Sponsors (20)
Official title: 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.
Introduced June 6, 2025 by Kelly Morrison · Last progress June 6, 2025
The bill improves safety and clarity for people with food allergies and gluten sensitivity by requiring clearer medicine labeling, at the cost of added compliance and labeling expenses for drugmakers (especially smaller firms) and potential short-term implementation uncertainty for health providers, which could modestly affect prices and availability.
People with food allergies, celiac disease, or gluten sensitivity will be able to identify when a medicine contains or is derived from major food allergens (including which gluten-containing grain is present), reducing the risk of allergic reactions and enabling safer medication use.
Medicare, Medicaid beneficiaries and other patients at risk of accidental exposures may have fewer emergency visits and lower healthcare utilization because of clearer labeling, which could reduce related medical costs.
Drug manufacturers will incur costs to update labels and verify ingredients, and those costs could be passed on to consumers and taxpayers through higher drug prices.
Smaller drug makers and compounders will face disproportionate compliance burdens (testing, verification, relabeling) that could increase administrative costs or reduce product availability.
If regulatory implementation guidance is delayed or inconsistent, hospitals, pharmacies, and health systems will face uncertainty about which products comply during the transition, complicating procurement and dispensing.
Based on analysis of 2 sections of legislative text.
Requires drug labels to disclose and identify any major food allergen or gluten-containing grain ingredient (and type of grain if applicable).
Requires drug labels to disclose when a human-intended drug contains (or is derived from) any major food allergen or a gluten-containing grain and to identify each such ingredient (and, if relevant, the type of gluten-containing grain). The labeling rule becomes effective on the earlier of a date set by the HHS Secretary or two years after enactment.