[Federal Register Volume 68, Number 133 (Friday, July 11, 2003)]
[Notices]
[Pages 41387-41390]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-17702]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003N-0069]


Release of Task Force Report; Guidance for Industry and FDA: 
Interim Evidence-Based Ranking System for Scientific Data; Interim 
Procedures for Health Claims on the Labeling of Conventional Human Food 
and Human 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 the report of its Task Force on Consumer Health 
Information for Better Nutrition (the Task force) and two final 
guidance documents entitled ``Guidance for Industry and FDA: Interim 
Evidence-Based Ranking System for Scientific Data'' and ``Guidance for 
Industry and FDA: Interim Procedures for Health Claims in the Labeling 
of Conventional Human Food and Human Dietary Supplements.'' These 
documents further update the agency's approach on how it intends to 
implement the Court of Appeals decision in Pearson v. Shalala. FDA is 
taking this action to inform interested persons of the release of the 
Task Force report and to make available the guidances announced in the 
Task Force report in accordance with FDA's good guidance practices.

DATES:  The guidances are final on July 11, 2003. However, you may 
submit written or electronic comments on the guidances at any time.

ADDRESSES:  Submit written requests for single copies of the Task Force 
report and the final guidances 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. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the Task Force report and the final guidances.
    Submit written comments on the final guidances to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Please identify whether 
you are commenting on one or both of the guidances when you submit your 
written comments. 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

    On December 18, 2002, FDA announced a major new initiative, the 
Consumer Health Information for Better Nutrition Initiative, to make 
available more and better information about conventional human food and 
human dietary supplements to help American consumers improve their 
health and prevent diseases by making sound dietary decisions. This 
initiative has as its central focus improving the public availability 
and consumer understanding of up-to-date scientific evidence on how 
dietary choices can affect health. FDA announced on January 16, 2003, 
that one element of this initiative was to set up an FDA Task Force and 
to issue a report of that Task Force approximately 6 months after the 
initiative was launched. The Task Force includes representatives from 
FDA, the Federal Trade Commission (FTC), and the National Institutes of 
Health.
    The Task Force was charged with: (1) Reporting on how the agency 
can improve consumer understanding of the health consequences of their 
dietary choices and increase competition by product developers in 
support of healthier diets, including how the agency should evaluate 
scientific evidence for qualified health claims in order to achieve 
these goals; (2) developing a framework of regulations that will give 
these principles the force and the effect of law; (3) identifying 
procedures for implementing the initiative, as well as determining the 
organizational staffing needs necessary for the timely review of 
qualified health claim petitions; and (4) developing a consumer studies 
research agenda designed to identify the most effective ways to present 
scientifically-based, truthful and nonmisleading information to 
consumers and to identify the kinds of information known to be 
misleading to consumers.
    On March 13, 2003, the Task Force established a public docket 
(docket number 2003N-0069) to receive views and comments from 
interested stakeholders. As part of FDA's continued commitment to 
ensure that stakeholders remain fully informed of our progress as we 
implement this initiative, FDA is making available the Task Force 
report, which includes nine attachments (Attachments A through I). 
Refer to section II of this document for a brief description of the 
attachments. The Task Force report entitled ``Consumer Health 
Information for Better Nutrition Initiative--Task Force Report--July 
2003'' is available on FDA's Web sites at http://www.fda.gov/oc/mcclellan/chbn.html or http://www.fda.gov/ohrms/dockets/default.htm and 
by requesting paper copies from the contact person (see FOR FURTHER 
INFORMATION CONTACT). The final guidances are available at http://www.cfsan.fda.gov/guidance.html or http://www.fda.gov/ohrms/dockets/default.htm.

