10 companies receive warning letters for selling products that agency says appeal to youths,
SILVER SPRING, Md. — The U.S. Food and Drug Administration (FDA) is cracking down on e-cigarette companies, including Puff Bar, that sell fruity, disposable products that the agency says appeal to youths.
Puff Bar operated until through one of the many exemptions and loopholes in the FDA’s policy released in January, which restricted flavors for closed-system e-liquid cartridges but not disposable products, according to the nonprofit anti-tobacco advocate the Truth Initiative. Other e-cigarette companies, like Juul Labs, San Francisco, had already suspended sales of flavored vaping pods and submitted applications for products to be reviewed through the FDA’s premarket tobacco application (PMTA) process.
On July 20, the FDA issued warning letters to 10 companies, including Cool Clouds Distribution Inc., dba Puff Bar, to remove flavored disposable e-cigarettes and youth-appealing e-liquid products from the market because they do not have the required premarket authorization.
“The FDA continues to prioritize enforcement against e-cigarette products, specifically those most appealing and accessible to youth,” FDA Commissioner Stephen Hahn said. “We are concerned about the popularity of these products among youth and want to make clear to all tobacco product manufacturers and retailers that, even during the ongoing pandemic, the FDA is keeping a close watch on the marketplace and will hold companies accountable.”
The FDA said Puff Bar, HQD Tech USA LLC and Myle Vape Inc. were illegally marketing disposable e-cigarettes that were first introduced or modified after Aug. 8, 2016–the effective date of the rule that extended the FDA’s authority to all tobacco products. New tobacco products not in compliance with the premarket requirements of the Federal Food, Drug and Cosmetic Act cannot be marketed without FDA authorization, the administration said.
Warning letters also went to Eleaf USA, Vape Deal LLC, Majestic Vapor LLC, E Cigarette Empire LLC, Ohm City Vapes Inc., Breazy Inc. and Hina Singh Enterprises, dba Just Eliquids Distro Inc., which the FDA said distribute unauthorized electronic nicotine delivery system (ENDS) products targeted to youth. Unauthorized e-liquids imitated packaging for food products that often appeal to youth, such as Cinnamon Toast Crunch cereal, Twinkies, Cherry Coke and popcorn, the FDA said.
The FDA asked each firm to respond in 15 working days with a plan on how each company will address the agency’s concerns. Failure to correct violations could result in a civil money penalty complaint, seizure or injunction.
On July 21, Puff Bar’s website had a message that said it had ceased all online sales and distribution in the United States until further notice.
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