FDA WARNING_LETTER - Simply Vapour LLC - August 02, 2022

On August 1, 2022, the FDA issued a Warning Letter to Simply Vapour LLC for manufacturing and distributing e-liquid products without required marketing authorization. The FDA determined that Simply Vapour LLC's "SV Signature Menthol PREMIUM BLEND 6mg/mL 60mL e-liquid product" is a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007.

Under sections 910(a) and 910(c)(1)(A)(i) of the FD&C Act, new tobacco products require a premarket authorization order. Simply Vapour LLC's product lacks this order and is not exempt, rendering it adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. The failure to provide a required report under section 905(j) is also a prohibited act under section 301(p).

The FDA requires Simply Vapour LLC to submit a written response within 15 working days detailing actions taken to address violations, including discontinuation of violative sales and distribution, and a plan for maintaining compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.