II. Task Force Report

    The Task Force report includes a transmittal memorandum from the 
Chair and Vice Chair of the Task Force to the Commissioner of Food and 
Drugs, an executive summary, and the following attachments:

A. Possible Regulatory Frameworks for Qualified Health Claims in the 
Labeling of Conventional Human Food and Human Dietary Supplements

    This attachment describes three options or alternatives for 
regulating health claims that do not meet the ``significant scientific 
agreement'' standard of evidence by which the health claims regulations 
require FDA to evaluate the scientific validity of claims.

B. Guidance: Interim Evidence-Based Ranking System for Scientific Data

    This interim evidence-based ranking system describes a process for 
systematically evaluating the scientific evidence relevant to a 
substance/disease relationship that is the subject of a petition for a 
qualified health claim. The scientific rating system provides a means 
by which the totality of the publicly available scientific evidence 
relevant to a substance/disease

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relationship can be assigned to one of four ranked levels.

C. Resources for Review of Scientific Data

    This attachment describes a process to augment the agency's limited 
scientific review resources on an as-needed basis by using outside 
contractors.

D. Consumer Studies Research Agenda--Improving Consumer Understanding 
and Product Competition on the Health Consequences of Dietary Choices

    This attachment sets forth the consumer research studies planned, 
pending Office of Management and Budget (OMB) approval, to provide the 
agency with information about consumers' reactions to qualified health 
claims.

E. Guidance: Interim Procedures for Qualified Health Claims in the 
Labeling of Conventional Human Food and Human Dietary Supplements

    This attachment describes the interim procedures for qualified 
health claims in the labeling of conventional human food and human 
dietary supplements.

F. ``One-Year'' Time Line for Qualified Health Claim Activities

    This attachment consolidates the main activities for June 30, 2003, 
through June 1, 2004.
    The Task Force report also contains the list of the Task Force 
members, a summary of the four stakeholder meetings the Task Force 
held, and a summary of public comments submitted to the docket on this 
initiative (see Task Force report attachments G, H, and I, 
respectively).

III. Final Guidances

A. Background

    After the enactment of the Nutrition Labeling and Education Act of 
1990 (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) and (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 (Sec.  101.14(d) and 
(e) (21 CFR 101.14(d) and (e) and 101.70)). The standard requires a 
finding of ``significant scientific agreement'' (SSA) before FDA may 
authorize a health claim by regulation (Sec.  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 SSA, among experts qualified by scientific 
training and experience to evaluate such claims; and 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 (Sec.  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)).
    NLEA required that FDA itself initially consider health claims for 
10 substance/disease relationships. FDA determined that there was SSA 
concerning a number of these specified substance/disease relationships 
and in turn authorized eight claims. Not all relationships that 
Congress specified to be reviewed were found to meet the standard of 
SSA, and so not all were authorized by FDA.
    Several of the substance/disease relationships for which FDA failed 
to find significant scientific agreement became the subject of a 
lawsuit brought by a dietary supplement manufacturer. The case is known 
as Pearson v. Shalala (Pearson). 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)).\1\ 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.
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    \1\ On March 1, 1999, the Government filed a petition for 
rehearsing en banc (reconsideration by the full court of appeals). 
The U.S. Court of Appeals for the D.C. Circuit denied the petition 
for rehearsing on April 2, 1999 (172 F.3d 72 (D.C. Cir. 1999)).
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    The court of appeals further stated that it did not ``rule out the 
possibility that where evidence in support of a claim is outweighed by 
evidence against the claim, the FDA could deem it incurable by a 
disclaimer and ban it outright.'' (Id. at 659.) Also, the court saw 
``no problem with the FDA imposing an outright ban on a claim where 
evidence in support of the claim is qualitatively weaker than the 
evidence against the claim.'' (Id. at 659 and n.10.) This language was 
the genesis of the ``weight-of-the evidence'' criterion discussed in 
this document.
    In the Federal Register of October 6, 2000 (65 FR 59855), FDA 
published a notice announcing its intention to exercise enforcement 
discretion with regard to certain categories of dietary supplement 
health claims that do not meet the SSA 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, including as a criterion whether the scientific 
evidence in support of a given claim outweighed the scientific evidence 
against it.
    As discussed previously, on December 18, 2002, FDA announced the 
Consumer Health for Better Nutrition Initiative to encourage the flow 
of high quality, science-based information regarding the health 
benefits of conventional foods and dietary supplements to consumers. In 
the Federal Register of December 20, 2002 (67 FR 78002), FDA announced 
that it would apply Pearson to health claims in the labeling of 
conventional foods as well as dietary supplements. The agency also 
announced the availability of guidance concerning when FDA intended to 
consider exercising enforcement discretion with respect to health 
claims that do not meet the standard of SSA. Based on Pearson, the 
December 2002 guidance, like the October 2000 Federal Register notice 
stating FDA's intention to consider exercising enforcement discretion 
with respect to dietary supplement health claims that do not meet SSA, 
included as a criterion whether the scientific evidence in support of 
the claim outweighs the scientific evidence against the claim.
    Six days after publication of the December 20, 2002, notice and the 
guidance, the U.S. District Court for the District of Columbia issued 
its decision in Whitaker v. Thompson, 248 F. Supp.2d 1 (Whitaker). In 
Whitaker, the district court interpreting Pearson, found that 
``credible evidence,'' rather than ``weight of the evidence'' is the 
appropriate standard for FDA to apply in evaluating qualified health 
claims. In light of Whitaker, FDA believes that the weight of the 
evidence standard in the

