[Federal Register Volume 59, Number 2 (Tuesday, January 4, 1994)]
[Rules and Regulations]
[Pages 354-378]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 93-31813]
[[Page Unknown]]
[Federal Register: January 4, 1994]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket No. 90N-135D]
RIN 0905-AD96
Food Labeling; General Requirements for Nutrition Labeling for
Dietary Supplements of Vitamins, Minerals, Herbs, or Other Similar
Nutritional Substances
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is amending its food
labeling regulations to establish requirements for the nutrition
labeling of dietary supplements of vitamins, minerals, herbs, and other
similar nutritional substances (hereinafter referred to as dietary
supplements). This action is in response to certain provisions of the
Nutrition Labeling and Education Act of 1990 (the 1990 amendments) and
the Dietary Supplement Act of 1992 (the DS act).
EFFECTIVE DATE: July 5, 1995.
FOR FURTHER INFORMATION CONTACT: Susan Thompson, Center for Food Safety
and Applied Nutrition (HFS-165), Food and Drug Administration, 200 C
St. SW., Washington, DC 20204, 202-205-5587.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of June 18, 1993 (58 FR 33715), FDA
published a proposed rule entitled ``Food Labeling; General
Requirements for Nutrition Labeling for Dietary Supplements of
Vitamins, Minerals, Herbs, or Other Similar Nutritional Substances''
(hereinafter identified as ``the nutrition labeling proposal for
dietary supplements'') to establish regulations on the nutrition
labeling of dietary supplements of vitamins, minerals, herbs, and other
similar nutritional substances. A document correcting various editorial
errors in that proposed rule was published in the Federal Register of
July 27, 1993 (58 FR 40104).
The proposed rule was issued to implement the 1990 amendments (Pub.
L. 101-535), which were signed into law on November 8, 1990. This new
law amended the Federal Food, Drug, and Cosmetic Act (the act) in a
number of important ways. One of the notable aspects of the 1990
amendments is that it added section 403(q) to the act (21 U.S.C.
343(q)). This section requires that most foods bear nutrition labeling.
In response to section 403(q) of the act, FDA published a proposed
rule on nutrition labeling in the Federal Register of November 27, 1991
(56 FR 60366 at 60393). That document proposed, among other things, a
regulation specifically for the nutrition labeling of dietary
supplements of vitamins or minerals (proposed Sec. 101.36). It also
proposed to make the nutrition labeling of dietary supplements of herbs
or other similar nutritional substances subject to Sec. 101.9 (21 CFR
101.9), the general regulation on nutrition labeling. This distinction
reflects section 403(q)(5)(F) (formerly section 403(q)(5)(E)) of the
act. This section provides that if a food to which section 411 of the
act (21 U.S.C. 350) applies (i.e., a dietary supplement of vitamins or
minerals) contains one or more of the nutrients required to be listed
in nutrition labeling, ``the label or labeling of such food shall
comply with requirements of subparagraph (1) and (2) [of section 403(q)
of the act] in a manner which is appropriate for such food and which is
specified in regulations of the Secretary.'' Other dietary supplements
are not subject to section 403(q)(5)(F) of the act and thus are subject
to regulation under section 403(q) of the act as any other food.
In response to the proposed rule on nutrition labeling of November
27, 1991, FDA received over 45 responses, each containing one or more
comments, that pertained to the nutrition labeling of dietary
supplements. The agency summarized and discussed the issues in these
comments in the preamble of the mandatory nutrition labeling final rule
that it issued on January 6, 1993 (58 FR 2079 at 2167). However, the
regulations that FDA adopted in that final rule applied only to the
nutrition labeling of foods in conventional food form (Sec. 101.9).
They did not apply to dietary supplements because of a moratorium
established by the DS act.
The DS act (Pub. L. 102-571) was signed into law on October 6,
1992. In section 202(a)(1), the DS act established a moratorium until
December 15, 1993, on the implementation of the 1990 amendments, with
respect to dietary supplements. Thus, FDA did not finalize the proposed
rules pertaining to the nutrition labeling of dietary supplements of
vitamins and minerals (Sec. 101.36) or of herbs or other nutritional
substances.
Section 202(a)(2) of the DS act required that the Secretary of
Health and Human Services, and by delegation FDA, issue new proposed
regulations that are applicable to dietary supplements no later than
June 15, 1993, and final regulations by December 31, 1993. In response
to this provision, FDA issued the June 18, 1993 (58 FR 33715) proposal
and is now issuing this final rule. In addition, elsewhere in this
issue of the Federal Register, FDA is issuing final regulations that
address the use of nutrient content claims and health claims on dietary
supplements.
In addition, section 203 of the DS act instructed FDA not to
promulgate regulations before November 8, 1993, that establish
recommended daily allowances for vitamins or minerals other than those
recommended allowances specified in Sec. 101.9(c)(7)(iv) as in effect
on October 6, 1992. Therefore, in the January 6, 1993, mandatory
nutrition labeling final rule, FDA retained the U.S. Recommended Daily
Allowances (U.S. RDA) values specified in Sec. 101.9(c)(7)(iv), as in
effect on October 6, 1992. These U.S. RDA values were in large measure
based on the RDA's in the National Academy of Sciences' (NAS)
publication ``Recommended Dietary Allowances,'' 7th edition, 1968 (Ref.
1). The agency did, however, change the terminology for these values
from ``U.S. RDA's'' to ``Reference Daily Intakes (RDI's).''
FDA received over 400 responses to its June 18, 1993, proposed rule
on the nutrition labeling of dietary supplements, each of these
responses contained one or more comments. Responses were received from
consumers, consumer advocacy organizations, health care professionals,
professional societies, universities, industry, trade associations, and
State and local governments. Many comments addressed issues covered by
other proposals that are a part of this overall food labeling
initiative, and they will be addressed in those documents. Other
comments were outside the scope of these proposals and will not be
discussed here.
About half of the comments supported the proposal; about half of
these comments supported it without modification. These comments were
primarily from health professionals, although a few were from that
segment of the food industry that produces foods in conventional food
form. The remainder of the comments that supported the proposal
suggested modifications in various provisions of the proposal. About
half of the comments opposed the proposal. These comments were
primarily from consumers who opposed FDA's regulation of dietary
supplements. A summary of the comments that suggested changes and the
agency's responses follow:
II. Scope of New Sec. 101.36
1. One comment from a manufacturer of dietary supplements supported
the proposed rule to allow only vitamins and minerals that have RDI's
or Daily Reference Values (DRV's) to be listed in the nutrition label
of dietary supplements of vitamins and minerals. However, several
comments wanted non-RDI vitamins and minerals to be listed,
particularly those in the NAS's ``Recommended Dietary Allowances''
(i.e., chloride, chromium, fluoride, manganese, molybdenum, selenium,
and vitamin K). The comments pointed out that advances in scientific
knowledge have shown that these nutrients are considered essential to
human health. Some comments also suggested listing nutrients such as
arsenic, boron, silicon, tin, and vanadium that they stated are of
major significance in human nutrition.
Some of these comments suggested that an asterisk in the ``Percent
Daily Value'' column could refer to a footnote, such as ``No Daily
Value has been established for this nutrient.'' Another comment
suggested that these additional nutrients could be listed in a
subsection of the nutrition panel below the bar after the last nutrient
for which there is an RDI or DRV. One comment stated that to put
information on nutrients of this type outside of the ``Nutrition
Facts'' box would be inconvenient and may cause some consumers to
overlook the presence of these additional nutrients, some of which
should not be consumed in excess.
The agency is persuaded that it is appropriate to allow the
nutrients that are listed as being essential to humans in the NAS's
``Recommended Dietary Allowances'' (Refs. 2 and 10), but for which FDA
has not established RDI's, to be declared in the nutrition label of
dietary supplements of vitamins and minerals when they are present in
supplements at more than insignificant amounts. The agency agrees that
there have been significant advances in scientific knowledge with
respect to essential nutrient requirements since 1968. In 1989, the NAS
updated its RDA's to include values for vitamin K and selenium and to
make significant revisions in the allowances for several nutrients
including vitamin B6, folate (folic acid), vitamin B12, magnesium, iron
and zinc (Ref. 2). In addition, scientific advances permitted the NAS
to revise the values, known as ``Estimated Safe and Adequate Daily
Dietary Intakes'' (ESADDI's) in 1980 for chloride (Ref. 10) and in
1989, for three nutrients (biotin, pantothenic acid, and copper), for
which FDA established U.S. RDA's in 1973, and to establish new ESADDI's
for manganese, fluoride, chromium, and molybdenum (Ref. 2).
It was in response to these scientific advances that FDA proposed
RDI's in the Federal Register of November 27, 1991 (56 FR 60366 at
60390 and 60393) for the nutrients mentioned previously that are
included in the 1980 and the 1989 NAS RDA's but for which RDI's have
not been established (i.e., chloride, chromium, fluoride, manganese,
molybdenum, selenium, and vitamin K). The establishment of RDI's would
have allowed these nutrients to be listed on the nutrition label of
dietary supplements of vitamins and minerals as well of foods in
conventional food form. However, as stated above, section 203 of the DS
act instructed FDA not to promulgate regulations that require the use
of, or that are based upon, recommended daily allowances of vitamins or
minerals before November 8, 1993, other than those specified in
Sec. 101.9(c)(7)(iv), as in effect on October 6, 1992. In accordance
with this provision of the DS act, the agency issued a final rule on
January 6, 1993 (58 FR 2206) that retained the former U.S. RDA values.
As a result, the final rule did not include RDI's for chloride,
chromium, fluoride, manganese, molybdenum, selenium, and vitamin K.
Because the prohibition in section 203 of the DS act has now
expired, the agency is proposing, elsewhere in this issue of the
Federal Register, to establish RDI values for those nutrients listed by
the NAS as being essential to humans and that do not already have RDI
values. The agency is proposing this action because these nutrients are
essential for the maintenance of good health in humans.
In recognition of the essentiality of these nutrients and in
response to the comments summarized above, the agency is requiring in
new Sec. 101.36(b)(3) that chloride, chromium, fluoride, manganese,
molybdenum, selenium and vitamin K be included in the nutrition label
when present in the dietary supplement. The agency also is providing in
Sec. 101.36(b)(4)(vi) that if any of these nutrients are declared, they
are to be followed by an asterisk in the ``Percent Daily Value''
column. The asterisk is to refer to another asterisk that is placed at
the bottom of the table and that is followed by the statement ``Daily
Value not established.'' This action is a logical outgrowth of the
nutrition labeling proposal for dietary supplements because that
proposal put into issue the question of whether the list of nutrients
that FDA proposed be included in the nutrition label under Sec. 101.36
was the appropriate list. The comments have persuaded FDA that the list
needs to be expanded in the manner described in this final rule.
FDA is not persuaded, however, that other trace elements for which
the NAS has not established RDA's or ESADDI's should be declared within
the nutrition label. The comments that suggested that such elements be
included on the label provided some published reports that certain of
these elements have been found to be essential in the diets of various
animals but did not provide sufficient evidence for the agency to
conclude that there is scientific consensus about their essentiality
for the maintenance of good health in humans. The agency strongly
believes that evidence of the usefulness of a nutrient for humans is
necessary before that nutrient can be allowed to be listed within the
nutrition label. This policy is consistent with current
Sec. 101.9(i)(5) (redesignated and revised in the January 6, 1993,
final rules, as Sec. 101.9(k)(5)) which prohibits a food's label from
stating or implying that the food has special dietary properties
because of the presence of a substance when, in fact, the usefulness of
the substance has not been established in human nutrition.
In addition, in its proposed rule on mandatory nutrition labeling
(55 FR 29487 at 29493, July 19, 1990), FDA stated that it was concerned
about the possibility of a large number of nutrients being listed in
nutrition labeling and about the way in which their presence on the
label may be interpreted by consumers. FDA expressed concern that the
presence of a large number of nutrients could be misinterpreted as
implying that a food has a greater public health significance than may
be the case. The potential for this happening and misleading the
consumer about the contribution of the food to human nutrition is
especially likely if the nutrition label were to include nutrients not
known to be important to humans. Therefore, FDA believes that foods
that list such nutrients in the nutrition label would be misbranded
under section 403(a) of the act which prohibits misleading information
on the labels and labeling of foods. However, statements about amounts
and percentages can be made outside of the nutrition label as discussed
in the final rule on nutrient content claims published elsewhere in
this issue of the Federal Register.
The agency is specifying that the new nutrients to be listed appear
in an order that reflects the order that FDA proposed in the nutrition
labeling proposal of November 27, 1991 (56 FR 60390). Vitamin K is to
be listed after vitamin E with the fat soluble vitamins, selenium is to
be listed before copper, and the remaining nutrients (manganese,
fluoride, chromium, molybdenum, and chloride) are to be listed after
copper at the bottom of the list.
The agency points out that it is not allowing the listing of these
nutrients on the nutrition labels of foods in conventional food form.
