FDA Issues Warning Letters to Online Retailers for Unauthorized Youth-Targeted E-Cigarette Sales

On July 31, 2024, the U.S. Food and Drug Administration (FDA) issued warning letters to five online retailers for selling unauthorized disposable e-cigarette products marketed under the brand names Geek Bar, Lost Mary, and Bang. The retailers involved are:

• Smoke and Vape Company, LLC (operating as Smoke and Vape Co.)
• Smoking Vibes LLC (operating as Smoking Vibes)
• Cavalry Industries (operating as Select Vape)
• HTXW LLC (operating as FOMO Culture)
• Global Supply Allies Inc. (operating as Vapor Grab)

The FDA’s action is part of its ongoing efforts to monitor and regulate products that appeal to youth. Through multiple surveillance systems and data reviews, the FDA identified these products as particularly concerning. Notably, Geek Bar, a Chinese-owned and manufactured brand, has recently seen a rise in sales and is known to appeal to youth.

Recipients of the warning letters have 15 working days to respond, detailing the steps they will take to address the cited violations and prevent future occurrences. Failure to comply may lead to further FDA actions, including injunctions, seizures, and civil money penalties.

The FDA emphasizes its commitment to holding retailers accountable for selling unauthorized tobacco products, especially those popular with youth. To date, the agency has issued over 680 warning letters to firms for manufacturing, selling, or distributing unauthorized new tobacco products. Additionally, more than 690 warning letters have been sent to retailers for the sale of unauthorized tobacco products, and civil money penalty complaints have been filed against 64 manufacturers and over 140 retailers.

As of August 1, 2024, the FDA has authorized 34 e-cigarette products and devices. The agency provides a printable flyer listing all authorized e-cigarette products, which retailers can use to ensure they are selling lawful products. Entities involved in manufacturing, importing, selling, or distributing e-cigarettes without the required premarket authorization face enforcement actions.

The FDA’s vigilance aims to curb the rising trend of e-cigarette use among youth and ensure that only authorized products are available in the market. Retailers are urged to remain compliant with FDA regulations to avoid penalties and contribute to the protection of public health.