FDA Wants Certain E-cigarette Products Removed From Market
The U.S. Food and Drug Administration (FDA) has warned ten retailers and manufacturers of unauthorized electronic nicotine delivery system (ENDS) products to remove certain E-cigarette products from the market that are targeted at the youth or likely to promote use by youth.
The ten companies, who got warning include Vaprwear Gear, LLC, Vapewear, LLC, Wizman Ltd., EightCig, LLC, Ejuicepack, LLC, Vape Royalty, LLC, VapeCentric, Inc., Dukhan Store , VapeSourcing and Shenzhen Uwell Technology Co., Ltd. d/b/a DTD Distribution Inc.
The warning letters were sent to them for 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.
Such unauthorized products enable children and teens to conceal tobacco product use from parents, teachers, law enforcement or other adults.
The FDA also targeted 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 companies may face additional FDA action such as an injunction, seizure and/or civil money penalty actions if they do not take the appropriate actions to withdraw these unauthorized 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.
The FDA has also issued warning letters to 73 brick-and-mortar retailers for selling unauthorized flavored, cartridge-based ENDS products, following the 22 warning letters it issued in March for similar violations.
The warning letters notify the retailers and manufacturers that new ENDS products without a marketing authorization order are adulterated and misbranded, and selling or distributing these products to customers in the U.S. is prohibited under the FD&C Act.
The FDA has also issued letters to more than 110 companies seeking information about the legal marketing status of more than 140 ENDS products.
The agency noted that manufacturers that intend to continue marketing any deemed, new tobacco product, including ENDS products, must submit an application to the FDA by September 9, 2020 that demonstrates that the product meets the applicable standard in the law for the protection of public health.
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