Vapestore.to – FDA Warning Letter, Aug 23, 2023

The FDA Center for Tobacco Products issued a Warning Letter to Vapestore.to after reviewing its website and determining that it offers electronic nicotine delivery system (ENDS) products for sale or distribution to U.S. customers. These products, including BBK-RG Gloomy Bear, FOUNS Tiger, A+++ Super Mario, and Elf Bar BC 5000, are considered "new tobacco products" under section 910(a) of the FD&C Act because they were not commercially marketed in the U.S. as of February 15, 2007. The FDA found that these ENDS products lack the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act, rendering them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) for failing to provide required notice under section 905(j). The FDA expressed particular concern that the product labeling and advertising for some products imitate toys and video game characters, potentially promoting youth use and concealing the products' nature as tobacco products. The firm is required to submit a written response within 15 working days detailing actions taken to address these violations, including discontinuing sales and a plan for future compliance, to avoid potential regulatory or legal actions such as civil money penalties, seizure, or injunction.