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.

 

This document has been generated through artificial intelligence translation and is provided solely for the purposes of industry discourse and learning. Please note that the intellectual property rights of the content belong to the original media source or author. Owing to certain limitations in the translation process, there may be discrepancies between the translated text and the original content. We recommend referring to the original source for complete accuracy. In case of any inaccuracies, we invite you to reach out to us with corrections. If you believe any content has infringed upon your rights, please contact us immediately for its removal.

Germany Sees 18.2% Jump in Taxed Tobacco Substitutes in 2025, Including E-liquids
Germany Sees 18.2% Jump in Taxed Tobacco Substitutes in 2025, Including E-liquids
Germany’s Federal Statistical Office (Destatis) said 66.4 billion cigarettes were taxed in 2025, up 0.2% from 2024, while long-term volumes have more than halved since 1991 and per-capita consumption fell to 795 cigarettes. Taxed tobacco substitutes such as e-cigarette liquids reached 1.5 million liters, up 18.2% year on year.
Jan.26 by 2FIRSTS.ai
JTI reshuffles regional leadership; Gabriella Offeddu to lead Romania, Moldova and Bulgaria
JTI reshuffles regional leadership; Gabriella Offeddu to lead Romania, Moldova and Bulgaria
Japan Tobacco International (JTI) has appointed Gabriella Offeddu as general manager for Romania, Moldova and Bulgaria, effective January 2026.
Jan.22 by 2FIRSTS.ai
After Export Tax Rebates Go to Zero: How China’s E-Cigarette Supply Chain Is Being Reshaped, According to 2Firsts Research
After Export Tax Rebates Go to Zero: How China’s E-Cigarette Supply Chain Is Being Reshaped, According to 2Firsts Research
China’s e-cigarette industry is adjusting to a major policy shift. From April 1, 2026, China will scrap the 13% export VAT rebate on e-cigarette products, a move affecting manufacturers centered in Shenzhen. Industry participants told 2Firsts the change is forcing a reassessment of pricing and capacity, with competition shifting toward cash flow resilience, regulatory compliance, and multi-location strategies.
Industry Insight
Jan.16
European survey: current e-cigarette use among 15–19-year-olds rises from 14% (2019) to 22% (2024)
European survey: current e-cigarette use among 15–19-year-olds rises from 14% (2019) to 22% (2024)
A European study cited in the report says the share of young people aged 15 to 19 who are current e-cigarette users increased from 14% in 2019 to 22% in 2024, with Italy reflecting the broader European pattern. Over the same period, conventional cigarette smoking among young people is described as declining, with the proportion of students who have smoked at least once in their lifetime falling sharply from 1995 to 2024, and the largest drop occurring between 2019 and 2024.
Feb.12 by 2FIRSTS.ai
Walgreens Brings Vapes Back to Some U.S. Stores; Juul Says It’s in or Near 6,000 Locations
Walgreens Brings Vapes Back to Some U.S. Stores; Juul Says It’s in or Near 6,000 Locations
Walgreens has begun selling vape products again in some U.S. stores, marking a notable reversal after the chain pulled vapes from shelves in 2019 amid concerns over youth use and health risks. Juul says it is expanding across thousands of Walgreens locations, and NJOY also lists Walgreens stores as retailers.
Jan.26 by 2FIRSTS.ai
PMTA Manufacturing Panel Sees Small Firms Warn “Unknown Is Death” as FDA Defends Review Boundaries
PMTA Manufacturing Panel Sees Small Firms Warn “Unknown Is Death” as FDA Defends Review Boundaries
During FDA’s Feb 10 PMTA roundtable (manufacturing controls panel), small ENDS manufacturers warned that uncertainty in manufacturing expectations creates existential financial risk. FDA officials reiterated review flexibility is constrained by statutory and scientific boundaries. The panel debated testing standards, documentation requirements, open-system responsibility, supply chain changes, and software updates—highlighting unresolved PMTA challenges for small manufacturers.
Feb.11