Homeopathic drug product makers warned to follow FDA premarket and GMP rules

Homeopathy is an alternative medical practice that has a historical basis in theory and practice first systematized in the late 1700s. Recent years have seen an increase in the sale of homeopathic drug products, and they are now frequently mass manufactured and widely marketed without a prescription on retail shelves. However, there are no FDA-approved products labeled as homeopathic, and the agency has expressed concerns that it cannot ensure these drugs meet its standards for safety, effectiveness, and quality.

In December 2017, FDA issued the draft guidance “Drug Products Labeled as Homeopathic,” later revised in October 2019, and finalized this past month under the title “Homeopathic Drug Products.” The guidance documents describe FDA’s approach toward regulating homeopathic products, and have received around 1,500 public comments. The new final guidance is updated to include the provisions from the March 2020 Coronavirus Aid, Relief, and Economic Security (CARES) Act.

Of note, FDA has not reviewed homeopathic products under FDA’s Over-the-Counter (OTC) Drug Review because FDA categorized homeopathic products as a separate category, and deferred consideration of them.

Now, the CARES Act has added Section 505G to the Federal Food, Drug, and Cosmetic Act (FDCA), which reforms the OTC drug review process by authorizing FDA to make GRAS/E determinations for certain nonprescription drugs marketed without an approved application. Nevertheless, the final guidance says that subsequent to the enactment of CARES, FDA will continue to refrain from making GRAS/E determinations for homeopathic drug products because section 505G does not apply to homeopathic drug products. This means that all homeopathic drug products remain subject to FDA’s premarket approval requirements, the final guidance warns.

Aside from this change in the final version of FDA’s homeopathic drug guidance, both the draft and final versions emphasize FDA’s concerns over violations of Current Good Manufacturing Practice (CGMP) requirements that have been observed by manufacturers of homeopathic drug products, saying in the final guidance that the agency has “significant concerns about the safety of products made with inadequate process controls.” Accordingly, FDA said it issued the guidance because “it is in the best interest of public health” that FDA apply “a risk-based enforcement approach to homeopathic drug products marketed without the required FDA approval, consistent with FDA’s risk-based regulatory approaches generally.”

Under FDA’s risk-based enforcement approach, the agency will prioritize enforcement and regulatory actions for certain categories of homeopathic products, including products containing ingredients associated with potentially significant safety concerns; products intended to be used for the prevention or treatment of serious and/or life-threatening diseases or conditions; and products for vulnerable populations, such as immunocompromised individuals, infants and children, the elderly, and pregnant women.

Yet, FDA said it anticipates many homeopathic drug products will fall outside the categories of drug products it intends to prioritize for regulatory enforcement action. The agency has previously warned the public about homeopathic products, including those containing a toxic substance and ones recalled due to contamination.

If you have any questions on complying with FDA’s premarket approval requirements, or on Good Manufacturing Practice requirements more generally, feel free to contact either of the authors of this alert or the Hogan Lovells attorney with whom you generally work.

Authored by Heidi Gertner and Bert Lao