The "Allergen Disclosure In Non-food Articles Act" (ADINA Act) aims to enhance consumer safety by requiring clear labeling of potential allergens in human-use drugs. It amends Section 502 of the Federal Food, Drug, and Cosmetic Act, specifying that a drug will be considered misbranded if its label fails to disclose certain ingredients. Specifically, this legislation mandates that drug labels must identify any ingredient that is, or is derived directly or indirectly from, a major food allergen or a gluten-containing grain , including wheat, barley, rye, and their crossbred hybrids. The label must explicitly state the presence of such an ingredient and identify each specific allergen or grain type. These new labeling requirements will become applicable either on a date set by the Secretary of Health and Human Services or two years after the Act's enactment, whichever comes first.
Referred to the House Committee on Energy and Commerce.
Sponsor introductory remarks on measure. (CR H2516)
Health
ADINA Act
USA119th CongressHR-3821| House
| Updated: 6/6/2025
The "Allergen Disclosure In Non-food Articles Act" (ADINA Act) aims to enhance consumer safety by requiring clear labeling of potential allergens in human-use drugs. It amends Section 502 of the Federal Food, Drug, and Cosmetic Act, specifying that a drug will be considered misbranded if its label fails to disclose certain ingredients. Specifically, this legislation mandates that drug labels must identify any ingredient that is, or is derived directly or indirectly from, a major food allergen or a gluten-containing grain , including wheat, barley, rye, and their crossbred hybrids. The label must explicitly state the presence of such an ingredient and identify each specific allergen or grain type. These new labeling requirements will become applicable either on a date set by the Secretary of Health and Human Services or two years after the Act's enactment, whichever comes first.