The Food and Drug Administration (FDA) has sent warning lettersTrusted Source to 10 companies about selling flavored, disposable e-cigarettes that especially appeal to young people without having proper approval.
“Despite suspending in-person activities — such as retail compliance checks and vape shop inspections — due to the COVID-19 pandemic, our enforcement against unauthorized e-cigarettes products has endured,” said Mitch ZellerTrusted Source, JD, director of the FDA’s Center for Tobacco Products, in the FDA announcement. “These warning letters are the result of ongoing internet monitoring for violations of tobacco laws and regulations.”
The FDA said the companies on the list must remove their flavored, disposable e-cigarettes and youth-appealing e-liquid products from the market because they don’t have the necessary premarket authorization.
“The FDA continues to prioritize enforcement against e-cigarette products, specifically those most appealing and accessible to youth,” said Dr. Stephen M. HahnTrusted Source, the commissioner of the FDA, in the agency’s statement.
“We are concerned about the popularity of these products among youth and want to make it 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,” he said.
The FDA officially accused Cool Clouds Distribution Inc. (also known as Puff Bar), HQD Tech USA, and Myle Vape Inc. of illegally marketing e-cigarettes.
The FDA said websites for each company revealed each was selling or distributing unauthorized tobacco products first introduced after Aug. 8, 2016. That was the effective date of new regulations that extended the FDA’s authority to all tobacco products.
The FDA also accused the three companies of marketing their products as “modified risk” without FDA approval.
The agency also sent warning letters to Eleaf USA, Vape Deal LLC, Majestic Vapor LLC, E Cigarette Empire LLC, Ohm City Vapes Inc., Breazy Inc., and Hina Singh Enterprises.
All seven companies were accused of selling or distributing unauthorized electronic nicotine delivery systems (ENDS) targeted to youth.
All were cited for marketing unauthorized e-liquids that imitate packaging for food products targeted to youth, such as Twinkies, Cherry Coke, Cinnamon Toast Crunch cereal, popcorn, or those featuring cartoon characters.
“The first time you try a beer or a cigarette, they don’t taste good,” said Dr. Andrew Stiehm, a pulmonologist and director of Allina Health United Lung and Sleep Clinic in St. Paul, Minnesota. “There are a lot of people who try those things one time and the taste keeps them from returning.”
“With vaping, the first time you try it, you may taste cotton candy or cherry,” Stiehm told Healthline. “That’s tasty. You don’t have the taste aversion from trying it again. So, it’s an easier habit to begin. It becomes a gateway to bigger behaviors.”
All 10 companies have 15 working days to detail to the FDA how they plan on addressing the accusations and then maintain compliance moving forward.
They all could face monetary penalties, injunction, or seizure if they fail to comply. Any products imported into the United States could be subject to refusal of admission.
This isn’t the first action taken by the FDA concerning the e-cigarette industry during the COVID-19 pandemic.
The agency recently warnedTrusted Source e-liquid manufacturer StemStix Inc. about marketing tobacco products with false and misleading advertising and marketing modified-risk tobacco products without authorization.
In June, the FDA also issued letters to seven tobacco companies requesting information to help the agency determine whether certain violations took place, according to the agency’s press statement.
The agency also said it has refused admission into the United States of at least 74 disposable ENDS products for possible violations.