New bill seeks to fix drug preclusion provision to boost dietary supplement innovation

Congresswoman Diana Harshbarger introduced the Dietary Supplement Innovation Act to reform the FDA’s drug preclusion provision, aiming to provide greater transparency and regulatory certainty for dietary supplement manufacturers. The bill seeks to narrow the FDA’s authority to exclude ingredients based on prior drug research, create clearer eligibility criteria for supplement ingredients, and establish legal avenues to challenge FDA decisions. While trade associations welcomed the bill as a balanced update supporting innovation and consumer access, some experts argue it fails to address key sections of the original DSHEA law that also hinder supplement innovation.