FDA WARNING_LETTER - VPR Collection - July 18, 2025

The FDA issued a Warning Letter to VPR COLLECTION, located at 1355 Darius Court, City of Industry, CA, following an inspection by the Center for Tobacco Products. The inspection revealed that VPR COLLECTION sells electronic nicotine delivery system (ENDS) products in the U.S. without the necessary premarket authorization, violating the Federal Food, Drug, and Cosmetic Act (FD&C Act). The inspection took place prior to the letter dated July 17, 2025.

The main violation identified is the sale of ENDS products, specifically the SKWEZED MESH COIL BERRY BLUE 5.0% SALT NIC 15ml, which lacks an FDA marketing authorization order. This product is considered a "new tobacco product" as it was not marketed in the U.S. before February 15, 2007, and does not have the required authorization, making it adulterated and misbranded under sections 902(6)(A) and 903(a)(6) of the FD&C Act.

The regulatory framework includes the FD&C Act and its amendments, which extend FDA jurisdiction to products containing nicotine from any source. The FDA requires that all new tobacco products have premarket authorization to be legally marketed in the U.S.

VPR COLLECTION is required to submit a written response within 15 working days detailing actions taken to address the violations and ensure compliance with the FD&C Act. Failure to comply may result in enforcement actions such as civil penalties, seizure, or injunctions. The company must also ensure that all related advertising complies with FDA regulations.