On Oct. 24, 2019, in a joint statement from U.S. Food and Drug Administration (FDA) acting Commissioner Norman E. Sharpless, and the Center for Drug Evaluation and Research (CDER) Director Janet Woodcock, FDA announced that it had re-examined its policies related to homeopathic drug products. FDA said its current Compliance Policy Guide (CPG) “is inconsistent with [FDA’s] risk-based approach to regulatory and enforcement action generally and therefore does not reflect [FDA’s] current thinking.” Accordingly, FDA has withdrawn its CPG 400.400 and issued a revised draft guidance document describing its intent to prioritize enforcement actions for unapproved homeopathic drug products.
What Are Homeopathic Drugs?
Homeopathy is an alternative form of medicine based on the theory that a disease can be cured with a substance that produces similar symptoms in healthy people, by using the original substance in a diluted form, under the principle of “like cures like.” (See the National Institutes of Health overview of homeopathy.) Homeopathic drugs are listed in the Homeopathic Pharmacopeia of the United States (HPUS) and are included in the legal definition of a drug as defined in the Federal Food, Drug, and Cosmetics Act (FDCA). As such, they are subject to the same pre-market requirements as allopathic drugs. (See Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 321(g)(1)(A).) Since the passage of the FDCA, FDA has exercised enforcement discretion and allowed for the marketing of any homeopathic drug recognized in the HPUS without FDA approval.
Why Is FDA Now Enforcing?
FDA’s recent shift to enforcement is due to the rise of homeopathic products being attributed to adverse events, specifically toxicity. FDA cites several cases of homeopathic products, used according to their labeling, which harmed and even killed patients due to the products containing higher-than-advertised levels of toxic substances. FDA pointed to 99 cases of belladonna toxicity potentially related to teething products in 2016, and more than 130 reported cases of patients losing their sense of smell due to their use of an intranasal zinc product. Additionally, FDA has seen a rise in current good manufacturing practice (cGMPs) violations by manufacturers of homeopathic drugs. FDA expressed concern that homeopathic drugs are often found next to over-the-counter (OTC) products, are not labeled as homeopathic, and are marketed to treat serious diseases and conditions, thus increasing the risks to consumers. Until now, FDA has not reviewed any homeopathic drug products under the OTC drug review because FDA considers them a completely separate product category.
What Is in the New Guidance?
The newly issued guidance expands upon and amends the 2017 draft guidance, which described FDA’s intent to switch to a risk-based enforcement approach for homeopathic products marketed without FDA approval. The revised draft guidance includes a definition of homeopathic drug product, with any product labeled as such containing only active ingredients and dilutions referenced in the HPUS. It also specifies the categories of products for which the agency will prioritize enforcement and regulatory actions:
- 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 for vulnerable populations
- Products with significant quality issues
Furthermore, enforcement will not be limited solely to these categories. FDA stated that its updated guidance is “intended to provide notice that any homeopathic drug product that is marketed without FDA approval is subject to FDA enforcement action at any time.” Of note, FDA has issued more than 10 warning letters to manufacturers and distributors of homeopathic drug products so far this year; expect that number to rise significantly in the future.
FDA requested comments on the revised draft guidance, with the comment period closing Jan. 23, 2020.