Last month, the Agency published a compliance guidance document intended for FDA staff and industry entitled simply “Homeopathic Drug Products” (“Homeopathic Guidance”).  The new guidance document describes the FDA’s risk-based approach to the regulation of such drugs and explains how the Agency intends to prioritize its enforcement efforts with respect to unapproved homeopathic products that are marketed and sold in the U.S.  It replaces Compliance Policy Guide (“CPG”) 400.400 “Conditions Under Which Homeopathic Drugs May be Marketed” originally issued in May 1988 and subsequently withdrawn in October 2019.  The CPG however remains a valuable resource for understanding the FDA’s general thinking on the subject.

Homeopathic drugs are specifically mentioned in the Federal Food, Drug and Cosmetic Act of 1938.  As noted in the Homeopathy Guidance, homeopathy is generally based on two main principles: (1) that a substance that causes symptoms in a healthy person can be used in diluted form to treat symptoms and illnesses; and (2) the more diluted the substance, the more potent it is.  These products are different than allopathic drugs; and can be marketed for both over-the-counter and prescription use despite FDA taking exception with the latter.

FDA identifies its enforcement priorities as focused on the following types of homeopathic products:

• With reported safety concerns,
• That contain or purport to contain ingredients associated with potentially significant safety concerns,
• With routes of administration other than oral or topical (e.g. for use as an injection or taken nasally,
• That claim to treat or prevent serious and/or life-threatening diseases and conditions, such as cancer,
• Marketed to vulnerable populations, including children, pregnant women and the elderly, or
• With significant quality issues.

The Homeopathic Pharmacopeia of the United States (“HPUS”) has yet to directly comment on the new guidance.  It is however issuing a series of white papers for public comment designed to facilitate discussion of current good manufacturing practice concepts and procedures applied to homeopathic drugs and associated guidelines.

Similar to the CPG, the Homeopathic Guidance fails to address the question of veterinary homeopathic drug products. Considering the FDA’s position that all animal drugs and Agency-regulated biologics require approval as reflected by its current approach to both veterinary grandfathered drugs and regenerative therapies, there is concern that its Center for Veterinary Medicine (CVM), which is not a signatory to the Homeopathic Guidance, could take a similar stance with respect to homeopathic drugs.  This lack of clarity presents a heightened need for attention when entering this market.

What does this mean for the marketing and sale of homeopathic drugs moving forward?  If you are selling a product that falls within one of the FDA’s identified enforcement priorities, there is a need for heightened caution, appropriate labeling, truthful claims and the adoption of a risk mitigation strategy.  If you market veterinary homeopathic drugs, there remains an unknown risk that could serve as a potential barrier to entry.