requirements contained in Sec. 101.108(b) have been
approved by this Office of Management and Budget and assigned number
0910-0151.
[48 FR 15240, Apr. 8, 1983, as amended at 59 FR 14364, Mar. 28, 1994]
Appendix A to Part 101--Monier-Williams Procedure (With Modifications)
for Sulfites in Food, Center for Food Safety and Applied Nutrition, Food
and Drug Administration (November 1985)
The AOAC official method for sulfites (Official Methods of Analysis,
14th Edition, 20.123-20.125, Association of Official Analytical
Chemists) has been modified, in FDA laboratories, to facilitate the
determination of sulfites at or near 10 ppm in food. Method
instructions, including modifications, are described below.
Apparatus--The apparatus shown diagrammatically (Figure 1) is
designed to accomplish the selective transfer of sulfur dioxide from the
sample in boiling aqueous hydrochloric acid to a solution of 3% hydrogen
peroxide. This apparatus is easier to assemble than the official
apparatus and the back pressure inside the apparatus is limited to the
unavoidable pressure due to the height of the 3% H2O2 solution
above the tip of the bubbler (F). Keeping the backpressure as low as
possible reduces the likelihood that sulfur dioxide will be lost through
leaks.
The apparatus should be assembled as shown in Fig. 1 with a thin
film of stopcock grease on the sealing surfaces of all the joints except
the joint between the separatory funnel and the flask. Each joint should
be clamped together to ensure a complete seal throughout the analysis.
The separatory funnel, B, should have a capacity of 100 ml or greater.
An inlet adapter, A, with a hose connector (Kontes K-183000 or
equivalent) is required to provide a means of applying a head of
pressure above the solution. (A pressure equalizing dropping funnel is
not recommended because condensate, perhaps with sulfur dioxide, is
deposited in the funnel and the side arm.) The round bottom flask, C, is
a 1000 ml flask with three 24/40 tapered joints. The gas inlet tube, D,
(Kontes K-179000 or equivalent) should be of sufficient length to permit
introduction of the nitrogen within 2.5 cm of the bottom of the flask.
The Allihn condenser, E, (Kontes K-431000-2430 or equivalent) has a
jacket length of 300 mm. The bubbler, F, was fabricated from glass
according to the dimensions given in Fig. 2. The 3% hydrogen peroxide
solution can be contained in a vessel, G, with an i.d. of ca. 2.5 cm and
a depth of 18 cm.
Buret--A 10 ml buret (Fisher Cat. No. 03-848-2A or equivalent) with
overflow tube and hose connections for an Ascarite tube or equivalent
air scrubbing apparatus. This will permit the maintenance of a carbon
dioxide-free atmosphere over the standardized 0.01N sodium hydroxide.
[[Page 147]]
Chilled Water Circulator--The condensor must be chilled with a
coolant, such as 20% methanol-water, maintained at 5 deg.C. A
circulating pump equivalent to the Neslab Coolflow 33 is suitable.
Reagents
(a) Aqueous hydrochloric acid, 4N.--For each analysis prepare 90 ml
of hydrochloric acid by adding 30 ml of concentrated hydrochloric acid
(12N) to 60 ml of distilled water.
(b) Methyl red indicator.--Dissolve 250 mg of methyl red in 100 ml
ethanol.
(c) Hydrogen peroxide solution, 3%--Dilute ACS reagent grade 30%
hydrogen peroxide to 3% with distilled water. Just prior to use, add
three drops of methyl red indicator and titrate to a yellow end-point
using 0.01N sodium hydroxide. If the end-point is exceeded discard the
solution and prepare another 3% H2O2 solution.
(d) Standardized titrant, 0.01N NaOH--Certified reagent may be used
(Fisher SO-5-284). It should be standardized with reference standard
potassium hydrogen phthalate.
(e) Nitrogen--A source of high purity nitrogen is required with a
flow regulator that will maintain a flow of 200 cc per minute. To guard
against the presence of oxygen in the nitrogen, an oxygen scrubbing
solution such as an alkaline pyrogallol trap may be used. Prepare
pyrogallol trap as follows:
1. Add 4.5 g pyrogallol to the trap.
2. Purge trap with nitrogen for 2 to 3 minutes.
3. Prepare a KOH solution prepared by adding 65g KOH to 85 ml
distilled water (caution: heat).
4. Add the KOH solution to the trap while maintaining an atmosphere
of nitrogen in the trap.
Determination
Assemble the apparatus as shown in Fig. 1. The flask C must be
positioned in a heating mantle that is controlled by a power regulating
device such as Variac or equivalent. Add 400 ml of distilled water to
flask C. Close the stopcock of separatory funnel, B, and add 90 ml of 4N
hydrochloric acid to the separatory funnel. Begin the flow of nitrogen
at a rate of 20010 cc/min. The condenser coolant flow must
be initiated at this time. Add 30 ml of 3% hydrogen peroxide, which has
been titrated to a yellow end-point with 0.01N NaOH, to container G.
After fifteen minutes the apparatus and the distilled water will be
thoroughly de-oxygenated and the apparatus is ready for sample
introduction.
Sample preparation (solids)--Transfer 50 g of food, or a quantity of
food with a convenient quantity of SO2 (500 to 1500 mcg SO2),
to a food processor or blender. Add 100 ml of 5% ethanol in water and
briefly grind the mixture. Grinding or blending should be continued only
until the food is chopped into pieces small enough to pass through the
24/40 point of flask C.
Sample preparation (liquids)--Mix 50 g of the sample, or a quantity
with a convenient quantity of SO2 (500 to 1500 mcg SO2), with
100 ml of 5% ethanol in water.
Sample introduction and distillation--Remove the separatory funnel
B, and quantitatively transfer the food sample in aqueous ethanol to
flask C. Wipe the tapered joint clean with a laboratory tissue, apply
stopcock grease to the outer joint of the separatory funnel, and return
the separatory funnel, B, to tapered joint flask C. The nitrogen flow
through the 3% hydrogen peroxide solution should resume as soon as the
funnel, B, is re-inserted into the appropriate joint in flask C. Examine
each joint to ensure that it is sealed.
Apply a head pressure above the hydrochloric acid solution in B with
a rubber bulb equipped with a valve. Open the stopcock in B and permit
the hydrochloric acid solution to flow into flask C. Continue to
maintain sufficient pressure above the acid solution to force the
solution into the flask C. The stopcock may be closed, if necessary, to
pump up the pressure above the acid and then opened again. Close the
stopcock before the last few milliliters drain out of the separatory
funnel, B, to guard against the escape of sulfur dioxide into the
separatory funnel.
Apply the power to the heating mantle. Use a power setting which
will cause 80 to 90 drops per minute of condensate to return to the
flask from condenser, E. After 1.75 hours of boiling the contents of the
1000 ml flask and remove trap G.
Titration--Titrate the contents with 0.01N sodium hydroxide. Titrate
with 0.01N NaOH to a yellow end-point that persists for at least twenty
seconds. Compute the sulfite content, expressed as micrograms sulfur
dioxide per gram of food (ppm) as follows:
ppm=(32.03xVBxNx1000)Wt
where 32.03=milliequivalent weight of sulfur dioxide; VB=volume of
sodium hydroxide titrant of normality, N, required to reach endpoint;
the factor, 1000, converts milliequivalents to microequivalents and
Wt=weight (g) of food sample introduced into the 1000 ml flask.
[[Page 148]]
[GRAPHIC] [TIFF OMITTED] TR01JA93.362
Figure 1. The optimized Monier-Williams apparatus. Component
identification is given in text.
[[Page 149]]
[GRAPHIC] [TIFF OMITTED] TR01JA93.363
Figure 2. Diagram of bubbler (F in Figure 1). Lengths are given in
mm.
[42 FR 14308, Mar. 15, 1977, as amended at 51 FR 25017, July 9, 1986]
[[Page 150]]
Appendix B to Part 101--Graphic Enhancements Used by the FDA
[[Page 150]]
[GRAPHIC] [TIFF OMITTED] TR01JA93.364
[[Page 151]]
[GRAPHIC] [TIFF OMITTED] TR01JA93.365
[58 FR 17332, Apr. 2, 1993]
[[Page 152]]
PART 102--COMMON OR USUAL NAME FOR NONSTANDARDIZED FOODS--Table of Contents
Subpart A--General Provisions
Sec.
102.5 General principles.
102.19 Petitions.
Subpart B--Requirements for Specific Nonstandardized Foods
102.22 Protein hydrolysates.
102.23 Peanut spreads.
102.26 Frozen ``heat and serve'' dinners.
102.28 Foods packaged for use in the preparation of ``main dishes'' or
``dinners.''
102.33 Beverages that contain fruit or vegetable juice.
102.37 Mixtures of edible fat or oil and olive oil.
102.39 Onion rings made from diced onion.
102.41 Potato chips made from dried potatoes.
102.45 Fish sticks or portions made from minced fish.
102.46 Pacific whiting.
102.47 Bonito.
102.49 Fried clams made from minced clams.
102.50 Crabmeat.
102.54 Seafood cocktails.
102.55 Nonstandardized breaded composite shrimp units.
102.57 Greenland turbot (Reinhardtius hippoglossoides).
Authority: Secs. 201, 403, 701 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321, 343, 371).
Source: 42 FR 14322, Mar. 15, 1977, unless otherwise noted.
Subpart A--General Provisions
Sec. 102.5 General principles.
(a) The common or usual name of a food, which may be a coined term,
shall accurately identify or describe, in as simple and direct terms as
possible, the basic nature of the food or its characterizing properties
or ingredients. The name shall be uniform among all identical or similar
products and may not be confusingly similar to the name of any other
food that is not reasonably encompassed within the same name. Each class
or subclass of food shall be given its own common or usual name that
states, in clear terms, what it is in a way that distinguishes it from
different foods.
(b) The common or usual name of a food shall include the
percentage(s) of any characterizing ingredient(s) or component(s) when
the proportion of such ingredient(s) or component(s) in the food has a
material bearing on price or consumer acceptance or when the labeling or
the appearance of the food may otherwise create an erroneous impression
that such ingredient(s) or component(s) is present in an amount greater
than is actually the case. The following requirements shall apply unless
modified by a specific regulation in subpart B of this part.
(1) The percentage of a characterizing ingredient or component shall
be declared on the basis of its quantity in the finished product (i.e.,
weight/weight in the case of solids, or volume/volume in the case of
liquids).
(2) The percentage of a characterizing ingredient or component shall
be declared by the words ``containing (or contains) ---- percent (or %)
----'' or ``---- percent (or %) ----'' with the first blank filled in
with the percentage expressed as a whole number not greater than the
actual percentage of the ingredient or component named and the second
blank filled in with the common or usual name of the ingredient or
component. The word ``containing'' (or ``contains''), when used, shall
appear on a line immediately below the part of the common or usual name
of the food required by paragraph (a) of this section. For each
characterizing ingredient or component, the words ``---- percent or %)
----'' shall appear following or directly below the word ``containing''
(or contains), or directly below the part of the common or usual name of
the food required by paragraph (a) of this section when the word
``containing'' (or contains) is not used, in easily legible boldface
print or type in distinct contrast to other printed or graphic matter,
and in a height not less than the larger of the following alternatives:
(i) Not less than one-sixteenth inch in height on packages having a
principal display panel with an area of 5 square inches or less and not
less than one-eighth inch in height if the area of the principal display
panel is greater than 5 square inches; or
[[Page 153]]
(ii) Not less than one-half the height of the largest type appearing
in the part of the common or usual name of the food required by
paragraph (a) of this section.
(c) The common or usual name of a food shall include a statement of
the presence or absence of any characterizing ingredient(s) or
component(s) and/or the need for the user to add any characterizing
ingredient(s) or component(s) when the presence or absence of such
ingredient(s) or component(s) in the food has a material bearing on
price or consumer acceptance or when the labeling or the appearance of
the food may otherwise create an erroneous impression that such
ingredient(s) or component(s) is present when it is not, and consumers
may otherwise be misled about the presence or absence of the
ingredient(s) or component(s) in the food. The following requirements
shall apply unless modified by a specific regulation in subpart B of
this part.
(1) The presence or absence of a characterizing ingredient or
component shall be declared by the words ``containing (or contains) ----
------'' or ``containing (or contains) no ----------'' or ``no --------
--'' or ``does not contain ----------'', with the blank being filled in
with the common or usual name of the ingredient or component.
(2) The need for the user of a food to add any characterizing
ingredient(s) or component(s) shall be declared by an appropriate
informative statement.
(3) The statement(s) required under paragraph (c)(1) and/or (2) of
this section shall appear following or directly below the part of the
common or usual name of the food required by paragraphs (a) and (b) of
this section, in easily legible boldface print or type in distinct
contrast to other printed or graphic matter, and in a height not less
than the larger of the alternatives established under paragraphs (b)(2)
(i) and (ii) of this section.
(d) A common or usual name of a food may be established by common
usage or by establishment of a regulation in subpart B of this part, in
part 104 of this chapter, in a standard of identity, or in other
regulations in this chapter.
Sec. 102.19 Petitions.
(a) The Commissioner of Food and Drugs, either on his own initiative
or on behalf of any interested person who has submitted a petition, may
publish a proposal to issue, amend, or revoke, under this part, a
regulation prescribing a common or usual name for a food, pursuant to
part 10 of this chapter.
(b) If the principal display panel of a food for which a common or
usual name regulation is established is too small to accommodate all
mandatory requirements, the Commissioner may establish by regulation an
acceptable alternative, e.g., a smaller type size. A petition requesting
such a regulation, which would amend the applicable regulation, shall be
submitted pursuant to part 10 of this chapter.
[42 FR 14322, Mar. 15, 1977, as amended at 42 FR 15673, Mar. 22, 1977]
Subpart B--Requirements for Specific Nonstandardized Foods
Sec. 102.22 Protein hydrolysates.
The common or usual name of a protein hydrolysate shall be specific
to the ingredient and shall include the identity of the food source from
which the protein was derived.
(a) ``Hydrolyzed wheat gluten,'' ``hydrolyzed soy protein,'' and
``autolyzed yeast extract'' are examples of acceptable names.
``Hydrolyzed casein'' is also an example of an acceptable name, whereas
``hydrolyzed milk protein'' is not an acceptable name for this
ingredient because it is not specific to the ingredient (hydrolysates
can be prepared from other milk proteins). The names ``hydrolyzed
vegetable protein'' and ``hydrolyzed protein'' are not acceptable
because they do not identify the food source of the protein.
(b) [Reserved]
[58 FR 2876, Jan. 6, 1993]
Sec. 102.23 Peanut spreads.
(a) The common or usual name of a spreadable peanut product that
does not conform to Sec. 164.150 of this chapter, and more than 10
percent of which consists of nonpeanut ingredients, shall consist of the
term ``peanut spread''
[[Page 154]]
and a statement of the percentage by weight of peanuts in the product in
the manner set forth in Sec. 102.5(b), except that peanut percentages
shall be based on the amount of peanuts used to make the finished food
and shall be declared in 5-percent increments expressed as a multiple of
5, not to exceed the actual percentage of peanuts in the products.
(b) A spreadable peanut product that is nutritionally inferior to
peanut butter shall be labeled as an imitation of peanut butter under
Sec. 101.3(e)(2) of this chapter; a spreadable peanut product shall be
considered nutritionally equivalent to peanut butter if it meets all of
the following conditions:
(1) Protein. (i) The protein content of the product is at least 24
percent by weight of the finished product, and the overall biological
quality of the protein contained in the product is at least 68 percent
that of casein; or
(ii) The protein content of the product is at least 16.6 percent by
weight of the finished product, and the overall biological quality of
the protein contained in the product is equal to or greater than that of
casein.
(2) Other nutrients. The product contains the following levels of
nutrients per 100 grams of product:
------------------------------------------------------------------------
Amount
Nutrient (milligrams)
------------------------------------------------------------------------
Niacin.................................................... 15.3
Vitamin B6................................................ 0.33
Folic acid................................................ 0.08
Iron...................................................... 2.0
Zinc...................................................... 2.9
Magnesium................................................. 173.0
Copper.................................................... 0.6
------------------------------------------------------------------------
(c) Compliance with the requirements of paragraph (b) of this
section shall be determined by methods described in the following
references except that in determining protein quantity in products with
mixed protein sources a nitrogen conversion factor of 6.25 may be used.
(1) Protein quantity: ``Official Methods of Analysis of the
Association of Official Analytical Chemists'' (AOAC), 13th Ed. (1980),
using the method described in section 27.007, which is incorporated by
reference. Copies may be obtained from the Association of Official
Analytical Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA 22201-
3301, or may be examined at the Office of the Federal Register, 800
North Capitol Street, NW., suite 700, Washington, DC.
(2) Biological quality of protein: AOAC, 13th Ed. (1980), using the
method described in sections 43.212-43.216, which is incorporated by
reference. The availability of this incorporation by reference is given
in paragraph (c)(1) of this section.
(3) Niacin: AOAC, 13th Ed. (1980), using the method described in
sections 43.044-43.046, which is incorporated by reference. The
availability of this incorporation by reference is given in paragraph
(c)(1) of this section.
(4) Vitamin B6: AOAC, 13th Ed. (1980), using the method
described in sections 43.188-43.193, which is incorporated by reference.
The availability of this incorporation by reference is given in
paragraph (c)(1) of this section.
(5) Folic acid: Using the method described in U.S. Department of
Agriculture Handbook No. 29, modified by use of ascorbate buffer as
described by Ford and Scott, Journal of Dairy Research, 35:85-90 (1968),
which is incorporated by reference. Copies are available from the Center
for Food Safety and Applied Nutrition (HFS-150), Food and Drug
Administration, 200 C St. SW., Washington, DC 20204, or available for
inspection at the Office of the Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC.
