FDA Issues Warnings to Online Retailers Selling Unauthorized E-cigarette Products

On December 13, the Center for Tobacco Products (CTP) in the United States issued warning letters to 11 online retailers for selling unauthorized e-cigarette products. These products include brands such as Lost Mary, Funky Republic/Funky Lands, Elf Bar/EB Design, Kangvape, Cali, and Breeze.

Fifteen business days are given to the companies that receive the warning letter to respond, stating the actions they will take to address the non-compliant behavior discussed in the warning letter and prevent future violations. Failure to promptly rectify the non-compliant behavior may result in enforcement action by the FDA, such as injunctions, seizures, and/or civil penalties.

Selling or distributing e-cigarette products in the United States without FDA authorization is a violation of the Federal Food, Drug, and Cosmetic Act. In order for new tobacco products to be legally sold in the United States, they must obtain written authorization from the FDA. There are three possible ways for new tobacco products to obtain marketing authorization.

Dr. Brian King, Director of the FDA Center for Tobacco Products, stated:

Selling, importing, distributing, or providing any e-cigarette to American consumers without FDA authorization is considered illegal. The products identified in these warning letters are being marketed without the necessary authorization. We have issued warning letters to products that have submitted applications and are currently awaiting review. The suspension of an application for unauthorized tobacco products does not grant the right to sell such products.

These warning letters represent the latest step in the FDA's ongoing efforts to address the sales and promotion of unauthorized e-cigarettes that are attracting teenagers. By December 2023, the FDA had issued over 400 warning letters to retailers regarding unauthorized e-cigarette sales and filed civil monetary penalty complaints against more than 65 retailers and manufacturers for producing or selling unauthorized products.