Showing posts with label comment. Show all posts
Showing posts with label comment. Show all posts

Thursday, April 12, 2007

Stop the FDA from classifying CAM as drugs!

Regarding: Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration http://www.fda.gov/OHRMS/DOCKETS/98fr/06d-0480-gld0001.pdf This proposal is in a public comment period. I believe that it goes too far in re-classifying natural products as drugs based solely on practitioner claims. While the concept of the FDA determining which regulations certain products or procedures fall into seems reasonable, the agency's attitude that they can call a vegetable juice product a drug just because someone suggests using it to treat a disease should be considered unreasonable. The FDA already has the power to regulate drug claims, but not to treat a food (including dietary supplements) or cosmetic item as a drug simply because of an unapproved claim or use. In other words, the act of claiming that a product can treat a disease is already regulated under current laws concerning drug claims on product labels or advertising. It is too confusing and illogical to treat an individual product sometimes as a food and sometimes as a drug, varying with the label claim, especially when the drug claim is already illegal. The FDA's given example of cranberries, which do have a biological function of helping to inhibit the implantation of new bacterial colonies in the urinary tract but do not actually remove existing colonies, is very misleading. Cranberries cannot be used to treat an existing infection, though it may aid the body in managing urinary tract health. The unapproved (and inaccurate) disease claim is already prohibited under current law (DSHEA), yet the FDA now proposes to regulate illegally labeled cranberry products as drugs if someone does make this illegal claim! The FDA did not propose that foods or dietary supplements be generally regulated as drugs and only be available by prescription. The agency is actually trying to prevent doctors from making drug claims for supplements and foods. Yet physicians can currently make off-label prescriptions for drugs! The distinction is artificial, and the drugs are the more dangerous products by far! Concerned citizens are encouraged to submit their own comments by the end of the month. I suggest stressing your strong support for health freedom, which includes the ability to freely access CAM services and products (including dietary supplements) without undue government interference. You may also wish to support CAM practitioners' ability to prescribe natural products without the FDA treating them as unapproved drugs. If the agency applies this same logic to other CAM modalities, the FDA's proposed enforcement of current regulations on licensed, credentialed health practitioners would be a disaster. The comment period ends May 29, 2007. Please send your comments to the FDA to oppose this new power grab: http://www.accessdata.fda.gov/scripts/oc/dockets/comments/COMMENTSMain.CFM?EC_DOCUMENT_ID=1451&SUBTYP=CONTINUE&CID=&AGENCY=FDA