H.R.3821 - Allergen Disclosure In Non-food Articles Act; ADINA Act (119th Congress)
Summary
H.R.3821, the Allergen Disclosure In Non-food Articles Act (ADINA Act), aims to amend the Federal Food, Drug, and Cosmetic Act. The bill mandates that drug labels identify ingredients derived from major food allergens or gluten-containing grains. This requirement seeks to enhance transparency and protect individuals with allergies or sensitivities.
The bill directs the Secretary of Health and Human Services to determine the applicability date, or sets a default of two years after enactment. The bill was introduced in the House of Representatives on June 6, 2025, and referred to the Committee on Energy and Commerce.
Ultimately, the goal is to provide consumers with better information about potential allergens in medications.
Expected Effects
The primary effect of this bill would be to require drug manufacturers to disclose the presence of major food allergens and gluten-containing grains in their products' labeling. This would allow consumers with allergies and sensitivities to make more informed choices about the medications they use.
Drug manufacturers will need to update their labeling processes to comply with the new regulations. Healthcare providers and pharmacists may also need to be educated about the changes to better advise their patients.
This bill could also lead to increased awareness and research into the prevalence of allergic reactions to medications.
Potential Benefits
- Improved Consumer Safety: Individuals with food allergies or gluten sensitivities will be better informed about potential allergens in medications.
- Enhanced Transparency: Drug manufacturers will be required to disclose allergen information, increasing transparency in the pharmaceutical industry.
- Informed Decision-Making: Consumers can make more informed choices about the medications they use, reducing the risk of allergic reactions.
- Reduced Healthcare Costs: By preventing allergic reactions, the bill could potentially reduce healthcare costs associated with treating those reactions.
- Increased Awareness: The bill could raise awareness among healthcare providers and the general public about the importance of allergen labeling in medications.
Potential Disadvantages
- Increased Costs for Manufacturers: Drug manufacturers may incur additional costs to update their labeling processes and test for allergens.
- Potential for Confusion: Consumers may find the additional labeling information confusing or overwhelming.
- Limited Scope: The bill only addresses major food allergens and gluten-containing grains, potentially overlooking other allergens.
- Enforcement Challenges: Ensuring compliance with the labeling requirements may pose challenges for regulatory agencies.
- Potential for Supply Chain Disruptions: Manufacturers may need to reformulate products or find new suppliers to comply with the allergen disclosure requirements, potentially leading to supply chain disruptions.
Constitutional Alignment
The bill appears to align with the general welfare clause of the Constitution, as it aims to promote public health and safety by providing consumers with information about potential allergens in medications. The Constitution does not explicitly address labeling requirements for drugs; however, Congress has broad authority to regulate interstate commerce, which includes the regulation of drugs and pharmaceuticals.
This bill does not appear to infringe upon any specific constitutional rights or freedoms. It does not restrict speech, religion, or any other protected activity.
Therefore, the bill seems to fall within the scope of Congress's legislative powers as defined by Article I, Section 8 of the Constitution.
Impact Assessment: Things You Care About ⓘ
This action has been evaluated across 19 key areas that matter to you. Scores range from 1 (highly disadvantageous) to 5 (highly beneficial).