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Litigation Update: FDA Issues Warning Letters for the Removal of Flavored E-Cigarettes

Litigation Update: FDA Issues Warning Letters for the Removal of Flavored E-Cigarettes

The FDA has issued warning letters to a number of e-cigarettes companies, demanding they remove from the market their flavored disposable e-cigarettes and other e-liquid products that appeal to children because of their failure to comply with the pre-market authorization.

Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products, stated that although the ongoing Covid-19 pandemic has not allowed for in-person store inspections, the FDA has stayed on top of these compliance with these regulations through internet monitoring of companies’ activities that violated tobacco laws.

The warning letters issued relate to a variety of violations. Three of the companies have been warned against illegally marketing disposable e-cigarettes. Based on these companies’ websites, they were selling tobacco products that did not comply with the pre-market requirements of the Federal Food, Drug and Cosmetic Act.

Another seven warning letters were sent to companies that were selling or distributing unauthorized electronic nicotine delivery system (ENDS) products that particularly target youth. The packaging for these ENDS imitates those of popular children’s snacks, which increases youth appeal.

In the warning letters, the FDA provides a 15-working day deadline for the companies to reply to the FDA on how they plan on addressing the agency’s concerns and requests other details on the discontinuation of the products in question. Failure to address the concerns will result in penalties or other further actions.

In the last few months, the FDA has also blocked the entrance into the U.S. of over 70 disposable ENDS that were in violation of the Federal Food, Drug and Cosmetic Act.

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