[Federal Register Volume 67, Number 245 (Friday, December 20, 2002)]
[Notices]
[Pages 78002-78004]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-32194]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02D-0515]


Guidance for Industry: Qualified Health Claims in the Labeling of 
Conventional Foods and Dietary Supplements; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance entitled ``Guidance for Industry: Qualified 
Health Claims in the Labeling of Conventional Foods and Dietary 
Supplements.'' This guidance updates the agency's approach to 
implementing the court of appeals decision in Pearson v. Shalala 
(Pearson) to include conventional foods. FDA is taking this action to 
inform interested persons of the circumstances under which the agency 
intends to consider exercising its enforcement discretion to permit 
qualified health claims for conventional foods and dietary supplements.

DATES: Submit written or electronic comments on the guidance at any 
time.

ADDRESSES: Submit written requests for single copies of the guidance to 
the Office of Nutritional Products, Labeling and Dietary Supplements 
(HFS-800), Food and Drug Administration, 5100 Paint Branch Pkwy., 
College Park, MD 20740. Send one self-addressed adhesive label to 
assist that office in processing your request, or include a fax number 
to which the guidance may be sent. See the SUPPLEMENTARY INFORMATION 
section for electronic access to the guidance.
    Submit written comments on the guidance to the Dockets Management 
Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 
1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Kathleen Ellwood, Office of 
Nutritional Products, Labeling and Dietary Supplements (HFS-800), Food 
and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 
20740, 301-436-1450.

SUPPLEMENTARY INFORMATION:

I. Background

    After the enactment of the Nutrition Labeling and Education Act of 
1990 (the NLEA), FDA issued regulations establishing general 
requirements for health claims in food labeling (58 FR 2478, January 6, 
1993 (conventional foods); 59 FR 395, January 4, 1994 (dietary 
supplements)). By regulation, FDA adopted the same procedure and 
standard for health claims in dietary supplement labeling that Congress 
had prescribed in the NLEA for health claims in the labeling of 
conventional foods (see 21 U.S.C. 343(r)(3),(r)(4)). The procedure 
requires the evidence supporting a health claim to be presented to FDA 
for review before the claim may appear in labeling (21 CFR 
101.14(d),(e); 21 CFR 101.70)). The standard requires a finding of 
``significant scientific agreement'' before FDA may authorize a health 
claim by regulation Sec.  101.14(c) (21 CFR 101.14(c)). FDA's current 
regulations, which mirror the statutory language in 21 U.S.C. 
343(r)(3)(B)(i), provide that this standard is met only if FDA 
determines that there is significant scientific agreement, among 
experts qualified by scientific training and experience to evaluate 
such claims, that the claim is supported by the totality of publicly 
available scientific evidence, including evidence from well-designed 
studies conducted in a manner that is consistent with generally 
recognized scientific procedures and principles (21 CFR 101.14(c)). 
Without a regulation authorizing use of a particular health claim, a 
food bearing the claim is subject to regulatory action as a misbranded 
food (see 21 U.S.C. 343(r)(1)(B)), a misbranded drug (see 21 U.S.C. 
352(f)(1)), and an unapproved new drug (see 21 U.S.C. 355(a)).
    In Pearson, the plaintiffs challenged FDA's general health claims 
regulations for dietary supplements and FDA's decision not to authorize 
health claims for four specific substance/disease relationships. The 
district court ruled for FDA (14 F. Supp. 2d 10 (D.D.C. 1998)). 
However, the U.S. Court of Appeals for the D.C. Circuit reversed the 
lower court's decision (164 F.3d 650 (D.C. Cir. 1999)). The appeals 
court held that, on the administrative record compiled in the 
challenged rulemakings, the first amendment does not permit FDA to 
reject health claims that the agency determines to be potentially 
misleading unless the agency also reasonably determines that no 
disclaimer would eliminate the potential deception. On March 1, 1999, 
the Government filed a petition for rehearing en banc (reconsideration 
by the full court of appeals). The U.S. Court of Appeals for the D.C. 
Circuit denied the petition for rehearing on April 2, 1999 (172 F.3d 72 
(D.C. Cir. 1999)).
    In the Federal Register of October 6, 2000 (65 FR 59855), FDA 
published a

