[Federal Register Volume 59, Number 2 (Tuesday, January 4, 1994)]
[Rules and Regulations]
[Pages 395-426]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 93-31815]
[[Page Unknown]]
[Federal Register: January 4, 1994]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Parts 20 and 101
[Docket No. 85N-061D]
RIN 0905-AB67
Food Labeling; General Requirements for Health Claims for Dietary
Supplements
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending its food
labeling regulations to make dietary supplements of vitamins, minerals,
herbs, or other similar nutritional substances (dietary supplements)
subject to the same general requirements that apply to all other types
of food with respect to the use of health claims that characterize the
relationship of a substance to a disease or health-related condition on
the label or in labeling and the content of petitions for obtaining
authorization for such health claims. This action is being taken in
response to provisions of the Nutrition Labeling and Education Act of
1990 (the 1990 amendments) and the Dietary Supplement Act of 1992 (the
DS act) that bear on health claims.
EFFECTIVE DATE: July 5, 1994.
FOR FURTHER INFORMATION CONTACT: James R. Taylor, Jr., Center for Food
Safety and Applied Nutrition (HFS-158), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-205-5229.
SUPPLEMENTARY INFORMATION:
I. Background
On November 8, 1990, President Bush signed into law the 1990
amendments (Pub. L. 101-535). 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 their confirmation of
FDA's authority to regulate health claims on food labels and in food
labeling. The new provisions amended the act by adding a provision,
section 403(r)(1)(B) (21 U.S.C. 343(r)(1)(B)), that provides that a
product is misbranded if it bears a claim that characterizes the
relationship of a nutrient to a disease or health-related condition,
unless the claim is made in accordance with sections 403(r)(3) of the
act (which pertains to foods in conventional food form) or 403(r)(5)(D)
(which pertains to dietary supplements).
Congress enacted the health claims provisions of the 1990
amendments to help U.S. consumers maintain healthy dietary practices
and to protect these consumers from unfounded health claims. The House
Report of June 13, 1990, states, ``Health claims supported by
significant scientific agreement can reinforce the Surgeon General's
recommendations and help Americans to maintain a balanced and healthful
diet'' (Ref. 1). In addition, the statement of the House Floor Managers
noted that ``There is a great potential for defrauding consumers if
food is sold that contains inaccurate or unsupportable health claims''
(Ref. 2). The House Report characterized the need for regulation of
health claims as ``compelling'' (Ref. 1).
FDA's first step to effect the health claims provisions of the 1990
amendments appeared in the form of a November 27, 1991, proposed health
claims regulation (56 FR 60537) (hereinafter referred to as ``the
health claims proposal''). That document proposed to establish general
requirements pertaining to the use of health claims that characterize
the relationship of a food component to a disease or health-related
condition on the labels and in labeling of both foods in conventional
food form and dietary supplements. The health claims proposal contained
definitions to clarify the meaning of specific terms used in the
regulations, preliminary requirements that a component of food must
meet to be eligible to be the subject of a health claim, a scientific
standard for assessing the validity of claims, general labeling
requirements for health claims that are permitted by regulation, and
prohibitions on certain types of health claims. Also, the health claims
proposal contained provisions pertaining to the required content of
petitions for health claims.
In response to the health claims proposal, FDA received over 6,000
letters, each containing one or more comments, from consumers, health
care professionals, universities, State and local governments, foreign
governments, trade organizations, consumer advocacy organizations,
research institutes, industry, and professional organizations. Many of
the comments pertained to dietary supplements. The agency summarized
and addressed the issues raised in the comments in the final rule on
health claims that published in the Federal Register of January 6, 1993
(58 FR 2478) (hereinafter referred to as ``the health claims final
rule''). The health claims final rule became effective on May 8, 1993.
Although the health claims proposal pertained to dietary
supplements as well as foods in conventional food form, the final rule
applied only to the latter type of foods. In October of 1992, Congress
passed the DS act (Pub. L. 102-571), which imposed a moratorium on FDA
implementation of the 1990 amendments with respect to dietary
supplements until December 15, 1993. The DS act provides that by June
15, 1993, FDA was to have issued proposed rules to implement the 1990
amendments with respect to dietary supplements, and that by December
31, 1993, the agency is to issue final rules based on these proposals.
The DS act also amends the 1990 amendments to reflect the fact that if
the agency does not issue final rules with respect to health claims for
dietary supplements by December 31, 1993, the proposed regulations are
to be considered final regulations at that time.
In the Federal Register of June 18, 1993 (58 FR 33700), FDA
responded to the DS act by issuing a proposal that sets forth a
standard and procedure for making health claims for dietary supplements
(hereinafter referred to as ``the dietary supplement health claims
proposal''). In that proposal, FDA proposed to make health claims on
dietary supplements subject to the same general requirements that apply
to health claims on all other types of food.
In response to the dietary supplement health claims proposal, FDA
received over 1,200 letters, each containing one or more comments, from
consumers, health care professionals, universities, State and local
governments, trade organizations, consumer advocacy organizations,
research institutes, industry, and professional organizations. Some
comments agreed with one or more provisions of the proposed rule
without providing further grounds for support other than those provided
by FDA in the preamble to the proposal. Other comments disagreed with
one or more provisions of the proposal without providing specific
grounds for their disagreement. Many comments addressed issues that are
beyond the scope of these regulations and will not be addressed in this
document. For example, some responded to various aspects of FDA's June
18, 1993, advance notice of proposed rulemaking concerning the general
regulation of dietary supplements (58 FR 33690). Most of the comments,
however, addressed the proposed regulations and provided specific
grounds in support of their positions. The agency has summarized and
addressed the issues raised in the comments in the discussion that
follows.
II. Regulatory Approach
A. General Approach Based on FDA's Review of the 1990 Amendments
The 1990 amendments did not provide a specific standard for when a
health claim should be authorized on dietary supplements or a specific
procedure for authorizing such claims. Under section 403(r)(5)(D) of
the act, the establishment of such a standard and such a procedure is
left to the Secretary of the U.S. Department of Health and Human
Services (DHHS) (and, by delegation, FDA). Thus, in the dietary
supplement health claims proposal (58 FR 33700 at 33702), FDA reviewed
the legislative history of the 1990 amendments to identify the features
that Congress intended would guide the agency's choice of a scientific
standard and procedure for regulating health claims on dietary
supplements. FDA identified the following features that it believes
should guide its choice:
o The regulations are to deal only with the procedure and
standard for health claims for the substances in dietary
supplements. They are to have no bearing on the availability of any
dietary supplements.
o The regulations must prohibit the use of health claims that
are not authorized under their provisions.
o The regulations must ensure that any health claims that appear
in labeling are scientifically valid.
o The regulations must ensure that any health claims that appear
in labeling are understandable.
o The regulations should be such that all segments of the food
industry are treated fairly and in a consistent manner, unless there
is an appropriate basis on which to draw a distinction. This factor
embodies a principle of equity implicitly in the act.
(58 FR 33700 at 33703)
With these features in mind, FDA considered all of the approaches
of which it was aware that might be used to regulate dietary
supplements. The agency tentatively concluded that it should adopt an
approach that would subject dietary supplements to the same standard
that applies to foods in conventional food form. FDA stated that it was
its tentative view that that approach strikes the appropriate balance
between the congressional concern for consumer fraud, public health,
and sound science, on the one hand, and the desire to provide the
consumer with information on the other. Furthermore, the agency advised
that if it adopts this standard for dietary supplements, all foods will
be regulated under the same standard.
FDA pointed out that under the same procedure that applies with
respect to claims for substances in food in conventional food form,
there is a premarket review that ensures that the safety of the
substance that is to be the subject of the claim has been established
as well as the scientific validity of the claim. A claim linking a
substance to a disease, whether on a food in conventional food form or
on a dietary supplement, is intended to increase intake of that
substance. Thus, the agency said, it is important to ensure that a
claim encouraging such increased intake can be safely implemented.
Therefore, FDA proposed to adopt the same procedure for health claims
for dietary supplements as for foods in conventional food form.
1. Availability of Dietary Supplements
1. A great many comments, primarily from consumers, raised
objections that indicated that the commenters were misinformed about
the proposed regulations, or that they simply did not believe what FDA
stated in the dietary supplement proposal. Many of the comments
expressed considerable anger, resentment, and even fear over the
proposal. A large number of these comments characterized the proposal
as an attack against the dietary supplement industry. Many of these
comments stated that FDA is plotting to ban all dietary supplements. A
number of comments explained that the proposed regulations would limit
the number of dietary supplements available to consumers by limiting
the amount of health information that could appear on supplement labels
and thus diminish supplements' marketability. The comments maintained
that FDA's proposed policy of requiring premarket review of a
supplement's safety is contrary to the agency's stated intent to
preserve supplement availability and consumer choice. Some of the
comments maintained that many manufacturers would be put out of
business. Many of the comments argued that the nation's health would be
adversely affected, and that health care costs would increase without
dietary supplements to maintain good health. Some comments contained
testimonials that certain dietary supplements were responsible for
curing and preventing a variety of diseases, including cancer.
However, a few comments pointed out that assertions that FDA plans
to ban dietary supplements are unfounded. A number of these comments
predicted that the vast majority of dietary supplements will remain in
the marketplace because about 80 percent of supplement labels are
already in compliance with the proposed provisions.
There is no basis for virtually all of the concerns raised in the
comments about the availability of dietary supplements. Nothing in
these regulations will make them unavailable to consumers. These
regulations focus only on ensuring that health claims, if made on the
labels or in the labeling of dietary supplements, are scientifically
valid and understandable. Thus, the availability of dietary supplements
will not be affected by these regulations. While it is likely that some
claims may have to be removed from product labeling as a result of this
final rule, the products themselves can continue to be marketed.
It is true that prohibiting the use of claims that have not been
authorized by FDA may have an adverse impact on the marketability of
some products. However, any such impact is outweighed by the need to
assure consumers that the claims that are made in labeling are
scientifically valid, and that they can rely on such claims. In fact,
the only products whose marketability will ultimately suffer under
these regulations will be those whose labeling has borne claims that
cannot be supported by the available scientific evidence.
The requirement that the agency be confident that the presence of a
health claim will not result in unsafe intakes of the substance that is
the subject of the claim is not inconsistent with supplement
availability and consumer choice. If a manufacturer does not choose to
make a claim about a substance, nothing in these regulations will
affect the manufacturer's ability to continue to market supplements
that contain that substance. FDA believes, however, that it has an
obligation to ensure that before it authorizes a claim that encourages
consumers to increase their consumption of a substance, it have some
assurance that increased consumption of that substance will not be
harmful.
2. Fair and Consistent Treatment of All Segments of the Food Industry
2. Many comments asserted that FDA has not been evenhanded in its
approval of health claims for use on dietary supplements and on foods
in conventional food form. Some of these comments maintained that FDA's
unfair treatment of dietary supplements is evidenced by the agency's
approval of health claims involving cancer and coronary heart disease
for use on fruits, vegetables, and grain products but not for use on
fortified foods or supplements that provide fiber or antioxidant
vitamins. The comments stated that FDA should authorize health claims
involving particular nutrients for use on any food that contains those
nutrients, including dietary supplements, unless there is significant
scientific agreement that the claim is valid only when the nutrient is
consumed in a particular form. To ensure that such an approach is taken
in evaluating health claims for use on dietary supplements in the
future, a few comments requested that FDA add the following provision
to the end of Sec. 101.14(g) (21 CFR 101.14(g)):
A health claim that has been approved for any substance that is
to be consumed at other than decreased dietary levels shall be
permitted on all foods (including dietary supplements) containing
the requisite amounts of that substance, unless FDA determines that
(i) there is significant scientific agreement (as defined in
subparagraph (c)) that the consumption of the substance in the
particular food will not provide the benefits claimed, or (ii) the
food contains disqualifying amounts of another substance.
A few comments contended that FDA also has treated dietary
supplements unfairly by withholding approval of a health claim
concerning the role of folic acid in reducing the risk of neural tube
defects (NTD's) simply because of its concerns that allowing the claim
on foods in conventional food form would raise safety issues because of
overfortification of the food supply and the subsequent effect on
certain subpopulations. These comments asserted that the proper course
of action for the agency would have been to allow health claims on
dietary supplements but to prohibit their use on foods in conventional
food form until the public health concerns associated with such use had
been resolved.
However, a few comments supported FDA's decision to approve
particular health claims for use on fruits, vegetables, and fiber-
containing grains while not authorizing their use on dietary
supplements or fortified foods with added antioxidant vitamins or
fiber. These comments noted that there are many compounds in fruits and
vegetables that may be involved in reducing the risk of disease that
may not have been identified. The comments asserted that before
allowing a dietary supplement to bear a health claim authorized for use
on food in conventional food form, it is important to establish that
the supplement provides the same health protection benefits as the
conventional food.
FDA disagrees with the assertions in the comments that it has been
unfair with the dietary supplement industry with respect to its
approval of specific health claims. FDA believes that the health claims
should be consistent with the scientific evidence available to the
agency. In the Federal Register of January 6, 1993 (58 FR 2537, 2552,
and 2622), FDA explained why it was authorizing health claims
pertaining to: (1) Heart disease and diets low in saturated fat and
cholesterol and high in fruits, vegetables, and grain products that
contain fiber; (2) cancer and diets low in fat and high in fruits,
vegetables, and grain products that contain fiber; and (3) cancer and
diets low in fat and high in fruits and vegetables that may contain
fiber, vitamin A (beta-carotene) and vitamin C. The agency also
explained in detail why it was not authorizing health claims pertaining
to any specific nutrients (i.e., heart disease and dietary fiber,
cancer and dietary fiber, and cancer and antioxidant vitamins).
In the case of the antioxidant vitamins, FDA found that although
there was sufficient evidence to justify a health claim concerning the
relationship between diets low in fat and high in fruits and vegetables
that may contain fiber, vitamin A, and vitamin C and a reduced risk of
cancer, the available evidence did not provide a basis on which to
attribute the reduction in risk of disease to any individual vitamin or
combination of vitamins, regardless of whether the vitamin is
classified as an antioxidant or not (see discussion under section IV.,
58 FR 2622 at 2633). Yet, because of the usefulness of vitamins A (as
beta-carotene) and C and dietary fiber in identifying those fruits and
vegetables that correlate with reduced cancer risk, FDA identified
these nutrients as being characteristic of the foods associated with a
protective effect. Any one or a combination of these three nutrients
can serve as the identifying marker. Moreover, because fruits and
vegetables are also characterized by an absence of fat, and because of
the identified relationship of low fat diets to reduced risk of cancer,
FDA highlighted low fat intakes as part of the dietary pattern
associated with decreased cancer risk. Because the mechanism of the
protective effect of fruits and vegetables is not known, and because it
is not possible to determine which of the nutrients or other components
in fruits and vegetables is causing the observed effect, the health
claim authorized by FDA focuses on fruits and vegetables as a class of
foods and their relationship to cancer risk, and not on particular
nutrients. By requiring that all characterizing nutrients be identified
as characteristic of dietary patterns rich in fruits and vegetables
without specifically attributing reduced cancer risk to a single
nutrient or single type of nutrient (antioxidant vitamins), FDA made
the claim consistent with the scientific knowledge available to it at
the time it authorized the claim.
Because of the rapidly evolving science base relative to this
topic, however, FDA has continued to update its evaluation of the
scientific evidence and the degree of scientific agreement on the
relationship between antioxidant vitamins and cancer. As part of these
efforts, FDA initiated, along with other major research and health
organizations as cosponsors, a public conference on antioxidant
vitamins and cancer and cardiovascular disease that was held on
November 1 through 3, 1993. The transcript of that meeting has been
submitted to the Docket as a comment on the antioxidant vitamins and
cancer rulemaking, along with other comments received in response to
the announcement of the conference (58 FR 54595, October 22, 1993). FDA
is reviewing the results of this conference and other scientific
evidence that has become publicly available since the publication of
the January 6, 1993, final rule on antioxidant vitamins and cancer.
Similarly, in the case of heart disease and dietary fiber and of
cancer and dietary fiber, the agency found that there was insufficient
evidence to attribute the reduction in risk specifically to dietary
fiber or to specific fiber components. The agency did conclude,
however, that dietary fiber and soluble fiber, along with other
nutrients, serve as useful markers in identifying those foods for which
the scientific evidence showed that inclusion in a daily diet was
associated with reduced risk of cancer and of heart disease (58 FR 2552
and 58 FR 2537).
For both topic areas, the agency also noted the inability of
commonly used analytical methodologies to detect many of the
characteristics that vary among dietary fibers and that may be related
to biological function (e.g., particle size, chemical composition,
water-holding capacity). With regard to heart disease, other components
variable associated with soluble fiber in foods (e.g., lipid
components) may also contribute to a cholesterol-lowering effect. FDA
found that the inability to detect many of the differences among
fibers, fiber components, and other substances in foods that contain
dietary fibers, including soluble fiber, and the general lack of
conclusions as to the mechanism of action of dietary fibers and fiber
components were limiting factors on FDA's ability to draw conclusions
from the available evidence. Furthermore, FDA noted that foods high in
dietary fiber are also generally low in calories and total fat, factors
that are associated with reduced risk of cancer. Fiber-rich foods are
also generally low in saturated fats and cholesterol, substances that
also affect the risk of developing heart disease. Thus, some or all of
the benefits associated with diets high in fiber-rich foods could be
the result of displacement of fat and saturated fat from the total diet
rather than an effect of fiber per se.
The agency stated that although the specific roles of the numerous
potentially protective substances or displacement of negative
substances (e.g., fat, saturated fat, and cholesterol) in such plant
foods are not yet understood, populations with diets rich in these
foods experience many health advantages, including lower rates of heart
disease and cancer. Thus, FDA did not authorize the use of a health
claim on the association between ingestion of dietary fiber, or
specific fiber components, and a reduced risk of heart disease or
cancer. Instead, for cancer, FDA, to be consistent with the available
scientific evidence and prevailing scientific agreement, focused on
fiber-containing grain products, fruits, and vegetables as product
classes. Similarly, for heart disease, FDA focused on fruits,
vegetables, and grain products that contain fiber, particularly soluble
fiber. Because of the usefulness of dietary fiber or soluble fiber in
identifying the types of foods whose consumption is most likely to
correlate with decreased cancer or heart disease risk, these substances
can serve as identifying markers for selecting useful foods, even in
the absence of adequate evidence of a direct effect of fiber.
FDA is aware, however, of the rapidly evolving nature of the
science base relative to these topic areas. FDA intends to update its
review of the science by initiating, in the near future, along with
other major research and health organizations as cosponsors, a public
symposium on dietary fiber and heart disease and cancer.
With respect to assertions concerning folic acid, FDA disagrees
that it should have allowed health claims on dietary supplements while
prohibiting their use on foods in conventional food form. While FDA did
not authorize a health claim for folic acid and NTD's, in the final
rule on heath claims and label statements for folic acid and NTD's
published in the Federal Register of January 6, 1993 (58 FR 2606)
(hereinafter referred to as ``the folic acid final rule''), the agency
did announce its plans to work expeditiously to authorize a claim, if
appropriate.
The agency noted that the Public Health Service (PHS), including
FDA, had recommended (Ref. 7) that all women of childbearing age in the
United States should consume 0.4 milligram (mg) (400 micrograms
(g)) of folic acid daily to reduce their risk of having a
pregnancy affected with spina bifida or other neural tube defects. FDA
acknowledges that this recommendation evidenced that significant
scientific agreement existed regarding a relationship between folate
and NTD's but said that there were factors that prevented FDA from
authorizing a claim. The agency said that the act must be read as a
whole, and that sections 403(r)(3)(A)(ii) and 409 of the act (21 U.S.C.
348) reflect the proposition that the use of a substance that is the
subject of a health claim must be safe. The agency pointed out that the
PHS recommendation stated that there were significant questions that
persist about the safe use of folic acid in food. As stated in the
folic acid final rule, FDA expected that the authorization of a claim
would likely result in significant increases in consumption of folic
acid by women in their childbearing years and by the general
population, because manufacturers would add folic acid to their
products in order to claim that these products were useful in reducing
the risk of birth defects. Intakes of multiple doses of folic acid from
supplements and from its increased presence in the food supply could
rapidly result in intakes of 3 to 7 mg (3,000 to 7,000 g) per
day (58 FR 2606 at 2614). Such intakes represent increases of 10-fold
or more above current intakes.
In the folic acid final rule, the agency reviewed the safety
considerations raised by such increases in folic acid intakes,
including: (1) Potential effects in persons with poor vitamin B12
status; (2) potential risks for persons taking medications that
interfere with folate metabolism; (3) potential risks for pregnant
women because of uncertainties about effects of high blood levels of
folic acid on the embryo during gestation; and (4) uncertainties
regarding possible interactions between folic acid and other nutrients
with increased folic acid intakes. The agency concluded that it could
not authorize a health claim on folic acid until the questions
regarding the safe use of this nutrient were satisfactorily resolved.
In the folic acid final rule the agency described the efforts it was
undertaking to address and resolve these concerns.
Following publication of this document, based on its review of the
evidence, its discussions with an advisory committee, and its review of
the comments that it received, the agency tentatively concluded that
the safety problems raised by folic acid can be resolved by setting a
safe upper limit of intake of 1 mg folate per day for all population
groups. The agency announced its tentative conclusion in a proposal to
authorize a health claim on folate and neural tube defects (58 FR
53254, October 14, 1993). In companion documents, FDA also proposed to
amend the food additive regulation for folic acid to specify the foods
that could be fortified with folic acid and the level at which they
could be fortified (58 FR 53312) and to amend the standards of identity
for specific cereal-grain products to permit the addition of folic acid
(58 FR 53305).
Thus, based on this review of the agency's actions, it is clear
that the nondiscriminatory provision suggested in the comments is not
necessary. When FDA has concluded that a substance has a relationship
to a disease, FDA has acted to authorize a claim (see final rule on
calcium and osteoporosis (58 FR 2665) and the proposed rule on folic
acid and neural tube defects (58 FR 53254)). In the case of antioxidant
vitamins and cancer, dietary fiber and heart disease, and dietary fiber
and cancer, the evidence did not establish that the named substances
had an effect on the named diseases. The evidence showed that these
nutrients were merely markers of foods that had been shown in studies
to affect the risk of the disease. FDA has reflected the scientific
evidence in the claims that it has authorized and proposed to
authorize. Any other course of action would be inconsistent with the
act because it would result in claims that were both not scientifically
valid and misleading.
