Jayde's Vapor Lounge – FDA Warning Letter, Nov 30, 2022

The FDA issued a Warning Letter to Jayde’s Vapor Lounge on November 30, 2022, following a review of submissions and inspection records. The letter states that Jayde’s Vapor Lounge manufactures and distributes e-liquid products, specifically "Baker’s Dream e-liquid products," which are deemed tobacco products under section 201(rr) of the FD&C Act and subject to FDA jurisdiction.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. The "Baker’s Dream e-liquid products" were not commercially marketed in the United States as of February 15, 2007, and lack FDA marketing authorization orders or exemptions. Consequently, these products are 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 information under section 905(j).

The FDA cites sections 301(k) and 301(p) of the FD&C Act as prohibited acts. The letter emphasizes that all new tobacco products on the market without premarket authorization are unlawful and subject to enforcement actions, including civil money penalties, seizure, and/or injunction.

Jayde’s Vapor Lounge is required to submit a written response within 15 working days detailing actions taken to address the violations,