FDA Warns Against Illegal Marketing Of Disposable E-cigarettes, E-liquids

The U.S. Food and Drug Administration has warned ten companies, including Cool Clouds Distribution Inc. doing business as Puff Bar, for marketing flavored disposable e-cigarettes and youth-appealing e-liquid products without authorization.

The agency issued warning letters, urging the companies to remove the products that don’t have the premarket authorization.

Due to the COVID-19 pandemic, the agency has suspended in-person inspection activities, such as retail compliance checks and vape shop inspections, but monitor internet.

Three firms, including Puff Bar, HQD Tech USA LLC and Myle Vape Inc., have been warned for illegally marketing disposable e-cigarettes following FDA’s review of their websites. It was found that they are selling unauthorized tobacco products that were first introduced or modified after August 8, 2016, when a rule extended the FDA’s authority to all tobacco products.

Puff Bar and HQD Tech USA LLC were also cited for an additional violation for marketing their products as modified risk tobacco products.

Further seven companies, which sell unauthorized electronic nicotine delivery system or ENDS products targeting youth, were warned for marketing unauthorized e-liquids that imitate packaging for food products.

These companies include 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.

The companies are required to respond within 15 working days detailing how each one intends to address the agency’s concerns. Failure to correct violations may result in further action including a civil money penalty complaint, seizure or injunction.

Recently, the agency has warned e-liquid manufacturer StemStix Inc. for marketing unauthorized tobacco products, with false and misleading advertising and unauthorized modified risk tobacco products.

In June, the FDA had issued letters to seven tobacco product manufacturers. Over the past four months, admission into the U.S. was refused for at least 74 entries of disposable ENDS products for violations of the FD&C Act.

FDA Commissioner Stephen Hahn said, “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.”

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