FDA WARNING_LETTER - Mini Cup Vape - August 23, 2023

The FDA's Center for Tobacco Products issued a Warning Letter to minicupvape.com after reviewing its website and finding electronic nicotine delivery system (ENDS) products offered for sale or distribution in the United States. These products, including specific disposable vapes like A+++ Tiger and WDG Mini Cup, are classified as "new tobacco products" under section 201(rr) of the FD&C Act, as they were not commercially marketed before February 15, 2007, and contain nicotine from any source. The primary violation is the marketing of these ENDS products without the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, these unauthorized products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act for failing to provide necessary information as required by section 905(j). The FDA expressed particular concern that the product labeling and design imitate children's toys and beverage containers, potentially promoting youth use and concealing the products' nature. The firm is required to submit a written response within 15 working days, outlining actions taken to cease violative sales and ensure future compliance. Failure to address these violations may result in significant regulatory and legal actions, including civil money penalties, product seizure, injunctions, and import detention.