FDA to Regulate Vitamins and Non-Traditional Medicine

The Food and Drug Administration (FDA) has issued a relatively broad and vague draft document titled "Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration". It opens with "This draft guidance, when finalized, will represent the Food and Drug Administration's current thinking on this topic." It then goes on for 17 pages to propose that the FDA should have authority over virtually all herbs and supplements as drugs if they actually benefit a medical condition, thereby vastly expanding the reach of the FDA through the use of a change in terminology.

Currently, complementary and alternative medicine is regulated by DSHEA (Dietary Supplement Health and Education Act of 1994) rather than the FDA. Under this provision, any claims to prevent, treat, or cure a specific disease are expressly prohibited (unless approved by the FDA). Rather than being subject to FDA approval, statements describing the supplement's effects on the "structure and function" or general "well-being" of the body are allowed, as long as they are truthful and bear the disclaimer statement "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease."The FDA does have the authority to establish good manufacturing processes governing the production of dietary supplements.

In addition to shifting the regulation of vitamins and supplements from the DSHEA to the FDA, the change in definition also may open up a host of problems for practitioners of various forms of alternative medicine. This is because of already established regulations and laws in all 50 states as to whom may treat medical conditions. Once we have expanded the definition of treatment such that it could even include water, many new people will be suddenly practicing medicine by doing the same things they have always done. Any practitioner - homeopathic, naturopathic, reflexologist, Chinese or Ayruvedc practitioners, nutritionists, etc. - will all be at risk for practicing medicine without a license if they even suggest something like vegetable juice may prevent, treat or mitigate the symptoms of a disease.

Regina Wilshire states in her blog "The document, if approved, effectively renders the DSHEA null-and-void, not by congressional mandate, but by a cunning use of terminology to eliminate the limitations the law imposes on the FDA in its current oversight of dietary supplements."

Others, such as OrganicConsumers, are less alarmed by the proposed change. OrganicConsumers state on their website "Because this is a "guidance directive," rather than proposed legislation, the OCA is not currently calling for a mass letter writing campaign. Nonetheless, the OCA and our allies are keeping a close eye on what this directive might mean in terms of future proposed regulations."

The FDA is taking comments on this document until April 30^th. Comments can be made on-line here,
or send comments via snail mail to:

Dockets Management Branch (HFA-305)
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

Be sure if you use snail mail to include Docket Number 2006D-0480 in your submission.