ADINA Act
Sponsored By: Representative Morrison, Kelly [D-MN-3]
Introduced
Summary
Requires drug labels to disclose ingredients derived from major food allergens and specific gluten-containing grains. This bill would add a new misbranding standard to the Federal Food, Drug, and Cosmetic Act so drugs intended for human use must state if they contain an ingredient that is, or is derived from, a major food allergen or a gluten-containing grain.
Show full summary
- Consumers and patients: People with food allergies or celiac disease would get clearer warning labels that say a drug contains a major food allergen or a gluten-derived ingredient and name each such ingredient.
- Drug manufacturers: Companies would need to update labels to identify each allergen-derived ingredient and, when relevant, specify the gluten-containing grain type such as wheat, barley, rye, or crossbred hybrids.
- Regulators and enforcement: The requirement would be enforced under the FDA’s misbranding framework and would apply beginning on the earlier of a date set by the Secretary of Health and Human Services or two years after enactment.
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Bill Overview
Analyzed Economic Effects
1 provisions identified: 1 benefits, 0 costs, 0 mixed.
Clear allergen labels on human drugs
This bill would require clear labels on human drugs with food allergens or gluten grains. Manufacturers, packagers, labelers, and distributors would need to comply. Labels would have to say the drug contains such ingredients and list each one. If gluten is present, the label would name the grain (wheat, barley, rye, or hybrids). Drugs without these notices would be misbranded. The rule would start on the earlier of a date set by the Health Secretary or two years after enactment.
Sponsors & CoSponsors
Sponsor
Morrison, Kelly [D-MN-3]
MN • D
Cosponsors
Rep. Lawler, Michael [R-NY-17]
NY • R
Sponsored 6/6/2025
Rep. Matsui, Doris O. [D-CA-7]
CA • D
Sponsored 6/6/2025
Rep. Cline, Ben [R-VA-6]
VA • R
Sponsored 6/6/2025
Rep. Fitzpatrick, Brian K. [R-PA-1]
PA • R
Sponsored 6/6/2025
Rep. Bacon, Don [R-NE-2]
NE • R
Sponsored 6/6/2025
Craig
MN • D
Sponsored 6/23/2025
Rep. Davids, Sharice [D-KS-3]
KS • D
Sponsored 8/15/2025
Rep. Quigley, Mike [D-IL-5]
IL • D
Sponsored 11/4/2025
Rep. Grothman, Glenn [R-WI-6]
WI • R
Sponsored 11/4/2025
Pingree
ME • D
Sponsored 11/7/2025
Del. Norton, Eleanor Holmes [D-DC-At Large]
DC • D
Sponsored 11/7/2025
Carson
IN • D
Sponsored 11/19/2025
McDowell
NC • R
Sponsored 12/10/2025
Rep. Thanedar, Shri [D-MI-13]
MI • D
Sponsored 1/8/2026
Rep. Frost, Maxwell [D-FL-10]
FL • D
Sponsored 3/3/2026
Van Drew
NJ • R
Sponsored 3/17/2026
Roll Call Votes
No roll call votes available for this bill.
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