FDA WARNING_LETTER - Center Point Vapes - January 18, 2024

The FDA issued a Warning Letter to Center Point Vapes on January 18, 2024, based on a review of inspection records. The FDA determined that Center Point Vapes manufactures and distributes e-liquid products, which are classified as tobacco products under the FD&C Act, including those containing nicotine from any source.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. Specifically, the product "Center Point Vapes French Vanilla 120ml 5mg" was cited as a new tobacco product not commercially marketed before February 15, 2007, and lacking 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 information under section 905(j).

These actions constitute prohibited acts under sections 301(k) and 301(p) of the FD&C Act. The FDA requires Center Point Vapes 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, and/or injunction.