[Federal Register: December 20, 2002 (Volume 67, Number 245)]
[Notices]
[Page 78002-78004]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20de02-64]
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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.
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