FDA Cracks Down on Unauthorized ENDS
WASHINGTON—This week, the U.S. Food & Drug Administration (FDA) issued warning letters notifying 10 companies, including Cool Clouds Distribution Inc. (doing business as Puff Bar), to remove their flavored disposable e-cigarettes and e-liquid products from the market because they do not have the required premarket authorization. The moves are part of the agency’s ongoing effort to act against illegally marketed tobacco products amid the public health crisis of youth e-cigarette use.
The FDA’s action closes “a loophole after the agency cracked down on market leader JUUL Labs Inc. earlier this year,” the Wall Street Journal reports.
The three firms receiving warning letters for illegally marketing disposable e-cigarettes are Puff Bar, HQD Tech USA LLC and Myle Vape Inc. 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.
Additionally, FDA issued seven other 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 (doing business as Just Eliquids Distro Inc.), who sell or distribute unauthorized electronic nicotine delivery system (ENDS) products targeted to youth or likely to promote use by youth.
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.
The FDA has asked each firm to respond within 15 working days detailing how each company intends to address the agency’s concerns, including the dates on which each firm discontinued the sale and/or distribution of these tobacco products, and plans for maintaining compliance.
Last week, the FDA issued Not Substantially Equivalent (NSE) orders for 13 tobacco products that had been provisionally permitted to be sold on the market since 2011. These tobacco products are now misbranded and adulterated and can no longer be distributed, imported, sold, marketed or promoted in the United States, the agency said.