[Federal Register: July 9, 2007 (Volume 72, Number 130)]
[Notices]
[Page 37246-37247]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09jy07-78]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007D-0125]
Draft Guidance for Industry: Evidence-Based Review System for the
Scientific Evaluation of Health Claims; 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availability of a draft guidance entitled ``Guidance for Industry:
Evidence-Based Review System for the Scientific Evaluation of Health
Claims.'' This draft guidance updates the agency's approach to the
review of the publicly available scientific evidence for significant
scientific agreement (SSA) and qualified health claims. FDA is taking
this action to inform interested persons of the system it intends to
use to review the scientific evidence in the evaluation of SSA and
qualified health claims.
DATES: Submit written or electronic comments on the draft guidance
document by September 7, 2007.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Nutritional Products, Labeling and Dietary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 the office in processing your request, or include a fax
number to which the draft guidance may be sent. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance.
Submit written comments on the draft guidance to the Division of
Dockets Management (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: Paula Trumbo, Center for Food Safety
and Applied Nutrition (HFS-830), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740, 310-436-2579.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance entitled
``Guidance for Industry: Evidence-Based Review System for the
Scientific Evaluation of Health Claims.'' The Nutrition Labeling and
Education Act of 1990 (NLEA) was designed to give consumers more
scientifically valid information about foods they eat. Among other
provisions, NLEA directed FDA to issue regulations providing for the
use of statements that describe the relationship between a substance
and a disease (``health claims'') in the labeling of foods, including
dietary supplements, after such statements have been reviewed and
authorized by FDA. For these health claims, that is, statements about
substance/disease relationships, FDA has defined the term ``substance''
by regulation as a specific food or food component (Sec. 101.14(a)(2)
(21 CFR 101.14(a)(2)). An authorized health claim may be used on both
conventional foods and dietary supplements, assuming that the substance
in the product and the product itself meet the appropriate standards in
the authorizing regulation. Health claims are directed to the general
population or designated subgroups (e.g., the elderly) and are intended
to assist the consumer in maintaining healthful dietary practices.
In evaluating a petition for an SSA health claim submitted under
Sec. 101.70 (21 CFR 101.70), FDA considers whether the evidence
supporting the relationship that is the subject of the claim meets the
SSA standard. This standard derives from section 403(r)(3)(B)(i) of the
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C.
343(r)(3)(B)(i)), which provides that FDA shall authorize a health
claim to be used on conventional foods if the agency ``determines,
based on the totality of the publicly available scientific evidence
(including evidence from well-designed studies conducted in a manner
which is consistent with generally recognized scientific procedures and
principles), that there is significant scientific agreement, among
experts qualified by scientific training and experience to evaluate
such claims, that the claim is supported by such evidence.'' This
scientific standard was prescribed by statute for conventional food
health claims; by regulation, FDA adopted the same standard for dietary
supplements health claims (see Sec. 101.14(c)).
The genesis of qualified health claims was the court of appeals
decision in Pearson v. Shalala (Pearson). In that case, the plaintiffs
challenged FDA's decision not to authorize health claims for four
specific substance/disease relationships for dietary supplements.
Although the district court ruled for FDA (14 F. Supp. 2d 10 (D.D.C.
1998)), the U.S. Court of Appeals for the DC Circuit reversed the lower
court's decision (164 F.3d 650 (DC Cir. 1999)). The appeals court held
that 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 a disclaimer would not eliminate
the potential deception. The appeals court also held that the
Administrative Procedure Act required FDA to clarify the SSA standard
for authorizing health claims.
On December 22, 1999, FDA announced the issuance of a guidance
entitled ``Guidance for Industry: Significant Scientific Agreement in
the Review of Health Claims for Conventional Foods and Dietary
Supplements'' (64 FR 71794). This guidance document was issued to
clarify FDA's interpretation of the SSA standard in response to the
court of appeals second holding in Pearson.
[[Page 37247]]
On December 20, 2002, the agency announced its intention to extend
Pearson to health claims for conventional foods (67 FR 78002).
Recognizing the need for an approach for scientific evaluations for
qualified health claims, the task force on ``Consumer Health
Information for Better Nutrition'' was formed. As part of the task
force's final report,\1\ FDA developed an interim evidence-based review
system that the agency intended to use to evaluate the substance/
disease relationships that are subjects of qualified health claims.
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\1\See guidance entitled ``Interim Evidence-based Ranking System
for Scientific Data,'' July 10, 2003 (http://www.cfsan.fda.gov/~dms/hclmgui4.html
).
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In reviewing both the December 22, 1999, guidance document and the
2003 task force report, it became apparent to the agency that the
components of the scientific review process for an SSA health claim and
qualified health claim are very similar. Because of the similarity
between the scientific reviews for SSA and qualified health claims, FDA
intends to generally use the approach set out in this draft guidance
for evaluating the scientific evidence in petitions that are submitted
for an SSA health claim or qualified health claim.
The primary purpose of this document is to set out FDA's current
thinking on the process for evaluating the scientific evidence for a
health claim, the meaning of the SSA standard in section 403(r)(3) of
the act and Sec. 101.14(c), and credible scientific evidence to
support a qualified health claim.
This draft guidance is being issued consistent with FDA's good
guidance practice regulations (21 CFR 10.115). The draft guidance, when
finalized, will represent the agency's current thinking on the
scientific review process for SSA and qualified health claims. 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 statutes
and regulations.
II. Paperwork Reduction Act of 1995
This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in Sec. Sec. 101.14 and 101.70 have been
approved under OMB control number 0910-0381.
III. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding the draft
guidance document. Submit a single copy of 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 draft guidance
and received comments are available for public examination in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
IV. Electronic Access
Persons with access to the Internet may obtain the draft guidance
at http://www.cfsan.fda.gov/guidance.html.
Dated: June 28, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-13274 Filed 7-6-07; 8:45 am]
BILLING CODE 4160-01-S