B. Alternative Approaches
In the dietary supplement health claims proposal (58 FR 33700 at
33703), FDA advised that a variety of approaches had come to FDA's
attention about how health claims for dietary supplements would best be
regulated under the 1990 amendments. These approaches came to the
agency's attention by various means, including the comments on the
health claims proposal that addressed the most appropriate method for
regulating dietary supplements, testimony before Congress about
implementation of the 1990 amendments, as well as the legislative
history of the 1990 amendments. FDA carefully evaluated each of these
approaches to determine how they compare with the characteristics that
FDA has listed above. A number of comments addressed the agency's
tentative conclusions about these approaches.
1. Use of Advisory Committees
In the dietary supplement health claims proposal (see section
II.B.1., 58 FR 33700 at 33704), FDA advised that it had tentatively
decided not to adopt a committee-based approach suggested in comments
for evaluating the validity of health claims on herbs. This approach,
known as the Botanical Ingredient Review (BIR), would involve the
establishment of expert panels under the direction of an oversight
committee. FDA would participate as a nonvoting member of the expert
panels. The oversight committee, which would be charged with the
responsibility of reviewing all health claim petitions pertaining to
herb or botanical components, would relieve FDA of all responsibility
for initial review of these petitions. Each expert panel would conduct
an evaluation of scientific data pertaining to the requested claim,
subject the evaluation to peer review, and prepare a final
recommendation about the claim. The recommendation and all supporting
documents would then be forwarded to FDA, and the agency would be
permitted 120 days to approve, disapprove, or modify the report. Under
draft regulations prepared and submitted for FDA adoption by one
comment on the health claims proposal, there would be a codified
presumption in favor of the committee recommendation.
The agency based its tentative decision about the BIR on its belief
that the suggested approach would involve a significant transfer of
agency authority on health claims because of this presumption in the
draft regulations submitted by the comment. Under this presumption, FDA
would be obligated to prove that the committee was wrong if the agency
decided not to follow the committee's recommendation. In such
circumstances, FDA could be forced to propose to authorize health
claims that it was not satisfied were scientifically valid. FDA noted
that there is no basis under the act for such a transfer. Also, the
agency noted that the creation of such a committee would be financially
burdensome and stated that it would be inappropriate to commit its
limited resources to a committee with as narrow a scope as that
suggested by the comment.
3. A few comments addressed this advisory committee issue. Some
comments voiced opposition to FDA's tentative decision not to establish
a BIR. These comments disputed the agency's assertion that the
establishment of a BIR would involve any transfer of authority, noting
that FDA would retain full and final discretion in approving health
claims. The comments also disputed FDA's finding that the creation of a
BIR would be burdensome and costly in light of the agency's limited
resources. The comments stated that such a finding is inconsistent with
FDA's current use of advisory committees for very narrow subject
matters such as over-the-counter (OTC) antiplaque products, circulatory
system medical devices, and drug abuse. The comments stated that the
use of a BIR to help screen petitions from the much larger herbal
products industry would be an efficient, economical, and scientifically
credible way to ration FDA's scarce resources and would also help FDA
meet statutorily-imposed deadlines for actions on petitions that it
might not otherwise be able to meet.
The comments also asserted that the agency's statement that it has
the ``ultimate responsibility to determine whether the petitioned-for
health claim is valid'' implies a mistrust of the integrity of the BIR
process and the involved scientists and reveals an agency belief that
it is the only authority competent to judge the scientific validity of
health claims for herbal dietary supplements. The comments disagreed
with such a conclusion and argued that health claim petitions will only
receive adequate and full consideration from the scientific community
best qualified to determine whether they meet the significant
scientific agreement standard set by Congress through the creation of a
BIR, which would represent the most competent and knowledgeable body in
a field that remains largely esoteric to FDA. One of these comments
suggested that appropriate selections for herbal experts panels might
include experienced herbal practitioners who are familiar with
potential adverse reactions to herbs as well as medical practitioners
in foreign countries where herb safety has been studied by government
and industry panels. The comment stated that the inclusion of foreign
medical practitioners would be especially appropriate during the
evaluation of a claim whose merits are agreed upon throughout the world
but are not generally recognized in the United States, such as in the
case of using peppermint tea for its soothing or carminative effects on
the digestive tract.
However, one comment supported the agency's tentative decision not
to adopt the BIR process. The comment stated that FDA could well be
legally liable for decisions made by the BIR that were later shown to
have placed the public health at risk.
Several comments called for FDA to establish an advisory committee
for health claims for dietary supplements where the committee would
select expert panels responsible for the evaluation of proposed health
claims for all dietary supplements. The comments suggested that the
expert panels should be composed of scientists and health care
professionals with expertise on a given nutrient-disease relationship
as well as nonvoting industry and consumer representatives. These
comments contended that one reason for the agency's slowness in
approving a health claim for folic acid has been its reliance on
advisory panels that were not sufficiently familiar with the research
in the area and who had to be educated about the strength of the
evidence before they could act. Some of these comments suggested that
FDA could retain the authority to reject the recommendations of the
committee, as long as it published its reasons for doing so.
Another comment stated that both the dietary supplement industry
and FDA have been slow to recognize and utilize a great deal of
research that has been done in the area of nutrition and health. The
comment attributed this slowness to a gap between the scientific
community, FDA, and the dietary supplement industry. The comment
suggested that in order to close this gap, FDA should form a committee
of its leading scientists to meet with a similar industry committee
every 3 to 6 months, or as required, to discuss the latest research in
the area of nutrition and health published in highly accredited
scientific journals so that the research could be used to create and
support health claim petitions. The comment suggested that when the
agency committee and the industry reach an agreement on the data, FDA
could authorize the use of a health claim on the nutrient-disease
relationship on which there is agreement.
FDA recognizes that advisory committees may make valuable
contributions in assisting the agency to evaluate scientific evidence
about health claims in certain circumstances. For example, the Folic
Acid Subcommittee of the Food Advisory Committee provided valuable
recommendations in support of FDA proposing to authorize a health claim
for folic acid and proposing to fortify cereal-grain products. The
agency intends to continue its use of advisory committees wherever the
need arises.
FDA believes, however, that it should retain the right to decide
when the use of an advisory committee is necessary. There may
frequently be circumstances in which evidence establishes that use of
advisory committees is not necessary because the evidence shows that
the claim is clearly supported or clearly not supported. In addition,
if the agency were to establish a standing advisory committee for
health claims, FDA would want it to have a broader focus than just
dietary supplements. FDA's view is that claims should focus on the
substance, and not the food in which it is found, because the primary
issue is whether the substance-disease relationship has been
established. Thus, if FDA were to establish a standing advisory
committee, it would be on health claims in general. Although a number
of comments asserted that FDA lacks knowledge of herbal products, the
agency believes that its personnel are fully competent to evaluate
properly substantiated petitions concerning health claims in this area.
Also, if the agency were to decide to establish an advisory committee,
it would take steps to ensure that the membership of the committee had
the necessary expertise, including pertinent expertise on herbal
products.
There is an implication in some of the comments that the evaluation
of the scientific evidence supporting a claim is somehow different
depending on the substance involved. In fact, whether a claim is for a
vitamin, mineral, herb, or other similar nutritional substance,
including fat, saturated fat, and cholesterol, the skills needed for
evaluation of a claim are basically the same. These skills are found in
epidemiologists, nutritionists, biostatisticians, clinicians, and
experts in the disease being addressed, as well as in people aware of
how the substance is, or should be, consumed. Thus, FDA does not agree
with the implication in these comments.
FDA is interested in having communication with the dietary
supplement industry. However, the agency does not believe that it would
be appropriate for the communication to take the form of the suggested
standing committee to meet with a similar industry committee every 3 to
6 months. While FDA believes that regular communication with the
dietary supplement industry is likely to be useful, the process by
which health claims are authorized must be a more open and public
process than that suggested by the comment. Certainly the 1990
amendments envisioned a public process for claims for substances in
foods in conventional food form, as reflected in section 403(r)(4) of
the act. FDA has been presented with no convincing reason why a similar
process should not apply to claims for substances in dietary
supplements.
Furthermore, FDA continues to believe that the BIR advisory
committee approach would involve a significant transfer of agency
authority for health claims, even though comments on the health claims
proposal and the dietary supplement health claims proposal have made
arguments to the contrary. The suggested regulation for health claims
that was submitted to FDA on May 10, 1991, and referred to by the
agency in the proposals that it has issued, states in part:
B. If the Committee determines that a proposed health claim is
appropriate for a particular herb or botanical, either as proposed or
as modified by the Committee, it shall forward its recommendation(s) to
FDA together with all the data and other information before the
Committee when it made its decision.
C. If the Committee determines that, on the basis of the data, and
other information before it, the proposed health claim is not
scientifically justified for the herb or botanical, it shall so notify
the proposer. The proposer may then direct the Committee to forward to
FDA all the information before the Committee with respect to the
proposal together with its conclusions and the reasons therefore.
D. Within 120 days of receipt of the information described in (B)
and (C) above, FDA shall either accept the recommendation, reject it,
or modify it based upon the Agency's independent evaluation with
analysis and reasons for rejection or modification of recommended
health claims. In arriving at its decision FDA may consider data or
information other than that before the Committee. There shall be a
presumption, to be sustained when the record is viewed as a whole, in
favor of a Committee recommendation under either (B) or (C). (Emphasis
added.)
Despite assertions to the contrary, the last sentence of paragraph
``D'' obligates FDA to establish that the committee was wrong in order
not to follow the committee's recommendation. Ultimately, therefore,
there would, in fact, be a significant transfer of authority if the
suggested provision were to be adopted by FDA. As FDA noted in the
dietary supplement health claims proposal (58 FR 33700 at 33704), there
is no basis under the act for such a transfer of authority.
FDA does not question that experts on an industry committee or
panel on herbs and botanicals could be helpful. The agency encourages
firms to work through such groups. For this reason, FDA revised the
provision pertaining to petitions in the health claims final rule to
clarify that the agency will consider all recommendations by such
committees and panels (see Sec. 101.70(b)). FDA recognizes that those
petitions that have undergone an independent scientific review and
received endorsement by qualified expert groups will likely be well-
supported petitions and could be very persuasive to FDA. Further, FDA
is likely to place considerable weight on the recommendations of
outside experts, and its decision as to whether a petition should be
granted could be influenced significantly by these experts.
Although FDA encourages firms to work through groups of outside
experts, the agency would be concerned if such groups were heavily
weighted with medical practitioners as one of the comments suggested.
Over reliance on such practitioners, to the exclusion of scientists
representing other relevant scientific descriptives, implies that the
herbs are to be used for medicinal purposes. FDA stresses again that
health claims are about the relationship of foods, rather than drugs,
to a disease or health-related condition.
2. Establishment of an Approach Based on a More Lenient or the Same
Standard
FDA proposed to subject dietary supplements to the same scientific
standard and procedure that the statute provides for foods in
conventional food form (section 403(r)(3)(B)(i) of the act). The
standard, codified in Sec. 101.14(c), states:
(c) Validity requirement. FDA will promulgate regulations
authorizing a health claim only when it determines, based on the
totality of publicly available scientific evidence (including
evidence from well-designed studies conducted in a manner which is
consistent with generally recognized scientific procedures and
principles), that there is significant scientific agreement, among
experts qualified by scientific training and experience to evaluate
such claims, that the claim is supported by such evidence.
FDA explained in the dietary supplement health claims proposal (58
FR 33700 at 33705) that it knows of no standard and procedure for
dietary supplements that would both be more lenient than the standard
and procedure for foods in conventional food form and yet still have
the characteristics that FDA considers necessary under the 1990
amendments and their legislative history. The agency stated that it had
tentatively concluded that a standard for health claims for dietary
supplements that is based only on section 403(a)(1) of the act (21
U.S.C 343(a)(1)), or that allows health claims based on the existence
of substantial scientific evidence, even though significant scientific
agreement about the validity of the claim does not exist, would be
inconsistent with Congress's desire to ensure that health claims that
are made on food, including dietary supplements, are scientifically
valid. FDA said that it was concerned that if it were to allow claims
in the marketplace whose validity had not been established, these
claims would undercut the credibility of those health claims that are
in fact valid. The agency said that if it were to allow such claims,
consumers would be left little better off, and no less confused, than
they were in 1989, before the passage of the 1990 amendments. FDA also
expressed its tentative view that the proposed approach strikes the
appropriate balance between the congressional concern for consumer
fraud, public health, and sound science, on the one hand, and the
desire to provide the consumer with information on the other (58 FR
33700 at 33706).
4. A large number of comments asserted that FDA should establish an
approach based on a more lenient standard for dietary supplements. Some
of these comments argued that such an approach is directed by Congress
and cited a statement of Senator Hatch, one of the primary authors of
the 1990 amendments, that ``a more lenient standard for dietary
supplement[s] is envisioned.'' One comment argued that by providing for
the establishment of a separate standard for dietary supplements,
Congress had implicitly rejected the rigid standard of ``significant
scientific agreement'' adopted for foods in conventional food form. The
comment asserted that FDA was therefore bound by basic tenets of
statutory construction to adopt a more lenient standard for dietary
supplements, as such an action would give meaning to Congress's
instructions, whereas the adoption of the proposed standard would in
effect render those instructions meaningless. The comment noted that
courts have traditionally not interpreted provisions of a statute in
ways that would render other provisions superfluous.
A number of comments stated that using the same standard and
procedure for dietary supplements as for foods in conventional food
form is counter to the intent of the 1990 amendments because Congress
intended to make more, rather than less, information about the health
benefits of dietary supplements available to consumers. The comments
asserted that health information about the effects of diet on disease
is particularly important to consumers of dietary supplements in
deciding which products to buy.
Several comments argued that restricting this information on
dietary supplements will deny millions of Americans the information
that they need to improve their health and to help reduce their risk of
deadly afflictions such as heart disease and cancer. The comments
asserted that such restriction will cost the nation millions of dollars
in health care expenditures that could have been saved through disease
prevention.
Some comments expressed concern that restricting the use of
properly qualified health claims based on preliminary evidence would
encourage information-hungry consumers to seek information about the
health benefits of various dietary supplements from sources such as
books and the media, which may be unreliable and which are not
regulated by FDA. These comments argued that adopting a policy that
results in consumers turning to information that may well be misleading
or outright false is contrary to the educational goals of the 1990
amendments. One comment stressed that FDA should assist consumers by
encouraging them to reduce their risk of disease by changing their
diets, lifestyle, and other factors.
Comments suggested that FDA should place more weight on the
potential benefits of the health information than on eliminating all
possibility for consumer misunderstanding or all elements of risk
associated with increased consumption of dietary supplements. A few of
these comments advised that a more lenient standard would be
appropriate for dietary supplements because they are being sold to
educated consumers rather than to the general population. Some of these
comments disputed the argument that consumers could be misled by a more
lenient standard. These comments noted that consumers continue to rely
on health messages on products such as cigarettes and condoms, despite
the fact that the messages have changed over the years in response to
new scientific findings. Other comments stated that studies have
indicated that consumers are able to use various advertising claims
about diet and disease in a rational and beneficial manner.
Several comments asserted that FDA should allow the use of
preliminary health claims on dietary supplements and foods in
conventional food form because it allows their use on drugs. The
comments stated that FDA's proposed revision of the``Pediatric Use''
subsection of prescription drug labeling in the Federal Register of
October 16, 1992 (57 FR 47423) would allow prescription drugs that had
not been tested for safety and efficacy in children to nevertheless be
given to children provided that the drugs' efficacy claims were
qualified by the statement, ``Safety and effectiveness in children have
not been established.'' The comments stated that because these drugs
had not been tested for safety and efficacy in children, their claims
would be ``preliminary'' at best and misbranding at worst.
However, many comments argued against a more lenient standard and
procedure for dietary supplements. Several comments stressed that the
adoption of the proposed standard and procedure is supported by the
legislative histories of the 1990 amendments and the DS act. One of
these comments maintained that while the 1990 amendments give FDA the
option of adopting a more lenient standard for dietary supplements, the
Congressional Record denotes a majority opinion in favor of FDA
applying the same standard to supplements that the act provides for
conventional foods.
A number of comments also warned FDA that holding dietary
supplements and foods in conventional food form to different standards
for health claims would lead to consumer confusion, as the health
benefits of nutrients derived from dietary supplements would be allowed
to be characterized as superior to the benefits of those same nutrients
derived from foods in conventional food form. Some comments asserted
that the creation of public confusion would directly undermine the
intent of the 1990 amendments to clear up consumer confusion about
health claim information and would jeopardize consumer confidence in
existing health claims, food labels, and the government, particularly
public health officials. Another comment asserted that adopting a more
lenient standard for dietary supplements could also allow some
supplement manufacturers to make unsubstantiated claims and undercut
consumer belief in the credibility of the entire supplement industry.
These comments asserted that a single universal standard would best
prevent consumer confusion by ensuring that health claim information is
uniform on all foods.
Several comments supported the same standard and procedure on the
grounds that it would ensure that health claims appearing on the labels
of dietary supplements are based on reliable, peer-reviewed,
reproducible evidence. A number of these comments stated that because
supplements, unlike conventional foods, are taken specifically for the
health benefits associated with them, it is especially important that
health claims on these products be reliable because more and more
consumers are using these products in the belief that the products will
protect their health. The comments said that these consumers were
responding to the large amounts of recent evidence indicating that
vitamins, minerals, and other nutrients may play a role in reducing the
risk of chronic diseases.
Some comments cautioned FDA that the failure to ensure that health
claims on dietary supplements are reliable would leave consumers open
to fraud. A few of these comments pointed out that many consumers do
not have the scientific knowledge to judge the veracity of label claims
for themselves and presume that FDA regulations ensure that label
claims are properly substantiated. One of these comments warned that
older Americans are especially vulnerable to fraud. This comment
pointed out that the elderly suffer disproportionally from diet-related
diseases, read supplement labels more often than other people, are more
trusting of salespersons, and do less research than younger consumers.
Other comments warned that unsubstantiated health claims can harm
consumers by inducing them to consume products that are inherently
unsafe, to consume excessive doses of some substances, or to forego
more beneficial forms of treatment for a given malady.
A number of comments insisted that the proposed regulations will
not restrict the flow of information on nutrition and health to
consumers. One of these comments stated that roughly 80 percent of
supplement labels are already in compliance with the proposed
regulations. Other comments noted that educational materials are not
covered by the proposed regulations, and that there are many available
channels through which information can be freely disseminated other
than food labeling. Moreover, one comment contended that supplement
labels are neither intended, nor currently used, to educate the public
but instead serve to sell the product to which they are attached.
Some comments stated that applying the same standard to both
conventional foods and dietary supplements would create a desirable
``level playing field'' for all food processors and manufacturers. One
comment stated the adoption of the proposed standard will provide an
atmosphere in which all food manufacturers can move toward the
production of healthier foods, which will benefit the public health.
In FDA's reconsideration of how best to regulate dietary
supplements, one of the most significant issues has been the issue of
whether supplements should be regulated under a more lenient standard
or the same scientific standard as that established by Congress for
food in conventional food form. Despite assertions by some that
Congress directed that a more lenient standard be established, the
legislative history of the 1990 amendments does not support such a
position. To the contrary, as other comments point out, and as the
agency explained in the preambles of the health claims proposal (56 FR
60537 at 60539 through 60540), the health claims final rule (58 FR 2478
at 2507 through 2509), and the dietary supplement health claims
proposal (58 FR 33700 at 33703), Congress did not intend that the
agency be forced to adopt a different standard for dietary supplements.
Instead, Congress gave the agency the discretion to adopt any
appropriate scientific standard and procedure for dietary supplements.
There was nothing in the comments that indicated that FDA does not have
this discretion. Indeed, as some of the comments pointed out, there was
considerable support in both the House of Representatives and the
Senate for adoption of the same scientific standard and procedure for
dietary supplements. FDA addressed the position of members of Congress
on this issue in the preamble of the dietary supplement health claims
proposal (58 FR 33703):
Senator Hatch left no question about his position that FDA
should use this flexibility [to adopt the standard and procedure for
dietary supplements that appears appropriate to the agency] to adopt
a more lenient standard * * *
However, other members of Congress were equally clear about
their position that FDA should not adopt a more lenient standard. In
the October 24, 1990 Congressional Record at S 16608 [Ref. 4],
Senator Metzenbaum, the other primary author of the Senate
amendments, stated:
* * * It is my view that there is no reason to do anything other
than utilize the same procedure and standard for dietary
supplements.
Whatever approach the Secretary takes, he must establish a
system that evaluates the validity of health claims for dietary
supplements. The system must be based on the same considerations
that guide other agency decisions: public health, sound scientific
principles and consumer fraud.
Further, the House of Representatives clearly did not support a
more lenient standard for dietary supplements. The statement of
House Floor Managers that appears in the October, 26, 1990
Congressional Record at H 12953 [Ref. 2] states:
* * * Whatever approach the agency takes, it must adopt a system
that evaluates the validity of any disease claims made with respect
to these substances. Its system must be based on considerations of
public health and consumer fraud. As in every similar decision made
by the agency today, we fully expect that the agency's evaluation of
disease claims made with respect to vitamins will be based on sound
scientific principles.
There is a great potential for defrauding consumers if food is
sold that contains inaccurate or unsupportable health claims. The
potential is just as great for vitamins as it is for other products.
In our view, vitamins and other substances covered by this provision
should be subject to at least as strong a standard as is applicable
to other foods that contain claims that the food will treat a
disease or health condition.
Nothing in the DS act or its legislative history indicates in
any way that Congress changed its position about its goals of the
1990 amendments with respect to prohibiting misleading health claims
and improvement of the public health through use of valid and
understandable claims in food labeling [Ref. 3].
Although Congress left no question that the exact standard and
procedure for the regulation of health claims for dietary supplements
is left to the discretion of FDA, and although Congress did not provide
direct guidance concerning how FDA should use this discretion, Congress
did provide considerable general guidance about the intent of the
health claims provisions of the 1990 amendments. In view of the fact
that this guidance does not distinguish between dietary supplements and
foods in conventional food form, FDA considers this guidance to be
applicable to both types of foods. As pointed out above in this
response, Senator Metzenbaum, the other primary author of the Senate
amendments, stated that whatever approach the Secretary takes, he must
establish a system that evaluates the validity of health claims for
dietary supplements. He stressed that the system must be based on the
same considerations that guide other agency decisions: Public health,
sound scientific principles, and consumer fraud (Ref. 4). The quoted
statements of the House Floor Managers also stress that the agency's
approach to regulating dietary supplements must be based on
considerations of public health, sound scientific principles, and
consumer fraud (Ref. 2). In addition, these quoted statements make it
clear that Congress considered the use of ``inaccurate or unsupportable
health claims'' on food labeling to be harmful to the public (Ref. 2).