(6) Iron: AOAC, 13th Ed. (1980), using the method described in
sections 43.217-43.219, which is incorporated by reference. The
availability of this incorporation by reference is given in paragraph
(c)(1) of this section.
(7) Zinc: AOAC, 13th Ed. (1980), using the method described in
sections 25.150-25.153, which is incorporated by reference. The
availability of this incorporation by reference is given in paragraph
(c)(1) of this section.
(8) Copper: AOAC, 13th Ed. (1980), using the method described in
sections 25.038-25.043, which is incorporated by reference. The
availability of this incorporation by reference is given in paragraph
(c)(1) of this section.
(9) Magnesium: AOAC, 13th Ed. (1980), using the method described in
sections 2.109-2.113, which is incorporated by reference. The
availability of this
[[Page 155]]
incorporation by reference is given in paragraph (c)(1) of this section.
[42 FR 36455, July 15, 1977, as amended at 47 FR 11821, Mar. 19, 1982;
49 FR 5609, Feb. 14, 1984; 54 FR 24891, June 12, 1989; 61 FR 14479, Apr.
2, 1996]
Sec. 102.26 Frozen ``heat and serve'' dinners.
(a) A frozen ``heat and serve'' dinner:
(1) Shall contain at least three components, one of which shall be a
significant source of protein and each of which shall consist of one or
more of the following: meat, poultry, fish, cheese, eggs, vegetables,
fruit, potatoes, rice, or other cereal based products (other than bread
or rolls).
(2) May also contain other servings of food (e.g., soup, bread or
rolls, beverage, dessert).
(b) The common or usual name of the food consists of all of the
following:
(1) The phrase ``frozen `heat and serve' dinner,'' except that the
name of the predominant characterizing ingredient or other appropriately
descriptive term may immediately precede the word ``dinner'' (e.g.,
``frozen chicken dinner'' or ``frozen heat and serve beef dinner''). The
words ``heat and serve'' are optional. The word ``frozen'' is also
optional, provided that the words ``Keep Frozen'' or the equivalent are
prominently and conspicuously placed on the principal display panel in
type size not less than that specified in Sec. 102.5(b)(2)(i).
(2) The phrase ``containing (or contains) ------'' the blank to be
filled in with an accurate description of each of the three or more dish
components listed in paragraph (a)(1) of this section in their order of
descending predominance by weight (e.g., ham, mashed potatoes, and
peas), followed by any of the other servings specified in paragraph
(a)(2) of this section contained in the package (e.g., onion soup,
enriched white bread, and artificially flavored vanilla pudding) in
their order of descending predominance by weight. This part of the name
shall be placed immediately following or directly below the part
specified in paragraph (b)(1) of this section in the manner set forth in
Sec. 102.5(c)(3). The words ``contains'' or ``containing'' are optional.
(3) If the labeling implies that the package contains other foods
and these foods are not present in the package, e.g., if a vignette on
the package depicts a ``serving suggestion'' which includes any foods
not present in the package, the principal display panel shall bear a
statement that such foods are not present, in type size not less than
that specified in Sec. 102.5(b)(2)(i).
Sec. 102.28 Foods packaged for use in the preparation of ``main dishes'' or ``dinners.''
(a) The common or usual name of a packaged food which is represented
on the principal display panel by word or vignette to be used in the
preparation of a ``main dish'', ``dinner'', or other such food serving,
and to which some other important characterizing ingredient(s) or
component(s) not present in the package must be added, consists of all
the following:
(1) The common or usual name of each important ingredient or
component in the package, in descending order of predominance by weight
(e.g., ``noodles and tomato sauce'').
(2) An appropriate informative statement identifying the food to be
prepared by use of the package contents (e.g., ``for preparation of
chicken casserole'').
(3) An appropriate informative statement that additional
characterizing ingredient(s) or component(s) must be added and which
names the additional characterizing ingredient(s) or component(s) (e.g.,
``you must add ------ to complete the recipe,'' the blank to be filled
in with the name(s) of the important characterizing ingredient(s) or
component(s) that must be added).
(b) The labeling required by paragraph (a) of this section shall
appear on the principal display panel.
(1) No word in the statement required by paragraph (a)(2) of this
section may appear on the principal display panel more conspicuously or
in larger type than the smallest and least conspicuous type employed on
the panel for any word, phrase or statement within the scope of
paragraph (a)(1) of this section.
(2) Every word in the statement required by paragraph (a)(3) of this
section shall appear on the principal display panel in easily legible
bold face print or type in distinct contrast to other printed or graphic
matter, and in a height not less than the larger of the following
alternatives:
(i) Not less than one-sixteenth inch in height on packages having a
principal display panel with an area of 5 square inches or less and not
less than one-eighth inch in height if the area of the principal display
panel is greater than 5 square inches; or
(ii) Not less than one-half the height of the largest type appearing
in the part of the common or usual name of the food required by
paragraphs (a) (1) and (2) of this section.
(c) Any vignette which shows any food or characterizing
ingredient(s) or component(s) not included in the package shall be
accompanied either by the statement required by paragraph (a)(3) of this
section or by a separate statement specifying the food or characterizing
ingredient(s) or component(s) shown in the vignette but not included in
the package.
(d) If the statement specified in paragraph (a)(2) of this section
is used on any panel in addition to the principal display panel as a
product identification statement, the complete common or usual name
shall appear on such panel in the manner specified in paragraph (b) of
this section.
(e) When a brand name or other prominent product designation
contains a word or words that includes or suggests an important
characterizing ingredient(s) or component(s) that must be added, or
otherwise states or implies that the package contains a complete main
dish, dinner, or other food serving, the part of the common or usual
name of the food required by paragraph (a)(3) of this section shall
appear in direct conjunction with such brand name or other designation
and in type size not less than one-half the height of the largest type
appearing in such brand name or other designation.
Sec. 102.33 Beverages that contain fruit or vegetable juice.
(a) For a carbonated or noncarbonated beverage that contains less
than 100 percent and more than 0 percent fruit or vegetable juice, the
common or usual name shall be a descriptive name that meets the
requirements of Sec. 102.5(a) and, if the common or usual name uses the
word ``juice,'' shall include a qualifying term such as ``beverage,''
``cocktail,'' or ``drink'' appropriate to advise the consumer that the
product is less than 100 percent juice (e.g., ``diluted grape juice
beverage'' or ``grape juice drink'').
(b) If the product is a diluted multiple-juice beverage or blend of
single-strength juices and names, other than in the ingredient
statement, more than one juice, then the names of those juices, except
in the ingredient statement, must be in descending order of predominance
by volume unless the name specifically shows that the juice with the
represented flavor is used as a flavor (e.g., raspberry-flavored apple
and pear juice drink). In accordance with Sec. 101.22(i)(1)(iii) of this
chapter, the presence of added natural flavors is not required to be
declared in the name of the beverage unless the declared juices alone do
not characterize the product before the addition of the added flavors.
(c) If a multiple-juice beverage or blend of single-strength juices
contains a juice that is named or implied on the label or labeling other
than in the ingredient statement (represented juice), and also contains
a juice other than the named or implied juice (nonrepresented juice),
then the common or usual name for the product shall indicate that the
represented juice is not the only juice present (e.g., ``Apple blend;
apple juice in a blend of two other fruit juices.'')
(d) In a multiple-juice beverage or blend of single-strength juices
where one or more, but not all, of the juices are named on the label
other than in the ingredient statement, and where the named juice is not
the predominant juice, the common or usual name for the product shall:
(1) Indicate that the named juice is present as a flavor or
flavoring (e.g., ``Raspcranberry''; raspberry and cranberry flavored
juice drink); or
(2) Include the amount of the named juice, declared in a 5- percent
range (e.g., Raspcranberry; raspberry and cranberry juice beverage, 10-
to 15-percent cranberry juice and 3- to 8-percent
[[Page 157]]
raspberry juice). The 5-percent range, when used, shall be declared in
the manner set forth in Sec. 102.5(b)(2).
(e) The common or usual name of a juice that has been modified shall
include a description of the exact nature of the modification (e.g.,
``acid-reduced cranberry juice,'' ``deflavored, decolored grape
juice'').
(f) If the product is a beverage that contains a juice whose color,
taste, or other organoleptic properties have been modified to the extent
that the original juice is no longer recognizable at the time processing
is complete, or if its nutrient profile has been diminished to a level
below the normal nutrient range for the juice, then the source fruits or
vegetables from which the modified juice was derived may not be depicted
on the label by vignette or other pictorial representation.
(g)(1) If one or more juices in a juice beverage is made from
concentrate, the name of the juice must include a term indicating that
fact, such as ``from concentrate,'' or ``reconstituted.'' Such terms
must be included in the name of each individual juice or it may be
stated once adjacent to the product name so that it applies to all the
juices, (e.g., ``cherry juice (from concentrate) in a blend of two other
juices'' or ``cherry juice in a blend of 2 other juices (from
concentrate)''). The term shall be in a type size no less than one-half
the height of the letters in the name of the juice.
(2) If the juice is 100 percent single species juice consisting of
juice directly expressed from a fruit or vegetable whose Brix level has
been raised by the addition of juice concentrate from the same fruit or
vegetable, the name of the juice need not include a statement that the
juice is from concentrate. However, if water is added to this 100
percent juice mixture to adjust the Brix level, the product shall be
labeled with the term ``from concentrate'' or ``reconstituted.''
[58 FR 2926, Jan. 6, 1993; 58 FR 17103, Apr. 1, 1993, as amended at 58
FR 44063, Aug. 18, 1993]
Effective Date Note: Section 102.33, was added at 45 FR 39250, June
10, 1980, effective July 1, 1981. The compliance date was extended to
July 1, 1982, at 45 FR 80497, Dec. 5, 1980, and further extended to July
1, 1984, at 48 FR 2736, Jan. 21, 1983. At 49 FR 26541, June 27, 1984,
the effective date for compliance was extended indefinitely.
Sec. 102.37 Mixtures of edible fat or oil and olive oil.
The common or usual name of a mixture of edible fats and oils
containing less than 100 percent and more than 0 percent olive oil shall
be as follows:
(a) A descriptive name for the product meeting the requirements of
Sec. 102.5(a), e.g., ``cottonseed oil and olive oil'' or another
descriptive phrase, and
(b) When the label bears any representation, other than in the
ingredient listing, of the presence of olive oil in the mixture, the
descriptive name shall be followed by a statement of the percentage of
olive oil contained in the product in the manner set forth in
Sec. 102.5(b)(2).
Sec. 102.39 Onion rings made from diced onion.
(a) The common or usual name of the food product that resembles and
is of the same composition as onion rings, except that it is composed of
comminuted onions, shall be as follows:
(1) When the product is composed of dehydrated onions, the name
shall be ``onion rings made from dried diced onions.''
(2) When the product is composed of any form of onion other than
dehydrated, the name shall be ``onion rings made from diced onions.''
(b) The words ``made from dried diced onions'' or ``made from diced
onions'' shall immediately follow or appear on a line(s) immediately
below the words ``onion rings'' in easily legible boldface print or type
in distinct contrast to other printed or graphic matter, and in a height
not less than the larger of the following alternatives:
(1) Not less than one-sixteenth inch in height on packages having a
principal display panel with an area of 5 square inches or less and not
less than one-eighth inch in height if the area of the principal display
panel is greater than 5 square inches; or
(2) Not less than one-half the height of the largest type used in
the words ``onion rings.''
[[Page 158]]
Sec. 102.41 Potato chips made from dried potatoes.
(a) The common or usual name of the food product that resembles and
is of the same composition as potato chips, except that it is composed
of dehydrated potatoes (buds, flakes, granules, or other form), shall be
``potato chips made from dried potatoes.''
(b) The words ``made from dried potatoes'' shall immediately follow
or appear on a line(s) immediately below the words ``potato chips'' in
easily legible boldface print or type in distinct contrast to other
printed or graphic matter, and in a height not less than the larger of
the following alternatives:
(1) Not less than one-sixteenth inch in height on packages having a
principal display panel with an area of 5 square inches or less and not
less than one-eighth inch in height if the area of the principal display
panel is greater than 5 square inches; or
(2) Not less than one-half the height of the largest type used in
the words ``potato chips.''
Sec. 102.45 Fish sticks or portions made from minced fish.
(a) The common or usual name of the food product that resembles and
is of the same composition as fish sticks or fish portions, except that
it is composed of comminuted fish flesh, shall be ``fish ------------
made from minced fish,'' the blank to be filled in with the word
``sticks'' or ``portions'' as the case may be.
(b) The words ``made from minced fish'' shall immediately follow or
appear on a line(s) immediately below the words ``fish ------------'' in
easily legible boldface print or type in distinct contrast to other
printed or graphic matter, and in a height not less than the larger of
the following alternatives:
(1) Not less than one-sixteenth inch in height on packages having a
principal display panel with an area of 5 square inches or less and not
less than one-eighth inch in height if the area of the principal display
panel is greater than 5 square inches; or
(2) Not less than one-half the height of the largest type used in
the words ``fish ------------.''
Sec. 102.46 Pacific whiting.
``Pacific whiting'' or ``North Pacific whiting'' is the common or
usual name of the food fish Merluccius productus.
[44 FR 45617, Aug. 3, 1979]
Sec. 102.47 Bonito.
``Bonito'' or ``bonito fish'' is the common or usual name of the
following food fishes:
Cybiosarda elegans (Whitely, 1935)--Leaping bonito
Gymnosarda unicolor (Ruppell, 1838)--Dogtooth tuna
Orcynopsis unicolor (Geoffroy St. Hilaire, 1817)--Plain bonito
Sarda australis (Macleay, 1880)--Australian bonito
Sarda chiliensis (Cuvier, 1831)--Eastern Pacific bonito
Sarda orientalis (Temminck and Schlegel, 1844)--Striped bonito
Sarda sarda (Bloch, 1793)--Atlantic bonito
[55 FR 45797, Oct. 31, 1990]
Sec. 102.49 Fried clams made from minced clams.
(a) The common or usual name of the food product that resembles and
is of the same composition as fried clams, except that it is composed of
comminuted clams, shall be ``fried clams made from minced clams.''
(b) The words ``made from minced clams'' shall immediately follow or
appear on a line(s) immediately below the words ``fried clams'' and in
easily legible boldface print or type in distinct contrast to other
printed or graphic matter, and in a height not less than the larger of
the following alternatives:
(1) Not less than one-sixteenth inch in height on packages having a
principal display panel with an area of 5 square inches or less and not
less than one-eighth inch in height if the area of the principal display
panel is greater than 5 square inches; or
(2) Not less than one-half the height of the largest type used in
the words ``fried clams.''
Sec. 102.50 Crabmeat.
The common or usual name of crabmeat derived from each of the
following designated species of crabs shall be as follows:
[[Page 159]]
------------------------------------------------------------------------
Common or usual name of
Scientific name of crab crabmeat
------------------------------------------------------------------------
Chionoecetes opilio, Snow crabmeat.
Chionoecetes tanneri,
Chionoecetes bairdii, and
Chionoecetes angulatus,
Erimacrus isenbeckii Korean variety crabmeat or
Kegani crabmeat.
Lithodes aequispina Brown King crabmeat.
Paralithodes brevipes King crabmeat or Hanasaki
crabmeat.
Paralithodes camtschaticus King crabmeat. and
Paralithodes Platypus.
------------------------------------------------------------------------
[42 FR 14322, Mar. 15, 1977, as amended at 60 FR 34460, July 3, 1995]
Sec. 102.54 Seafood cocktails.
The common or usual name of a seafood cocktail in package form
fabricated with one or more seafood ingredients shall be:
(a) When the cocktail contains only one seafood ingredient, the name
of the seafood ingredient followed by the word ``cocktail'' (e.g.,
shrimp cocktail, crabmeat cocktail) and a statement of the percentage by
weight of that seafood ingredient in the product in the manner set forth
in Sec. 102.5(b).
(b) When the cocktail contains more than one seafood ingredient, the
term ``seafood cocktail'' and a statement of the percentage by weight of
each seafood ingredient in the product in the manner set forth in
Sec. 102.5(b).
Sec. 102.55 Nonstandardized breaded composite shrimp units.
(a) The common on usual name of the food product that conforms to
the definition and standard of identity described by Sec. 161.175(c)(6)
of this chapter, except that the food is made from comminuted shrimp and
is not in raw frozen form, shall be ``------------ made from minced
shrimp,'' the blank to be filled in with the words ``breaded shrimp
sticks'' or ``breaded shrimp cutlets'' depending upon the shape of the
product, or if prepared in a shape other than that of sticks or cutlets
``breaded shrimp ------------ made from minced shrimp,'' the blank to be
filled by a word or phrase that accurately describes the shape and that
is not misleading.
(b) The words ``made from minced shrimp'' shall immediately follow
or appear on a line(s) immediately below the other words required by
this section in easily legible boldface print or type in distinct
contrast to other printed or graphic matter, and in a height not less
than the larger of the following alternatives:
(1) Not less than one-sixteenth inch in height on packages having a
principal display panel with an area of 5 square inches or less and no
less than one-eighth inch in height if the area of the principal display
panel is greater than 5 square inches; or
(2) Not less than one-half the height of the largest type used in
the words ``breaded shrimp sticks'' or the other comparable words
required by this section.
Sec. 102.57 Greenland turbot (Reinhardtius hippoglossoides).
