FDA: No Screened E-Cigs in US Have Marketing Granted Orders under PMTA Pathway Currently

Regulations by 2FIRSTS, edited by Sophia Lv
Jul.29.2024
FDA: No Screened E-Cigs in US Have Marketing Granted Orders under PMTA Pathway Currently
On July 27th, Jim McKinney, the FDA's Press Officer, discussed the regulatory issues surrounding screened e-cigarettes.

Editor's Note: On July 27th, 2FIRSTS contacted the U.S. Food and Drug Administration (FDA) regarding the popular screened e-cigarettes in the American market. Jim McKinney, FDA's Press Officer, responded to 2FIRSTS via email on this issue. 

 


 

Since the second half of 2023, screened e-cigarettes have been gradually gaining popularity in the US market. Now, on e-cigarette distributor websites in the US, a wide variety of screened e-cigarette products and their advertisements are displayed. As an innovative development in the e-cigarette industry, what is the US FDA's stance on screened e-cigarettes? On July 27th, Jim McKinney, the FDA's Press Officer, discussed the regulatory issues surrounding screened e-cigarettes.

 

In a contact, Jim told 2FIRSTS that so far, the FDA has authorized 34 e-cigarette products and devices, however, none of these products have screens. At the same time, the FDA remains vigilant in overseeing the market and continues to prioritize the use of enforcement resources to curb illegal marketing of tobacco products throughout the supply chain. Unauthorized tobacco products will face enforcement action, including products with screens.

 

The following is a transcript of the contact:

 

1.     Has FDA noticed the trend of popularizing disposable e-cigarettes with large screens in the US market?

 

To date, the FDA has authorized 34 e-cigarette products and devices – none of which have screens. These are the only e-cigarette products that currently may be lawfully marketed and sold in the United States. Firms manufacturing, importing, selling or distributing e-cigarettes without the required premarket authorization risk compliance and enforcement actions, which can include warning letters, civil money penalties, no-tobacco-sale orders, seizures, injunctions and even criminal prosecution.

The FDA uses a variety of surveillance tools to monitor the evolving tobacco product landscape and to identify emerging threats to public health. As always, we are committed to holding those accountable who manufacture, import, distribute or sell unauthorized tobacco products, including products labeled, advertised and/or designed to encourage youth use. This includes unauthorized e-cigarette products with screens.

 

2.     In FDA's view, what are the potential impacts of such large-screen e-cigarettes on the market and the environment?

 

Regarding environmental impacts, e-cigarettes contain lithium batteries, which can become damaged and cause fires. Additionally, e-cigarettes typically contain nicotine, which is toxic and poses a risk to the environment. Accordingly, the United States Environmental Protection Agency’s webpage, How to Safely Dispose of E-Cigarettes: Information for Individuals, includes important information and a printable fact sheet about proper and safe disposal of e-cigarettes. Most importantly, e-cigarettes should be taken to a household hazardous waste collection site and not disposed in household trash or recycling. 

 

3.     Do disposable e-cigarettes with large screens pose new challenges or demands on existing regulatory policies? How will FDA respond to these challenges and ensure public health and safety?

 

The FDA is vigilant in overseeing the market and continuing to prioritize the use of enforcement resources to curb the unlawful marketing of tobacco products across the entire supply chain. Unauthorized tobacco products are subject to enforcement – which includes products with screens. Attempting to import such unauthorized products, including those that may be misdeclared or misrepresented as other types of products, subjects them to refusal or destruction. The FDA and other federal agencies work together to bring all available criminal and civil tools to bear against the illegal distribution and sale of e-cigarettes responsible for nicotine addiction among American youth.

 

We welcome news tips, article submissions, interview requests, or comments on this piece.

Please contact us at info@2firsts.com, or reach out to Alan Zhao, CEO of 2Firsts, on LinkedIn


Notice

1.  This article is intended solely for professional research purposes related to industry, technology, and policy. Any references to brands or products are made purely for objective description and do not constitute any form of endorsement, recommendation, or promotion by 2Firsts.

2.  The use of nicotine-containing products — including, but not limited to, cigarettes, e-cigarettes, nicotine pouchand heated tobacco products — carries significant health risks. Users are responsible for complying with all applicable laws and regulations in their respective jurisdictions.

3.  This article is not intended to serve as the basis for any investment decisions or financial advice. 2Firsts assumes no direct or indirect liability for any inaccuracies or errors in the content.

4.  Access to this article is strictly prohibited for individuals below the legal age in their jurisdiction.

 

Copyright

 

This article is either an original work created by 2Firsts or a reproduction from third-party sources with proper attribution. All copyrights and usage rights belong to 2Firsts or the original content provider. Unauthorized reproduction, distribution, or any other form of unauthorized use by any individual or organization is strictly prohibited. Violators will be held legally accountable.