Moreover, Mr. Waxman, one of the House Floor Managers stated the
following in the July 30, 1990 Congressional Record (H5844):
What we have sought to do is to permit health claims but only
health claims based on scientifically valid information, and we hope
by having that scientifically valid information upon which a claim
can be made, that health claims in the future will be healthful and
not misleading.
Furthermore, as the agency pointed out in the January 6, 1993
Federal Register (58 FR 2478 at 2526):
By enacting the 1990 amendments, Congress sought to ensure that
health claims would be scientifically valid and not misleading.
(See, for example, statement of Rep. Madigan, and statement of Rep.
Waxman, [Ref. 2]). Experience had shown that many ``unfounded''
health claims were being used on foods (statement of Rep. Waxman
[Ref. 2]). Congress recognized the ``great potential for defrauding
consumers if food is sold that contains inaccurate or unsupportable
health claims.'' Id. (statement of House floor managers).
In response to the high potential for health claims to be
misleading, Congress legislated that any claim that is not
consistent with FDA regulations will misbrand a food. Section
403(r)(1)(B) of the act states that a food is misbranded if its
label or labeling contains a claim that ``expressly or by
implication * * * characterizes the relationship of any nutrient * *
* of the food to a disease or a health-related condition unless the
claim complies with regulations promulgated by FDA.
Sec. 403(r)(1)(B)'' (emphasis added). By taking this approach,
Congress chose to permit only those health claims on food that FDA
determines to be scientifically valid, effectively recognizing that
health claims are so potentially misleading as to be inherently
misleading.
Applying the same standard and procedure to health claims on
dietary supplements as that that applies to foods in conventional food
form will not affect the availability of any dietary supplements, will
ensure that health claims that appear in labeling are scientifically
valid and understandable, and will subject all segments of the food
industry to regulation in a fair and consistent manner. Those comments
favoring the same standard and procedure, for reasons of fairness,
control of consumer fraud, and conveyance of valid information about
diet and its impact on a disease or health-related condition, serve to
reinforce FDA's conclusion that the agency's proposed rule should be
finalized as proposed.
The agency disagrees with arguments that use of the same approach
for dietary supplements as for conventional foods would deny millions
of Americans the dietary information that they need to improve their
health and thereby cost the nation millions of dollars in health care
expenditures that could have been avoided. As FDA explained in the
preamble of the dietary supplement health claims proposal (58 FR 33700
at 33705):
* * * In the absence of adequate data to establish that health
claims are valid, assertions about costs associated with the lack of
information in food labeling and about the benefits of consumption
of substances in dietary supplements are highly speculative and
highly questionable. FDA does not agree that it should place more
weight on the potential benefits of the health information than on
eliminating the possibility of consumer misunderstanding. FDA must
weigh the public health impact of permitting a multitude of
preliminary claims against the possibility that a significant
portion of those claims will be determined to be not scientifically
valid. The latter result would likely produce a perception among
many consumers that food labels and health claims, even those that
are valid, are not reliable. To the extent that, as a result,
consumers do not change their dietary patterns to reduce their risk
of disease, they will be less healthy, and there will be more
needless deaths from disease and more costs to the national economy,
rather than less.
When FDA made this statement, the phrase ``adequate data to
establish that health claims are valid'' was intended to express the
position that until the validity requirements of Sec. 101.14(c) are
met, cost assertions about the benefits of substance consumption are
highly speculative and highly questionable. In general, prior to
fulfillment of this requirement, there may often be studies with a wide
variety of strengths and weaknesses indicating that there may, or may
not, be a valid association between a substance and a disease or
health-related condition. In deciding whether or not to authorize a
claim, FDA must consider that, while benefits may accrue from the
availability of the claim, there is a very real possibility that
significant costs may accrue if the claim is authorized prematurely. A
few studies may often be found about a multitude of associations, and
many, if not most, of those associations will ultimately be found not
to be valid. If FDA were to permit preliminary claims about such a
multitude of associations, the agency believes that ultimately what
would be lost is the confidence of most consumers in the validity of
all claims that appear in food labeling. FDA believes that the costs to
consumers of such a situation would prove to be greater than the costs
of not permitting preliminary claims. Of greater significance, however,
is that needless deaths would ultimately occur where consumers would
not change their dietary patterns to adopt a more healthful diet.
The agency believes that Congress, in its enactment of the
scientific standard in section 403(r)(3)(B)(i) of the act, struck what
it believed to be an appropriate balance between the costs and benefits
of claims on foods in general. FDA is not aware of any reason to strike
a different balance for dietary supplements. FDA would like to assure
all affected parties that the agency will move as expeditiously as
possible to permit health claims once the scientific evidence is
sufficiently supportive to conclude that associations between
substances and disease or health-related conditions are valid.
Although some comments asserted that claims based on a more lenient
standard would not be confusing because consumers of dietary
supplements are more knowledgeable than the general population, FDA
pointed out in the preamble of the dietary supplement health claims
proposal (58 FR 33700 at 33705) that there is nothing that limits the
purchasers of dietary supplements to ``knowledgeable consumers.'' The
comments did not submit justification for FDA to change its position in
this regard.
Assertions that use of the same scientific standard for dietary
supplements as that established for food in conventional food form is
counter to the 1990 amendments because less information about diet and
disease will be available to consumers are not correct. Under the 1990
amendments, authorized health claims provide considerably more
information about the effects of diet on disease where the effects are
recognized as scientifically valid than was the case before the passage
of the 1990 amendments. In the Federal Register of January 6, 1993, FDA
authorized claims with respect to 7 relationships (see 58 FR 2537,
2552, 2622, 2665, 2739, 2787, and 2820). Also, in the Federal Register
of October 14, 1993 (58 FR 53254), FDA proposed to permit health claims
concerning the relationship between folate and the risk of neural tube
birth defects. Admittedly, other health claims are not permitted to
appear on food labels and labeling, but Congress clearly intended
through enactment of section 403(r) of the act that only valid health
claims be permitted.
With respect to concerns that consumers will be forced to seek
information about diet and health from
unregulated sources such as books and the media, if FDA does not
authorize preliminary claims, FDA advises that it must implement the
provisions of the amendments as Congress chose to enact them. The 1990
amendments focus only on food labels and labeling. FDA cannot ignore
its clear responsibilities under the 1990 amendments because of
concerns about the unregulated sources of information that were
mentioned in the comments. Moreover, while such sources of information
may lead consumers to seek out products containing particular
substances, FDA's action will ensure that the labels and labeling of
those products contain only scientifically valid information that can
dispel any misconceptions created by the unregulated sources. With
respect to other concerns expressed by these comments, the agency
believes that the specific required elements in the health claims that
it has authorized to date demonstrate that the agency is encouraging
consumers to reduce their risk of disease by changing their diets and
lifestyle. For example, the specific requirements in
Sec. 101.72(c)(2)(A) requires, in part, that a claim about calcium and
osteoporosis make clear that an adequate level of exercise and a
healthful diet are needed in addition to adequate calcium consumption.
Arguments that the agency should allow preliminary claims because
of FDA's implementation of the drug provisions of the act have no
merit. Assertions about FDA's proposed action pertaining to ``Pediatric
Use'' for drug labeling in (57 FR 47423) are clearly wrong. The
agency's proposed action with respect to requiring the statement
``Safety and effectiveness in children have not been established''
pertains only to drugs for which there is no agency approval for any
pediatric population to use the drug. In point of fact, the agency
proposed to require this statement as a further warning that the
product should not be used for pediatric populations. Thus, this action
provides no support for authorizing preliminary health claims.
As FDA pointed out in the preamble of the dietary supplement health
claims proposal (58 FR 33700 at 33706), making dietary supplements
subject to the same scientific standard and procedure as for
conventional foods does not render section 403(r)(5)(D) of the act
superfluous. This section requires that the agency consider what
procedure and standard respecting the validity of claims are most
appropriate. This is what the agency has done. The fact that the agency
has found that, on balance, the standard and procedure established for
foods in conventional food form are also the most appropriate for
dietary supplements does not render the agency's efforts invalid or the
underlying provision superfluous. The agency was charged with
exercising its expertise and discretion, and that is what it has done.
5. A number of comments provided specific suggestions about the way
in which a more lenient approach could be implemented. Some comments
argued that the approach should be sufficiently lenient to permit
marketing of dietary supplements without any restrictions. Some of
these comments argued that dietary supplements needed no stringent
requirements because dietary supplements could be adequately regulated
under the requirement in section 403(a)(1) of the act that the labeling
of a food must be truthful and not misleading. Other comments suggested
that FDA could require a warning informing the consumer that FDA had
not substantiated particular claims appearing on a product. One comment
suggested that substantiated claims could be allowed to appear within a
specific advisory panel of the label, while preliminary claims would be
allowed to appear only outside the panel. Another comment suggested
that FDA adopt a split label approach, in which preliminary health
claims would be allowed, but the agency would have the right to comment
upon them on the label.
One comment suggested that health claims for which there is
substantial scientific evidence but not yet significant scientific
agreement be subject to a certification and notification procedure
rather than rulemaking proceedings. Under the procedure suggested by
the comment, claims could be made for dietary supplements so long as:
(1) The claim expressly discloses the absence of scientific agreement
as to the relationship, (2) the manufacturer provides FDA with a fully
documented certification by a panel of at least three qualified experts
that there is substantial scientific evidence supporting the claim, and
(3) FDA does not disapprove the claim within 90 days of receipt of the
certification. (When additional information is needed, the 90 day
period could be extended an additional 45 days.) Under this suggested
alternative, FDA would have an opportunity to participate in the
selection of the expert panel.
One comment requested that FDA only disallow the use of those
health claims on dietary supplements that are not supported by any
evidence, and that it classify all other health claims into one of five
categories and allow for their use on products in conjunction with a
code system indicating to consumers the level of substantiation that
the claim has achieved. The comment suggested that the highest category
be full substantiation; the second, those claims that have a high
degree of substantiation as judged by non-FDA experts, but that FDA
finds to be not fully substantiated; the third, claims that have
support in the form of double-blind placebo controlled studies
published in peer-reviewed professional journals; the fourth, claims
that are supported by some evidence from in vitro studies, animal
studies, or other studies that do not involve humans; and the fifth,
those claims supported by anecdotal evidence. In support of its call
for various approval levels, the comment stated that simply
categorizing a claim as ``substantiated'' or ``unsubstantiated'' does
not accommodate the reality that full substantiation of a health claim
consists of cumulative evidence from many studies. The comment
maintained that if FDA were to place all claims that have not achieved
full substantiation into the same category, FDA would not be providing
a means for the public to distinguish claims that are nearly
substantiated from those that are entirely false. Moreover, the comment
stated that an agency determination that a claim is or is not supported
by ``significant scientific agreement'' often reflects a political
decision rather than a scientific one. The comments said that FDA
panels comprise a very small percentage of the scientific community,
that other scientists often disagree with the panels' findings, and
that there even may be differing opinions within the panels themselves.
The comment stated that, given these conditions, it is blatantly
dishonest and misleading to the public for FDA to make a general
declaration that a claim is or is not substantiated.
A few similar comments called for FDA to devise a multilevel
approval scheme for health claims on dietary supplements that would
allow statements concerning the traditional use of a product to appear
on the label and would permit the label of a supplement that contained
a substance that was the subject of a pending health claim petition to
indicate that the product was under FDA review for a health claim but
not to indicate the nature of the claim. The comments stated that the
adoption of this approach would encourage manufacturers of products
that qualify only for the ``traditional uses'' or ``claim pending''
approval categories to gather, perform, and submit research information
to FDA in order to reach higher approval levels.
One comment suggested that FDA allow manufacturers to use
facsimiles of the FDA seal in conjunction with the various ratings. The
comment asserted that this approach would encourage manufacturers to
come into compliance with FDA regulations quickly, as the seals would
become valuable marketing tools for which consumers look when
purchasing supplements, and the lack of a seal would become a marketing
disadvantage for a company.
FDA has considered these alternative standards and procedures
suggested by the comments and finds that none of them have the
characteristics that are necessary to achieve the goal envisioned by
Congress in passing the 1990 amendments. Previously in this preamble
the agency concluded that Congress intended that FDA adopt a scientific
standard and a procedure that ensure that health claims that appear in
labeling are scientifically valid and understandable. None of the
alternative standards and procedures offered by the comments meets this
objective. One of Congress' primary concerns in passing the 1990
amendments was the widespread use of health claims whose scientific
validity had not been established (Ref. 1). The purpose of the 1990
amendments was to bring that situation under control. The problem with
the alternative procedures offered by the comments is that, rather than
bringing the use of claims on dietary supplements under control, they
would ratify the state of affairs that caused Congress to act.
As FDA explained in the preamble of the dietary supplement health
claims proposal, a standard for health claims for dietary supplements
that is based only on section 403(a)(1) of the act, or that allows
health claims based on the traditional use of the supplement or the
existence of substantial scientific evidence but not significant
scientific agreement about the validity of the claim, would be
inconsistent with Congress's desire to ensure that health claims that
are made on dietary supplements, or on any other food, are
scientifically valid. FDA pointed out that if such claims were to be
permitted, consumers would be faced with a multitude of claims, some
valid and some not valid. FDA stated that it would be unlikely that
consumers could distinguish between valid and invalid claims. Although
comments on the dietary supplement health claims proposal asserted that
consumers would not be confused by a multitude of claims, the comments
did not actually go further in addressing how consumers would react to
such a situation in food labeling. More specifically, the comments did
not provide data to resolve the question of whether consumers would be
able to understand gradations of scientific reliability of claims on
food labeling, or whether consumers would, in fact, be left as confused
as they were before passage of the 1990 amendments. While a number of
comments did assert that some studies show that consumers are able to
use various advertising claims about diet and disease in a rational and
beneficial manner, the studies were not actually submitted. In the
absence of the studies, FDA has no basis upon which it can evaluate the
assertions of the relevance of the studies to food labeling. In the
absence of evidence to the contrary, the agency considers it more
likely that consumers would be considerably confused by a multitude of
claims with differing degrees of reliability. One of the purposes of
the 1990 amendments was to end such confusion (see statement of Mr.
Waxman, 136 Congressional Record H12953 (Ref. 2)). Therefore, FDA
rejects this assertion.
Approaches such as those involving a ``split label'' or the use of
an FDA seal would also not be consistent with the congressional desire
for scientific validity because manufacturers would still be able to
market dietary supplements with claims that were not scientifically
valid. Even if FDA seals were being used to distinguish those claims
that FDA considered to be valid, there would be a question as to
whether consumers would be able to ascertain which claims were
preliminary and which were not. These approaches would not restrict the
number of health claims that were of questionable validity, about which
Congress was specifically concerned (Ref. 1).
Thus, FDA has concluded that it would not be appropriate to adopt
any of the alternative approaches suggested by the comments.
6. Several comments suggested that FDA adopt the reasonable
substantiation standard used by the Federal Trade Commission (FTC) (see
FTC Policy Statement Regarding Advertising Substantiation Program (49
FR 30999, August 2, 1984)). The comments asserted that under this
policy, FDA could allow manufacturers to make claims provided that the
nature of the scientific finding is accurately represented, the degree
of evidence is not misrepresented, and the claim passes a rough cost/
benefit test. The comments argued that this policy would facilitate
harmonization with the FTC regulations governing the use of health
claims in food advertising, would allow consumers to have access to
truthful, nonmisleading, and reliable labeling information, and would
still allow FDA to take action against those dietary supplements
bearing health claims that are not properly substantiated.
Arguments that FDA should adopt for dietary supplements FTC's
approach for regulating advertising are not consistent with Congress'
expectations for health claims. While the FTC and FDA are working
together to achieve as much consistency in their approaches to health
claims as their respective statutes allow, adoption by FDA of the FTC
advertising substantiation approach would not provide FDA the
confidence Congress intended concerning the scientific validity of the
claims. Specifically, as explained above, one of Congress' main
purposes in passing the 1990 amendments was to ensure that health
claims made in food labeling are scientifically valid. No such
assurance of scientific validity is provided under the standard that
FTC must employ. Under that standard, there must be some evidence to
support a claim, but it need not rise to the level of establishing the
claim's validity. Thus, the FTC standard is not adequate for health
claims. In this context, it is appropriate to reiterate FDA's response
to comments asserting that it was bound to follow cases involving FTC's
regulation of advertising in the preamble of the health claims final
rule (58 FR 2478 at 2528):
Although cases involving FTC may sometimes be relevant, it is
important to note that fundamental differences exist between the
regulatory schemes administered by the two agencies. Congress has
long recognized the division of roles between the two agencies--FTC
concentrates on the interests of commerce and economic needs,
whereas the objective of FDA is ``the health of the people.'' FTC
regulates unfair competition and trade practices, including food
advertising. (See, for example, 15 U.S.C. sections 45 and 52.) In
contrast, FDA is a scientific agency empowered to regulate the food
label, among other things. Under section 403(r)(3)(B)(i) of the act,
FDA may permit health claims on foods only if it has determined that
those claims meet the statutory test for scientific validity. The
laws under which FTC operates do not include a comparable statutory
standard. Thus, it would not be appropriate for FDA to follow the
case law involving FTC.
III. The Final Regulation
In light of the foregoing, FDA is subjecting dietary supplements to
the same standard and procedure that applies to food in conventional
food form. The agency believes that this approach strikes the
appropriate balance between the congressional concern for consumer
fraud, public health, and sound science, on the one hand, and the
desire to provide the consumer with information on the other. Thus, the
agency is revising Secs. 101.14 and 101.70 to include dietary
supplements.
A. Definitions
In the health claims proposal, FDA proposed definitions for
``health claim,'' ``substance,'' ``nutritive value,'' and ``dietary
supplement'' to serve as tools for clearly establishing the scope of
the types of claims that would be subject to the regulations
promulgated under section 403(r)(1)(B) of the act. In addition, the
agency proposed a definition for ``disqualifying nutrient levels'' to
establish limits on the levels at which certain nutrients that are
known to increase the risk of a disease or health-related condition
could be present in a food, and the food would still be eligible to
bear a health claim (see section 403(r)(3)(A)(ii) of the act).
In the health claims final rule, the agency adopted definitions for
the terms ``health claim,'' ``substance,'' ``nutritive value,'' and
``disqualifying nutrient levels,'' that it revised in response either
to comments or to the DS act (see Sec. 101.14(a)(1), (2), (3), and
(5)). Also, FDA adopted a definition for the term ``disease or health-
related condition.'' Although the term is used in the definition of
``health claim,'' and the term serves to identify one of the basic
elements of a health claim, the agency had not proposed a definition
for it. The agency added this definition to clarify the coverage of the
health claim provisions (see Sec. 101.14(a)(6)). Because of the DS act,
the agency reserved the question as to whether these definitions would
apply to dietary supplements. The agency also did not include a
definition of ``dietary supplement'' in the final rule because of the
moratorium imposed by the DS act.
In the dietary supplement health claims proposal, FDA proposed to
adopt the same regulatory scheme for health claims for dietary
supplements that it had established for foods in conventional food
form. To effect this tentative decision, the agency proposed to revise
the definition of ``substance'' to make clear that it covers both food
in conventional food form and dietary supplements and to establish a
definition for ``dietary supplement.''
FDA received no comments on the former aspect of the proposal.
Therefore, the agency is adopting it as proposed. However, FDA did
receive some comments on its proposed definition of ``dietary
supplement.''
1. Dietary Supplement
FDA proposed the following definition for the term ``dietary
supplement'' (proposed Sec. 101.14(a)(4)):
Dietary supplement means a food, not in conventional food form,
that supplies a component to supplement the diet by increasing the
total dietary intake of that component.
In the past, FDA has taken a position that the term ``dietary
supplement'' applied only to supplements composed of essential
nutrients. However, FDA did not propose to limit the definition in
Sec. 101.14(a) in this way because section 403(r)(5)(D) of the act
includes dietary supplements of herbs, substances that generally
contain few essential nutrients. In addition, the legislative history
indicates that the term ``other nutritional substances'' could include
a number of substances that have not been shown to be essential or
nutrients (Ref. 4).
7. One comment commended the agency for proposing a definition of
``dietary supplement'' that recognized that these foods could have
components other than substances known to be essential nutrients. The
comment asserted that the proposed definition would appropriately move
supplements out of the food additive category.
FDA advises that the comment's assertion that the definition moves
dietary supplements out of the food additive category is not correct. A
dietary supplement, as the definition recognizes, is a compounded food
that may include compounds that are food additives. Whether a component
of food is a food additive or not is determined under section 201(s) of
the act (21 U.S.C. 321(s)), not section 403(r) of the act. Congress
specifically provided in section 9 of the 1990 amendments that these
amendments ``shall not be construed to alter the authority of the
Secretary of Health and Human Services * * * under the Federal Food,
Drug, and Cosmetic Act.'' Thus, the components of dietary supplements
that are food additives are still fully subject to the food additive
requirements under section 409 of the act.
8. A few comments requested that the proposed definition of
``dietary supplement'' be modified to explicitly include all herbal
extracts. One of these comments asserted that the definition should
include ``processed or unprocessed plant parts (bark, leaves, flowers,
fruits, and stems) as well as extracts of essential oils, marketed as
teas, powders, tablets, capsules, and elixirs.''
FDA is adopting the definition of ``dietary supplement'' as
proposed. This definition is intentionally broad to cover the range of
substances that, under the legislative history, could be included in a
dietary supplement and could be the subject of a health claim. The
purpose of the definition of ``dietary supplement'' is not to define
the substances that may be eligible to be the subject of a health claim
but to define the form in which they are to be sold to be subject to
regulation as a ``dietary supplement.'' Under the scheme that FDA is
adopting, and that Congress envisioned (see Ref. 4, statement of
Senator Metzenbaum), the determination as to what substances are
appropriately the subject of a health claim is made on a case-by-case
basis, based on the factors set out in Sec. 101.14(b) and the evidence
presented to the agency. The agency disagrees with the comment in one
respect, however. Teas are food in conventional food form and thus not
included within the definition of ``dietary supplement.''
9. One comment asserted the definition of ``dietary supplement''
should include foods in conventional food form that are fortified with
a vitamin or mineral to a level of 50 percent or more of the Reference
Daily Intake (RDI) per serving (e.g., many breakfast cereals).
FDA does not agree that such foods should be included in the
definition of ``dietary supplements.'' As discussed in the preamble to
the dietary supplement proposal (58 FR 33700 at 33707), FDA has limited
this definition to foods not in conventional food form to reflect the
approach taken by Congress in the DS act. The manager's statements for
the DS act from the Senate and the House (Ref. 3) clearly state that
the moratorium on the implementation of the 1990 amendments applies
only to dietary supplements ``not in the form of conventional food.''
