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

JTI Invests ₱2.1 Billion to Upgrade Batangas Manufacturing Hub, Adds First Southeast Asia DIET Facility
JTI Invests ₱2.1 Billion to Upgrade Batangas Manufacturing Hub, Adds First Southeast Asia DIET Facility
JTI Asia Manufacturing Corp. has invested ₱2.1 billion, or about $37 million, in its manufacturing site in Malvar, Batangas, Philippines, to expand tobacco-processing capabilities. About ₱1.9 billion is allocated to JTI's first Dry Ice Expanded Tobacco, or DIET, facility in Southeast Asia, while more than ₱177 million has been spent on expanding its Controlled Atmosphere treatment facility. The Batangas plant supplies the Philippine market and exports to 22 overseas markets, making it one of JTI's key manufacturing hubs in Asia.
Sep.24
Wisconsin Vape Directory One Year On: Retailer Reports Four Store Closures and 70% Staff Cuts
Wisconsin Vape Directory One Year On: Retailer Reports Four Store Closures and 70% Staff Cuts
Wisconsin's electronic vaping device directory has been fully enforced for more than a year, and local vape retailers say the reduced range of eligible products has contributed to declining sales, store closures and layoffs. Johnny Vapes owner Ben Hall said he has closed four of seven locations and cut about 70% of his staff. State law bars the sale of vaping devices not listed on the Wisconsin Department of Revenue directory and allows penalties of $1,000 per day for each unlisted device sold or offered for sale. In April 2026, the U.S. Court of Appeals for the Seventh Circuit allowed enforcement of the law to continue.
Regulations
Oct.10
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
Germany Probes 7.6 Million Illegal Vape Case With Estimated €33.3 Million Tax Loss; Four Chinese Manufacturer Employees Under Investigation, Some Packaging in Enforcement Images Resembles FUMOT Products
Germany Probes 7.6 Million Illegal Vape Case With Estimated €33.3 Million Tax Loss; Four Chinese Manufacturer Employees Under Investigation, Some Packaging in Enforcement Images Resembles FUMOT Products
German prosecutors and customs authorities are conducting a criminal investigation into an alleged cross-border organised vape network. Authorities say that between January 2024 and March 2025, four employees of an unnamed Chinese e-cigarette manufacturer allegedly built a network of sales agents and wholesalers that brought more than 7.6 million nicotine disposable vapes into Germany, causing an estimated €33.3 million in excise-tax losses. The manufacturer has not been named. Some products visible in enforcement images have packaging resembling products from FUMOT’s portfolio. European regulatory records from 2024, FUMOT’s public overseas-sales materials and records involving German vape importer and distribution company Zamu-Pro GmbH also show FUMOT/RandM products and German distribution activity during the period covered by the investigation.
Sep.21
UK Extends Age-18 Rules to Zero-Nicotine Vapes and Nicotine Pouches From Oct. 29, Bans Vending Machines and Promotional Giveaways
UK Extends Age-18 Rules to Zero-Nicotine Vapes and Nicotine Pouches From Oct. 29, Bans Vending Machines and Promotional Giveaways
Key provisions of the UK's Tobacco and Vapes Act 2026 will take effect on Oct. 29, extending an age-18 sales restriction to all vaping and non-medicinal nicotine products. In England, Wales and Northern Ireland, the change brings zero-nicotine vapes within statutory age-of-sale rules and also covers products including nicotine pouches, strips and pearls. The law will also prohibit proxy purchasing for under-18s, consumer-facing vending machines, promotional giveaways and substantial discounts intended to promote vaping and nicotine products.
Regulations
Oct.10
Sweden Finds ZYN Ingredient Labels Noncompliant Over Generic Flavoring Disclosure, Swedish Match Faces SEK 2 Million Monthly Penalty
Sweden Finds ZYN Ingredient Labels Noncompliant Over Generic Flavoring Disclosure, Swedish Match Faces SEK 2 Million Monthly Penalty
Sweden's Public Health Agency has found ingredient labels on ZYN nicotine pouches sold by Philip Morris International subsidiary Swedish Match to be noncompliant, according to Dagens industri. The products' packaging listed 10 to 13 ingredients, compared with 11 to 42 in regulatory submissions, with multiple flavoring ingredients grouped under the generic term "aromer." The agency ordered corrective action, warning of a conditional penalty of SEK 2 million per month for noncompliance. The order applies only to products manufactured after the decision becomes legally effective and does not require recalls. Swedish Match disputes the agency's interpretation and plans to appeal.
PMI
Oct.22