FDA Asks 10 Companies to Halt U.S. Sales

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Recently, the U.S. Food and Drug Administration (FDA) has sent warning letters to 10 vape companies, including Puff Bar parent Cool Clouds Distribution and asked to end their sale of flavored disposable e-cigarettes in the market.

According to Stephen Hahn, the FDA Commissioner said:

"These new actions are part of the FDA's ongoing, aggressive effort to act against illegally marketed tobacco products amid the public health crisis of youth e-cigarette use in America."

"The agency is particularly concerned about the appeal of flavored, disposable e-cigarettes to youth and continues to monitor all available data."

Puff Bar, HQD Tech USA LLC, and Myle Vape Inc received warning letters due to their illegal marketing of disposable e-cigarettes. The FDA reviewed companies' websites and found that all of them sell or distributing unauthorized tobacco products, which were introduced or modified after Aug. 8, 2016, the enacted date of the rule to extend the authority of FDA on all tobacco products.

Mitch Zeller, director of the FDA's Center for Tobacco Products, explained:

"Despite suspending in-person inspection activities—such as retail compliance checks and vape shop inspections—due to the COVID-19 pandemic, our enforcement against unauthorized e-cigarette products has endured."

"These warning letters are the result of ongoing internet monitoring for violations of tobacco laws and regulations."

According to the rule of FDA, any tobacco product not complies with the premarket requirements of the Federal Food, Drug and Cosmetic Act (FD&C Act) is misbranded and adulterated and can not be sold in the market without FDA authorization. Moreover, the FDA warned Puff Bar and HQD Tech USA LLC for an additional violation, that they were marketing their products as modified risk tobacco products without FDA's order to allow such marketing.

Besides, the FDA issued seven warning letters to the following companies: Eleaf USA, Vape Deal LLC, Majestic Vapor LLC, E Cigarette Empire LLC, Ohm City Vapes Inc., Breazy Inc., and Hina Singh Enterprises.

FDA pointed out that those companies "sell or distribute unauthorized electronic nicotine delivery system (ENDS) products targeted to youth or likely to promote use by youth. These firms were cited for unauthorized marketing e-liquids that imitate packaging for food products that often are marketed and appeal to youth, such as Cinnamon Toast Crunch cereal, Twinkies, Cherry Coke, and popcorn, or feature cartoon characters."

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