[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