``Greenland turbot'' is the common or usual name of the food fish
Reinhardtius hippoglossoides, a species of Pleuronectidae right-eye
flounders. The term ``halibut'' may be associated only with Atlantic
halibut (Hippoglossus hippoglossus) or Pacific halibut (Hippoglossus
stenolepis).
PART 103--QUALITY STANDARDS FOR FOODS WITH NO IDENTITY STANDARDS--Table of Contents
Subpart A--General Provisions
Sec.
103.3 Definitions.
103.5 General principles.
Subpart B--Standards of Quality
103.35 Bottled water.
Authority: Secs. 201, 401, 403, 409, 410, 701, 721 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321, 341, 343, 348, 349, 371,
379e).
Subpart A--General Provisions
Sec. 103.3 Definitions.
(a) A lot is:
(1) For purposes of determining quality factors related to
manufacture, processing, or packing, a collection of primary containers
or units of the same size, type, and style produced under conditions as
nearly uniform as possible and usually designated by a common container
code or marking, or in the absence of any common container code or
marking, a day's production.
[[Page 160]]
(2) For purposes of determining quality factors related to
distribution and storage, a collection of primary containers or units
transported, stored, or held under conditions as nearly uniform as
possible.
(b) A sample consists of 10 subsamples (consumer units), taken one
from each of 10 different randomly chosen shipping cases to be
representative of a given lot, unless otherwise specified in a specific
quality standard in this part.
(c) An analytical unit is the portion(s) of food taken from a
subsample of a sample for the purpose of analysis.
[42 FR 14325, Mar. 15, 1977]
Sec. 103.5 General principles.
(a) The quality of a food depends upon numerous characteristics
including but not limited to the levels of microorganisms and such
physical factors as turbidity, color, flavor, and odor. Such
characteristics are indicative of the quality of the raw materials and
ingredients, the degree of quality control used in manufacture,
processing, and packing, and the conditions of distribution and storage.
The diversity of raw materials, food processing, and distribution
practices, as well as the variation in quality factors important to
consumers, requires that individual standards of quality be established
for different types of food.
(b)(1) The label of a food that fails to meet the requirements of an
applicable standard of quality promulgated pursuant to this part shall
bear the general statement of substandard quality specified in
Sec. 130.14(a) of this chapter in the manner and form therein specified;
but in lieu of such general statement of substandard quality, the label
may bear the alternative statement, ``Below Standard in Quality--------
--'', the blank to be filled in with whichever of the following are
applicable:
(i) ``Contains Excessive Bacteria''.
(ii) ``Excessively Turbid''.
(iii) ``Abnormal Color''.
(iv) The phrase specified in the applicable standard of quality to
describe any other quality deviation.
(2) The statement of substandard quality shall appear on the
principal display panel or panels and shall immediately and
conspicuously precede or follow, without intervening written, printed or
graphic matter, the name of the food.
(c) Product descriptions included in a standard of quality
promulgated pursuant to this part are intended only to designate the
class of foods to which the standards apply, and are not standards of
identity for the products involved. Should a standard of identity later
be established for any of these foods, the standard of quality will be
recodified to appear in the same part of the regulations.
(d) The food characteristics included in a standard of quality
published in this part relate only to the quality of the food and not to
compliance with any of the adulteration provision of section 402 of the
act. Compliance with a standard of quality promulgated pursuant to this
part does not excuse failure to observe either the requirement of
section 402(a)(4) of the act that food may not be prepared, packed, or
held under insanitary conditions, or the provisions of parts 110 and 129
of this chapter requiring that food manufacturers must observe current
food manufacturing practices. For example, evidence obtained through
factory inspection indicating such a violation renders the food
unlawful, even though the food contains levels of microorganisms lower
than those prescribed by an applicable standard.
(e) The Commissioner of Food and Drugs, either on his own initiative
or on behalf of any interested person who has submitted a petition, may
establish, amend, or repeal, under subpart B of this part, a regulation
prescribing a standard of quality for a food pursuant to part 10 of this
chapter.
[42 FR 14325, Mar. 15, 1977, as amended at 42 FR 15673, Mar. 22, 1977;
44 FR 12172, Mar. 6, 1979]
Subpart B--Standards of Quality
Sec. 103.35 Bottled water.
(a) Definitions. (1) Bottled water is defined as water that is
sealed in bottles or other containers and intended for human
consumption. Bottled water does not include mineral water or any type of
soft drink commonly known as soda water, which is made by absorbing
carbon dioxide in potable water.
[[Page 161]]
(2) Trihalomethane (THM) means one of the family of organic
compounds, named as derivatives of methane, wherein three of the four
hydrogen atoms in methane are each substituted by a halogen atom in the
molecular structure.
(3) Total Trihalomethanes (TTHM) means the sum of the concentration
in milligrams per liter of the trihalomethane compounds
(trichloromethane [chloroform], dibromochloromethane,
bromodichloromethane and tribromomethane [bromoform]), rounded to two
significant figures.
(b) Microbiological quality. Bottled water shall, when a sample
consisting of analytical units of equal volume is examined by the
methods described in applicable sections of ``Standard Methods for the
Examination of Water and Wastewater,'' 15th Ed. (1980), American Public
Health Association, which is incorporated by reference (copies may be
obtained from the Center for Food Safety and Applied Nutrition (HFS-
300), 200 C St., SW., Washington, DC 20204, or may be examined at the
Office of the Federal Register, 800 North Capitol Street, NW., suite
700, Washington, DC), meet the following standards of microbiological
quality:
(1) Multiple-tube fermentation method. Not more than one of the
analytical units in the sample shall have a most probable number (MPN)
of 2.2 or more coliform organisms per 100 milliliters and no analytical
unit shall have an MPN of 9.2 or more coliform organisms per 100
milliliters; or
(2) Membrane filter method. Not more than one of the analytical
units in the sample shall have 4.0 or more coliform organisms per 100
milliliters and the arithmetic mean of the coliform density of the
sample shall not exceed one coliform organism per 100 milliliters.
(c) Physical quality. Bottled water shall, when a composite of
analytical units of equal volume from a sample is examined by the method
described in applicable sections of ``Standard Methods for the
Examination of Water and Wastewater,'' 15th Ed. (1980), which is
incorporated by reference (the availability of this incorporation by
reference is given in paragraph (b) of this section), meet the following
standards of physical quality:
(1) The turbidity shall not exceed 5 units.
(2) The color shall not exceed 15 units.
(3) The odor shall not exceed threshold odor No. 3.
(d) Chemical quality. (1)(i) Bottled water shall, when a composite
of analytical units of equal volume from a sample is examined by the
methods described in paragraph (d)(1)(ii) of this section, meet
standards of chemical quality and shall not contain chemical substances
in excess of the following concentrations:
Substance--Concentration in Milligrams per Liter
Arsenic...................................................... 0.05
Chloride..................................................... 250.0
Iron......................................................... 0.3
Manganese.................................................... 0.05
Phenols...................................................... 0.001
Sulfate...................................................... 250.0
Total dissolved solids....................................... 500.0
Zinc......................................................... 5.0
Organics:
Endrin (1,2,3,4,10,10-hexachloro-6,7-epoxy-
1,4,4a,5,6,7,8,8a-0cta-hydro-1,4-endo, endo-5,8-dimethano
naphthalene).............................................. 0.0002
Total Trihalomethanes...................................... 0.10
(ii) Analyses conducted to determine compliance with paragraph
(d)(1)(i) of this section shall be made in accordance with the methods
described in the applicable sections of ``Standard Methods for the
Examination of Water and Wastewater,'' 15th Ed. (1980), or ``Methods for
Chemical Analysis of Water and Wastes,'' Environmental Monitoring and
Support Laboratory, EPA-600/4-82-055, March 1983, U.S. Environmental
Protection Agency, both of which are incorporated by reference. Analyses
for organic substances shall be determined by appropriate methods
described in ``Methods for Organochlorine Pesticides in Industrial
Effluents'' and ``Methods for Chlorinated Phenoxy Acid Herbicides in
Industrial Effluents,'' November 28, 1973, which are incorporated by
reference, and ``Part I: The Analysis of Trihalomethanes in Finished
Waters by the Purge and Trap Method,'' Method 501.1 and ``Part II: The
Analysis of Trihalomethanes in Drinking Water by Liquid/Liquid
Extraction,'' Method 501.2 in 40 CFR part 141, appendix C (45
[[Page 162]]
FR 68672; November 29, 1979). The availability of these incorporations
by reference are given in paragraph (b) of this section.
(2)(i) Bottled water packaged in the United States to which no
fluoride is added shall not contain fluoride in excess of the levels in
Table 1 and these levels shall be based on the annual average of maximum
daily air temperatures at the location where the bottled water is sold
at retail.
Table 1
------------------------------------------------------------------------
Fluoride
Annual average of maximum daily air temperatures ( deg. concentration
F) in milligrams
per liter
------------------------------------------------------------------------
53.7 and below........................................... 2.4
53.8-58.3................................................ 2.2
58.4-63.8................................................ 2.0
63.9-70.6................................................ 1.8
70.7-79.2................................................ 1.6
79.3-90.5................................................ 1.4
------------------------------------------------------------------------
(ii) Imported bottled water to which no fluoride is added shall not
contain fluoride in excess of 1.4 milligrams per liter.
(iii) Bottled water packaged in the United States to which fluoride
is added shall not contain fluoride in excess of levels in Table 2 and
these levels shall be based on the annual average of maximum daily air
temperatures at the location where the bottled water is sold at retail.
Table 2
------------------------------------------------------------------------
Fluoride
Annual average of maximum daily air temperatures ( deg. concentration
F) in milligrams
per liter
------------------------------------------------------------------------
53.7 and below........................................... 1.7
53.8-58.3................................................ 1.5
58.4-63.8................................................ 1.3
63.9-70.6................................................ 1.2
70.7-79.2................................................ 1.0
79.3-90.5................................................ 0.8
------------------------------------------------------------------------
(iv) Imported bottled water to which fluoride is added shall not
contain fluoride in excess of 0.8 milligram per liter.
(3) Having consulted with the U.S. Environmental Protection Agency
(EPA) as required by section 410 of the Federal Food, Drug, and Cosmetic
Act, the Food and Drug Administration has determined that bottled water,
when a composite of analytical units of equal volume from a sample is
examined by the methods listed in paragraphs (d)(3)(v), (d)(3)(vi), and
(d)(3)(vii) of this section, shall not contain the following chemical
contaminants in excess of the concentrations specified in paragraphs
(d)(3)(i), (d)(3)(ii), (d)(3)(iii), and (d)(3)(iv) of this section.
(i) The allowable levels for inorganic substances are as follows:
------------------------------------------------------------------------
Concentration milligrams per
Contaminant liter (or as specified)
------------------------------------------------------------------------
Barium.................................... 2
Cadmium................................... 0.005
Chromium.................................. 0.1
Copper.................................... 1.0
Lead...................................... 0.005
Mercury................................... 0.002
Nitrate................................... 10 (as nitrogen)
Nitrite................................... 1 (as nitrogen)
Total Nitrate and Nitrite................. 10 (as nitrogen)
Selenium.................................. 0.05
------------------------------------------------------------------------
(ii) The allowable levels for volatile organic chemicals (VOC's) are
as follows:
------------------------------------------------------------------------
Concentration in
Contaminant (CAS Reg. No.) milligrams per liter
------------------------------------------------------------------------
Benzene (71-43-2).............................. 0.005
Carbon tetrachloride (56-23-5)................. 0.005
o-Dichlorobenzene (95-50-01)................... 0.6
p-Dichlorobenzene (106-46-7)................... 0.075
1,2-Dichloroethane (107-06-2).................. 0.005
1,1-Dichloroethylene (75-35-4)................. 0.007
cis-1,2-Dichloroethylene (156-59-2)............ 0.07
trans-1,2-Dichloroethylene (156-60-5).......... 0.1
1,2-Dichloropropane (78-87-5) 0.005
Ethylbenzene (100-41-4)........................ 0.7
Monochlorobenzene (108-90-7)................... 0.1
Styrene (100-42-5)............................. 0.1
Tetrachloroethylene (127-18-4)................. 0.005
Toluene (108-88-3)............................. 1
1,1,1-Trichloroethane (71-55-6)................ 0.20
Trichloroethylene (79-01-6).................... 0.005
Vinyl chloride (75-01-4)....................... 0.002
Xylenes (1330-20-7)............................ 10
------------------------------------------------------------------------
(iii) The allowable levels for pesticides and other synthetic
organic chemicals are as follows:
------------------------------------------------------------------------
Concentration
Contaminant (CAS Reg. No.) in milligrams
per liter
------------------------------------------------------------------------
Alachlor (15972-60-8).................................... 0.002
Atrazine (1912-24-9)..................................... 0.003
Carbofuran (1563-66-2)................................... 0.04
Chlordane (57-74-9)...................................... 0.002
1,2-Dibromo-3-chloropropane (96-12-8).................... 0.0002
2,4-D (94-75-7).......................................... 0.07
Ethylene dibromide (106-93-4)............................ 0.00005
[[Page 163]]
Heptachlor (76-44-8)..................................... 0.0004
Heptachlor epoxide (1024-57-3)........................... 0.0002
Lindane (58-89-9)........................................ 0.0002
Methoxychlor (72-43-5)................................... 0.04
Pentachlorophenol (87-86-5).............................. 0.001
PCB's (as decachlorobiphenyl) (1336-36-3)................ 0.0005
Toxaphene (8001-35-2).................................... 0.003
2,4,5-TP (Silvex) (93-72-1).............................. 0.05
------------------------------------------------------------------------
(iv) The allowable levels for certain chemicals for which EPA has
established secondary maximum contaminant levels in its drinking water
regulations are as follows:
------------------------------------------------------------------------
Concentration
Contaminant in milligrams
per liter
------------------------------------------------------------------------
Aluminum................................................. 0.2
Silver................................................... 0.1
------------------------------------------------------------------------
(v) Analyses to determine compliance with the requirements of
paragraph (d)(3)(i) of this section shall be conducted in accordance
with an applicable method or applicable revisions to the methods listed
in paragraphs (d)(3)(v)(A) through (d)(3)(v)(H) of this section and
described, unless otherwise noted, in ``Methods for Chemical Analysis of
Water and Wastes,'' U.S. EPA Environmental Monitoring and Support
Laboratory (EMSL), Cincinnati, OH 45258 (EPA-600/4-79-020), March 1983,
which is incorporated by reference in accordance with 5 U.S.C 552(a) and
1 CFR part 51. Copies of this publication are available from the
National Technical Information Service, U.S. Department of Commerce,
5825 Port Royal Rd., Springfield, VA 22161, or may be examined at the
Center for Food Safety and Applied Nutrition's Library, Food and Drug
Administration, 200 C St. SW., Washington, DC, or at the Office of the
Federal Register, 800 North Capitol St. NW., Suite 700, Washington, DC.
(A) Barium shall be measured using the following methods:
(1) Method 208.2--''Atomic absorption, furnace technique,'' which is
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51, or
(2) Method 208.1--''Atomic absorption, direct aspiration,'' which is
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. The availability of this incorporation by reference is given in
paragraph (d)(3)(v) of this section.
(3) Method 200.7--''Determination of Metals and Trace Elements in
Water and Wastes by Inductively Coupled Plasma- Atomic Emission
Spectrometry,'' revision 3.3, April 1991, U.S. EPA, EMSL. The revision
is contained in the manual entitled ``Methods for the Determination of
Metals in Environmental Samples,'' Office of Research and Development,
Washington, DC 20460, (EPA/600/4-91/010), June 1991, which is
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. Copies of this publication are available from the National
Technical Information Service, U.S. Department of Commerce, 5825 Port
Royal Rd., Springfield, VA 22161, or may be examined at the Center for
Food Safety and Applied Nutrition's Library, Food and Drug
Administration, 200 C St. SW., Washington, DC, or at the Office of the
Federal Register, 800 North Capitol St. NW., Suite 700, Washington, DC.
(B) Cadmium shall be measured using the following methods:
(1) Method 213.2--''Atomic absorption, furnace technique,'' which is
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. The availability of this incorporation by reference is given in
paragraph (d)(3)(v) of this section.
(2) Method 200.7--''Determination of Metals and Trace Elements in
Water and Wastes by Inductively Coupled Plasma- Atomic Emission
Spectrometry,'' revision 3.3, April 1991, U.S. EPA, EMSL. The revision
is contained in the manual entitled ``Methods for the Determination of
Metals in Environmental Samples,'' Office of Research and Development,
Washington, DC 20460, (EPA/600/4-91/010), June 1991, which is
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. The availability of this incorporation by reference is given in
paragraph (d)(3)(v)(A)(3) of this section.
(C) Chromium shall be measured using the following methods:
[[Page 164]]
(1) Method 218.2--''Atomic absorption, furnace technique,'' which is
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. The availability of this incorporation by reference is given in
paragraph (d)(3)(v) of this section.
(2) Method 200.7--''Determination of Metals and Trace Elements in
Water and Wastes by Inductively Coupled Plasma- Atomic Emission
Spectrometry,'' revision 3.3, April 1991, U.S. EPA, EMSL. The revision
is contained in the manual entitled ``Methods for the Determination of
Metals in Environmental Samples,'' Office of Research and Development,
Washington, DC 20460, (EPA/600/4-91/010), June 1991, which is
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. The availability of this incorporation by reference is given in
paragraph (d)(3)(v)(A)(3) of this section.
(D) Mercury shall be measured using the following methods:
(1) Method 245.1--''Manual cold vapor technique,'' which is
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51, or
(2) Method 245.2--''Automated cold vapor technique,'' which is
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. The availability of this incorporation by reference is given in
paragraph (d)(3)(v) of this section.
