FDA Orders 10 E-Cigarette Companies to Remove Unauthorized Products From Market
SILVER SPRING, Md. — The Food and Drug Administration (FDA) continues its efforts to keep tobacco products out of the hands of underage users, issuing warning letters to several companies marketing flavored disposable electronic cigarettes and youth-appealing e-liquid products.
The agency sent the letters to 10 companies that are marketing the products without premarket authorization from the FDA.
"The FDA continues to prioritize enforcement against e-cigarette products, specifically those most appealing and accessible to youth," said FDA Commissioner Stephen M. Hahn. "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 sent warning letters to three companies for illegally marketing disposable e-cigarettes — Puff Bar, HQD Tech USA LLC and Myle Vape Inc. The FDA's review of the companies' websites found 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.
According to the agency, any new tobacco product not in compliance with the premarket requirements of the Federal Food, Drug and Cosmetic 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.
"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," said Mitch Zeller, director of the FDA's Center for Tobacco Products. "These warning letters are the result of ongoing internet monitoring for violations of tobacco laws and regulations."
The FDA also issued warning letters to seven other companies that sell or distribute unauthorized electronic nicotine delivery system products targeted to youth or likely to promote use by youth. The companies are to the following firms: Eleaf USA, Vape Deal LLC, Majestic Vapor LLC, E Cigarette Empire LLC, Ohm City Vapes Inc., Breazy Inc. and Hina Singh Enterprises dba as Just Eliquids Distro Inc.
According to the agency, these firms 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.
Each company has 15 working days to respond the warnings letters and give the FDA details on how they will address the concerns, including the dates on which each firm discontinued the sale and/or distribution of these tobacco products, and its plans for maintaining compliance.
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 United States are subject to detention and refusal of admission, the agency added.