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

The FDA issued a Warning Letter to Vapors Inc. d/b/a Vapors of Alabama Gardendale 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.

The primary violation identified is the marketing of "Vapors Inc. 6mg Georgia Peach e-liquid product" without the required premarket 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) of the FD&C Act and misbranded under section 903(a)(6) for failing to provide required notice or information 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 without premarket authorization are unlawfully marketed and subject to enforcement, including civil money penalties, seizure, and injunction.

The company must submit a written response within 15 working days detailing actions taken to address violations