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

The FDA issued a Warning Letter to Vapors Inc. d/b/a Vapors of Alabama Arab on February 17, 2022, following a review of submissions and inspection records. The company manufactures and distributes e-liquid products, which are deemed tobacco products under the FD&C Act and subject to FDA jurisdiction.

The primary violation identified is the manufacturing, sale, and/or distribution of "Vapors Inc Banana 6mg 10ml e-liquid product" without the required premarket marketing authorization. This product is considered 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. Consequently, the product is adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required notice or information.

The FDA states that marketing new tobacco products without authorization is unlawful and subject to enforcement actions, including civil money penalties, seizure, and/or injunction. The company, a registered manufacturer with over 1,800 listed products, is responsible for ensuring all products comply with the FD&C Act.

Vapors Inc. must submit a written response within 15 working days detailing actions taken to address violations, including discontinuing the sale/distribution of