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.

China’s Jiangsu Tobacco Monopoly Bureau and Drug Regulator Target Illegal Vape Sales Disguised as Medical Devices, Define Six Violations
China’s Jiangsu Tobacco Monopoly Bureau and Drug Regulator Target Illegal Vape Sales Disguised as Medical Devices, Define Six Violations
China’s Jiangsu Tobacco Monopoly Bureau and Jiangsu Provincial Medical Products Administration have issued a joint notice targeting illegal production and sales of vape products disguised as medical devices. The notice identifies six categories of violations, including obtaining medical licenses through false materials, misusing medical device credentials, expanding production beyond approved scopes, and using medical device-related online platforms to promote or sell vape products. The action is based on China’s tobacco and medical device regulations and aims to strengthen vape oversight and consumer protection.
Aug.04
Spain Plans to Extend Smoking Ban to Terraces and Beaches, Bringing Vapes Under New Restrictions
Spain Plans to Extend Smoking Ban to Terraces and Beaches, Bringing Vapes Under New Restrictions
Spain is advancing a new tobacco-control reform that would expand smoking restrictions to additional public spaces, including restaurant terraces and beaches, while bringing vaping and other nicotine products into the same regulatory framework. The proposed measures aim to reduce secondhand smoke exposure, protect young people and expand smoke-free environments. The proposal remains under legislative development, and final implementation details have not yet been confirmed.
Jul.23
Altria Smokeable Profit Rises 2.4% as Marlboro Share Falls and U.S. Discounts Gain
Altria Smokeable Profit Rises 2.4% as Marlboro Share Falls and U.S. Discounts Gain
Altria’s second-quarter results show a U.S. nicotine market splitting across price, product and regulation. Smokeable profit rose 2.4% as Marlboro pricing offset lower volumes, while discount brand Basic gained share among value-conscious smokers. In oral nicotine, on! PLUS expanded distribution but faced intensifying competition from ZYN and Velo. NJOY remained off the market as patent and regulatory hurdles delayed its return. The broader lesson: U.S. growth increasingly depends on price-tier strategy, retail execution, authorisation and enforcement readiness across the industry.
Special Report
Jul.31
UK HMRC Plans 30,000 Retail Enforcement Actions as Illegal Tobacco and Vape Sellers Face Tougher Crackdown
UK HMRC Plans 30,000 Retail Enforcement Actions as Illegal Tobacco and Vape Sellers Face Tougher Crackdown
The UK government has announced that HM Revenue & Customs (HMRC) will carry out more than 30,000 interventions targeting businesses and retail premises during the 2026-2027 financial year. The actions will focus on tax fraud, illegal goods sales and businesses involved in unlawful activities through retail channels. The government said illegal tobacco and illegal vape sales remain areas of concern. The move shows that UK enforcement against illegal nicotine products is expanding from import and supply channels toward retail-level oversight, alongside the upcoming introduction of the Vaping Products Duty.
Jul.24
Russian Strikes Destroy JTI and Imperial Brands Ukraine Warehouses, With Losses Reaching Tens of Millions of Hryvnias
Russian Strikes Destroy JTI and Imperial Brands Ukraine Warehouses, With Losses Reaching Tens of Millions of Hryvnias
According to Ukrainska Pravda, Russian strikes on the Kyiv region during the night of Aug. 4-5, 2026, damaged warehouses storing products of Japan Tobacco International (JTI) and Imperial Brands Ukraine. JTI said a finished goods warehouse in Kyiv Oblast was destroyed, with no employees injured, and that it did not expect disruptions to retail supplies. Imperial Brands Ukraine said products stored at warehouses of distributors and retail partners were affected and estimated losses from the strikes at “tens of millions of Ukrainian hryvnias” (roughly hundreds of thousands of U.S. dollars).
JTI
Aug.07
China’s HTP Exports Fell 14.3% in H1 2026 as Russia and Belarus Accounted for 76% Lead
China’s HTP Exports Fell 14.3% in H1 2026 as Russia and Belarus Accounted for 76% Lead
In H1 2026, China’s HS 24041100 exports stood at $1.32 million, down 14.3% YoY, with volume falling 17.2% to 55.33 tons. Market distribution shifted drastically amid overall export drops. Exports to Russia and Belarus totaled $1 million, taking 76.0% of all shipments versus 29.5% in H1 2025. Belarus became the top destination with export value jumping 177.5%, while the Philippines, Singapore and Indonesia’s combined share slumped from 49.3% to 11.2%.Domestically, Yunnan led exporter registrations; Jiangsu and Shanghai were key suppliers, yet Anhui and Sichuan had no exports. Heavy concentration means order or declaration changes for Russia/Belarus greatly affect national aggregate data. The data shows customs entry points (not end markets), covering tobacco consumables only, excluding heating equipment and the complete HTP supply chain.
Aug.11