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119th CONGRESS
1st Session |
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.
Ms. Morrison (for herself, Mr. Lawler, Ms. Matsui, Mr. Cline, Mr. Fitzpatrick, and Mr. Bacon) introduced the following bill; which was referred to the Committee on Energy and Commerce
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.
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,
This Act may be cited as the “Allergen Disclosure In Non-food Articles Act” or the “ADINA Act”.
SEC. 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:
“(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
“(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.