For copyright-related inquiries, please contact: info@2firsts.com

 

AI Assistance Disclaimer

 

This article may have been enhanced using AI tools to improve translation and editorial efficiency. However, due to technical limitations, inaccuracies may occur. Readers are encouraged to refer to the cited sources for the most accurate information.

We welcome any corrections or feedback. Please contact us at: info@2firsts.com

UK HMRC Issues One-Month Countdown Warning, Urges Vape Businesses to Prepare for New Tax Rules
UK HMRC Issues One-Month Countdown Warning, Urges Vape Businesses to Prepare for New Tax Rules
The UK’s Vaping Products Duty and Vaping Duty Stamps Scheme will take effect on October 1, 2026. All vaping liquids manufactured in or imported into the UK will face a flat excise duty of £2.20 per 10ml, whether or not they contain nicotine. Newly manufactured or imported products released onto the UK market from October 1 will require a valid duty stamp, while eligible existing unstamped inventory can continue to be sold through March 31, 2027. From April 1, 2027, all vaping products outside duty suspension must carry a valid stamp.
Sep.03
PMI Expands Its Second Global and First Asian Business Services Hub in the Philippines, Serving 160 Markets and Scaling Up AI Capabilities
PMI Expands Its Second Global and First Asian Business Services Hub in the Philippines, Serving 160 Markets and Scaling Up AI Capabilities
Philip Morris International's PMI Business Solutions Philippines has expanded its global business services hub in Makati and plans to add more than 80 positions. Established in 2021 primarily to provide finance and IT support to about 20 markets, the center now employs 519 professionals delivering roughly 600 services across 160 markets. Its functions now span finance, human resources, IT, commercial operations, data analytics, supply chain and project management. PMI says the hub's next phase will focus on AI-enabled and higher-value work. The company did not disclose the size or investment cost of the expansion.
Sep.24
Kelly White Bets on Female Consumers as Nicotine Pouch Competition Intensifies | 2Firsts Interview
Kelly White Bets on Female Consumers as Nicotine Pouch Competition Intensifies | 2Firsts Interview
Swedish nicotine pouch brand Kelly White is building its strategy around adult female consumers. Founder and CEO Sophia Wilsby told 2Firsts that women accounted for around 70% of the brand’s repeat customers on HAYPP in Sweden in 2025. The interview explores female consumer segmentation, product and design differentiation, gender stereotypes, packaging regulation, and how independent brands can compete with global players such as ZYN and VELO while considering funding, partnerships and future ownership options.
Business
Sep.24
German Tobacco Tax Revenue Falls 10.8% Through August as Tax-Paid Cigarette Volume Drops 12.6%
German Tobacco Tax Revenue Falls 10.8% Through August as Tax-Paid Cigarette Volume Drops 12.6%
Germany collected €9.789 billion in total tobacco tax revenue from January through August 2026, down 10.8% from a year earlier, according to the Federal Ministry of Finance. Germany's tobacco tax base covers not only cigarettes and fine-cut tobacco but also heated tobacco and vaping liquids taxed as tobacco substitutes. The German Association of the Tobacco Industry and Novel Products, or BVTE, citing federal statistical data, said tax-paid cigarette volume fell 12.6% to 40.6 billion sticks. BVTE is using the latest figures to argue against further tax increases planned from 2027 through 2030, while Germany's parliament is scheduled to hold a first reading of the bill on September 24.
Sep.23
Wall Street Journal: U.S. FDA Plans Faster Vape and Nicotine Pouch Reviews, Revisit of 2021 PMTA Rule
Wall Street Journal: U.S. FDA Plans Faster Vape and Nicotine Pouch Reviews, Revisit of 2021 PMTA Rule
The Trump administration is preparing changes intended to accelerate FDA market authorization reviews for e-cigarettes and nicotine pouches, according to The Wall Street Journal. The FDA is expected to revisit its 2021 PMTA rule and may simplify some scientific study requirements and shorten review times. The agency has not formally announced the changes. Over the past year, the FDA has already accelerated nicotine-pouch reviews, expanded ENDS authorizations and upgraded its CTP Portal NextGen application system. As of August 2026, 43 nicotine pouch products and 48 e-cigarette products had received FDA marketing authorization.
Sep.24
IVG Parent Secures HMRC Excise Warehouse and Duty Stamp Approvals Ahead of UK Vape Tax
IVG Parent Secures HMRC Excise Warehouse and Duty Stamp Approvals Ahead of UK Vape Tax
Acme Vape Ltd, the company behind UK vaping brand IVG, has received HM Revenue & Customs approval to operate an excise warehouse for vaping products and participate in the Vaping Duty Stamps Scheme. 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. Acme Vape Ltd says its approved warehouse in Preston will become operational under the new regime on the same date.
Regulations
Sep.18 by 2Firsts Perspectives