WASHINGTON — The FDA ordered ten e-cigarette companies to pull their unauthorized flavored disposable e-cigs and e-liquids designed to be appealing to kids from the market.
This enforcement move was the result of internet monitoring for violations of tobacco laws, the FDA noted, as the ongoing Covid-19 pandemic prevented the agency from conducting in-person inspections.
“The FDA continues to prioritize enforcement against e-cigarette products, specifically those most appealing and accessible to youth,” said FDA Commissioner Stephen M. Hahn, in a statement. “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 agency reported that three of the ten companies — Cool Clouds Distribution Inc. (doing business as Puff Bar), HQD Tech USA LLC, and Myle Vape Inc. — received warning letters for marketing illegal disposable e-cig products. “The FDA’s review of the companies’ websites revealed that each firm is selling or distributing unauthorized tobacco products that were first introduced or modified after Aug. 8, 2016—the effective date of the deeming rule that extended the FDA’s authority to all tobacco products,” the agency wrote. “Any new tobacco product not in compliance with the premarket requirements of the Federal Food, Drug and Cosmetic Act (FD&C Act) is adulterated and misbranded and may not be marketed without FDA authorization. Puff Bar and HQD Tech USA LLC were also cited for an additional violation for marketing their products as modified risk tobacco products without an FDA order in effect that permits such marketing.”
The remaining seven companies— Eleaf USA, Vape Deal LLC, Majestic Vapor LLC, E Cigarette Empire LLC, Ohm City Vapes Inc., Breazy Inc. and Hina Singh Enterprises (doing business as Just Eliquids Distro Inc.), all of which sell unauthorized electronic nicotine delivery systems (ENDS) products targeted to a young audience — were cited “for marketing unauthorized 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,” the FDA explained.
The FDA demanded responses within 15 working days outlining the corrective actions each company intends to put in place to address these issues, including the dates on which each firm discontinued the sale and/or distribution of these tobacco products, and its plans for maintaining compliance,” the agency wrote. “Failure to correct violations may result in further action such as a civil money penalty complaint, seizure or injunction. In addition, misbranded or adulterated products imported into the U.S. are subject to detention and refusal of admission.”
John McKenna, Associate Editor, BreakingMED™
Cat ID: 143
Topic ID: 86,143,730,143,192,151,725
