OTC Homeopathic Claims Go Under FTC Microscope, Potential For Regulatory Shift Magnifies
This article was originally published in The Pink Sheet Daily
FTC says the homeopathic market “shifted from one based primarily on formulations prescribed for an individual user to mass-market formulations widely advertised and sold nationwide in major retail stores.” The workshop could signal FTC interest in asking for clinical trials to support for OTC homeopathic claims.
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The industry wants FDA to consider that a fraction of poison control reports are for homeopathics compared to other drugs and the agency’s current enforcement authorities maintain compliance in manufacturing and marketing the products. FDA is considering whether to maintain its policy that recognizes an ingredient’s inclusion in the HPUS monograph as pre-market approval.
FTC shuts down the second marketer this year for making fraudulent claims for human chorionic gonadotropin weight-loss products. Enforcing against other homeopathics’ claims that violate advertising regulations, however, is on hold until FTC resolves its differences with FDA’s regulatory oversight of the products.