Because foods in conventional food form were not covered by the DS act
moratorium, the health claims regulations already apply to them.
Consequently, FDA believes that it will reduce confusion about the
impact of these regulations if the agency limits coverage of the term
``dietary supplements'' to foods not in conventional food form. Of
course, foods in conventional food form that are formulated to
supplement the dietary intake of nutrients will be free to reflect
their characteristics in their common or usual name (e.g., vitamin and
mineral supplement cereal).
2. Nutritive Value
In the health claims final rule, FDA defined ``nutritive value'' as
follows:
Nutritive value means a value in sustaining human existence by
such processes as promoting growth, replacing loss of essential
nutrients, or providing energy.
Although FDA did not propose any changes in the definition of
``nutritive value'' in the dietary supplement health claims proposal,
many comments expressed concern about the impact of this definition in
conjunction with the preliminary requirement in Sec. 101.14(b)(3)(i)
that the substance that is the subject of a health claim contribute
taste, aroma, or nutritive value, or any technical effect listed in
Sec. 170(o), and that the substance must retain that attribute when
consumed at levels that are necessary to justify a claim. (Preliminary
requirements are criteria in Sec. 101.14(b) that have to be met before
a substance will qualify to be the subject of a health claim. An
indepth discussion of all preliminary requirements follows in section
III.B. of this document.)
10. Some comments urged the agency to broaden its definition of
``nutritive value.'' These comments urged the agency to recognize that
the processes by which a nutrient promotes health, maintains proper
bodily functioning, and protects the body from the development of
chronic disease or other health-related conditions are, in and of
themselves, characteristic of ``nutritive value.'' The comments noted
that the basic function of Vitamin E, for example, relates to its
antioxidant properties in preventing cell damage by trapping peroxyl
free radicals and inhibiting the oxidation of unsaturated fatty acids.
Also, the comments pointed out that fiber does not promote growth,
replace essential nutrients, or provide energy, but that Congress
specifically required FDA to study the relationship between various
diseases and fiber. Some of the comments asked that the phrase
``preventing or repairing the negative metabolic consequences of life
processes'' be added to the list of processes that characterize the
nutritive value of a food to ensure that such components can be the
subject of health claims. A few comments asserted that FDA should
revise the definition of ``nutritive value'' to provide for claims
about ``prevention'' of a disease or health-related condition.
However, one comment maintained that the definition of ``nutritive
value'' in Sec. 101.14(a)(3) is broad enough to include the functions
of most dietary supplements. The comment supported its position by
agreeing with FDA's statement in the health claims final rule (58 FR
2478 at 2488) that the inclusion of the phrase ``such as'' in the
definition ensures that the three referenced processes are examples of
how a substance may confer nutritive value rather than as an all-
inclusive list.
The comment that highlighted FDA's use of the phrase ``such
processes as'' in this definition is correct. FDA intended the three
referenced processes to be examples of how a substance may confer
nutritive value rather than as an all-inclusive list of the functions
that provide such value. As FDA explained in the health claims final
rule (58 FR 2478 at 2488), the definition of ``nutritive value'' is
intended to be very flexible. The agency incorporated this flexibility
in the definition because FDA recognizes that certain substances can
play a major role in reducing the risk of certain chronic diseases and
may confer their benefits through a number of processes. FDA believes
that the agency should evaluate the nutritive value claimed for a
substance that is proposed as the subject of a health claim, as
described in a health claim petition, on a case-by-case basis. This
approach will best ensure that the definition retains its intended
flexibility and does not become an unintentional barrier to
authorization for legitimate health claims.
FDA does believe, however, that this preamble should provide
guidance concerning how the agency will determine if a claimed
nutrient-disease relationship derives from the nutritive value of a
substance. In general, the agency will look for evidence that the
claimed effect on disease is associated with the normal maintenance of
human existence. If the substance is used to correct an abnormal
physiological function caused by a disease or health-related condition,
the action of the substance is clearly beyond a normal maintenance
function, and the health benefit would therefore not derive from the
substance's nutritive value. Such a substance would be a drug. (Note
also that claims about classical nutrient deficiency diseases are not
health claims (see 58 FR 2478 at 2481).)
FDA recognizes that many of the benefits mentioned in the comments
may derive from the nutritional value of a substance. The agency's
broad definition of ``nutritive value'' includes assisting in the
efficient functioning of classical nutritional processes and of other
metabolic processes necessary for the normal maintenance of human
existence. Dietary fiber, for example, helps to assure normal
intestinal transit time, thereby providing nutritional value by
promoting efficient bowel function. Vitamin E provides nutritive value
through its antioxidant function of reduction of cell damage.
With respect to assertions that FDA should revise the definition of
``nutritive value'' to provide for claims about ``prevention'' of a
disease or health-related condition, the agency points out that the
preamble of the health claims final rule (58 FR 2478 at 2501 through
2502) fully addressed this matter and concluded that a claim that a
substance can be used in the prevention, diagnosis, cure, mitigation,
or treatment of a disease or symptom is inappropriate for a food (see
section 201(g)(1)(B) of the act and Sec. 101.9(k)(1) (21 U.S.C.
101.9(k)(1))). FDA reached this conclusion because the relationship of
a food or a food component to a disease is quite different from that of
a drug. The comments making these assertions did not provide any basis
upon which FDA could conclude that the agency's position in this matter
should be different for dietary supplements than for foods in
conventional food form. As FDA explained in the preamble of the health
claims final rule, the Surgeon General's Report on Nutrition and Health
(Ref. 5) points out that, apart from classic disorders resulting from
dietary deficiencies of essential nutrients (e.g., pellagra and
niacin), it has proved difficult to demonstrate causal associations
between specific dietary factors and chronic or other diseases (e.g.,
dietary fiber and cancer). The report states:
Development of the major chronic disease conditions--coronary
heart disease, stroke, diabetes, or cancer--is affected by multiple
genetic, environmental, and behavioral factors among which diet is
only one--albeit an important--component. These other factors
interact with diet in ways that are not completely understood. In
addition, foods themselves are complex; they may contain some
factors that promote disease as well as others that are protective.
The relationship of dietary fat intake to causation of
atherosclerotic heart disease is a prominent example. An excess
intake of total fat, if characterized by high saturated fat, is
associated with high blood cholesterol levels and therefore an
increased risk for coronary heart disease in many populations. A
higher proportion of mono- and polyunsaturated fats in relation to
saturated fats is associated with lower blood cholesterol levels
and, therefore, with a reduced risk for coronary heart disease.
Because of these complexities, definitive scientific proof that
specific dietary factors are responsible for specific chronic
disease conditions is difficult--and may not be possible--to obtain,
given available technology.
(Ref. 5).
11. Several comments argued that the definition of ``nutritive
value'' should include levels of nutrients that are achievable only
through the use of fortified foods or dietary supplements. Several of
these comments referenced studies recently reported in the New England
Journal of Medicine that indicate that vitamin E reduces the risk of
heart disease when consumed at levels that are almost impossible to
achieve through a conventional diet but that can be easily and safely
attained through the use of dietary supplements. These comments
asserted that it would be inappropriate for FDA to categorize the
involved nutrient levels of vitamin E as therapeutic and to refuse to
consider approving a health claim simply because the claim concerns
levels of a nutrient above that achievable in a normal daily diet. A
few of the comments supported this assertion by noting that the
mechanism by which Vitamin E protects against cell damage when consumed
at normal dietary levels is identical to the mechanism by which it
protects against heart disease when consumed at higher levels. The
comments maintained that, in cases such as this one, the agency should
approve health claims for use strictly on dietary supplements, provided
that the nutrient is safe when consumed at the level at which the
claimed effect is achieved, and the supplement is intended to be
consumed to optimize health rather than as a drug. The comments
supported this regulatory approach by noting that the health benefits
of calcium occur when the nutrient is consumed at increased levels that
can be achieved through the diet or by supplementation and stating that
vitamin E should not be treated differently simply because the
beneficial levels cannot be reached without the use of dietary
supplements.
Similar comments argued that FDA should at least avoid establishing
a maximum level of a nutrient that is considered to be characteristic
of ``nutritive value.'' One of these comments noted such an approach
results in an extremely fuzzy line, because the maximum level of a
nutrient that is achievable in a diet varies widely from one individual
to another. As an example, the comment pointed out that a person who
eats ten oranges or drinks a quart of orange juice per day gets more
vitamin C than is provided by most currently marketed vitamin C
supplements. A few comments asserted that there is much scientific
disagreement over what levels of a nutrient are ``nutritive,'' with
many scientists contending that levels much higher than the U.S.
Recommended Daily Allowances (U.S. RDA) fall within the definition. A
few comments requested that FDA explicitly express in its regulations a
policy that nutritive value may involve relatively high levels of a
nutrient.
A few comments maintained that FDA should presume that all
nutrients function in a nutritive manner regardless of their level,
unless it has proof to the contrary. In support of this position, a
number of comments objected to the use of niacin's effect on blood
cholesterol levels in the dietary supplement proposal as an example of
an effect that is not nutritive. One of these comments questioned FDA's
assertion that niacin does not exhibit cholesterol-reducing properties
when ingested at the levels conventionally associated with its function
as a vitamin. The comment stated that niacin's vitamin effect occurs
below the level of tissue saturation and maintained that the excretion
of niacin when consumed at higher levels known to be associated with
cholesterol-lowering effects does not necessarily indicate that tissue
saturation has occurred. This comment also disagreed with the agency's
statement that the occurrence of liver damage when high levels of
niacin are consumed indicates that the effect of niacin at these levels
is not nutritive in nature. The comment argued that it is quite
possible that niacin continues to have nutritive effects at these
levels but simply is overloading the body's normal metabolic pathways
for ridding itself of excessive levels of the nutrient. The comment
asserted that while legitimate safety concerns exist in particular
cases of excessive nutrient intake, FDA should not use this fact to
conclude that high levels of those nutrients are inherently
nonnutritive in nature and are instead pharmacological.
Other comments expressed the belief that nothing in the proposed
regulations would automatically exclude high levels of nutrients from
the definition of ``nutritive value'' and urged the agency to include
such levels in instances where they would benefit the public health.
These comments also agreed with FDA's decision to review on a case-by-
case basis whether the amount of a substance is appropriate as the
subject of a health claim. One of these comments stated that such an
approach would help to ensure that health information about fortified
foods and dietary supplements can be conveyed without triggering the
drug regulations.
FDA does not believe that it is necessary for the rules to
explicitly state that nutritive value includes relatively high levels
of a nutrient. As some comments pointed out, the case-by-case approach,
which, as stated above, is intrinsically linked with the preliminary
requirement in the provisions of Sec. 101.14(b)(3)(i), provides the
agency with considerable flexibility with respect to high levels of
substances in dietary supplements. Under this approach, FDA has not, as
a general rule, established any maximum level at which a nutrient would
cease to have ``nutritive value.'' Furthermore, the agency advises that
there is no basis for concerns that FDA would use safety concerns alone
to conclude that high levels of nutrients are pharmacological. FDA will
not do so.
As some of the comments pointed out, petitions for claims that
require that high levels of substances be ingested should have no
problem demonstrating that the substance has nutritive value where the
mechanism by which the substance affects the risk of disease at these
high levels is the same as the mechanism by which it functions as a
nutrient at normal dietary levels. However, it will still be necessary,
as the agency explained in response to the previous comment, for the
petition to show that the substance's effect on disease is associated
with the normal functioning of the human body (e.g., the substance
could not be used to correct an abnormal physiological function caused
by a disease or health-related condition.)
In its response to the previous comment, the agency acknowledged
that vitamin E provides nutritive value through its antioxidant
function of reduction of cell damage. If there are situations where it
can be established that this same antioxidant mechanism affects the
risk of disease when the vitamin is consumed at levels significantly
higher than normal dietary levels, such levels would satisfy the
requirement in Sec. 101.14(b)(3)(i) that a substance retain its food
attribute (i.e., its nutritive value) when consumed at levels that are
necessary to justify a claim.
FDA does not agree, however, that it should presume that all
nutrients function in a nutritive manner, regardless of their level,
unless it has proof to the contrary. It would not be practicable for
the agency to bear the burden of determining the mechanism by which the
claimed effect is occurring for each petitioned claim. Thus, the agency
finds that it is appropriate to require that petitioners provide the
basis for why it is reasonable to conclude that the claimed effect is
nutritional and not pharmacological. However, the agency does not
necessarily expect absolute proof on this issue. FDA will evaluate
petitions on this issue on a case-by-case basis.
The agency has considered assertions that the dietary supplement
proposal should not have cited the cholesterol-reducing properties of
niacin as an example of a high dose effect that is not nutritive. FDA
has again concluded that niacin is an appropriate example because there
are significant indications that a nutritive mechanism is not
responsible for the cholesterol-lowering effect that occurs with high
levels of niacin intake. When FDA stated in the dietary supplement
proposal that levels of niacin necessary to produce the cholesterol-
lowering effect are far in excess of the levels at which there is
tissue saturation for niacin's vitamin function, the agency was
attempting to explain that for niacin's function as a vitamin there is
a level beyond which additional niacin will not provide additional
functional results for that vitamin. The term ``tissue saturation'' may
imply either this type of situation (sometimes referred to as
``function saturation'') or the type of situation referred to in one of
the comments wherein the tissue is saturated with a concentration of a
substance, and more substance could immediately spill out into the
urine. FDA was not attempting to assert that the tissue itself was
actually saturated. There is no question that additional niacin will be
absorbed by cells when the vitamin function saturation level is
reached.
In addition to the situation with vitamin function saturation,
there are other indications that the cholesterol-reducing properties of
niacin do not result from the same mechanism as that presented by its
vitamin function. Vitamin function saturation may be achieved through
dietary supplementation with either of the two forms of the vitamin,
nicotinic acid or nicotinamide. However, only nicotinic acid provides,
at high levels, the cholesterol-reducing effects. Such effects do not
appear with high level consumption of nicotinamide (Ref. 6). If the
same mechanism were involved with the vitamin function of niacin as
with the cholesterol-reducing properties of niacin, both forms of this
vitamin should have cholesterol-reducing properties.
3. Health Claim
In the dietary supplement health claim proposal, FDA did not
propose to make any modifications in the definition of ``health claim''
in Sec. 101.14(a)(1):
Health claim means any claim made on the label or in labeling of
a food, including a dietary supplement, that expressly or by
implication, including ``third party'' references, written
statements (e.g., a brand name including a term such as ``heart''),
symbols (e.g., a heart symbol), or vignettes, characterizes the
relationship of any substance to a disease or health-related
condition. Implied health claims include those statements, symbols,
vignettes, or other forms of communication that suggest, within the
context in which they are presented, that a relationship exists
between the presence or level of any substance in the food and a
disease or health-related condition.Nonetheless, FDA received
several comments on this definition.
12. Some comments asserted that FDA should clarify the types of
statements that will be regulated as health claims. A few of these
comments asked whether statements that indicate that a product may be
useful in maintaining good health (e.g., ``Substance X may be
beneficial to good health'') or that describe the biochemical functions
of vitamins, minerals, and other nutrients (e.g., ``Vitamin A is
necessary for good eyesight,'' ``Protein helps build a strong body'')
will be considered to be health claims. The comments objected to FDA's
failure to provide clear instruction in this regard. These comments
asserted that the agency's allowance of case-by-case interpretation of
the regulations will hinder industry compliance, create enforcement
problems for the agency, and cause continued antagonism between FDA and
the food industry.
FDA believes that it provided ample guidance on what types of
statements constitute health claims in the health claims final rule. As
the agency explained in the preamble of that rule (58 FR 2478 at 2479
through 2488), the definition establishes that a claim must have at
least two basic elements for it to be regulated as a ``health claim.''
First, the claim must be about a ``substance'' as defined in
Sec. 101.14(a)(2). Secondly, the claim must characterize the
relationship of that substance to a ``disease or health-related
condition,'' as defined in Sec. 101.14(a)(6):
Disease or health-related condition means damage to an organ,
part, structure, or system of the body such that it does not
function properly (e.g., cardiovascular disease), or a state of
health leading to such dysfunctioning (e.g., hypertension); except
that diseases resulting from essential nutrient deficiencies (e.g.,
scurvy, pellagra) are not included in this definition (claims
pertaining to such diseases are thereby not subject to 101.14 or
101.70).
If a statement has one of these elements without the other, it
would not be a ``health claim,'' although it may still be subject to
regulation under other provisions of the act (e.g., the requirement
of section 403(a)(1) of the act that a label statement be truthful
and not misleading). Thus, all of the statements mentioned by the
comments would not be health claims because they do not address a
disease or health-related condition as defined under
Sec. 101.14(a)(6). The agency has provided a lengthy and detailed
discussion on what types of statements constitute health claims in
the health claims final rule at the pages cited above.
12. A few comments asked whether FDA would remove or prohibit the
publishing of books containing information on health claims and argued
that such regulations would clearly be unconstitutional. Other comments
addressed the issue of whether FDA's health claims regulations for
dietary supplements would apply to advertising. One of these comments
interpreted an excerpt from the report of FDA's Task Force on Dietary
Supplements as an attempt to disallow the use of unapproved health
claims in magazines, newsletters, or other media channels unless the
information has been preapproved by FDA. That excerpt reads:
The task force considered various issues in its deliberations,
including how to assure the safety of dietary supplements; how to
limit the potential for fraud, i.e., disease claims made on labels
or through other means, e.g., magazine articles, newsletters, and
advertisements * * *.
The comment further asserted that this same intent is reflected in
the health claim regulations proposed in November 1991. The comment
stated that this broad-based application of the health claims
regulations would severely jeopardize the reporting of health and
disease-related information in almost every form of media, would
inhibit the evolution of scientific knowledge, would have a significant
negative impact on the public health of America, and was likely
unconstitutional.
FDA advises that the provisions of this regulation pertain only to
a product's label and labeling. This regulation does nothing to censor
the content of books, magazines, or advertising. This regulation also
does not in any way regulate the availability of books, magazines, or
advertising. However, firms sometimes choose to use such material as
labeling for their products, and if used as such, the material would be
subject to this regulation. For example, sometimes firms copy an
article from a magazine and display that article with a product that is
offered for sale. Under such circumstances, the article would be a part
of the labeling of that product. What is significant to note is that
these regulations in no way limit what articles may be published, or
what books may be printed. They limit only the claims that may be made
in the labeling of food products. Under the act, advertising may
provide objective evidence of what the intended use of a particular
product is. If the advertising reveals that the product is intended to
be used as a drug, the product may be regulated as a drug. In addition,
claims made in advertising may affect the type of nutrition labeling
that is provided (see Sec. 101.9(j)). Claims made in advertising,
however, are not subject to section 403(r)(1)(B) of the act.
Thus, the agency finds no merit in the concerns expressed by these
comments.
B. Preliminary Requirements for a Claim
In the health claims final rule, FDA established several criteria
in Sec. 101.14(b) that have to be met before a substance will qualify
to be the subject of a health claim. The criteria provide that the
substance must: (1) Be associated with a disease or health-related
condition for which the general U.S. population is at risk
(alternatively, the relevance of the claim may be explained within the
context of the daily diet) (see Sec. 101.14(b)(1)); (2) be a food (see
Sec. 101.14(b)(2) and (b)(3)(i)); and (3) be safe and lawful under
applicable food safety provisions of the act (see
Sec. 101.14(b)(3)(ii)). These criteria reflect not only the
requirements of section 403(r) of the act but also the fact that FDA is
charged with ensuring that the food supply is safe, and that the food
label is not misleading. Given that agency evaluations of the validity
of a health claim will be resource intensive, FDA decided not to
undertake such evaluations unless a petition for a health claim
demonstrates that the preliminary requirements are met. While FDA had
proposed in November of 1991 that these preliminary requirements cover
substances in dietary supplements as well as foods in conventional food
form, the provisions of the DS act precluded the agency from applying
these preliminary requirements to substances in dietary supplements at
the time that the rule was finalized. Thus, the preliminary
requirements established in the health claims final rule apply only to
substances in foods in conventional food form.
The dietary supplement health claim proposal contained provisions
to subject the components of dietary supplements to the same
preliminary requirements in Sec. 101.14(b) that apply to any other
substance that is proposed as the subject of a health claim. This final
rule for dietary supplements retains these provisions as proposed.
Specific reference to dietary supplements in Sec. 101.14(b)(1) and
(b)(2) is not necessary because the requirements in these paragraphs
apply generally to any ``substance,'' and FDA's revision of the
definition of ``substance'' in Sec. 101.14(a)(2) includes the
components of dietary supplements within the coverage of this term.
However, FDA proposed to add a specific reference to dietary
supplements to paragraph (b)(3)(i) of Sec. 101.14 to clarify that the
substance may be a component of a food that is in the form of a dietary
supplement. The only comments on the issue agreed with the agency's
proposed revision. Accordingly, as proposed, FDA is including in the
final regulations a reference to dietary supplements in the codified
language of Sec. 101.14(b)(3)(i). Specifically, FDA is inserting the
phrase ``regardless of whether the food is in conventional food form or
dietary supplement form'' into Sec. 101.14(b)(3)(i).
1. Effect on General Population
13. One comment argued that the proposed requirement that a
substance be associated with a disease or health-related condition for
which the general U.S. population or a subpopulation thereof is at
risk, or that the claim be explained within the context of the daily
diet, would prohibit the appearance of health claims on herbal dietary
supplements. However, the comment did not explain how the requirement
would have this effect, and the comment's own analysis of how garlic
would or would not meet various proposed requirements indicated that
garlic would meet this particular requirement.
FDA does not agree that this preliminary requirement will present
any significant barriers to the appearance of health claims on dietary
supplements. To the contrary, as the agency explained in the preamble
of the health claims final rule (58 FR 2478 at 2499), FDA intends to
employ a flexible approach in interpreting this provision. The
alternative aspect of the provision, which creates the possibility of
claims about the relationship of a substance to a disease or health
related-condition that affects very few in the U.S. population as long
as the petition in support of the claim addresses that fact and the
relevance of the claim in the context of the total daily diet,
evidences a determination by FDA to provide the widest latitude
possible for proposed claims to qualify under this provision.
14. One comment requested that FDA not limit the diseases or
health-related conditions that may be the subject of a health claim to
those for which the entire United States is at potential risk. The
comment asserted that health claims should also be allowed in cases
where dietary factors have been conclusively shown to affect diseases
or health-related conditions for which only a particular subportion of
the U.S. population is at risk (e.g., ovarian cancer in women).
