I have been working on this issue recently. I read the document titled:
"Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration" It didn't seem as bad as the hype suggested, but, it is really really bad. Basically they are trying to find a way to regulate all the herbs and therapies that are in use in the US. Our needles are already regulated. but under this law become a higher level medical device and the courts in each state would need to decide who can use them. -Maybe only MDs. An herb that is primarily used to treat a disease or condition will be considered and regulated as a drug. That's not good, unless an herbalist can prescribe them which is not likely. So basically we and other non MD health care would be illegal. Here is the link to the article that started the stir. http://www.newstarget.com/021789.html Here is the link to the FDA document. http://www.fda.gov/OHRMS/DOCKETS/98fr/06d-0480-gld0001.pdf The article states that the FDA will take comments until April 30, 2007. The FDA give you two ways to comment. Send Mail to: The Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm 1061 Rockville, MD 20852 Reference Docket Number: 2006D-0480 OR Click on the following web link. http://www.accessdata.fda.gov<http://www.accessdata.fda.gov/scripts/oc/dockets/comments/COMMENTSMain.CFM?EC_DOCUMENT_ID=1451&SUBTYP=CONTINUE&CID=&AGENCY=FDA> /scripts/oc/dockets/comments<http://www.accessdata.fda.gov/scripts/oc/dockets/comments/COMMENTSMain.CFM?EC_DOCUMENT_ID=1451&SUBTYP=CONTINUE&CID=&AGENCY=FDA> /COMMENTSMain.CFM?EC_DOCUMENT<http://www.accessdata.fda.gov/scripts/oc/dockets/comments/COMMENTSMain.CFM?EC_DOCUMENT_ID=1451&SUBTYP=CONTINUE&CID=&AGENCY=FDA> _ID=1451&SUBTYP=CONTINUE&CID=<http://www.accessdata.fda.gov/scripts/oc/dockets/comments/COMMENTSMain.CFM?EC_DOCUMENT_ID=1451&SUBTYP=CONTINUE&CID=&AGENCY=FDA> &AGENCY=FDA<http://www.accessdata.fda.gov/scripts/oc/dockets/comments/COMMENTSMain.CFM?EC_DOCUMENT_ID=1451&SUBTYP=CONTINUE&CID=&AGENCY=FDA> Here is a sample comment: "I oppose the classification of herbs intended for health benefit as drugs. This classification would relegate their use to a prescription from an MD. MD's by their own admission don't understand the use of herbs and would therefore be unqualified to prescribe herbs to the general public."
