FDA Proposed Rule to Significantly Reduce Nicotine in Tobacco Products

Dec.13.2024
FDA Proposed Rule to Significantly Reduce Nicotine in Tobacco Products
FDA proposes rule to drastically reduce nicotine in tobacco products as Biden administration nears end, aiming to reduce addiction.

According to a report by CNN on December 11th, the U.S. Food and Drug Administration (FDA) has submitted a proposed rule aimed at significantly reducing the nicotine content in tobacco products as the Biden administration's term comes to an end.


The FDA first hinted at its intention to limit nicotine content in 2018. In 2022, FDA Commissioner Dr. Robert Califf announced that the agency is developing a rule that would require tobacco companies to lower the nicotine content in cigarettes.


On Tuesday (10), the FDA submitted its proposal to the Office of Management and Budget. The FDA told CNN on Wednesday (11), "Establishing a maximum nicotine content standard to reduce the addictiveness of cigarettes and certain combustible tobacco products, when finalized, will be one of the most impactful actions in the history of tobacco product regulation in the United States.


The CEO of the American Lung Association, Harold Wimmer, expressed appreciation for the initiative.


Once this rule is finalized, it could change our country's efforts to eliminate tobacco use. Making tobacco products less addictive will greatly reduce the number of young people becoming addicted. Additionally, reducing the nicotine content in all commercial tobacco products, including e-cigarettes, is crucial.


Dr. Rose Marie Robertson, Deputy Chief Science and Medical Officer of the Heart Association, pointed out that even with restricted nicotine levels, not all smokers will quit as a result.


CNN has pointed out that the approval process may take several months, and the tobacco industry typically sues the government to prevent new regulations.


We welcome news tips, article submissions, interview requests, or comments on this piece.

Please contact us at info@2firsts.com, or reach out to Alan Zhao, CEO of 2Firsts, on LinkedIn


Notice

1.  This article is intended solely for professional research purposes related to industry, technology, and policy. Any references to brands or products are made purely for objective description and do not constitute any form of endorsement, recommendation, or promotion by 2Firsts.

2.  The use of nicotine-containing products — including, but not limited to, cigarettes, e-cigarettes, nicotine pouchand heated tobacco products — carries significant health risks. Users are responsible for complying with all applicable laws and regulations in their respective jurisdictions.

3.  This article is not intended to serve as the basis for any investment decisions or financial advice. 2Firsts assumes no direct or indirect liability for any inaccuracies or errors in the content.

4.  Access to this article is strictly prohibited for individuals below the legal age in their jurisdiction.

 

Copyright

 

This article is either an original work created by 2Firsts or a reproduction from third-party sources with proper attribution. All copyrights and usage rights belong to 2Firsts or the original content provider. Unauthorized reproduction, distribution, or any other form of unauthorized use by any individual or organization is strictly prohibited. Violators will be held legally accountable.

For copyright-related inquiries, please contact: info@2firsts.com

 

AI Assistance Disclaimer

 

This article may have been enhanced using AI tools to improve translation and editorial efficiency. However, due to technical limitations, inaccuracies may occur. Readers are encouraged to refer to the cited sources for the most accurate information.

We welcome any corrections or feedback. Please contact us at: info@2firsts.com

Canada Health Minister Says She Is Not Considering Looser Nicotine Pouch Retail Rules as PMI-Linked Group Pushes for Wider Access
Canada Health Minister Says She Is Not Considering Looser Nicotine Pouch Retail Rules as PMI-Linked Group Pushes for Wider Access
Canadian Health Minister Marjorie Michel says she is not considering loosening retail restrictions on nicotine pouches. Canada regulates pouches containing 4 mg or less of nicotine per unit as non-prescription nicotine replacement therapy and requires newer NRT formats such as pouches to be sold from behind pharmacy counters. Meanwhile, Unsmoke Canada, linked to Philip Morris International's Canadian business, is pushing to allow pouches in convenience stores and other general retail outlets. Health Canada also acknowledges continued unauthorized sales, while recent research shows rising pouch use among Canadian youth aged 16 to 19.
Sep.24
Philippines Customs Seizes PHP11.68 Billion($200 Million) in Illegal Tobacco and Vapes in First Seven Months of 2026
Philippines Customs Seizes PHP11.68 Billion($200 Million) in Illegal Tobacco and Vapes in First Seven Months of 2026
Philippines Customs data showed that illegal cigarettes and vape products seized during the first seven months of 2026 were valued at about PHP11.68 billion, exceeding the PHP2.516 billion recorded for the full year of 2025. The figures were disclosed by a Bureau of Customs official during a House Committee on Ways and Means hearing on tobacco excise tax reforms. Vape-related seizures were valued at about PHP1.65 billion, with most cases recorded at the Manila International Container Port. Customs officials said enforcement against illicit tobacco trade would continue.
Aug.26
Why AIRSCREAM Built its European Production Hub for Regulated Market Growth
Why AIRSCREAM Built its European Production Hub for Regulated Market Growth
AIRSCREAM’s production hub in the Czech Republic brings nicotine pouch manufacturing, e-liquid bottling, product documentation, warehousing and international logistics into one operation, giving brands and commercial partners a practical platform from which to launch, expand and enter new markets.
Market
Sep.16 by 2Firsts Perspectives
FDA Unifies Tobacco Registration and Product Listing Form Across Product Categories
FDA Unifies Tobacco Registration and Product Listing Form Across Product Categories
The U.S. FDA has consolidated two tobacco establishment registration and product listing forms into a redesigned Form FDA 3741 covering all regulated product categories, including e-cigarettes, heated tobacco products and nicotine pouches. The current requirements remain limited to domestic establishments. Separately, the FDA has proposed extending registration and product listing requirements to foreign manufacturers, signaling greater regulatory attention to manufacturing entities and product-level information across the tobacco and nicotine supply chain.
FDA
Sep.30
U.S. Customs Plan to Require Foreign Export Declarations Could Deal ‘Devastating’ Blow to China’s Vape Exports, Logistics gl Expert Says
U.S. Customs Plan to Require Foreign Export Declarations Could Deal ‘Devastating’ Blow to China’s Vape Exports, Logistics gl Expert Says
A U.S. Customs and Border Protection proposal to collect foreign export declarations and other overseas customs documents could expose discrepancies in the value, classification and description of China-made vape shipments entering the United States. A veteran Chinese logistics professional told 2Firsts that the measure, if implemented, could undermine the all-inclusive shipping model used by some unauthorized vape exporters and push parts of the trade toward costlier underground channels. The risk extends beyond higher duties: accurately declared products may also be more readily identified as unauthorized e-cigarettes subject to FDA enforcement.
Special Report
Sep.07
China Tobacco Hubei explores staged nicotine pouch delivery, using dynamic membranes to slow early release and gradient particles to sustain later delivery
China Tobacco Hubei explores staged nicotine pouch delivery, using dynamic membranes to slow early release and gradient particles to sustain later delivery
China Tobacco Hubei Industrial Co., Ltd. disclosed several oral nicotine-related patent applications in August 2026, including two that approach staged nicotine release from different directions. One uses a high-viscosity membrane that forms inside the pouch after contact with saliva to slow rapid early release, while the other uses gradient particles with a faster-disintegrating outer layer and a slower core to create a fast-to-sustained release profile. Together, the filings explore how nicotine pouches could balance initial delivery with release later in use.
Sep.03