Under Sec. 101.9(c)(8), quantitative amounts by weight of vitamins and
minerals are not listed within the nutrition label of foods in
conventional food form. As a result, the listing of only an asterisk in
conjunction with the statement ``Daily Value not established'' would
provide consumers with no indication of the amount of chloride,
chromium, fluoride, manganese, molybdenum, selenium and vitamin K
present in the food. Therefore, FDA has not provided in Sec. 101.9 for
a provision comparable to that in Sec. 101.36(b)(3) and (b)(4) that
allows for the placement of these nutrients on the nutrition label.
FDA wishes to point out that Sec. 101.36(a) only requires the label
of a dietary supplement of a vitamin or mineral to bear nutrition
labeling in accordance with the provisions of Sec. 101.36 if the
vitamins or minerals in the supplement have an RDI or DRV. Accordingly,
dietary supplements containing only chloride, chromium, fluoride,
manganese, molybdenum, selenium, or vitamin K need not adhere to
Sec. 101.36 until such time as RDI's are established for them.
2. A couple of comments said that nutrients such as fat and sodium
should not be required to be declared in the nutrition labeling of
dietary supplements of vitamins and minerals. One of these comments
said that dietary supplements are not taken because of their fat or
sodium levels, and that these substances should not be declared. Other
comments specifically supported the proposed rule in requiring that
nutrients of this type be declared when they are present.
The agency is not persuaded that nutrients such as fat and sodium
should not be declared in the nutrition labeling of dietary supplements
of vitamins and minerals when present in significant amounts. The
majority of the comments supported FDA's view that this information is
needed to fully inform consumers of the nutrient content of these
products. Although dietary supplements of vitamins and minerals are not
consumed because of their fat or sodium levels, this type of
information on products that contain significant levels of such
nutrients will assist consumers in maintaining healthy dietary
practices. Therefore, the agency is not making the requested change in
the regulation.
3. A few comments stated that dietary supplements of herbs and of
other nutritional substances should be labeled under Sec. 101.36. One
of these comments said it would be less confusing if all supplements
were labeled in the same manner. Other comments agreed that dietary
supplements of herbs should be labeled in accordance with Sec. 101.9
for foods in conventional food form. However, at least one comment
requested that dietary supplements of herbs be exempt from declaring
the ``core'' nutrients if they have to be labeled in accordance with
Sec. 101.9, and another comment said that these dietary supplements
should not have to list ``Percent Daily Values.'' At least one comment
stated that dietary supplements of herbs should have their own format
for nutrition labeling, and a few other comments requested that dietary
supplements of herbs be exempt from all nutrition labeling. One of
these comments agreed that FDA did not have the authority to exempt
dietary supplements of herbs from Sec. 101.9 and wanted an amendment to
the 1990 amendments that would exempt these dietary supplements from
nutrition labeling. This comment said that dietary supplements of herbs
are not normally consumed for their nutritive value, and that nutrition
labeling on these products is irrelevant and unimportant to consumers.
As explained in the nutrition labeling proposal for dietary
supplements (58 FR 33715 at 33716, June 18, 1993), the difference in
the labeling of dietary supplements of vitamins or minerals and of
dietary supplements of herbs and of other similar nutritional
substances is a result of section 403(q)(5)(F) of the act. As stated
above, this section provides that if a food to which section 411 of the
act applies (i.e., a dietary supplement of vitamins or minerals)
contains one or more of the nutrients required to be listed in
nutrition labeling, the label or labeling of such food is to comply
with the requirements of section 403(q)(1) and (q)(2) of the act in a
manner that FDA determines, by regulation, is appropriate for such
food. Other dietary supplements are not subject to section 403(q)(5)(F)
of the act and thus are subject to regulation under section 403(q) of
the act in the same manner as any other food. There is nothing in the
1990 amendments, or elsewhere in the act, that would allow the agency
to exempt the broad category of dietary supplements of herbs and of
other similar nutritional substances from section 403(q)(1) and (q)(2)
of the act. Thus, supplements that are not dietary supplements of
vitamins and minerals are appropriately subject to nutrition labeling
under Sec. 101.9.
Under Sec. 101.9, the nutrition label of dietary supplements of
herbs and of other similar nutritional substances may be presented in
either a full or simplified format as specified in Sec. 101.9(d) or
(f). The simplified format in Sec. 101.9(f) may be used when a
supplement of herbs or of other similar nutritional substances contains
insignificant amounts of seven or more of the following nutrients:
Calories, total fat, saturated fat, cholesterol, sodium, total
carbohydrate, dietary fiber, sugars, protein, vitamin A, vitamin C,
calcium, and iron.
FDA is not persuaded that nutrition labels on dietary supplements
of herbs using the simplified format should be exempt from the
requirement to declare the ``core'' nutrients (i.e., calories, total
fat, sodium, total carbohydrate, and protein). The agency has stated
its belief in the mandatory nutrition labeling final rule (58 FR 2079
at 2142) that this core information is essential to aid consumers in
learning about the relative nutritional qualities of all foods, and the
information allows consumers to judge the consequences of the food
selections they make. No new information was presented in the comments
to change FDA's position on this issue.
The agency also advises that Sec. 101.9(j)(4) provides that foods
subject to Sec. 101.9, including dietary supplements of herbs and of
other similar nutritional substances, are exempt from nutrition
labeling requirements when all of the nutrients required to be declared
under Sec. 101.9(c) are absent or are present in insignificant amounts.
FDA is also not persuaded that nutrition labels on supplements of
herbs should be excused from listing ``Percent Daily Values.'' As
called for in section 2(b)(1)(A) of the 1990 amendments, a primary
purpose of the nutrition label is to help consumers make informed food
choices by enabling them to both comprehend the nutritional value of
the food and to understand its relative significance in the context of
the total daily diet. The consumer research that the agency reviewed in
the mandatory nutrition labeling final rule supports FDA's assertion
that the listing of percent Daily Value improves consumers' abilities
to make correct dietary judgments about a food in the context of a
total daily diet (58 FR 2079 at 2125). In part, this improved ability
to make judgments is achieved by the use of a consistent system of
percentages, so that virtually all the nutrients on the label can be
declared in equivalent units. Also, the percentages communicate
information about the nutrient level in a food without the consumer
having to be concerned about the absolute level or units of the
underlying scale being used.
Therefore, for the reasons stated, the agency has not acceded to
the requests that dietary supplements of herbs and of other similar
nutritional substances be labeled under Sec. 101.36, have their own
format for nutrition labeling, be exempt from all nutrition labeling,
or be exempt from declaring the ``core'' nutrients and the ``Percent
Daily Values'' in Sec. 101.9.
4. One comment requested that the language of Secs. 101.36(a) and
101.9(j)(6) be revised to refer to ``dietary supplements that are
represented as a source of vitamins and minerals,'' instead of
``dietary supplements of vitamins and minerals.'' This comment was
concerned that alfalfa tablets that have calcium as a binder would be
required to be labeled under Sec. 101.36.
The agency would like to make clear that it does not consider a
product that contains a substance that is a vitamin or a mineral, but
that is used in the food solely for technological purposes, to be a
dietary supplement of a vitamin or mineral because of the presence of
that substance. In these circumstances, the product would not be
represented as supplying a vitamin or mineral (see section 411(c) of
the act). Thus, alfalfa tablets that have calcium as a binder would be
required to be labeled under Sec. 101.9.
5. A few comments requested clarification of the type of nutrition
labeling that would be required for ``combination'' products that
contain herbs with added vitamins.
The agency advises that the type of nutrition labeling that would
be required for products that contain herbs and added vitamins would
depend upon the contents of the product as well as how the product is
represented. If a ``combination'' product is primarily a dietary
supplement of vitamins and minerals and is marketed as such, the
product would have to be labeled in accordance with Sec. 101.36. If the
product is not primarily a dietary supplement of vitamins or minerals
and is not represented as such, it would have to be labeled in
accordance with Sec. 101.9. The agency believes that the manufacturer
makes the determination as to whether a product is primarily a dietary
supplement of an herb, of vitamins or minerals, or of a ``similar
nutritional substance'' based on how it labels and formulates the
product.
The types of claims that are made on a dietary supplement will both
determine, and be limited by, whether it is a dietary supplement of
vitamins or minerals or of herbs or of other nutritional substances.
Section 411(b)(2)(B) of the act states that the labeling and
advertising for dietary supplements of vitamins and minerals may not
give prominence to or emphasize ingredients that are not vitamins,
minerals, or represented as a source of vitamins or minerals. Thus, if,
for example, a dietary supplement of an herbal extract adds vitamins
and minerals yet remains primarily a dietary supplement of the herbal
extract and is advertised as such, section 411(b)(2)(B) of the act
would not apply to the product. This would be the case when the label
of such a product made no reference to any added vitamins or minerals
other than in the ingredient list and nutrition label. Section
411(b)(2)(B) is discussed in more detail in the companion document on
nutrient content claims for dietary supplements, which is published
elsewhere in this issue of the Federal Register.
6. One comment requested that the language of Sec. 101.36(a) be
revised to delete ``and labeling.'' The comment says that nutrition
labeling is not required on labeling under Sec. 101.9.
The agency agrees with this comment and is revising the first
sentence of Sec. 101.36(a) to delete the words ``and labeling,''
thereby requiring that the required nutrition information appear on the
label of dietary supplements of vitamins and minerals. FDA notes that
Sec. 101.9(a)(2) allows the required nutrition information to be placed
on labeling of foods in conventional food form when such foods are not
in packaged form. The types of labeling that are identified in
Sec. 101.9(a)(2) and that allow the required information to be clearly
displayed at the point of purchase are counter cards, signs, tags
affixed to the product, booklets, looseleaf binders, and other
appropriate devices. The only manner in which the agency envisions that
dietary supplements of vitamins and minerals would not be sold in
packaged form is when they would be sold directly from bulk containers.
If and when dietary supplements of vitamins and minerals are sold in
this manner, Sec. 101.36(g) specifically provides that they are subject
to the special labeling provisions in Sec. 101.9(j)(16) for foods sold
from bulk containers. Section 101.9(j)(16) allows for the required
nutrition information to be displayed to consumers either on the
labeling of the bulk container plainly in view or in accordance with
Sec. 101.9(a)(2).
III. Nutrition Labeling of Dietary Supplements
A. Serving Size Information
7. At least one comment stated that information on serving size is
not needed because it is given in the directions for use. Other
comments supported the proposed rule stating that serving size
information should be declared in the nutrition label.
The agency believes that information on serving size is as
essential on the nutrition label of dietary supplements of vitamins and
minerals as it is on that of foods in conventional food form. First,
this information may not be given in the directions. For instance, the
directions may state ``take 3 tablets a day'' without indicating if
they are to be taken at one setting as one serving or spread out
throughout the day in three separate servings. Thus, it is fair to
conclude that in many instances the serving size will not be
duplicative.
Additionally, this information quickly informs the consumer about
the amount of the product that contains the levels of nutrients
declared. It also provides a degree of consistency between the
nutrition labels of dietary supplements of vitamins and minerals and
those of foods in conventional food form. FDA concluded in the
mandatory nutrition labeling final rule that if the nutrition label was
to be readily observable and comprehensible, it must be presented in as
consistent a manner as possible from label to label (58 FR 2079 at 2136
and 2139). This consistent look to the required nutrition information
on packages of both dietary supplements of vitamins and minerals and
foods in conventional food form will help consumers to find and
recognize the information. Consistent treatment is important for the
effective use of the nutrition label by consumers. As a result, the
agency is not changing Sec. 101.36 to delete the requirement for
serving size information.
8. One comment stated that the reference amounts for dietary
supplements should be specified in absolute terms but did not provide
any data. The comment argued that absolute amounts are needed so that
if comparative claims are made, one product recommending consumption
of, for example, one tablespoon per day is not compared to a product
recommending five tablespoons per day. A few other comments supported
the proposed definition for reference amounts.
The agency has defined the reference amount customarily consumed
for a dietary supplement in Sec. 101.12(b) as ``the maximum amount
recommended on the label for consumption per eating occasion or, in the
absence of recommendations, one tablet, capsule, packet, or
teaspoonful, as appropriate.'' As discussed in the nutrition labeling
proposal on dietary supplements (54 FR 33715 at 33716), the agency
relied upon labeling recommendations in this definition because it
believed that consumption is determined in large part by the amount
recommended on the label of these products, and it lacked the data to
specify absolute amounts. The agency requested comments on this
approach in the proposal. No comments provided data for the agency to
use in determining absolute amounts that could be used as reference
amounts. Therefore, the reference amount for dietary supplements will
continue to be based on labeling recommendations.
The agency does not agree with the comment that absolute amounts
are needed to prevent a product with a 1 tablespoon serving from being
compared to a product with a 5 tablespoon serving. Lacking data to the
contrary, the agency must assume that the recommended amount on the
label is the amount customarily consumed. Based on that assumption, it
is consistent with Sec. 101.13, General Principles for Nutrient Content
Claims, which provides for comparative claims to be based on reference
amounts customarily consumed. This topic as it relates to comparative
claims is further discussed in the companion document on nutrient
content claims for dietary supplements, published elsewhere in this
issue of the Federal Register.
