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FDA Will No Longer Give Special Treatment for Homeopathic Drug Products

The U.S. Food and Drug Administration (“FDA”) has announced its intent to withdraw its Compliance Policy Guide 400.400 (1988) (“CPG 400.400”) for homeopathic drug products pursuant to which such products have been  permitted to be marketed without having to comply with the new drug, adulteration and misbranding requirements that are otherwise applied to all drug products. Under CPG 400.400, homeopathic drug products were permitted to be manufactured and marketed without the FDA approval applicable to all other drug products.  However, due to certain incidents involving improperly manufactured homeopathic drug products, in 2017 the FDA announced its intention to switch to a risk-based enforcement approach for unapproved 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  The FDA also announced a revision to the 2017 draft guidance pertaining to homeopathic drug products specifying some of the safety issues that contributed to the development of the draft guidance.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Comments regarding the draft guidance must be submitted by January 23, 2020.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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