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October 2000 Federal Register notice and the December 2002 guidance 
must be tempered by the test of credible evidence. Communication of 
that or any other level of evidence to consumers in a nonmisleading way 
remains of critical importance.
    The reason for the decision to apply Pearson to conventional foods 
is to provide consumers with better health/nutrition information so 
they can make better dietary choices. By making clear that 
manufacturers may label foods with truthful and nonmisleading health 
claims, FDA believes that the guidance will precipitate greater 
communication in food labeling of the health benefits of consuming 
particular foods, thereby enhancing the public's health, because 
consumers will respond to health claims in food labeling by making 
better informed dietary choices (67 FR 78002).
    The decision announced in the December 2002 notice was also based 
on a desire to avoid further litigation over the constitutionality of 
the health claims provisions of the NLEA applicable to conventional 
food labeling to the extent that these provisions do not permit 
qualified claims. As explained previously, 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. The agency, however, did not have any consumer 
data to show that a disclaimer would not eliminate the potential 
deception.
    Pearson and subsequent related cases including Whitaker, concern 
dietary supplement labeling, but as stated previously, FDA by 
regulation adopted the same procedure and standard for health claims 
for dietary supplement labeling that Congress prescribed in the NLEA 
for health claims in conventional food labeling. These dietary 
supplement regulations, like the NLEA provisions in question, do not 
provide for qualified claims. Hence, based on Pearson and related 
cases, a court faced with a decision by FDA to not permit a qualified 
health claim for a conventional food might well find the same tension 
between the NLEA provisions and the first amendment. It is possible 
that consumer data will show that potentially misleading health claims 
cannot be cured by disclaimers in at least some cases, but the agency 
does not have such data for conventional foods, as it did not (and does 
not) have such data for dietary supplements. Within the next year, the 
agency will be completing research in this area. The results of this 
research, together with further evaluation of the regulatory 
alternatives identified by the Task Force, and evaluation of any 
additional alternatives, will inform any rulemaking FDA initiates.
    In the interim, FDA intends to use the procedures and evidence-
based ranking systems for scientific data set out in the below-
described guidances on these matters, and consider the exercise of 
enforcement discretion on a case-by-case basis with respect to 
qualified health claims in conventional human food and human dietary 
supplement labeling under certain circumstances. (See Heckler v. 
Chaney, 470 U.S. 821 (1985); Community Nutrition Institute v. Young, 
818 F.2d 943, 949-50 (D.C. Cir. 1987)).
    FDA believes that its interim approach to qualified claims is a 
reasonable effort to combine the spirit of the NLEA with the current 
public health and legal circumstances, and one that reflects practical 
common sense. And, as the Court of Appeals for the District of Columbia 
Circuit observed in Niagara Mohawk Power Corp. v. FPC, 379 F.2d 153, 
160, ``Courts are loath to say that good sense is not good law.''

