Home / Agencies / FDA / 2025-00397
Proposed Rule

Tobacco Product Standard for Nicotine Yield of Cigarettes and Certain Other Combusted Tobacco Products

Agency
Document Number
2025-00397
Published
January 16, 2025
Effective Date
-

Abstract

The Food and Drug Administration (FDA, the Agency, or we) is proposing a tobacco product standard that would regulate nicotine yield by establishing a maximum nicotine level in cigarettes and certain other combusted tobacco products. FDA is proposing this action to reduce the addictiveness of these products, thus giving people who are addicted and wish to quit the ability to do so more easily. The proposed product standard is anticipated to benefit the population as a whole. For example, it would help to prevent people who experiment with cigarettes and cigars from developing addiction and using combusted tobacco products regularly.

Federal Register Source

This document is published by the Office of the Federal Register, National Archives and Records Administration. Access the full regulatory text, preamble, and docket comments below.

View Full Text on FederalRegister.gov →

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Frequently Asked Questions

What is the 2025-00397 Federal Register document?

Document 2025-00397 is a Proposed Rule published by the Food and Drug Administration in the Federal Register on January 16, 2025. The Food and Drug Administration (FDA, the Agency, or we) is proposing a tobacco product standard that would regulate nicotine yield by establishing a maximum nicotine level in cigarettes and certain other combusted tobacco products. FDA is proposing this action to reduce the addictiveness of these products, thus giving people who are addicted and wish to quit the ability to do so more easily. The proposed product standard is anticipated to benefit the population as a whole. For example, it would help to prevent people who experiment with cigarettes and cigars from developing addiction and using combusted tobacco products regularly. View the original at https://www.federalregister.gov/documents/2025/01/16/2025-00397/tobacco-product-standard-for-nicotine-yield-of-cigarettes-and-certain-other-combusted-tobacco.

Is document 2025-00397 an economically significant rule?

No. Document 2025-00397 is not classified as economically significant under Executive Order 12866. Economically significant rules require OIRA review and are estimated to have impacts of $100 million or more per year.

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