In the Nutritional Outlook article "What Supplement Companies Can Do Now on the Dietary Supplement Innovation Act," Todd Harrison examines gaps in the proposed legislation and practical steps supplement companies can take as the bill moves forward. The following is an excerpt:
Part 2 of our interview with Todd Harrison, co-chair of the FDA practice group at Venable LLP covers preclusion's structural gaps: no defined end point, no tracking registry, and a push for mandatory drug-sponsor engagement.
In this second installment of our conversation with Todd Harrison, co-chair of the FDA practice group at Venable LLP, we turn to the practical consequences of gaps in the Dietary Supplement Innovation Act. In part 1 of this series, "Redefining Drug Preclusion: Legal Perspectives on Dietary Supplement Innovation Act," Harrison unpacked the bill's foundational problems—including the "Phase 2" preclusion trigger. Because Phase 2 trials could involve as few as 25 participants, he explained, the standard could let a small, early-stage trial trigger up to 7 years of preclusion for an ingredient. Here, he goes further, addressing what happens when critical details are left unresolved: no defined end point for post-approval preclusion, and no dedicated registry to track which ingredients are affected.
Harrison argues that supplement manufacturers deserve transparency from FDA about active IND filings before they invest in a new dietary ingredient notification—pointing out the disconnect between the country's broader transparency values and the secrecy surrounding the drug approval pipeline. He also proposes a concrete fix: requiring drug sponsors to demonstrate "active engagement" in moving their trials forward, rather than allowing preclusion to sit indefinitely and passively block ingredient innovation.
On the path forward, Harrison offers direct advice to industry: encourage trade organizations to formally reject the Phase 2 language, and manufacturers need to engage their own congressional representatives directly to voice which parts of the bill work and which don't.
For the full article, click here.