Long Wait Ahead: FDA's Proposal to Reduce Nicotine Content in Cigarettes

Jun.28.2022
Long Wait Ahead: FDA's Proposal to Reduce Nicotine Content in Cigarettes
The FDA's proposal to lower nicotine in cigarettes may take up to a decade to resolve, with tobacco companies likely to appeal.

According to a report by the Winston-Salem Journal citing Barclays Bank analyst Jain Gaurav, it could take up to a decade to resolve whether the US Food and Drug Administration (FDA) has the authority to require a minimum nicotine level in traditional cigarettes.

 

On June 21st, the U.S. Food and Drug Administration officially announced its recommendation to lower the nicotine content in traditional cigarettes to the lowest possible level and achieve a level equivalent to being non-addictive.

 

It is expected that the FDA's proposal will trigger appeals from tobacco manufacturers, which could take several years to resolve.

 

In a recent investor statement, Barclays analyst Jain Gaurav stated, "We believe that due to the lengthy nine-step process of the FDA, inevitable litigation, and one year given to retailers to sell remaining stocks, it will take the FDA a decade or more to establish a nicotine cap.

 

The FDA will need to consider the opinions of stakeholders with interests related to science, law, enforcement, public health, industry, and budget, and will need to respond to all opinions before releasing the final regulations.

 

Some analysts are questioning whether the US Food and Drug Administration (FDA) has the authority to decrease the demand for legal products, as in this case, by lowering nicotine levels to 5% of most popular traditional cigarettes.

 

In June 2019, analysts at Morgan Stanley released a report titled "Industry Risk Navigator," which projected that if the US Food and Drug Administration successfully implemented significantly reduced levels of nicotine, tobacco companies would experience a significant decline in revenue, with a projected 50% decrease by the year 2034.

 

As nicotine levels decrease, even manufacturers who generate revenue from innovative nicotine products such as electronic cigarettes, non-burning traditional cigarettes, and oral nicotine products may experience a potential loss of up to $165 billion in overall profits for the tobacco industry over the next 15 years.

 

Analysts predict that the market value of BAT, which is currently at $88 billion, is likely to decrease by at most 13%. This is partly due to the fact that only 40% of BAT's profits come from the United States.

 

The only beneficiary of the proposal by the Food and Drug Administration (FDA) is the 22nd Century Group, which specializes in reducing nicotine and has expressed readiness to license their technology to other companies.

 

The FDA has authorized 22nd Century Group to sell its low-nicotine VLN King and VLN Menthol King cigarettes as modified-risk tobacco products. These are the only combustible cigarettes that the FDA has authorized during its process of modifying tobacco product risk. As of December 2021, they are the only cigarettes on the US market to have received this authorization.

 

Source: Tobaccoreporter.

 


Disclaimer

This article is provided solely for professional research, industry discussion, and informational purposes. Any references to brands, companies, products, technologies, or policies are made for factual reporting and analytical purposes only, and do not constitute endorsement, recommendation, promotion, or advertising by 2Firsts.

Nicotine-containing products, including but not limited to cigarettes, e-cigarettes, heated tobacco products, and nicotine pouches, carry significant health risks. Readers are responsible for complying with all applicable laws and regulations in their respective jurisdictions, including age restrictions and access limitations.

The information contained in this article should not be regarded as investment, legal, medical, regulatory, or commercial advice. While 2Firsts strives to ensure the accuracy and reliability of its content, it does not assume liability for any direct or indirect loss arising from errors, omissions, inaccuracies, or reliance on the information contained herein.

This article is not intended for individuals below the legal age for accessing tobacco or nicotine-related information in their jurisdiction.

 

Copyright Notice

This article is either original content produced by 2Firsts or content reproduced, translated, summarized, or adapted from third-party sources with attribution where applicable. The intellectual property rights of the original content remain with 2Firsts or the respective original rights holders.

No individual or organization may copy, reproduce, distribute, republish, modify, translate, or otherwise use this content without prior authorization. Any unauthorized use may result in legal action.

For copyright-related inquiries, corrections, or removal requests, please contact: info@2firsts.com.