[[Page 78003]]

notice announcing its intention to exercise enforcement discretion with 
regard to certain categories of dietary supplement health claims that 
do not meet the significant scientific agreement standard in Sec.  
101.14(c). The notice set forth criteria for when the agency would 
consider exercising enforcement discretion for a qualified health claim 
in dietary supplement labeling. FDA is now issuing these criteria in 
the form of guidance and is expanding them to include health claims in 
the labeling of conventional foods. The October 6, 2000, Federal 
Register notice also described the process that FDA intends to use to 
respond to future health claim petitions; FDA is reissuing this 
information in the form of guidance. FDA is also clarifying that the 
agency will use a ``reasonable consumer'' standard in evaluating 
whether food labeling is misleading.
    FDA believes that this guidance will assist food manufacturers and 
distributors in formulating truthful and nonmisleading messages about 
the health benefits of their products. As the agency has found (52 FR 
28843, August 4, 1987), food labeling is a vehicle for ``improv[ing] 
the public's understanding about the health benefits that can result 
from adhering to a sound and nutritious diet.'' Food labeling can also 
communicate information concerning positive health consequences, beyond 
basic nutrition, of consuming particular foods. Such consequences can 
be communicated in nutrient content claims or health claims, for 
example.
    Consumers are more likely to respond to health messages in food 
labeling if the messages are specific with respect to the health 
benefits associated with particular substances in the food. According 
to the Bureau of Economics Staff of the Federal Trade Commission (FTC) 
(Bureau of Economics Staff, ``Advertising Nutrition & Health: Evidence 
from Food Advertising 1977-1997'' (September 2002)), ``consumers are 
not as responsive to simple nutrient claims'' as they are to health 
claims. This difference in responsiveness reflects the explicit linkage 
in health claims of health benefits to particular nutrients or food 
components. If consumers understand the health advantages of consuming 
foods containing particular components, they are more likely to select 
foods containing those substances. In the aggregate, decisions by 
individual consumers to incorporate beneficial foods into their diets 
improve public health.
    Conventional food manufacturers and distributors are more likely to 
include specific health claims in labeling if FDA makes clear their 
entitlement under the law to engage in such communications with 
consumers. There is evidence, reviewed by the FTC Bureau of Economics 
Staff (Bureau of Economics Staff, ``Advertising Nutrition & Health: 
Evidence from Food Advertising 1977-1997'' (September 2002)), that the 
content of food promotional messages responds to changes in applicable 
legal and regulatory requirements. As the FTC report stated, ``the 
evidence is consistent with the hypothesis that a more open environment 
leads to competitive pressures that induce producers to reveal 
information on more nutrient dimensions in advertising.'' By making 
clear the lawfulness of conventional foods labeled with truthful and 
nonmisleading health claims, FDA believes that this guidance will 
precipitate greater communication in food labeling of the health 
benefits of consuming particular foods, thereby enhancing the public's 
health.
    As discussed further in the guidance, to meet the criteria for a 
qualified health claim, the petitioner would need to provide a credible 
body of scientific data supporting the claim. Although this body of 
data need not rise to the level of significant scientific agreement 
defined in FDA's previous guidance, the petitioner would need to 
demonstrate, based on a fair review by scientific experts of the 
totality of publicly available scientific information, that the 
``weight of the scientific evidence'' supports the proposed claim. The 
test is not whether the claim is supported numerically (i.e., whether 
more studies support the proposed claim than not), but rather whether 
the pertinent data and information presented in those studies is 
sufficiently scientifically persuasive. For a claim that meets the 
``weight of the scientific evidence'' standard, the agency would 
decline to initiate regulatory action, provided the claim is qualified 
by appropriate language so consumers are not misled as to the degree of 
scientific uncertainty that would still exist.
    FDA anticipates that this policy will facilitate the provision to 
consumers of additional, scientifically supported health information. 
FDA expects that, as scientific inquiry into the role of dietary 
factors in health proceeds, particular qualified health claims will be 
further substantiated, while for other qualified health claims the 
``weight of the scientific evidence'' will shift from ``more for'' to 
``more against.'' It is conceivable, therefore, that the information 
provided to consumers through qualified health claims in food labeling 
could change over time. FDA nevertheless believes that the 
dissemination of current scientific information concerning the health 
benefits of conventional foods and dietary supplements should be 
encouraged, to enable consumers to make informed dietary choices 
yielding potentially significant health benefits.
    As FDA facilitates the provision of scientifically supported health 
information for food products, the agency must also strengthen its 
enforcement of the rules prohibiting unsubstantiated or otherwise 
misleading claims in food labeling. In assessing whether food labeling 
is misleading, FDA will use a ``reasonable consumer'' standard, as 
discussed below in section I of this document. Use of this standard 
will contribute to the rationalization of the legal and regulatory 
environment for food promotion, by making FDA's regulation of dietary 
supplement and conventional food labeling consistent with the FTC's 
regulation of advertising for these products.
    The FTC's jurisdiction over food advertising derives from sections 
5 and 12 of the FTC Act (15 USC 45 and 52), which broadly prohibit 
unfair or deceptive commercial acts or practices and specifically 
prohibit the dissemination of false advertisements for foods, drugs, 
medical devices, or cosmetics. The FTC has issued two policy 
statements, the Deception Policy Statement (appended to Cliffdale 
Assocs., Inc., 103 F.T.C. 110, 174 (1984)) and the Statement on 
Advertising Substantiation (appended to Thompson Med. Co., 104 F.T.C. 
648, 839 (1984)), that articulate the basic elements of the deception 
analysis employed by the FTC in advertising cases. According to these 
policies, in identifying deception in an advertisement, the FTC 
considers the representation from the perspective of a consumer acting 
reasonably under the circumstances: ``The test is whether the 
consumer's interpretation or reaction is reasonable.'' 103 F.T.C. at 
177.
    FDA's general statutory authority to regulate food labeling derives 
from section 403(a)(1) of the Federal Food, Drug, and Cosmetic Act (the 
act) (21 U.S.C. 343(a)(1)), which deems a food misbranded if its 
labeling is false or misleading ``in any particular.''\1\ The act

