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.

BAT Adds Former Apple General Counsel Bruce Sewell to Board as Finance, Legal, Marketing and Regional Leadership Shift
BAT Adds Former Apple General Counsel Bruce Sewell to Board as Finance, Legal, Marketing and Regional Leadership Shift
British American Tobacco has appointed former Apple Senior Vice President, General Counsel and Secretary Bruce Sewell as an independent non-executive director, effective January 1, 2027. He will also join BAT's Audit and Nominations Committees. BAT Chair Luc Jobin highlighted Sewell's experience in technology, government and regulatory affairs, public-company governance and AI-company boards. Over the past 18 months, BAT has changed or announced changes to its CFO, general counsel, CMO and APMEA regional leadership, while the main board has also seen multiple changes. The appointment comes as BAT advances Horizon 2030 and its Fit2Win transformation while expanding New Categories and reshaping parts of its digital, technology and operating structure.
Business
Oct.29
UK Directors Banned After 352,688 Vapes Imported From China Were Misdeclared as Medical Nebulizers in £15 Million Tax Case
UK Directors Banned After 352,688 Vapes Imported From China Were Misdeclared as Medical Nebulizers in £15 Million Tax Case
The UK Insolvency Service said YSK Enterprises imported large quantities of vapes from China in 2023, with a shipment addressed to the company declared as medical nebulizers before Border Force found 352,688 vaping products. HMRC calculated nearly £15 million ($20.3 million) in unpaid VAT and customs duty, alongside about £437,000 in corporation tax. Two directors were disqualified for nine years. The case predates the UK's Vaping Products Duty, which will introduce vape-specific excise and duty-stamp requirements from October 2026.
Regulations
Sep.11
Special report|Indonesia's Vape Industry Has 200 Manufacturers and $1.7 Billion in Investment. Could a Regulatory Divide Derail Its Rise as the World's No. 2 Manufacturing Hub After Shenzhen?
Special report|Indonesia's Vape Industry Has 200 Manufacturers and $1.7 Billion in Investment. Could a Regulatory Divide Derail Its Rise as the World's No. 2 Manufacturing Hub After Shenzhen?
Indonesia's Ministry of Industry said at a November 3, 2026, policy forum that the country has about 200 electronic cigarette companies, Rp31 trillion (approximately $1.71 billion) in cumulative industry investment and around 100,000 jobs across the supply chain. The National Narcotics Agency is seeking a comprehensive ban on vape use and circulation, while the industry ministry favors tighter import, product-standard and distribution controls. Indonesia exported approximately $518 million in vaping products in 2025, and Chinese manufacturers including Smoore, GEEKVAPE and Jinjia Group have established local operations. An international logistics specialist interviewed by 2Firsts said more Chinese vape companies began production in Indonesia from the second half of 2025, accompanied by increased shipments of manufacturing equipment and investment in logistics facilities. The regulatory debate comes as Indonesia expands its role in international vaping manufacturing.
Special Report
Nov.05
Global Nicotine-Pouch E-Commerce Group Haypp Shuts Sweden’s Snusnetto Over Age Verification as Identity Checks Become Industry Infrastructure for New Nicotine Products
Global Nicotine-Pouch E-Commerce Group Haypp Shuts Sweden’s Snusnetto Over Age Verification as Identity Checks Become Industry Infrastructure for New Nicotine Products
Sweden's Supreme Administrative Court has declined to hear an appeal over age verification for tobacco and nicotine products collected from parcel lockers, leaving in place a lower-court ruling that geo-located BankID verification is insufficient to securely verify the actual recipient. Haypp Group has stopped tobacco and nicotine sales through Snusnetto and is deploying a new system across its other Swedish e-commerce sites to verify the age of the person who actually opens the locker and receives the shipment. The change comes as age verification across next-generation nicotine products expands from purchase checks into retail, delivery and, for some e-cigarettes, device access itself.
Regulations
Oct.20
Beyond IQOS ILUMA, PMI Expands Lower-Priced BONDS Heated Tobacco Platform: Seven Markets Added in Q3, With Rollouts in Japan, Europe and North Africa
Beyond IQOS ILUMA, PMI Expands Lower-Priced BONDS Heated Tobacco Platform: Seven Markets Added in Q3, With Rollouts in Japan, Europe and North Africa
Philip Morris International (PMI) is expanding the international footprint of BONDS by IQOS, its lower-priced heated tobacco platform. The company's third-quarter 2026 SEC filing shows that BONDS devices and BLENDS tobacco sticks were available in 15 markets at the end of September, up from eight at the end of June. In November, PMI announced plans to extend sales from three to 17 Japanese prefectures and introduced BONDS in Spain and Morocco. The platform uses ROUNDHEAT external heating technology and proprietary tobacco sticks, separate from the IQOS ILUMA system. In Japan, BONDS retails for ¥2,980, approximately 25% below ILUMA i ONE, while BLENDS costs ¥570 per pack. PMI management says BONDS targets cigarette smokers who have not adopted heated tobacco. Separate sales and revenue figures remain undisclosed.
company
Nov.06
Altria’s USSTC Starts $250 Million Kentucky Expansion, Adding More Than 200 Jobs
Altria’s USSTC Starts $250 Million Kentucky Expansion, Adding More Than 200 Jobs
U.S. Smokeless Tobacco Company, an Altria Group company, has broken ground on an approximately $250 million manufacturing expansion in Hopkinsville, Kentucky. The roughly 270,000-square-foot facility is expected to create more than 200 jobs and absorb processing, manufacturing and packaging operations currently split between Hopkinsville and Nashville, Tennessee. USSTC previously said production at its Nashville facility is expected to wind down by early 2028. The project forms part of Altria’s broader effort to modernize and consolidate its U.S. smokeless tobacco manufacturing network.
Sep.10