FDA WARNING_LETTER - The 505 Vapor Room, LLC - June 02, 2022

The FDA issued a Warning Letter to The 505 Vapor Room, LLC, on June 2, 2022, following a review of submissions and inspection records. The FDA determined that the company manufactures and distributes e-liquid products, which are classified as tobacco products under the FD&C Act and are subject to FDA jurisdiction.

The primary violation identified is the marketing of a "new tobacco product," specifically "The 505 Vapor Room Candy Cane 14 Nic 120 ml e-liquid product," without the required premarket authorization. This product 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, as no required notice or information was provided under section 905(j).

These actions constitute prohibited acts under sections 301(k) and 301(p) of the FD&C Act. The company is a registered manufacturer with over 28,800 listed products. The FDA prioritizes enforcement against new tobacco products marketed without authorization.

The company must submit a written response within 15 working days detailing actions taken to address violations, including discontinuation dates for violative sales and a