The US FDA has issued 10 warning letters to retailers and manufacturers who sell, manufacture and/or import unauthorized electronic nicotine delivery system (ENDS) products targeted to youth or likely to promote use by youth.
The warning letters were sent to establishments marketing unauthorized 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.
Warning letters were also issued to companies marketing 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.
“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,” said Mitch Zeller, JD, director of the FDA’s Center for Tobacco 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.”
The following retailers and/or manufacturers or importers received a warning letter:
- 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)
These warning letters are part of the FDA’s ongoing enforcement efforts against ENDS and other deemed tobacco products illegally on the market. The warning letters are also in line with the agency’s stated enforcement priorities against any ENDS product targeted to youth or likely to promote use by youth. If the recipients of these warning letters do not cease the manufacture, distribution and/or sale of these unauthorized tobacco products, they risk additional FDA action such as an injunction, seizure and/or civil money penalty actions.
These products appeal to youth in the way they are designed and labeled. For example, Vaprwear Gear’s pullover and backpack products hold pod systems that deliver vapor through hosing discreetly woven through hidden pockets. This design allows the products to be used for vaping without raising the attention of parents, teachers or other adults. Similarly, the Vapewear vWaTch Starter Kit, Wizman Puff Boy Mod and VooPoo Rota 340mAh Pod System Kit look like products that are popular with kids, such as smartwatches, video game systems and fidget spinners, that can be carried or worn without revealing they are tobacco products. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), all these products are considered tobacco products because they are made or derived from tobacco and intended for human consumption or components or parts of such products. Images and additional details of each product are included in the individual warning letters available on CTP’s website.
The FDA has also issued warning letters to 73 brick-and-mortar retailers for selling unauthorized flavored, cartridge-based ENDS products. This follows 22 warning letters that FDA issued last month for similar violations to online and brick-and-mortar retailers and manufacturers across the country. These warning letters are part of a series of ongoing actions consistent with the FDA’s recently issued policy of enforcement priorities for e-cigarettes and other deemed products on the market.