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

UK Vape Tax Countdown: Retailer Vape HQ Estimates 100ml E-liquid Prices Could Rise From £12.99 to £39.39, While Pod Kits Increase Less Than 10%
UK Vape Tax Countdown: Retailer Vape HQ Estimates 100ml E-liquid Prices Could Rise From £12.99 to £39.39, While Pod Kits Increase Less Than 10%
The UK’s Vaping Products Duty (VPD), scheduled to take effect in October 2026, is prompting retailers to assess how different vape categories may be affected. UK retailer Vape HQ has estimated potential price changes under the new volume-based tax system, showing that 100ml shortfill e-liquids could see prices rise from around £12.99 to £39.39, a 203% increase, while 2ml prefilled pod vape kits could rise from £5.99 to £6.52, an increase of about 9%. The estimates highlight how a volume-based tax structure creates uneven cost impacts across product categories.
Aug.19
FDA Revises Import Alert 98-07 Rules, Bringing May Enforcement Priorities Into Unauthorized ENDS Detentions
FDA Revises Import Alert 98-07 Rules, Bringing May Enforcement Priorities Into Unauthorized ENDS Detentions
The U.S. Food and Drug Administration has revised the rules under Import Alert 98-07 to incorporate its May 2026 enforcement-priority policy for certain electronic nicotine delivery systems marketed without premarket authorization. The alert continues to allow detention without physical examination, or DWPE, for ENDS lacking required marketing authorization, while directing field divisions to apply the May risk-based framework. When necessary, detention or refusal decisions must also undergo review by the FDA's Center for Tobacco Products. Products including PACHA and Vuse Pro have already emerged as industry examples of the May policy, although enforcement discretion does not constitute FDA marketing authorization.
News
Sep.28 by 2Firsts Perspectives
China’s Jiangsu Tobacco Monopoly Bureau and Drug Regulator Target Illegal Vape Sales Disguised as Medical Devices, Define Six Violations
China’s Jiangsu Tobacco Monopoly Bureau and Drug Regulator Target Illegal Vape Sales Disguised as Medical Devices, Define Six Violations
China’s Jiangsu Tobacco Monopoly Bureau and Jiangsu Provincial Medical Products Administration have issued a joint notice targeting illegal production and sales of vape products disguised as medical devices. The notice identifies six categories of violations, including obtaining medical licenses through false materials, misusing medical device credentials, expanding production beyond approved scopes, and using medical device-related online platforms to promote or sell vape products. The action is based on China’s tobacco and medical device regulations and aims to strengthen vape oversight and consumer protection.
Aug.04
UK Vape Duty Starts in October as Hayati, DOJO and Others Launch Lower-Capacity Products With Lower Per-Unit Tax
UK Vape Duty Starts in October as Hayati, DOJO and Others Launch Lower-Capacity Products With Lower Per-Unit Tax
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. Ahead of implementation, DOJO, PIXL and Hayati have introduced or been reported to be adding lower-capacity tiers alongside larger products. DOJO has added a 6ml BLAST7K Fresh below its 10ml BLAST10K Fresh, PIXL offers both a 12ml 8000 and a 6ml 5K, while retailer Ninja Vapes says Hayati is preparing a 7ml 4K alongside its existing 12ml 6K. The pattern points to a growing lower-capacity tier in the UK market, although the brands have not all explicitly linked the changes to the new duty.
Sep.23
Product | KT&G to Launch lil Tonino Lamborghini in South Korea, Bringing 3-Second Heat-Up to New HTP Platform
Product | KT&G to Launch lil Tonino Lamborghini in South Korea, Bringing 3-Second Heat-Up to New HTP Platform
KT&G will launch the lil Tonino Lamborghini heated tobacco device in Seoul on September 15, 2026. The product introduces a new heating technology called Flashwave Heating, which uses microwaves to heat tobacco sticks internally and delivers a manufacturer-rated heat-up time of about three seconds. The device features an all-metal aluminum body, a color display and a dedicated GUI, and launches alongside a new line of NAU tobacco sticks that are incompatible with existing lil consumables. Korean media describe the product as KT&G's first new heated tobacco platform since lil AIBLE was introduced in 2022.
Aug.31
Reynolds Seeks to Join Altria Lawsuit Challenging FDA PMTA Rule and Calculation of 180-Day Deadline
Reynolds Seeks to Join Altria Lawsuit Challenging FDA PMTA Rule and Calculation of 180-Day Deadline
Three R.J. Reynolds companies are seeking to intervene in a lawsuit filed by Altria subsidiaries Helix Innovations and NJOY challenging the FDA's 2021 PMTA final rule. The companies dispute how the agency uses Acceptance and Filing reviews and completeness determinations to establish when the Tobacco Control Act's 180-day decision period begins. Reynolds has also linked prolonged PMTA reviews to competition from unauthorized vaping products. The FDA, meanwhile, has been accelerating reviews and reducing its backlog.
Sep.14