WASHINGTON — The FDA cracked down on ten manufacturers and retailers for peddling unauthorized electronic nicotine delivery system (ENDS) and e-liquid products targeted to kids.
According to the agency, these manufacturers marketed products such as “a backpack and sweatshirt designed with stealth pockets to hold and conceal an e-cigarette, ENDS products that resemble smartwatches, or devices appearing as children’s toys such as a portable video game system or fidget spinner,” as well as e-liquids “that imitate packaging for food products that often are marketed and appeal to youth, such as candy, or feature cartoon characters like SpongeBob SquarePants” — all without a marketing authorization order. And, if they don’t stop selling these unauthorized products, the FDA warned, they risk injunction, seizure, and financial penalties.
The agency also issued warning letters to 73 brick-and-mortar retailers for selling unauthorized flavored, cartridge-based ENDS products.
“The FDA is focused on manufacturers and retailers that make and sell ENDS products that are targeted to youth and increase their appeal. The public should really be outraged by these products. The FDA is especially disturbed by some of these new products being marketed to children and teens by promoting the ease with which they can be used to conceal product use, which appeals to kids because it allows them to conceal tobacco product use from parents, teachers, law enforcement or other adults,” said Mitch Zeller, JD, director of the FDA’s Center for Tobacco Products, in a statement. “Even in the midst of the Covid-19 pandemic, we have not lost our focus on protecting youth against the dangers of e-cigarettes and will do everything we can to take action. These warning letters should send a clear message to all tobacco product manufacturers and retailers that the FDA is keeping a close watch on the marketplace. If you’re marketing or selling these products to youth, the FDA will not tolerate it.”
The FDA sent warning letters to ten retailers and manufacturers, including:
- Vaprwear Gear, LLC (manufacturer, online retailer).
- Vapewear, LLC (manufacturer, online retailer).
- Wizman Limited (manufacturer, online retailer).
- EightCig, LLC (online retailer).
- Ejuicepack, LLC (online retailer).
- Vape Royalty, LLC (online retailer).
- VapeCentric, Inc. (online retailer).
- Dukhan Store (online retailer).
- VapeSourcing (online retailer).
- Shenzhen Uwell Technology Co., Ltd. d/b/a DTD Distribution Inc. (importer, retailer).
A list of all enforcement actions against illegally marketed tobacco products, including the 10 warning letters, can be found on the website of the FDA’s Center for Tobacco Products.
“Ultimately, manufacturers that intend to continue marketing any deemed, new tobacco product on the market as of Aug. 8, 2016—including ENDS products—must submit an application to the FDA by Sept. 9, 2020 that demonstrates that the product meets the applicable standard in the law, such as whether the product is appropriate for the protection of the public health,” the FDA wrote. “This date was recently extended (from May 12, 2020) due to the impact of the coronavirus pandemic. As a resource for manufacturers preparing and submitting tobacco product applications for new deemed products, the FDA recently launched a new webpage to provide a single location for all relevant information, including tips and resources on the application submission processes. For certain deemed tobacco products, the FDA is already prioritizing its enforcement, as outlined in its guidance on enforcement priorities for ENDS and other deemed tobacco products.”
John McKenna, Production Editor, BreakingMED™
Cat ID: 143
Topic ID: 86,143,730,143,192,151,489
