Todd Harrison spoke with Nutritional Outlook about proposed changes to the FDA’s drug preclusion standard and their potential implications for the dietary supplement industry. The following is an excerpt:
Todd Harrison, co-chair of the FDA practice group at Venable LLP, details the Dietary Supplement Innovation Act's language, its unintended consequences, and what industry stakeholders should watch for.
The recently introduced Dietary Supplement Innovation Act aims to modernize FDA's drug preclusion provision—the rule that can bar an ingredient from dietary supplement use if it was first studied as a drug. In the first part of this multipart video interview, Nutritional Outlook Associate Editor Erin McEvoy interviews Todd Harrison, co-chair of the FDA practice group at Venable LLP, to unpack what the bill actually does, and where it falls short.
Harrison argues that while reforming drug preclusion is worthwhile, the bill's attempt to define "substantial clinical trials" as either Phase 2 or Phase 3 trials is a significant misstep. Because Phase 2 trials could involve as few as 25 participants, he warns the standard could let a small, early-stage trial trigger up to 7 years of preclusion for an ingredient with real potential health benefits. He also flags drafting inconsistencies around the bill's 7-year inactivity clock, cautioning that vague statutory language carries new risk in the wake of the Supreme Court's Loper Bright decision.
Despite these concerns, Harrison highlights provisions he supports, including a new ability for companies to sue the FDA over warning letters. He also proposes an additional safeguard: a petition process allowing companies to show that a lower-dose use of an ingredient is safe for everyday consumption, even if a higher dose has drug-like therapeutic effects.
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