FDA Finalizes Homeopathic Guidance

By Alissa Gould, AAHP Communications Chair

Seven years after the U.S. Food and Drug Administration (FDA) held a public hearing on homeopathic product regulation and two rounds of public comments, the agency published its finalized guidance on Dec. 7, 2022. “Homeopathic Drug Products; Guidance for Food and Drug Administration Staff and Industry” officially replaces the 1988 Compliance Policy Guide 400.000, “Conditions under Which Homeopathic Drugs May Be Marketed,” which was retired in October 2019.

The final guidance changed very little from the revised draft published in October 2019. Originally published in December 2017, the guidance has come to include several recommendations that AAHP submitted as comments to FDA.

While AAHP believes many of the agency’s assertions, policy choices, legal arguments, and conclusions in the final guidance are incorrect, FDA reiterated its second paragraph in the guidance: “The Agency anticipates that many homeopathic drug products will fall outside the categories of drug products that FDA intends to prioritize for enforcement and regulatory action”… according to six categories FDA identified as potentially posing higher risks to public health. The six categories are as follows:

  1. Products with reports of injury that, after evaluation, raise potential safety concerns.
  2. Products that contain or purport to contain ingredients associated with potentially significant safety concerns.
  3. Products for routes of administration other than oral and topical.
  4. Products intended to be used for the prevention or treatment of serious and/or life-threatening diseases or conditions.
  5. Products for vulnerable populations.
  6. Products with significant quality issues.

The industry has been operating largely successfully under these priorities since 2017 and AAHP expects the finalized guidance to have little impact on most currently marketed products that are manufactured properly.

That stated, AAHP’s previously articulated concern with the draft guidance continues to exist with this final guidance. Namely, that a risk-based, enforcement-only guidance is deficient because it does not provide manufactures with clear direction and standards for marketing homeopathic drug products. Such clarity existed in FDA’s prior homeopathic guidance — CPG 400.400 — but unfortunately the agency has ignored the association’s call to reinstate such “guardrails” in its new guidance. The result of this omission in the final guidance is less certainty for all homeopathic stakeholders.

Your association plans to continue to work with FDA to strengthen and define the regulatory framework for homeopathic drug products in the United States. AAHP has been supporting the Homeopathic Pharmacopeia Convention of the United States (HPCUS) to build compliance and build a relationship with FDA by working on regulatory and technical ambiguity in the manufacturing process. We are pleased to report FDA provided meaningful comments two white papers: Starting Material white paper and the Hahnemannian Liquid Homeopathic Attenuations: Process Validation. Watch for updates at the next AAHP Summit in 2023. Look for an educational Summit in 2023 on these and other topics.

AAHP also hosted a briefing exclusively for members on the final guidance on Monday, Dec. 12.