US Federal 2025-2026 Regular Session

US Federal House Bill HB3821

Introduced
 
Introduced
6/6/25  

Caption

ADINA Act

Impact

The implementation of HB3821 would significantly impact pharmaceutical labeling practices and enhance transparency within the industry. By requiring explicit identification of allergenic ingredients, the bill aims to reduce the likelihood of adverse allergic reactions among consumers, thereby promoting public health. The enforcement of these labeling requirements would likely necessitate changes in production practices among pharmaceutical manufacturers and may incur additional costs linked to compliance and labeling updates.

Summary

House Bill 3821, also known as the Allergen Disclosure In Non-food Articles Act (ADINA Act), aims to enhance consumer protection by amending the Federal Food, Drug, and Cosmetic Act. The bill mandates that all drugs intended for human use must clearly label any ingredients derived from major food allergens or gluten-containing grains. This initiative seeks to ensure that individuals with food allergies can make informed decisions regarding their medications and avoid potential health risks associated with allergenic substances.

Contention

While proponents argue that this initiative is essential for consumer safety, there may be concerns regarding the feasibility of implementation for drug manufacturers. Some stakeholders might argue that the bill could lead to increased manufacturing costs, which could, in turn, affect drug pricing and availability in the market. Additionally, there are potential challenges in clearly defining and classifying allergens in pharmaceutical contexts, which could lead to disputes over compliance and enforcement.

Companion Bills

No companion bills found.

Previously Filed As

US HB8385

Food Labeling Modernization Act of 2026

US SR24

Urging the Congress of the United States to pass a food labeling modernization act and an allergen disclosure in non-food articles act.

US A3131

Requires labeling of over-the-counter and prescription drugs containing major food allergen or gluten-containing grain.

US HB9048

Celiac Safety Act of 2026

US SB628

Further providing for definitions and for misbranding.

US SB149

Modifies provisions relating to food labeling

US SB786

Food allergen training and certificates of food protection practices, rules addressing food allergens, and granting rule-making authority. (FE)

US HB597

PURR Act of 2025 Pet Food Uniform Regulatory Reform Act of 2025

US SB3677

Dietary Supplement Listing Act of 2026

US HB1178

Alpha-gal Allergen Inclusion Act

Similar Bills

No similar bills found.