FDA WARNING_LETTER - ALL-IN Vapors - March 16, 2023

The FDA issued a Warning Letter to ALL-IN Vapors on March 16, 2023, following a review of submissions and inspection records. The company manufactures and distributes e-liquid products, specifically "ALL-IN Vapors Tigers Blood e-liquid," which are deemed tobacco products under the FD&C Act.

The primary violation is the marketing of a "new tobacco product" without the required premarket authorization. The "Tigers Blood e-liquid" 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, as the required notice or information under section 905(j) was not provided.

These actions constitute prohibited acts under sections 301(k) and 301(p) of the FD&C Act. The FDA emphasizes that unlawful marketing of new tobacco products without authorization is a high enforcement priority.

ALL-IN Vapors must submit a written response within 15 working days detailing actions taken to address violations, including discontinuing sales/distribution and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.