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 Tobacco Hubei explores staged nicotine pouch delivery, using dynamic membranes to slow early release and gradient particles to sustain later delivery
China Tobacco Hubei explores staged nicotine pouch delivery, using dynamic membranes to slow early release and gradient particles to sustain later delivery
China Tobacco Hubei Industrial Co., Ltd. disclosed several oral nicotine-related patent applications in August 2026, including two that approach staged nicotine release from different directions. One uses a high-viscosity membrane that forms inside the pouch after contact with saliva to slow rapid early release, while the other uses gradient particles with a faster-disintegrating outer layer and a slower core to create a fast-to-sustained release profile. Together, the filings explore how nicotine pouches could balance initial delivery with release later in use.
Sep.03
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
Product | JNR Launches Shisha Hookah 70K E-Hookah With 60ml E-Liquid and 0.6% Nicotine
Product | JNR Launches Shisha Hookah 70K E-Hookah With 60ml E-Liquid and 0.6% Nicotine
JNR has introduced the Shisha Hookah 70K, a high-capacity rechargeable disposable vape designed around a hookah-inspired experience. The device comes prefilled with 60ml of e-liquid at 6mg/ml (0.6%) nicotine strength, alongside a 1,000mAh rechargeable battery and a 0.38Ω single mesh coil. It also features adjustable airflow and battery and e-liquid level displays. JNR claims the device can deliver up to 70,000 puffs and offers more than 20 flavors. Retail listings for the product have appeared in markets including Tunisia.
Market
Aug.24 by 2Firsts Perspectives
From Nicotine Pouches to Soft Candy Forms: China Tobacco Hubei explores adjustable-release oral nicotine products
From Nicotine Pouches to Soft Candy Forms: China Tobacco Hubei explores adjustable-release oral nicotine products
China-based China Tobacco Hubei Industrial Co., Ltd. has filed a patent application covering an oral nicotine product and its preparation method. The patent proposes a soft candy-shaped oral nicotine product containing nicotine ingredients, gelling agents, sweeteners and alkaline pH regulators. Through formulation adjustments and homogeneous or dual-layer structures, the technology aims to achieve different nicotine release profiles. The filing reflects exploration of new oral nicotine product formats and controlled nicotine delivery approaches.
Aug.06
UK Vape Duty Starts in October as Hayati, DOJO and Others Launch Lower-Capacity Products With Lower Per-Unit Tax
UK Vape Duty Starts in October as Hayati, DOJO and Others Launch Lower-Capacity Products With Lower Per-Unit Tax
The UK's Vaping Products Duty will take effect on October 1, 2026, at a flat rate of £2.20 per 10ml of vaping liquid. Ahead of implementation, DOJO, PIXL and Hayati have introduced or been reported to be adding lower-capacity tiers alongside larger products. DOJO has added a 6ml BLAST7K Fresh below its 10ml BLAST10K Fresh, PIXL offers both a 12ml 8000 and a 6ml 5K, while retailer Ninja Vapes says Hayati is preparing a 7ml 4K alongside its existing 12ml 6K. The pattern points to a growing lower-capacity tier in the UK market, although the brands have not all explicitly linked the changes to the new duty.
Sep.23
Product | JT Refreshes Ploom CUBE Design and Expands Japan Retail Distribution, Targeting Younger Men and Female Users
Product | JT Refreshes Ploom CUBE Design and Expands Japan Retail Distribution, Targeting Younger Men and Female Users
Japan Tobacco (JT) launched a refreshed Ploom CUBE design in Japan on September 8, 2026, with broader convenience-store and tobacco-retail distribution planned from October 13. The updated device retains the existing Rounded Cube form and heating platform while replacing four previous body colors with Pebble White and Cobalt Black. JT is also introducing new Front Panels and Fabric Back Covers, although the new accessories are not compatible with the previous Ploom CUBE design. The company says the update is intended to broaden appeal among younger male and female users.
Sep.09