FDA Draft Guidance for Industry on Complementary and Alternative Medicine

Michael Harless Administrative Law, Health Law

Today, on behalf of TREA Senior Citizens League (“TSCL”), we filed comments with the Food and Drug Administration (“FDA”) in opposition to the FDA’s  “Draft Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation”.  According to the Draft Guidance,  the FDA asserted that it had authority to regulate products utilized by practitioners of  Complementary and Alternative Medicine (“CAM”), with special emphasis upon its power to regulate vitamins, minerals, and dietary supplements as drugs, if those products were “intended” to be used by a CAM practitioners as part of a disease treatment program.  Additionally, the FDA stated in its Draft Guidance that it had the right to regulate products used in chiropractic and massage as medical devices.  If the Draft Guidance is adopted by the FDA, it could mean that ordinary foods — such as raw vegetable juice — would be subject to FDA “premarket review” just as is the case now for prescription drugs used in conventional allopathic medicine.  Further, if the Guidance were adopted, the FDA presumably would make substantial intrusions into the regulation of alternative medicinal practices traditionally left to the states.

In our Comments submitted on behalf of TSCL, we urged the FDA to withdraw its Draft Guidance on the grounds that its proposal to regulate ordinary foods as drugs was both unauthorized and unworkable.  Additionally, the Comments raised serious questions about the fairness of the Draft Guidance procedure, confusing to the public and prejudicing the rights of seniors by depriving them of adequate time to respond to the FDA’s far-reaching proposal.  Finally, our comments pointed out the likely adverse effects of the Draft Guidance:  (a) on the financial health of Medicare; (b)  on Congressional policy encouraging CAM; (c) on the traditional role of state regulation of the practice of medicine; and (d) the constitutional rights of  the free exercise of religion and of self-preservation.

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