FDA WARNING_LETTER - The Vapery LLC d/b/a the Vapery - October 20, 2023

The FDA issued a Warning Letter to The Vapery LLC d/b/a theVapery on October 19, 2023, following a review of inspection records. The FDA determined that The Vapery manufactures and distributes e-liquid products, including "One Night Stand," which are considered tobacco products under the FD&C Act, specifically section 201(rr), due to containing nicotine.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. These e-liquid products were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization orders (section 910(c)(1)(A)(i)) 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, as required notices or information under section 905(j) were not provided.

The FDA cites prohibited acts under section 301(k) for holding adulterated or misbranded products for sale after interstate shipment, and section 301(p) for failing to provide required reports. The Vapery is required 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