II 118th CONGRESS 1st Session S. 2079 IN THE SENATE OF THE UNITED STATES June 21, 2023 Mr. Blumenthal introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To amend the Federal Food, Drug, and Cosmetic Act to require the label of a drug intended for human use to identify each ingredient in such drug that is, or is derived directly or indirectly from, a major food allergen or a gluten-containing grain, and for other purposes.

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 (a) Misbranding Section 502 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 352 ) is amended by adding at the end the following: (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. . (b) Applicability Section 502(hh) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), shall apply beginning on the earlier of— (1) a date to be determined by the Secretary of Health and Human Services; or (2) the date that is 2 years after the date of the enactment of this Act.