Congress·In Committee·H.R. 3821

ADINA Act

Rep. Morrison Introduces ADINA Act to Require Allergen and Gluten Labels on Medications

10 months ago·View on Congress.gov·Read full text

The ADINA Act is currently in the early stages of the legislative process and is being reviewed by the House Committee on Energy and Commerce. It is actively moving forward, though no further committee hearings or votes have been scheduled at this time.

Legislative Progress

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Key Points

The ADINA Act would require drug manufacturers to clearly label any ingredient in medications for human use that comes from a major food allergen or a gluten-containing grain, including wheat, barley, rye, and their crossbred hybrids.
From policy text
“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”
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Drugs that fail to disclose allergen or gluten-derived ingredients on their labels would be considered "misbranded" under federal law, which means they could face enforcement action by the FDA.
From policy text
“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.”
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The labeling requirement covers not just ingredients that are allergens themselves, but also those derived directly or indirectly from allergens — casting a wide net to protect people with sensitivities.
From policy text
“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)”
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The new rules would take effect either on a date chosen by the Secretary of Health and Human Services or two years after the bill becomes law, whichever comes first.
From policy text
“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.”
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The bill has bipartisan support, introduced by Rep. Morrison along with five cosponsors from both parties, and has been referred to the House Committee on Energy and Commerce.
From policy text
“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”
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Healthcare

Impact Analysis

Personal Impact

Who is affectedScoreImpactCertaintyScopeDurationSentiment

Scores: 1 = low, 5 = highSentiment: -5 to +5 (net benefit)

Milestones

2 milestones3 actions

Jun 6, 2025House

Referred to the House Committee on Energy and Commerce.

Jun 6, 2025

Sponsor introductory remarks on measure. (CR H2516)

Jun 6, 2025

Introduced in House

What Happens Next

Projected impacts based on AI analysis

No later than 2 years after enactment

New allergen labeling requirements take effect on all human medications

Drug labels must clearly list any ingredient derived from major food allergens or gluten-containing grains like wheat, barley, and rye. People with allergies and celiac disease can check their medication labels for the first time.

Related News

4 articles

Allergic Living·2 months ago

Momentum Builds for New ADINA Bill to Label Allergens in Drugs

The ADINA Act (H.R. 3821) was reintroduced in June 2025 by Rep. Kelly Morrison to mandate labeling for the top 9 food allergens and gluten in medications. Advocacy efforts in early 2026 have seen co-sponsors double as families push for federal transparency on prescription and OTC drug labels.

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Maple Grove 7th grader on a mission to require medications list allergens

CBS News·over 2 years ago

Maple Grove 7th grader on a mission to require medications list allergens

Profiles Adina Togal, whose hospitalization from an antibiotic with undisclosed allergens inspired the ADINA Act. The bill seeks to close a loophole where pharmaceutical drugs, unlike food products, are not required to list potential allergens like gluten or lactose in their inactive ingredients.

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ADINA Act would require allergen labeling on OTC, prescription medication

Healio·almost 3 years ago

ADINA Act would require allergen labeling on OTC, prescription medication

The Allergen Disclosure in Non-Food Articles (ADINA) Act would amend the Food, Drug, and Cosmetic Act to require drug labels to indicate ingredients derived from major food allergens or glutens. Research shows 93% of medicines contain potential allergens, often in undisclosed inactive ingredients.