From Center for Tobacco Products | COMPLETE INFORMATION HERE
On December 13, the Center for Tobacco Products issued warning letters to 11 online retailers selling unauthorized e-cigarette products marketed under the brand names Lost Mary, Funky Republic/Funky Lands, Elf Bar/EB Design, Kangvape, Cali, and Breeze. Warning letter recipients are given 15 working days to respond with the steps they’ll take to correct the violations discussed in the warning letter and to prevent future violations. Failure to promptly correct the violations can result in FDA enforcement actions such as an injunction, seizure, and/or civil money penalties.
“It is illegal to sell, import, distribute, or offer for sale or distribution to U.S. consumers any e-cigarette that has not been authorized by FDA,” said Brian King, PhD, MPH, Director of FDA’s Center for Tobacco Products. “The products identified in these warning letters are being marketed without the required authorization. We can issue, and have issued, warning letters for products for which an application has been submitted and is pending review. For unauthorized tobacco products, the pendency of an application does not create any sort of a safe harbor to sell that product.”