The U.S. Food and Drug Administration (FDA) issued warning letters to ten manufacturers, calling on them to remove their disposable e-cigarettes and e-liquid products that may appeal to youth because they do not have required premarket authorization. This is part of the FDA’s ongoing aggressive effort to take action to stop illegally marketed tobacco products from being distributed in the U.S. It is also a continuation of 2019’s focus to address the increasing number of youth in the U.S. using e-cigarettes. The recent actions taken by the FDA is in line with its 2019 statement that it was prioritizing e-cigarette regulation and enforcement following the 2019 vape crisis. The FDA is also sending a clear message to the e-cigarette category that despite the COVID-19 pandemic, enforcement of policy is far from slowed down and that the agency plans to use its power to fully regulate e-cigarettes and vapor companies.
In a press release, Stephen M. Hahn, FDA commissioner issued the following statement: “The FDA continues to prioritize enforcement against e-cigarette products, specifically 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.”
Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products, added: “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.”
Those companies that received warning letters for illegally marketing disposable e-cigarettes included Puff Bar, HQD Tech USA LLC and Mule Vape Inc. The FDA reviewed each of these companies’ websites and determined that they were selling or distributing unauthorized tobacco products that were introduced or modified after Aug. 8, 2016, the effective date of the Deeming Rule that gave the FDA the power to regulate all tobacco products. After this date, any new tobacco product brought to market must have FDA authorization. The FDA also accused Puff Bar and HQD Tech USA LLC of marketing their products as modified risk tobacco products without receiving authorization from the FDA to do so.
Seven additional warning letters were issued to Leaf 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.) for selling and/or distributing unauthorized electronic nicotine delivery systems (ENDS) targeted to youth or promoting use by youth. These companies were found to have been marketing products with packaging that could be confused with other products that’d appeal to youth, such as Cherry Coke, popcorn, cartoon characters or popular cereals. Another company, e-liquid manufacturer StemStix Inc., received a warning letter for violating the Federal Food, Drug and Cosmetic Act (FD&C Act) by marketing a new tobacco product without FDA authorization and marketing tobacco products with false and misleading advertising and marketing unauthorized modified risk tobacco products.
Companies that received a warning letter from the FDA have 15 working days to respond to the agency detailing how they plan to address the agency’s concerns, including the exact dates each product named in the warning letters will be discontinued in terms of being sold and distributed. Companies will also need to inform the FDA of their plans for remaining in compliance going forward. Failure to respond to the FDA could result in further actions being taken against the companies, including monetary penalties, seizures and injunctions.
In addition to these warning letters, seven manufacturers were issued letters requesting information to help the FDA determine whether or not certain products were marketed before or after the Deeming Rule’s effective date. Depending on how these companies respond, more warning letters could be issued if its determined these products fail to meet the premarket requirements for certain deemed products. Though the FDA referred to these companies as tobacco manufacturers, those who received these letters were mostly manufacturing vapor and e-cigarette products including Bidi Vapor LLC, California Grown E-Liquids LLC< Fuma Vapor Inc., HITT Vape, Kenosha Tobacco Inc., Pop Vapor Co. LLC, and Romeo Vapors Inc.