April 2007

FDA draft guidance open for comment

A draft guidance entitled “Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration” is available for public comment. The comment period is open until April 30, 2007, according to the Federal Register notice.

The comment period, however, is being questioned by the American Herbal Products Association (AHPA), which noted in a letter to the FDA that the notice was posted on Feb. 27 and is open for comment for 90 days — until May 29.

The draft guidance discusses when a CAM (complementary and alternative medicine) product is subject to the Federal Food, Drug, and Cosmetic Act or the Public Health Service Act.

The draft guidance has been under attack by some consumer groups, such as the Natural Solutions Foundation (www.healthfreedomusa.org). According to this organization’s Web site, “The FDA is using legal maneuvering to end your access to natural health products (like vitamins, minerals, and herbs) and natural health therapies of all sorts. Again. This time, their ploy is to declare the therapies are ‘medicine’ so any non-physician who uses them will be practicing medicine without a license. Since these practices are ‘medicine,’ any products used would be untested drugs and therefore forbidden.”

The Natural Products Association, in an e-mail, said the scare tactics are untrue. It said, “The document in question [draft guidance] should not be cause for alarm. First, a “’guidance’ document is by definition not legally binding and does not change or create laws or regulations. Guidances … are usually issued to help explain how a law or laws are applied. In this case, the guidance clarifies how products used in CAM, such as foods and dietary supplements, are regulated under different provisions or statutes depending on their intended use and claims. Whether finalized or not, the draft guidance will not change current laws and regulations, such as the Dietary Supplement Health and Education Act.”

To read the entire draft guidance, go to www.chiroeco.com/news/2007/April/FDA_CAM_Guide.pdf

Comments may be sent by mail to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Reference Docket No. 2006D00480.

E-comments can be sent to www.fda.gov/dockets/ecomments.

Sources: Federal Register, Vol. 72, No. 38, Feb. 27, 2007, Notices; Natural Products Association, www.naturalproductsassn.org; American Herbal Products Association, www.ahpa.org

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