[Federal Register Volume 72, Number 130 (Monday, July 9, 2007)]
[Notices]
[Pages 37246-37247]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-13274]


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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Draft Guidance for Industry: Evidence-Based Review System for the 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availability of a draft guidance entitled ``Guidance for Industry: 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 This draft guidance updates the agency's approach to the 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DATES: Submit written or electronic comments on the draft guidance 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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Nutritional Products, Labeling and Dietary 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number to which the draft guidance may be sent.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INFORMATION section for electronic access to the draft guidance.
    Submit written comments on the draft guidance to the Division of 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    FDA is announcing the availability of a draft guidance entitled 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