(E) Nitrate and/or nitrite shall be measured using the following
methods:
(1) Method 353.3--''Spectrophotometric, cadmium reduction,'' which
is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1
CFR part 51, or
(2) Method 353.2--''Colorimetric, automated, cadmium reduction,''
which is incorporated by reference in accordance with 5 U.S.C. 552(a)
and 1 CFR part 51. The availability of this incorporation by reference
is given in paragraph (d)(3)(v) of this section.
(3) Method 300.0--''The Determination of Inorganic Anions in Water
by Ion Chromatography--Method 300.0,'' EPA, EMSL (EPA-600/4-84-017),
March 1984, which is incorporated by reference in accordance with 5
U.S.C. 552(a) and 1 CFR part 51. Copies of this publication are
available from the National Technical Information Service, U.S.
Department of Commerce, 5825 Port Royal Rd., Springfield, VA 22161, or
may be examined at the Center for Food Safety and Applied Nutrition's
Library, Food and Drug Administration, 200 C St. SW, Washington, DC, or
at the Office of the Federal Register, 800 North Capitol St. NW., suit
700, Washington, DC.
(4) Method 353.1--''Colorimetric, automated, hydrazine reduction,''
which is incorporated by reference in accordance with 5 U.S.C. 552(a)
and 1 CFR part 51. The availability of this incorporation by reference
is given in paragraph (d)(3)(v) of this section.
(F) Selenium shall be measured using the following methods:
(1) Method 270.2--''Atomic absorption, furnace technique,'' which is
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51, or
(2) Method 270.3--``Atomic absorption, gaseous hydride,'' which is
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. The availability of this incorporation by reference is given in
paragraph (d)(3)(v) of this section.
(G) Copper shall be measured as total recoverable metal without
filtration using the following methods:
(1) Method 220.2--Atomic absorption; furnace technique, in ``Methods
for Chemical Analysis of Water and Wastes,'' which is incorporated by
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 or
(2) Method 220.1--Atomic absorption; direct aspiration, in ``Methods
for Chemical Analysis of Water and Wastes,'' which is incorporated by
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The
availability of this incorporation by reference is given in paragraph
(d)(3)(v) of this section.
(3) Method 200.7--entitled ``Determination of Metals and Trace
Elements in Water and Wastes by Inductively Coupled Plasma-Atomic
Emission Spectrometry,'' Revision 3.3, April 1991, U.S. EPA,
Environmental Monitoring and Support Laboratory (EMSL). The revision is
contained in the manual entitled ``Methods for the Determination of
Metals in Environmental Samples,'' Office of Research and Development,
Washington, DC
[[Page 165]]
20460, (EPA/600/4-91/010), June 1991, which is incorporated by reference
in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies of this
publication are available from the National Technical Information
Service, U.S. Department of Commerce, 5825 Port Royal Rd., Springfield,
VA 22161, or may be examined at the Center for Food Safety and Applied
Nutrition's Library, Food and Drug Administration, 200 C St. SW.,
Washington, DC 20204, or at the Office of the Federal Register, 800
North Capitol St. NW., suite 700, Washington, DC.
(4) Method 200.8--entitled, ``Determination of Trace Elements in
Water and Wastes by Inductively Coupled Plasma-Mass Spectrometry,''
Revision 4.4, April 1991, U.S. EPA, EMSL. The revision is contained in
the manual entitled ``Methods for the Determination of Metals in
Environmental Samples,'' which is incorporated by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The availability of
this incorporation by reference is given in paragraph (d)(3)(v)(G)(3) of
this section.
(5) Method 200.9--entitled, ``Determination of Trace Elements by
Stabilized Temperature Graphite Furnace Atomic Absorption
Spectrometry,'' Revision 1.2, April 1991, U.S. EPA, EMSL. The revision
is contained in the manual entitled ``Methods for the Determination of
Metals in Environmental Samples,'' which is incorporated by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The availability of
this incorporation by reference is given in paragraph (d)(3)(v)(G)(3) of
this section.
(H) Lead shall be measured as total recoverable metal without
filtration using the following methods:
(1) Method 239.2--Atomic absorption; furnace technique, from
``Methods for Chemical Analysis of Water and Wastes,'' which is
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. The availability of this incorporation by reference is given in
paragraph (d)(3)(v) of this section.
(2) Method 200.8--entitled, ``Determination of Trace Elements in
Water and Wastes by Inductively Coupled Plasma-Mass Spectrometry,''
Revision 4.4, April 1991. The revision is contained in the manual
entitled ``Methods for the Determination of Metals in Environmental
Samples,'' June 1991, which is incorporated by reference in accordance
with 5 U.S.C. 552(a) and 1 CFR part 51. The availability of this
incorporation by reference is given in paragraph (d)(3)(v)(G)(3) of this
section.
(3) Method 200.9--from ``Determination of Trace Elements by
Stabilized Temperature Graphite Furnace Atomic Absorption
Spectrometry,'' Revision 1.2, April 1991. The revision is contained in
the manual entitled ``Methods for the Determination of Metals in
Environmental Samples,'' June 1991, which is incorporated by reference
in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The availability
of this incorporation by reference is given in paragraph (d)(3)(v)(G)(3)
of this section.
(vi) Analyses to determine compliance with the requirements of
paragraphs (d)(3)(ii) and (d)(3)(iii) of this section shall be conducted
in accordance with an applicable method or applicable revisions to the
methods listed in paragraphs (d)(3(vi)(A) through (d)(3)(vi)(M) of this
section and described, unless otherwise noted, in ``Methods for the
Determination of Organic Compounds in Drinking Water,'' Office of
Research and Development, EMSL, EPA/600/4-88/039, December 1988, which
is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1
CFR part 51. Copies of this publication are available from the National
Technical Information Service, U.S. Department of Commerce, 5285 Port
Royal Rd., Springfield, VA 22161, or may be examined at the Center for
Food Safety and Applied Nutrition's Library, Food and Drug
Administration, 200 C St. SW., Washington, DC, or at the Office of the
Federal Register, 800 North Capitol St. NW., Suite 700, Washington, DC.
(A) Method 502.1--``Volatile Halogenated Organic Compounds in Water
by Purge and Trap Gas Chromatography,'' revision 2.0, 1989, (applicable
to VOC's), which is incorporated by reference in accordance with 5 U.S.C
552(a) and 1 CFR part 51, or
(B) Method 502.2--``Volatile Organic Compounds in Water by Purge and
Trap Capillary Column Gas Chromatography with Photoionization and
[[Page 166]]
Electrolytic Conductivity Detectors in Series,'' revision 2.0, 1989
(applicable to VOC's), which is incorporated by reference in accordance
with 5 U.S.C. 552(a) and 1 CFR part 51, or
(C) Method 503.1--``Volatile Aromatic and Unsaturated Organic
Compounds in Water by Purge and Trap Gas Chromatography,'' revision 2.0,
1989 (applicable to VOC's), which is incorporated by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or
(D) Method 524.1--``Measurement of Purgeable Organic Compounds in
Water by Packed Column Gas Chromatography/Mass Spectrometry,'' revision
3.0, 1989 (applicable to VOC's), which is incorporated by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or
(E) Method 524.2--``Measurement of Purgeable Organic Compounds in
Water by Capillary Column Gas Chromatography/Mass Spectrometry,''
revision 3.0, 1989 (applicable to VOC's), which is incorporated by
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or
(F) Method 504--``1,2-Dibromoethane (EDB) and 1,2-Dibromo-3-
Chloropropane (DBCP) in Water by Microextraction and Gas
Chromatography,'' revision 2.0, 1989 (applicable to dibromochloropropane
(DBCP) and ethylene dibromide (EDB)), which is incorporated by reference
in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or
(G) Method 505--``Analysis of Organohalide Pesticides and Commercial
Polychlorinated Biphenyl (PCB) Products in Water by Microextraction and
Gas Chromatography,'' revision 2.0, 1989 (applicable to alachlor,
atrazine, chlordane, heptachlor, heptachlor epoxide, lindane,
methoxychlor, toxaphene and as a screen for polychlorinated biphenyl's
(PCB's)), which is incorporated by reference in accordance with 5 U.S.C.
552(a) and 1 CFR part 51, or
(H) Method 507--``Determination of Nitrogen- and Phosphorus-
Containing Pesticides in Water by Gas Chromatography with a Nitrogen-
Phosphorus Detector,'' revision 2.0, 1989 (applicable to alachlor and
atrazine), which is incorporated by reference in accordance with 5
U.S.C. 552(a) and 1 CFR part 51, or
(I) Method 508--``Determination of Chlorinated Pesticides in Water
by Gas Chromatography with an Electron Capture Detector,'' revision 3.0,
1989 (applicable to chlordane, heptachlor, heptachlor epoxide, lindane,
methoxychlor, toxaphene, and as a screen for PCB's), which is
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51, or
(J) Method 508A--``Screening for Polychlorinated Biphenyls by
Perchlorination and Gas Chromatography,'' revision 1.0, 1989 (used to
quantitate PCB's as decachlorobiphenyl if detected in Methods 505 or 508
in paragraph (d)(3)(vi)(G) or (d)(3)(vi)(I) of this section,
respectively), which is incorporated by reference in accordance with 5
U.S.C. 552(a) and 1 CFR part 51, or
(K) Method 515.1--``Determination of Chlorinated Acids in Water by
Gas Chromatography with an Electron Capture Detector,'' revision 5.0,
May 1991 (applicable to 2,4-D, 2,4,5-TP (Silvex) and pentachlorophenol),
which is incorporated by reference in accordance with 5 U.S.C. 552(a)
and 1 CFR part 51, or
(L) Method 525.1--``Determination of Organic Compounds in Drinking
Water by Liquid-Solid Extraction and Capillary Column Gas
Chromatography/Mass Spectrometry,'' revision 2.2, May 1991 (applicable
to alachlor, atrazine, chlordane, heptachlor, heptachlor epoxide,
lindane, methoxychlor, and pentachlorophenol), which is incorporated by
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or
(M) Method 531.1--``Measurement of N-Methylcarbamoyloximes and N-
Methylcarbamates in Water by Direct Aqueous Injection HPLC with Post
Column Derivatization,'' revision 3.0, 1989 (applicable to carbofuran),
which is incorporated by reference in accordance with 5 U.S.C. 552(a)
and 1 CFR part 51. The availability of this incorporation by reference
is given in paragraph (d)(3)(vi) of this section.
(vii) Analyses to determine compliance with the requirements of
paragraph (d)(3)(iv) of this section shall be
[[Page 167]]
conducted in accordance with an applicable method and applicable
revisions to the methods listed in paragraphs (d)(3)(vii)(A) and
(d)(3)(vii)(B) of this section and described, unless otherwise noted, in
``Methods of Chemical Analysis of Water and Wastes,'' which is
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. The availability of this incorporation by reference is given in
paragraph (d)(3)(v) of this section.
(A) Aluminum shall be measured using the following methods:
(1) Method 202.1--``Atomic absorption technique; direct
aspiration,'' which is incorporated by reference in accordance with 5
U.S.C. 552(a) and 1 CFR part 51.
(2) Method 202.2--``Atomic absorption; furnace technique,'' which is
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. The availability of this incorporation by reference is given in
paragraph (d)(3)(v) of this section.
(3) Method 200.7--``Determination of Metals and Trace Elements in
Water and Wastes by Inductively Coupled Plasma-Atomic Emission
Spectrometry,'' revision 3.3, April 1991, in ``Methods for the
Determination of Metals in Environmental Samples,'' which is
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. The availability of the incorporation by reference is given in
paragraph (d)(3)(v)(A)(3) of this section.
(4) Method 200.8--``Determination of Trace Elements in Waters and
Wastes by Inductively Coupled Plasma-Mass Spectrometry,'' revision 4.4,
April 1991, in ``Methods for the Determination of Metals in
Environmental Samples,'' which is incorporated by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The availability of
this incorporation by reference is given in paragraph (d)(3)(v)(A)(3) of
this section.
(5) Method 200.9--``Determination of Trace Elements by Stabilized
Temperature Graphite Furnace Atomic Absorption, Spectrometry,'' revision
1.2, April 1991, in ``Methods for the Determination of Metals in
Environmental Samples,'' which is incorporated by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The availability of
this incorporation by reference is given in paragraph (d)(3)(v)(A)(3) of
this section.
(B) Silver shall be measured using the following methods:
(1) Method 272.1--``Atomic absorption, direct aspiration,'' which is
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51, or
(2) Method 272.2--``Atomic absorption, furnace technique,'' which is
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. The availability of this incorporation by reference is given in
paragraph (d)(3)(v) of this section.
(3) Method 200.7--``Determination of Metals and Trace Elements in
Water and Wastes by Inductively Coupled Plasma-Atomic Emission
Spectrometry,'' revision 3.3, April 1991, U.S. EPA, EMSL, in ``Methods
for the Determination of Metals in Environmental Samples,'' which is
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. The availability of this incorporation by reference is given in
paragraph (d)(3)(v)(A)(3) of this section.
(4) Method 200.8--``Determination of Trace Elements in Waters and
Wastes by Inductively Coupled Plasma-Mass Spectrometry,'' revision 4.4,
April 1991, in ``Methods for the Determination of Metals in
Environmental Samples,'' which is incorporated by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The availability of
this incorporation by reference is given in paragraph (d)(3)(v)(A)(3) of
this section.
(5) Method 200.9--``Determination of Trace Elements by Stabilized
Temperature Graphite Furnace Atomic Absorption, Spectrometry,'' revision
1.2, April 1991, in ``Methods for the Determination of Metals in
Environmental Samples,'' which is incorporated by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The availability of
this incorporation by reference is given in paragraph (d)(3)(v)(A)(3) of
this section.
(e) Radiological quality. (1) Bottled water shall, when a composite
of analytical units of equal volume from a sample is examined by the
methods described in paragraph (e)(2) of this section, meet standards of
radiological quality as follows:
[[Page 168]]
(i) The bottled water shall not contain a combined radium-226 and
radium-228 activity in excess of 5 picocuries per liter of water.
(ii) The bottled water shall not contain a gross alpha particle
activity (including radium-226, but excluding radon and uranium) in
excess of 15 picocuries per liter of water.
(iii) The bottled water shall not contain beta particle and photon
radioactivity from manmade radionuclides in excess of that which would
produce an annual dose equivalent to the total body or any internal
organ of 4 millirems per year calculated on the basis of an intake of 2
liters of the water per day. If two or more beta or photon-emitting
radionuclides are present, the sum of their annual dose equivalent to
the total body or to any internal organ shall not exceed 4 millirems per
year.
(2) Analyses conducted to determine compliance with paragraph (e)(1)
of this section shall be made in accordance with the methods described
in the applicable sections of ``Standard Methods for the Examination of
Water and Wastewater,'' 15th Ed. (1980), and ``Interim Radiochemical
Methodology for Drinking Water,'' Environmental Monitoring and Support
Laboratory, EPA-600/4-75-008 (Revised), March 1976, U.S. Environmental
Protection Agency, both of which are incorporated by reference. The
availability of these incorporations by reference is given in paragraph
(b) of this section.
(f) Label statements. Bottled water, the quality of which is below
that prescribed by this section, shall be labeled with a statement of
substandard quality as follows:
(1) When the microbiological quality of bottled water is below that
prescribed by paragraph (b) of this section, the label shall bear the
statement of substandard quality specified in Sec. 103.5(b).
(2) When the physical, chemical, and/or radiological quality of
bottled water is below that prescribed by paragraphs (c) through (e)
respectively of this section, the label shall bear the statement of
substandard quality specified in Sec. 103.5(b) except that, as
appropriate, instead of or in addition to the words ``Contains Excessive
Bacteria'' the following statement(s) shall be used:
(i) ``Excessively Turbid'', ``Abnormal Color'', and/or ``Abnormal
Odor'' if the bottled water fails to meet the requirements of paragraph
(c) (1), (2), and/or (3), respectively, of this section.
(ii) ``Contains Excessive Chemical Substances'', if the bottled
water fails to meet any of the requirements of paragraph (d) of this
section. The specific chemical(s) may be declared in lieu of the words
``Chemical Substances'' in the statement ``Contains Excessive Chemical
Substances''. When a specific chemical is declared, that name by which
the chemical(s) is designated in paragraph (d) of this section shall be
used. Example: ``Contains Excessive Copper''.
(iii) ``Excessively Radioactive'' if the bottled water fails to meet
the requirements of paragraph (e) of this section.
(g) Adulteration. Bottled water containing a substance at a level
considered injurious to health under section 402(a)(1) of the act is
deemed to be adulterated, regardless of whether or not the bottled water
bears a label statement of substandard quality prescribed by paragraph
(f) of this section.
[42 FR 14325, Mar. 15, 1977, as amended at 44 FR 12172, Mar. 6, 1979; 46
FR 41037, Aug. 14, 1981; 47 FR 11821, Mar. 19, 1982; 49 FR 10090, Mar.
19, 1984; 54 FR 400, Jan. 6, 1989; 54 FR 24891, June 12, 1989; 58 FR
381, Jan. 5, 1993; 59 FR 26937, May 25, 1994; 59 FR 61535, Dec. 1, 1994;
61 FR 14479, Apr. 2, 1996]
Effective Date Note: At 60 FR 57123, Nov. 13, 1995, Sec. 103.35 was
removed and reserved, effective May 13, 1996.
PART 104--NUTRITIONAL QUALITY GUIDELINES FOR FOODS--Table of Contents
Subpart A--General Provisions
Sec.