FDA advises that the general eligibility provisions of its health
claims regulations in Sec. 101.14(b)(1) do not contain the restriction
cited by the comment. While these provisions contain a requirement that
health claims pertain to diseases or health-related conditions
affecting the general U.S. population, they also provide that health
claims may pertain to diseases or health-related conditions for which
an identified subgroup of the U.S. population is at risk. Thus, ovarian
cancer in women would clearly be an appropriate subject of a health
claim.
2. Components of Food Within the Context of a Daily Diet
The preliminary requirement that a substance that is to be the
subject of a health claim must be a food appears in Sec. 101.14(b)(2)
and (b)(3)(i). If the substance is present at decreased dietary levels,
under Sec. 101.14(b)(2), it must be a nutrient that is required to be
included in nutrition labeling (e.g., cholesterol, total fat). If the
substance is present at other than decreased dietary levels, under
Sec. 101.14(b)(3)(i), it: (1) Must contribute taste, aroma, or
nutritive value, or any other technical effect listed in Sec. 170.3(o),
to the food and (2) must retain that attribute when consumed at levels
that are necessary to justify a claim.
15. Numerous comments expressed concern about the aspect of the
preliminary requirement of Sec. 101.14(b)(3)(i) that requires that a
substance contribute taste, aroma, or nutritive value, or any technical
effect listed in Sec. 170.3(o), in view of the agency's definition of
``nutritive value'' in Sec. 101.14(a)(3). A number of these comments
characterized these provisions as an attack by the agency against
dietary supplements. Some comments asserted that the proposed
preliminary requirement would prohibit dietary supplements, especially
those containing herbs, from bearing health claims. Comments pointed
out that many herbs, such as garlic, are specially processed to remove
the flavor or odor from the final supplement product. A number of
comments explained that such supplements would fail to meet this
requirement because their beneficial effects on the body often are
derived from substances unique to the plant that do not promote growth,
replace loss of essential nutrients, or provide energy. A few comments
also noted that many herbs contain insignificant amounts of vitamins,
minerals, and other nutrients.
Some comments asserted that the adoption of any preliminary
requirement that would automatically disqualify herbal dietary
supplements from bearing health claims would undermine the intent of
Congress to establish a nondrug review process for health claims
involving herbs. These comments asserted that the 1990 amendments
clearly provide that herbal dietary supplements can be the topic of a
health claim. Furthermore, a comment asserted that the Court of Appeals
held in Nutrilab, Inc. v. Schweiker, 713 F.2d 335, 338 (7th Cir. 1983)
that some products, such as prune juice or coffee, may be consumed for
reasons other than taste, aroma, or nutritive value.
One comment asserted that all dietary supplements already meet the
this preliminary requirement. The comment noted that a substance to be
consumed at other than decreased dietary levels may also be shown to be
a food by contributing any technical effect listed in Sec. 170.3(o).
The comment stated that Sec. 170.3(o)(20) lists one of those technical
effects as nutrient supplementation and broadly defines a ``nutrient
supplement'' as ``substances which are necessary for the body's
nutritional and metabolic processes.''
FDA does not believe that it is overly restrictive to require, as
it does in Sec. 101.14(b)(3)(i), that a substance be a food or a
component of food for it to be the subject of a health claim. Section
403 of the act, which includes the health claims provisions, states,
``A food shall be deemed to be misbranded * * *'' (emphasis added).
Thus, section 403(r) of the act describes the circumstances in which a
food will, and will not be, misbranded if it bears a health claim. It
is therefore appropriate for the agency to make it incumbent on the
proponent of a health claim to demonstrate that the substance that is
to be the subject of the claim is a food or component of food.
FDA disagrees with the comments' interpretation of the Nutrilab
decision. As FDA explained in the preamble of the health claims final
rule (58 FR 2478 at 2499-2500), the Nutrilab court adopted a ``common
sense'' definition of ``food'' under section 201(f)(1) of the act:
``When the statute defines `food' as `articles used for food,' it means
that the statutory definition of `food' includes articles used by
people in the ordinary way most people use food--primarily for taste,
aroma, or nutritive value.'' Nutrilab, 713 F.2d at 338. Other courts
have followed suit. See United States v. Undetermined Quantities of
Cal-Ban 3000, 776 F. Supp. 249, 254-55 (E.D.N.C. 1991); American Health
Products Co. v. Hayes, 574 F. Supp. 1498, 1508-09 (S.D.N.Y. 1983),
aff'd, 744 F.2d 912 (2d Cir. 1984). By describing taste, aroma, and
nutritive value as the ``primary'' reasons for consuming food, the
Nutrilab court acknowledged that a food consumed for one of these
reasons might sometimes also be consumed for an additional purpose (713
F.2d at 338 (giving prune juice and coffee as examples of foods that
``may be consumed on occasion for reasons other than taste, aroma, or
nutritive value'')). Under Nutrilab, however, a substance whose uses do
not include taste, aroma, or nutritive value is not a food.
In Sec. 101.14(b)(3)(i), FDA incorporated this common sense
definition of food and the phrase ``or any technical effect listed in
Sec. 170.3(o),'' which reflects the fact that the definition of
``food'' in section 201(f)(3) of the act includes ``articles used for
components of food,'' as a preliminary requirement to ensure that a
substance that is to be the subject of a health claim is in fact a
food. This preliminary requirement is fundamental because both the
component of a food that is the subject of a health claim and a
component of a drug have a characterizable relationship to a disease.
Congress recognized this fact by creating an exception from section
201(g)(1)(B) of the act, in the definition of ``drug'' for foods that
bear a claim authorized under section 403(r) of the act. Thus, it is
crucial to the continuing viability of the act itself that the choice
of the test that determines whether a claim that characterizes the
relationship of a substance to a disease can be made be based on the
appropriate factors. Under the act, that choice turns in part on
whether the substance is a food. Therefore, FDA has reflected in
Sec. 101.14(b)(3)(i) the judicially recognized characteristics of a
food.
In this regard, interested persons should not presume that
inclusion of the phrase ``or any technical effect listed in
Sec. 170.3(o)'' in Sec. 101.14(b)(3)(i) means that substances that may
be classified within one or more of the categories of food additives in
Sec. 170.3(o) automatically meet this preliminary requirement. The
classifications within Sec. 170.3(o) are of a general nature to reflect
the uses to which food ingredients are put. All of the classifications
pertain to the effect of the ingredients on food (e.g., by affecting
the texture of the food) rather than on the human body. Only a
substance that is used for the technical effect in Sec. 170.3(o)(20),
that of a nutrient supplement, has the potential to have a useful
effect in the body because of the characteristics that cause it to be
used in the food. The ``nutrient supplement'' category includes
``Substances which are necessary for the body's nutritional and
metabolic processes.'' As the comments themselves recognized, not every
component of a dietary supplement has such an effect.
In view of the agency's broad, flexible definition of ``nutritive
value,'' FDA does not find any merit in arguments that the provisions
requiring that a substance be a food should be removed. To the
contrary, FDA believes that these provisions will benefit the public
health by allowing the agency to devote its limited resources for
review of petitions to those that are appropriate for consideration
under the health claim provisions of the act. Accordingly, FDA
considers these provisions essential elements under the framework that
it has created in its regulations for the regulation of health claims
and fully consistent with the act.
FDA disagrees with the comments' characterization of its actions as
an attack against dietary supplements. FDA believes that the combined
effect of Sec. 101.14(b)(3)(i), the preliminary requirement that a
substance be a food, and Sec. 101.14(a)(3), the definition of
``nutritive value,'' will not present dietary supplements with any
unreasonable barriers for agency evaluation of potential health claims
for components of these products. Without question, these provisions do
restrict health claims to effects on a disease or a health-related
condition resulting from the nutritive value of substances. However, as
one comment pointed out, the current definition of ``nutritive value''
in Sec. 101.14(a)(3) is broad enough to include the functions of most
dietary supplements.
One observation that might bear making in this context is that
Congress has given the agency a statutory structure with which to deal.
In relevant part, that structure divides the world of substances that
have a relationship to disease into foods and drugs. Congress placed
the health claims provisions on the food side of the ledger. FDA is
charged with implementing those provisions in accordance with the act
and applicable legal precedents. FDA has announced its intention to
implement the health claim provisions as flexibly as possible, but at
some point the agency simply cannot be as flexible as some of the
comments have suggested. At that point, the agency would start to erode
the scheme that the statute has established for drugs. The agency
cannot do that. If Congress intended something that goes beyond the
scheme that FDA has established in these final regulations, then what
is required is a change in the law itself.
16. Many comments objected to the aspect of Sec. 101.14(b)(3)(i)
that requires that a substance retain its food status (i.e., its
nutritive value) when consumed at levels that are necessary to justify
a claim. Almost all concern was directed toward consumption of
substances at levels significantly higher than those present in the
daily diet. Some comments urged FDA to evaluate proposed health claims
involving relatively high levels of nutrients on the grounds that
categorically prohibiting them would deny Americans beneficial
information rather than educating them on how to alter their diets to
achieve optimal health. Other comments stated that FDA's categorical
refusal to evaluate such health claims because of the nutrient levels
involved would directly violate both the Proxmire Amendment and the
congressional intent behind the 1990 amendments. These comments noted
that the 1990 amendments provide for the appearance of health claims on
foods and stated that, subject to certain conditions, the Proxmire
Amendment's prohibition against regulating a vitamin supplement as a
drug ``solely because it exceeds the level of potency which the
Secretary determines is nutritionally rational or useful'' guarantees
the regulation of vitamins as foods regardless of the levels of
nutrients that they supply. The comments also stated that Congress
envisioned the approval of such health claims, as it was aware that
dietary supplements substantially in excess of the U.S. RDA's were
routinely being consumed by Americans, and it chose to direct that FDA
conduct a review of antioxidant vitamins/cancer claims with dietary
supplements in mind. Other comments further asserted that FDA was
attempting to circumvent the Proxmire Amendment and create maximum
potency levels for all supplements by establishing an upper limit for
``nutritive value.''
FDA does not agree that any conflict with section 411 of the act is
presented by a requirement that, to be the subject of a health claim,
the substance must be a food, that is, consumed primarily for its
taste, aroma, or nutritive value. There is nothing in the health claims
final rule or in the regulations established by this document that will
affect in any way the availability of dietary supplements or consumers'
freedom to choose to purchase them. Rather, the regulations that FDA is
establishing are intended to ensure that any health claims that may be
made for dietary supplements are scientifically valid. This is what
section 403(r)(5)(D) of the act directs FDA to do.
Nothing in these regulations would necessarily prevent a supplement
from bearing a health claim when it contains a level of a substance
that exceeds the level achievable in the context of the daily diet. To
the contrary, the final rule concerning calcium and osteoporosis, for
example, which was published in the Federal Register of January 6, 1993
(58 FR 2665), permits a calcium health claim for dietary supplements
and requires only that the supplement labeling advise consumers, in
appropriate circumstances, that there is no known benefit from
consuming more than 200 percent of the recommended daily intake for
calcium.
Section 411 of the act does not authorize health claims for dietary
supplements or in any way affect FDA's authority under section
403(r)(5)(D) of the act to regulate such claims. Under section
411(a)(1)(B) of the act, FDA may not classify a dietary supplement as a
drug solely because it contains a vitamin or mineral at a level that
exceeds the level of potency that the agency determines is
nutritionally rational or useful. Nothing in these proposed regulations
would do so. Absent a claim, FDA will not consider a dietary supplement
to be a drug because it contains vitamins or minerals at levels above
those normally found in food. However, a claim on a product is an
indication of the product's intended use. If a claim reveals that the
product is intended for a use other than for its taste, aroma, or
nutritive value, then nothing in section 411 of the act would require
that it be treated as a food.
17. Many comments addressed the circumstances under which dietary
supplements should be considered drugs. A number of these comments
referred to the following agency statement in the health claims final
rule (comment 49, 58 FR 2478 at 2501):
A product that is intended for medicinal effects, that is,
intended for use in the diagnosis, cure, mitigation, treatment, or
prevention of disease, is a drug and not a food. Thus, there is no
basis under the act for FDA to permit health claims for herbs whose
only known use is for medicinal effects. Health benefits of such
herbs may appear in the labeling only in accordance with the drug
provisions of the act.
Although a few comments agreed with this statement, many comments
expressed categorical opposition to the classification of any herbs or
other dietary supplements as drugs. While most of these comments did
not offer reasons in support of their position, one comment expressed
concern that such a policy would be grounds for FDA to categorically
ban all such supplements as unapproved new drugs. Several comments
noted that many herbs have traditionally been used both as foods and
drugs and asked for assurance that FDA would not automatically regulate
such herbs as drugs. Other comments argued that herbs should always be
regulated as foods where they are consumed for their nutritive value.
Some comments stressed that intended use, as stated on its
labeling, should be the determinative factor in deciding whether a
supplement should be regulated as a food or as a drug. As an example,
one of these comments stated that a supplement marketed for a specific
therapeutic use (e.g., a vitamin C tablet sold to cure cancer) is
appropriately regarded as a drug, while a supplement sold to be taken
over a period of time to reduce the risk of developing a disease (e.g.,
a vitamin C tablet sold to be taken daily to reduce the risk of cancer)
should be regulated as a food. The comment asserted that this approach
is consistent with FDA's determination that a supplement containing
large amounts of niacin should be regulated as a drug when consumed to
lower serum cholesterol. Another of these comments emphasized that a
consumer's use of a legally labeled product should not have any weight
in determining whether that product is a drug. As an example, the
comment noted that FDA does not regulate either fiber or water as a
drug as long as their labeling does not bear drug claims, even though
consumers may use them to facilitate bowel movement or to prevent,
mitigate, or treat dehydration, respectively.
A few comments suggested that FDA determine whether a substance is
a food or a drug by its chemical composition. The comments asserted
that while the boundary between drugs and supplements is fuzzy at
times, drugs are typically synthetic molecules that are of a unique and
patentable nature, while dietary supplements consist of natural,
nonpatentable materials.
Another comment stated that FDA should exempt substances taken to
treat a symptom of a disease from regulation as drugs, as the act
defines as drugs only those substances used in the diagnosis, cure,
mitigation, treatment, or prevention of the disease itself.
Earlier in this preamble, FDA explained that these regulations do
not affect the availability of dietary supplements. Again, these
regulations affect only the food label and food labeling. FDA has no
intention of banning all dietary supplements of herbs or similar
substances as unapproved new drugs. FDA will carry out its
responsibility to regulate inappropriate claims, but the agency will
not attempt to restrict the sale of dietary supplements to consumers
unless the supplements present safety concerns.
With respect to the specific words for use in labeling statements,
FDA advises that statements that a product may be effective in the
cure, mitigation, treatment, or prevention of disease will make the
product a drug. However, statements that a product may reduce the risk
of developing a disease or health-related condition may, or may not,
make the product a drug. Exactly how a substance-disease relationship
is to be characterized is one of the issues that the agency will
address in deciding whether to authorize a health claim and how to
ensure that the claim describes the significance of the substance in
affecting the disease or health-related condition. FDA points out that
as a general matter, merely using terms such as ``reduce the risk''
instead of ``prevent'' will not automatically make a claim a health
claim and not a drug claim. FDA will make a case-by-case assessment
based on all relevant factors in determining whether a claim is
appropriately subject to the health claims regime. The agency also
agrees that the main focus in deciding whether a product is subject to
regulation as a food or a drug is the intent of the vendor and not how
consumers use the product (although how consumers understand claims
that are made can be used to determine vendor intent).
FDA advises that there is no provision in the act for the agency to
exempt statements about symptoms of disease from causing products to be
regulated as drugs. Although such statements may not be claims that the
product will treat the disease that causes the symptoms, the statements
clearly pertain to the mitigation of disease by addressing the symptoms
caused by the disease. Section 201(g)(1)(B) of the act provides, in
part, that articles intended for use in the mitigation of disease are
drugs. Similarly, there is no provision in the act for FDA to exempt
natural, nonpatentable materials from the definition of a drug in
section 201(g) of the act.
FDA advises that it not true that all natural materials are not
drugs. It has been estimated that about 25 percent of the drugs
currently prescribed by physicians are plant compounds, and that an
additional 25 percent are related to plants. Therefore, fully half of
the drugs commonly used can be considered plant derived. Such commonly
used drugs as digitalis, aspirin, quinidine, atropine, and hundreds of
others were once considered herbals. Thus, the agency finds that it
cannot rely on the distinction of whether a product is natural or
synthetic in deciding whether it is a food or a drug.
3. Safety
Section 101.14(b)(3)(ii) provides that, to justify a claim for a
substance that is to be consumed at other than decreased levels, the
substance must be a food or a food ingredient or a component of a food
ingredient whose use at the levels necessary to justify a claim has
been demonstrated by the proponent of the claim, to FDA's satisfaction,
to be safe and lawful under the applicable food safety provisions of
the act.
The preamble of the dietary supplement health claims proposal (58
FR 33700 at 33709) explained:
* * * This showing can be based on: (1) A demonstration that the
substance is generally recognized as safe (GRAS) within the meaning
of Sec. 170.30; (2) a listing of the substance as GRAS in 21 CFR
Part 182 or as affirmed as GRAS in 21 CFR Part 184; (3) a food
additive regulation; or (4) a sanction or approval granted by FDA or
the United States Department of Agriculture prior to September 6,
1958. If the safety and lawfulness of the substance is not expressly
recognized in an FDA regulation, the burden will rest on the claim's
proponent, as a prerequisite to FDA's evaluation of the health
claim, to submit all the scientific data and other relevant
information required to demonstrate safety and lawfulness in
accordance with applicable petition requirements. FDA will withhold
review of the health claim until it is satisfied on these points.
18. Many comments objected that the proposed safety provisions are
unreasonable. A few of these comments specifically asserted that herbal
supplements would almost universally fail the proposed safety
requirements because most herbs are not GRAS for use as a dietary
supplement, are not approved food additives, and are not the subject of
prior sanctions or are the subject of prior sanctions that have been
waived. Furthermore, the comments complained that FDA's process for
acting on GRAS affirmation petitions is notoriously slow and extremely
costly. The comments maintained that the proposed safety requirements
would discourage manufacturers from submitting health claim petitions
for dietary supplements, would delay the approval of such petitions,
and could well amount to a total ban on health claims for certain
dietary supplements. The comments suggested that FDA require safety
determinations only for those substances with no history of safe use
and provide that the absence of known safety problems will be
sufficient proof of safety for substances with a long history of use.
Other comments urged FDA to be flexible in its determination of
safety for substances in dietary supplements. A number of these
comments stressed the importance of FDA recognizing that safety can be
determined solely through the historical use of such substances. Some
of the comments noted that many components of supplements, particularly
herbs, have been used for hundreds or thousands of years without safety
problems. The comments also noted that herbs are used safely throughout
three-fourths of the world as a principal means of medicine. The
comments declared that regulatory authorities in Great Britain,
Germany, Japan, and many other nations have researched various herbal
supplements and found them to be safe when consumed at the levels of
use likely to be contemplated under a health claim petition. One
comment also noted that information concerning accurate dosage,
indications, contraindications, and quality control measures are also
available in past editions of the U.S. Pharmacopeias and National
Formularies. These comments urged FDA to accept all relevant data on
the safe use of herbal dietary supplements, including foreign studies
and monographs that evidence the safety of these products. One comment
declared that FDA is legally bound to consider evidence involving herb
usage outside the United States when reviewing the safety of herbs.
One comment asserted that FDA should evaluate the safety of
vitamins and minerals in terms of their effect on the normal population
and not on those consumers with unusual conditions or sensitivities.
The comment acknowledged that such consumers need clear label
ingredient statements as well as education on foods to deal with their
problems. The comment asserted, however, that these consumers should be
held responsible for some degree of self-protection. The comment
maintained that this approach is consistent with the agency's policy on
persons with allergies to food components. A few comments asserted that
the safety of a dietary supplement should be defined in terms of
whether or not harm may occur under the conditions of use defined by
the supplement's labeling, rather than in terms of an arbitrary cutoff
such as the RDI. The comment maintained that a systematic review of all
components of dietary supplements is not necessary and suggested that
the agency undertake safety reviews on a case-by-case basis where it
believes a potential safety concern might exist.
Several comments asserted that FDA is not equitable in its concern
for the safety of dietary supplements as compared to the safety of
other products regulated by the agency. Some comments asserted that the
safety record of dietary supplements is far better than many FDA-
approved food additives such as aspartame, against which, according to
the comments, the agency receives and ignores thousands of consumer
complaints annually. Other comments asserted that FDA's intense
interest in the safety of products would be better focused on
prescription drugs, which are responsible for over 1/2 million deaths
annually as compared to the no or few deaths attributable to the
consumption of dietary supplements.
However, several comments supported FDA's proposal to require that
petitioners for a health claim for a substance in a dietary supplement
demonstrate that the substance is safe and lawful. The comments agreed
with the agency that such a requirement is implicit in the act, and
that the labeling law in no way diminishes FDA's responsibility to
ensure the safety of foods.
FDA concludes that the preliminary requirement that the safety of a
substance be demonstrated should apply to substances in dietary
supplements in the same manner that it applies to substances in foods
in conventional food form. The amendment to the act enacted by the 1990
amendments cannot be implemented independently of the remaining
portions of the act (see section 9 of the 1990 amendments). The act
must be considered as a whole, and FDA's responsibility for ensuring
the safety of foods is explicitly provided for in other sections of the
act (see sections 201(s), 402(a)(1) and (2), and 409 of the act).
As the agency explained in the dietary supplement health claims
proposal, the fact that the act contains such explicit safety authority
is particularly significant because the agency will be specifically
authorizing the health claims that will be made. In view of this
affirmative action, FDA authorization of a health claim places the
agency's imprimatur on the claim. Moreover, the claim will encourage
consumption of the substance. It would be a violation of the agency's
responsibility under the act to authorize a health claim about a
substance, whether it be in a dietary supplement or in food in
conventional food form, without being satisfied that the use of the
substance is safe. Certainly, FDA would have almost no assurance that
it would be protecting the public health if it permitted, as some
comments suggest, all substances except those that are actually known
to cause safety problems to be the subject of health claims. It would
be a great and tragic irony if substances that were the subject of
health claims because of one effect caused injury because of another.
This is the situation that Congress sought to avert by including
section 403(r)(3)(A)(ii) in the act. FDA's preliminary requirement is
fully consistent with the principles that underlie that section.
