FDA Targets Vape Manufacturers and Distributors with New Warning Letters Following Trade Show Surveillance
The FDA intensified its crackdown on unauthorized vaping products, announcing today that it issued warning letters to six vape manufacturers and distributors for offering unapproved products at a recent trade show. Additionally, five other companies were cited for selling unauthorized products strictly through online sales. This marks the agency's continued effort to regulate the vape industry and address concerns over youth vaping.
According to the FDA's press release, staff from the agency's Center for Tobacco Products (CTP) were present at the trade show and observed six of the cited companies selling or distributing illegal products. The agency emphasized that selling unauthorized tobacco products, even at industry events like trade shows, is illegal under U.S. law. However, products not authorized for sale in the United States can legally be sold to foreign retailers, which often occurs at these trade events.
The six companies identified at the trade show and the five online sellers were issued nearly identical warning letters, accusing them of marketing and selling products not approved by the FDA. The unauthorized products primarily consisted of disposable vapes, with popular brands like Breeze, Mr. Fog, and Raz being singled out. The FDA noted that Breeze and Mr. Fog were among the most popular brands mentioned by teen vapers in the latest National Youth Tobacco Survey (NYTS).
The 11 companies cited are as follows:
- Beard Management Inc. (Beard Vape Co., Fifty Bar)
- Breeze Smoke Official
- Bugatti Vape, LLC
- FUNCOOL Technology Co., Limited (RAZ Vape)
- Mery Vape
- MR FOG (MR FOG Officials, Mr Fog Switch)
- Quad Life USA Inc.
- Shenzhen Greensound High-Tech Co. Ltd. (ENVA)
- SS Vape Brands Inc. (Monster Vape Labs, The Monster Group)
- Sweet TSV 1 (Sweet Vape Shop)
Of the companies cited, two were foreign entities—one based in China and the other in Japan. One domestic company received a warning for selling what appeared to be a 10% DIY nicotine base. The rest were cited for offering a range of disposable vape products that are not authorized for sale by the FDA.
It remains unclear whether the trade show surveillance involved other federal agencies as part of the joint FDA-Justice Department task force established in June. However, the timing of these actions is noteworthy, as the FDA's enforcement efforts are often announced around congressional hearings. Just three days before this announcement, U.S. House members grilled CTP Director Brian King about the FDA’s approach to vape enforcement during a subcommittee hearing.
Enforcement Focus on Small Vape Companies
The FDA's enforcement strategy has primarily targeted smaller vape manufacturers and distributors, many of whom lack the resources to fight back against regulatory actions. This contrasts sharply with the major tobacco companies, whose products have been largely unaffected by these crackdowns. Despite receiving millions of premarket tobacco applications (PMTAs) from independent vape manufacturers, the FDA has only authorized a small number of products—all from companies affiliated with Big Tobacco.
As the vaping industry awaits further clarity on enforcement, today's actions signal that the FDA will continue to prioritize monitoring and policing trade events, as well as scrutinizing online sales, in its effort to control the market for unauthorized products. With youth vaping remaining a top concern for regulators, the future of small, independent vape companies remains uncertain as they navigate increasingly stringent oversight.