[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