[MPWG] Public Comment Sought: Draft Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims

[Patricia_DeAngelis at fws.gov]

On July 9, 2007, the Food and Drug Administration (FDA) published their 
Draft Guidance for 
Industry: Evidence-Based Review System for the Scientific Evaluation of 
Health Claims in the 
Federal Register. 

Comments and suggestions regarding this draft document should be 
submitted within 60 days of publication as follows:

Written comments should be submitted to Division of Dockets Management 
(HFA-305), Food 
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
All comments 
should be identified with the docket number listed in the notice of 
availability that publishes in 
the Federal Register (Volume 72, Number 130, Pages 37246-372470).

According to the notice, electronic comments may be submitted at (Cut and 
paste the above url 
into your browser; I could not get this link to work): 
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www/fda/gov/dockets/ecomments

About the notice:
This draft guidance document represents the Agency's current thinking on 
1) the
process for evaluating the scientific evidence for a health claim, 2) the
meaning of the significant scientific agreement (SSA) standard in section
403(r)(3) of the "Federal Food, Drug, and Cosmetic Act" (the "Act") (21 
U.S.C.
343(r)(3)) and 21 CFR 101.14(c), and 3) credible scientific evidence to 
support
a qualified health claim  (EdNet 2007).

According to the document, "this new guidance document, if finalized, will 
replace FDA's 
guidance 'Interim Evidence-based Ranking System for Scientific Data' which 
addresses the 
science review of qualified health claims. Although the interim 
evidence-based ranking 
system guidance includes a section on ranking the strength of the 
scientific evidence, 
this draft guidance document does not include such a section because 
studies are being 
conducted on the consumer's understanding of various possible ranking 
systems that 
could be used to describe the strength of the evidence for a health claim. 
FDA intends 
to reexamine its ranking systems and issue appropriate guidance once these 
studies 
are completed. In addition, if this guidance is finalized, it will replace 
'Guidance for Industry: 
Significant Scientific Agreement in the Review of Health Claims for 
Conventional Foods and Dietary Supplements.'"

To view the document:
Cut and paste one of these urls into your browser:
        http://www.cfsan.fda.gov/~dms/hclmgui5.html
OR:     http:
//frwebgate5.access.gpo.gov/cgi-bin/waisgate.cgi?WAISdocID=805783159355+1+0+0&WAISaction=retrieve 


For questions:
Contact the Center for Food Safety and Applied Nutrition (CFSAN) at 
301-436-2367.

Responsible Agency:
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition

REFERENCE:

EdNet (National Food Safety Educator's Network).  2007.  FDA's Guidance 
for Industry: "Evidence-Based 
        Review System for the Scientific Evaluation of Health Claims." 
EdNet Newsletter - July 2007. Available at: EdNet-L at foodsafety.gov.

+++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++
+++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++

Patricia S. De Angelis, Ph.D.
Botanist - Division of Scientific Authority
Chair - Plant Conservation Alliance - Medicinal Plant Working Group
US Fish & Wildlife Service
4401 N. Fairfax Dr., Suite 750
Arlington, VA  22203
703-358-1708 x1753
FAX: 703-358-2276
Working for the conservation and sustainable use of our green natural 
resources.
<www.nps.gov/plants/medicinal>



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