Section 1 Short title
This Act may be cited as the “Allergen Disclosure In Non-food Articles Act” or the “ADINA Act”.
Allergen Disclosure In Non-food Articles Act
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.
Sec. 2 Labeling of drugs with an ingredient that is a major food allergen or is made from a gluten-containing grain
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.”
Applicability— 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.