The FDA warning letters describe three companies as “illegally marketing disposable e-cigarettes,” while a further seven were issued letters for apparently selling or distributing “unauthorized electronic nicotine delivery system (ENDS) products targeted to youth or likely to promote use by youth.” The FDA called out in particular e-liquid products that enticed minors by emulating snack food packaging, including products that parodied Twinkies, Cherry Coke and Cinnamon Toast Crunch cereal.
Below are the 10 companies named by the FDA, and the specific vape products and e-liquid flavors subject to enforcement and likely to be removed, at least temporarily, from market.
Some of the companies were warned against selling tobacco products without premarket authorization, which makes the products “adulterated” under the Federal Food, Drug and Cosmetic Act. Seven of the companies were additionally warned for “misbranded” product packaging. Others made statements on their website, according to the FDA, portraying vaping products as having a lower risk of tobacco-related diseases, including unfounded claims regarding carcinogens.
- Cool Clouds Distribution, Inc., doing business as Puff Bar:
Puff Bar Plus - Mixed BerriesPuff Bar Plus - Cool MintPuff Bar - CucumberPuff Bar - MangoPuff Bar - Blue RazzPuff Bar - Banana IcePuff Bar - Sour Apple
- HQD Tech USA, LLC:
HQD Cuvie - Orange SodaHQD Cuvie - StrawberryHQD Cuvie - PineappleHQD Rosy - Green AppleHQD Rosy - Peach NectarHQD Rosy - Lemonade
- Myle Vape, Inc.
Mylé Mini - Iced Lychee Disposable DeviceMylé Mini - Lemon Mint Disposable DeviceMylé Mini - Peach Disposable DeviceMylé Mini - Pink Lemonade Disposable DeviceMylé Mini 2 - Cubano Disposable DeviceMylé Mini 2 - Iced Apple Mango Disposable DeviceMylé Mini 2 - Iced Watermelon Disposable deviceMylé Mini 2 - Menthol Disposable DeviceMylé Mini 2 - Peach Disposable DeviceMylé Mini 2 - Red Apple Disposable Device
- E Cigarette Empire LLC
Strawberry Milk and Drip Fried Cream Cakes E Juice By FrydDrip Fried Cream Cakes E Juice By Fryd
- Eleaf USA
Remit Orange Cream Pod PacksRemit Orange Dream Nic Salt Pod PacksRemit Tropical Blend Pod PacksRemit Tropical Oasis Nic Salt Pod PacksYami Vapor Ninja Man
- Ohm City Vapes Inc.
Puff Bar Pods Juul Compatible - StrawberrySkol Pods Juul Compatible - Double AppleSkol Pods Juul Compatible - MangoOriginal Cinnaroo by Cloud Thieves
- Hina Singh Enterprises, Inc., doing business as Just Eliquids Distro Inc.
Salteez Pods - Blue Razz GummyJuice Man USA E-Juice - Cherry Lime Cola
- Breazy Inc.
Baset Thor Multi-Flavor Pod Cartridges Gods of Egypt E Liquid (Strawberry, Watermelon and Spearmint)Osiris Thor Pod Cartridges Gods of Egypt E Liquid (Orange and Candy)Raa Thor Pod Cartridges Gods of Egypt E Liquid (Lime, Cucumber and Mojito)Unicorn Frappe - Juice Man E Liquid
- Majestic Vapors, LLC
The FITT by Envii Starter Kit - FruitThe FITT by Envii Starter Kit - CreamSteep Vapors - Pop Deez
- Vape Deal, LLC
Naked 100 E-Liquid Pods - Amazing MangStrawberry Churrios by The Milkman
Newsweek has reached out to all 10 companies who received a letter from the FDA, but did not receive immediate comment in time for publication. At least one vendor who received a letter—Puff Bar—has halted all sales and distribution in the United States.
“The FDA continues to prioritize enforcement against e-cigarette products, specifically those most appealing and accessible to youth,” FDA Commissioner Stephen M. Hahn said in a press release announcing the enforcement efforts. “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 FDA characterizes the letters as part of an “ongoing, aggressive effort to act against illegally marketed tobacco products amid the public health crisis of youth e-cigarette use in America.” Flavored and disposable products have been a particular focus.
Companies who received a warning letter will have 15 working days to respond with a description of their “corrective actions, including the dates on which you discontinued the violative labeling, advertising, sale, and/or distribution of these tobacco products and your plan for maintaining compliance with the FD&C Act.”
Further enforcement could result in injunctions, seizures and cash penalties.
