The 2021 Synthetic Nicotine Regulation Act

Apr.21.2022
New Jersey congresswoman introduces a bill granting the FDA power to regulate synthetic nicotine products to protect minors.

On December 15th, New Jersey Representative Mikie Sherrill introduced the 2021 Nicotine Regulation Act, a bipartisan bill that grants the Food and Drug Administration (FDA) the regulatory power over synthetic nicotine products, analogous to that over tobacco-derived or tobacco-related nicotine products. This new legislation was enacted on March 15th and took effect on April 14th.

 

In a press release, Congressman Sherrill stated that the bill aims to protect minors. "This legislation will ensure that all tobacco products, including those made with synthetic nicotine, are regulated by the US Food and Drug Administration to protect our communities' children and those who may consider using these products.

 

Currently, the Federal Food, Drug, and Cosmetic Act (FDCA) defines "tobacco products" as "any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product." However, in addition to regulating synthetic nicotine as a component of tobacco products, the FDA also has the authority to regulate it as a drug.

 

During the discussion of this measure, Michael Landl, Director of the World Vapers' Alliance (WVA), a global harm reduction advocacy organization, explained how this regulation would harm current smokers and vapers.

 

The bill threatens the availability of less harmful alternatives to smoking, such as e-cigarettes, and poses a looming disaster for public health. By forcing thousands of e-cigarette shops to close, many smokers will be pushed back to smoking. Targeting specific products that help people quit smoking is pointless. Synthetic nicotine is an innovative way to reduce the harmful effects of smoking, providing people with an alternative to traditional cigarettes," said Landl.

 

The goal of harm reduction is to minimize the negative consequences for those unable to quit smoking. It has been proven effective in many countries around the world and has helped millions quit smoking. Free societies should follow the example of these countries instead of becoming nanny states.

 

Due to strict tobacco pre-market approval (PMTA) regulations, many brands have turned to synthetic nicotine.

 

At the same time, many people are turning to synthetic nicotine in an effort to avoid the rigorous, expensive, and often futile pre-market review process faced by tobacco product manufacturers in recent months, as millions of pre-market tobacco product applications (PMTAs) have been rejected.

 

This legislation will bring many negative consequences to the efforts to reduce tobacco harm, potentially restricting access to electronic cigarette products and forcing former smokers to return to smoking traditional cigarettes," added Landl.

 

Source: VapingPost

 

The ban on synthetic nicotine is counterproductive to public health for several reasons. Synthetic nicotine is not derived from tobacco, making it an alternative that could potentially help people who are trying to quit smoking tobacco. The ban will also lead to a black market for synthetic nicotine products, increasing the risk of dangerous and unregulated products. Additionally, it will limit innovation and research in the vaping industry, preventing the development of safer and more effective products. Therefore, experts argue that the ban on synthetic nicotine is misguided and could ultimately harm public health.

 


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.

