FDA WARNING_LETTER - Vaping Studio Inc - March 06, 2024

The FDA's Center for Tobacco Products issued a Warning Letter to Vaping Studio Inc. on March 6, 2024, based on inspection records. The letter states that Vaping Studio Inc. sells and/or distributes Electronic Nicotine Delivery Systems (ENDS) products, which are classified as tobacco products under section 201(rr) of the FD&C Act.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. Specifically, the product "Wave Strawberry Mango 8000 Puffs" was cited as a new tobacco product that was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order or exemption. This renders the product 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 the receipt, delivery, or introduction into interstate commerce of adulterated or misbranded tobacco products, and the failure to provide required reports, are prohibited acts under sections 301(c), 301(a), and 301(p) of the FD&C Act.

Vaping Studio Inc. is required to submit a written response within 15 working days detailing