[MPWG] FDA Draft Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration

[Megan_Haidet at fws.gov]

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draft guidance for industry entitled "Complementary and Alternative 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Therefore, the draft guidance discusses when a CAM product is subject to 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To view the draft guidance document from the FDA, visit: 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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