Mandatory Allergen Labels on Human Drugs
New rules require human drug labels to disclose the presence of major food allergens or gluten-containing ingredients. This will help individuals with allergies or gluten intolerance make safer choices when selecting medications, avoiding adverse reactions. These changes aim to enhance consumer safety and awareness.
Key points
Drugs intended for human use must clearly state on their labels if they contain major food allergens (e.g., peanuts, milk, eggs) or gluten-containing ingredients (e.g., wheat, barley, rye).
Failure to include this information on the label will result in the drug being considered misbranded, potentially leading to its removal from the market.
The regulations will take effect no later than two years after enactment, or earlier if determined by the Secretary of Health and Human Services.
Status:
Introduced
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