9. A few comments stated that the term ``Serving Size'' is
confusing on dietary supplements. A few comments had questions about
the determination of serving size, and one of these comments requested
that the term ``Recommended Intake'' be used instead of the term
``Serving Size.'' Another comment suggested that the term ``Minimum
Recommended Serving Size'' be used when the label directions specify a
range of possible intakes for a product (e.g., two to three tablets per
day). This comment was concerned that ``someone reading only the
nutritional information portion of the label will think that the
serving amount listed there is the recommended amount when it is really
the maximum recommended amount.'' Other comments disagreed with this
position and supported the proposed rule which stated that the serving
size should refer to the maximum amount when a range is specified for a
product.
One comment asked what the serving size is when the label
recommends one to four tablets per day. This comment also asked about
serving size when the label recommends two tablets a day. Another
comment supported the statement in the proposal that if there is no
amount recommended on the label, the serving size is one unit of the
supplement. This comment observed that the issue arises as to how a
determination can be made of ``servings per container'' if there is no
recommendation as to serving size. The comment stated that this issue
needs to be considered to avoid a regulatory gap.
The agency is not persuaded that a term other than ``serving size''
should be used to describe the basis for nutrient declaration for
dietary supplements. It would be confusing for consumers if dietary
supplements of vitamins and minerals used a term such as ``Recommended
Intake'' and other foods used the term ``Serving Size.'' As discussed
in the nutrition labeling proposal on dietary supplements (58 FR 33715
at 33716), the agency proposed that the nutrition labeling of vitamin
or mineral supplements be presented in a manner that is as similar as
possible to the nutrition labeling of other foods. The agency believes
that use of the same term on all labels will help to avoid confusion.
As use of the new nutrition label becomes more widespread, and
consumers become familiar with it, they will come to understand that
the serving size represents the amount of product that they are likely
to consume in one eating occasion. Thus, they will come to understand
that for a dietary supplement, the serving size represents the amount
of that product that they are likely to consume at those times that
they decide to take the supplement.
As explained in the proposal of June 18, 1993 (58 FR 33715 at
33716), the agency believes that it is more useful for consumers to
have the serving size be based on the maximum amount recommended, and
to have the nutrition information be reported on this basis, than to
have serving size be based on the minimum or the average amount.
However, in some cases, the serving size is the same regardless of
whether the maximum or minimum amount is used. For example, if label
directions recommend a range of one to three tablets per day, the
serving size is one tablet based on the fact that there are three
separate eating occasions per day. If label directions recommend a
range of one to four tablets per day, the serving size is also one
tablet given the rounding rules (i.e., four divided by three, rounded
off to one). As for the question what is the serving size if the label
recommends two tablets per day, the serving size would also be one
tablet because of rounding. In the absence of recommendations on the
label, a serving size of one unit is appropriate for determining the
``Serving Size'' and the ``Servings Per Container.''
When the serving is one unit, the number of servings per container
would duplicate the number of units declared on the principal display
panel. To avoid redundancy the agency is providing in
Sec. 101.36(b)(2), as proposed, that information on servings per
container need not be provided when the identical information is stated
in the net quantity of contents declaration. However, dietary
supplements in liquid or powdered form will have to declare ``Servings
Per Container'' because the net quantity of contents information will
be reported in net volume or net weight measures, such as fluid ounces
or grams (g), while the serving size will be expressed in common
household measures, such as teaspoonfuls.
In conclusion, the agency has reexamined the proposed rule with
respect to these comments on serving size and believes that no changes
are needed.
B. ``Amount Per Serving''
10. A few comments stated that nutrition information should not be
reported on the basis of ``per serving.'' These comments requested that
the heading ``Amount Per Serving'' be replaced by the term ``Amount Per
Day'' or by the terms ``Amount Per Tablet'' or ``Each Tablet
Contains.''
The agency does not agree with the comment that nutrition
information should be reported as ``amount per day.'' As explained in
the nutrition labeling proposal for dietary supplements (58 FR 33715 at
33717), the agency proposed in the November 27, 1991, document (56 FR
60366 at 60383) that nutrition information be presented under the
heading of ``Per Unit,'' but that when label directions specified that
more than one unit be consumed during a day, it also be presented under
the heading of ``Per Day'' (i.e., dual declaration). The agency
proposed dual declaration when more than one unit was to be consumed
per day to more fully inform consumers.
The agency received a number of comments opposing the dual
declaration of nutrition information on supplements. Some of these
comments supported declaration on the basis of ``per day'' because they
believed that it is the total daily amount of nutrients that is
important. Other comments favored a ``per unit'' basis because some
consumers may deviate from the recommended intake, or the intake may be
presented as a range. In the preamble of the mandatory nutrition
labeling final rule of January 6, 1993 (58 FR 2079 at 2168), the agency
stated that dual declaration may create a readability problem for
consumers, and that in general a ``per unit'' approach was more useful
than a ``per day'' approach.
In the nutrition labeling proposal for dietary supplements (58 FR
33715 at 33717), however, the agency took a different approach. It
stated that it had tentatively concluded that declaration on the basis
of ``per serving'' is preferable because reporting information solely
on a ``per unit'' basis could confuse consumers when more that one unit
is to be consumed at one time (e.g., two capsules with each meal). The
agency expressed concern that if consumers do not notice or do not
understand the heading that states ``per unit,'' they might assume that
the information is for the amount specified for consumption at one time
(i.e., ``per serving''), particularly because information for foods in
conventional food form is expressed on a ``per serving'' basis.
Furthermore, the agency tentatively concluded that consistency with the
labeling of foods in conventional food form in this regard is the best
approach because it will reduce consumer confusion (58 FR 33715 at
33717).
Inasmuch as most of the comments supported the proposed rule on
this issue, and comments opposing did not provide any information
demonstrating that there is enhanced consumer understanding or ease of
use when information is expressed on a daily basis, the agency is not
changing Sec. 101.36(b)(3) in response to these comments. FDA has
reconsidered its position in response to comments requesting use of the
terms ``Amount Per Tablet'' and ``Each Tablet Contains,'' however, in
light of the comments. The agency concludes that where the serving size
is one tablet, there is little, if any, chance for misunderstanding if
either of these terms is used in place of the term ``Amount Per
Serving.'' Therefore, the agency is revising Sec. 101.36(b)(3) to state
that when the serving size of the product is one unit, a heading
consistent with the declaration of serving size, such as ``Amount per
Tablet'' or ``Each Tablet Contains,'' may be used in lieu of ``Amount
Per Serving.'' Other appropriate terms, such as ``capsule,''
``packet,'' or ``teaspoonful,'' may be used in place of the term
``Serving.'' While a consistent change in Sec. 101.9(d)(4) appears
reasonable, FDA believes that it is necessary to address such a change
through notice-and-comment rulemaking. The agency intends to propose
such a change in the near future.
C. Nutrient Information
1. Listing of Nutrient Names and Amounts
11. Several comments recommended that information on the
quantitative amount by weight for the nutrients listed should be
presented in a separate column, rather than immediately following
nutrient names. These comments stated that some consumers buy on the
basis of amounts, using them to make product comparisons, and that
separate columns would help consumers to more readily locate this
information. An additional comment requested that information on
amounts be presented either in a separate column or after the ``Percent
Daily Value'' in parenthesis. On the other hand, several comments
supported the proposed rule, arguing that the format for dietary
supplements of vitamins or minerals should follow the format for foods
in conventional food form.
The agency disagrees with the recommendation that information on
the quantitative amount by weight for the nutrients listed should be
presented in a separate column. The agency observes that space on the
label is conserved by not requiring a separate column. Furthermore, FDA
believes that the comprehensibility of this information will be
enhanced when it is presented immediately next to the name of the
nutrient. As discussed in the mandatory nutrition labeling final rule
(58 FR 2079 at 2117), multiple column nutrient information displays are
much more difficult than single column displays for consumers to use
for product comparisons. Both FDA's first experimental format study and
the major industry format study found that declaring nutrient amounts
per serving in adjacent columns of grams per milligram (g/mg) amounts
and percent Daily Value led consumers to make more mistakes and to take
longer on the product comparison type of task (Refs. 3 and 4). FDA's
second experimental study, however, showed that when g/mg nutrient
amount information was placed immediately next to the nutrient name in
an unordered array, and percents were placed in a column array, the
adverse effects on product comparison performance disappeared (Ref. 5).
Thus, the agency is requiring in Sec. 101.36(b)(3) that the name of
each nutrient listed shall be immediately followed by the quantitative
amount by weight of the nutrient, to be consistent with
Sec. 101.9(d)(7)(i).
12. A few comments requested that only the calcium portion of
calcium gluconate be listed in the nutrition panel and on the principal
display panel. Similarly, another comment requested that the agency
clarify that vitamin B6 refers to pyridoxine, not pyridoxine
hydrochloride.
The agency wishes to emphasize that the declaration of the
quantitative amount by weight in the nutrition label is to indicate the
weight of a particular nutrient and not the weight of the salt of that
nutrient used to make the supplement. For example, only the calcium
portion of calcium gluconate is to be declared in the nutrition label,
although in some circumstances the weight of the whole substance may
appear on the principal display panel if it clearly refers to the whole
substance, such as when the statement of identity states ``calcium
gluconate, 600 mg.'' Similarly, only the pyridoxine portion of
pyridoxine hydrochloride is to be declared in the nutrition label. The
agency believes that no changes in Sec. 101.36 are necessary based on
these comments.
13. One comment recommended that biotin and folate be declared in
terms of micrograms (g), not mg, and that calcium and
phosphorus be declared in terms of mg, not g. The comment stated that
consumers are more familiar with these nutrients being expressed in
this manner.
FDA proposed on July 19, 1990 (56 FR 29476) to change to the units
suggested in this comment. However, section 203 of the DS act
prohibited FDA from adopting any reference values for vitamins and
minerals different from the U.S. RDA's contained in
Sec. 101.9(c)(7)(iv), as in effect on October 6, 1992, until after
November 8, 1993. Accordingly, FDA adopted those U.S. RDA values as the
RDI's, with biotin and folate expressed in terms of mg and calcium and
phosphorus expressed in terms of g.
Since the prohibition in section 203 of the DS Act has now expired,
the agency is proposing elsewhere in this issue of the Federal Register
to amend Sec. 101.9 to change the units of declaration for biotin and
folate to g and for calcium and phosphorus to mg. This
proposal responds fully to the comment.
14. One comment was opposed to the agency's proposal, in
Sec. 101.36(b)(3), to allow amounts of protein below 1 g to be left off
the nutrition label. This comment requested that such amounts of
protein be declared because individuals who are highly sensitive to
monosodium glutamate (MSG) may have adverse reactions.
FDA has recognized that certain individuals are sensitive to MSG
and believes that the appropriate means to convey the presence of this
ingredient to consumers is by use of the ingredient statement because
MSG is a food ingredient. The agency reiterates that dietary
supplements of vitamins and minerals are required to comply with
Sec. 101.4 (21 CFR 101.4), which requires full ingredient labeling of
food. Furthermore, in the Federal Register of January 6, 1993, the
agency proposed changes in the regulations pertaining to ingredient
labeling to accommodate those individuals who are sensitive to MSG.
Proposed Sec. 101.22 (58 FR 2950) would require that when the amount of
free glutamate in hydrolyzed protein reaches a specified level, the
declaration in the ingredient statement must include the parenthetical
``(contains glutamate).''
The agency has reexamined proposed Sec. 101.36 in response to this
comment and notes that there is an inconsistency in the labeling of
protein, total carbohydrate, and dietary fiber between Sec. 101.9 and
proposed Sec. 101.36. For example, 0.5 g to 0.99 g of these substances
in a dietary supplement of a vitamin or mineral would not be declared
under proposed Sec. 101.36(b)(3), yet these amounts in a food in
conventional food form would be declared either as ``1 g'' or ``less
than 1 g'' under Sec. 101.9(c). To correct this inconsistency, the
agency is modifying Sec. 101.36(b)(3) to provide that amounts of
nutrients that can be declared as zero in the nutrition label of foods
in conventional food form shall not be declared in the nutrition
labeling of dietary supplements of vitamins and minerals. Thus, the
agency is requiring the declaration of protein, as well as total
carbohydrate and dietary fiber, when they are present in amounts of 0.5
g to 1 g. Amounts under 0.5 g would continue to not be listed in the
nutrition label of dietary supplements of vitamins and minerals,
because these amounts would allow a declaration of zero in the
nutrition labeling of foods in conventional form.
15. One comment recommended that ``active'' ingredients present at
less than 2 percent of the Daily Value be allowed to be listed in the
nutrition label.
The agency is not allowing vitamins and minerals (except sodium and
potassium, which are not included in Sec. 101.9(c)(8)(iv)) present at
less than 2 percent of the Daily Value to be listed because the
declaration of such amounts would be misleading. Such values are
insignificant under Sec. 101.9(f) and may be declared as 0 percent of
the RDI in the nutrition labeling of foods in conventional food form.
They are amounts that are dietetically trivial and physiologically
inconsequential. In addition, FDA is concerned that some consumers will
be misled by the mere presence of names of nutrients within the
nutrition label, because they would assume that products with more
nutrients listed have a greater public health significance than those
with less, regardless of the amount of each nutrient present.
