Homeopathic Drug Regulation: Safety, Quality, and Transparency Act.
This act establishes a distinct regulatory pathway for homeopathic drug products, ensuring continued consumer access while mandating specific safety and quality standards. It requires clear labeling, including a mandatory disclaimer that the product's indications have not been evaluated by the FDA. The law also limits private lawsuits against manufacturers based solely on the lack of clinical trials if labeling requirements are met.
Key points
Homeopathic products are exempt from mandatory FDA premarket approval required for conventional drugs.
Labels must include a prominent statement that the product's indications for use have not been evaluated by the Food and Drug Administration.
Manufacturers must adhere to quality and safety standards defined in the Homeopathic Pharmacopoeia of the United States.
The law limits private lawsuits against manufacturers for false advertising based solely on the lack of clinical trials, provided labeling is compliant.
Status:
Introduced
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