To anyone who has been following government enforcement and private litigation trends related to the over-the-counter (OTC) homeopathic drug industry over the past several years, the Food and Drug Administration’s (FDA) announcement on October 24, 2019 likely came as no surprise. But to stakeholders in this industry, it was certainly unwelcome news and may portend a coming wave of unapproved drug enforcement actions by the FDA. The agency announced that it had reexamined its policies related to the OTC homeopathic drug industry and had determined that its Compliance Policy Guide (CPG) for homeopathic drugs – issued in 1988 – “is inconsistent with our risk-based approach to regulatory and enforcement action generally and therefore does not reflect our current thinking” (see the joint statement from FDA’s Acting Commissioner and drug center director here). The two agency leaders added that: “Since the issuance of [the CPG] in 1988, the FDA has encountered multiple situations in which homeopathic drug products posed a significant risk to patients, even though the products, as labeled, appeared to meet the conditions described” in the CPG.
Accordingly, the agency has withdrawn the homeopathic drug CPG and issued a revised draft guidance document describing how it intends to prioritize enforcement actions for this subset of unapproved drug products. As we discussed when the original draft guidance was released in late 2017 (see prior post here), FDA has developed a risk-based enforcement policy for homeopathic drug products marketed directly to consumers. The newly revised draft guidance describes the following categories as enforcement priorities because they tend to pose higher risks to the public health:
- 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 or life-threatening diseases or conditions;
- Products for vulnerable populations, such as pregnant women, infants, and children; and
- Product with significant quality issues.
At the same time, however, FDA makes clear that its identification of these high-risk categories of homeopathic drug products does not mean that future enforcement activities will be limited to these categories – the agency will take action against any unapproved drug product. Furthermore, the revised draft guidance itself is “intended to provide notice that any homeopathic drug product that is being marketed illegally is subject to FDA enforcement action at any time.” In the statement issued by agency leadership, Dr. Sharpless and Dr. Woodcock pointed out that FDA has issued more than ten Warning Letters to companies for violations of the Food, Drug, and Cosmetic Act related to homeopathic drug products (five of which FDA issued in May 2019 and which we reported on at the time in this prior post) and that the agency will continue to take appropriate actions to protect the public health.
FDA is accepting comments on the revised draft guidance on homeopathic drug products until January 23, 2020; more information about how and where to submit written comments is available in the Federal Register notice dated October 25, 2019. Given that the agency received more than 4,500 comments in response to its 2017 draft guidance that it also needs to consider, it may still be several months or even years before FDA releases the final guidance. But in the interim, manufacturers and distributors of OTC homeopathic drug products should also reexamine their own compliance policies and determine whether FDA’s stated enforcement priorities may warrant a change in business practices.