The agency is unaware of any reason, nor does the comment present
any reason, for allowing the declaration of nutrients that are present
in such small amounts. Thus, the agency is making no change in response
to this comment.
16. One comment requested that FDA revise Sec. 101.36(b)(3)(i) to
more clearly state the increments to be used for expressing the
quantitative amounts by weight of vitamins and minerals. Another
comment stated that amounts should not be rounded. This comment stated,
``We really see no reason why products should not be formulated to
contain the amounts stated on the label, subject to reasonable overages
based on shelf-life considerations and the like and reasonable
analytical variation.''
The agency inadvertently did not address the increments to be used
for expressing the quantitative amounts by weight of vitamins and
minerals. Proposed Sec. 101.36(b)(3)(i) stated that amounts of vitamins
and minerals are to be expressed in the increments specified in
Sec. 101.9(c) using the units of measure and the level of significance
given in Sec. 101.9(c)(8)(iv), except that zeros following decimal
points may be dropped. While the agency is adopting this rule, FDA
recognizes that, as the comment points out, Sec. 101.9(c) does not
address the question of the increments in which the quantitative
amounts of vitamins and minerals are to be declared because in the
nutrition labeling of foods in conventional food form, vitamins, and
minerals are declared only as a percentage of the Daily Value. The
quantitative amounts by weight of these nutrients, except for potassium
and sodium, which are considered electrolytes, are not required in the
nutrition label of conventional foods.
The agency has considered this issue and notes that dietary
supplements, unlike most foods in conventional food form, are
fabricated to contain specific amounts of vitamins and minerals. It is
for this reason that the vitamins and minerals in dietary supplements
are categorized as Class I nutrients, and that under Sec. 101.9(g)(4),
a food is misbranded if it contains less of an added vitamin or mineral
than the amount declared on the label. In view of how dietary
supplements of vitamins and minerals are made, the agency agrees that
it makes no sense to permit the amounts of vitamins and minerals in
such products to be rounded and declared only in specified increments.
Therefore, the agency has modified Sec. 101.36(b)(3)(i) to provide that
the actual amounts of vitamins and minerals in the supplement are to be
declared using the units of measure specified in Sec. 101.9(c)(8)(iv),
except that zeros following decimal points may be dropped.
With respect to levels of significance, that is, the number of
decimal places used in declaring amounts, the agency proposed that only
the levels of significance shown in Sec. 101.9(c)(8)(iv) could be
presented. In some cases, however, the number of decimal places allowed
is not sufficient to express actual amounts of certain vitamins and
minerals because the amounts are very small. For example, a product
that contains 10 percent of the Daily Value for copper would contain
0.2 mg of copper. If the amount of copper had to be expressed using the
same level of significance as that used in Sec. 101.9(c)(8)(iv) for
expressing its RDI (i.e., 2 mg), the lowest amount that could be
declared would be 1 mg, which would be inaccurately high.
To ensure that amounts of vitamins and minerals that have
nutritional significance can be declared, the agency is modifying
Sec. 101.36(b)(3)(i) to provide that amounts shall be expressed in the
increments specified in Sec. 101.9(c), except that 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 mg, but the quantitative amount may be declared in
tenths of a mg). Additionally, the agency is modifying
Sec. 101.36(b)(3)(i) to describe how amounts of the nutrients from NAS'
9th and 10th editions (Refs. 2 and 10) for which RDI's have not been
established are to be declared. Amounts for chloride, fluoride, and
manganese shall be expressed in mg, and amounts for chromium,
molybdenum, selenium, and vitamin K shall be expressed in g.
These values shall be expressed in whole numbers, except that tenths
may be used for fluoride. These values reflect the amounts in which the
RDI's or EASDDL's for these nutrients are given (Refs. 2 and 10).
17. One comment stated there was an apparent inconsistency between
the requirement in Sec. 101.36(b)(3)(ii) that nutrients ``be listed in
the order specified in Sec. 101.9(c) except that calcium and iron, when
present, should be grouped with other minerals,'' and the sequence of
vitamin D and vitamin E in the examples provided in Sec. 101.36(c)(8).
The comment recommended that the appropriate order of nutrients be
clarified in the regulations.
While FDA finds no inconsistency with the sequence of vitamin D and
vitamin E in the sample labels provided in Sec. 101.36(c)(8), the
agency points out that there was an error in the order of nutrients in
Sec. 101.9(c)(8)(iv) in the Federal Register of January 6, 1993 (58 FR
2227). FDA published a correction in the Federal Register of April 1,
1993 (58 FR 17104), which listed the order as follows: Vitamin A,
vitamin C, calcium, iron, vitamin D, vitamin E, thiamin, riboflavin,
niacin, vitamin B6, folate, vitamin B12, biotin, pantothenic acid,
phosphorus, iodine, magnesium, zinc, and copper. This order is the one
used by FDA in the June 18, 1993, proposal on nutrition labeling of
dietary supplements of vitamins and minerals, except that calcium and
iron were listed with the minerals, following pantothenic acid.
The agency wishes to make these regulations as clear as possible.
Therefore, in response to the comment's request for clarification of
the appropriate order of nutrients, and to make clear where in the list
to include the nutrients that have no RDI but that are required to be
included in the nutrition label on dietary supplements of vitamins and
minerals when they are present, FDA is revising Sec. 101.36(b)(3)(ii)
to specify the exact order in which vitamins and minerals are to be
declared (see section II. comment 1. of this document). Any nutrients
not present in the supplement, or present at insignificant levels, must
be omitted from the list.
18. At least one comment requested that vitamins be listed in
alphabetical order. Another comment requested that calcium and
magnesium be the first minerals to be listed.
The agency has not accepted these suggestions. As discussed in the
nutrition labeling proposal for dietary supplements (58 FR 33719), with
the exception of calcium and iron, FDA proposed in
Sec. 101.36(b)(3)(ii) that nutrients declared in the nutrition labeling
of vitamin or mineral supplements be listed in the order that nutrients
are listed in the nutrition labeling of foods in conventional food
form. The agency proposed that calcium and iron be listed after the
listing of any vitamins that are present so that all of the vitamins
will be grouped together. While vitamin A and vitamin C are to be
listed first, consistent with Sec. 101.9(c), they are then followed by
the fat-soluble vitamins, then the water-soluble vitamins and the
minerals. The NAS in its RDA publications has traditionally grouped the
fat-soluble vitamins ahead of the water-soluble vitamins. The agency
notes that this order is followed on the labels of many vitamin
supplements in the marketplace. The comment requesting alphabetical
order gave no convincing justification for following a different order,
and, thus, FDA is not changing the order.
Additionally, the comment requesting that calcium and magnesium be
the first minerals to be listed presented no reason for the agency to
make this change. Calcium and iron are required to be the first
minerals listed on the labels of foods in conventional food form. In
the absence of any reason for why calcium and magnesium should be the
first minerals to be declared on the labels of supplements of vitamins
and minerals, the agency is making no change in the order for minerals.
19. One comment requested that Sec. 101.36(b)(3)(ii) be revised to
require that potassium be listed with the other minerals, preferably
last on the list. This comment and others expressed confusion about
whether potassium could be listed and requested clarification. One
comment requested that Sec. 101.36(b)(3) be clarified to allow for the
voluntary listing of potassium in dietary supplements because,
according to the comment, potassium is usually present at less than 100
mg per tablet, primarily because of existing FDA restrictions on
potassium salt preparations.
The agency agrees that the listing of potassium needs
clarification. Potassium is not required to be listed on the nutrition
label of foods in conventional food form. However, it can be listed
voluntarily, and when it is, it is to be listed under sodium, as an
electrolyte rather than with the minerals. In contrast, the agency
proposed that potassium be required to be listed on the nutrition label
of dietary supplements of vitamins and minerals when present in
supplements at more than insignificant amounts (i.e., 5 mg and above),
consistent with the listing of other vitamins and minerals. The agency
knows of no reason why potassium in supplements of vitamins and
minerals should be treated differently from other vitamins and minerals
in these products, and the comment did not provide a reason for why the
listing of potassium should be voluntary rather than mandatory.
Therefore, the agency is not making this change. However, the agency is
modifying the language of Sec. 101.36(b)(3) to make it clear that the
declaration of potassium is required when it is present at more than
insignificant amounts. To this end, FDA has revised the second sentence
of Sec. 101.36(b)(3) to state: ``In addition, potassium * * * shall be
declared, except when present at an amount that allows a declaration of
zero * * *. ''
With respect to the placement of potassium within the nutrition
label, FDA agrees with the comment that the regulation should be
modified. The proposal stated that nutrients that are present shall be
listed in the order specified in Sec. 101.9(c), which would mean that
potassium, as well as sodium, would precede the listing of any other
vitamins or minerals present in a supplement. FDA has concluded that it
is not appropriate and might confuse consumers to have the declaration
of potassium, as well as that of sodium, precede the declaration of
other vitamins and minerals on these labels because traditionally
vitamins have appeared first. The agency agrees with the comment that
it is appropriate for potassium to be listed at the bottom of the list
because it is an electrolyte, and the electrolyte, chloride, is listed
at the bottom. For the same reason, the agency concludes that sodium
should be listed with the other electrolytes. Accordingly, the agency
is revising Sec. 101.36(b)(3)(ii) to state that sodium and potassium
should be listed, in that order, following the electrolyte chloride at
the bottom of the list of minerals.
20. One comment requested clarification regarding the labeling to
be used on a package that has two compartments, each containing a
different supplement to be taken at the same time, three times daily
with meals. The company asked if the regulations permit the information
for both supplements to be reported aggregately in one nutrition label
that has one column of names and amounts and one column of percent
Daily Values. The firm requested that if an aggregate label is not
permitted, the additional nutrition label be permitted in a package
insert. The company also asked how the information should be presented
if children one to four years of age are to take the same amount as
adults, and how it is to be presented if such children are to take half
the amount of adults.
The agency advises that if two supplements are to be taken at the
same time, one unit of each three times daily, the nutrition
information for both supplements must be reported aggregately. In this
situation, the serving size must clearly state that a serving includes
one of each supplement, with one column listing names and the total
quantitative amount by weight for both supplements and another column
containing the total percent Daily Values. If this product is also
represented for use by children one to four years of age, the percent
Daily Values for this age group would have to be presented in a third
column. In the case where the serving size is different for children, a
nutrition label for adults and a separate nutrition label for children
must be used to avoid confusion.
21. A few comments requested that the declaration of the percent of
vitamin A present as beta-carotene be mandatory. These comments argued
that this information is needed to help consumers compare the amounts
of beta-carotene in various products. They stated that this information
would help consumers understand claims such as ``Now with beta-
carotene.'' One of these comments requested the voluntary declaration
of the quantitative amount of beta-carotene in addition to the
percentage of vitamin A present as beta-carotene. This comment stated
that calculations of vitamin A and beta-carotene values are difficult
even for scientists, and that merely providing a percentage will not
allow consumers to readily determine just how much beta-carotene is
present in the product. The comment requested that the amount of beta-
carotene be expressed in mg. Two comments requested that the percent of
vitamin A present as retinol also be mandatory. One of these comments
explained that most people are better off getting their vitamin A from
beta-carotene rather than from retinol because beta-carotene is safer
in high doses and may help reduce the risk of certain cancers, heart
disease, cataracts, and other health problems.
FDA is not persuaded that the declaration of the percent of vitamin
A present as beta-carotene should be mandatory because quantitative
recommendations about the intake of beta-carotene have not yet been
established by the scientific community. In the July 19, 1990,
mandatory nutrition labeling proposal (55 FR 29476 at 29493), the
agency set out the factors that it considered in deciding whether a
nutrient or food component should be mandatory or voluntary in
nutrition labeling:
The agency has proposed to make the declaration of a nutrient or
food component mandatory in nutrition labeling when quantitative
intake recommendations with respect to the nutrient or component are
highlighted in the reports * * * (e.g., ``Reduce total fat intake to
30% or less of calories.'' * * *), and the nutrient or
component is of particular public health significance as defined in
several recent consensus documents * * *. On the other hand, for
those nutrients or food components for which quantitative intake
recommendations are not highlighted but that do have some public
health significance * * *, or for which quantitative recommendations
are available but that are not of pressing public health importance
(e.g., the Recommended Dietary Allowances for several vitamins and
minerals * * *), the agency is proposing to make declaration of the
nutrient or component voluntary.
(55 FR 29487 at 29493.)
The agency concludes that its decision to have the percent of
vitamin A present as beta-carotene be voluntary is consistent with
these guidelines because quantitative intake recommendations have not
been established. On the other hand, if a claim about beta-carotene is
made, information on the percent of vitamin A present as beta-carotene
is needed to help consumers to understand the claim. Therefore, the
agency is modifying Sec. 101.36(b)(3)(iv) to require declaration of the
percent of vitamin A present as beta-carotene when a claim is made
about beta-carotene. The agency tentatively concludes that a parallel
change in Sec. 101.9(c)(8)(vi) for the labels of foods in conventional
food form is appropriate. The agency intends to propose this change in
the near future.
The agency is accepting the comment's suggestion to provide that
when the percent of vitamin A present as beta-carotene is declared, the
quantitative amount of beta-carotene may also be declared voluntarily.
