<br><font size=2 color=#000080 face="Arial"><b>A little more insight from
another working group member...</b></font>
<br>
<br><font size=2 color=#000080 face="Arial"><b>RE: Draft Guidance
for Industry on Complementary and Alternative Medicine Products and Their
regulation by the Food and Drug Administration</b></font>
<br><font size=2 color=#000080 face="Arial"><b>[Date: December 2006:
Contact: Sheryl Lard-Whiteford, Esq. 301-827-0379]</b></font>
<br><font size=2 color=#000080 face="Arial"> </font>
<br><font size=2 color=#000080 face="Arial">The draft guidance puts into
straightforward language how the FDA regulates all products. There
is nothing novel in this document. My guess is that it was written
to provide clarification to a general audience who would not normally be
aware of the current regulatory schema. </font>
<br><font size=2 color=#000080 face="Arial"> </font>
<br><font size=2 color=#000080 face="Arial">To provide you with the overall
regulatory approach, products are regulated by the route, formulation,
safety and “intended use.” </font>
<br><font size=2 color=#000080 face="Arial"> </font>
<br><font size=2 color=#000080 face="Arial">If the product seller wishes
to make claims that the product will “diagnose, prevent, treat, mitigate
or cure” heart disease, these claims will make the product a “drug.”
The same identical product sold with claims to “promote heart
health” or “reduce the risk to cardiovascular disease” could be sold
as foods, dietary supplements, etc. Indeed on page three of the
draft guidance the agency specifically states: <b><i> “Botanical
products, depending on the circumstances, may be regulated as drugs, cosmetics,
dietary supplements or foods. All four types of products are subject
to the [Food, Drug & Cosmetic”] Act.” </i></b></font>
<br><font size=2 color=#000080 face="Arial"> </font>
<br><font size=2 color=#000080 face="Arial">Again, none of this information
represents new laws, regulations, or even policies, nor does it signal
any change in compliance efforts. It appears to be mainly explanatory
to the public who [in large part, does not understand] how products are
regulated in the US. </font>
<br>
<br><font size=2 color=#000080 face="Times New Roman">Freddie Ann Hoffman,
MD</font><font size=3 color=#000080 face="Times New Roman"> </font><font size=4 color=#000080><b><br>
H</b></font><font size=3 color=#000080><b>eteroGeneity, LLC</b></font><font size=3 color=#000080 face="Times New Roman">
</font><font size=2 color=#000080 face="Times New Roman"><br>
5611 16th Street, NW</font><font size=3 color=#000080 face="Times New Roman">
</font><font size=2 color=#000080 face="Times New Roman"><br>
Washington, DC 20011-6809</font><font size=3 color=#000080 face="Times New Roman">
</font><font size=2 color=#000080 face="Times New Roman"><br>
Tel.: 202-545-6843</font><font size=3 color=#000080 face="Times New Roman">
</font><font size=2 color=#000080 face="Times New Roman"><br>
Fax: 202-545-6844</font><font size=3 color=#000080 face="Times New Roman">
</font><font size=2 color=blue face="Times New Roman"><u><br>
</u></font><a href="mailto:fhoffman@heterogeneity-LLC.com"><font size=3 color=#000080 face="Times New Roman"><u>fhoffman@heterogeneity-LLC.com</u></font></a>
<br><a href="http://www.heterogeneity-llc.com/"><font size=3 color=#000080 face="Times New Roman"><u>www.heterogeneity-LLC.com</u></font></a>
<br>
<br><font size=2 face="sans-serif"><br>
</font>
<br><font size=1 color=#800080 face="sans-serif">----- Forwarded by Patricia
De Angelis/ARL/R9/FWS/DOI on 04/17/2007 02:15 PM -----</font>
<br>
<table width=100%>
<tr valign=top>
<td width=40%><font size=1 face="sans-serif"><b>Megan_Haidet@fws.gov</b>
</font>
<br><font size=1 face="sans-serif">Sent by: mpwg-bounces@lists.plantconservation.org</font>
<p><font size=1 face="sans-serif">04/17/2007 11:11 AM</font>
<td width=59%>
<table width=100%>
<tr valign=top>
<td>
<div align=right><font size=1 face="sans-serif">To</font></div>
