[Title 21 CFR C]
[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]
[Subchapter B - FOOD FOR HUMAN CONSUMPTION]
[Part 101 - FOOD LABELING]
[Subpart C - Specific Nutrition Labeling Requirements and Guidelines]
[From the U.S. Government Publishing Office]
21
FOOD AND DRUGS
2
1996-04-01
1996-04-01
false
Specific Nutrition Labeling Requirements and Guidelines
C
Subpart C
FOOD AND DRUGS
FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--CONTINUED
FOOD FOR HUMAN CONSUMPTION
FOOD LABELING
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,
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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
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``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
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``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
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(ii) Multiple vitamin for children and adults.
[GRAPHIC] [TIFF OMITTED] TR01JA93.359
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(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:
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[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
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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
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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
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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]