104.5 General principles.
104.19 Petitions.
Subpart B--Fortification Policy
104.20 Statement of purpose.
Subpart C--Specific Nutritional Quality Guidelines
104.47 Frozen ``heat and serve'' dinner.
Authority: Secs. 201, 403, 701(a) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321, 343, 371(a)).
[[Page 169]]
Source: 42 FR 14327, Mar. 15, 1977, unless otherwise noted.
Subpart A--General Provisions
Sec. 104.5 General principles.
(a) A nutritional quality guideline prescribes the minimum level or
range of nutrient composition (nutritional quality) appropriate for a
given class of food.
(b) Labeling for a product which complies with all of the
requirements of the nutritional quality guideline established for its
class of food may state ``This product provides nutrients in amounts
appropriate for this class of food as determined by the U.S.
Government,'' except that the words ``this product'' are optional. This
statement, if used, shall be printed on the principal display panel, and
may also be printed on the information panel, in letters not larger than
twice the size of the minimum type required for the declaration of net
quantity of contents by Sec. 101.105 of this chapter. Labeling of
noncomplying products may not include any such statement or otherwise
represent, suggest, or imply the product as being, in whole or in part,
in compliance with a guideline.
(c) A product bearing the statement provided for in paragraph (b) of
this section, in addition to meeting the requirements of the applicable
nutritional quality guideline, shall comply with the following
requirements:
(1) The label of the product shall bear the common or usual name of
the food in accordance with the provisions of the guideline and
Secs. 101.3 and 102.5(a) of this chapter.
(2) The label of the product shall bear nutrition labeling in
accordance with Secs. 101.2 and 101.9 of this chapter and all other
labeling required by applicable sections of part 101 of this chapter.
(d) No claim or statement may be made on the label or in labeling
representing, suggesting, or implying any nutritional or other
differences between a product to which nutrient addition has or has not
been made in order to meet the guideline, except that a nutrient
addition shall be declared in the ingredient statement.
(e) Compliance with a nutrient level specified in a nutritional
quality guideline shall be determined by the procedures and requirements
established in Sec. 101.9(e) of this chapter.
(f) A product within a class of food for which a nutritional quality
guideline has been established and to which has been added a discrete
nutrient either for which no minimum nutrient level or nutrient range or
other allowance has been established as appropriate in the nutritional
quality guideline, or at a level that exceeds any maximum established as
appropriate in the guideline, shall be ineligible to bear the guideline
statement provided for in paragraph (b) of this section, and such a
product shall also be deemed to be misbranded under the act unless the
label and all labeling bear the following prominent and conspicuous
statement: ``The addition of ---- to (or ``The addition of ---- at the
level contained in) this product has been determined by the U.S.
Government to be unnecessary and inappropriate and does not increase the
dietary value of the food,'' the blank to be filled in with the common
or usual name of the nutrient(s) involved.
[42 FR 14327, Mar. 15, 1977]
Sec. 104.19 Petitions.
The Commissioner of Food and Drugs, on his own initiative, on the
advice of the National Academy of Sciences or other experts, or on
behalf of any interested person who has submitted a petition, may issue
a proposal to issue, amend, or revoke a regulation prescribing a
nutritional quality guideline for a class of foods, pursuant to part 10
of this chapter.
[42 FR 14327, Mar. 15, 1977, as amended at 42 FR 15673, Mar. 22, 1977]
Subpart B--Fortification Policy
Sec. 104.20 Statement of purpose.
(a) The fundamental objective of this subpart is to establish a
uniform set of principles that will serve as a model for the rational
addition of nutrients to foods. The achievement and maintenance of a
desirable level of nutritional quality in the nation's food supply is an
important public health objective. The addition of nutrients to specific
[[Page 170]]
foods can be an effective way of maintaining and improving the overall
nutritional quality of the food supply. However, random fortification of
foods could result in over- or underfortification in consumer diets and
create nutrient imbalances in the food supply. It could also result in
deceptive or misleading claims for certain foods. The Food and Drug
Administration does not encourage indiscriminate addition of nutrients
to foods, nor does it consider it appropriate to fortify fresh produce;
meat, poultry, or fish products; sugars; or snack foods such as candies
and carbonated beverages. To preserve a balance of nutrients in the
diet, manufacturers who elect to fortify foods are urged to utilize
these principles when adding nutrients to food. It is reasonable to
anticipate that the Reference Daily Intakes (RDI's) as delineated in
Sec. 101.9 of this chapter and in paragraph (d) of this section will be
amended from time to time to list additional nutrients and/or to change
the levels of specific RDI's as improved knowledge about human nutrient
requirements and allowances develops. The policy set forth in this
section is based on U.S. dietary practices and nutritional needs and may
not be applicable in other countries.
(b) A nutrient(s) listed in paragraph (d)(3) of this section may
appropriately be added to a food to correct a dietary insufficiency
recognized by the scientific community to exist and known to result in
nutritional deficiency disease if:
(1) Sufficient information is available to identify the nutritional
problem and the affected population groups, and the food is suitable to
act as a vehicle for the added nutrients. Manufacturers contemplating
using this principle are urged to contact the Food and Drug
Administration before implementing a fortification plan based on this
principle.
(2) The food is not the subject of any other Federal regulation for
a food or class of food that requires, permits, or prohibits nutrient
additions. (Other Federal regulations include, but are not limited to,
standards of identity promulgated under section 401 of the Federal Food,
Drug, and Cosmetic Act, nutritional quality guidelines established in
subpart C of this part, and common or usual name regulations established
in part 102 of this chapter.)
(c) A nutrient(s) listed in paragraph (d)(3) of this section may
appropriately be added to a food to restore such nutrient(s) to a
level(s) representative of the food prior to storage, handling, and
processing, when:
(1) The nutrient is shown by adequate scientific documentation to
have been lost in storage, handling, or processing in a measurable
amount equal to at least 2 percent of the Daily Reference Value (DRV) of
protein and of potassium and 2 percent of the Reference Daily Intake
(RDI) in a normal serving of the food.
(2) Good manufacturing practices and normal storage and handling
procedures cannot prevent the loss of such nutrient(s),
(3) All nutrients, including protein, iodine and vitamin D, that are
lost in a measurable amount are restored and all ingredients of the food
product that contribute nutrients are considered in determining
restoration levels; and
(4) The food is not the subject of any other Federal regulation that
requires or prohibits nutrient addition(s), or the food has not been
fortified in accordance with any other Federal regulation that permits
voluntary nutrient additions.
(d) A nutrient(s) listed in paragraph (d)(3) of this section may be
added to a food in proportion to the total caloric content of the food,
to balance the vitamin, mineral, and protein content if:
(1) A normal serving of the food contains at least 40 kilocalories
(that is, 2 percent of a daily intake of 2,000 kilocalories);
(2) The food is not the subject of any other Federal regulation for
a food or class of food that requires, permits, or prohibits nutrient
additions; and
(3) The food contains all of the following nutrients per 100
calories based on 2,000 calorie total intake as a daily standard:
[[Page 171]]
----------------------------------------------------------------------------------------------------------------
Nutrient Unit of measurement DRV or RDI1 Amount per 100 calories
----------------------------------------------------------------------------------------------------------------
Protein.............................. grams (g).............. 50..................... 2.5
Vitamin A............................ International Unit (IU) 5,000.................. 250
Vitamin C............................ milligrams (mg)........ 60..................... 3
Calcium.............................. g...................... 1...................... 0.05
Iron................................. mg..................... 18..................... 0.9
Vitamin D............................ IU..................... 400.................... 20
Vitamin E............................ do..................... 30..................... 1.5
Thiamin.............................. mg..................... 1.5.................... 0.08
Riboflavin........................... do..................... 1.7.................... 0.09
Niacin............................... do..................... 20..................... 1
Vitamin B6........................... do..................... 2.0.................... 0.1
Folate............................... micrograms (g) 400.................... 20
Vitamin B12.......................... do..................... 6.0.................... 0.3
Biotin............................... mg..................... 0.3.................... 0.015
Pantothenic acid..................... do..................... 10..................... 0.5
Phosphorus........................... g...................... 1.0.................... 0.05
Magnesium............................ mg..................... 400.................... 20
Zinc................................. do..................... 15..................... 0.8
Iodine............................... g............. 150.................... 7.5
Copper............................... mg..................... 2.0.................... 0.1
Potassium............................ do..................... 3,500.................. 175
----------------------------------------------------------------------------------------------------------------
\1\ RDI's for adults and children 4 or more years of age.
(e) A nutrient(s) may appropriately be added to a food that replaces
traditional food in the diet to avoid nutritional inferiority in
accordance with Sec. 101.3(e)(2) of this chapter.
(f) Nutrient(s) may be added to foods as permitted or required by
applicable regulations established elsewhere in this chapter.
(g) A nutrient added to a food is appropriate only when the
nutrient:
(1) Is stable in the food under customary conditions of storage,
distribution, and use;
(2) Is physiologically available from the food;
(3) Is present at a level at which there is a reasonable assurance
that consumption of the food containing the added nutrient will not
result in an excessive intake of the nutrient, considering cumulative
amounts from other sources in the diet; and
(4) Is suitable for its intended purpose and is in compliance with
applicable provisions of the act and regulations governing the safety of
substances in food.
(h) Any claims or statements in the labeling of food about the
addition of a vitamin, mineral, or protein to a food shall be made only
if the claim or statement is not false or misleading and otherwise
complies with the act and any applicable regulations. The following
label claims are acceptable:
(1) The labeling claim ``fully restored with vitamins and minerals''
or ``fully restored with vitamins and minerals to the level of
unprocessed ----'' (the blank to be filled in with the common or usual
name of the food) may be used to describe foods fortified in accordance
with the principles established in paragraph (c) of the section.
(2) The labeling claim, ``vitamins and minerals (and ``protein''
when appropriate) added are in proportion to caloric content'' may be
used to describe food fortified in accordance with the principles
established in paragraph (d) of this section.
(3) When labeling claims are permitted, the term ``enriched,''
``fortified,'' ``added,'' or similar terms may be used interchangeably
to indicate the addition of one or more vitamins or minerals or protein
to a food, unless an applicable Federal regulation requires the use of
specific words or statements.
(i) It is inappropriate to make any claim or statement on a label or
in labeling, other than in a listing of the nutrient ingredients as part
of the ingredient statement, that any vitamin, mineral, or protein has
been added to a food to which nutrients have been added pursuant to
paragraph (e) of this section.
[45 FR 6323, Jan. 25, 1980, as amended at 58 FR 2228, Jan. 6, 1993]
[[Page 172]]
Subpart C--Specific Nutritional Quality Guidelines
Sec. 104.47 Frozen ``heat and serve'' dinner.
(a) A product, for which a common or usual name is established in
Sec. 102.26 of this chapter, in order to be eligible to bear the
guideline statement set forth at Sec. 104.5(b), shall contain at least
the following three components:
(1) One or more sources of protein derived from meat, poultry, fish,
cheese, or eggs.
(2) One or more vegetables or vegetable mixtures other than
potatoes, rice, or cereal-based product.
(3) Potatoes, rice, or cereal-based product (other than bread or
rolls) or another vegetable or vegetable mixture.
(b) The three or more components named in paragraph (a) of this
section, including their sauces, gravies, breading, etc.:
(1) Shall contribute not less than the minimum levels of nutrients
prescribed in paragraph (d) of this section.
(2) Shall be selected so that one or more of the listed protein
sources of paragraph (a)(1) of this section, excluding their sauces,
gravies, breading, etc., shall provide not less than 70 percent of the
total protein supplied by the components named in paragraph (a) of this
section.
(c) If it is necessary to add any nutrient(s) in order to meet the
minimum nutrient levels prescribed in paragraph (d) of this section, the
addition of each such nutrient may not result in a total nutrient level
exceeding 150 percent of the minimum level prescribed. Nutrients used
for such addition shall be biologically available in the final product.
(d) Minimum levels of nutrients for a frozen ``heat and serve''
dinner are as follows:
------------------------------------------------------------------------
Minimum levels for
frozen ``heat and
serve'' dinner--
-----------------------
For each
100
Nutrient Calories For the
(keal) of total
the total components
components specified
specified in par.
in par. (a)
(a)
------------------------------------------------------------------------
Protein, grams.................................. 4.60 16.0
Vitamin A, IU................................... 150.00 520.0
Thiamine, mg.................................... .05 .2
Riboflavin, mg.................................. .06 .2
Niacin, mg...................................... .99 3.4
Pantothenic acid, mg............................ .32 1.1
Vitamin, B6, mg................................. .15 .5
Vitamin, B12, mcg............................... .33 1.1
Iron, mg........................................ .62 2.2
------------------------------------------------------------------------
(1) A frozen ``heat and serve'' dinner prepared from conventional
food ingredients listed in paragraph (a) of this section will also
contain folic acid, magnesium, iodine, calcium, and zinc. Minimum levels
for these nutrients cannot be established at the present time but may be
specified as additional data are obtained.
(2) The minimum levels for pantothenic acid, vitamin B-6, and
vitamin B-12 are tentative. Final levels will be established when
sufficient data are available. Until final levels are established, a
product containing less than the tentative levels will not be deemed to
be misbranded when labeled in accordance with Sec. 104.5(b).
(3) When technologically practicable, iodized salt shall be used or
iodine shall be present at a level equivalent to that which would be
present if iodized salt were used in the manufacture of the product.
(4) When technologically practicable, product components and
ingredients shall be selected to obtain the desirable calcium to
phosphorous ratio of 1:1. Technological addition of phosphates shall be
minimized and shall not exceed the amount necessary for the intended
effect.
(e) If the product includes servings of food which are not
prescribed by paragraph (a) of this section (e.g., soup, bread or rolls,
beverage, or dessert), their contribution shall not be
[[Page 173]]
considered in determining compliance with the nutrient levels
established in paragraph (d) of this section but shall be included in
any nutrition labeling.
(f) For the purposes of labeling, an ``average serving'' shall be
one entire frozen ``heat and serve'' dinner.
[42 FR 14327, Mar. 5, 1977]
PART 105--FOODS FOR SPECIAL DIETARY USE--Table of Contents
Subpart A--General Provisions
Sec.
105.3 Definitions and interpretations.
Subpart B--Label Statements
105.62 Hypoallergenic foods.
105.65 Infant foods.
105.66 Label statements relating to usefulness in reducing or
maintaining body weight.
105.67 Certain label statements relating to food for use in the diet of
diabetics.
105.69 Foods used to regulate sodium intake.
Subpart C [Reserved]
Subpart D--Standards of Identity [Reserved]
Authority: Secs. 201, 401, 403, 409, 411, 701, 721 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321, 341, 343, 348, 350, 371,
379e).
Source: 42 FR 14328, Mar. 15, 1977, unless otherwise noted.
Subpart A--General Provisions
Sec. 105.3 Definitions and interpretations.
The definitions and interpretations of terms contained in section
201 of the Federal Food, Drug, and Cosmetic Act (hereafter ``the act'')
shall be applicable with the following additions:
(a)(1) The term ``special dietary uses'', as applied to food for
man, means particular (as distinguised from general) uses of food, as
follows:
(i) Uses for supplying particular dietary needs which exist by
reason of a physical, physiological, pathological or other condition,
including but not limited to the conditions of diseases, convalescence,
pregnancy, lactation, allergic hypersensitivity to food, underweight,
and overweight;
(ii) Uses for supplying particular dietary needs which exist by
reason of age, including but not limited to the ages of infancy and
childhood;
(iii) Uses for supplementing or fortifying the ordinary or usual
diet with any vitamin, mineral, or other dietary property. Any such
particular use of a food is a special dietary use, regardless of whether
such food also purports to be or is represented for general use.
(2) The use of an artificial sweetener in a food, except when
specifically and solely used for achieving a physical characteristic in
the food which cannot be achieved with sugar or other nutritive
sweetener, shall be considered a use for regulation of the intake of
calories and available carbohydrate, or for use in the diets of
diabetics and is therefore a special dietary use.
(b)--(d) [Reserved]
(e) For the purposes of the regulations in this part, the terms
``infant,'' ``child,'' and ``adult'' mean persons not more than 12
months old, more than 12 months but less than 12 years old, and 12 years
or more old, respectively.
[42 FR 14328, Mar. 15, 1977, as amended at 44 FR 16006, Mar. 16, 1979;
44 FR 49665, Aug. 24, 1979]
Subpart B--Label Statements
Sec. 105.62 Hypoallergenic foods.
If a food purports to be or is represented for special dietary use
by reason of the decrease or absence of any allergenic property or by
reason of being offered as food suitable as a substitute for another
food having an allergenic property, the label shall bear:
(a) The common or usual name and the quantity or proportion of each
ingredient (including spices, flavoring, and coloring) in case the food
is fabricated from two or more ingredients.
(b) A qualification of the name of the food, or the name of each
ingredient thereof in case the food is fabricated from two or more
ingredients, to reveal clearly the specific plant or animal that is the
source of such food or of such ingredient, if such food or such
ingredient consists in whole or in part of plant or animal matter and
such name does not reveal clearly the specific plant or animal that is
such a source.
[[Page 174]]
(c) An informative statement of the nature and effect of any
treatment or processing of the food or any ingredient thereof, if the
changed allergenic property results from such treatment or processing.
Sec. 105.65 Infant foods.
(a) If a food (other than a dietary supplement of vitamins and/or
minerals alone) purports to be or is represented for special dietary use
for infants, the label shall bear, if such food is fabricated from two
or more ingredients, the common or usual name of each ingredient,
including spices, flavoring, and coloring.