The fact that some herbs and other ingredients of dietary
supplements have been used for thousands of years does not necessarily
justify a conclusion by FDA that their use under all conditions is
safe, but it may. First, FDA needs a basis for concluding that such use
was in fact without harmful effect. Second, FDA needs a basis for
concluding that consumption of ingredients in a supplement carrying a
health claim would be in amounts comparable to those consumed safely in
the past. The proponents of claims for such substances are certainly
free to demonstrate that the use of those substances is generally
recognized as safe based on their common use in food prior to 1958. The
agency notes, however, that the use of many of these substances has
been primarily as a drug, tonic, or folk remedy, rather than as food
(see 53 FR 16544 at 16545; May 10, 1988). This fact is confirmed by
some of the comments summarized above. As drugs, the levels and
frequency of use of these substances may have been significantly
different than the levels and frequency of use that will result from
their use as foods. Although the agency will consider evidence
involving herb usage outside the United States, FDA still needs to
review data on the identity of the substance, the safety of the
substance, the use of the substance in food, the context of its use,
and the frequency of use in the country where use of the substance
occurred (see 50 FR 27294 at 27295, July 2, 1985). Evidence that
another country has studied the safety of an herbal supplement and
found it to be safe would certainly be relevant and should be submitted
to FDA. It is important, however, that as much of the evidence that
provided the basis for the country's determination as is possible be
submitted to FDA.
Although formal recognition of safety by FDA admittedly can be
lengthy and expensive, such formal recognition is not required under
this preliminary requirement. In responding to concerns raised by
comments suggesting that FDA recognize manufacturers' private GRAS
determinations, the agency stated in the health claims final rule the
following concerning Sec. 101.14(b)(3)(ii) (58 FR 2478 at 2502 through
2503):
FDA acknowledges that the GRAS affirmation and food additive
listing process can be lengthy. Thus, FDA designed
Sec. 101.14(b)(3)(ii) to provide flexibility with respect to the
type of showing of safety that is necessary to make a substance
eligible to be the subject of a health claim. GRAS affirmation and
food additive listing are but two of the procedures by which a
substance may meet this preliminary requirement.
FDA intends to consider the basis of manufacturers' independent
GRAS determinations where such determinations are submitted with
petitions for health claims and may use its discretion to accept,
without formal affirmation, the independent determination of GRAS where
FDA believes that such action would be appropriate. As FDA pointed out
in the previous comment, however, the agency would not be fulfilling
its responsibilities under the act if it were to permit a substance to
be the subject of a health claim without satisfying itself that the use
of that substance is safe.
Although FDA will consider all manufacturers' independent GRAS
determinations where the basis for such determinations are submitted
with petitions for health claims, the agency advises that it will
generally not be possible for FDA to judge whether GRAS
determinations based on complex scientific evidence are valid within
the short timeframes mandated under the 1990 amendments for health
claims petitions. Instead, agency agreement with an independent
determination that a substance is GRAS will be most likely where the
substance is an ingredient, or a component of a food ingredient,
that was in common use in food prior to January 1, 1958, in a
similar context. However, where such agreement occurs, the agreement
does not constitute GRAS affirmation. Instead, the history of common
use in food, coupled with the fact that FDA knows of no reason to
question the safety of the food ingredient, means that the substance
will be treated as if it is an unlisted GRAS substance (as provided
for in Sec. 170.30(d) and 182.1(a) (21 CFR 170.30(d) and 182.1(a)))
in the manner provided for in the food ingredient list in 21 CFR
Part 182.
(58 FR 2478 at 2503.)
Under this final rule, this statement is fully applicable to
substances in dietary supplements. The agency believes that this policy
on independent determinations that a substance is GRAS demonstrates
that FDA will be flexible in assessing conformance with the safety
preliminary requirement.
FDA disagrees with assertions that the agency should evaluate the
safety of dietary supplements in terms of only the normal population.
It would be unconscionable for the agency to adopt a policy of ignoring
adverse effects, some of which could be life-threatening, of any foods,
including dietary supplements, on vulnerable segments of the
population. Furthermore, there is no basis under the act for such a
policy. FDA does attempt, however, to find the most practicable
solutions to assuring consumers of a safe food supply. For example, the
agency generally does not base safety decisions on atypical population
subgroups that will use the product. Where there are subgroups of
consumers (e.g., consumers with certain sensitivities) that could
suffer adverse effects from consuming the product, FDA may place
certain restrictions on the use of the product or rely on labeling
solutions (such as those the agency has used for sulfiting agents and
yellow 5) as a condition for its safe use, rather than denying the
availability of the product to the entire population.
Thus, for all the foregoing reasons, FDA is making health claims
for substances in dietary supplements, like claims for any other food,
subject to Sec. 101.14(b)(3)(ii).
C. Scientific Standard
19. Many comments expressed concern that FDA would apply the term
``significant scientific agreement'' in an unreasonable manner by
demanding too much supporting evidence on substance/disease
relationships before approving health claims.
Several comments insisted that FDA is misinterpreting the
requirements for the scientific standard for food in conventional food
form as well as for dietary supplements. The comments asserted that the
law does not require that there be significant scientific agreement
that a nutrient/disease relationship has been conclusively established,
but only that the statements made in a claim be supported by the
available evidence. As an example, one of the comments asserted that
the requirements of the law would be fully met by a properly qualified
label claim such as, ``Although no scientific consensus has been
established, several clinical studies suggest that daily consumption of
Vitamin C as part of a well-balanced diet may reduce the frequency of
colds.'' A number of comments asserted that the standards for
authorizing health claims on foods are more stringent than those
authorizing the use of drug claims. Several comments argued that FDA is
being unduly restrictive by requiring that manufacturers perform
expensive randomized, double-blind, placebo-controlled tests to prove
the validity of a claim under the proposed regulations. These comments
stated that such requirements would deter manufacturers from seeking
new uses for herbs and other substances used in dietary supplements.
The comments maintained that a more lenient standard would encourage
manufacturers to engage in research to develop more healthful products.
The comments further asserted that the disparate treatment of foods and
drugs is especially unfair when the enormous difference in safety
factors between dietary supplements and untested prescription drugs is
considered.
Some of the comments asserted that FDA had not been fair to date in
its evaluations of health claims under this standard. One of these
comments asserted that FDA had approved only four of the ten
congressionally-proposed health claims, not seven, as FDA claimed in
the preamble to the proposed regulations.
Some comments maintained that FDA should not require a unanimous or
near-unanimous consensus among experts in order to find that there is
``significant scientific agreement'' concerning a claim. A few of the
comments pointed out that the legislative history of the 1990
amendments clearly indicates that such a level of agreement is not to
be required. Other comments urged that FDA consider the requirement for
``significant scientific agreement'' to be satisfied as long as there
is agreement among a majority of scientists familiar with the research
in a given area. These comments noted that Commissioner Kessler offered
testimony supporting this interpretation before the U.S. House of
Representatives Subcommittee on Health and the Environment. Other
comments maintained that the requirement for ``significant scientific
agreement'' only requires agreement among a significant number of
qualified experts. One of these comments requested that FDA include a
provision in the regulations that the standard of ``significant
scientific agreement'' is not one of unanimity to prevent confusion
among manufacturers and consumers. A few comments asked that FDA's
regulations include a provision that guarantees that ``significant
scientific agreement'' will be considered to have been achieved when a
credible health authority, particularly an agency of the U.S.
Government, recommends the consumption of a nutrient because of its
relationship to a disease or health-related condition.
One comment suggested that FDA not use the phrase ``significant
scientific agreement'' to evaluate proposed health claims, despite its
inclusion in the language of the 1990 amendments, because the meaning
of the phrase is ambiguous. The comment suggested that FDA should
simply consider the totality of publicly available scientific evidence
to determine whether or not a particular health claim can be justified.
FDA disagrees with assertions that it is conducting validity
assessments for health claims in an unduly restrictive manner. FDA does
not require that manufacturers perform controlled clinical trials to
prove the validity of a claim. To the contrary, as discussed in the
health claims final rule (58 FR 2478 at 2506), the scientific standard
for health claims is less stringent than the requirements for approval
of a new drug. In the case of a new drug, section 505(d)(5) of the act
(21 U.S.C. 355(d)(5)) states that the Secretary shall refuse to approve
an application for approval of such a drug where there is a lack of
substantial evidence that the drug will have the effect that it
purports or is represented to have under the conditions of use
prescribed, recommended, or suggested in the proposed labeling thereof.
Section 505(d) provides further that the term ``substantial evidence''
means evidence consisting of adequate and well-controlled
investigations, including clinical investigations (human studies
conducted in a controlled clinical setting), by experts qualified by
scientific training and experience to evaluate the effectiveness of the
drug involved. (The statutory term ``substantial evidence'' should not
be confused with the same term used by some comments to refer to ``more
than a scintilla and less than a preponderance'' of evidence.) Based on
this statutory direction, the agency has identified a number of
characteristics that are present in ``adequate and well-controlled''
studies in Sec. 314.126 (21 CFR 314.126).
Section 101.14(c) of FDA regulations does not mandate requirements
as stringent as those for drugs in section 505(d)(5) of the act.
Section 101.14(c) contains no mention of ``substantial evidence,''
``adequate and well-controlled investigations,'' or of ``clinical
investigations.'' To the contrary, Sec. 101.14(c) contains more
flexibility than the drug provisions of the act because it provides FDA
with authority to authorize claims based on ``scientific evidence
(including evidence from well-designed studies conducted in a manner
which is consistent with generally recognized scientific procedures and
principles), that there is significant agreement among experts
qualified by scientific training and experience to evaluate such
claims, that the claim is supported by such evidence'' (section
403(r)(3)(B)(i) of the act).
Consistent with this flexibility, FDA did not prescribe a specific
set, type, or number of studies as being sufficient to support a health
claim in the health claims final rule that applied to food in
conventional food form. In that rule, the agency advised (58 FR 2478 at
2506) that it would consider all relevant data on a topic, including
clinical studies, epidemiological data, and animal studies.
In addition, the 1990 amendments directed FDA to consider 10
nutrient-disease relationships. In the January 6, 1993, final rules,
FDA authorized claims with respect to seven of those 10 relationships
(see 58 FR 2537, 2552, 2622, 2665, 2739, 2787, and 2820). In addition,
FDA has recently proposed to authorize claims concerning an eighth,
folic acid and neural tube defects (see 58 FR 53254, October 14, 1993).
FDA believes that these approvals demonstrate that it is not conducting
validity assessments for health claims in an unduly restrictive manner.
FDA agrees that the legislative history of the 1990 amendments
makes clear that Congress did not intend, in calling for significant
scientific agreement about the support for a claim, to require that
such agreement represents a full consensus among scientists. The House
Report (Ref. 1) states:
* * * the standard does not require that there be a unanimous
agreement among experts. Instead there must be a significant
agreement among experts, but it does not require that every expert
in the field approve or agree with the claim.
The agency shares the comments' concern that a requirement of
consensus would mean that some valid health claims would not be
authorized and, by restricting such claims, would counter Congress'
intent that health claims supported by a significant scientific
agreement be made available to consumers. The agency never intended to
require that claims be supported by a consensus among scientists and
has not done so.
The agency is sensitive to the comments' perception that the
scientific standard, particularly the phrase ``significant scientific
agreement,'' is subjective. The agency believes, however, that any
standard involving the evaluation of scientific evidence and opinions
derived from that evidence must be somewhat subjective. FDA, in
proposing not to define ``significant agreement'' among experts in the
November 27, 1991 (56 FR 60537 at 60548) proposal, noted that each
situation may differ with the nature of the claimed substance/disease
relationship. The agency believes that in deciding whether significant
scientific agreement about the validity of a claim exists, it is
necessary to consider both the extent of agreement and the nature of
the disagreement on a case-by-case basis.
The House Report (Ref. 1) makes clear that Congress intended the
``significant scientific agreement'' standard to be a flexible one by
pointing out that, in reviewing scientific studies, FDA may give
greater weight to the studies that it finds more persuasive. The House
Report also clarifies that the overriding consideration in assessing
whether to authorize a claim should be the Secretary's level of comfort
about the validity of the claim. The agency believes that this
clarification provides clear guidance for the application of the
standard, and thus it is not incorporating the changes requested by the
comments in the codified language of the regulations.
FDA does not believe it has in any way been unfair in its approval
of health claims to date. Earlier in this preamble in response to
comment 2, FDA explained why certain specific health claims were not
approved. Nevertheless, the agency's statement in the dietary
supplement health claims proposal that it had authorized claims on 7 of
the 10 nutrient-disease relationships is correct. In the case of 3 of
the relationships, however, the claims were authorized for foods rather
than specific nutrients. In these cases, as explained previously,
although there was sufficient evidence to attribute certain disease
risk reductions to the consumption of certain foods, and those foods
are marked by significant levels of the nutrients in question, there
was insufficient evidence to attribute any disease risk reduction
directly to consumption of the nutrients themselves.
FDA does not agree that it should define ``significant scientific
agreement'' as agreement among a majority of scientists familiar with
the issues. Commissioner Kessler's statements about significant
scientific agreement being 50 or 60 percent agreement were intended to
show the contrast between this term and the term ``consensus,'' not to
provide a specific definition of ``significant scientific agreement.''
There is simply no bright line that FDA can draw in this area.
Ultimately, the agency must exercise its scientific judgment, arrived
at after input from the scientific community.
The agency does not agree that significant scientific agreement
should be considered to have been achieved when a credible health
authority, particularly an agency of the U.S. Government, recommends
the consumption of a nutrient because of its relationship to a disease
or health-related condition. While FDA recognizes the significance of
such recommendations, Congress charged FDA with the responsibility of
authorizing health claims on the food label and labeling. Nonetheless,
the agency is mindful of the admonition in section 403(r)(4)(C) of the
act that reads: ``If a petition for a regulation under subparagraph
(3)(B) relies on a report from an authoritative scientific body of the
United States, the Secretary shall consider such report and shall
justify any decision rejecting the conclusions of such report.''
Accordingly, FDA is retaining the requirement for ``significant
scientific agreement'' in this regulation.
20. Many comments applauded the agency's determination not to
underrate any scientific evidence on the basis of its cultural or
geographic origin. One of these comments noted that the United States
is one of the most ethnically diverse nations in the world and stated
that a study done anywhere in the world is likely to be relevant to at
least one U.S. subpopulation. A few of these comments noted that some
of the studies done on herbal dietary supplements have been conducted
under foreign drug protocols and requested assurance that FDA would
consider such data to be part of the publicly available scientific
evidence supporting prospective health claims. Another of these
comments asserted that the ``totality of publicly available scientific
evidence'' should include not only ``well designed studies'' but also
ethnobotanical and other traditional usage information which is often
available for herbs and other dietary supplements.
The agency reaffirms its commitment to consider any evidence
submitted in support of the scientific merits of a claim and in the
context of the totality of available evidence. FDA will not underrate
any study on the basis of its cultural or geographic origin. Evidence
in support of a proposed health claim, however, will attain value in
direct proportion to the significance in the U.S. population of the
effects of the substance in question on the disease or health-related
condition addressed by the claim (see Sec. 101.14(b)(1)). Also, the
agency advises that it will consider ethnobotanical and other
traditional usage information. However, the agency points out that
under Sec. 101.14(c), the evidence must provide the basis for
significant scientific agreement that the claim is valid.
D. General Labeling Requirements
In the health claims final rule, FDA established a number of
general requirements for health claims for food in conventional food
form in Sec. 101.14(d) to ensure that consumers are provided with valid
and reliable information about the value that ingestion (or reduced
ingestion) of a particular substance, as part of a total dietary
pattern, may have in affecting certain diseases or health-related
conditions.
In the dietary supplement health claims proposal, the agency
proposed that dietary supplements be subject to the same general
requirements that it has established for food in conventional food form
in Sec. 101.14(d). The agency advised that specific references to
dietary supplements in Sec. 101.14(d) are not necessary because FDA's
revision of Sec. 101.14(a)(2), the definition of the term
``substance,'' to include components of dietary supplements will link
dietary supplements to the health claim for which Sec. 101.14(d)
prescribes general requirements.
1. FDA Authorization of Valid Claims
Section 101.14(d)(1) provides that when FDA determines that a
health claim is valid, the agency will propose a regulation in Subpart
E of Part 101 to authorize the use of the claim. Further, the provision
states that if the claim pertains to a substance not provided for in
Sec. 101.9, FDA will propose to amend that regulation to include
declaration of the substance. To ensure that the provisions established
in Sec. 101.14(d)(1) apply equally to all forms of dietary supplements,
the agency proposed in the dietary supplement proposal to revise
Sec. 101.14(d)(1) to reference, in addition to Sec. 101.9, the
provisions of Sec. 101.36 (21 CFR 101.36), which establish requirements
for the nutrition labeling of dietary supplements of vitamins and
minerals.
FDA received no comments requesting changes in this aspect of the
proposal. Therefore, the agency is adopting this section as proposed.
2. General Requirements
Section 101.14(d)(2) requires that health claims on foods in
conventional food form: (1) Be consistent with the specific authorizing
regulation for the claim; (2) be limited to describing the value that
ingestion (or reduced ingestion) of the substance, as part of a total
dietary pattern, may have on a particular disease or health-related
condition; (3) be complete, truthful, and not misleading; (4) contain
all required information for that claim in one place without other
intervening material (except that the principal display panel (PDP) of
the label or labeling may bear a reference statement such as ``See
attached pamphlet for information about calcium and osteoporosis,''
with the entire claim appearing elsewhere on the other labeling); and
(5) enable the public to comprehend the information provided and to
understand the relative significance of such information in the context
of a total daily diet. If the claim is about the effects of consuming
the substance at decreased dietary levels, the level of the substance
in the food must be sufficiently low to justify the claim. For example,
if a definition for use of the term ``low'' has been established for
that substance, the substance must be present at a level that meets the
requirements for use of that term, unless a specific alternative level
has been established for the substance in the authorizing regulation.
If the claim is about the effects of consuming the substance at other
than decreased dietary levels, the level of the substance in the food
must be sufficiently high and in an appropriate form to justify the
claim. For example, if a definition for use of the term ``high'' for
that substance has been established, the substance must be present at a
level that meets the requirements for use of that term, unless a
specific alternative level has been established for the substance in
the authorizing regulation. (See Sec. 101.14(d)(2)(vii)(A) for
additional requirements where the food meets the ``high'' or ``low''
requirements based on its reference amount customarily consumed and the
labeled serving size differs from that amount. See
Sec. 101.14(d)(2)(vii)(B) for guidance about how a food can meet the
``high'' and ``low'' requirements where the food is sold in a
restaurant.)
In the dietary supplement health claims proposal, FDA proposed that
dietary supplements be subject to these requirements to ensure that
consumers are provided with scientifically valid, nonmisleading, and
reliable information about the value that ingestion of the particular
substance in the dietary supplement may have in affecting a disease or
health-related condition.
21. One comment stated that FDA should mandate that dietary
supplements bear health claims for which they are eligible in order to
promote public awareness of the benefits associated with those
supplements.
FDA does not believe that it is appropriate to adopt a general
policy requiring the inclusion of health claims on the labels of all
foods eligible to bear them. The agency notes that while the 1990
amendments provide for the appearance of health claims on the labels of
foods qualified to bear them, they do not make the appearance of those
claims mandatory.
FDA believes that many manufacturers will choose to include health
claims on the labels of qualified foods because of the marketing
benefit offered by their appearance. Because health claims provide
information regarding the benefits associated with the increased or
decreased dietary intake of various substances in the product rather
than information regarding the particular product itself, consumers
will be made aware of the benefits of consuming other foods that do or
do not contain the particular substance, even if a particular food
product does not itself bear the health claim.
22. One comment asserted that FDA should require manufacturers who
elect to craft their own health claims, rather than to use the model
claim verbatim, to secure agency approval for their claims with respect
to understandability.
FDA disagrees with this comment. Section 3(b)(1)(A)(vii) of the
1990 amendments prohibits FDA from requiring persons to secure agency
approval before placing a health claim on a product, provided that the
claim is in compliance with the applicable regulation authorizing the
health claim. The House Report (Ref. 1) states that this section
``makes it clear that the regulations will not require premarket review
of each claim; they will only require that the claim be consistent with
the terms and requirements of the regulations.'' The agency believes
that it is possible to paraphrase a model health claim while remaining
consistent with the terms and requirements of the regulations
permitting that claim. This position is similar to agency policy that
permits the use of terminology other than that established in a final
OTC drug monograph in labeling of an OTC drug product to describe
indications for use (51 FR 16258, May 1, 1986). Consistent with that
policy for OTC drug labeling, the agency believes that the goal of
ensuring scientifically valid, truthful, and nonmisleading labeling
without inhibiting effective consumer communication does not require
exclusive use of language in a model health claim. The model language
along with other requirements for a claim will, nevertheless, provide
the standard for measuring the accuracy of alternative language
developed by food manufacturers for their products because FDA has
included all mandatory labeling elements of a health claim in the model
claim. Of course, manufacturers should recognize that a health claim
that fails to convey all the mandatory elements of the claim will
subject a product to regulatory action.
3. Nutrition Labeling
Section 101.14(d)(3) requires that health claims on foods in
conventional food form must bear nutrition labeling in accordance with
Sec. 101.9 and 101.10 (21 CFR 101.9 and 101.10). In the dietary
supplement health claims proposal, the agency proposed to revise
Sec. 101.14(d) to reference Sec. 101.36 (21 CFR 101.36), in addition to
Sec. 101.9 and 101.10. In response to section 403(q)(5)(F) of the act
(formerly section 403(q)(5)(E)), Sec. 101.36 establishes requirements
for the nutrition labeling of dietary supplements of vitamins and
minerals.
FDA received no comments requesting changes in this aspect of the
proposal. Therefore, the agency is adopting this section as proposed.
E. Prohibited Health Claims
In Sec. 101.14(e) of the health claims final rule, FDA established,
for foods in conventional food form, a number of situations where
health claims are prohibited. In that paragraph, FDA provides that a
health claim may not be made on the label or in the labeling of a food
unless: (1) The claim is specifically provided for in authorizing
regulations in Subpart E of 21 CFR part 101; (2) the claim conforms to
all general provisions of Sec. 101.14, as well as to all specific
provisions in the authorizing regulation; (3) none of the disqualifying
levels identified in Sec. 101.14(a)(5) is exceeded in the food, unless
specific alternative levels have been established for the substance in
the authorizing regulation, and the labeling bears a statement that
complies with Sec. 101.13(h) highlighting the nutrient that exceeds the
disqualifying level; (4) no substance is present at an inappropriate
level as determined in the specific provision authorizing the claim in
Subpart E of 21 CFR part 101; (5) the label does not represent or
purport that the food is for infants and toddlers less than 2 years of
age except if the claim is specifically provided for in Subpart E of 21
CFR part 101; and (6) except for dietary supplements, the food contains
10 percent or more of the RDI or Daily Reference Value (DRV) for
vitamin A, vitamin C, iron, calcium, protein, or fiber before any
nutrient addition.
