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Mandatory labeling of major allergens and gluten in human drugs.

This Act mandates that labels on all drugs intended for human use must clearly disclose the presence of major food allergens or ingredients derived from gluten-containing grains (like wheat, barley, rye). This change is vital for the safety of individuals with food allergies and celiac disease, allowing them to consciously avoid ingredients that trigger adverse reactions. The new labeling rules will take effect no later than two years after the Act's enactment.
Key points
All human-use drugs must clearly state on the label if they contain major food allergens (or derivatives thereof).
Labeling is also required for ingredients derived from gluten-containing grains (e.g., wheat, barley, rye).
The change aims to enhance consumer safety and prevent accidental ingestion of allergens in medicinal products.
Manufacturers have a maximum of two years to comply with the new drug labeling requirements.
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Additional Information
Print number: 118_S_2079
Sponsor: Sen. Blumenthal, Richard [D-CT]
Process start date: 2023-06-21