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.

Swedish-Founded Nicotine Pouch Retailer GotPouches Shifts to U.S.-Based Operations, Reaching Over 25 States
Swedish-Founded Nicotine Pouch Retailer GotPouches Shifts to U.S.-Based Operations, Reaching Over 25 States
Swedish-founded online nicotine pouch retailer GotPouches has completed the localization of its U.S. operations under UpNorth Retail LLC, with corporate operations in Franklin, Tennessee, domestic fulfillment from Nashville and U.S.-based customer support. The company says its catalog covers more than 20 nicotine pouch brands and it currently serves customers in more than 25 U.S. states.
Sep.18
Charlie’s Bets on Age-Gating and 678 PMTA Assets as U.S. Vape Enforcement Landscape Shifts
Charlie’s Bets on Age-Gating and 678 PMTA Assets as U.S. Vape Enforcement Landscape Shifts
Charlie’s Holdings said in its latest shareholder letter that it is moving to commercialize PACHA products and monetize its PMTA assets as the FDA changes enforcement priorities for unauthorized ENDS products. Thirty PACHA SKUs were previously tentatively identified for a proposed public list of products that the FDA generally does not intend to prioritize for enforcement. Charlie’s is also preparing test-market sales of age-gated flavored disposables and says it currently holds 678 PMTA-related product assets while seeking additional strategic transactions and partnerships.
Sep.11
Reynolds Showcases Vuse Pro Flavors and VELO Nicotine Pouches at NACS Show 2026
Reynolds Showcases Vuse Pro Flavors and VELO Nicotine Pouches at NACS Show 2026
Reynolds American, a BAT subsidiary, showcased four Vuse Pro flavored e-cigarette pods and its VELO nicotine pouch portfolio at NACS Show 2026. Booth staff confirmed to 2Firsts that the Vuse Pro flavors are sold in the U.S., although they have not received FDA marketing authorization. BAT outlined plans to expand Vuse retail distribution and reported that VELO held a 30.5% year-to-date volume share of the U.S. modern oral nicotine category through August 2026. The booth also featured the newly launched VELO MAX range and merchandising displays combining cigarettes, vaping products and oral nicotine brands.
EXPO
Oct.09
Product | BAT Expands VELO Travellers’ Collection With Mexico, Spain and Sweden Summer Edition Nicotine Pouches
Product | BAT Expands VELO Travellers’ Collection With Mexico, Spain and Sweden Summer Edition Nicotine Pouches
British American Tobacco (BAT) Global Travel Retail has expanded the VELO Travellers’ Collection with three new Summer Editions: Mexico, Spain and Sweden. Inspired by destination themes, the new nicotine pouch variants are designed for global travel-retail channels. The launch further strengthens VELO’s positioning as a travel-retail exclusive product collection.
Aug.27
Latest UK ONS Data: 54% of Vapers Are Former Cigarette Smokers, 26% Also Smoke and 20% Never Smoked Regularly
Latest UK ONS Data: 54% of Vapers Are Former Cigarette Smokers, 26% Also Smoke and 20% Never Smoked Regularly
Former cigarette smokers accounted for an estimated 54% of current e-cigarette users in Great Britain in 2025, while 26% also smoked cigarettes and 20% had never regularly smoked, according to a 2Firsts analysis of Office for National Statistics (ONS) data. Among former cigarette smokers who currently vape, approximately 81% used e-cigarettes daily, compared with about 50% of dual users. The ONS found that 33.8% of current cigarette smokers also vaped in 2025, up from 10.6% in 2014. Approximately 1.1 million adults who had never regularly smoked cigarettes used e-cigarettes, representing 2.9% of that population, compared with 0.2% in 2014. The figures highlight differences in the composition, frequency of use and long-term trends across Britain's vaping population.
DATA
Oct.14
Product | PMI Launches ZYN Melts in UK, Extending ZYN Beyond Nicotine Pouches Into Dissolvable Tablets
Product | PMI Launches ZYN Melts in UK, Extending ZYN Beyond Nicotine Pouches Into Dissolvable Tablets
Philip Morris International (PMI) has launched ZYN Melts in the UK, introducing a fully dissolvable oral nicotine tablet format alongside the brand's existing nicotine pouches. The range includes Cool Mint and Peppermint, each offered at 1mg and 2mg of nicotine per tablet, creating four SKUs. Each can contains 20 tablets and is priced at £6.50 in the UK. Unlike ZYN nicotine pouches, Melts are placed between the upper lip and gum and dissolve completely during use.
News
Sep.29 by 2Firsts Perspectives