Vape E's Ltd – FDA Warning Letter, Jun 15, 2021

The FDA Center for Tobacco Products issued a Warning Letter to Vape E’s Ltd, identifying that the firm manufactures and distributes e-liquid products, specifically "Igor Chemist Absolutely Tobacco 30mL 6mg/mL e-liquid product," for commercial distribution in the United States. These products are classified as tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction.

The primary violation is that the "Igor Chemist Absolutely Tobacco 30mL 6mg/mL e-liquid product" is a "new tobacco product" that was not commercially marketed in the U.S. as of February 15, 2007, and lacks the required premarket marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, this product is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act because the required notice or information under section 905(j) was not provided.

The FDA states that the firm is a registered manufacturer with over 163,100 products listed. The failure to obtain marketing authorization or provide required reports constitutes prohibited acts under sections 301(k) and 301(p) of the FD&C Act.

Vape