Bill > S4692

This bill, titled the "Homeopathic Drug Product Safety, Quality, and Transparency Act," aims to establish a distinct regulatory framework for homeopathic drug products under the Federal Food, Drug, and Cosmetic Act (FFDCA). It defines a "homeopathic drug product" as a drug containing only homeopathic ingredients, which are listed in recognized pharmacopoeias or prepared using specific homeopathic manufacturing methods and standards. The bill clarifies that these products will be regulated by the Secretary of Health and Human Services in a manner appropriate to their unique characteristics and risk profile, exempting them from the standard new drug approval process (Section 505 of the FFDCA). Instead, they will be subject to specific safety, quality, and labeling requirements, with the Secretary mandated to issue a final rule on current good manufacturing practices and labeling within three years. The bill also outlines specific testing requirements, allows for traditional homeopathic evidence to support claims, and mandates a disclaimer for retail products stating that their intended uses have not been evaluated by the Food and Drug Administration (FDA). Furthermore, it establishes a Homeopathic Drug Product Advisory Committee to provide recommendations on regulation and requires the withdrawal of a previous FDA guidance document on the topic. The bill also includes provisions to prevent the misbranding of dietary supplements, drugs, and cosmetics that incorrectly use the term "homeopathic."