B. Guidance for Industry and FDA: Interim Evidence-Based Ranking System 
for Scientific Data

    This interim evidence-based ranking system describes a process for 
systematically evaluating the scientific evidence relevant to a 
substance/disease relationship that is the subject of a petition for a 
qualified health claim. The scientific rating system provides a means 
by which the totality of the publicly available scientific evidence 
relevant to a substance/disease relationship can be assigned to one of 
four ranked levels. The evidence-based ranking system presupposes that 
FTC's requirement of ``competent and reliable scientific evidence'' to 
substantiate an advertising claim related to health or safety has been 
met. FTC defines ``competent and reliable scientific evidence'' as 
``tests, analyses, research, studies, or other evidence'' based upon 
the expertise of professionals in the relevant area, that has been 
``conducted and evaluated in an objective manner by persons qualified 
to do so, using procedures generally accepted'' in the profession to 
``yield accurate and reliable results.'' In Re: Great Earth 
International, Inc., 110 F.T.C. 188 (1988). In applying the system, FDA 
intends to consider scientific evidence only if it is competent and 
reliable. FDA intends to use this interim system, beginning in 
September 2003, for qualified health claims in the labeling of 
conventional human food and human dietary supplements. See the 
Addresses section of this notice for information on submitting comments 
on this final guidance.

C. Guidance for Industry and FDA: Interim Procedures for Qualified 
Health Claims in the Labeling of Conventional Human Food and Human 
Dietary Supplements

    FDA intends to use these interim procedures, beginning in September 
2003, for qualified health claims in the labeling of conventional human 
food and human dietary supplements. See the Addresses section of this 
notice for information on submitting comments on this final guidance.

D. The Final Guidances Are Being Issued as Level 1 Guidance under FDA's 
Good Guidances Practices (GGPs) Regulation (Sec.  10.115 (21 CFR 
10.115))

    Consistent with GGPs, the agency will accept comment, but it is 
implementing these guidance documents immediately in accordance with 
section 10.115(g)(2) because the agency has determined that prior 
public participation is not feasible or appropriate. FDA tentatively 
concludes that the guidances contain no new collection of information. 
Therefore, clearance by OMB under the Paperwork Reduction Act of 1995 
is not required.

IV. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding the guidances. 
Submit a single copy of the electronic comments or two paper copies of 
any mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. The Task Force report, two final 
guidances, and received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

V. Electronic Access

    Interested persons may also access the guidance documents at http://www.cfsan.fda.gov/guidance.html or http://www.fda.gov/ohrms/dockets/default.htm.

VI. Future Agency Activities

    FDA emphasizes that it intends to use the evidence-based ranking 
system and the procedures on an interim basis. In the near future, the 
agency intends to publish an advance notice of proposed

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rulemaking consistent with the recommendations of the Task Force. As 
also recommended by the Task Force, FDA intends, within 1 year, to 
initiate notice-and-comment rulemaking to establish scientific review 
criteria and procedures for qualified health claim petitions. By that 
time, FDA expects to complete the consumer studies research as 
described in the Task Force report (attachment D). The results of this 
research, together with further evaluation of the regulatory 
alternatives identified by the Task Force, with the benefit of public 
comment, and evaluation of any additional alternatives that 
stakeholders suggest in response to the advance notice of proposed 
rulemaking, will inform the rulemaking FDA intends to initiate.

    Dated: July 8, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-17702 Filed 7-10-03; 8:45 am]
BILLING CODE 4160-01-S