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

Zhang Xiaotang Appointed Deputy Director of China’s Tobacco Regulator, Adding Another Finance-Background Official to Top Leadership
Zhang Xiaotang Appointed Deputy Director of China’s Tobacco Regulator, Adding Another Finance-Background Official to Top Leadership
China’s State Council has appointed Zhang Xiaotang as deputy director of the State Tobacco Monopoly Administration, with the regulator’s official website now listing him as a Party leadership group member and deputy director. Zhang previously led Hebei China Tobacco and earlier headed the STMA’s finance and audit department. His appointment follows the elevation earlier this year of former tax official Yao Laiying to head the STMA, adding another senior official with a strong fiscal or financial-management background to China Tobacco’s top leadership in 2026.
News
Sep.20
New York City Opens Lottery for 55 Vape Retail License Slots Across 23 Community Districts, Including 28 in Brooklyn
New York City Opens Lottery for 55 Vape Retail License Slots Across 23 Community Districts, Including 28 in Brooklyn
New York City's Department of Consumer and Worker Protection (DCWP) opened applications on November 2, 2026, for a lottery covering tobacco and electronic cigarette retail dealer licenses, with a deadline of 5 p.m. New York local time on November 30. According to the city's October 1 notice, 55 electronic cigarette retail license slots are available across 23 community districts, including 28 in Brooklyn, alongside 322 tobacco retail license slots across 41 districts. Businesses must enter the lottery and, if invited, complete licensing requirements within 65 days. New York City continues to restrict e-cigarette retail sales to tobacco-flavored or unflavored products, while city retail licenses do not replace FDA product marketing authorization.
Market
Nov.04
Special Report | From New York to Washington: How FDA’s Tobacco Center Is Reworking Product Review
Special Report | From New York to Washington: How FDA’s Tobacco Center Is Reworking Product Review
FDA’s Center for Tobacco Products is reshaping how it approaches tobacco product review. Based on 2Firsts’ on-site reporting in New York and Washington, this report traces CTP’s emerging direction: stronger links between PMTA and tobacco harm reduction, more category-specific review, greater emphasis on decision-relevant science, more predictable timelines and expanded use of sPMTA for product modifications. CTP also acknowledged major constraints, including just nine PMTA review teams, persistent backlogs and limits on hiring capacity.
Regulations
Oct.08
Russia's Vape Ban Decisions Reach 17 Regions With 39 More Considering Laws, Putting Over 3,000 St. Petersburg Retail Outlets in Focus
Russia's Vape Ban Decisions Reach 17 Regions With 39 More Considering Laws, Putting Over 3,000 St. Petersburg Retail Outlets in Focus
Russia's regional vape retail restrictions are expanding. State Duma Speaker Vyacheslav Volodin said on November 7 that 17 regions had adopted decisions to ban vape sales, while another 39 were preparing or considering similar legislation. On November 12, lawmakers in Leningrad Oblast and the Republic of Karelia adopted bans scheduled to begin on March 1, 2027. A day earlier, St. Petersburg unanimously approved a five-year ban proposal in its first reading. The city has 615 specialist vape shops and more than 2,400 other retail outlets selling vaping products alongside other goods. Under Federal Law No. 186-FZ, enacted in June 2026, Russian regions may prohibit retail sales of electronic nicotine delivery systems and related liquids between March 2027 and March 2032. The legislation also restricts licensed suppliers from delivering covered products to retail premises in regions where bans apply.
Regulations
Nov.13
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
Product | JT Launches Three Autumn-Limited Ploom Tobacco Sticks in Japan Across EVO, MEVIUS and CAMEL Brands
Product | JT Launches Three Autumn-Limited Ploom Tobacco Sticks in Japan Across EVO, MEVIUS and CAMEL Brands
Japan Tobacco Inc. (JT) launched three limited-edition autumn tobacco sticks for its Ploom heated tobacco devices in Japan on October 16, 2026, under the EVO, MEVIUS and CAMEL brands. All three are regular tobacco variants with seasonal packaging. Each pack contains 20 sticks, priced at ¥620, ¥590 and ¥570, respectively, including tax. The products are compatible with all Ploom devices and are sold in limited quantities exclusively through the CLUB JT online store while supplies last.
product
Oct.20