The agency is persuaded by the comment that this information on the
labels of dietary supplements of vitamins and minerals would be useful
to those individuals who are interested in maintaining a certain
quantitative intake of beta-carotene in their diets.
The agency notes that the comment requested that the amount of
beta-carotene be declared in terms of mg. However, the agency is
requiring that international units (IU) be used in place of mg to be
consistent with the declaration of vitamin A. FDA finds the usefulness
of this added information would be reduced if the units used to
quantify vitamin A and beta-carotene levels differ.
Accordingly, the agency is amending Sec. 101.36(b)(3)(iv) to
provide that when the percent of vitamin A present as beta-carotene is
declared, the quantitative amount in terms of IU may also be declared,
e.g., ``Vitamin A 5000 IU (90 percent (4500 IU) as beta-carotene'').
The agency intends to propose a parallel change in Sec. 101.9(c)(8)(vi)
as soon as possible. Until the agency does so, the agency advises that
it is unlikely that it will take enforcement action against foods
regulated under Sec. 101.9 that declare beta-carotene in a manner
consistent withSec. 101.36(b)(3)(iv) as long as they comply with
Sec. 101.9 in all other respects.
Additionally, the provision on type size requirements for the added
statement on beta-carotene in Sec. 101.36(c)(6) is corrected to refer
to paragraph (b)(3)(iv) instead of to (b)(3)(ii). There was an
inadvertent error in this reference in the proposal.
With respect to retinol, the agency concludes that, in accordance
with the guidelines set out above, the declaration of retinol should be
neither mandatory nor voluntary because of the absence of quantitative
intake recommendations and of public health significance. Thus, the
agency is not changing the proposed rule to provide for the inclusion
of retinol in the nutrition label.
22. One comment requested that Sec. 101.36(b)(3)(v) be revised to
``permit common synonyms,'' instead of only the synonyms specified.
This comment stated that allowing all synonyms would provide people
with more information and would ensure that the contents of products
were, in fact, comprehensible to more people. The comment mentioned,
for example, that niacin is known by many as vitamin B3 and vitamin E
by the name alpha-tocopherol. Another comment expressed support for
restricting the use of synonyms to the ones allowed in the proposed
rule.
The agency is not persuaded that the provision on synonyms should
be revised to ``permit common synonyms,'' instead of only the synonyms
specified. The terminology that the agency has recognized is that which
is used in NAS' RDA table (Ref. 2). These include: Vitamin C (ascorbic
acid), thiamin (vitamin B1), riboflavin (vitamin B2), folate (folacin),
and calories (energy). The agency has restricted the use of synonyms to
simplify nutrition labeling and to avoid potential confusion among
consumers. The agency believes that allowing the unrestricted use of
other synonyms will contribute to confusion about the nutrients that
are present in the product. It will also make product comparisons more
difficult because of the absence of consistent terminology. Therefore,
FDA is not making the change requested by the comment.
23. At least one comment requested that the nutrition label of
vitamins with iron, for example, be allowed to highlight the listing of
iron. The comment stated that such highlighting is a useful and
necessary tool to differentiate various product lines.
The agency is not persuaded that the highlighting of iron in the
example described in the comment is necessary for consumers to
differentiate between various product lines because the name, or
statement of identity, of the product must identify the product as a
multivitamin with iron. This identification is sufficient to
differentiate the product from other multivitamin products. As
discussed in the mandatory nutrition labeling final rule (58 FR 2079 at
2138), FDA is not permitting highlighting of this type because it can
be used inconsistently in a way that would be potentially misleading to
consumers. Among products with similar nutrition profiles, some would
highlight certain nutrients and others would not. Consumers could not
depend on the fact that all labels of similar products would look the
same, and the differences in highlighting could undermine the
credibility of the information on the nutrition label and lead to
consumer confusion. Accordingly, the agency is not providing for the
highlighting requested by the comment.
24. A number of comments suggested that the source of a vitamin or
mineral be included in the nutrition label immediately following the
listing of that vitamin or mineral, in a manner similar to the allowed
listing of beta-carotene as a source of vitamin A. One comment stated
that this information should be listed in a separate column entitled
``Source.'' One comment requested that the source information should at
least be optional. The comments stated that if this suggestion is
adopted, it will be unnecessary to repeat source information in the
ingredient statement, and one comment requested that the regulations on
ingredient labeling be revised accordingly. The comments said that this
approach would conserve space and more effectively communicate source
information to consumers.
The agency notes that the parenthetical listing of the source of a
vitamin or mineral in the nutrition label is a common practice by some,
but not all, manufacturers in the dietary supplement industry. The
agency finds, however, that the comments submitted failed to provide
adequate justification and supporting information demonstrating that
adoption, on an industry-wide basis, of this manner of expressing
nutrition and ingredient information would result in a nutrition label
that is readily observable and comprehensible, as required by the act.
Comments have not demonstrated that consumers will be able to
distinguish and understand the meaning of both the nutrition and
ingredient information provided. FDA has no means on which to
determine, for example, whether the name of the source of the nutrient
is indeed that and not the chemical name of the nutrient. The comments
also failed to provide data to demonstrate that this manner of
presentation truly conserves label space, especially if additional
columns are added to the nutrition label. Further, if as suggested by
one comment, source information within the nutrition label were made
optional, the consistency of presentation of information that has been
a guiding principle of the agency throughout the food label reform
efforts would be violated. Accordingly, the agency is not providing for
the parenthetical listing of nutrient source within the nutrition
label.
The agency advises, however, that it would be receptive to a
adequately supported petition on this issue, and that it will act
expeditiously on such petition. Given that, elsewhere in this issue of
the Federal Register, the agency is establishing a date of
applicability of July 1, 1995, for the regulation governing nutrition
labeling of dietary supplements, if a petition is promptly submitted,
that petition could be acted upon before the date of applicability.
Any petition submitted to permit source declaration within the
nutrition label would have to address, in detail, at least the issues
of how the source information is to be consistently and clearly
expressed, and why this manner of expression is advantageous to the
consumer.
Because a primary purpose of the nutrition label is to allow
consumers to compare the nutrition profile of products at the point of
purchase, it is imperative that there be a high degree of consistency
in the presentation of nutrition information for all dietary
supplements. FDA would also need information on precisely how source
information should be expressed within the nutrition label. For
example, how would the source information be expressed if a single
ingredient (e.g., fish liver oil) is a source of a number of nutrients
(e.g., vitamins A and D) within a dietary supplement? If the source is
required to be listed multiple times, how does this conserve label
space? Also, would multiple listing of a source mislead consumers about
the amount of the ingredient in the food? Conversely, if a nutrient in
a supplement is provided from several sources (e.g., iodine from kelp
and potassium iodide), how would this information be clearly and
consistently conveyed? Would the source listed be all sources, or only
the primary source, of the nutrient? If source listing in the nutrition
label were to be limited to the primary source, how would the primary
source be determined? Are safeguards necessary to ensure that consumers
are not misled by inappropriate emphasis on certain sources of
nutrients? For example, how would consumers be fully informed and be
protected from being misled if a nutrient is derived from more than one
source, and only the primary source is listed, particularly if a valued
ingredient provides some, but not all, of the nutrient in question?
Should source information be permitted in the nutrition label only
when there is some significance to the source? For example, because
there are potential safety concerns about high intakes of vitamin A
from some other sources, FDA found that there is was a public health
reason for permitting beta-carotene to be shown as a source of vitamin
A. Should such a finding be a prerequisite for permitting source
labeling? If source labeling is limited to cases in which the source is
significant (e.g., particularly valued sources, concern about other
potential sources), how should such significance be consistently
determined?
Also, any petition on source labeling in the nutrition label should
address the issue of clarity of presentation. Section 2(b)(1)(A) of the
1990 amendments states that the nutrition information should be readily
observable and comprehensible. Would adding information about the
source of nutrients detract from the comprehensibility of the nutrition
label? Given that source information will be available in the
ingredient statement, would source declarations unnecessarily burden
the nutrition label and detract from its primary purpose of providing a
nutrient profile of the product? Would it be more difficult for
consumers to find the listing of the quantitative amounts by weight of
nutrients in the nutrition label when source information is given?
Petitions on this issue would be strengthened by the inclusion of
consumer survey or other similar data showing that consumers readily
observe and comprehend information presented in the manner suggested by
the comments.
As discussed in the mandatory labeling final rule (58 FR 2079 at
2170), dietary supplements of vitamins and minerals, like other foods,
are required to bear a complete list of ingredients. Under section
403(i)(2) of the act, the statement of ingredients must list all
ingredients of these foods, including , for example, lactose and other
fillers, artificial colors, flavors, binders, and excipients, as well
as the source of the vitamins and minerals in the dietary supplement.
This section of the act provides FDA with authority to grant exemptions
from the ingredient listing requirements, but such exemptions have not
been sought by the dietary supplement industry. The agency advises that
the fact that the name of an ingredient appears elsewhere on the label
is not, in and of itself, sufficient justification to grant such
exemptions. Therefore, any petition on this subject must address the
issue of how this manner of presentation of the source of nutrients
continues to fulfill the primary purpose of the ingredient label to
adequately inform consumers about all ingredients used to make a food,
including those that might be of concern because of personal health
reasons (e.g., lactose).
The agency advises that its current policy, as stated in the
Federal Register of August 2, 1973 (38 FR 20730) and March 16, 1979 (44
FR 16005), and in subsequent correspondence with industry (Refs. 6 and
7), is that the label for dietary supplements of vitamins and minerals
must contain a list of nutrients and a separate full statement of
ingredients, except those exempted by section 403(i)(2) of the act,
declared by their common or usual name. This policy is consistent with
the ingredient declaration requirements for other types of products.
Therefore, for all the reasons cited above, FDA has decided not to
take the action requested by these comments, pending receipt and review
of petitions on this issue.
2. Listing of Percent Daily Value
25. The agency received a number of comments that opposed the use
of the term ``Percent Daily Value'' and that stated that they preferred
to continue to use the term ``percent U.S. RDA.''
The agency disagrees with these comments. As explained in the final
rule on RDI's that published in the Federal Register of January 6, 1993
(58 FR 2206 at 2207 and 2208), the agency has established two sets of
label references values (i.e., RDI's, which were previously the U.S.
RDA's, and DRV's). Because the agency believed the use of the two terms
on food labels could be confusing to consumers, it established a single
term, ``Daily Value'' to refer to both the RDI's and DRV's (58 FR 2079
at 2124). The comments did not provide any new arguments or data that
were not considered in that rulemaking. Furthermore, the agency advises
that it knows of no reason why dietary supplements of vitamins and
minerals should not use the terminology prescribed for foods in
general. Consistency in terminology will assist consumers in
maintaining healthy dietary practices by facilitating their use of the
nutrition label to construct a healthy diet that includes both dietary
supplements and foods in conventional food form. Therefore, the agency
is not making any change in the regulations in response to these
comments.
26. One comment requested that the agency eliminate the use of the
term ``RDI'' and use the term ``DRV'' for both macronutrients and
micronutrients. The comment stated that it is confusing to have more
the one term.
The comment appears to be requesting new terms not only for the
nutrition label of dietary supplements of vitamins and minerals but
also for the nutrition label of foods in conventional food form. The
terms ``RDI'' and ``DRV'' were established in the final rule on RDI's
(58 FR 2206).As discussed in the proposed rule of July 19, 1990 (55 FR
29476 at 29479), the distinction between the RDI's and DRV's is
necessary for several reasons. First, the RDI's are based on the RDA's,
which are considered intake levels to be achieved. However, while some
DRV's are based on recommendations to increase or maintain intake of
the particular food component, other DRV's reflect levels that are
limitations on intake. Furthermore, many of the DRV's must be based on
a specific caloric intake, and, unlike the RDI's, the DRV's are not
relevant for infants and young children. Finally, the RDI's serve as
criteria for use in several regulatory functions, such as the
application of the agency's food fortification policy and the
assessment of the nutritional equivalency of imitation foods. The DRV's
do not have such uses. Therefore, FDA believes that it is appropriate
to treat RDI's and DRV's as two different sets of reference values.
However, the agency notes that both terms are referred to as ``Daily
Values'' on the nutrition label. The agency believes that the use of a
single term on the label will limit consumer confusion. Thus, the
concern articulated by the comment is fully addressed by FDA's current
regulatory scheme. Accordingly, the agency is not making the requested
change.
27. One comment requested that products containing 5 to 17 mg of
potassium should be allowed to state, ``Contains less than 1 percent of
the Daily Value of this nutrient.'' The comment explained that 17 mg of
potassium expressed to the nearest whole percent comes to ``0 percent
Daily Value'' (3,500 mg divided by 17, which rounds to zero), yet
Sec. 101.9(c)(5) only allows amounts less than 5 mg to be considered as
zero. As a result, the nutrition label of such a product would state 15
mg potassium and 0 percent Daily Value. The comment expressed concern
that such apparently contradictory statements would be confusing to
consumers.
