FDA WARNING_LETTER - The Vapor Hutt - July 30, 2021

The FDA issued a Warning Letter to The Vapor Hutt, identifying that their "Vapor Hutt Cowboy 18 MG 120 ML" e-liquid product is a new tobacco product lacking required marketing authorization. This determination was based on a review of submissions and inspection records, establishing that the product was not commercially marketed in the U.S. as of February 15, 2007.

The product is deemed adulterated under section 902(6)(A) of the FD&C Act (21 U.S.C. § 387b(6)(A)) due to the absence of an FDA marketing authorization order. It is also misbranded under section 903(a)(6) of the FD&C Act (21 U.S.C. § 387c(a)(6)) because required notice or information under section 905(j) was not provided. Prohibited acts include holding for sale an adulterated or misbranded product (section 301(k)) and failing to provide a required report (section 301(p)).

The Vapor Hutt, a registered manufacturer with over 600 listed products, is responsible for ensuring compliance. Failure to address these violations may result in regulatory actions such as civil money penalties, seizure, and/or injunction. The firm must submit a written response within 15 working days detailing corrective actions,