Bill > HR7050

This bill, titled the Homeopathic Drug Product Safety, Quality, and Transparency Act, aims to establish a distinct regulatory pathway for homeopathic drug products under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to ensure consumer access to safe and quality products while providing transparency. It defines a "homeopathic drug product" as one containing only homeopathic ingredients, which are defined as those listed in the Homeopathic Pharmacopoeia of the United States or prepared according to specific homeopathic safety and quality standards. The bill exempts homeopathic drug products from most provisions of Chapter V of the FD&C Act, applying only specific sections related to adulteration, misbranding, and establishment registration, unless other provisions do not conflict with the new framework. It sets forth specific standards for adulteration, requiring compliance with the Homeopathic Pharmacopoeia or accredited voluntary consensus standards, with alternative regulations for good manufacturing practices if no such standards apply, and allows manufacturers to petition for exemptions or variances if they do not affect safety. The bill also clarifies labeling requirements, stating that indications for use supported by traditional homeopathic references or scientific evidence will not be considered false or misleading, provided they are accompanied by a disclaimer that they have not been evaluated by the Food and Drug Administration (FDA). Furthermore, it prohibits premarket approval for these products, mandates the establishment of a Homeopathic Drug Product Advisory Committee to advise the FDA, and withdraws a specific FDA guidance document related to homeopathic drug products. Importantly, the bill clarifies that it does not preempt state laws concerning the practice of homeopathy and places the burden of proof on the United States to establish any violation of these new provisions.

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https://www.congress.gov/bill/119th-congress/house-bill/7050/all-info