FDA Issues Warning Letters for Unauthorized Vape Sales

Agency Collaborates with State Partners to Enforce Tobacco Laws and Regulations

The Food and Drug Administration (FDA) has issued warning letters to 115 retailers for selling unauthorized e-cigarette products, citing the sale of disposable vape products owned by Chinese manufacturers and marketed under popular brand names such as Geek Bar Pulse, Geek Bar Skyview, Geek Bar Platinum, and Elf Bar. The agency emphasized that these warning letters are a result of its ongoing enforcement efforts, in coordination with state partners, to identify and crack down on the sale of unauthorized e-cigarettes.

FDA Contracts with States and Territories for Compliance Check Inspections

The FDA has contracts with states, territories, and third-party entities to assist with compliance check inspections of retail establishments. The agency closely monitors industry compliance with tobacco laws and regulations under the Federal Food, Drug, and Cosmetic Act and takes action when violations occur.

Warning letter recipients have 15 working days to respond with the steps they will take to correct the violation and prevent future violations. Failure to promptly correct the violations can result in additional FDA actions, such as an injunction, seizure, and/or civil money penalty.

Joint Federal Task Force to Combat Illegal E-Cigarette Distribution and Sale

In June, the FDA and the Department of Justice announced a joint federal task force to curb the distribution and sale of illegal e-cigarettes. FDA Commissioner Robert M. Califf stated, "The FDA is on high alert and, in coordination with our federal partners, remains committed to stopping unauthorized e-cigarettes at our nation's borders. These products too often end up in kids' hands, and the newly formed federal task force is well positioned to collectively combat this unscrupulous activity."

The joint federal task force will continue to focus its efforts on the flow of unauthorized e-cigarettes into the U.S., which may include investigating and prosecuting new criminal, civil, seizure, and forfeiture actions under various authorities.

Only 34 E-Cigarette Products Currently Authorized for Sale in the U.S.

To date, the FDA has authorized 34 e-cigarette products and devices, which are the only e-cigarette products that currently may be lawfully marketed and sold in the United States. The agency maintains a Searchable Tobacco Products Database that provides further information on tobacco products that may be legally marketed in the country.

As the FDA continues its efforts to combat the sale of unauthorized e-cigarette products and protect public health, particularly that of youth, retailers must remain vigilant in complying with tobacco laws and regulations to avoid potential enforcement actions.

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