FDA WARNING_LETTER - steam puff vapor llc - March 22, 2022

The FDA issued a Warning Letter to Steam Puff Vapor LLC d/b/a The Vapery 2 for manufacturing and distributing e-liquid products, specifically "The Vapery PEACH 6mg/30ml e-liquid," without the required premarket authorization. The FDA determined this product is 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.

This renders the product adulterated under section 902(6)(A) of the FD&C Act and misbranded under section 903(a)(6) for failure to provide required notice under section 905(j). The letter states that manufacturing, selling, or distributing such products is a prohibited act under sections 301(k) and 301(p) of the FD&C Act.

The FDA emphasizes that all new tobacco products without premarket authorization are unlawfully marketed and subject to enforcement, including civil money penalties, seizure, and/or injunction. The company, a registered manufacturer with over 5 listed products, must submit a written response within 15 working days detailing corrective actions, including discontinuation dates for violative sales/distribution, and a plan for future compliance.