H.R. 10336 — Dietary Supplement Innovation Act

This section revises the prohibition on introducing into interstate commerce any food or dietary supplement containing an approved drug, licensed biological product, or substance under Phase 2 or Phase 3 clinical investigation. It adds seven exceptions, including prior marketing before October 15, 1994, seven years of inactive status, use solely to enhance food safety under GRAS or food additive rules, and pre-2007 smoking cessation marketing. It requires the Secretary to consider differences in route of administration, dosage, concentration, and safety when making preclusion determinations, makes certain warning letters and agency responses immediately reviewable in court with the burden of proof on the United States, and removes the prior exclusion from the dietary supplement definition for substances that would otherwise be unlawful.