21 U.S.C. § 331
Prohibited acts
United States · Title 21 — FOOD AND DRUGS · Status: effective
Cite this
- Citation
- 21 U.S.C. § 331, Prohibited acts, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/454175
- Permanent ID
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Full text
The following acts and the causing thereof are prohibited:
The failure or refusal—
In the case of a drug, device, or food—
The introduction or delivery for introduction into interstate commerce of any food to which has been added a drug approved under section 355 of this title, a biological product licensed under section 262 of title 42, or a drug or a biological product for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, unless—
the use of the drug or the biological product in the food is to enhance the safety of the food to which the drug or the biological product is added or applied and not to have independent biological or therapeutic effects on humans, and the use is in conformity with—
Making any express or implied statement or representation directed to consumers with respect to a tobacco product, in a label or labeling or through the media or advertising, that either conveys, or misleads or would mislead consumers into believing, that—
the product is safe or less harmful by virtue of—
In this paragraph—
The failure of a sponsor of a product approved under accelerated approval pursuant to section 356(c) of this title—
Legislative history
The public laws that enacted or amended this section. Tallies are for the whole bill as it passed each chamber — often an omnibus covering far more than this provision — not a vote on this section alone. The law that originally enacted this section predates the public laws loaded here, so only later amendments are listed.
- Medical Device Amendments of 1976House: no recorded tallySenate: no recorded tally
- An act to amend the Federal Food, Drug, and Cosmetic Act to strengthen the authority under that Act to assure the safety and nutrition of infant formulas, and for other purposes.House: no recorded tallySenate: no recorded tally
- Anti-Drug Abuse Act of 1986House: no recorded tallySenate: no recorded tally
- Prescription Drug Marketing Act of 1987House: no recorded tallySenate: no recorded tally
- Vaccine and Immunization Amendments of 1990House: no recorded tallySenate: no recorded tally
- Omnibus Budget Reconciliation Act of 1990
- Medical Device Amendments of 1992House: no recorded tallySenate: no recorded tally
- To amend the Federal Food, Drug, and Cosmetic Act to authorize human drug application, prescription drug establishment, and prescription drug product fees and for other purposes.House: no recorded tallySenate: no recorded tally
- Nutrition Labeling and Education Act Amendments of 1993House: no recorded tallySenate: no recorded tally
- Animal Medicinal Drug Use Clarification Act of 1994House: no recorded tallySenate: no recorded tally
- Dietary Supplement Health and Education Act of 1994House: no recorded tallySenate: no recorded tally
- Omnibus Consolidated Rescissions and Appropriations Act of 1996
- Food Quality Protection Act of 1996House: no recorded tallySenate: no recorded tally
- Animal Drug Availability Act of 1996House: no recorded tallySenate: no recorded tally
- Food and Drug Administration Modernization Act of 1997House: no recorded tallySenate: 98–2
- Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2001
- Public Health Security and Bioterrorism Preparedness and Response Act of 2002
- Medical Device User Fee and Modernization Act of 2002House: no recorded tallySenate: no recorded tally
- National Defense Authorization Act for Fiscal Year 2004
- Medicare Prescription Drug, Improvement, and Modernization Act of 2003
- Medical Devices Technical Corrections ActHouse: 396–0Senate: no recorded tally
- Minor Use and Minor Species Animal Health Act of 2003House: no recorded tallySenate: no recorded tally
- SAFETEA-LU
- Dietary Supplement and Nonprescription Drug Consumer Protection ActHouse: 203–98Senate: no recorded tally
- Food and Drug Administration Amendments Act of 2007House: 405–7Senate: no recorded tally
- To protect the public health by providing the Food and Drug Administration with certain authority to regulate tobacco products, to amend title 5, United States Code, to make certain modifications in the Thrift Savings Plan, the Civil Service Retirement System, and the Federal Employees' Retirement System, and for other purposes.
- FDA Food Safety Modernization ActHouse: 215–144Senate: no recorded tally
- Food and Drug Administration Safety and Innovation ActHouse: no recorded tallySenate: 96–1
- Drug Quality and Security ActHouse: no recorded tallySenate: no recorded tally
- Microbead-Free Waters Act of 2015House: no recorded tallySenate: no recorded tally
- 21st Century Cures ActHouse: no recorded tallySenate: no recorded tally
- SUPPORT for Patients and Communities Act
- Consolidated Appropriations Act, 2023House: 225–201Senate: no recorded tally