Homeopathic Drug Product Safety, Quality, and Transparency Act

Key Points

• The bill creates a distinct legal category for homeopathic drug products, defining them as drugs containing one or more homeopathic ingredients and no other active ingredient. These ingredients must be listed in the Homeopathic Pharmacopoeia of the United States or prepared according to recognized homeopathic manufacturing methods.
• Homeopathic products would be permanently exempt from the FDA's standard drug approval process. They would not need an approved application under Section 505 of the Federal Food, Drug, and Cosmetic Act, which governs new drug approvals for conventional medicines.
• Within three years, the FDA must issue a final rule establishing good manufacturing practices and labeling requirements tailored specifically for homeopathic products. These rules cannot impose testing standards for which no analytical methods currently exist for homeopathic products.
• All homeopathic products sold to consumers must carry a disclaimer stating the FDA has not evaluated the intended uses and that the product is for traditional homeopathic use. Any health claims must be preceded by the phrase 'Traditionally used for.'
• The bill bans dietary supplements, non-homeopathic drugs, and cosmetics from using terms like 'homeopathic' on their labels, treating such use as misbranding. This protects the homeopathic label from being used by products that do not meet the bill's definition.
• The bill withdraws a 2022 FDA guidance document on homeopathic products and replaces it with this statutory framework. It also creates a new advisory committee with homeopathic practitioners, manufacturers, and consumers to advise the FDA on regulation of these products.