H.R. 3821: Allergen Disclosure In Non-food Articles Act

The bill titled "Allergen Disclosure In Non-food Articles Act" aims to enhance labeling requirements for drugs intended for human use. Specifically, it seeks to amend the Federal Food, Drug, and Cosmetic Act by introducing clearer labeling standards regarding ingredients that could pose allergenic risks to consumers. The key points of the bill are as follows:

Labeling Requirements

The bill mandates that:

• Drugs that are intended for human use must have labels that explicitly identify any ingredient that is:
• A major food allergen, or
• Derived from a gluten-containing grain (which includes wheat, barley, rye, and their hybrids).
• If a drug contains such ingredients, the label must:
• State that the drug contains that ingredient, and
• Specifically identify each allergenic ingredient and, where applicable, the type of gluten-containing grain used.

Enforcement and Compliance

The FDA will be responsible for determining the implementation timeline for these labeling requirements. The requirements are expected to come into effect either on a date set by the Secretary of Health and Human Services or two years after the bill is enacted, whichever comes first.

Purpose of the Bill

The intention behind this legislation is to improve consumer safety and awareness by ensuring that anyone using medications is informed of potential allergenic ingredients, thereby allowing them to make better-informed choices regarding their health and safety.

Relevant Companies

• None found