On April 20 and 21, 2015, the Food and Drug Administration (FDA) held public hearings to obtain information and comments on the regulatory framework governing homeopathic drugs and products. Citing the tremendous growth of the homeopathic drug industry, the FDA issued a public notice announcing the hearings and seeking comments on enforcement policies related to drug products labeled as homeopathic. 80 Fed. Reg. 16327 (March 27, 2015).
The Food, Drug, and Cosmetic Act (FD&C Act) defines a “drug” to include (i) articles recognized in the official United States Pharmacopoeia (USP), official Homeopathic Pharmacopoeia of the United States (HPUS) or official National Formulary or their supplements; (ii) articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals; and (iii) articles (other than food) intended to affect the structure or any function of the body of man or other animals. 21 U.S.C. 321 § (g)(1). Drugs that meet this definition are subject to regulation under the FD&C Act. The FD&C Act provides that drug products labeled as homeopathic are required to meet standards for product strength, quality and purity as set forth in the HPUS, and not the United States Pharmacopeia. 21 U.S.C. 351 § (b). Drugs labeled as homeopathic that are listed in the HPUS, an addendum to it or its supplements are thus subject to the HPUS standards. Homeopathic drug products are also expected to be manufactured in conformance with certain current good manufacturing practices.
In its request for comment, the FDA noted the following issues: (i) consumer and health care provider attitudes toward human drug and biological products labeled as homeopathic, and whether consumers and health care providers have sufficient information about those products; (ii) data sources that the FDA could use to assess risks and benefits of products labeled as homeopathic; (iii) whether current enforcement policies toward homeopathic products are appropriate and sufficient; and (iv) whether current FDA guidance is sufficient.
The FDA is accepting written or electronic comments until June 22, 2015.