119-HR3821

Bill is currently in: House
Path to Law
House Senate President

119th CONGRESS

1st Session

H. R. 3821

1. Short title
2. Labeling of drugs with an ingredient that is a major food allergen or is made from a gluten-containing grain

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.