FDA Warns Retailers of Unauthorized ELFBAR, LOST MARY E-Cigarette Sales to Teens

Regulations by 2FIRSTS.ai
Jul.26.2024
FDA Warns Retailers of Unauthorized ELFBAR, LOST MARY E-Cigarette Sales to Teens
FDA warns 80 retailers in 15 states for selling unauthorized e-cigarettes popular among youth, imposing fines on non-compliant stores.

On July 25th, the US Food and Drug Administration (FDA) issued warning letters to 80 physical retail stores in 15 states for selling unauthorized e-cigarette products popular among teenagers, including brands like ELFBAR and Lost Mary.

 

At the same time, the FDA announced that it has taken civil monetary penalty (CMP) actions against eight retailers who had previously received warnings for selling unauthorized e-cigarettes but had not taken any action. Each retailer is required to pay a fine of $20,678.

 

Warning letters and CMPs are the result of FDA using multiple monitoring systems to identify products that are appealing to or targeting youth. After confirming or investigating violations, the FDA will first send a warning letter, and recipients have 15 working days to respond with a plan of action to correct current violations and prevent future ones.

 

In the past year, the FDA has conducted inspections on retailers to identify those selling unauthorized e-cigarettes. As a result of these actions, the FDA has issued over 690 warning letters and taken over 140 civil enforcement actions against retailers selling unauthorized e-cigarettes.

 

So far, the FDA has authorized 34 types of e-cigarette products and devices, which are currently the only e-cigarette products that may be legally sold in the United States.

 

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

U.S. Ninth Circuit Upholds FDA Denial of MH Global’s Flavored Vape PMTA Applications
U.S. Ninth Circuit Upholds FDA Denial of MH Global’s Flavored Vape PMTA Applications
The U.S. Court of Appeals for the Ninth Circuit upheld the FDA’s denial of MH Global LLC’s applications to market flavored electronic nicotine delivery systems (ENDS). The court ruled that FDA’s comparative-efficacy framework, which requires applicants to show that flavored products provide greater cessation or switching benefits than tobacco-flavored alternatives, is consistent with the Tobacco Control Act’s “appropriate for the protection of the public health” standard. The court also found that FDA was not required to establish the framework through notice-and-comment rulemaking.
Aug.26
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
UK PM Andy Burnham Reshapes Vape Retail Rules as Licensing Could Raise Barriers for New Shops
UK PM Andy Burnham Reshapes Vape Retail Rules as Licensing Could Raise Barriers for New Shops
UK Prime Minister Andy Burnham is pushing a high street reform agenda that could give local authorities greater powers over commercial activity, including vape retail. The reforms could involve expanded planning powers and a potential vape retail licensing system, allowing councils to play a larger role in store locations and market access. The measures are part of the UK’s broader shift toward tighter vape regulation, although no nationwide vape retail restrictions have yet been implemented.
Aug.11
Retail Case Study | Wisconsin Vape Market One Year After New Regulations: Johnny Vapes Reports 80% Sales Decline as Consumers Shift Online and Across State Lines
Retail Case Study | Wisconsin Vape Market One Year After New Regulations: Johnny Vapes Reports 80% Sales Decline as Consumers Shift Online and Across State Lines
According to WNCY on August 24, 2026, some independent vape retailers in Wisconsin say they have faced significant business pressure one year after new vape regulations took effect. Johnny Vapes, a retailer operating in northeast Wisconsin, said its store count fell from seven locations to four, sales declined by about 80%, and roughly 90% of its inventory was affected. Retailers said some consumers have shifted to online purchases or traveled to neighboring Michigan to buy vape products. The case highlights how local regulations can reshape retail operations, inventory management and consumer purchasing patterns.
Aug.28
On-Site Report | After FDA Announces Review of PMTA Framework, CTP Director Details Reform Priorities
On-Site Report | After FDA Announces Review of PMTA Framework, CTP Director Details Reform Priorities
FDA CTP Director Bret Koplow used his FDLI keynote in Washington to outline how the agency is rethinking the PMTA framework. He discussed category-specific review, nicotine pouch and sPMTA pilots, AI-assisted review, a 70% reduction in pending applications, and a major staffing constraint: CTP currently has only nine scientific review teams. He also reaffirmed tobacco harm reduction while stressing youth protection, flavored products, risk communication, and the challenge of unauthorized e-cigarettes.
Regulations
Oct.06
U.S. Expands Illicit Vape Enforcement as ATF Brings PACT Act Powers Into Trade Fraud Task Force
U.S. Expands Illicit Vape Enforcement as ATF Brings PACT Act Powers Into Trade Fraud Task Force
The U.S. Bureau of Alcohol, Tobacco, Firearms and Explosives said on September 23 that it has joined the interagency Trade Fraud Task Force to strengthen enforcement against illegal, misdeclared and smuggled vape and tobacco products. ATF will bring its authority under the Prevent All Cigarette Trafficking Act into the task force, including registration, reporting, shipping and record-inspection requirements covering interstate sales of electronic nicotine delivery systems. ATF said the move will strengthen its ability to trace illicit products from U.S. points of entry through domestic trafficking and distribution networks.
News
Sep.28 by 2Firsts Perspectives