ADINA Act

Key Points

• The ADINA Act would require drug manufacturers to clearly label any ingredient in medications for human use that comes from a major food allergen or a gluten-containing grain, including wheat, barley, rye, and their crossbred hybrids.
• Drugs that fail to disclose allergen or gluten-derived ingredients on their labels would be considered "misbranded" under federal law, which means they could face enforcement action by the FDA.
• The labeling requirement covers not just ingredients that are allergens themselves, but also those derived directly or indirectly from allergens — casting a wide net to protect people with sensitivities.
• The new rules would take effect either on a date chosen by the Secretary of Health and Human Services or two years after the bill becomes law, whichever comes first.
• The bill has bipartisan support, introduced by Rep. Morrison along with five cosponsors from both parties, and has been referred to the House Committee on Energy and Commerce.