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

Australia Adds 6-Methylnicotine to Schedule 9 Prohibited Substances, Effective October 1
Australia Adds 6-Methylnicotine to Schedule 9 Prohibited Substances, Effective October 1
Australia's Therapeutic Goods Administration published a final decision on September 25 to classify 6-methylnicotine as a Schedule 9 prohibited substance under the Poisons Standard, effective October 1, 2026. TGA said the chemical has been reported in e-cigarette liquids sold in Australia and marketed as nicotine-free or nicotine alternatives, while evidence also indicates its use in preparations such as oral pouches. The government originally proposed a Schedule 7 classification but ultimately adopted the stricter Schedule 9 designation, citing acute toxicity, dependence risk, use in unapproved consumer products and misleading marketing.
News
Sep.29 by 2Firsts Perspectives
India Steps Up Nicotine Pouch Enforcement as ZYN, White Fox Circulate and Drug Panel Urges Halt to New Nicotine Formulations
India Steps Up Nicotine Pouch Enforcement as ZYN, White Fox Circulate and Drug Panel Urges Halt to New Nicotine Formulations
India's Ministry of Health and Family Welfare has directed states to step up enforcement against nicotine pouch sales, citing increased availability through online and offline channels and concern about nicotine exposure among children. Reuters reported that international brands including ZYN and White Fox are being sold in India. A study led by ICMR-NICPR found pouches in seven of 10 surveyed locations and identified 68 brands and 445 flavors online. Separately, India's Drugs Technical Advisory Board recommended in August that no new nicotine formulation be approved.
Regulations
Sep.28 by 2Firsts Perspectives
JTI Invests ₱2.1 Billion to Upgrade Batangas Manufacturing Hub, Adds First Southeast Asia DIET Facility
JTI Invests ₱2.1 Billion to Upgrade Batangas Manufacturing Hub, Adds First Southeast Asia DIET Facility
JTI Asia Manufacturing Corp. has invested ₱2.1 billion, or about $37 million, in its manufacturing site in Malvar, Batangas, Philippines, to expand tobacco-processing capabilities. About ₱1.9 billion is allocated to JTI's first Dry Ice Expanded Tobacco, or DIET, facility in Southeast Asia, while more than ₱177 million has been spent on expanding its Controlled Atmosphere treatment facility. The Batangas plant supplies the Philippine market and exports to 22 overseas markets, making it one of JTI's key manufacturing hubs in Asia.
Sep.24
FDA Authorizes JUUL2, Cites Adult Switching Amid Efforts to Speed PMTA Reviews
FDA Authorizes JUUL2, Cites Adult Switching Amid Efforts to Speed PMTA Reviews
The FDA authorized the JUUL2 device and tobacco- and menthol-flavored pods on Aug. 28, bringing the number of authorized e-cigarette products to 48. The agency highlighted complete switching among adult smokers, with six-week switching rates reaching 28.4%–49.3% for the menthol pod. The decision comes as FDA works to speed PMTA reviews, reduce application backlogs and expand authorized e-cigarette and nicotine-pouch products while maintaining enforcement priorities for unauthorized products.
Regulations
Aug.29
China Tobacco Yunnan files patent for cellulose-free nicotine pouch scaffold to replace microcrystalline cellulose
China Tobacco Yunnan files patent for cellulose-free nicotine pouch scaffold to replace microcrystalline cellulose
China Tobacco Yunnan Industrial Co., Ltd. has filed a patent application for a cellulose-free scaffold material for nicotine pouches, proposing a combination of bioceramic material, polydextrose and sugar alcohols to replace conventional microcrystalline cellulose and cellulose derivatives. The filing aims to address issues including powdery mouthfeel, residue and limited release control, while also reducing reliance on existing cellulose-based patent portfolios. In patent examples, one fast-release formulation reached a nicotine release rate of 50% at 10 minutes and more than 90% at 20 minutes.
Sep.02
Ukraine Raises Excise Stamp Fees for Tobacco, Heated Tobacco and Vape Liquids by 30.5% as Parliament Backs E-Excise Delay to 2027
Ukraine Raises Excise Stamp Fees for Tobacco, Heated Tobacco and Vape Liquids by 30.5% as Parliament Backs E-Excise Delay to 2027
Ukraine's Cabinet of Ministers adopted Resolution No. 1259 on October 15, 2026, increasing excise stamp production fees for tobacco products and e-cigarette liquids by approximately 30.5%, from UAH 0.1643 to UAH 0.2144 per stamp. Fees for alcoholic beverages rose by about 30.2%. Separately, Ukraine's parliament passed Bill No. 15532 on October 13, proposing to postpone the full implementation of electronic excise stamps and traceability for alcohol, tobacco and e-cigarette liquids from November 1, 2026, to July 1, 2027. Parliament cited additional testing, configuration and integration requirements. The bill was sent to the president for signature on October 19.
Regulations
Oct.21