In the dietary supplement health claims proposal, the agency
proposed that dietary supplements be subject to the general
prohibitions that have been established for foods in conventional food
form in Sec. 101.14(e). The agency tentatively concluded that this
action was appropriate because these prohibitions: (1) Reflect the
statutory restriction in section 403(r)(1)(B) of the act that requires
that health claims be made in accordance with the provisions of section
403(r)(5)(D) for dietary supplements; (2) ensure that inappropriate,
unsubstantiated, and fraudulent health claims are not made; and (3)
reduce the potential for consumer confusion when confronted with a
situation in which there would be health claims for substances when
they are present in dietary supplements but not when they are present
in foods in conventional food form. The agency advised that specific
references to dietary supplements in Sec. 101.14(e) generally are not
necessary because FDA's proposed revision in Sec. 101.14(a)(2) of the
definition of the term ``substance'' to include components of dietary
supplements will bring dietary supplements within the coverage of
Sec. 101.14(e).
FDA did propose, however, to include a reference to dietary
supplements in the introductory sentence of paragraph (e) to clarify
that dietary supplements may be food. Specifically, FDA proposed to
insert the phrase ``regardless of whether the food is in conventional
food form or dietary supplement form'' into that sentence to make clear
that no expressed or implied health claims may be made on the label or
in labeling of any food unless the conditions in that paragraph are
met.
1. Claims Not Authorized By FDA
Section 101.14(e)(1) and (e)(2) prohibit the use on a food label or
in food labeling of any claim that expressly or by implication
characterizes the relationship of any substance to a disease or health-
related condition unless: (1) The claim is specifically provided for in
Part 101, Subpart E--Specific Requirements for Health Claims; and (2)
the claim conforms to all general provisions of Sec. 101.14, as well as
to all specific provisions in the appropriate section in subpart E of
21 CFR part 101.
23. A number of comments asserted that the marketplace is currently
saturated with hundreds of false and misleading claims, ranging from
rather innocuous statements to blatant claims concerning the treatment
of cancer, AIDS, heart disease, asthma, high blood pressure,
Alzheimer's disease, diabetes, and other diseases and health-related
conditions. One of these comments urged FDA to regulate as implied
health claims those brand names that imply that a product is useful in
preventing particular diseases. The comment asserted that an implied
health claim can be made by the inclusion of the name of a disease in a
brand name, as well as by label statements that slant the meaning of a
brand name toward disease prevention.
FDA realizes there are a number of misleading claims in use on
products. The agency reviews these claims as part of its regular
enforcement activities and takes action against such claims based on
such factors as the public health significance of the claim, how
clearly it violates the act, and the availability of agency resources.
24. A number of comments stated that manufacturers should be
allowed to include information on the traditional use of various
supplements on their labels. These comments noted that many other
countries allow supplement labels to indicate traditional uses of the
product, provided that the level of evidence supporting such use is
accurately represented. Many comments asserted that statements
concerning the safe usage of dietary supplements should not be
considered a health claim. The comments maintained that the exclusion
of such information from food labeling would endanger the public
health.
Dietary supplements that bear labeling that expressly or by
implication characterizes the relationship of any substance to a
disease or health-related condition will be subject to the provisions
of section 403(r) of the act. However, if the claim reveals that the
product is intended to be used in the diagnosis, cure, mitigation,
treatment, or prevention of a disease, as would likely be the situation
where the product is presented as an alternative to conventional drug
therapy, the product, like any other product that does so, is a drug
under section 201(g)(1)(B) of the act and subject to the requirements
for drugs in Chapter V of the act.
However, supplement manufacturers, like all other food
manufacturers, are welcome to submit health claim petitions that
establish the validity of claims that characterize the relationship of
a substance to a disease or a health-related condition in a manner that
is appropriate for a food. (See section III.G. of this document.) Any
such petition that shows that the preliminary requirements in
Sec. 101.14(b) and the scientific standard for a health claim in
Sec. 101.14(c) are met will provide the basis for a proposal to
authorize a claim in accordance with section 403(r)(4)(A)(i) of the
act.
In addition, FDA advises manufacturers of dietary supplements that
where a claim does not include one or both of the basic elements of a
health claim, it generally constitutes dietary guidance that may be
provided on the label or in labeling, so long as it is presented in a
truthful and nonmisleading manner.
25. One comment urged that FDA permit the appearance of preliminary
health claims on the labeling of a product other than its label. The
comment maintained that the 1990 amendments draw a clear distinction
between a product label and its labeling and noted that labeling has
much more room in which a manufacturer may sufficiently explain the
current state of scientific evidence regarding a preliminary claim.
FDA disagrees with this comment. Section 403(r)(1) of the act
clearly prohibits the appearance of health claims that are not made in
accordance with FDA regulations and that appear ``in the label or
labeling of the food (emphasis added).'' The agency's objections to
preliminary claims are fully discussed in this preamble in its response
to comment 4.
2. Additional Limits on Health Claims
In the health claims final rule (58 FR 2478 at 2534), FDA adopted
new Sec. 101.14(e)(6) to require consistency with dietary guidelines by
prohibiting health claims unless the food contains 10 percent or more
of the RDI or DRV for vitamin A, vitamin C, iron, calcium, protein, or
fiber per reference amount customarily consumed prior to any nutrient
addition. (A complete discussion of why these specific criteria were
selected appears in the preamble of that document (see 58 FR 2478 at
2521 through 2522).) This provision stresses the importance of
selecting foods so that dietary sources of calories are coupled with
sources of nutrients. This approach incorporates established levels of
significance for nutrients in food and is based on the amounts in foods
of certain nutrients required to be listed on the label as part of
mandatory nutrition labeling. As such, this approach applies to food in
conventional food form.
FDA specifically exempted dietary supplements from this
requirement. Such supplements are intended only to provide nutritive
value to the daily diet, and they make no pretense of serving as
substitutes for conventional food. (Nutrient supplements in
conventional food form are, however, intended to serve as substitutes
for conventional food.) As a result, it would not be logical to hold
such products to criteria designed to ensure consistency with dietary
guidelines for conventional food. A dietary supplement that meets the
qualifying criterion in Sec. 101.14(d)(2)(vii) and that does not
contain a nutrient at a disqualifying level specified in
Sec. 101.14(a)(5) possesses nutritive value for a health claim
irrespective of whether or not it may also provide calories.
Accordingly, in the dietary supplement health claims proposal, FDA did
not propose to make any change in the exemption for dietary supplements
from the provisions of Sec. 101.14(e)(6). For consistency with the
proposed definition of the term ``dietary supplement,'' however, FDA
proposed to revise the wording for this exemption to delete the phrase
``not in conventional food form'' because the definition of ``dietary
supplement'' states that such foods are not in conventional food form.
FDA received no comments requesting changes in this aspect of the
proposal. Therefore, the agency is adopting this section as proposed.
F. Applicability
In the health claims final rule, FDA established a provision in
Sec. 101.14(g) stating that the requirements for health claims in
Sec. 101.14 apply to foods intended for human consumption that are
offered for sale. In the dietary supplement proposal, FDA proposed that
dietary supplements also be covered by Sec. 101.14(g). FDA stated that
it had tentatively concluded that a reference to dietary supplements
was appropriate in paragraph (g) to clarify that dietary supplements
can be food. Specifically, FDA proposed to revise paragraph (g) as
follows:
Applicability. The requirements of this section apply to foods
intended for human consumption that are offered for sale, regardless
of whether the foods are in conventional food form or dietary
supplement form.
26. One comment asserted that FDA should allow health claims
authorized for use on dietary supplements to also appear on OTC drug
products that provide ``high'' levels of a particular nutrient, e.g.,
calcium-osteoporosis claims on calcium carbonate antacid tablets.
FDA received a comment similar to this one on the health claims
proposal. This comment provides no basis for the agency to provide a
different response to this comment than it did in the health claims
final rule.
As explained in the preamble of the health claims final rule (58 FR
2478 at 2500), multiple use products that are both foods and drugs
present a difficult set of competing concerns for the agency. Such
products are likely to be both an OTC drug and a dietary supplement.
Most OTC drug products are developed to address some type of acute
medical problem that is expected to be of short duration. If the
problem persists, it is important that the person with the problem know
that it may be more severe than he or she otherwise thought, and that
he or she should seek medical attention. Labeling on such products,
therefore, includes instructions to use the product for a limited
period of time and, if the problem persists, to seek medical
intervention. Thus, the time limits on use of the product are important
to the health of the users.
Dietary supplements, on the other hand, are developed for inclusion
in a daily diet at levels that are consistent with dietary use and may
often be consumed throughout most of a person's lifetime. Labeling on
dietary supplements contains no instructions for seeking medical
intervention or for limiting the duration of consumption of the
supplement. Rather, under the new regulations, dietary supplements will
be able to bear nutrient content and health claims, which focus the
consumer's attention on the advantages that consuming the product will
have in helping the consumer to maintain a healthy diet. Moreover,
where the supplement bears a health claim, the claim will contain
information about how long-term ingestion of the supplement may promote
health.
Where dietary levels and therapeutic levels differ (as is generally
the case and is in fact the case with antacids and calcium
supplements), an apparent conflict is created when both food and drug
labeling appear on the same product. In the case of the drug labeling,
consumers are given directions for use that involve high consumption
during a limited time period. In the case of the food labeling,
consumers are given directions for lower consumption with no time
constraints. Even though label instructions may identify those
directions for food and drug use in separate locations, FDA is
concerned that consumers will incorrectly assume that the therapeutic
dosage is appropriate for dietary use, and that the directions for food
use will undercut the warning in the drug labeling to seek medical care
if the condition persists. Where the labeling is not properly followed,
significant adverse consequences may result.
The agency knows of no broad approach that it can use to harmonize
a nutrient content claim or a health claim with drug labeling. A drug
that is labeled with instructions for use that both limit and do not
limit consumption would be misbranded under section 502(a) of the act
(21 U.S.C. 352(a)) if it failed to contain a material fact--that is,
how to reconcile these conflicting instructions.
However, FDA does not believe that it would be appropriate to
preclude such claims under all circumstances. Such claims may be
permissible if a firm can demonstrate that dual claims can be made in a
manner that will neither misbrand the product nor create a safety
problem. The agency suggests that anyone desiring to make a health
claim or a nutrient content claim that complies with section 403(r) of
the act on a product that is both a food and a drug contact the Center
for Drug Evaluation and Research, OTC Compliance Branch (HFD-312), FDA,
7500 Standish Pl., Rockville, MD 20855, to discuss whether it would be
possible to put such a claim on the product and still comply with the
drug provisions of the act.
G. Petitions
27. A number of comments urged FDA to streamline its procedures for
approving health claims in order that dietary supplement manufacturers
may include the most current, reliable information on their products.
The comments stated that the inclusion of such information is
critically important to dietary supplements because, unlike foods in
conventional food form, they are consumed only for the health benefits
associated with them. The comments specifically proposed that FDA add
the following paragraphs to Sec. 101.70(j):
(4) Final Rule. FDA will, within 120 days of the date of
publication of the proposed rule, issue a final rule authorizing or
prohibiting the requested use of the health claim.
(5) Expedited Action on certain petitions. If FDA determines
during its initial review of the petition that it accurately
represents the recommendations of any agency or department of the
U.S. Government with public health responsibilities, or of any other
public health organization that is recognized as a credible source
of information on diet and health, FDA will publish a proposed rule
authorizing the requested use of the claim no later than 60 days
from the date of receipt of the petition and will issue a final rule
no later than 60 days from the date of publication of the proposed
rule.
The comments maintained that new provision in paragraph (j)(4)
would correct an obvious oversight in the existing regulations, i.e.,
the establishment of a firm deadline for a proposed rule but no firm
deadline for a final rule. The comments also contended that paragraph
(j)(5) is necessary to address FDA's failure to act promptly to approve
claims that are based on the recommendations of public health
authorities, such as its failure to approve a health claim for folic
acid in accord with the recommendations of PHS agencies.
FDA advises that its failure to specify in Sec. 101.70(j) a
deadline for the publication of a final rule regarding the use of a
proposed health claim was not an oversight. Section 403(r)(4)(A)(i)
does not require that the agency adhere to any deadline for the
publication of a final rule. While FDA could establish such a timeframe
by regulation, it does not believe that the adoption of such a
requirement would be prudent. The comment period following the
publication of proposed rules is a critical step in determining whether
a proposed regulation is appropriate for adoption. In the instance of
health claim regulations, significant information concerning the
validity of the substance-disease relationship underlying the proposed
health claim may be submitted by interested parties during the comment
period. Also, the comment period may bring to light a previously
unforeseen potential for the use of a health claim, if adopted without
modification, to be misleading to consumers or to create serious
potential threats to the public health. The agency has no way to
guarantee that it will be able to adequately resolve such problems
within the suggested timeframe. In such instances, if faced with a
specific timeframe, FDA would be forced to either deny an otherwise
valid health claim petition, or to approve it without erecting the
regulatory framework that it believes necessary to ensure that the
public health is safeguarded. Therefore, FDA is not adopting the
suggested time limit on the issuance of a final rule. However, the
agency advises that it committed to issuing final rules on health claim
petitions as quickly as possible consistent with the issues presented
and the agency's available resources.
With respect to suggestions for shorter timeframes for certain
petitions, FDA advises that the agency's ability to meet timeframes is
influenced by many factors, such as work priorities and availability of
personnel. FDA considers the statutory timeframes for assessing the
validity of health claims and for issuing a proposed regulation to be
extremely short, given the need to evaluate the totality of available
scientific evidence on a substance and a disease or a health-related
condition. Given the agency's limited resources, it would not be
practicable to shorten these timeframes further. However, FDA points
out that although action on petitions for most claims will require
virtually all of the time provided by the statutory timeframes, nothing
would prohibit the agency from acting in less time than the timeframes
provide if it is possible to do so. Thus, it is likely that a petition
for a claim on a well-accepted substance/disease relationship would be
reviewed more expeditiously than one for which scientific agreement is
not as clear.
28. A few comments urged FDA to consider the limited label space
available on many dietary supplements in developing model health
claims. The comments stated that concise model claims will provide
guidance to manufacturers on how to convey health claims in succinct
statements that comply with all of FDA's requirements and will thus
help ensure that the health claims presented to consumers are clear and
comprehensible.
FDA realizes that there is a limit to the amount of information
that can be presented on a food label. However, the agency believes
that it must ensure that consumers understand that factors other than
dietary intake of the nutrient may bear on the substance-disease
relationship. Given the imperative of ensuring consumer understanding
of a message that must be presented in a very limited space, the agency
is faced with the difficult task of determining what information is
necessary in a claim, and what information is not. FDA believes that
its regulations in subpart E of 21 CFR part 101 represent an acceptable
balance between the consumer's right to understand the full context of
the claim and the manufacturer's concern over claim length. By
delineating the information that is mandatory and optional in a claim,
FDA is relieving manufacturers from having to include information that
is of tangential importance but ensuring that those who wish to make a
claim do so in a manner that provides a useful and understandable
message to consumers. FDA advises that it will take a similar approach
when providing model health claims in the future. FDA also notes that
manufacturers who are not satisfied with the model claim are free to
develop their own versions of the claim, provided that those versions
include all of the information required by the authorizing regulation.
29. Several comments raised the issue of product-specific health
claims by asserting that many manufacturers will be dissuaded from
undertaking the scientific studies and other investments necessary to
obtain approval of new health claims petitions by the fact that
approved health claims will be allowed for use on all qualifying
products. However, a number of comments stressed that in a health
claim, the role of the total diet should be emphasized rather than the
role of a specific food in risk reduction.
FDA advises that section 403(r)(1)(B) of the act pertains to a
claim about the relationship between a nutrient and a disease or
health-related condition, rather than about particular food product and
such a condition. While the agency has used the term ``substance'' in
lieu of the word ``nutrient'' and has said that a ``substance'' can be
a food, in doing so the agency was only trying to cover circumstances
such as those presented by fruits, vegetables, and grain products in
which it was not possible to identify the specific nutrient in a broad
class of foods that was having the observed effect on the risk of
disease. FDA was not thereby including formulated products as possible
subjects of health claims. Such products are formulated to include
particular substances because of the nutritional effects of those
substances. Thus, a health claim for such a product would appropriately
be about the substance in the formulated product and not about the
product itself.
In addition, section 403(r)(3)(B)(iii) of the act directs the
agency to require that health claims enable the public to understand
the information in the context of the total daily diet. As explained
above, FDA finds that to effect Congress' intent in passing the 1990
amendments, the same requirement should apply to health claims made on
dietary supplements. FDA believes that a claim that refers specifically
to the effects on a disease or health-related condition resulting from
the consumption of a certain brand name of product would unduly
emphasize the importance of that product and not the importance of the
total daily diet. Also, such claims could imply that other brands of
the same food, as well as other foods containing the substance that is
the subject of the claim, might not have the same effect on the disease
or health-related condition and thus would be misleading under section
403(a) of the act. Accordingly, the agency finds that it is not
appropriate to approve product-specific health claims.
30. One comment suggested that FDA provide regular monthly or
quarterly reports concerning newly approved health claim petitions for
display in the supplement section of stores. The comment maintained
that such a list distributed by FDA would increase consumer confidence
in the claims when they appear on supplement labels.
Although FDA recognizes that there could be benefits to consumers
from such reports, the agency simply does not have the resources to
provide the reports on an ongoing basis. However, FDA expects that
trade associations and other interested parties will provide
information to firms that will ultimately be passed on to consumers.
IV. Constitutional Issues
A. First Amendment
1. General
31. Several comments raised concerns that the regulations violate
the First Amendment. Comments cautioned that the regulations would be
unconstitutional if they limited the dissemination of scientific
opinion or prevented scientifically valid, well-balanced information
from reaching the public.
In the final rule on health claims for foods in conventional food
form, 58 FR 2478 at 2524 through 2528 (January 6, 1993), the agency
addressed in detail the First Amendment implications of its regulation
of health claims on the food label and in food labeling. The agency
concluded that its regulations, and the act as amended by the 1990
amendments, do not violate the First Amendment. FDA considers its
earlier analysis to be relevant to the present rulemaking and
incorporates it into this document. The agency notes that none of the
comments submitted on the proposed rule on health claims for dietary
supplements disputed the agency's earlier discussion, and no comments
argued that subsequent court decisions have called the agency's
conclusions into question.
FDA disagrees with the comments that asserted that these
regulations unconstitutionally suppress scientific opinion. The
regulations address what may appear in labeling; they do not affect any
other means of disseminating information. Indeed, far from limiting the
dispersal of scientific information, as stated above, these
regulations, which implement the 1990 amendments to the act, permit
more information to appear on the label than the act allowed before its
amendment.
The agency does not agree with the comments' implication that the
Constitution requires a more lenient standard of scientific validity
than that codified in Sec. 101.14(c). FDA has a strong interest in
ensuring that the information that appears on the food label is
scientifically valid and believes that the standard it has adopted best
furthers that interest. When FDA seeks to ensure that food is not
misbranded, it may place restrictions on label contents. See SEC v.
Wall Street Publishing Institute, 851 F.2d 365, 373 (D.C. Cir. 1988),
cert. denied, 489 U.S. 1066 (1989); American Frozen Food Institute v.
Mathews, 413 F. Supp. 548, 555 (D.D.C. 1976), aff'd, 555 F.2d 1059
(D.C. Cir. 1977). Contrary to the view of the comments, ``the First
Amendment does not guarantee the right to employ every conceivable
method of communication at all times and in all places'' (Members of
City Council v. Taxpayers for Vincent, 466 U.S. 789, 812 (1984)).
Indeed, ``Freedom of Speech does not include the freedom to violate the
labeling provisions of the Federal Food, Drug, and Cosmetic Act.''
(United States v. Articles of Food * * * Clover Club Potato Chips, 67
F.R.D. 419, 424 (D. Idaho 1975)).
2. Pure Speech
31a. One comment asserted that health claims are not commercial in
nature and are entitled to full First Amendment protection. This
comment described health claims as typically being mere recitations of
scientific findings made by independent medical authorities and backed
by substantial agreement in the medical community. The comment asserted
that the proposed regulations reach ``pure scientific speech'' placed
on labels and in product advertisements and violate the First Amendment
by: (1) denying speakers channels of communication to present truthful,
nonmisleading health claims; (2) denying speakers the right to
communicate a particular kind of content; (3) discriminating against
certain speakers and forms of communication; and (4) denying the
constitutional rights of willing listeners, viewers, and readers.
FDA disagrees with the comment. The agency notes initially that the
comment misinterprets the scope of the agency's action. These
regulations apply only to health claims made on the label or in
labeling of dietary supplements and not to advertising.
The agency disagrees that health claims are entitled to full First
Amendment protection. The agency has stated that, although it does not
consider it necessary for its First Amendment analysis to determine
whether or not food labeling fits the definition of commercial speech,
labeling should certainly be considered closer to commercial speech
than to ``pure'' speech (58 FR 2478 at 2525 through 2526). It has also
stated that ``[l]abeling statements on food products intended for sale
would clearly appear in the context of a commercial transaction and
would `propose' such a transaction.'' (58 FR 2478 at 2527 (citing
Bolger v. Youngs Drug Products Corp., 463 U.S. 60, 66 (1983)); Central
Hudson Gas & Electric Corp. v. Public Service Commission, 447 U.S. 557,
562 n.5 (1980)); see also Adolph Coors v. Brady, 944 F.2d 1543, 1546
(10th Cir. 1991); United States v. General Nutrition, Inc., 638 F.
Supp. 556, 562 (W.D.N.Y. 1986). Commercial speech receives a lesser
degree of protection than noncommercial speech. (See, e.g., City of
Cincinnati v. Discovery Network, Inc., 113 S. Ct. 1505, 1513 (1993)).
The comment does not make a persuasive argument for considering health
claims on dietary supplement labels to be pure speech, and FDA is not
aware of any circumstance in which a court has considered such
information on the food label to be ``pure'' speech. Contrary to the
comment's assertion, information that is placed on the label by a
commercial enterprise in order to encourage the consumer to make a
purchase should not be considered protected speech simply because it
was generated by an independent source. (See, e.g., United States v.
Article of Drug * * * B-Complex Cholinos Capsules, 362 F.2d 923, 927
(3d Cir. 1966) (free speech was not implicated when third party's
statements were taken as evidence of manufacturer's intent); United
States v. Articles of Drug, 32 F.R.D. 32, 34-35 (S.D. Ill. 1963) (First
Amendment did not prohibit seizure of third party's book used as
labeling)).
