[MPWG] Fw: FDA Draft Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration

Tue Apr 17 13:21:55 CDT 2007

A little more insight from another working group member...

RE:  Draft Guidance for Industry on Complementary and Alternative Medicine 
Products and Their regulation by the Food and Drug Administration
[Date:  December 2006:  Contact:  Sheryl Lard-Whiteford, Esq. 
301-827-0379]

The draft guidance puts into straightforward language how the FDA 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. 

To provide you with the overall regulatory approach, products are 
regulated by the route, formulation, safety and “intended use.” 

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page three of the draft guidance the agency specifically states:   
“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.” 

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. 

Freddie Ann Hoffman, MD 
HeteroGeneity, LLC 
5611  16th Street, NW 
Washington, DC  20011-6809 
Tel.:  202-545-6843 
Fax:  202-545-6844 
fhoffman at heterogeneity-LLC.com
www.heterogeneity-LLC.com

----- Forwarded by Patricia De Angelis/ARL/R9/FWS/DOI on 04/17/2007 02:15 
PM -----

Megan_Haidet at fws.gov 
Sent by: mpwg-bounces at lists.plantconservation.org
04/17/2007 11:11 AM

To
mpwg at lists.plantconservation.org
cc

Subject
[MPWG] FDA Draft Guidance for Industry on Complementary and Alternative 
Medicine Products and Their Regulation by the Food and Drug Administration

There is a public comment period concerning the FDA classification of 
complementary and alternative medicine (CAM) products open until April 30, 
2007.   

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. 

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. 

If you are interested please take a look at the links below to learn more 
about this issue. 

To view the draft guidance document from the FDA, visit: 
http://www.fda.gov/OHRMS/DOCKETS/98fr/06d-0480-gld0001.pdf 

To view the Federal Register notice referring to this announcement of 
public comment, visit: 
http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-3259.htm 

To submit comments, visit:  
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments 

Megan Haidet
Communications Coordinator
Plant Conservation Alliance 
US Fish & Wildlife Service
4401 N. Fairfax Dr., Suite 750
Arlington, VA  22203
Phone: 703.358.2120
Fax: 703.358.2276_______________________________________________
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