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Requires labels for certain FDA-regulated human drugs to disclose if the product contains a major food allergen or an ingredient made from a gluten-containing grain. Labels must both state the presence of the allergen/grain-derived ingredient and list each such ingredient — and, when applicable, identify the type of gluten‑containing grain (for example, wheat, barley, or rye). The rule takes effect on the earlier of a date set by the HHS Secretary or two years after enactment.
Adds a new paragraph (hh) to Section 502 of the Federal Food, Drug, and Cosmetic Act making certain labeling failures a form of misbranding.
Requires that if a drug is intended for human use and contains an ingredient that is, or is derived directly or indirectly from, a major food allergen or a gluten-containing grain, the drug's label must (A) state that the drug contains such an ingredient and (B) identify each such ingredient and, as applicable, the type of gluten-containing grain.
Specifies that 'gluten-containing grain' includes wheat, barley, rye, and their crossbred hybrids.
Establishes when the new labeling requirement applies: it takes effect on the earlier of a date determined by the Secretary of Health and Human Services or the date that is two years after enactment of this Act.
Primary effects: drug manufacturers and labelers must review products and supply chains to identify major food allergens and whether ingredients are made from gluten-containing grains, then revise labels and product information. That will require documentation from suppliers, possible testing or supplier attestations, and repackaging or relabeling costs. Pharmacies, pharmacy benefit managers, and health care providers will receive clearer information on drug allergen content, reducing the risk of accidental exposure for patients with food allergies or celiac disease. Patients and caregivers will benefit from improved transparency, making it easier to avoid products that pose allergy or gluten-related risks. Smaller manufacturers and niche producers (including some compounding pharmacies and importers) may face proportionally larger compliance burdens. FDA will need to issue or apply guidance and enforcement policies; the Secretary may set an earlier compliance date, which could shorten the preparation window. The provision does not provide implementation funding or alter tax/appropriations authorities; costs to industry are borne by manufacturers and could influence labeling, formulation, or supply-chain choices but do not create direct obligations for state or local governments.
Last progress June 6, 2025 (8 months ago)
Introduced on June 6, 2025 by Kelly Morrison
Referred to the House Committee on Energy and Commerce.