FDA WARNING_LETTER - South Coast Vapor Company - January 06, 2022

The FDA issued a Warning Letter to South Coast Vapor Company on January 6, 2022, for manufacturing and distributing e-liquid products without required marketing authorization. The company's e-liquid products, specifically "YOU GOT E-JUICE PAPAYA PEACH ON ICE 3MG 60ML," are deemed "new tobacco products" under section 910(a) of the FD&C Act because they were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization.

This renders the product adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as required information under section 905(j) was not provided. The company had submitted a Premarket Tobacco Product Application (PMTA), STN PM0002388, covering 2,046 products, which received a Marketing Denial Order on September 9, 2021.

The FDA considers new tobacco products without premarket authorization, especially those with Marketing Denial Orders, high enforcement priorities. South Coast Vapor Company must respond within 15 working days, detailing actions taken to address violations, including discontinuing sales/distribution, and outlining a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, or