<br><font size=3 face="sans-serif">On July 9, 2007, the Food and Drug Administration
(FDA) published their Draft Guidance for </font>
<br><font size=3 face="sans-serif">Industry: Evidence-Based Review System
for the Scientific Evaluation of Health Claims in the </font>
<br><font size=3 face="sans-serif"><u>Federal Register</u>. </font>
<br>
<br><font size=3 face="sans-serif"><b>Comments and suggestions regarding
this draft document should be </b></font>
<br><font size=3 face="sans-serif"><b>submitted within 60 days of publication</b>
as follows:</font>
<br>
<br><font size=3 face="sans-serif">Written comments should be submitted
to Division of Dockets Management (HFA-305), Food </font>
<br><font size=3 face="sans-serif">and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852. All comments </font>
<br><font size=3 face="sans-serif">should be identified with the docket
number listed in the notice of availability that publishes in </font>
<br><font size=3 face="sans-serif">the <i>Federal Register</i> (Volume
72, Number 130, Pages 37246-372470).</font>
<br>
<br><font size=3 face="sans-serif">According to the notice, electronic
comments may be submitted at (Cut and paste the above url </font>
<br><font size=3 face="sans-serif">into your browser; I could not get this
link to work): </font><a href="http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www/fda/gov/dockets/ecomments" target=_parent><font size=3 color=blue face="sans-serif"><u>http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www/fda/gov/dockets/ecomments</u></font></a>
<br>
<br><font size=3 face="sans-serif"><b>About the notice:</b></font>
<br><font size=3 face="sans-serif">This draft guidance document represents
the Agency's current thinking on 1) the<br>
process for evaluating the scientific evidence for a health claim, 2) the<br>
meaning of the significant scientific agreement (SSA) standard in section<br>
403(r)(3) of the "Federal Food, Drug, and Cosmetic Act" (the
"Act") (21 U.S.C.<br>
343(r)(3)) and 21 CFR 101.14(c), and 3) credible scientific evidence to
support<br>
a qualified health claim (EdNet 2007).</font>
<br>
<br><font size=3 face="sans-serif">According to the document, "this
new guidance document, if finalized, will replace FDA's </font>
<br><font size=3 face="sans-serif">guidance '</font><a href=http://www.cfsan.fda.gov/~dms/hclmgui4.html><font size=3 color=#0000cc face="sans-serif"><u>Interim
Evidence-based Ranking System for Scientific Data</u></font></a><font size=3 face="sans-serif">'
which addresses the </font>
<br><font size=3 face="sans-serif">science review of qualified health claims.
<b>Although the interim evidence-based ranking </b></font>
<br><font size=3 face="sans-serif"><b>system guidance includes a section
on ranking the strength of the scientific evidence, </b></font>
<br><font size=3 face="sans-serif"><b>this draft guidance document does
not include such a section because studies are being </b></font>
<br><font size=3 face="sans-serif"><b>conducted on the consumer's understanding
of various possible ranking systems that </b></font>
<br><font size=3 face="sans-serif"><b>could be used to describe the strength
of the evidence for a health claim. FDA intends </b></font>
<br><font size=3 face="sans-serif"><b>to reexamine its ranking systems
and issue appropriate guidance once these studies </b></font>
<br><font size=3 face="sans-serif"><b>are completed.</b> In addition, if
this guidance is finalized, it will replace '</font><a href=http://www.cfsan.fda.gov/~dms/ssaguide.html><font size=3 color=#0000cc face="sans-serif"><u>Guidance
for Industry: </u></font></a>
<br><font size=3 color=#0000cc face="sans-serif"><u>Significant Scientific
Agreement in the Review of Health Claims for Conventional Foods and Dietary
Supplements.</u></font><font size=3 face="sans-serif">'"</font>
<br>
<br><font size=3 face="sans-serif"><b>To view the document:</b></font>
<br><font size=3 face="sans-serif">Cut and paste one of these urls into
your browser:</font>
<br><font size=3 face="sans-serif"> http://www.cfsan.fda.gov/~dms/hclmgui5.html</font>
<br><font size=3 face="sans-serif">OR: http:<u>//frwebgate5.access.gpo.gov/cgi-bin/waisgate.cgi?WAISdocID=805783159355+1+0+0&WAISaction=retrieve</u>
</font>
<br>
<br><font size=3 face="sans-serif"><b>For questions:</b></font>
<br><font size=3 face="sans-serif">Contact the Center for Food Safety and
Applied Nutrition (CFSAN) at 301-436-2367.</font>
<br>
<br><font size=3 face="sans-serif"><b>Responsible Agency:</b></font>
<br><font size=3 face="sans-serif">U.S. Department of Health and Human
Services<br>
Food and Drug Administration<br>
Center for Food Safety and Applied Nutrition</font>
<br>
<br><font size=3 face="sans-serif"><b>REFERENCE:</b></font>
<br>
<br><font size=3 face="sans-serif">EdNet (National Food Safety Educator's
Network). 2007. FDA's Guidance for Industry: "Evidence-Based
</font>
<br><font size=3 face="sans-serif"> Review
System for the Scientific Evaluation of Health Claims." EdNet
Newsletter - July 2007. Available at: EdNet-L@foodsafety.gov.</font>
<br>
<br><font size=3 face="sans-serif">+++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++</font>
<br><font size=3 face="sans-serif">+++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++<br>
</font>
<br><font size=3 face="sans-serif">Patricia S. De Angelis, Ph.D.<br>
Botanist - Division of Scientific Authority<br>
Chair - Plant Conservation Alliance - Medicinal Plant Working Group<br>
US Fish & Wildlife Service<br>
4401 N. Fairfax Dr., Suite 750<br>
Arlington, VA 22203<br>
703-358-1708 x1753<br>
FAX: 703-358-2276<br>
Working for the conservation and sustainable use of our green natural resources.<br>
<www.nps.gov/plants/medicinal></font>
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