Dietary Supplement Innovation Act

This bill, known as the "Dietary Supplement Innovation Act," aims to amend the Federal Food, Drug, and Cosmetic Act to foster innovation and enhance consumer access to dietary supplements. It primarily achieves this by clarifying the regulatory framework surrounding "drug preclusion," which generally prevents substances approved as drugs or undergoing significant clinical trials from being marketed as dietary supplements. The legislation revises the conditions under which such substances can still be included in food or dietary supplements, aiming to provide more flexibility for certain ingredients.

The revised exceptions to drug preclusion include substances marketed before October 15, 1994, or marketed as food or dietary supplements prior to any drug approval or public clinical investigation. Significantly, the bill introduces new pathways, such as when Phase 2 or 3 clinical investigations have been inactive or withdrawn for at least seven years, or if the sponsor has publicly discontinued drug development. It also grants the Secretary of Health and Human Services discretion to issue an administrative order approving the use of a drug or biological product in food or dietary supplements, offering another route for market entry.

Furthermore, the bill establishes a new section requiring the Secretary to consider specific factors when evaluating drug preclusion, including the route of administration, dosage, concentration, and safety profile of the substance in food or dietary supplements. Crucially, it allows for immediate judicial review of any FDA warning letter or statement asserting a violation of drug preclusion, regardless of whether it constitutes a final agency action. In such legal challenges, the United States government will bear the burden of proof to demonstrate a violation, shifting the onus from manufacturers.