FDA WARNING_LETTER - Wagco Distribution, Inc. - March 21, 2024

On March 21, 2024, the FDA's Center for Tobacco Products issued a Warning Letter to Wagco Distribution, Inc. following a review of inspection records. The letter states that Wagco manufactures and distributes e-liquid products, which are classified as tobacco products under section 201(rr) of the FD&C Act due to containing nicotine and being intended for human consumption.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. Specifically, the product "BALD HEAD VAPER’S E-LIQUID Strazz Berry 6mg/ml 60ml" is 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.

The letter emphasizes that all new tobacco products require premarket authorization (e.g., marketing order, substantial equivalence report, or exemption). Wagco is required to submit a written response within 15 working days detailing actions taken to address the violations, including discontinuing the sale and distribution of the violative products and outlining a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure