FDA issues more warning letters over unauthorized e-cigarettes

On December 13, 2023, the U.S. Food and Drug Administration (FDA) Center for Tobacco Products (CTP) issued warning letters to 11 online retailers selling unauthorized e-cigarette products marketed under brands such as Lost Mary, Funky Republic/Funky Lands, Elf Bar/EB Design, Kangvape, Cali, and Breeze. Recipients of the warning letters were given 15 business days to respond, detailing the measures they will take to correct the violations discussed in the letters and prevent future violations. Failure to promptly correct the violations may result in the FDA taking enforcement actions, such as bans, seizures, and/or civil fines.

CTP Director Brian King stated in a release: “Selling, importing, distributing, or offering for sale or distribution e-cigarettes to U.S. consumers without FDA authorization is illegal. The products mentioned in these warning letters are being marketed without the required authorization. For products that have submitted applications and are under review, we can and have issued warning letters. Pending applications for unauthorized tobacco products do not create any safe harbor for selling those products.”

As of December 2023, the FDA has issued over 400 warning letters to retailers selling unauthorized e-cigarettes and has filed civil fine complaints against over 65 retailers and manufacturers for producing or selling unauthorized products.

To date, the FDA has authorized 23 types of e-cigarette devices and tobacco-flavored e-cigarette products.