In two Federal Register notices and the denial of a citizens petition, FDA laid out a revised enforcement program for homeopathic drugs.
Under the FDC Act, just as allopathic drug product, homeopathic drug products are subject to new drug requirements related to approval, adulteration, and misbranding. However, historically drug products labeled as homeopathic have been manufactured and distributed without FDA approval and with perceived Agency tolerance under the enforcement policies in FDA’s Compliance Policy Guide (CPG) 400.400 from 1988. This permissive regulatory posture allowed the growth and expansion of a market for safe, properly manufactured homeopathic products as the public interest in nutrition and alternative therapies has grown.
However, as readers of our blog may recall, in response to comments resulting from an FDA public hearing in 2015 and several incidents related to improperly manufactured homeopathic drug products, FDA more recently became concerned about safety. In 2017, the Agency announced the availability of a draft guidance describing FDA’s intent to switch to a risk-based enforcement approach to homeopathic products marketed without FDA approval. In the 2017 draft guidance, FDA indicated that it would withdraw the CPG once it finalized the new guidance, because, according to the Agency, the CPG is inconsistent with a risk-based approach to regulatory and enforcement action.
The draft guidance, particularly FDA’s proposal to withdraw the CPG once the guidance, generated many adverse comments. In 2018, Americans for Homeopathy Choice petitioned FDA to keep the CPG or convert it to a regulation so as to allow the continued marketing of and consumer’s access to homeopathic drug products.
FDA was not convinced. In actions last week, the Agency not only denied the Petition, it also decided to withdraw the CPG now rather than wait until it finalizes the draft guidance. According to the Agency’s announcement, FDA has concluded that CPG 400.400 is inconsistent with the Agency’s risk-based approach to enforcement generally and that the CPG no longer accurately reflect the Agency’s current thinking. FDA stresses, both in the announcement of the withdrawal and in its denial of the Petition, that the withdrawal of the CPG does not represent a change in the legal obligations that apply to homeopathic drugs under the statutes FDA administers.
FDA also announced issuance of a revision to the 2017 draft guidance. The revised draft guidance includes a definition of “homeopathic drug product” for purposes of the guidance, additional explanation of some of the safety issues that contributed to the development of the draft guidance, and clarification of FDA’s intent to use risk-based factors to prioritize enforcement and regulatory actions involving the marketing unapproved homeopathic products.
Until the draft guidance is finalized, FDA intends to apply its general approach to prioritizing regulatory and enforcement action, which involves risk-based prioritization considering all the facts of a given circumstance.
To ensure that the Agency considers comments to the draft guidance before it begins work on the final version of the guidance, comments should be submitted by January 23, 2020.