H.R. 3821 — ADINA Act

This section amends the misbranding provisions of the Federal Food, Drug, and Cosmetic Act (21 USC 352) by adding a new subsection (hh) deeming a human drug misbranded if its label fails to declare the presence of, and identify, any ingredient that is or is derived directly or indirectly from (1) a major food allergen or (2) a gluten-containing grain (i.e., wheat, barley, rye, or their crossbred hybrids). The new requirement applies beginning on the earlier of a date determined by the Secretary of Health and Human Services or two years after enactment.