TSCL & CMF Comments on FDA Draft Guidance on Homeopathic Products

admin Administrative Law, Health Law

On behalf of The Senior Citizens League, and the Center for Medical Freedom, we filed comments with the FDA supporting the view that the FDAt has no authority over homeopathic products other than to prevent adulterated products.

“These commentors believe that the FDA is wholly without authority to impose regulations and direct enforcement efforts against homeopathic remedies, except with respect to the sixth proposed priority — ‘Products with significant quality issues.’ If products are contaminated, that would trigger FDA’s jurisdiction over contaminated products. All of FDA’s efforts with respect to homeopathy should be in this one area, so that the FDA would do this one thing well. The FDA simply does not have authority to regulate homeopathic remedies manufactured in accordance with the Homeopathic Pharmacopeia of the United States (“HPUS”). Obviously, contaminated products are not being manufactured in accordance with HPUS”

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