 

AI-Assisted Translation and Editing Notice

Portions of this article may have been translated, edited, or reviewed with the assistance of artificial intelligence tools to improve efficiency and readability. Due to the limitations of AI-assisted translation and editing, discrepancies, omissions, or inaccuracies may exist when compared with the original source.

Where applicable, readers are advised to refer to the original source for the most complete and accurate information. If you identify any errors or believe that any content infringes upon your rights, please contact us at info@2firsts.com, and we will review and address the matter promptly.

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
JAMA Study: U.S. Vape Directories Fail to Sustainably Curb Unlisted Sales as Product Shifts May Redistribute Brand Share 2Firsts Recommended
JAMA Study: U.S. Vape Directories Fail to Sustainably Curb Unlisted Sales as Product Shifts May Redistribute Brand Share 2Firsts Recommended
A study by CDC Foundation researchers found no sustained decline in e-cigarette sales across Alabama, Oklahoma and Louisiana, the first three U.S. states to implement e-cigarette directory laws. Louisiana initially saw a significant sales decline, followed by a rebound and a persistent reduction in product availability. Sales also shifted from nontobacco-flavored disposables toward prefilled cartridges, with Vuse Alto driving much of the increase in menthol cartridges. By April 2025, unlisted products still accounted for more than half of e-cigarette nicotine sales in all three states.
Sep.18
Product | RELX Partners With UK E-Liquid Brand T-Juice for Prime Pro × Red Astaire Bundle in France
Product | RELX Partners With UK E-Liquid Brand T-Juice for Prime Pro × Red Astaire Bundle in France
RELX and UK e-liquid brand T-Juice have launched the Prime Pro × Red Astaire bundle in France, combining the RELX Prime Pro open-system pod device with T-Juice’s signature Red Astaire nicotine salt e-liquid. The collaboration retains the existing Prime Pro hardware platform while using an established flavor brand to create a complete open-system offering. The product appeared in French retail and distribution channels in August 2026 and represents a co-branded retail bundle rather than a new device launch.
Aug.27
2Firsts Compliance Solutions Hosts PMTA Briefing on FDA Review Signals After JUUL2 Authorization
2Firsts Compliance Solutions Hosts PMTA Briefing on FDA Review Signals After JUUL2 Authorization
Following recent FDA authorizations for JUUL2 and ZYN ULTRA, 2Firsts Compliance Solutions held an online PMTA briefing on Sept. 4 to examine what the decisions may signal about review efficiency, scientific evidence and U.S. market access. Nearly 30 participants from brands, manufacturers, compliance service providers and investment firms joined the discussion.
2Firsts Events
Sep.06
PMI Expands U.S. ZYN Portfolio With New 1.5 mg and 8 mg Strengths, Moves Toward a Unified 20-Pouch-Per-Can Format
PMI Expands U.S. ZYN Portfolio With New 1.5 mg and 8 mg Strengths, Moves Toward a Unified 20-Pouch-Per-Can Format
Philip Morris International is expanding its U.S. ZYN nicotine pouch portfolio with new 1.5 mg and 8 mg strengths and plans to move its core 3 mg and 6 mg dry-pouch products from 15 to 20 pouches per can in the fourth quarter of 2026. ZYN ULTRA is also commercially available, with FDA authorization covering 10 products at 9 mg and one 11 mg Smooth product. PMI U.S. lists the new 1.5 mg and 8 mg strengths as commercially available, but as of September 10 they do not appear on the FDA’s public authorization list. Public materials do not identify which PMTA submissions cover the two new strengths or their current review status.
Sep.11
Reynolds Seeks to Join Altria Lawsuit Challenging FDA PMTA Rule and Calculation of 180-Day Deadline
Reynolds Seeks to Join Altria Lawsuit Challenging FDA PMTA Rule and Calculation of 180-Day Deadline
Three R.J. Reynolds companies are seeking to intervene in a lawsuit filed by Altria subsidiaries Helix Innovations and NJOY challenging the FDA's 2021 PMTA final rule. The companies dispute how the agency uses Acceptance and Filing reviews and completeness determinations to establish when the Tobacco Control Act's 180-day decision period begins. Reynolds has also linked prolonged PMTA reviews to competition from unauthorized vaping products. The FDA, meanwhile, has been accelerating reviews and reducing its backlog.
Sep.14