Tuesday, December 6, 2022

FDA issued a final guidance, Homeopathic Drug Products,


  • Today, the FDA issued a final guidance, Homeopathic Drug Products, describing the agency’s approach to prioritizing enforcement and regulatory actions for homeopathic products marketed in the U.S. without the required FDA approval. The FDA has developed a risk-based approach under which the Agency intends to prioritize specific categories of homeopathic drug products that potentially pose a higher risk to public health, such as those intended for populations at greater risk for adverse reactions, including those with weakened immune systems, infants and children, the elderly, and pregnant women, as well as  ophthalmic and injectable products, because the routes of administration for these products bypass some of the body’s natural defenses. The agency anticipates many homeopathic drug products will fall outside the categories of drug products it intends to prioritize for enforcement and regulatory action. There are no FDA-approved products labeled as homeopathic, and the agency cannot ensure these drugs meet standards for safety, effectiveness, and quality. Previously, the FDA warned the public about certain homeopathic products, including those containing a toxic substance and ones recalled due to contamination.  

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