118 S2079 IS: Allergen Disclosure In Non-food Articles Act U.S. Senate 2023-06-21 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

II118th CONGRESS1st SessionS. 2079IN THE SENATE OF THE UNITED STATESJune 21, 2023Mr. Blumenthal introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and PensionsA BILLTo 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.