Juul Sublicense Reshapes Vuse Alto Patent Bill as Court Ends R.J. Reynolds’ 5.25% Royalty Obligation to Altria
Juul Sublicense Reshapes Vuse Alto Patent Bill as Court Ends R.J. Reynolds’ 5.25% Royalty Obligation to Altria
According to Law360 on August 31, 2026, a federal judge in North Carolina ruled that a patent sublicense between R.J. Reynolds Vapor Co. and Juul Labs Inc. relieves Reynolds of its obligation to continue paying royalties to Altria Client Services LLC over Vuse Alto. A jury had previously found that Vuse Alto infringed three Altria patents and awarded approximately $95.2 million in past damages, after which Reynolds was ordered to pay an ongoing royalty equal to 5.25% of positive net sales. The new ruling finds that a valid sublicense can eliminate future infringement, potentially ending what Altria described as hundreds of millions of dollars in future royalties.
Sep.01
South Korea Constitutional Court Upholds Volume-Based E-Liquid Tax, With Challenged Rates at KRW 370 and KRW 628 per Milliliter
South Korea Constitutional Court Upholds Volume-Based E-Liquid Tax, With Challenged Rates at KRW 370 and KRW 628 per Milliliter
South Korea's Constitutional Court has upheld fixed taxes on nicotine-containing e-cigarette liquids based on solution volume, ruling that challenged provisions imposing KRW 370 per milliliter in individual consumption tax and KRW 628 per milliliter in tobacco consumption tax do not violate the Constitution. The cases stemmed from historical disputes involving importers that reported nicotine as being extracted from tobacco stems rather than leaves. South Korea has since broadened its tobacco definition to include synthetic nicotine, while current tax laws provide reduced rates for certain products not derived from tobacco.
Sep.18
China Tobacco Supply-Chain Leader Huabao’s Three-Way Transformation Takes Hold as Overseas Revenue Jumps 216%, Non-Flavor Businesses Reach 42.2% and the Company Expands Into Global Next-Generation Tobacco Supply Chains
China Tobacco Supply-Chain Leader Huabao’s Three-Way Transformation Takes Hold as Overseas Revenue Jumps 216%, Non-Flavor Businesses Reach 42.2% and the Company Expands Into Global Next-Generation Tobacco Supply Chains
Huabao’s H1 2026 results show the company advancing across three connected fronts: international expansion, entry into next-generation tobacco supply chains and diversification beyond its traditional tobacco-related base. Overseas revenue rose 216.08% to CNY 96.02 million, while non-flavor businesses reached 42.2% of total revenue. Huabao also said it had entered the supply chains of leading global tobacco customers, as its nutrition, food ingredient, fragrance and personal-care businesses gained ground in Europe, Southeast Asia, Australia and New Zealand. However, adjusted net profit increased only 2.78%, and next-generation tobacco revenue was not separately disclosed, showing that the transformation is reshaping revenue and customer exposure but has yet to translate fully into underlying earnings.
Aug.28
U.S. Health Groups Seek to Overturn FDA Enforcement Discretion for Pending PMTAs as Altria's Helix, NJOY and AVM Move to Intervene
U.S. Health Groups Seek to Overturn FDA Enforcement Discretion for Pending PMTAs as Altria's Helix, NJOY and AVM Move to Intervene
American Vapor Manufacturers (AVM) and Altria subsidiaries Helix Innovations and NJOY filed separate motions on October 7, 2026, seeking to intervene on the FDA's side in a lawsuit challenging its enforcement guidance for certain e-cigarette and nicotine pouch products with pending premarket tobacco product applications (PMTAs). Seven public health and tobacco-control organizations, including the Campaign for Tobacco-Free Kids, sued the agency in July to overturn the policy. AVM argues that vacating the guidance could disrupt orders, inventory, retail distribution and investments in regulatory submissions.
Regulations
Oct.09
Latest UK ONS Data: Vaping Rate Edges Down to 9.9% in 2025, a Year After Overtaking Cigarette Smoking
Latest UK ONS Data: Vaping Rate Edges Down to 9.9% in 2025, a Year After Overtaking Cigarette Smoking
Vaping prevalence in Great Britain edged down to 9.9% in 2025 from 10.0% in 2024, with the number of adult users holding at approximately 5.4 million for a second consecutive year, according to the Office for National Statistics (ONS). E-cigarette use had risen from 6.4% in 2020 to 10.0% in 2024, when it exceeded cigarette smoking prevalence for the first time. Cigarette smoking continued to decline to 8.7% in 2025, widening the gap to 1.2 percentage points. Daily vaping declined slightly, while usage among adults aged 25–34 increased despite falling rates in other age groups.
DATA
Oct.14
On-Site Report | After FDA Announces Review of PMTA Framework, CTP Director Details Reform Priorities
On-Site Report | After FDA Announces Review of PMTA Framework, CTP Director Details Reform Priorities
FDA CTP Director Bret Koplow used his FDLI keynote in Washington to outline how the agency is rethinking the PMTA framework. He discussed category-specific review, nicotine pouch and sPMTA pilots, AI-assisted review, a 70% reduction in pending applications, and a major staffing constraint: CTP currently has only nine scientific review teams. He also reaffirmed tobacco harm reduction while stressing youth protection, flavored products, risk communication, and the challenge of unauthorized e-cigarettes.
Regulations
Oct.06