FDA WARNING_LETTER - E-Cig Innovation - February 09, 2022

On February 9, 2022, the FDA issued a Warning Letter to E-Cig Innovation, identifying violations related to the manufacturing and distribution of e-liquid products. The FDA determined that E-Cig Innovation's e-liquid products, specifically "Ecig Innovation Guava 6mg e-liquid product," are tobacco products subject to FDA jurisdiction.

The primary violation is the marketing of a "new tobacco product" without the required premarket authorization. The "Ecig Innovation Guava 6mg e-liquid product" was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order or exemption. This renders the product adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as required information under section 905(j) was not provided.

The letter states that manufacturing or distributing such products constitutes prohibited acts under sections 301(k) and 301(p) of the FD&C Act. E-Cig Innovation is a registered manufacturer with over 20 listed products. The FDA prioritizes enforcement against new tobacco products marketed without authorization.

E-Cig Innovation must submit a written response within 15 working days detailing actions to address violations, including discontinuation of violative sales/distribution and a