- Representative Diana Harshbarger (R-TN) recently introduced the Dietary Supplement Innovation Act (H.R. 10336), legislation that would amend the Federal Food, Drug, and Cosmetic Act’s drug preclusion provisions. The bill is intended to encourage dietary supplement innovation and preserve consumer access to ingredients that may otherwise be excluded from the supplement market due to prior or ongoing drug development activities.
- Under the proposal, an ingredient would no longer be automatically precluded from use in food or dietary supplements if all Phase 2 or Phase 3 clinical investigations involving the substance have been inactive, withdrawn, or both for at least seven continuous years, or if the sponsor has publicly announced the discontinuation of drug development activities. This provision is designed to prevent abandoned pharmaceutical development programs from indefinitely blocking the marketing of ingredients as dietary supplements.
- The legislation directs FDA to consider factors such as route of administration, dosage, concentration, composition, and safety differences when determining whether a substance marketed as a dietary supplement should be treated the same as a drug for preclusion purposes.
- The bill has received backing from several major dietary supplement trade associations, which have criticized FDA’s interpretation of drug preclusion as overly restrictive. If enacted, the legislation could significantly reshape the relationship between dietary supplement regulation and pharmaceutical development by creating a clearer pathway for certain ingredients to remain available to consumers while preserving FDA’s authority over active drug development programs.
- Keller and Heckman will continue to monitor legislative and regulatory developments related to drug preclusion and dietary supplement ingredient eligibility.