FR Doc 03-17702

[Federal Register: July 11, 2003 (Volume 68, Number 133)]
[Notices]
[Page 41387-41390]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11jy03-72]

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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

[[Page 41388]]

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

[[Page 41389]]

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