FDA'S LATEST 'GUIDANCE DOCUMENT' ON COMPLEMENTARY & ALTERNATIVE MEDICI

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FDA'S LATEST 'GUIDANCE DOCUMENT' ON COMPLEMENTARY & ALTERNATIVE MEDICINE

American Association for Health Freedom and the Health Freedom

Foundation are very concerned with the FDA document 2006D-0480 - Draft

Guidance for Industry on Complementary and Alternative Medicine Products

and Their Regulation by the Food and Drug Administration (read FDA

Summary). A guidance like this is very confusing and there are

legal issues that must be carefully examined and responded to in

writing. Therefore, as a first step, AAHF has officially requested

the FDA extend the deadline for comment to July 31, 2007. While the AAHF

has several concerns with the CAM Regulation Guidance, the two biggest

are broadening the definition of " health claim " and the desire to

pre-empt the states in the regulation of some health care issues. The

two things that are most likely to influence the FDA's actions as it

pertains to the issues outlined in the Guidance document are: Members of

Congress who have a variety of mechanisms for shaping the authority of

the FDA. State Attorneys General who can threaten legal action if the

agency tries to usurp the authority of the states in regulating health

care activities within their states.

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