FDA Guidance Document on Complementary and Alternative Medicine (CAM)
You have probably received emails about a new FDA “guidance” document for Complementary and Alternative Medicine, published in the FDA’s website. This document reminds us that FDA believes that under certain circumstances any vitamins, supplements, herbs and even vegetables juices can be treated under current law as FDA-regulated drugs. FDA believes, it appears from the guidance, that even massage oils could be classified as “medical devices” subject to FDA approval. The proposal is posted at http://www.fda.gov/ohrms/dockets/dockets/06d0480/06d0480.htm.
Before sending out this alert, we consulted with Jim Turner, our General Counsel, who described this FDA document as an “opening shot of little significance in itself” but an indication of the direction that the FDA would like to go in expanding its regulation of complementary and alternative “medicine” products. That direction could include making the use of certain products currently important to the practice of complementary and alternative medicine (CAM) a criminal offense, including certain products subject to FDA control used in conjunction with nutritional counseling, wellness consulting and many other alternative practices FDA defines as “alternative medicine,”.
The comment period ends April 30, 2007. We ask all of you to voice your protest to this draconian proposal by asking FDA to withdraw this guidance, so that it goes no further. We also suggest that you urge FDA to conduct one or more public hearings on how it can effectively defer to state laws governing the practice of medicine, and can comply with the directions of Federal Courts to restrict its regulatory practices to the least intrusive actions available under the law.
COMMENTSMain.CFM?EC_DOCUMENT_ID=1451&SUBTYP=CONTINUE&CID=&AGENCY=FDA to file your comments in support of natural health care. (Note: You must copy and paste the entire URL, ending with =FDA, and you might have to copy and paste in two pieces to get it all.)
To submit comments by letter, be sure to reference FDA Document 2006D-0480: Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration, and write to:
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20853
You may also have been hearing a great deal about the European Codex Alimentarius lately. We are preparing an Information Alert on this subject and will be sending it out shortly.
Swiss Native Judy Mudrak needs to make a decision about the proposed trip to Switzerland by Tuesday April 24th. If you are interested, please contact her immediately at reversemydisease (at) yahoo.com. At least four more participants are needed to make the tour economically viable. Without more participants, the trip will be cancelled.
Participants will see cows, goats and sheep and meet the mountain farmers! Judith has arranged demonstrations of modern versus Alpine cheese making and wood wheel butter (a dying art!), tastings and attendance at Swiss festivals!
Guided Alpine plant walk and salve making, bread baking and much more! Visit various regions including the Loetschental, the Swiss Federal Research Institute (dairy, food and farming), bring questions!!
Length of trip: two weeks, latest arrival in Switzerland should be Thursday July 19, through Thursday August 2, 2007. You will book your own flight.
For more information please e-mail: reversemydisease (at) yahoo.com ,
Subject: Judy’s Swiss trip. Or Judith Mudrak, 58 Cranberry Run, Southampton,
NJ 08088 USA Phone: 609 859-3828 EST.