FDA’s Final Guidance for Homeopathic Drug Products

CPG SEC. 400.400 Image

FDA’s Final Guidance for Homeopathic Drug Products

Monday, January 16, 2023
Written by: Jim Lassiter

The Food and Drug Administration has been guided by the Law (meaning the Federal Food Drug and Cosmetic Act of 1938 with amendments) and is obliged to implement the Law through the development of regulation and guidance. When the legislation was first enacted, an interesting recognition was incorporated into this Law. Not only was the United States Pharmacopoeia (USP) recognized as a definitive standard for drugs, but there was recognition of the Homeopathic Pharmacopoeia of the United States (HPUS) as the provider of standards for these types of drug products. The why’s and how’s of this recognition and not important but the fact of this recognition and acceptance (read this as allowance) was implemented in the form of a Compliance Policy Guide (CPG) –  CPG 400.400 which provided relatively clear directions and standards for the marketing of homeopathic drug products. This remained the case until 2017 when FDA determined the best path forward in terms of how these products should be further considered and evaluated. Originally published for comment in December of 2017 with a revised draft presented in October of 2019, a formal guidance document was finalized on December 7, 2022. This now is the framework and structure regarding evaluation, acceptability and presentation of these products. This document does not, however, identify clear direction and standards for marketing and the associated on-label claims for homeopathic drug products.

The most significant aspect of this regulatory activity is that it does set a precedent in terms of how FDA chooses to deal with product categories with which it is not comfortable. Such was the case for homeopathic drug products from the time of passage of FFDCA. The approach taken by FDA on this matter is that it alone is responsible for the determinations of whether products should be in the marketplace, despite the clear allowance within the Law itself. The application of this approach is one that needs to be considered and remembered in the coming months and years (as these things as demonstrated take a significant period of time to implement) as FDA moves its target focus to other challenging product categories such as dietary ingredients and dietary supplements that are commonly and readily prone to adulteration and misbranding. The approach and application of regulatory activity regarding “interpretation” of the Law is one that is now a standard approach. Even for homeopathic drug products, specifically identified in the Law as acceptable products, the assurance of the ability to market such products is no longer linked to the legislative outcome. Regulatory maneuvering in this manner (issuance of a guidance document) has afforded FDA the opportunity to forego the whole of regulatory recognition of legally presented and delivered products. FDA’s approach toward homeopathic drug products includes FDA’s anticipation that “many homeopathic drug products will fall outside the categories of drug product that FDA intends to prioritize for enforcement and regulatory action”. This is to say that – yes – there will be regulatory action taken with prioritization of products based on FDA’s identification if certain products or product categories can potentially pose higher risks to public health in general as well as to specific vulnerable demographics e.g. infants and children, etc. This affords FDA the opportunity to address (read this as “remove” rather) any number of products that it identifies as posing this “significant risk” at its sole discretion.

The cautionary note from this recent issuance of the final guidance document for homeopathic drug products is that FDA has identified itself as the sole determiner for any such potential public safety concerns. Having additional legislative requirements, affords the FDA with the opportunity to review such products as a matter of course, but more importantly, the Law places the burden of demonstration of a lack of safety exclusively on the FDA. FDA may make its determinations and apply regulatory action with relative ease under the heading of protecting the public health, so companies in the sector should be diligent and prepared and take steps to ensuring full product compliance with applicable published monographs, contribute to the development of new monographs where and when applicable, and carry out human safety and clinical studies as a means of better protecting the brand and product integrity from potential regulatory challenge from the Agency.

Make no mistake, homeopathic products are regulated though historically, the regulatory actions in this space have largely only cited the lack of operational controls, documentation and testing, and not so much around the specific ingredient allowances, labeling and/or claims. This final ruling starts the change of that regulatory tide so to speak, and companies with a vested interest for the long term in this sector should heed this. Homeopathic Manufacturers and Brands should recognize the need to take additional steps in a more proactive manner in their business strategy to have better data and safety information rather than a reactive one, given how disruptive interruptions and stoppages in operations can be due to more aggressive regulatory enforcements or the more likely proliferation of publicly published Warning Letters negatively challenging consumer confidence and brand loyalty.