Vapor Corner Inc – FDA Warning Letter, Feb 24, 2022

The FDA issued a Warning Letter to Vapor Corner, Inc. on February 24, 2022, after reviewing submissions and inspection records. The FDA determined that Vapor Corner, Inc. manufactures and distributes e-liquid products, which are classified as tobacco products under the FD&C Act.

The primary violation identified is the marketing of "The Vapor Corner MBL 12mg/100ml 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 deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the failure to provide required notice or information under section 905(j).

The letter emphasizes that marketing new tobacco products without premarket authorization is unlawful and subject to enforcement actions, including civil money penalties, seizure, and injunction. Vapor Corner, Inc., a registered manufacturer with over 1,100 listed products, is responsible for ensuring all its tobacco products comply with the FD&C Act and FDA regulations.

The FDA requires a written response within 15 working days detailing corrective actions, including dates of discontinued sales/distribution and a plan for maintaining compliance.