FDA WARNING_LETTER - JVS Vapor Inc d/b/a Jacks Vapor - May 25, 2022

The FDA issued a Warning Letter to JVS Vapor Inc d/b/a Jacks Vapor on May 25, 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 and subject to FDA regulation.

The primary violation identified is the marketing of "Jack’s Vapor Berry Blitz e-liquid product" without the required premarket authorization. This product is considered a "new tobacco product" as 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. The introduction of adulterated or misbranded tobacco products into interstate commerce, and the failure to provide required reports, are prohibited acts under sections 301(a) and 301(p) of the FD&C Act, respectively.

JVS Vapor Inc is a registered manufacturer with over 50 products listed with the FDA. The letter emphasizes that all new tobacco products marketed without premarket authorization are unlawful and subject to enforcement actions, including civil money penalties, seizure, and/or injunction.

The FDA requires a written response within 15 working days detailing actions taken to