H.R. 3821

119th CONGRESS 1st Session

To amend the Federal Food, Drug, and Cosmetic Act to require the label of a drug intended for human use to identify each ingredient in such drug that is, or is derived directly or indirectly from, a major food allergen or a gluten-containing grain, and for other purposes.

IN THE HOUSE OF REPRESENTATIVES · June 6, 2025 · Sponsor: Ms. Morrison · Committee: Committee on Energy and Commerce

Table of contents

• H.R. 3821
  • SEC. 1. Short title
  • SEC. 2. Labeling of drugs with an ingredient that is a major food allergen or is made from a gluten-containing grain

SEC. 1. Short title

• This Act may be cited as the or the .

SEC. 2. Labeling of drugs with an ingredient that is a major food allergen or is made from a gluten-containing grain

• (a) Misbranding
  • Section 502 of the Federal Food, Drug, and Cosmetic Act () is amended by adding at the end the following: 21 U.S.C. 352
    • If it is a drug—
      • that is intended for human use;
      • that contains an ingredient that is, or is derived directly or indirectly from—
        • a major food allergen; or
        • a gluten-containing grain (including wheat, barley, rye, and their crossbred hybrids); and
      • whose label fails—
        • to state that the drug contains such an ingredient; and
        • to identify each such ingredient and, as applicable, the type of gluten-containing grain.
• (b) Applicability
  • Section 502(hh) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), shall apply beginning on the earlier of—
    • a date to be determined by the Secretary of Health and Human Services; or
    • the date that is 2 years after the date of the enactment of this Act.