ADINA Act
Summary
What This Bill Does
The ADINA Act adds allergen and gluten disclosure requirements to the Food, Drug, and Cosmetic Act's drug misbranding section. A drug intended for human use is misbranded if it contains an ingredient that is, or is directly or indirectly derived from, a major food allergen or a gluten-containing grain and its label fails to state that the drug contains the ingredient and identify each such ingredient and, where applicable, the type of gluten-containing grain. The covered grains include wheat, barley, rye, and crossbred hybrids. The requirement begins on the earlier of a date chosen by HHS or two years after enactment. The bill closes a gap between food allergen labeling expectations and drug excipient labeling so patients and clinicians can identify allergen or gluten risks in medications.
Who Benefits and How
Patients with food allergies benefit from drug labels identifying ingredients derived from major food allergens. Patients with celiac disease benefit from disclosure of wheat, barley, rye, and hybrid grain ingredients in drugs. Pharmacists benefit from clearer label information when counseling patients about allergen or gluten risks. Clinicians benefit from better medication ingredient information for allergy-sensitive prescribing.
Who Bears the Burden and How
Drug manufacturers must identify allergen-derived and gluten-grain-derived ingredients on human-use drug labels. FDA labeling staff must implement and enforce the new misbranding standard. Generic drug sponsors may need label revisions for inactive ingredients and excipients. Pharmacy supply chains may need to update medication information systems before the compliance date.
Key Provisions
- Adds allergen and gluten disclosure to the FDCA drug misbranding standard.
- Requires labels to state when a human-use drug contains major food allergen-derived ingredients.
- Requires labels to identify gluten-containing grain ingredients, including wheat, barley, rye, and hybrids.
- Provides an effective date set by HHS or two years after enactment, whichever comes first.
Evidence Chain:
This summary is generated from the full bill text using AI analysis. Expand "Detailed Analysis" below for identified beneficiaries/burden bearers.
At a Glance
What This Bill Does
Deems a human-use drug misbranded unless its label states and identifies each ingredient that is or derives from a major food allergen or gluten-containing grain, including wheat, barley, rye, and crossbred hybrids, with compliance beginning on the earlier of an HHS-set date or two years after enactment.
Key Policy Areas
FDA, Drug Labeling, Food Allergens
Primary Purpose
Deems a human-use drug misbranded unless its label states and identifies each ingredient that is or derives from a major food allergen or gluten-containing grain, including wheat, barley, rye, and crossbred hybrids, with compliance beginning on the earlier of an HHS-set date or two years after enactment.
Policy Domains
Resolution provisions
Identified Gains
Contextual inference, no direct clause citation- Patients with food allergies
- Patients with celiac disease
- Pharmacists
- Clinicians
Contextual inference, no direct clause citation
Identified Costs
Contextual inference, no direct clause citation- Drug manufacturers
- FDA labeling staff
- Generic drug sponsors
- Pharmacy supply chains
Contextual inference, no direct clause citation
Sponsors
Legislative Progress
In CommitteeMs. Morrison (for herself, Mr. Lawler, Ms. Matsui, Mr. Cline, …
Referred to the House Committee on Energy and Commerce.
Sponsor introductory remarks on measure. (CR H2516)
Introduced in House
Bill Structure & Actor Mappings
Who is "The Secretary" in each section?
We use a combination of our own taxonomy and classification in addition to large language models to assess meaning and potential beneficiaries. High confidence means strong textual evidence. Always verify with the original bill text.
Learn more about our methodology