The FDA issued a revised draft guidance titled “Drug Products Labeled as Homeopathic Guidance for FDA Staff and Industry” (here) describing the FDA’s proposed risk-based enforcement approach to homeopathic products. This compliance guidance represents current Agency thinking after comments were reviewed based on the initial guidance (here) that was issued in December 2017.
The document states, “this draft guidance describes how we intend to prioritize enforcement and regulatory actions for homeopathic drug products marketed in the United States without the required FDA approval… The FDA has developed a risk-based approach under which the Agency intends to prioritize enforcement and regulatory actions involving certain categories of such products that potentially pose a higher risk to public health.”
The draft guidance provides a definition of a homeopathic drug, discusses the regulatory history of these products, and notes that, at this time, there are no FDA approved homeopathic drugs. We have written extensively about homeopathic drugs previously (here, here, here, here, and here). In those posts, we have cited Compliance Policy Guide (CPG) 400.400 (which was more than twenty years old), which provided guidance on how the FDA would exercise enforcement activities relative to homeopathic drugs (see below for more detail on FDA actions relative to this CPG guide).
The FDA discusses, in the revised draft guidance, two examples of the many instances of harm caused by some marketed homeopathic products, including belladonna toxicity and death, and the association of Zicam homeopathic intranasal zinc products and permanent loss of smell in some cases. In addition, the FDA notes the many instances of cGMP violations by the manufacturers of homeopathic products “raising significant concerns about the safety of the products made with inadequate process controls.”
Because of these and similar issues, the Agency will take a risk-based enforcement approach and, by issuance of this draft guidance, put the homeopathic manufacturers and distributors on notice that the Agency will prioritize its enforcement efforts based on the following criteria:
- Products with reports of injury that, after evaluation, raise potential safety concerns
- Products that contain or purport to contain ingredients associated with potentially significant safety concerns
- Products for routes of administration other than oral and topical
- Products intended to be used for the prevention or treatment of serious and/or life-threatening diseases or conditions
- Products for vulnerable populations
- Products with significant quality issues
This appears to be a step in the right direction but don’t be surprised if we see further regulatory approaches discussed in the future. Note: The FDA also published a Federal Register Notice that withdrew CPG 400.400 (here) on the same day the draft guidance issued. The FDA will take enforcement action now based on the elements of the revised draft guidance.