Dietary Supplement Innovation Act

This bill changes federal food and drug law on when a substance that is also an approved drug, a licensed biological product, or the subject of public Phase 2 or Phase 3 drug trials can be sold in food or dietary supplements. It lists exceptions, such as when the substance was sold as a food or supplement before the drug approval or trials, or when the drug trials have been inactive or withdrawn for at least seven years or drug development was publicly stopped. It directs the Food and Drug Administration to consider differences such as dosage, route of use, concentration, and safety when deciding whether a drug has been added to a food or supplement. It also allows FDA warning letters and similar statements finding a violation to be challenged in court right away, with the government bearing the burden of proof.

Full text and official record on Congress.gov

Sponsors

• Diana Harshbarger Republican sponsor
• 0 cosponsors