The Food and Drug Administration (FDA) issued warning letters to ten companies, telling them to stop selling of flavored e-cigarettes and e-liquid products marketed toward youth, saying they do not have the “required premarket authorization” to do so.
Three of the companies, Puff Bar (Cool Clouds Distribution Inc.), HQD Tech USA LLC, and Myle Vape Inc., are illegally marketing disposable e-cigarettes, the FDA said in a news release Monday. A review of their websites revealed that they have been “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 said.
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,” according to the press release.
Products that don’t adhere to the standards of premarket requirements of the Federal Food, Drug and Cosmetic Act (FD&C Act) cannot be sold without permission from the FDA, the agency said.
Seven other companies were issued warnings for selling or distributing electronic nicotine products that are targeted toward, or enticing to youth. Those companies are Eleaf USA, Vape Deal LLC, Majestic Vapor LLC, E Cigarette Empire LLC, Ohm City Vapes Inc., Breazy Inc. and Hina Singh Enterprises (Just Eliquids Distro Inc.).
The companies must respond within 15 days with a detailed plan as to how the issues will be dealt with. Should they fail to respond or change their policies, will result in actions such as civil money penalty complaint, seizure, or injunction.
The FDA said the letters are an effort to crackdown on the number of illegal sales of tobacco-based products.
“The FDA continues to prioritize enforcement against e-cigarette products, especially those most appealing and accessible to youth. 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,” said Stephen M. Hahn, the FDA commissioner.
The FDA indicated that despite the pandemic around the world, the administration will not be loosening its enforcement against e-cigarette products, according to Mitch Zeller, the director of the FDA’s Center for Tobacco Products.
“These warning letters are the result of ongoing internet monitoring for violation of tobacco laws and regulations,” Zeller said.
