FDA Will No Longer Give Special Treatment for Homeopathic Drug Products

On October 25, 2019, the FDA denied a petition to preserve CPG 400.400, which would have allowed unapproved marketing of homeopathic drug products to continue, stating that the policy was now inconsistent with the agency’s risk-based approach to enforcement.  The FDA also announced a revision to the 2017 draft guidance pertaining to homeopathic drug products specifying some of the safety issues that contributed to the development of the draft guidance.  The revised guidance proposes the use of risk-based factors to prioritize enforcement and regulatory actions involving the marketing of unapproved homeopathic drug products.

Comments regarding the draft guidance must be submitted by January 23, 2020.

Takeaway:  Distributors of homeopathic products should carefully evaluate the products’ safety and efficacy claims as long-standing exemptions applicable to this category are being taken away.

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