FDA WARNING_LETTER - Vapors Inc d/b/a Vapors of Alabama of Jasper - February 17, 2022

The FDA issued a Warning Letter to Vapors Inc d/b/a Vapors of Alabama for manufacturing and distributing e-liquid products without required marketing authorization. The FDA determined that Vapors Inc's "Cookies N Cream 24mg e-liquid product" is a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order or exemption.

This product is deemed adulterated under section 902(6)(A) of the FD&C Act and misbranded under section 903(a)(6) for failure to provide required notice under section 905(j). These actions constitute prohibited acts under sections 301(k) and 301(p) of the FD&C Act.

Vapors Inc is a registered manufacturer with over 1,800 listed products. The FDA emphasizes that all new tobacco products marketed without premarket authorization are unlawful and subject to enforcement, including civil money penalties, seizure, and injunction. The company must submit a written response within 15 working days detailing corrective actions, including discontinuation of violative sales and a plan for future compliance.