(b) If such food, or any ingredient thereof, consists in whole or in
part of plant or animal matter and the name of such food or ingredient
does not clearly reveal the specific plant or animal which is its
source, such name shall be so qualified as to reveal clearly the
specific plant or animal that is such source.
[42 FR 14328, Mar. 15, 1977, as amended at 47 FR 947, Jan. 8, 1982; 49
FR 10090, Mar. 19, 1984; 50 FR 1840, Jan. 14, 1985]
Sec. 105.66 Label statements relating to usefulness in reducing or maintaining body weight.
(a) General requirements. Any food that purports to be or is
represented for special dietary use because of usefulness in reducing or
maintaining body weight shall bear:
(1) Nutrition labeling in conformity with Sec. 101.9, or, where
applicable, Sec. 101.36 of this chapter, unless exempt under that
section; and
(2) A conspicuous statement of the basis upon which the food claims
to be of special dietary usefulness.
(b) Nonnutritive ingredients. (1) Any food subject to paragraph (a)
of this section that achieves its special dietary usefulness by use of a
nonnutritive ingredient (i.e., one not utilized in normal metabolism)
shall bear on its label a statement that it contains a nonnutritive
ingredient and the percentage by weight of the nonnutritive ingredient.
(2) A special dietary food may contain a nonnutritive sweetener or
other ingredient only if the ingredient is safe for use in the food
under the applicable law and regulations of this chapter. Any food that
achieves its special dietary usefulness in reducing or maintaining body
weight through the use of a nonnutritive sweetener shall bear on its
label the statement required by paragraph (b)(1) of this section, but
need not state the percentage by weight of the nonnutritive sweetener.
If a nutritive sweetener(s) as well as nonnutritive sweetener(s) is
added, the statement shall indicate the presence of both types of
sweetener, e.g., ``Sweetened with nutritive sweetener(s) and
nonnutritive sweetener(s).''
(c) ``Low calorie'' foods. A food purporting to be ``low calorie''
must comply with the criteria set forth for such foods in
Sec. 101.60(b)(2) and (b)(3) of this chapter.
(d) ``Reduced calorie'' foods and other comparative calorie claims.
A food purporting to be ``reduced calorie'' or otherwise containing
fewer calories than a reference food must comply with the criteria set
forth for such food in Sec. 101.60(b)(4) and (b)(5) of this chapter.
(e) Label terms suggesting usefulness as low calorie or reduced
calorie foods. (1) Except as provided in paragraphs (e)(2) and (e)(3) of
this section, and in Sec. 101.13(q)(2) of this chapter for soft drinks,
a food may be labeled with terms such as ``diet,'' ``dietetic,''
``artificially sweetened,'' or ``sweetened with nonnutritive sweetener''
only if the claim is not false and misleading, and the food is labeled
``low calorie'' or ``reduced calorie'' or bears another comparative
calorie claim in compliance with part 101 of this chapter and this
section.
(2) Paragraph (e)(1) of this section shall not apply to any use of
such terms that is specifically authorized by regulation governing a
particular food, or, unless otherwise restricted by regulation, to any
use of the term ``diet'' that clearly shows that the food is offered
solely for a dietary use other than regulating body weight, e.g., ``for
low-sodium diets.''
(3) Paragraph (e)(1) of this section shall not apply to any use of
such terms on a formulated meal replacement or other food that is
represented to be of special dietary use as a whole meal, pending the
issuance of a
[[Page 175]]
regulation governing the use of such terms on foods.
(f) ``Sugar free,'' and ``no added sugar.'' Criteria for the use of
the terms ``sugar free'' and ``no added sugar'' are provided for in
Sec. 101.60(c) of this chapter.
[58 FR 2430, Jan. 6, 1993]
Sec. 105.67 Label statement relating to food for use in the diet of diabetics.
(a) A food that purports to be represented for special dietary use
because of usefulness in the diet of diabetics shall bear nutrition
labeling in compliance with Sec. 101.9 of this chapter, unless exempt
under that section, and the statement ``Diabetics: This product may be
useful in your diet on the advice of a physician. This food is not a
reduced calorie food.'' If the food is useful in maintaining or reducing
calorie intake or body weight and labeled in conformity with
Sec. 105.66, the last sentence may be eliminated.
(b) A food shall not be represented to be useful in the diets of
diabetics if such representation is false or misleading.
(c) The term ``diabetic,'' ``for diabetics,'' ``diabetes,'' or the
like, shall not be included as part of the name of any food, or
otherwise be included on the labeling more prominently than the
statement required by paragraph (a) of this section.
(d) The term ``dietetic,'' ``diet,'' or the like, shall not be
included in the labeling of a food solely because of its possible
usefulness in the diet of diabetics.
(e) A food shall not purport to be or be represented for special
dietary use because of usefulness in the diet of diabetics solely by
virtue of its being a food useful in reducing or maintaining caloric
intake or body weight.
[43 FR 43259, Sept. 22, 1978]
Sec. 105.69 Foods used to regulate sodium intake.
If a food purports to be or is represented for special dietary use
by man by reason of its use as a means of regulating the intake of
sodium or salt (sodium chloride), the label shall bear either nutrition
labeling or a statement of the number of milligrams of sodium in a
specified serving (portion) of such food, in conformance with the
applicable provisions of Sec. 101.9 of this chapter.
[49 FR 15534, Apr. 18, 1984]
Subpart C [Reserved]
Subpart D--Standards of Identity [Reserved]
PART 106--INFANT FORMULA QUALITY CONTROL PROCEDURES--Table of Contents
Subpart A--General Provisions
Sec.
106.1 Status and applicability of the quality control procedures
regulation.
106.3 Definitions.
Subpart B--Quality Control Procedures for Assuring Nutrient Content of
Infant Formulas
106.20 Ingredient control.
106.25 In-process control.
106.30 Finished product evaluation.
106.90 Coding.
Subpart C--Records and Reports
106.100 Records.
Subpart D--Notification Requirements
106.120 New formulations and reformulations.
Authority: Secs. 201, 412, 701 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321, 350a, 371).
Source: 47 FR 17025, Apr. 20, 1982, unless otherwise noted.
Subpart A--General Provisions
Sec. 106.1 Status and applicability of the quality control procedures regulation.
(a) The criteria set forth in Secs. 106.20, 106.25, 106.30, 106.90,
and 106.100 shall apply in determining whether an infant formula meets
the safety, quality, and nutrient requirements of section 412 of the act
and the requirements of regulations promulgated under section 412(a)(2)
of the act.
(b) The failure to comply with any regulation set forth in
Secs. 106.20, 106.25, 106.30, 106.90, and 106.100 applicable to the
manufacturing, processing, and packaging of an infant formula shall
[[Page 175]]
render such formula adulterated under section 412(a)(1)(C) of the act.
(c) References in this part to regulatory sections of the Code of
Federal Regulations are to chapter I of title 21 unless otherwise noted.
Sec. 106.3 Definitions.
The definitions and interpretations contained in section 201 of the
act are applicable to such terms when used in this part. The following
definitions shall also apply:
(a) Indicator nutrient. An indicator nutrient is a nutrient whose
concentration is measured during the manufacture of an infant formula to
confirm complete addition and/or uniform distribution of a premix or
other substance of which the indicator nutrient is a part.
(b) In-process batch. An in-process batch is a combination of
ingredients at any point in the manufacturing process before packaging.
(c) Manufacturer. A manufacturer is a person who prepares,
reconstitutes, or otherwise changes the physical or chemical
characteristics of an infant formula and/or packages the product in a
container for distribution.
(d) Nutrient. A nutrient is any vitamin, mineral, or other substance
required in accordance with the table set out in section 412(g) of the
act or by regulations promulgated under section 412(a)(2)(A) of the act.
(e) Nutrient premix. A nutrient premix is a combination of
ingredients containing two or more nutrients. A nutrient premix either
may be received from a supplier or be prepared by an infant formula
manufacturer.
Subpart B--Quality Control Procedures for Assuring Nutrient Content of
Infant Formulas
Sec. 106.20 Ingredient control.
(a) Except as provided in Sec. 106.20(b), no analysis before use in
manufacturing is needed for ingredients that are generally stable in
shipping and storage, and that either are received under a supplier's
guarantee or certification that the mixture has been analyzed as to
nutrient composition or are labeled as having nutrient compositions
complying with specifications in the U.S. Pharmacopeia, the National
Formulary, the Food Chemicals Codex, or other similar recognized
standards.
(b) Unless each batch of finished product is analyzed as specified
in Sec. 106.30(b)(1) before release of product for commercial or
charitable distribution, the following shall apply:
(1) When an ingredient is relied upon as a source of a nutrient(s)
and when evidence indicates that such nutrient(s) in that ingredient is
likely to be affected adversely by shipping or storage conditions, the
manufacturer shall analyze that ingredient for each relied-upon nutrient
that may be affected, using validated analytical methods.
(2) Ingredients, including nutrient premixes, that are either
without a supplier's guarantee or certification, or not labeled as
complying with prescribed standards, shall be sampled and analyzed for
each relied-upon nutrient by the manufacturer, except that ingredients
used as a major source of protein or fat need not be analyzed for each
relied-upon nutrient if the manufacturer has records to show that each
relied-upon nutrient is present at a reasonably constant level. Nutrient
premixes prepared by the infant formula manufacturer shall be sampled
and analyzed for each relied-upon nutrient. Nutrient premixes which are
received from suppliers shall be sampled and analyzed for each relied-
upon nutrient unless the supplier has sampled and analyzed each batch of
premix for each relied-upon nutrient and has so certified in writing.
Sec. 106.25 In-process control.
(a) For each infant formula, a master manufacturing order shall be
prepared and approved by a responsible official of the manufacturer. The
manufacturer shall establish a quality control system that assures and
verifies the addition of each ingredient specified in the manufacturing
order.
(b) Unless each batch of finished product is analyzed as specified
in Sec. 106.30(b)(1), the manufacturer shall analyze each in-process
batch for:
(1) Solids;
(2) Protein, fat, and carbohydrates (carbohydrates either by
analysis or by mathematical difference);
[[Page 177]]
(3) The indicator nutrient(s) in each nutrient premix;
(4) Each nutrient added independently of nutrient premixes during
formulation of the product, except for linoleic acid, vitamin D, vitamin
K, choline, inositol, and biotin; and
(5) Solids or an appropriate nutrient to confirm proper dilution
when final dilution is made after performance of the analyses in
paragraph (b) (1) through (4) of this section.
Sec. 106.30 Finished product evaluation.
(a) The manufacturer shall establish criteria for sampling and
testing to ensure that each batch of infant formula meets the nutrient
requirements of section 412(g) of the act or of regulations promulgated
under section 412(a)(2) of the act before release of product for
commercial or charitable distribution.
(b)(1) Immediate analysis. Before release of product for commercial
or charitable distribution, the manufacturer shall analyze
representative samples of each batch of finished product for:
(i) Specific nutrient(s) to assess process degradation; and
(ii) All nutrients not previously analyzed for by the manufacturers,
unless each in-process batch is analyzed for nutrients as specified in
Sec. 106.25(b) and the ingredients are analyzed as specified in
Sec. 106.20(b). No analyses are needed for linoleic acid, vitamin D,
vitamin K, choline, inositol, and biotin; and for nutrients that are
added as a part of a nutrient premix analyzed by the manufacturer or
having a supplier's guarantee or certification and for which an
indicator nutrient(s) was analyzed by the manufacturer.
(2) Periodic analysis. The manufacturer shall sample at least one
newly processed finished product batch every 3 months and shall analyze
representative samples for all nutrients except those that the
manufacturers measured in the immediate analysis of that product batch.
(3) Stability analysis. Using representative samples collected from
finished product batches, the manufacturer shall conduct stability
analysis for selected nutrients with sufficient frequency to
substantiate the maintenance of nutrient content throughout the shelf
life of the product.
(c) The manufacturer shall evaluate new formulations and the effect
of changes in ingredients or processing conditions that could affect the
level of nutrients by means of a testing program designed to confirm
uniformity of batches and to determine the effects of such changes. The
following shall apply:
(1) A minor change is a minor reduction in nutrient levels, a minor
increase in levels of nutrients that are subject to maximum limits
established under section 412(g) of the act or in regulations
established under section 412(a)(2) of the act, or any other change
where experience or theory would not predict a possible significant
adverse impact on nutrient levels or nutrient availability. After a
minor change the manufacturer shall analyze representative samples for
all nutrients so changed and those possibly affected by the change.
(2) A major change is any new formulation, or any change of
ingredients or processes where experience or theory would predict a
possible significant adverse impact on levels of nutrients or
availability of nutrients. After a major change the manufacturer shall
analyze representative samples for osmolality, all nutrients, and the
biological quality of the protein. A protein biological quality analysis
is not necessary for a formulation change that is not expected to have
an adverse effect on the biological quality of the protein. Vitamin D
shall be determined by the rat bioassay method as prescribed in
``Official Methods of Analysis of the Association of Official Analytical
Chemists'' (AOAC), 13th Ed. (1980), sections 43.195-43.208, ``Vitamin D
(30)--Official Final Action,'' which is incorporated by reference.
Copies are available from the Association of Official Analytical
Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or
available for inspection at the Office of the Federal Register, 800
North Capitol Street, NW., suite 700, Washington, DC. Before release of
the product for commercial or charitable distribution, the manufacturer
shall have completed all appropriate analyses except that shipment of
the product need not be
[[Page 178]]
delayed until results of the vitamin D bioassay and, if required, a
protein biological quality bioassay are complete, provided such
bioassays have been initiated, and if another analysis for the vitamin D
has been run and the protein content has been determined by a suitable
method. The biological quality of the protein shall be determined by an
appropriate modification of the AOAC bioassay method of analysis. The
manufacturer shall analyze additional samples from the same batch for
vitamin D, by any suitable method, and for the biological quality of the
protein. The manufacturer shall perform such analyses at least annually
for a period not to exceed the expected shelf life of the product.
(d) A simple adjustment in the level of an ingredient to accommodate
inconsistencies in processing is considered to be neither a minor nor a
major change.
[47 FR 17025, Apr. 20, 1982, as amended at 54 FR 24891, June 12, 1989]
Sec. 106.90 Coding.
The manufacturer shall code all infant formulas in conformity with
the coding requirements that are applicable to thermally processed low-
acid foods packaged in hermetically sealed containers as prescribed in
Sec. 113.60(c).
Sec. 106.100 Records.
(a) Every manufacturer of infant formula shall maintain the records
specified in this regulation in order to permit the Food and Drug
Administration to determine whether each manufacturer is in compliance
with section 412 of the Federal Food, Drug, and Cosmetic Act (the act).
(b) The manufacturer shall maintain all records that pertain to
food-packaging materials subject to Sec. 174.5 of this chapter and that
bear on whether such materials would cause an infant formula to be
adulterated within the meaning of section 402(a)(2)(C) of the act.
(c) The manufacturer shall maintain all records that pertain to
nutrient premix testing that it generates or receives. Such records
shall include, but are not limited to:
(1) Any results of testing conducted to ensure that each nutrient
premix is in compliance with the premix certificate and guarantee and
specifications that have been provided to the manufacturer by the premix
supplier, including tests conducted when nutrients exceed their
expiration date or shelf life (retest date).
(2) All certificates and guarantees given by premix suppliers
concerning the nutrients required by section 412(i) of the act and
Sec. 107.100 of this chapter.
(d) The premix supplier shall maintain the results of all testing
conducted to provide all certificates and guarantees concerning nutrient
premixes for infant formulas. Such records shall include but are not
limited to:
(1) The results of tests conducted to determine the purity of each
nutrient required by section 412(i) of the act or Sec. 107.100 of this
chapter and any other nutrient listed in the certificate and guarantee;
(2) The weight of each nutrient added;
(3) The results of any quantitative tests conducted to determine the
amount of each nutrient certified or guaranteed; and
(4) The results of any quantitative tests conducted to identify the
nutrient levels present when nutrient premixes exceed their expiration
date or shelf life (retest date).
(e) The manufacturer shall maintain all records necessary to ensure
proper nutrient quality control in the manufacture of infant formula
products. Such records shall include the results of any testing
conducted to verify that each nutrient required by section 412(i) of the
act or Sec. 107.100 of this chapter is present in each batch of infant
formula at the appropriate concentration. This requirement pertains to
ingredients, in process batch and finished product from the time of
manufacture through its expiration date.
(f) The manufacturer shall maintain all records necessary to ensure
required nutrient content at the final product stage. Such records shall
include, but are not limited to, testing results for vitamins A, B1
(thiamine), C, and E for each batch of infant
[[Page 179]]
formula. ``Final product stage'' means the point in the manufacturing
process prior to distribution at which the infant formula is homogenous
and not subject to further degradation from the manufacturing process.
(g) The manufacturer shall maintain all records pertaining to
distribution of the infant formula. Such records shall include, but not
be limited to, all information and data necessary to effect and monitor
recalls of the manufacturer's infant formula products in accordance with
subpart E of part 107 of this chapter.
(h) The manufacturer shall maintain all records pertaining to the
microbiological quality and purity of raw materials and finished
powdered infant formula.
(i) [Reserved]
(j) The manufacturer shall maintain all records pertaining to
regularly scheduled audits, including audit plans and procedures. Audit
plans identify the specific manufacturing and quality control procedures
to be reviewed. Audit procedures are the methods used to review the
manufacturing and quality control procedures. Records of audits shall
include the information and data necessary for a determination as to
whether the manufacturer complies with the current good manufacturing
practices and quality procedures identified in parts 106, 107, 109, 110,
and 113 of this chapter. The records shall include written assurances
from the manufacturer that regularly scheduled audits are being
conducted by appropriately trained individuals who do not have any
direct responsibility for the manufacture or production of infant
formula, and that the complete audit plans and procedures for the firm
have been followed. The actual written reports of the audits need not be
made available.
