HR4263-118

1. Short title This Act may be cited as the Allergen Disclosure In Non-food Articles Act or the ADINA Act.

2. Labeling of drugs with an ingredient that is a major food allergen or is made from a gluten-containing grain Section 502 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352) is amended by adding at the end the following: If it is a drug— that is intended for human use; that contains an ingredient that is, or is derived directly or indirectly from— a major food allergen; or a gluten-containing grain (including wheat, barley, rye, and their crossbred hybrids); and whose label fails— to state that the drug contains such an ingredient; and to identify each such ingredient and, as applicable, the type of gluten-containing grain. Section 502(hh) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), shall apply beginning on the earlier of— a date to be determined by the Secretary of Health and Human Services; or the date that is 2 years after the date of the enactment of this Act. (hh)If it is a drug— (1)that is intended for human use; (2)that contains an ingredient that is, or is derived directly or indirectly from— (A)a major food allergen; or (B)a gluten-containing grain (including wheat, barley, rye, and their crossbred hybrids); and (3)whose label fails— (A)to state that the drug contains such an ingredient; and (B)to identify each such ingredient and, as applicable, the type of gluten-containing grain..