Although the agency disagrees that health claims should be
considered noncommercial speech, and although many of the cases cited
in the comment deal with fully protected speech rather than commercial
speech and thus do not provide a useful analytical framework for these
regulations, the agency will address the comment's arguments
individually.
The agency disagrees that its action denies speakers channels of
communication. As discussed above, the agency has placed no limits on
the dissemination of scientific information but has acted to permit
certain information to appear on the label or in labeling of dietary
supplements. Adequate alternative channels remain for the dissemination
of scientific information. For example, regulation of the information
that may appear on the food label in no way affects the ability of a
scientist to publish experimental results in a journal. Moreover, any
interested person may petition for a health claim regulation.
The agency disagrees that these regulations should be subjected to
the close scrutiny afforded restraints on the content of pure speech.
Of the cases cited by the comment to advance this argument, one is
particularly instructive. In Turner Broadcasting System, Inc. v. FCC,
the court declined to apply strict scrutiny to the ``must-carry''
provisions of the 1992 Cable Act, applying instead the ``interest-
balancing traditionally applied to content-neutral speech regulation or
legislation ostensibly unrelated to expression that is discovered to
impose incidental burdens on speech.'' 819 F. Supp. 32, 39 (D.D.C.
1993), prob. juris. noted, 114 S. Ct. 38 (1993). In passing the Cable
Act, ``Congress employed its regulatory powers over the economy to
impose order upon a market in dysfunction, but a market in a commercial
commodity nevertheless; not a market in speech'' (Id. at 40).
Similarly, with the 1990 amendments Congress sought to bring order to
the food market. (See, e.g., 136 Congressional Record S16611 (October
24, 1990) (statement of Sen. Hatch) (``It is up to us to make order out
of chaos in the regulation of food * * *.''); 136 Congressional Record
H12953 (October 26, 1990) (statement of Rep. Waxman) (``[T]he bill will
once and for all settle the confusion surrounding health claims.'')).
As discussed in the final rule on health claims for foods in
conventional food form, the case law establishes that FDA's power to
regulate the food label derives from its broad regulatory powers over
food (58 FR 2525). As in Turner, these regulations are valid under the
limited scrutiny that has been afforded restrictions on speech under
extensive regulatory schemes involving areas of economic activity (Id).
The comment argued that the regulations are impermissibly
discriminatory because they require government regulators to exercise
judgment based on subjective line-drawing, guided not by rational
principles of law and science but by the will of the censorship
authority. FDA disagrees. The agency has carefully articulated the
appropriate scientific standard that it will apply to proposed health
claims. Unlike the ordinance at issue in Forsyth County v. Nationalist
Movement, cited by the comment, the decision whether to authorize a
health claim is not left to the agency's whim but is based on objective
factors. 112 S. Ct. 2395, 2403 (1992). In Forsyth, the county
administrator's exercise of discretion to vary the fee for assembling
or parading was not reviewable and did not require an explanation (Id).
FDA's procedure for evaluating a proposed health claim, including use
of notice and comment rulemaking, presents a far different situation,
and one that does not offend the Constitution.
Contrary to the comment's assertion, the fact that FDA does not
presume to prohibit the publication of health claims in the popular
media does not show an ``arbitrary predilection to enforce [the] law
against particular speakers and forum owners rather than others.'' FDA
has no interest in regulating the dissemination of scientific
information in the popular media and has no authority to do so. Rather,
its strong interest is in ensuring that health claims made in labeling,
on which consumers are likely to rely when making purchasing decisions,
are truthful, not misleading, and scientifically valid. The agency's
action contrasts with the categorical ban on commercial newsracks
struck down in City of Cincinnati v. Discovery Network, Inc., 113 S.
Ct. 1505. In that case, the Supreme Court held that the restriction,
which was intended to advance Cincinnati's interest in safety and
esthetics, overemphasized the distinction between commercial and
noncommercial speech by prohibiting only newsracks holding commercial
handbills and not those holding ordinary newspapers (Id. at 1514). The
city thus discriminated against a use of newsracks that was no more
harmful to safety and esthetics than the use it permitted (Id. at
1511). On the other hand, FDA's regulation of health claims in labeling
bears a specific relationship to the interests the agency has asserted,
because it is directed specifically at ensuring the reliability and
validity of these claims (see id. at 1514.) Contrary to the comment's
assertion, the limited scope of FDA's regulations--i.e., food
labeling--does not amount to discrimination.
Finally, the agency disagrees that its regulations deny the
constitutional rights of willing listeners, viewers, and readers.
First, this argument overstates the impact of these regulations, which
will affect only the labeling of dietary supplements and not other
sources of information about these products. Second, these regulations
will actually advance consumers' First Amendment interest in obtaining
information on which to base a purchasing decision, ``by insuring that
the information is not false or deceptive'' (National Commission on Egg
Nutrition v. FTC, 570 F.2d 157, 162 (7th Cir. 1977), cert. denied, 439
U.S. 821 (1978)). ``The fact that health is involved enhances the
interests of both consumers and the public in being assured `that the
stream of commercial information flow clearly as well as freely''' (Id.
(citing Virginia State Board of Pharmacy v. Virginia Citizens Consumer
Council, 425 U.S. 748, 772 (1976)); see also American Home Products v.
FTC, 695 F.2d 681, 714 (3d Cir. 1982)).
3. Commercial Speech
31b. Two comments asserted that, if health claims on labels are
considered commercial speech, FDA's regulations violate the First
Amendment because they are more restrictive than necessary to achieve
the government's goals. One comment recognized that FDA has ``a great
interest in preventing false and misleading claims and in preventing
fraud in the marketplace,'' but argued that closing the door on
truthful, qualified claims that are based on significant scientific
evidence is not reasonably responsive to those interests. The other
comment asserted that the wholesale suppression of truthful,
nonmisleading speech carries with it the silencing of speech
indispensable to the health of the American people, and that the
agency's action not only lacks a rational relationship to the end
chosen, public health, but actually undercuts that goal by shrouding
the public in ignorance.
FDA disagrees that these regulations, if considered under the
commercial speech doctrine, are unconstitutional. The final rule on
health claims for foods in conventional food form, 58 FR 2478 at 2526-
2527 (January 6, 1993), contains an analysis of that regulation in
light of the four-part test set out in Central Hudson Gas & Electric
Corp. v. Public Service Commission, 447 U.S. 557, 563-564 (1980). That
discussion is equally applicable to the present rulemaking. Central
Hudson states that commercial speech that is inherently misleading is
not protected and may be prohibited (Id.). Speech that is only
potentially misleading may be restricted, so long as the restrictions
directly advance a substantial governmental interest and are no more
extensive than necessary to serve that interest (Id. at 566).
The comments do not dispute the government's substantial interest
in promoting public health by ensuring that consumers have access to
information about dietary supplements that is scientifically valid,
truthful, reliable, informative, and not misleading. (Indeed, one
comment stated that the government's interest is ``great.'') Rather,
the comments focus on the last two parts of the Central Hudson test:
whether the regulations directly advance the governmental interest, and
whether there is a reasonable fit between regulatory ends and means.
FDA disagrees that its regulations will undercut its stated goals.
Rather, the regulations directly advance the governmental interest. The
regulations provide for FDA review of the relevant scientific evidence
on a proposed health claim before the agency decides whether to
authorize use of the claim. In this way, the regulations ensure that
health claims are scientifically valid and reliable, and that they will
not mislead consumers. At the same time, the regulatory scheme
encourages the provision of information to consumers that will enable
them to maintain healthful dietary practices. Thus, these regulations
advance the government's interest in a ``direct and material way''
(Edenfield v. Fane, 113 S. Ct. 1792, 1798 (1993)).
FDA also disagrees that these regulations are more extensive than
necessary to serve the government interest. Recently, the Supreme Court
stated that the ``commercial speech cases require a fit between the
restriction and the government interest that is not necessarily
perfect, but reasonable'' (United States v. Edge Broadcasting Co., 113
S. Ct. 2696, 2705 (1993) (citing Board of Trustees v. Fox, 492 U.S.
469, 480 (1989); Posadas de Puerto Rico Associates v. Tourism Co. of
Puerto Rico, 478 U.S. 328, 344 (1986))). In Edge, the Court upheld a
federal statute prohibiting the broadcast of lottery advertising by a
broadcaster licensed to a State that does not allow lotteries. Although
the law prevented a broadcaster in North Carolina, with a majority of
its listeners in Virginia, from airing nonmisleading advertisements for
Virginia's lottery, the Court had ``no doubt that the fit * * * was a
reasonable one.'' Edge, 113 S. Ct. at 2705. The Court stated that the
validity of a restriction should be judged ``by the relation it bears
to the general problem of accommodating the policies of both lottery
and nonlottery States, not by the extent to which it furthers the
Government's interest in an individual case.'' Id. (citing Ward v. Rock
Against Racism, 491 U.S. 781 (1989)). Moreover, once the government has
established a strong interest in adopting and enforcing rules of
conduct designed to protect the public, it is entitled to protect its
interest by applying a prophylactic rule to those circumstances
generally, Id. at 2706 (citing Ohralik v. Ohio State Bar Association,
436 U.S. 447, 464 (1978)).
After considering alternate approaches, the agency has concluded
that the procedures and scientific standard set out in these
regulations best advance its stated interests under the act. (See
discussion supra.) As in Edge, the government has weighed competing
interests: the interest in making information available on the dietary
supplement label and in its labeling about the relationship between
nutritional substances and disease or health-related conditions, and
the interest in ensuring that the information provided is
scientifically valid, informative, and not misleading. As in Ohralik
and Edge, the agency is entitled to protect its interest by applying a
prophylactic rule to general circumstances, in this case by permitting
only health claims about substance-disease relationships that the
agency has determined are scientifically valid to appear in labeling.
See Edge, 113 S. Ct. at 2706.
The means that FDA has chosen to further its substantial interest
are reasonable, ``in proportion to the interest served,'' and
``narrowly tailored to achieve the desired objective.'' City of
Cincinnati v. Discovery Network, Inc., 113 S. Ct. at 1510 n.12 (quoting
Fox, 492 U.S. at 480). The regulations specifically target labeling
claims about relationships between substances and disease or health-
related conditions. They are not intended to restrict the flow of
information to the public, but rather to ensure that the scientific
validity of information provided to consumers in the labeling of a
product has been established. Indeed, the regulations leave open a
broad range of other possible methods of communication.
4. Chilling Effect
31c. One comment asserted that an overbroad suppression of
scientific speech on communications media used by manufacturers creates
a pervasive chilling effect on their willingness (and that of the
scientists they employ) to communicate their findings for public and
professional consideration.
The overbreadth doctrine is an exception to traditional rules of
standing and is applicable in First Amendment cases in order to ensure
that an overbroad statute does not chill the exercise of protected
rights. Leonardson v. City of E. Lansing, 896 F.2d 190, 195 (6th Cir.
1990)). The doctrine may apply to a regulation that, in all its
applications, directly restricts protected First Amendment activity and
is not narrowly tailored Secretary of State of Maryland v. Joseph H.
Munson Co., 467 U.S. 947, 965 n.13 (1984). FDA disagrees that these
regulations are overbroad or that they will chill free speech. The
activity prohibited under the act and these regulations--marketing
dietary supplements bearing unapproved health claims in their
labeling--constitutes a ``core of easily identifiable and
constitutionally proscribable conduct,'' (467 U.S. at 965-966).
Labeling is defined in the act and easily identifiable. See 21 U.S.C.
321(m) (``The term labeling means all labels and other written,
printed, or graphic matter (1) upon any article or any of its
containers or wrappers, or (2) accompanying such article.''). Moreover,
courts have held that misbranding food is not protected under the First
Amendment. See, e.g., Kellogg Co. v. Mattox, 763 F. Supp. 1369, 1381
(N.D. Tex. 1991), aff'd sub nom. Kellogg Co. v. Morales, 940 F.2d 1530
(5th Cir. 1991); United States v. General Nutrition, Inc., 638 F. Supp.
556, 562 (W.D.N.Y. 1986); United States v. Articles of Food * * *
Clover Club Potato Chips, 67 F.R.D. 419, 424 (D. Idaho 1975). Finally,
as discussed above, the regulations are narrowly tailored to accomplish
the government's goals.
In any event, it is doubtful that the overbreadth doctrine would
apply to these regulations, particularly if they are considered to
regulate commercial speech, because the overbreadth doctrine does not
apply to commercial speech. ``[C]ommercial speech is generally
considered less susceptible to the chilling effect of regulation than
other, more traditionally recognized forms of speech, such as political
discourse.'' Kraft, Inc. v. FTC, 970 F.2d 311, 321 (7th Cir. 1992),
cert. denied, 113 S. Ct. 1254 (1993).
B. Fifth Amendment
32. One comment asserted that the takings clause of the United
States Constitution provides protection to dietary supplement trade
names. It argued that Sec. 101.14 might proscribe certain trade names
that FDA has allowed to remain on the market for years. The comment
urged FDA to give more attention, under Executive Order 12630, to the
regulation's possible takings implications.
When it issued its final regulations governing conventional foods
under the 1990 amendments, FDA fully discussed the takings implications
of those regulations. (See 58 FR at 2397 through 2400 and 2528 through
2529). This discussion, including the underlying takings analysis, is
incorporated herein. The agency concluded that there would be no
regulatory taking under the Fifth Amendment if a manufacturer is
required to alter its brand name when the brand name asserts by
implication a relationship between the presence or level of a substance
in the food and a disease or health-related condition, and that
relationship is not the subject of an approved health claim (58 FR at
2529). Because the agency conducted its analysis before passage of the
DS act, it fully took into account the regulations' impact on dietary
supplements. Although the comment stated that FDA must address the
issues raised by its regulations in light of Executive Order 12630, it
did not provide any additional information that the agency has not
already considered. Therefore, the agency concludes that it is not
necessary to address potential takings issues in any greater detail.
V. Other Issues
33. A few comments objected to the period of time provided for
public comment on the proposal, stating that it was too short. One of
these comments asserted that FDA had no reason to establish such a
short deadline other than to curtail public input on the proposed
regulations. Another of these comments requested that FDA extend the
period for public comment on the proposed regulations to give consumer
advocacy groups, health care professionals, and the scientific
community adequate time to prepare the information and opinions needed
to fairly resolve the issues associated with the proposal.
As explained in the preamble of the proposals, the DS act requires
that final rules implementing the 1990 amendments with respect to
dietary supplements be issued by December 31, 1993. To meet this
statutory timeframe, FDA was forced to limit the comment period for the
proposed regulations to 60 days. Thus, the agency reaffirms that it is
unable to grant any extensions to the comment period.
34. One comment requested that FDA clarify that the compliance date
is the date on which manufacturers of dietary supplements must begin to
label products in accordance with Sec. 101.14.
FDA advises that the comment is correct. Section 10(a)(2) of the
1990 amendments specifically states that ``* * * section 403(r) of the
Federal Food, Drug, and Cosmetic Act * * * shall not apply to food
which was labeled before the effective date of the amendments * * *
[emphasis added].'' Accordingly, the effective date of the health
claims regulations for dietary supplements adopted by the agency under
section 403(r) refers to the date on which a dietary supplement is
labeled.
35. A number of comments concerned the requirement in
Sec. 101.14(d)(2)(iv) that states that all claims must appear in one
place, in the same type size, without intervening material. The
comments addressed the exception in this provision that a short
reference statement may appear on the label, ``See ------------ for
information about the relationship between ------------ and ----------
--,'' with the blanks filled in with references to the location of the
labeling on which the full claim appears, the name of the substance,
and the disease or health-related condition. The comment requested that
FDA allow graphic material constituting an implied health claim to
appear on the PDP without the accompanying referral statement or full
health claim, as long as the graphic material appeared in conjunction
with the full health claim elsewhere on the labeling. The comment
justified this request based on the lack of sufficient label space on
the PDP for the referral statement.
FDA does not believe that it should make the requested revision in
Sec. 101.14(d)(2)(iv). In situations where graphic material constitutes
an implied health claim, and the reference statement is not present,
the graphic material on the labeling is in fact a shortened form of the
health claim. FDA explained in response to comment 69 in the health
claims final rule that shortened health claims are misleading because
they do not include facts that are material in light of the
representation that is made and that are necessary to understand the
claim in the context of the daily diet.
IV. Impact Statements
A. Economic Impact
In its dietary supplement labeling proposals pertaining to health
claims, nutrition labeling, and nutrient content claims in the June 18,
1993 Federal Register (58 FR 33700, 33715, and 33731), 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 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 the
establishment of the date of application published elsewhere in this
issue of the Federal Register.
FDA has examined the economic implications of the final rules as
required by Executive Order 12866 and the Regulatory Flexibility Act
(Pub. L. 96-354). 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, and public
health and safety effects; distributive impacts; and equity). The
Regulatory Flexibility Act requires that the agency analyze the 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 that term is 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.
B. Environmental Impact
The agency has previously considered the environmental effects of
this rule when it was part of the proposed rule pertaining to both
foods in conventional food form and dietary supplements (November 27,
1991 Federal Register (56 FR 60537 at 60562)). At that time, FDA
determined under Sec. 25.24(a)(8) and (11) that the proposed action was
of a type that does not individually or cumulatively have a significant
impact on the human environment. No new information or comments have
been received with respect to health claims for dietary supplements
that would affect the agency's previous determination that there is no
significant impact on the human environment, and that an environmental
impact statement is not required.
C. Paperwork Reduction Act
In the dietary supplement proposal of June 18, 1993 (58 FR 33700 at
33714), FDA announced that the agency had submitted to the Office of
Management and Budget (OMB) for its review the collection of
information requirements contained in proposed Sec. 101.70, for
petitions regarding the use of health claims in conjunction with food
labeling on dietary supplements. Also in that document, FDA published
its estimated annual collection of information burden for this
provision.
None of the more than 1,200 comments received in response to the
dietary supplement proposal addressed the content of petitions under
the proposed health claim petition requirements. Thus, the agency's
estimate of the annual reporting and recordkeeping burden from the
health claim petition requirements contained in this final rule remains
unchanged from the estimate that it announced in June 1993.
FDA has submitted copies of the final rule to OMB for its review of
these reporting requirements.
V. References
The following references have been placed on display in the Dockets
Management Branch (HFA-305), Food and Drug Administration, rm. 1-23,
12420 Parklawn Dr., Rockville, MD 20857, and may be seen by interested
persons between 9 a.m. and 4 p.m., Monday through Friday.
1. House of Representatives, House Report 101-538, ``Nutrition
Labeling and Education Act of 1990,'' June 13, 1990.
1a. 136 Congressional Record--House H5843-5845, July 30, 1990.
2. 136 Congressional Record--House, H12951-12955, October 26,
1990.
3. 138 Congressional Record--House H12597 (October 8, 1992); 138
Congressional Record--Senate S17236 (October 7, 1992).
4. 136 Congressional Record--Senate, S16607-16612, October 24,
1990.
5. DHHS, PHS, ``The Surgeon General's Report on Nutrition and
Health,'' DHHS (PHS) Publication No. 88-50210 (GPO Stock No. 017-
001-00465-1, U.S. Government Printing Office, Washington, DC), 1988.
6. United States Pharmacopeia DI, ``NIACIN (Systemic),'' 9th
ed., 1989, Vol. IB, pp. 1737-1740.
7. Centers for Disease Control, ``Recommendations for the Use of
Folic Acid to Reduce the Number of Cases of Spina Bifida and Other
Neural Tube Defects,'' Morbidity and Mortality Weekly Reports,
September 11, 1992, volume 41/No. RR-14, pages 1-7.
List of Subjects in 21 CFR in 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 101.14 is amended by revising paragraph (a)(2), by
adding a new paragraph (a)(4), and by revising paragraphs (b)(3)(i),
(d)(1), (d)(3), the introductory text of paragraph (e) and (e)(6), and
(g) to read as follows:
Sec. 101.14 Health claims: general requirements.
(a) * * *
(2) Substance means a specific food or component of food,
regardless of whether the food is in conventional food form or a
dietary supplement that includes vitamins, minerals, herbs, or other
similar nutritional substances.
* * * * *
(4) Dietary supplement means a food, not in conventional food form,
that supplies a component to supplement the diet by increasing the
total dietary intake of that component.
* * * * *
(b) * * *
(3) * * *
(i) The substance must, regardless of whether the food is in
conventional food form or dietary supplement form, contribute taste,
aroma, or nutritive value, or any other technical effect listed in
Sec. 170.3(o) of this chapter, to the food and must retain that
attribute when consumed at levels that are necessary to justify a
claim; and
* * * * *
(d) General health claim labeling requirements. (1) When FDA
determines that a health claim meets the validity requirements of
paragraph (c) of this section, FDA will propose a regulation in subpart
E of this part to authorize the use of that claim. If the claim
pertains to a substance not provided for in Sec. 101.9 or Sec. 101.36,
FDA will propose amending that regulation to include declaration of the
substance.
* * * * *
(3) Nutrition labeling shall be provided in the label or labeling
of any food for which a health claim is made in accordance with
Sec. 101.9; for restaurant foods, in accordance with Sec. 101.10; or
for dietary supplements of vitamins or minerals, in accordance with
Sec. 101.36. The requirements of the introductory text of paragraph
(d)(3) of this section are effective as of May 8, 1993, except:
(i) [Reserved]
(ii) [Reserved]
(iii) For dietary supplements of vitamins, minerals, herbs, or
other similar nutritional substances for which the requirements of
paragraph (d)(3) of this section will be effective July 5, 1994.
(e) Prohibited health claims. No expressed or implied health claim
may be made on the label or in labeling for a food, regardless of
whether the food is in conventional food form or dietary supplement
form, unless:
* * * * *
(6) Except for dietary supplements, the food contains 10 percent or
more of the Reference Daily Intake or the Daily Reference Value for
vitamin A, vitamin C, iron, calcium, protein, or fiber per reference
amount customarily consumed prior to any nutrient addition.
* * * * *
(g) Applicability. The requirements of this section apply to foods
intended for human consumption that are offered for sale, regardless of
whether the foods are in conventional food form or dietary supplement
form.
Sec. 101.70(f) [Amended]
3. Section 101.70 is amended in paragraph (f) in the sample
petition for a health claim, in the paragraph beginning with ``The
undersigned,'' by adding the words ``or 403(r)(5)(D)'' after
``403(r)(4)''.
Dated: December 23, 1993.
David A. Kessler,
Commissioner of Food and Drugs.
Donna E. Shalala,
Secretary of Health and Human Services.
[FR Doc. 93-31815 Filed 12-29-93; 8:45 am]
BILLING CODE 4160-01-F