(k) The manufacturer shall maintain procedures describing how all
written and oral complaints regarding infant formula will be handled.
The manufacturer shall follow these procedures and shall include in them
provisions for the review of any complaint involving an infant formula
and for determining the need for an investigation of the possible
existence of a hazard to health.
(1) For purposes of this section, every manufacturer shall interpret
a ``complaint'' as any communication that contains any allegation,
written or oral, expressing dissatisfaction with a product for any
reason, including concerns about the possible existence of a hazard to
health and about appearance, taste, odor, and quality. Correspondence
about prices, package size or shape, or other matters that could not
possibly reveal the existence of a hazard to health shall not, for
compliance purposes, be considered a complaint and therefore need not be
made available to an FDA investigator.
(2) When a complaint shows that a hazard to health possibly exists,
the manufacturer shall conduct an investigation into the validity of the
complaint. Where such an investigation is conducted, the manufacturer
shall include in its file on the complaint the determination as to
whether a hazard to health exists and the basis for that determination.
No investigation is necessary when the manufacturer determines that
there is no possibility of a hazard to health. When no investigation is
necessary, the manufacturer shall include in the record the reason that
an investigation was found to be unnecessary and the name of the
responsible person making that determination.
(3) When there is a reasonable possibility of a causal relationship
between the consumption of an infant formula and an infant's death, the
manufacturer shall, within 15 days of receiving such information,
conduct an investigation and notify the agency as required in
Sec. 106.120(b).
(4) The manufacturer shall maintain in designated files all records
pertaining to the complaints it receives. The manufacturer shall
separate the files into two classes:
(i) Those complaints that allege that the infant became ill from
consuming the product or required treatment by a physician or health-
care provider.
(ii) Those complaints that may involve a possible existence of a
hazard to health but do not refer to an infant becoming ill or the need
for treatment by physician or a health care provider.
[[Page 180]]
(5) The manufacturer shall include in a complaint file the following
information concerning the complaint:
(i) The name of the infant formula;
(ii) The batch number;
(iii) The name of complainant;
(iv) A copy of the complaint or a memo of the telephone conversation
or meeting and all correspondence with the complainant;
(v) By reference or copy, all the associated manufacturing records
and complaint investigation records needed to evaluate the complaint.
When copies of such records are not maintained in the complaint file,
they must be available within 24 hours when requested by an FDA
official.
(vi) All actions taken to follow up on the complaint; and
(vii) All findings and evaluations of the complaint.
(6) The manufacturer should maintain the files regarding infant
formula complaints at the establishment where the infant formula was
manufactured, processed, or packed. When the manufacturer wishes to
maintain all consumer complaints for the entire firm at one location
other than at the facility where an infant formula was manufactured,
processed, or packed, the manufacturer may do so as long as all records
required by this section are available within 24 hours of request for
inspection at that facility. However, all records of consumer
complaints, including summaries, any reports, and any files, maintained
at the manufacturing facility or at any other facility shall be made
available to investigators for review and copying upon request.
(l) The manufacturer shall make readily available for authorized
inspection all records required under this part or copies of such
records. Records shall be available at any reasonable time at the
establishment where the activities described in such records occurred.
(Infant formula complaint files may be maintained at one facility, as
provided in Sec. 106.100(k)(6), if all required records are readily
available at that facility.) These records or copies thereof shall be
subject to photocopying or other means of reproduction as part of such
inspection. Records that can be immediately retrieved from another
location by electronic means shall be considered as meeting the
requirements of this paragraph.
(m) Records required under this part may be retained either as
original records or as true copies such as photocopies, microfilm,
microfiche, or other accurate reproductions of the original records.
Where reduction techniques, such as microfilming are used, suitable
reader and photocopying equipment shall be readily available.
(n) Production control, product testing, testing results,
complaints, and distribution records necessary to verify compliance with
parts 106, 107, 109, 110, and 113 of this chapter, or with other
appropriate regulations, shall be retained for 1 year after the
expiration of the shelf life of the infant formula or 3 years from the
date of manufacture, whichever is greater.
(o) The manufacturer shall maintain quality control records that
contain sufficient information to permit a public health evaluation of
any batch of infant formula.
[56 FR 66571, Dec. 24, 1991; 57 FR 7435, Mar. 2, 1992]
Subpart D--Notification Requirements
Sec. 106.120 New formulations and reformulations.
(a) Information required by section 412(b)(2) and (3) of the act
shall be submitted to Center for Food Safety and Applied Nutrition (HFS-
450), Food and Drug Administration, 200 C St. SW., Washington, DC 20204.
(b) The manufacturer shall promptly notify the Food and Drug
Administration when the manufacturer has knowledge (as defined in
section 412(c)(2) of the act) that reasonably supports the conclusion
that an infant formula that has been processed by the manufacturer and
that has left an establishment subject to the control of the
manufacturer may not provide the nutrients required by section 412(g) of
the act and by regulations promulgated under section 412(a)(2) of the
act, or when there is an infant formula that is otherwise adulterated or
misbranded and that may present risk to human health. This notification
shall be made, by telephone, to the Director of the
[[Page 181]]
appropriate Food and Drug Administration district office specified in
Sec. 5.115. After normal business hours (8 a.m. to 4:30 p.m.) the FDA
emergency number, 202-737-0448, shall be used. The manufacturer shall
send a followup written confirmation to the Center for Food Safety and
Applied Nutrition (HFS-605), Food and Drug Administration, 200 C St.
SW., Washington, DC 20204, and to the appropriate Food and Drug
Administration district office specified in Sec. 5.115.
[47 FR 17025, Apr. 20, 1982, as amended at 54 FR 24891, June 12, 1989;
61 FR 14479, Apr. 2, 1996]
PART 107--INFANT FORMULA--Table of Contents
Subpart A--General Provisions
Sec.
107.3 Definitions.
Subpart B--Labeling
107.10 Nutrient information.
107.20 Directions for use.
107.30 Exemptions.
Subpart C--Exempt Infant Formulas
107.50 Terms and conditions.
Subpart D--Nutrient Requirements
107.100 Nutrient specifications.
Subpart E--Infant Formula Recalls
107.200 Food and Drug Administration-required recall.
107.210 Firm-initiated product removals.
107.220 Scope and effect of infant formula recalls.
107.230 Elements of an infant formula recall.
107.240 Notification requirements.
107.250 Termination of an infant formula recall.
107.260 Revision of an infant formula recall.
107.270 Compliance with this subpart.
107.280 Records retention.
Authority: Secs. 201, 403, 412, 701 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321, 343, 350a, 371).
Source: 50 FR 1840, Jan. 14, 1985, unless otherwise noted.
Subpart A--General Provisions
Sec. 107.3 Definitions.
The following definitions shall apply, in addition to the
definitions contained in section 201 of the Federal Food, Drug, and
Cosmetic Act (the act):
Exempt formula. An exempt infant formula is an infant formula
intended for commercial or charitable distribution that is represented
and labeled for use by infants who have inborn errors of metabolism or
low birth weight, or who otherwise have unusual medical or dietary
problems.
Manufacturer. A manufacturer is a person who prepares,
reconstitutes, or otherwise changes the physical or chemical
characteristics of an infant formula or packages the infant formula in
containers for distribution.
References. References in this part to regulatory sections of the
Code of Federal Regulations are to chapter I of title 21, unless
otherwise noted.
[50 FR 48186, Nov. 22, 1985]
Subpart B--Labeling
Sec. 107.10 Nutrient information.
(a) The labeling of infant formulas, as defined in section 201(aa)
of the Federal Food, Drug, and Cosmetic Act, shall bear in the order
given, in the units specified, and in tabular format, the following
information regarding the product as prepared in accordance with label
directions for infant consumption:
(1) A statement of the number of fluid ounces supplying 100
kilocalories (in case of food label statements, a kilocalorie is
represented by the word ``Calorie''); and
(2) A statement of the amount of each of the following nutrients
supplied by 100 kilocalories:
------------------------------------------------------------------------
Nutrients Unit of measurement
------------------------------------------------------------------------
Protein................................... Grams.
Fat....................................... Do.
Carbohydrate.............................. Do.
Water..................................... Do.
Linoleic acid............................. Milligrams.
Vitamins:
Vitamin A............................... International units.
Vitamin D............................... Do.
Vitamin E............................... Do.
[[Page 182]]
Vitamin K............................... Micrograms.
Thiamine (Vitamin B 1).................. Do.
Riboflavin (Vitamin B 2................. Do.
Vitamin B 6............................. Do.
Vitamin B 12............................ Do.
Niacin.................................. Do.
Folic acid (Folacin).................... Do.
Pantothenic acid........................ Do.
Biotin.................................. Do.
Vitamin C (Ascorbic acid)............... Milligrams.
Choline................................. Do.
Inositol................................ Do.
Minerals:
Calcium................................. Milligrams.
Phosphorus.............................. Do.
Magnesium............................... Do.
Iron.................................... Do.
Zinc.................................... Do.
Manganese............................... Micrograms.
Copper.................................. Do.
Iodine.................................. Do.
Sodium.................................. Milligrams.
Potassium............................... Do.
Chloride................................ Do.
------------------------------------------------------------------------
(b) In addition the following apply:
(1) Vitamin A content may also be declared on the label in units of
microgram retinol equivalents, vitamin D content in units of micrograms
cholecalciferol, vitamin E content in units of milligram alpha-
tocopherol equivalents, and sodium, potassium, and chloride content in
units of millimoles, micromoles, or milliequivalents. When these
declarations are made they shall appear in parentheses immediately
following the declarations in International Units for vitamins A, D, and
E, and immediately following the declarations in milligrams for sodium,
potassium, and chloride.
(2) Biotin, choline, and inositol content shall be declared except
when they are not added to milk-based infant formulas.
(3) Each of the listed nutrients, and the caloric density, may also
be declared on the label on other bases, such as per 100 milliliters or
per liter, as prepared for infant consumption.
(4) One of the following statements shall appear on the principal
display panel, as appropriate:
(i) The statement ``Infant Formula With Iron'', or a similar
statement, if the product contains 1 milligram or more of iron in a
quantity of product that supplies 100 kilocalories when prepared in
accordance with label directions for infant consumption.
(ii) The statement ``Additional Iron May Be Necessary'', or a
similar statement, if the product contains less than 1 milligram of iron
in a quantity of product that supplies 100 kilocalories when prepared in
accordance with label directions for infant consumption.
(5) Any additional vitamin may be declared at the bottom of the
vitamin list and any additional minerals may be declared between iodine
and sodium, provided that any additionally declared nutrient (i) has
been identified as essential by the National Academy of Sciences through
its development of a recommended dietary allowance or an estimated safe
and adequate daily dietary intake range, or has been identified as
essential by the Food and Drug Administration through a Federal Register
publication or establishment of a U.S. Recommended Daily Allowance, and
(ii) is provided at a level considered in these publications as having
biological significance, when these levels are known.
(Information Collection requirements were approved by the Office of
Management and Budget under control number 0910-0159)
Sec. 107.20 Directions for use.
In addition to the applicable labeling requirements in parts 101 and
105 of this chapter, the product label shall bear:
(a) Under the heading ``Directions For Preparation and Use'',
directions for:
(1) Storage of infant formula before and after the container has
been opened, including a statement indicating that prolonged storage at
excessive temperatures should be avoided;
(2) Agitating liquid infant formula before opening the container,
such as ``Shake Well Before Opening'';
(3) ``Sterilization'' of water, bottle, and nipples when necessary
for preparing infant formula for use;
(4) Dilution of infant formula, when appropriate. Directions for
powdered infant formula shall contain the weight and volume of powdered
formula to be reconstituted.
(b) In close proximity to the ``Directions for Preparation and Use''
a pictogram depicting the major steps for preparation of that infant
formula, such as (for a concentrated formula):
[[Page 183]]
[GRAPHIC] [TIFF OMITTED] TR01JA93.366
(c) A ``Use by ------------'' date, the blank to be filled in with
the month and year selected by the manufacturer, packer, or distributor
of the infant formula on the basis of tests or other information showing
that the infant formula, until that date, under the conditions of
handling, storage, preparation, and use prescribed by label directions,
will: (1) when consumed, contain not less than the quantity of each
nutrient, as set forth on its label; and (2) otherwise be of an
acceptable quality (e.g., pass through an ordinary bottle nipple).
(d) The statement ``Add Water'' or ``Do Not Add Water'', as
appropriate, to appear on the principal display panel of concentrated or
ready-to-feed infant formulas. In close proximity to the statement ``Add
Water'', a symbol such as
[GRAPHIC] [TIFF OMITTED] TC01MR93.000
if the addition of water is necessary. The symbol shall be placed on a
white background encircled by a dark border.
(e) A warning statement beneath or in close proximity to the
``Directions For Preparation and Use'' that cautions against improper
preparation or use of an infant formula, such as ``THE HEALTH OF YOUR
INFANT DEPENDS ON CAREFULLY FOLLOWING THE DIRECTIONS FOR PREPARATION AND
USE''.
(f) A statement indicating that parents should consult their
physicians about the use of infant formulas, such as ``USE AS DIRECTED
BY A PHYSICIAN''.
(Collection of information requirements were approved by the Office of
Management and Budget (OMB) and assigned OMB control number 0910-0159)
Sec. 107.30 Exemptions.
When containers of ready-to-feed infant formula, to be sold at the
retail level, are contained within a multiunit package, the labels of
the individual containers shall contain all of the label information
required by section 403 of the Federal Food, Drug, and Cosmetic Act (the
act), Secs. 107.10 and 107.20, and all appropriate sections of part 101
of this chapter, except that the labels of the individual containers
contained within the outer package shall be exempt from compliance with
the requirements of section 403 (e)(1) and (i)(2) of the act; and
Secs. 107.10 (a) and (b)(2) and 107.20 (b), (e), and (f), provided that
(a) the multiunit package meets all the requirements of this part; (b)
individual containers are securely enclosed within
[[Page 184]]
and are not intended to be separated from the retail package under
conditions of retail sale; and (c) the label on each individual
container includes the statement ``This Unit Not Intended For Individual
Sale'' in type size not less than one-sixteenth inch in height. The word
``Retail'' may be used in lieu of or immediately following the word
``Individual'' in the statement.
Subpart C--Exempt Infant Formulas
Sec. 107.50 Terms and conditions.
(a) Terms and conditions. Section 412(f)(1) of the act exempts from
the requirements of section 412(a), (b), and (c)(1)(A) of the act infant
formulas that are represented and labeled for use by an infant who has
an inborn error of metabolism or low brith weight or who otherwise has
an unusual medical or dietary problem, if such formulas comply with
regulations prescribed by the Secretary. The regulations in this subpart
establish the terms and conditions that a manufacturer must meet with
respect to such infant formulas.
(b) Infant formulas generally available at the retail level. (1)
These exempt infant formulas can generally be purchased from retail
store shelves that are readily available to the public. Such formulas
are also typically represented and labeled for use to provide dietary
management for diseases or conditions that are not clinically serious or
life-threatening, even though such formulas may also be represented and
labeled for use in clinically serious or life-threatening disorders.
(2) Except as provided in paragraphs (b)(4) and (5) of this section,
an infant formula manufacturer shall, with respect to each formula
covered by this paragraph, comply with the nutrient requirements of
section 412(g) of the act or of regulations promulgated under section
412(a)(2) of the act, the quality control procedure requirements of part
106, and the labeling requirements of subpart B of this part.
(3) To retain the exempt status of an infant formula covered by this
paragraph, the manufacturer shall submit to the Food and Drug
Administration (FDA), at the address specified in paragraph (e)(1) of
this section, on or before May 21, 1986, or on or before the 90th day
before the first processing of the infant formula for commercial or
charitable distribution, whichever occurs later, the label and other
labeling of the infant formula, a complete quantitative formulation for
the infant formula, and a detailed description of the medical conditions
for which the infant formula is represented. FDA will review the
information under paragraph (d) of this section.
(4) To retain the exempt status of an infant formula covered by this
paragraph, when any change in ingredients or processes that may result
in an adverse impact on levels of nutrients or availability of nutrients
is instituted, the manufacturer shall submit to FDA at the address
specified in paragraph (e)(1) of this section, before the first
processing of the infant formula, the label and other labeling of the
infant formula, a complete quantitative formulation for the infant
formula, a detailed description of the reformulation and the rationale
for the reformulation, a complete description of the change in
processing, and a detailed description of the medical conditions for
which the infant formula is represented. FDA will review that
information under paragraph (d) of this section.
(5) A manufacturer may deviate from the requirements of paragraph
(b)(2) of this section only with respect to those specific requirements
for which it submits to FDA, at the address specified in paragraph
(e)(1) of this section, the medical, nutritional, scientific, or
technological rationale (including any appropriate animal or human
clinical studies). FDA will review that information under paragraph (d)
of this section.
(c) Infant formulas not generally available at the retail level. (1)
These exempt infant formulas are not generally found on retail shelves
for general consumer purchase. Such formulas typically are prescribed by
a physician, and must be requested from a pharmacist or are distributed
directly to institutions such as hospitals, clinics, and State or
Federal agencies. Such formulas are also generally represented and
labeled solely to provide dietary management for specific diseases or
conditions that are
[[Page 185]]
clinically serious or life-threatening and generally are required for
prolonged periods of time. Exempt infant formulas distributed directly
to institutions such as hospitals, clinics, and State or Federal
agencies that are of the same formulation as those generally available
at the retail level are subject to the requirements of paragraph (b) of
this section rather than to the requirements of this paragraph.