[[Page 78004]]

contains similar provisions for drugs and medical devices (21 U.S.C. 
352(a)) and cosmetics (21 U.S.C. 362(a)). In some cases, the courts 
have interpreted the act to protect ``the ignorant, the unthinking, and 
the credulous'' consumer. See, e.g., United States v. El-O-Pathic 
Pharmacy, 192 F.2d 62, 75 (9th Cir. 1951); United States v. An Article 
of Food * * * ``Manischewitz * * * Diet Thins,'' 377 F. Supp. 746, 749 
(E.D.N.Y. 1974). In other cases, the courts have interpreted the act to 
require evaluation of claims from the perspective of the ordinary 
person or reasonable consumer. See, e.g., United States v. 88 Cases, 
Bireley's Orange Beverage, 187 F.2d 967, 971 (3d Cir.), cert. denied 
342 U.S. 861 (1951). FDA believes that the latter standard is the 
appropriate standard to use in determining whether a claim in the 
labeling of a dietary supplement or conventional food is misleading.
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    \1\ The act does not require FDA to have survey evidence or 
other data before the agency is entitled to proceed under section 
403(a)(1) of the act. FDA nevertheless recognizes that survey data 
and other evidence will be helpful in evaluating whether consumers 
are misled by a particular claim. For example, surveys, copy tests, 
and other reliable evidence of consumer interpretation can be 
helpful in assessing the particular message conveyed by a statement 
that FDA believes constitutes an implied claim.
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    The reasonable consumer standard more accurately reflects FDA's 
belief that consumers are active partners in their own health care who 
behave in health promoting ways when they are given accurate health 
information. In addition, the reasonable consumer standard is 
consistent with the governing first amendment case law precluding the 
Government from regulating the content of promotional communication so 
that it contains only information that will be appropriate for a 
vulnerable or unusually credulous audience. Cf. Bolger v. Youngs Drug 
Prods. Corp., 463 U.S. 60, 73-74 (1983) (``the government may not 
`reduce the adult population * * * to reading only what is fit for 
children.''') (quoting Butler v. Michigan, 352 U.S. 380, 383 (1957)).
    Based on the FTC's success in policing the marketplace for 
misleading claims in food advertising, FDA believes that its own 
enforcement of the legal and regulatory requirements applicable to food 
labeling will not be adversely affected by use of the ``reasonable 
consumer'' standard in evaluating labeling for dietary supplements and 
conventional foods. Explicit FDA adoption of the reasonable consumer 
standard will rationalize the regulatory environment for food promotion 
while both protecting and enhancing the public health.
    This guidance represents the agency's current thinking on qualified 
health claims in the labeling of conventional foods and dietary 
supplements. It does not create or confer any rights for or on any 
person and does not operate to bind FDA or the public. An alternative 
approach may be used if such approach satisfies the requirements of the 
applicable statute and regulations.
    This guidance is a Level 1 guidance under FDA's good guidance 
practices (GGP) regulation (21 CFR 10.115). Under Sec.  10.115(g)(2), 
the guidance is being implemented immediately, without prior public 
comment, to help ensure that FDA's policies on health claims in food 
labeling comply with the governing first amendment case law. Consistent 
with the GGP regulation, FDA is now soliciting comment on the guidance 
and will revise it, if warranted.
    FDA tentatively concludes that this guidance contains no collection 
of information. Therefore, clearance by OMB under the Paperwork 
Reduction Act of 1995 is not required.

II. Comments

    Interested persons may, at any time, submit written or electronic 
comments on the guidance to the Dockets Management Branch (see 
ADDRESSES). Submit a single copy of electronic comments to http://www.fda.gov/dockets/ecomments or two hard copies of any written 
comments, except that individuals may submit one copy. Comments are to 
be identified with the docket number found in brackets in the heading 
of this document. The guidance and received comments are available for 
public examination in the Dockets Management Branch between 9 a.m. and 
4 p.m., Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
http://www.cfsan.fda.gov/dms/guidance.html or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: December 17, 2002.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 02-32194 Filed 12-18-02; 12:01 pm]
BILLING CODE 4160-01-S