<td><font size=1 face="sans-serif">mpwg@lists.plantconservation.org</font>
<tr valign=top>
<td>
<div align=right><font size=1 face="sans-serif">cc</font></div>
<td>
<tr valign=top>
<td>
<div align=right><font size=1 face="sans-serif">Subject</font></div>
<td><font size=1 face="sans-serif">[MPWG] FDA Draft Guidance for Industry
on Complementary and Alternative Medicine Products and Their Regulation
by the Food and Drug Administration</font></table>
<br>
<table>
<tr valign=top>
<td>
<td></table>
<br></table>
<br>
<br>
<br><font size=3 face="Times New Roman"><br>
There is a public comment period concerning the FDA classification of complementary
and alternative medicine (CAM) products open until April 30, 2007. </font><font size=3>
<br>
</font><font size=3 face="Times New Roman"><br>
The Food and Drug Administration (FDA) is announcing the availability of
a draft guidance for industry entitled "Complementary and Alternative
Medicine Products and Their Regulation by the Food and Drug Administration."
In recent years, the use of complementary and alternative medicine (CAM)
products has increased in the United States, and we have seen increased
confusion as to whether certain products used in CAM are subject to regulation
under the Federal Food, Drug, and Cosmetic Act ("the Act") or
Public Health Service Act ("PHS Act"). We have also seen an increase
in the number of CAM products imported into the United States. Therefore,
the draft guidance discusses when a CAM product is subject to the Act or
the PHS Act.</font><font size=3> <br>
</font><font size=3 face="Times New Roman"><br>
This guidance document, when finalized, will represent the Food and Drug
Administration's (FDA's) current thinking on this topic. It does not create
or confer any rights for or on any person and does not operate to bind
the FDA or the public. </font><font size=3><br>
</font><font size=3 face="Times New Roman"><br>
If you are interested please take a look at the links below to learn more
about this issue.</font><font size=3> <br>
</font><font size=3 face="Times New Roman"><br>
To view the <b>draft guidance document</b> from the FDA, visit: <u><br>
http://www.fda.gov/OHRMS/DOCKETS/98fr/06d-0480-gld0001.pdf</u></font><font size=3>
<br>
</font><font size=3 face="Times New Roman"><br>
To view the <b>Federal Register notice</b> referring to this announcement
of public comment, visit: <u><br>
http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-3259.htm</u></font><font size=3>
<br>
</font><font size=3 face="Times New Roman"><br>
To <b>submit comments</b>, visit: </font><a href="http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments"><font size=3 color=blue face="Times New Roman"><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><font size=3>
<br>
<br>
<br>
<br>
</font><font size=2 face="sans-serif"><br>
Megan Haidet<br>
Communications Coordinator<br>
Plant Conservation Alliance <br>
US Fish & Wildlife Service<br>
4401 N. Fairfax Dr., Suite 750<br>
Arlington, VA 22203<br>
Phone: 703.358.2120<br>
Fax: 703.358.2276</font><font size=2><tt>_______________________________________________<br>
PCA's Medicinal Plant Working Group mailing list<br>
MPWG@lists.plantconservation.org<br>
http://lists.plantconservation.org/mailman/listinfo/mpwg_lists.plantconservation.org<br>
<br>
To unsubscribe, send an e-mail to MPWG-request@lists.plantconservation.org
with the word "unsubscribe" in the subject line.<br>
<br>
Disclaimer
<br>
Any advice given on this list regarding diagnosis or treatments etc. reflects
ONLY the opinion of the individual who posts the message. The information
contained in posts is not intended nor implied to be a substitute for professional
medical advice relative to your specific medical condition or question.
All medical and other healthcare information that is discussed on this
list should be carefully reviewed by the individual reader and their qualified
healthcare professional. Posts do not reflect any official opinions or
positions of the Plant Conservation Alliance.
</tt></font>