The comment identifies a concern applicable to dietary supplements
and foods in conventional food form, namely that consumers may find it
confusing when there is a quantitative amount by weight for a nutrient,
and yet the percent Daily Value states 0 percent. This seeming conflict
can occur with sodium, potassium, and total carbohydrate on labels of
both supplements and foods in conventional food form, and with some
vitamins and minerals in dietary supplements, when both quantitative
amounts by weight and percent Daily Values are given. To avoid any
possible confusion that these apparently inconsistent declarations may
cause, the agency is modifying Sec. 101.36(b)(4)(ii) to provide for the
declaration of ``less than 1%'' in the percent of Daily Value column
when the declaration of the quantitative amount by weight is greater
than zero, and the calculation of percent Daily Value yields a value
that is less than 1 percent. The agency believes that a parallel change
in Sec. 101.9(d)(7)(ii) for foods in conventional food form is
appropriate. The agency intends to propose this change in the near
future.
Additionally, the agency notes that, consistent with
Sec. 101.9(d)(7)(ii), as modified in the technical amendments (58 FR
44063 at 44077, August 18, 1993), it is modifying Sec. 101.36(b)(4)(i)
to specify that 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. The agency is
making this change to provide for consistency on the food label between
the percent Daily Value and the quantitative amount by weight. The
agency had previously provided only that the amount declared be used in
the calculation.
28. One comment requested clarification of Sec. 101.36(b)(4)(iii),
which provides that when a product is represented or purports to be for
use by a group other than adults and children older than 4 years of
age, the percent Daily Value for each group must be presented in
separate columns. The comment asked if the label of a product
represented for use ``for the family'' would have to include
information for all of the groups for which FDA has established RDI's.
The agency believes that it is appropriate for the label of a
product represented for use ``for the family'' to include information
for adults and children older than 4 years of age and for children
younger than 4 years of age because families often include children in
this age group. Inasmuch as there generally would be safety concerns in
feeding infants supplements intended for use by adults, FDA also
advises that the statement ``for the family'' should be modified to
specifically exclude infants if a firm wants to include only a single
list of RDI values. The agency does not believe that this comment
requires any change in the language of the proposed rule. However, the
agency advises that for clarity, it has changed the word ``additional''
in Sec. 101.36(b)(4)(iii) to ``separate.''
D. Format
29. One comment requested that the first sentence in
Sec. 101.36(c)(1), ``The title of 'Nutrition Facts' shall be set in
type size larger than all other print size in the nutrition label and,
unless impractical, shall be set full width of the nutrition label,''
be revised to use the term ``nutrition panel'' instead of ``nutrition
label.'' The comment stated that the ``nutrition label'' could be
interpreted to mean the whole label, in which case the phrase
``Nutrition Facts'' would have to be the biggest print on the label.
The agency is not persuaded that this revision is needed. In
proposed Sec. 101.36 and in Sec. 101.9, the agency has consistently
used the term ``nutrition label'' to refer to the nutrition information
set off in a box presented under the heading of ``Nutrition Facts.''
Extensive changes would be required in both regulations to make
consistent changes wherever the term ``nutrition label'' is used.
Because no other comments indicated a similar concern, the agency is
not making the requested change.
30. One comment requested that Sec. 101.36 be revised to clarify
that selective reverse printing may not be used as a form of
highlighting, consistent with Sec. 101.9(d)(1)(iv).
The agency agrees with this comment. It unintentionally failed to
address reverse printing in Sec. 101.36. In the nutrition labeling
final rule, FDA decided not to permit reverse printing as a form of
highlighting because it would interfere with the ``consistent'' look of
the label (56 FR 2079 at 2138). For the same reason, the agency is not
permitting reverse printing on the nutrition labels of dietary
supplements of vitamins or minerals. Accordingly, the agency has
revised the second sentence of Sec. 101.36(c)(1) to read ``The title
and all headings shall be highlighted (reverse printing is not
permitted as a form of highlighting) to distinguish them from other
information.''
31. One comment stated that labels of multivitamin supplements and
multivitamin/multimineral supplements that have a total surface area
available to bear labeling of 10 or less square inches should be exempt
from the requirement in Sec. 101.36(c)(4) that all information within
the nutrition label shall have at least one point leading (i.e., space
between two lines of text). Other comments stated that this provision
of the proposed rule is appropriate.
The agency is not persuaded that the nutrition label on small
labels should be exempt from the requirement of at least one point
leading. This requirement is much less than that required for foods in
conventional food form (e.g., four point is required between nutrients
in Sec. 101.9(d)(1)(ii)(C) and does little more than insure that lines
of text do not touch). As discussed in the nutrition labeling proposal
for dietary supplements (58 FR 33715 at 33721), the agency proposed at
least one point leading because of concerns about legibility. To
maintain a consistent and distinctive format that is legible, some
leading is necessary. Accordingly, FDA is providing for the minimal
leading of one point in the nutrition labeling of dietary supplement of
vitamins and minerals and encourages manufacturers to use more leading
whenever possible. FDA is not making a similar change for dietary
supplements of herbs and of other similar nutritional substances
because comments did not demonstrate space concerns with those products
that would justify such a change.
Many of the changes in this document will help reduce space
requirements (e.g., type size changes). If a manufacturer finds that it
is still technologically infeasible or impracticable to fit the
nutrition label on a particular package, it may write to the Office of
Food Labeling as provided in Sec. 101.36(d)(2).
32. One comment requested that the kerning requirements be deleted,
and that instead, the regulation state that ``letters should never
touch,'' consistent with the technical amendments to Sec. 101.9
published on August 18, 1993 (58 FR 44063 at 44065). Another comment
requested that labels that are less than 10 square inches should be
exempt from the requirement in proposed Sec. 101.36(c)(5) that all
information within the nutrition label shall have type that is kerned
(i.e., has proximity of placement) no tighter than -4 setting. At least
one comment supported this provision of the proposed rule.
The agency agrees that the kerning requirements should be made
consistent with that for the nutrition labels on packages of foods in
conventional food form. As pointed out in a similar comment with
respect to the labeling of foods in conventional food form (58 FR 44063
at 44065), a numeric kerning value (which in effect limits the
proximity of one letter to another) has meaning only for a particular
type setting system. Each such system has a unique numeric scale, and,
as a result, a setting of -4 is meaningless for systems other than the
one that FDA used in designing its sample labels. The agency
acknowledges its error in including a single kerning limit that would
be required for all type setting systems. Accordingly, FDA is revising
Sec. 101.36(c)(5), consistent with Sec. 101.9(d)(1)(ii)(D), to delete
the requirement for a -4 setting and to state that letters should never
touch.
33. A couple of comments supported the provision in proposed
Sec. 101.36(c)(6) regarding type size, but more than ten comments
strongly opposed the provision. The agency proposed to require type
size no smaller than 8 point for nutrient information within the
nutrition label and to allow no smaller than 6 point type for column
headings and footnotes. In addition, the agency proposed to allow no
smaller than 6 point type for all of the information within the
nutrition label of packages having a total surface area available to
bear labeling of 40 or less square inches. The comments said that the
total surface area available for labeling for most dietary supplements
is well under 40 square inches. They stated that the proposed 6 point
minimum type size is far too large for many labels to include all of
the required nutrition information and to still allow space for the
ingredient statement, necessary product codes, lot number, expiration
dates, Universal Product Code (UPC) symbols, front panel copy, and
other information commonly provided on dietary supplement labels. To
alleviate this space problem, a number of comments requested that FDA
allow smaller type size. One comment requested a minimum type size of
3.0 point and another 4.0 point. However, most of the comments
suggested a minimum type size of 4.5 point, which they said is
consistent with the Nonprescription Drug Manufacturers Association
(NDMA) Label Readability Guidelines used for over-the-counter (OTC)
drugs.
The comments were divided about when FDA should allow smaller print
size. A few comments believed that smaller type is needed on labels
having up to 40 square inches of total surface area. Other comments
suggested that such type is necessary on various-sized labels, such as
those with surface areas of less than 25, 15, 12, and 10 square inches.
Finally, a few comments suggested that the regulation should state that
type size should be ``as large as possible,'' or that it should permit
manufacturers to decide for themselves.
After reviewing many dietary supplement labels, the agency is
persuaded that the 6 point minimum type size proposed for nutrition
labeling information is too large for many multivitamin and
multimineral supplement labels. The agency acknowledges that these
products often have many nutrients to declare in the nutrition label,
are often sold in relatively small packages/jars, and include on the
label other information not required for foods in conventional food
form. Therefore, FDA is accepting the recommendation, supported by the
NDMA Label Readability Guidelines, that 4.5 point minimum type size be
allowed on smaller labels. Throughout rulemaking to implement the 1990
amendments, FDA has responded to consumer concerns that the required
nutrition information be presented in a manner that will improve
legibility, particularly to help older and vision-impaired consumers
who otherwise would be effectively denied access to the nutrition
information. Because type size is a major determinant of legibility,
FDA does not believe type sizes less than 4.5 points should be allowed
on package labels and encourages manufacturers to use larger type size
when label space allows.
The agency finds that this minimum type size of 4.5 points is
appropriate on packages having less than 12 square inches of surface
area available to bear labeling. The agency selected less than of 12
square inches of area available to bear labeling as a result of its
review of the comments and because it promotes consistency within food
labeling regulations inasmuch as Sec. 101.2(c)(3)(i) uses this package
size as the standard for exempting small packages of foods from type
size requirements, and Sec. 101.9(j)(13)(i) uses it to differentiate
which food packages may use a telephone number or address for consumers
to use in obtaining nutrition information as the functional equivalent
of a nutrition label if no nutrient content or health claims are made
on the label. The agency also finds that this decision is reasonable
considering the practical need for smaller packages containing
supplements composed of many vitamins and minerals to have smaller
print, and the need for all labels to be as legible as possible.
Therefore, the agency is modifying Sec. 101.36(c)(6) to allow for
packages that have a total surface area available to bear labeling of
less than 12 square inches to use 4.5 point type size. FDA is not
making a similar change for dietary supplements of herbs and of other
similar nutritional substances because comments did not demonstrate the
same space concerns for those products. Additionally, the agency is
correcting Sec. 101.36(c)(6) to refer to paragraph (b)(3) instead of to
(b)(4) and to refer to paragraph (b)(4) instead of to (b)(4)(ii). There
were inadvertent errors in these references in the proposal.
FDA advises that under Sec. 101.36(g), dietary supplements of
vitamins and minerals may also use all provisions allowed in
Sec. 101.9(j)(13) to help accommodate the nutrition label on small and
intermediate-sized packages.
If, despite these provisions, there are still packages for which
there is insufficient area available to print all required information,
the agency advises manufacturers to write to the Office of Food
Labeling, FDA (HFS-150), on a case-by-case basis requesting alternative
means of compliance (e.g., reduced type size or leading) in accordance
with Sec. 101.36(d)(2).
34. One comment requested that all upper case lettering be allowed
for multivitamin and multimineral labels that are less than 25 square
inches in total available surface area to facilitate readability. Other
comments agreed with proposed Sec. 101.36(c)(3), which requires that
all information within the nutrition label utilize upper and lower case
letters.
In the technical amendments published in the Federal Register of
August 18, 1993, the agency modified Sec. 101.9(j)(13)(i)(B) to allow
all upper case lettering to be used on packages of food in conventional
food form that have less than 12 square inches of surface area
available to bear labeling (58 FR 44063 at 44072). To be consistent,
the agency has modified Sec. 101.36(c)(3) to allow packages of dietary
supplements of vitamins and minerals that have less than 12 square
inches of surface area available to bear labeling to use all upper case
lettering. To maximize legibility and to preserve the readily
identifiable image of the nutrition label, FDA is limiting this special
provision to small packages (i.e., those with less than 12 square
inches of surface area) rather than the 25 square inches requested in
the comment.
35. A few comments suggested ways to alleviate space problems other
than by using a smaller type size. One comment wanted to be able to
present the nutrition label on any package panel, to use the tabular or
linear method of listing nutrients, and to use the abbreviations
specified in Sec. 101.9(j)(13)(ii). Another comment requested that the
entire labeling, not just the label on the primary container, be
allowed to be used to relate nutrition information. One comment
requested that all supplements with less than 40 square inches of label
space be exempt from having a large heading entitled ``Nutrition
Facts,'' a box that surrounds the nutrition panel, and the lines that
separate each individual nutrient and the headings. Other comments
requested that the nonfunctional slack-fill regulations be revised to
allow containers to be bigger.
The agency notes that Sec. 101.36(g) provides, in part, that
dietary supplements of vitamins and minerals are subject to, among
other provisions, the special labeling conditions set out in
Sec. 101.9(j)(13) for foods in small and intermediate-sized packages.
Section 101.9(j)(13)(i) defines a small package as one that has a total
surface area available to bear labeling of less than 12 square inches
and allows for the use of an address or telephone number that a
consumer can use to obtain the required information (e.g., ``For
nutrition information, call 1-800-123-4567'') as the functional
equivalent of a nutrition label if no nutrient content or health claims
are made on the label. When foods in small packages either voluntarily
or because of nutrition claims bear nutrition labeling,
Sec. 101.9(j)(13)(i)(B) also allows the use of smaller type size than
that required on larger packages.
Section 101.9(j)(13)(ii) defines an intermediate-sized package as
one that has a total surface area available to bear labeling of 40 or
less square inches. This section of the regulations provides several
additional special labeling provisions to assist manufacturers in
fitting the required information on both small and intermediate-sized
packages. These provisions, which can apply to dietary supplements of
vitamins and minerals in small or intermediate-sized packages, include
using specified abbreviations and presenting the required nutrition
information on any label panel. Additionally, this section provides for
presenting the required information in a tabular (i.e., horizontal)
display or linear (i.e., string) fashion: (1) If the product has a
total surface available to bear labeling of less than 12 square inches,
or (2) 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 column display on any panel. Nutrition information
may be given in a linear fashion only if the label will not accommodate
a vertical or tabular display.
In response to the comment requesting use of labeling, not just the
label on the primary container, to convey nutrition information, the
agency advises that it has traditionally required that all required
information (e.g., the statement of identity, net weight statement,
ingredient list, name and place of manufacture, and nutrition
information) appear on the label of packaged foods. Labeling, which
includes materials not affixed to the package (such as posters,
notebooks, leaflets, and brochures available at the point of purchase),
may become separated from the packaged food and are inappropriate for
the delivery of required information. Therefore, FDA concludes that it
would not be appropriate to grant the request in this comment.
However, FDA considers outer packaging that securely encloses a
primary container and that is not intended to be separated from the
primary container under conditions of retail sale to be the equivalent
of the product label. Therefore, when a bottle containing a dietary
supplement in tablet, granular, or liquid form is placed within a
sealed box, the required information must be present on the outer
container where it is available to the consumer at the point of
purchase. While FDA regulations do not require that the information be
repeated on the primary container inside the box, the agency encourages
manufacturers to do so, so that consumers will have easy access to the
information once the container is removed from the outer box. Likewise,
if supplements are sold in sealed packaging that provides a cardboard
display around the primary container, the full display seen by the
consumer becomes the product label. In these situations, the required
information shall be placed on appropriate panels as directed in
Secs. 101.1 and 101.2, pertaining to the principal display panel and
the information panel, respectively.
It would not be consistent with section 2(b)(1)(A) of the 1990
amendments to allow packaging with less than 40 square inches of label
space to be exempt from graphic requirements such as having the title
``Nutrition Facts'' in the largest print within the nutrition label,
having the required information enclosed within a box, and using
hairlines to separate nutrients and headings. As stated above, the
agency concluded in the mandatory nutrition labeling final rule (58 FR
2079 at 2136) that if the nutrition label was to be readily observable
and comprehensible, it must be presented in as consistent a manner as
possible from label to label. Thus, in establishing the requirements
for the nutrition label, the agency went to great lengths to give the
format a distinctive look (e.g., through the use of a prominent
heading, highlighting of key nutrient information, and enclosure of the
information in a box) to facilitate consumer recognition of the label
and to encourage use of the information. Consistency of appearance
begins to be lost if these graphic elements are omitted on certain
packages. Such action would make it likely that some consumers would
fail to recognize the nutrition information and to understand the
significance of the information that it presented. For this reason, FDA
is not providing the flexibility requested.
However, the agency has reviewed the format requirements in
response to these comments concerned about space problems. To help
alleviate space problems, the agency has concluded that it can provide
for flexibility in the placement of the heading,``% Daily Value.'' When
a dietary supplement contains less than 5 calories per serving,
``Calories'' need not be declared. In this situation, shown in the
sample labels in Sec. 101.36(c)(8) of the proposal (58 FR 33715 at
33728 through 33730), the heading ``% Daily Value'' is placed to the
right and under the bar beneath the heading ``Amount Per Serving.''
Because there is sufficient space on one line for both headings, the
agency is modifying Sec. 101.36(b)(4) to provide that the heading ``%
Daily Value'' may be placed on the same line as the heading ``Amount
Per Serving,'' when calorie information is not required to be declared.
Also, consistent with provisions in Sec. 101.9(d)(11)(i) and (ii)
that allow lower portions of the vertical format to be split and moved
to the contiguous right, FDA is providing in Sec. 101.36(c)(10) that,
if space is not adequate to list the required information in one
vertical list (as shown in the sample labels in Sec. 101.36(c)(9)), the
list may be split and the lower information moved to the right as long
as the headings are repeated. The list to the right should be set off
by a line that distinguishes it and sets it apart from the nutrients
and the percent Daily Value information given to the left. A sample of
this split format is included in Sec. 101.36(c)(10).
The agency is not convinced by the comment that the nonfunctional
slack-fill regulations should be revised to allow containers of dietary
supplements to be larger than otherwise necessary to accommodate the
labeling requirements. As discussed in the final rule on nonfunctional
slack-fill (58 FR 64123 at 64134, December 6, 1993), the agency knows
of no reason for treating dietary supplements differently from foods in
conventional food form. In response to this and the other comments
suggesting ways to alleviate space constraints, the agency advises that
many of the changes that FDA has made from the proposal will help to
reduce space requirements (e.g., reduced type size requirements on
packages of dietary supplements of vitamins and minerals). If
manufacturers find that it is still technologically infeasible or
impracticable to fit the nutrition label on a particular package, they
may write to the Office of Food Labeling as directed in
Secs. 101.9(g)(9) and 101.36(d)(2). The agency points out that any
information, other than the net quantity of contents and statement of
identity, may be printed parallel to the base of a package. Thus, the
nutrition label may be printed parallel to the base of a package, which
may provide more space for this information. However, FDA urges
manufacturers to strive for consistency of presentation of nutrition
information in the market.
36. One comment requested that hairlines be required to separate
lines of nutrient declarations, and that these hairlines be centered
between the lines of text. This comment also requested clarification
that Appendix B to part 101, which is referenced in Sec. 101.36(c)(8),
contains several nonrequired elements, such as Helvetica typeface, at
least 13 point type for ``Nutrition Facts,'' and a specific thickness
for the separating bars on the nutrition label.
As discussed in the nutrition labeling proposal for dietary
supplements (58 FR 33715 at 33716), the agency intends that the
nutrition labeling on vitamin or mineral supplements be presented in a
manner that is as similar as possible to the nutrition labeling of
foods in conventional food form. Hairlines are required in the
nutrition labeling of foods in conventional food form as specified in
Sec. 101.9(d)(1)(v). The agency intended that Sec. 101.36 contain a
similar provision. However, it inadvertently failed to specifically
provide for hairlines in the proposed rule, although it included
hairlines in the samples labels presented in proposed Sec. 101.36(c)(9)
and urged that the graphic specifications set forth in Appendix B to
part 101 be followed. These graphic specifications describe the use of
hairlines under C-2. Accordingly, the agency concludes that it is
appropriate to modify Sec. 101.36(c) to require hairlines in
Sec. 101.36(c)(7) and to redesignate paragraphs (c)(7) and (c)(8) as
paragraphs (c)(8) and (c)(9), respectively, to reflect this
modification. New Sec. 101.36(c)(7) states: ``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 below it,
as shown in paragraph (c)(9) of this section, and shall separate
'Amount Per Serving' from the calorie statement, when the listing of
calories is required.''
With respect to Appendix B, the comment is correct in stating that
Appendix B contains several nonrequired elements, such as Helvetica
typeface, a specified type size for the title ``Nutrition Facts,'' and
a specific thickness for the separating bars on the nutrition label.
The required graphic elements are specified in Sec. 101.36(b) and (c).
37. A couple of comments objected to the bar at the bottom of the
nutrition label and requested that this requirement be deleted. They
stated that it is unnecessary and may interfere with the scanning of
the UPC symbol. Another comment requested that Sec. 101.36(c) be
revised to require a bar following the final vitamin or mineral listed.
Other comments supported the proposal.
In Sec. 101.36(b)(3)(ii), FDA proposed to require a bar at the
bottom of the nutrition label of dietary supplements of vitamins and
minerals to help ensure that the nutrition label on these types of
foods has the same readily identifiable image, or ``look,'' as the
nutrition label on foods in conventional food form (58 FR 33715 at
33719). Comments to the agency's proposed rule on the format for
nutrition labeling (57 FR 32058, July 20, 1992) had argued that a
consistent look to the required nutrition information on food packages
will help consumers find the information on the package and to
recognize it for what it is--a profile of the nutrient content of the
food. These comments convinced FDA that the specific format elements
mandated provide a visually integrated image that will give the
nutrition label a uniform appearance across the various types of
packages in the market and will enhance consumer use of the
information. Nothing in the comments on proposed Sec. 101.36 provide
the basis for a different conclusion. FDA finds that contrary to the
comments' assertion, this bar contributes directly to the consistent
look of the nutrition label. To avoid any possible interference of the
bar at the bottom of the nutrition label with the scanning of the UPC
symbol, manufacturers may design the package layout so that the UPC
symbol is not adjacent to the nutrition label. Accordingly, the agency
is not modifying Sec. 101.36(b)(3)(ii) in response to these comments.
38. One comment requested that bars be required after ``Serving
Size'' and ``Amount Per Serving.''
The agency points out that Sec. 101.36(b)(3) requires that the
heading ``Amount Per Serving'' be separated from other information on
the label by a bar above and beneath it. Thus, the upper bar will be
beneath the declaration of ``Servings Per Container'' or, when
``Servings Per Container'' is not required, of ``Serving Size.'' The
lower bar would separate the declaration ``Amount Per Serving'' from
the heading ``Percent Daily Value.'' The agency notes that this bar
should follow information on calories, when that information is
declared (i.e., when the dietary supplement of vitamins and minerals
contains 5 or more calories), to be consistent with the labeling of
foods in conventional food form (Sec. 101.9(d)(6)). However, the agency
inadvertently failed to specify in the proposed rule where this bar
should be placed. As discussed in the nutrition labeling proposal for
dietary supplements (58 FR 33715 at 33716), the agency intended that
the nutrition labeling on vitamin and mineral supplements be presented
in a manner as similar as possible to the nutrition labeling of foods
in conventional food form. Therefore, FDA finds that it is the logical
outgrowth of the proposal to specify in this final rule where the bar
following ``Amount Per Serving'' should be placed when information on
calories is declared in a nutrition label for a dietary supplement of
vitamins or minerals. Accordingly, the agency is modifying
Sec. 101.36(b)(3) to state: ``The heading 'Amount Per Serving' shall be
separated from other information on the label by a bar above and
beneath it, except when calories are listed, the bar shall be placed
beneath the calorie declaration.''
E. Compliance and Exemption Issues
39. At least three comments requested that dietary supplements be
able to indicate compliance with United States Pharmacopeia (USP)
requirements. One of these comments requested that a new paragraph,
Sec. 101.36(d)(3), be added that would provide that the label could
bear a box entitled ``Nutrition Facts'' that would contain nutrition
information for USP recognized substances that are the source of
vitamins and minerals. Immediately below that box, the label would bear
another section entitled, ``Other Ingredients'' that would list all
additional ingredients present in more than insignificant amounts,
followed by a listing of all other added substances incorporated in the
product as excipients. The comment stated that by listing all other
ingredients present, consistency with section 411(b)(2)(A)(i) of the
act would be achieved. Alternatively, this comment requested that the
following sentence be added after the first sentence of
Sec. 101.36(d)(2): ``Such allowances will also be considered where a
firm produces an article that purports to comply with the requirements
of the official USP and seeks to label it in accordance with the
requirements of the Pharmacopeia.'' The comment stated that this new
sentence would allow firms to comply with USP labeling requirements
with FDA's permission. Additionally, this comment requested that the
name of products that meet USP quality standards be followed by the
letters ``USP.''
Both of the comment's suggested changes in Sec. 101.36(d) would
allow for two very different forms of nutrition labeling on dietary
supplements of vitamins and minerals, depending upon whether a
manufacturer chose to follow FDA's requirements, which are generally
consistent with Sec. 101.9, or USP's, which would list only USP
recognized nutrients in the top box. A manufacturer's decision to
follow the USP approach would result in a nutrition label that was
inconsistent with labels of other dietary supplements of vitamins and
minerals, with dietary supplements of herbs and other similar
nutritional substances, and with foods in conventional food form. The
comment also appears to request that the determination of whether or
not a nutrient should be listed in the nutrition label should be based
upon its USP status.
FDA finds that it would not be consistent with section 2(b)(1)(A)
of the 1990 amendments to provide the flexibility sought by these
comments. As discussed in response to earlier comments, the agency
decided in the mandatory nutrition labeling final rule that if the
nutrition label was to be readily observable and comprehensible, it
must be presented in as consistent a manner as possible from label to
label. Thus, it was the agency's determination that, whenever possible,
nutrition labeling requirements should ensure a distinctive look and
order of nutrients to facilitate consumer recognition and understanding
of the label and to encourage use of the information. Allowing two
different nutrition labeling schemes would make it likely that some
consumers would fail to recognize the nutrition information or would be
too confused to be able to use it fully. FDA has made the same decision
with respect to dietary supplements and thus is not providing the
flexibility requested.
