HR 3821
ADINA Act
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Sign in to take action- Introduced
- Passed House
- Passed Senate
- To President
- Became Law
Bill overview
This bill, the Allergen Disclosure In Non-food Articles Act (ADINA Act), aims to improve patient safety by requiring drug labels to clearly identify any ingredients that are major food allergens or derived from gluten-containing grains. Currently, drug labels may not always disclose these potential allergens, which can cause serious reactions in sensitive individuals. The bill mandates that drug labels include a specific statement and a list of these ingredients, ensuring consumers are fully informed before taking medication.
Key provisions
- Requires drug labels to identify ingredients that are major food allergens.
- Requires drug labels to identify ingredients derived from gluten-containing grains (wheat, barley, rye).
- Addresses misbranding of drugs that fail to disclose these ingredients.
- The disclosure requirements apply to drugs intended for human use.
Who is affected
- Patients taking medications
- Pharmaceutical manufacturers
- The Food and Drug Administration (FDA)
Notable changes
- Adds a new provision to the Federal Food, Drug, and Cosmetic Act regarding allergen labeling.
- Establishes a timeline for implementation, starting two years after the bill's enactment.
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Primary sponsor
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119th CONGRESS — 1st Session
H. R. 3821
IN THE HOUSE OF REPRESENTATIVES
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.
This Act may be cited as the Allergen Disclosure In Non-food Articles Act ADINA Act
or the
.
that is intended for human use;
a major food allergen; or
a gluten-containing grain (including wheat, barley, rye, and their crossbred hybrids); and
whose label fails—
to state that the drug contains such an ingredient; and
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.