(2) Except as provided for in paragraph (c)(5) of this section, an
infant formula manufacturer shall, with respect to each formula covered
by this paragraph, comply with the nutrient requirements of section
412(g) of the act or of regulations promulgated under section 412(a)(2)
of the act, and the labeling requirements of subpart B of this part.
(3) Each manufacturer of an infant formula covered by this paragraph
shall establish quality control procedures designed to ensure that the
infant formula meets applicable nutrient requirements of this section,
including any special nutritional characteristics for the specific
disorders or conditions for which the formula is represented for use.
Each manufacturer shall maintain records of such quality control
procedures sufficient to permit a public health evaluation of each
manufactured batch of infant formula and shall permit any authorized FDA
employee at all reasonable times to have access to and to copy and
verify the records referred to in this paragraph.
(4) To retain the exempt status of an infant formula covered by this
paragraph, the manufacturer shall submit the information required by
paragraphs (b)(3) and (4) of this section.
(5) A manufacturer may deviate from the requirements of paragraph
(c)(2) of this section only with respect to those specific requirements
for which it submits to FDA, at the address specified in paragraph
(e)(1) of this section, the medical, nutritional, scientific, or
technological rationale (including any appropriate animal or human
clinical studies). FDA will review that information under paragaraph (d)
of this section.
(6) The requirements of this section do not apply to an infant
formula specially and individually prepared for one or more specific
infants on a physician's request.
(d) FDA review of exempt status. (1) FDA's Center for Food Safety
and Applied Nutrition will review information submitted by infant
formula manufacturers under paragraph (b) (3), (b) (4), or (c) (4) of
this section. On the basis of such review and other information
available to the agency, the Center for Food Safety and Applied
Nutrition may impose additional conditions on, or modify requirements
for, the quality control procedures, nutrient specifications, or
labeling of an infant formula, or withdraw a product's exempt status.
Such determinations will be made by the Director of the Center for Food
Safety and Applied Nutrition.
(2)(i) If after completing its review of all information submitted,
the Center for Food Safety and Applied Nutrition concludes that
additional or modified quality control, nutrient, or labeling
requirements are needed, or that a product's exempt status is withdrawn,
the Center for Food Safety and Applied Nutrition will so notify the
manufacturer and this notification will specify the reasons therefor.
Upon receipt of this notification, the manufacturer has 10 working days
to have the decision reviewed under Sec. 10.75 by the office of the
Commissioner of Food and Drugs. A determination by the Director of the
Center for Food Safety and Applied Nutrition that is not appealed
becomes a final agency decision.
(ii) After a final decision by the Director or by the office of the
Commissioner that a product's exempt status is withdrawn, the
manufacturer shall comply with the nutrient requirements of section
412(g) of the act or of regulations promulgated under section 412(a)(2)
of the act, the quality control requirements of part 106, and the
labeling requirements of subpart B of this part.
(iii) The compliance date for the withdrawal of a product's exempt
status or the imposition of additional or modified quality control,
nutrient, or labeling requirements is 60 calendar days after issuance of
the final decision except as otherwise provided for reasons stated in
the decision. If the agency determines that a health hazard may exist
and so notifies the
[[Page 186]]
manufacturer, withdrawal of a product's exempt status shall be effective
on the date of receipt of notification from the Director of the Center
for Food Safety and Applied Nutrition. Additional or modified
requirements, or the withdrawal of an exemption, apply only to those
formulas that are manufactured after the compliance date. A postponement
of the compliance date may be granted for good cause.
(3) FDA may decide that withdrawal of an exemption is necessary
when, on the basis of its review under paragraph (d)(1) of this section,
it concludes that quality control procedures are not adequate to ensure
that the formula contains all required nutrients, that deviations in
nutrient levels are not supported by generally accepted scientific,
nutritional, or medical rationale, or that deviations from subpart B of
this part are not necessary to provide appropriate directions for
preparation and use of the infant formula, or that additional labeling
information is necessary.
(4) FDA will use the following criteria in determining whether
deviations from the requirements of this subpart are necessary and will
adequately protect the public health:
(i) A deviation from the nutrient requirements of section 412(g) of
the act or of regulations promulgated under section 412(a)(2) of the act
is necessary to provide an infant formula that is appropriate for the
dietary management of a specific disease, disorder, or medical
condition;
(ii) For exempt infant formulas subject to paragraph (b) of this
section, a deviation from the quality control procedures requirements of
part 106 is necessary because of unusal or difficult technological
problems in manufacturing the infant formula; and
(iii) A deviation from the labeling requirements of subpart B of
this part is necessary because label information, including pictograms
and symbols required by those regulations, could lead to inappropriate
use of the product.
(e) Notification requirements. (1) Information required by
paragraphs (b) and (c) of this section shall be submitted to Center for
Food Safety and Applied Nutrition (HFS-450), Food and Drug
Administration, 200 C St. SW., Washington, DC 20204.
(2) The manufacturer shall promptly notify FDA when the manufacturer
has knowledge (as defined in section 412(c)(2) of the act) that
reasonably supports the conclusion that an exempt infant formula that
has been processed by the manufacturer and that has left an
establishment subject to the control of the manufacturer may not provide
the nutrients required by paragraph (b) or (c) of this section, or when
there is an exempt infant formula that may be otherwise adulterated or
misbranded and if so adulterated or misbranded presents a risk of human
health. This notification shall be made, by telephone, to the Director
of the appropriate FDA district office specified in Sec. 5.115. After
normal business hours (8 a.m. to 4:30 p.m.), the FDA emergency number,
202-737-0448, shall be used. The manufacturer shall send a followup
written confirmation to the Center for Food Safety and Applied Nutrition
(HFS-605), Food and Drug Administration, 200 C St. SW., Washington, DC
20204, and to the appropriate FDA district office specified in
Sec. 5.115.
(Information Collection requirements were approved by the Office of
Management and Budget under control number 0910-0158)
[50 FR 48187, Nov. 22, 1985, as amended at 61 FR 14479, Apr. 2, 1996]
Subpart D--Nutrient Requirements
Sec. 107.100 Nutrient specifications.
(a) An infant formula shall contain the following nutrients at a
level not less than the minimum level specified and not more than the
maximum level specified for each 100 kilocalories of the infant formula
in the form prepared for consumption as directed on the container:
------------------------------------------------------------------------
Minimum Maximum
Nutrients Unit of measurement level level
------------------------------------------------------------------------
Protein.......................... Grams.............. 1.8 4.5
Fat.............................. ......do........... 3.3 6.0
Percent calories... 30 54
Linoleic acid.................... Milligrams......... 300 .......
Percent calories... 2.7 .......
------------------------------------------------------------------------
Vitamins
------------------------------------------------------------------------
Vitamin A........................ International Units 250 750
[[Page 187]]
Vitamin D........................ ......do........... 40 100
Vitamin E........................ ......do........... 0.7 .......
Vitamin K........................ Micrograms......... 4 .......
Thiamine (vitamin B1)............ ......do........... 40 .......
Riboflavin (vitamin B2).......... ......do........... 60 .......
Vitamin B6....................... ......do........... 35 .......
Vitamin B12...................... ......do........... 0.15 .......
Niacin1.......................... ......do........... 250 .......
Folic acid (folacin)............. ......do........... 4 .......
Pantothenic acid................. ......do........... 300 .......
Biotin 2......................... ......do........... 1.5 .......
Vitamin C (ascorbic acid)........ Milligrams......... 8 .......
Choline2......................... ......do........... 7 .......
Inositol 2....................... ......do........... 4 .......
----------------------------------
Minerals................................................................
----------------------------------
Calcium.......................... ......do........... 60 .......
Phosphorus....................... ......do........... 30 .......
Magnesium........................ ......do........... 6 .......
Iron............................. ......do........... 0.15 3.0
Zinc............................. ......do........... 0.5 .......
Manganese........................ Micrograms......... 5 .......
Copper........................... Micrograms......... 60 .......
Iodine........................... ......do........... 5 75
Sodium........................... Milligrams......... 20 60
Potassium........................ ......do........... 80 200
Chloride......................... ......do........... 55 150
------------------------------------------------------------------------
\1\ The generic term ``niacin'' includes niacin (nicotinic acid) and
niacinamide (nicotinamide).
\2\ Required only for non-milk-based infant formulas.
In addition to the specifications established in the table in this
paragraph for vitamins and minerals, the following also apply:
(b) Vitamin E shall be present at a level of at least 0.7
International Unit of vitamin E per gram of linoleic acid.
(c) Any vitamin K added shall be in the form of phylloquinone.
(d) Vitamin B6 shall be present at a level of at least 15
micrograms of vitamin B6 for each gram of protein in excess of 1.8
grams of protein per 100 kilocalories of infant formula in the form
prepared for consumption as directed on the container.
(e) The ratio of calcium to phosphorus in infant formula in the form
prepared for consumption as directed on the container shall be no less
than 1.1 and not more than 2.0.
(f) Protein shall be present in an amount not to exceed 4.5 grams
per 100 kilocalories regardless of quality, and not less than 1.8 grams
per 100 kilocalories of infant formula in the form prepared for
consumption as directed on the container when its biological quality is
equivalent to or better than that of casein. If the biological quality
of the protein is less than that of casein, the minimum amount of
protein shall be increased proportionately to compensate for its lower
biological quality. For example, an infant formula containing protein
with a biological quality of 75 percent of casein shall contain at least
2.4 grams of protein (1.8/0.75). No protein with a biological quality
less than 70 percent of casein shall be used.
[50 FR 45108, Oct. 30, 1985]
Subpart E--Infant Formula Recalls
Source: 54 FR 4008, Jan. 27, 1989, unless otherwise noted.
Sec. 107.200 Food and Drug Administration-required recall.
When the Food and Drug Administration determines that an adulterated
or misbranded infant formula presents a risk to human health, a
manufacturer shall immediately take all actions necessary to recall that
formula, extending to and including the retail level, consistent with
the requirements of this subpart.
Sec. 107.210 Firm-initiated product removals.
(a) If a manufacturer has determined to recall voluntarily from the
market an infant formula that is not subject to Sec. 107.200 but that
otherwise violates the laws and regulations administered by the Food and
Drug Administration (FDA) and that would be subject to legal action, the
manufacturer, upon prompt notification to FDA, shall administer such
voluntary recall consistent with the requirements of this subpart.
(b) If a manufacturer has determined to withdraw voluntarily from
the market an infant formula that is adulterated or misbranded in only a
minor way and that would not be subject to legal action, such removal
from the market is deemed to be a market withdrawal, as defined in
Sec. 7.3(j) of this chapter. As required by Sec. 107.240(a), the
manufacturer shall promptly notify FDA of such violative formula and
may, but is not required to, conduct
[[Page 188]]
such market withdrawal consistent with the requirements of this subpart
pertaining to product recalls.
Sec. 107.220 Scope and effect of infant formula recalls.
(a) The requirements of this subpart apply:
(1) When the Food and Drug Administration has determined that it is
necessary to remove from the market a distributed infant formula that is
in violation of the laws and regulations administered by the Food and
Drug Administration and that poses a risk to human health; or
(2) When a manufacturer has determined that it is necessary to
remove from the market a distributed infant formula that:
(i) Is no longer subject to the manufacturer's control;
(ii) Is in violation of the laws and regulations administered by the
Food and Drug Administration and against which the agency could initiate
legal or regulatory action; and
(iii) Does not present a human risk.
(b) The Food and Drug Administration will monitor continually the
recall action and will take appropriate actions to ensure that the
violative infant formula is removed from the market.
Sec. 107.230 Elements of an infant formula recall.
A recalling firm shall conduct an infant formula recall with the
following elements:
(a) The recalling firm shall evaluate in writing the hazard to human
health associated with the use of the infant formula. This health hazard
evaluation shall include consideration of any disease, injury, or other
adverse physiological effect that has been or that could be caused by
the infant formula and of the seriousness, likelihood, and consequences
of the diseases, injury, or other adverse physiological effect. The Food
and Drug Administration will conduct its own health hazard evaluation
and promptly notify the recalling firm of the results of that evaluation
if the criteria for recall under Sec. 107.200 have been met.
(b) The recalling firm shall devise a written recall strategy suited
to the individual circumstances of the particular recall. The recall
strategy shall take into account the health hazard evaluation and
specify the following: The extent of the recall; if necessary, the
public warning to be given about any hazard presented by the infant
formula; the disposition of the recalled infant formula; and the
effectiveness checks that will be made to determine that the recall is
carried out.
(c) The recalling firm shall promptly notify each of its affected
direct accounts about the recall. The format of a recall communication
shall be distinctive, and the content and extent of a recall
communication shall be commensurate with the hazard of the infant
formula being recalled and the strategy developed for the recall. The
recall communication shall instruct consignees to report back quickly to
the recalling firm about whether they are in possession of the recalled
infant formula and shall include a means of doing so. The recalled
communication shall also advise consignees how to return the recall
infant formula to the manufacturer or otherwise dispose of it. The
recalling firm shall send a followup recall communication to any
consignee that does not respond to the initial recall communication.
(d) If the infant formula presents a risk to human health, the
recalling firm shall request that each establishment, at which such
infant formula is sold or available for sale, post at the point of
purchase of such formula a notice of such recall at such establishment.
The notice shall be provided by the recalling firm after approval of the
notice by the Food and Drug Administration. The recalling firm shall
also request that each retail establishment maintain such notice on
display until such time as the Food and Drug Administration notifies the
recalling firm that the agency considers the recall completed.
(e) The recalling firm shall furnish promptly to the appropriate
Food and Drug Administration district office listed in Sec. 5.115 of
this chapter, as they are available, copies of the health hazard
evaluation, the recall strategy, and all recall communications
(including, for a recall under Sec. 107.200, the notice to be displayed
at retail establishments)
[[Page 189]]
directed to consignees, distributors, retailers, and members of the
public.
Sec. 107.240 Notification requirements.
(a) Notification of a violative infant formula. A manufacturer shall
promptly notify the Food and Drug Administration when the manufacturer
has knowledge (as defined in section 412(e)(2) of the Federal Food,
Drug, and Cosmetic Act (the act)) that reasonably supports the
conclusion that an infant formula that has been processed by the
manufacturer and that has left an establishment subject to the control
of the manufacturer:
(1) May not provide the nutrients required by section 412(i) of the
act and by regulations promulgated under section 412(i)(2) of the act;
or
(2) May be otherwise adulterated or misbranded.
(b) Method of notification. The notification made pursuant to
Sec. 107.240(a) shall be made, by telephone, to the Director of the
appropriate Food and Drug Administration district office specified in
Sec. 5.115 of this chapter. After normal business hours (8 a.m. to 4:30
p.m.), FDA's emergency number, 202-857-8400, shall be used. The
manufacturer shall send written confirmation of the notification to the
Center for Food Safety and Applied Nutrition (HFS-605), Food and Drug
Administration, 200 C St. SW., Washington, DC 20204, and to the
appropriate Food and Drug Administration district office specified in
Sec. 5.115 of this chapter.
(c) Reports about an infant formula recall--(1) Telephone report.
When a determination is made that an infant formula is to be recalled,
the recalling firm shall telephone within 24 hours the appropriate Food
and Drug Administration district office listed in Sec. 5.115 of this
chapter and shall provide relevant information about the infant formula
that is to be recalled.
(2) Initial written report. Within 14 days after the recall has
begun, the recalling firm shall provide a written report to the
appropriate Food and Drug Administration district office. The report
shall contain relevant information, including the following cumulative
information concerning the infant formula that is being recalled:
(i) Number of consignees notified of the recall, and date and method
of notification, including, for a recall pursuant to Sec. 107.200
information about the notice provided for retail display and the request
for its display.
(ii) Number of consignees responding to the recall communication and
quantity of recalled infant formula on hand at the time it was received.
(iii) Quantity of recalled infant formula returned or corrected by
each consignee contacted and the quantity of recalled infant formula
accounted for.
(iv) Number and results of effectiveness checks that were made.
(v) Estimated timeframes for completion of the recall.
(3) Status reports. The recalling firm shall submit to the
appropriate Food and Drug Administration district office a written
status report on the recall at least every 14 days until the recall is
terminated. The status report shall describe the steps taken by the
recalling firm to carry out the recall since the last report and the
results of these steps.
[54 FR 4008, Jan. 27, 1989, as amended at 61 FR 14479, Apr. 2, 1996]
Sec. 107.250 Termination of an infant formula recall.
The recalling firm may submit a recommendation for termination of
the recall to the appropriate Food and Drug Administration district
office listed in Sec. 5.115 of this chapter for transmittal to the
Center for Food Safety and Applied Nutrition (HFS-605), for action. Any
such recommendation shall contain information supporting a conclusion
that the recall strategy has been effective. The agency will respond
within 15 days of receipt by the Center for Food Safety and Applied
Nutrition (HFS-605), of the request for termination. The recalling firm
shall continue to implement the recall strategy until it receives final
written notification from the agency that the recall has been
terminated. The agency will send such a notification unless it has
information, from FDA's own audits or from other sources, demonstrating
that the recall has not been effective. The agency may conclude that a
recall has not been effective if:
[[Page 190]]
(a) The recalling firm's distributors have failed to retrieve the
recalled infant formula; or
(b) Stocks of the recalled infant formula remain in distribution
channels that are not in direct control of the recalling firm.
[54 FR 4008, Jan. 27, 1989, as amended at 61 FR 14479, Apr. 2, 1996]