However, in regard to the request that the name of ingredients of
USP quality be allowed to indicate USP status, the agency advises that
although statements appearing outside of the nutrition label are beyond
the scope of this final rule, it would not object to the use of
truthful and nonmisleading statements regarding USP status elsewhere on
product labels. Further, FDA would not object to the use of the USP
symbol in the ingredient list to identify those ingredients that are
USP grade. The agency advises that it will not consider the USP symbol,
when used in this way, to constitute intervening material in the
ingredient list.
40. One comment requested that FDA recognize USP methodology. This
comment stated that Sec. 101.36(d)(1) requires that dietary supplements
comply with Sec. 101.9(g)(2), which specifies Association of Official
Analytical Chemists (AOAC) test methodology for nutrient analysis.
The agency wishes to clarify that Sec. 101.9(g)(2) states that when
FDA determines compliance, it will analyze composite samples by
appropriate methods as given in the ``Official Methods of Analysis of
the AOAC International,'' 15th edition, or, if no AOAC method is
available or appropriate, by other reliable and appropriate analytical
procedures. Manufacturers, however, are free to use whatever
methodology they believe will give results consistent with methods used
by FDA. Therefore, the requested change is unnecessary.
41. One comment requested that the compliance criteria be revised
to allow the actual content of any vitamin or mineral in a dietary
supplement to be 90 percent, instead of at least 100 percent, of the
declared value. This comment stated that the proposed rule (i.e.,
Sec. 101.36(d)(1), which refers to Sec. 101.9(g)(1) through (g)(2))
requires that products that contain added vitamins and minerals provide
at least the amount declared for each nutrient. The comment stated that
consideration should be given to the fact that many dietary
supplements, while formulated to contain at least 100 percent of the
declared amount, are designed to retain only at least 90 percent of
their declared amount over the shelf life declared on these products.
The comment attributed this practice to the fact that USP monographs
for several nutritional products require a minimum nutrient content of
90 percent of the label declaration.
The agency is not persuaded by this comment. As previously
discussed in response to a similar comment in the mandatory nutrition
labeling final rule (58 FR 2079 at 2171), dietary supplements of
vitamins and minerals are fabricated products. The comments provided no
convincing reason for why they should not be held to the same standards
as foods in conventional food form that are fortified or enriched. The
agency has informed USP that anything less than 100 percent of the
value declared on the label for vitamin and mineral products is not
acceptable to FDA, and that the only permissible deviation from this
requirement would be a deviation that is attributable to the
variability of the analytical method (Ref. 8).
The agency notes that, contrary to the statement in the comments,
the General Notices of the USP state that a dosage should be formulated
to provide 100 percent of the labeled amount (Ref. 9). The limits in
the USP monographs allow for overages of ingredients known to decrease
with time, for analytical error, for manufacturing and compounding
variations, and for deterioration to an extent considered insignificant
under practical conditions (Ref. 9).
42. One comment pertained to small businesses. The comment stated
that ``burdening the manufacturer with the cost of the nutrition
labeling requirements (listing that a vitamin supplement contains no
fat, no protein, no carbohydrate, etc.) would be a useless exercise,
especially in the case of the marketing of a single ingredient
substance.'' The comment requested that Sec. 101.36(f)(1) of the
proposed rule be revised to either delete the nutrition labeling
requirement for small businesses or to allow the nutrition label to
declare only those nutrients actually present in the supplement.
The agency believes that this comment misunderstood the proposed
rule. As the comment requested, the agency requires nutrition labeling
``only with respect to those substances actually contained in the
supplement.'' Manufacturers are not burdened with the cost of declaring
that a vitamin supplement contains no fat, no protein, or no
carbohydrate if they do not. Only nutrients present in significant
amounts are required to be declared under Sec. 101.36(b)(3). Therefore,
the agency is not changing the regulation in response to this comment.
FDA notes that Congress recently passed, and the President signed
on August 13, 1993, the Nutrition Labeling and Education Act Amendments
of 1993 (Pub. L. 103-80) that modified the treatment of small
businesses. As a result of this change, the exemption from nutrition
labeling requirements for small businesses that are food manufacturers
will be based on the number of employees in a firm and the number of
units of each product sold. FDA expects to publish a proposal to amend
Secs. 101.9 and 101.36 to reflect the new law.
F. Misbranding
43. One comment stated that Sec. 101.9(k)(1) through (k)(6) should
not apply to dietary supplements. The comment stated that
Sec. 101.9(k)(1) is overbroad such that it suppresses truthful,
nonmisleading speech about the beneficial properties of a nutrient
supplement product that may, by virtue of the supplement's inherent
properties, not only be a food but also aid in the prevention, cure,
mitigation, or treatment of any disease. This comment did not focus on
why Sec. 101.9(k)(2) through (k)(6) should not apply to dietary
supplements. Other comments specifically mentioned that the first
sentence of Sec. 101.9(k)(5) is vague, confusing, and contradictory.
This sentence provides that a food shall be deemed to be misbranded if
its label or labeling represents, suggests, or implies that the food
has dietary properties when such properties are of no significant value
or need in human nutrition. These comments suggested that this sentence
be revised to read: ``A food shall be deemed to be misbranded if its
label claims or represents that the food has a significant value or
need in human nutrition when the scientific evidence for the claim does
not exist.'' These comments argued that this change is necessary
because ``significant value or need in human nutrition'' is a matter of
consumer perception. They said that to a small child, the need for
eating spinach is very low, but to the mother the need for spinach is
very high. Other comments specifically agreed that Sec. 101.9(k) should
apply to dietary supplements of vitamins and minerals.
The agency does not agree with the comment that Sec. 101.9(k)(1)
through (k)(6) should not apply to dietary supplements, or that
Sec. 101.9(k)(1) suppresses truthful, nonmisleading speech. The comment
did not provide any basis for the agency to conclude that this
provision is not applicable to dietary supplements, or that it
suppresses truthful, nonmisleading speech.
In the final rule on nutrition labeling of January 6, 1993 (58 FR
2079 at 2167), the agency pointed out that the provisions of
Sec. 101.9(i) (redesignated as (k)) had long been in effect at the time
Congress drafted the 1990 amendments. While Congress did enact
provisions under the 1990 amendments that allow for health claims on
foods, nothing in the act or in the legislative history of the act
suggest that Congress intended that Sec. 101.9(i) should be changed.
Nor did the comments present any persuasive arguments that
Sec. 101.9(k)(5) of the proposed rule should be amended. The agency
does not agree that whether or not a significant value or need in human
nutrition has been established is a matter of consumer perception. The
agency notes that the phrase ``significant value or need in human
nutrition'' was promulgated and published in the Federal Register of
January 19, 1973 (38 FR 2125). In that final rule (38 FR 2125 at 2128),
the agency explained that over the years there have been a number of
ingredients of products marketed as nutrients and nutritional
supplements that have not been shown to be essential in human
nutrition, such as rutin, other bioflavonoids, para-aminobenzoic acid,
and inositol. The agency stated that calling attention to these
ingredients in a manner that implies some nutritional benefit is
misleading. The agency concludes that the language of Sec. 101.9(k)(5)
remains clear and does not need clarification.
Therefore, the agency is making no change in Sec. 101.9(b) in
response to these comments.
IV. Other Provisions
FDA did not receive any comments that dealt specifically with the
other provisions of the proposal. In the absence of any basis for doing
otherwise, FDA is adopting those provisions as proposed.
V. Economic Impact
In its dietary supplement labeling proposals of June 18, 1993, FDA
stated that the proposed rules on the labeling of dietary supplements,
taken as a whole, would have associated costs of approximately $20
million. Thus, the agency concluded that the proposed rules do not
constitute a major rule as defined by Executive Order 12291. In
accordance with the Regulatory Flexibility Act (Pub. L. 96-354), FDA
explored whether the proposed rules may have a significant impact on
small businesses and tentatively concluded that they do not.
FDA has evaluated the many comments that it received in response to
its economic impact analysis. Because the issues raised in the comments
relate to all three proposals, FDA has combined its discussion of these
comments and presented them in the final rule regarding a delay in the
date of application, which is published elsewhere in this issue of the
Federal Register.
FDA has examined the economic implications of the final rules
amending 21 CFR as required by Executive Order 12866 and the Regulatory
Flexibility Act. Executive Order 12866 directs agencies to assess all
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects; distributive impacts; and equity). The
Regulatory Flexibility Act requires that the agency analyze options for
regulatory relief for small businesses. FDA has concluded, based on its
review of the available data and comments, that these final rules are
not significant as defined by Executive Order 12866. Further, in
accordance with the Regulatory Flexibility Act, the agency certifies
that these final rules will not have a significant impact on a
substantial number of small businesses.
VI. Environmental Impact
The agency has determined under 21 CFR 25.24(a)(11) that this
action is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
VII. References
The following references have been placed on file in the Dockets
Management Branch (address above) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday.
1. Food and Nutrition Board, Division of Biology and
Agriculture, National Research Council, ``Recommended Dietary
Allowances, 7th ed., 1968,'' publication 1694, Printing and
Publishing Office, NAS, Washington, DC, 1968.
2. Subcommittee on the 10th edition of the Recommended Dietary
Allowances, Food and Nutrition Board, Commission on Life Sciences,
National Research Council, ``Recommended Dietary Allowances, 10th
edition,'' NAS, Washington, DC, National Academy Press, 1989.
3. Levy, A., S. B. Fein, and R. E. Schucker, ``More Effective
Nutrition Label Formats Are Not Necessarily More Preferred,''
Journal of the American Dietetic Association, 92:1230-1234, 1992.
4. Gardner, T. S., and E. T. Guarino, Grocery Manufacturers of
America, Inc., Letters to Dockets Management Branch, June 3, 1992.
5. Levy, A. S., S. B. Fein, and R. E. Schucker, ``Evaluation of
Nutrition Label Formats: FDA Study 2,'' Center for Food Safety and
Applied Nutrition, FDA, Washington, DC, March, 1992.
6. FDA opinion letter, Taylor M. Quinn, Office of Compliance,
Bureau of Foods, to Stanley Skelskie, March 30, 1979.
7. FDA opinion letter, Taylor M. Quinn, Office of Compliance,
Bureau of Foods, to Stanley Skelskie, January 25, 1980.
8. Tanner, J. T., Letter to V. Srinivasan, U.S. Pharmacopeial
Convention, Inc., May 7, 1991.
9. U.S. Pharmacopeial Convention, Inc., ``USP XXII, NF XVII, The
United States Pharmacopeia,'' The National Formulary, General
Notices and Requirements Applying to Standards, Tests, Assays, and
Other Specifications of the United States Pharmacopeia, pp. 1-3,
January 1, 1990.
10. Committee on Dietary Allowances, Food and Nutrition Board,
Assembly of Life Sciences, National Research Council, ``Recommended
Dietary Allowances, 9th revised ed., 1980,'' Washington, DC,
National Academy Press, 1980.
List of Subjects in 21 CFR Part 101
Food labeling, Reporting and recordkeeping requirements,
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
101 is amended as follows:
PART 101--FOOD LABELING
1. The authority citation for 21 CFR part 101 continues to read as
follows:
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).
2. Section 101.9, effective May 8, 1994, is amended by revising
paragraphs (d)(3)(ii), (h)(2), and (j)(6) to read as follows:
Sec. 101.9 Nutrition labeling of food.
* * * * *
(d) * * *
(3) * * *
(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.
* * * * *
(h) * * *
(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.
* * * * *
(j) * * *
(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.
* * * * *
3. Section 101.12, effective May 8, 1994, is amended in paragraph
(b), Table 2, by alphabetically adding a new entry under the subheading
``Miscellaneous category'' to read as follows:
Sec. 101.12 Reference amounts customarily consumed per eating
occasion.
* * * * *
(b) * * *
Table 2.--Reference Amounts Customarily Consumed Per Eating Occasion: General Food Supply1,2,3,4
--------------------------------------------------------------------------------------------------------------------------------------------------------
Product category Reference amount Label statement5
--------------------------------------------------------------------------------------------------------------------------------------------------------
*******
Miscellaneous category:
*******
Dietary supplements not in conventional food
form.......................................... The maximum amount recommended, as appropriate, on the
label for consumption per eating occasion or, in the
absence of recommendations, 1 unit, e.g., tablet,
capsule, packet, teaspoonful, etc. ------ tablet(s), ------ capsule(s), ------
packet(s), ------ tsp(s) (------ g), etc.
*******
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 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 mixes; concentrates; dough;
batter; dry, 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).
4. Section 101.36 is added to subpart C to read as follows:
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 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.
(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 (folacin), 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) and no percent shall be given for sugars,
vitamin K, chloride, chromium, fluoride, manganese, molybdenum,
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 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 ``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, 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
that is 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 ``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.
TR04JA94.000
(ii) Multiple vitamin for children and adults.
TR04JA94.001
(iii) Multiple vitamins in packets.
TR04JA94.002
(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:
TR04JA94.003
(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 mineral 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 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).
Dated: December 23, 1993.
David A. Kessler,
Commissioner of Food and Drugs.
Donna E. Shalala,
Secretary of Health and Human Services.
[FR Doc. 93-31813 Filed 12-29-93; 8:45 am]
BILLING CODE 4160-01-F