FDA Warns 61 Retailers for Unauthorized E-cigarette Sales in USA

Mar.27.2024
FDA Warns 61 Retailers for Unauthorized E-cigarette Sales in USA
FDA Issues Warnings to 61 Retailers Selling Unauthorized E-Cigarette Products, including popular brands among teenagers.

According to a statement from the U.S. Food and Drug Administration (FDA) on March 26th, the FDA has issued warning letters to 61 retail entities for selling unauthorized e-cigarette products. The warning letters specifically mention the sale of disposable e-cigarette products under the Elf Bar/EB Design and Lava brands.


The FDA stated that these warning letters are the result of long-term monitoring of multiple surveillance systems and their findings, with the aim of identifying products commonly used or popular among adolescents. Research results from the 2023 national youth tobacco survey showed that over 50% of adolescent e-cigarette users reported using the Elf Bar brand; in 2023, the manufacturer of Elf Bar began marketing their products under the name "EB Design". Furthermore, after reviewing retail sales data and recent youth survey data, the FDA has identified the Lava brand as popular among adolescents.


These retailers who received warning letters are selling or distributing e-cigarette products in the United States without FDA authorization, which violates the Federal Food, Drug, and Cosmetic Act. The recipients of the warning letters have been given 15 business days to respond, correct the violations, and prevent future violations. Failure to promptly correct the violations may result in the FDA taking further action, such as injunctions, seizure, and/or civil penalties.


These warning letters are part of the FDA's ongoing efforts to address the marketing and sales of unauthorized e-cigarettes targeting youth, including previous warning letters sent to online retailers selling similar unauthorized e-cigarettes.


So far, the FDA has issued more than 550 warning letters to retailers selling unauthorized e-cigarettes and has taken over 100 civil penalty actions.


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

PMI says Colorado ZYN plant build advances as first pouches hit market in 2025
PMI says Colorado ZYN plant build advances as first pouches hit market in 2025
Philip Morris International (PMI) is investing $600 million to build a ZYN nicotine pouch plant in Aurora, Colorado. While the facility is still under construction, PMI said production started in September 2025 and the first pouches made at the site have already gone to market.
Feb.10 by 2FIRSTS.ai
FDA PMTA Roundtable: Ongoing Comprehensive Coverage by 2Firsts
FDA PMTA Roundtable: Ongoing Comprehensive Coverage by 2Firsts
Feb.11
Philip Morris International: Over $20 Billion Invested in the U.S. Since 2022; IQOS ILUMA to Launch Pending FDA Authorization
Philip Morris International: Over $20 Billion Invested in the U.S. Since 2022; IQOS ILUMA to Launch Pending FDA Authorization
Philip Morris International (PMI) said its U.S.-related investments have topped $20 billion since 2022, when it entered the U.S. market through its roughly $19 billion acquisition of Swedish Match. The company also said it plans to launch its heated tobacco product IQOS ILUMA in the United States pending authorization from the U.S. Food and Drug Administration (FDA).
Jan.16 by 2FIRSTS.ai
FDA schedules online roundtable to gather small manufacturers’ input on ENDS PMTA requirements
FDA schedules online roundtable to gather small manufacturers’ input on ENDS PMTA requirements
FDA announced it will convene a Feb. 10, 2026 roundtable with small tobacco product manufacturers to gather feedback on PMTA submissions for ENDS products. The discussion will be viewable online, and a public docket is open for comments through March 12, 2026.
Feb.10 by 2FIRSTS.ai
Alan Zhao: What Altria’s on! PLUS Authorization Really Signals About FDA PMTA Enforcement
Alan Zhao: What Altria’s on! PLUS Authorization Really Signals About FDA PMTA Enforcement
In this in-depth commentary for 2Firsts, Alan Zhao examines what Altria’s on! PLUS authorization really signals about FDA PMTA enforcement. Beyond the headline approval, FDA’s language, process design and product choices offer rare insight into how nicotine pouch regulation is taking shape—and what it means for industry compliance, in one of the earliest expert reads of the decision.
Regulations
Dec.20 by 2Firsts Perspectives
Korea’s MFDS sets 2026 plan to manage and disclose harmful constituents in tobacco products
Korea’s MFDS sets 2026 plan to manage and disclose harmful constituents in tobacco products
South Korea’s Ministry of Food and Drug Safety (MFDS) said it has established its 2026 work plan to systematically manage harmful constituents in tobacco products and disclose related information under the Tobacco Harmfulness Management Act, which took effect in November 2025.
Jan.16 by 2FIRSTS.ai