FDA WARNING_LETTER - Virtue Vapes - August 20, 2024

The FDA's Center for Tobacco Products issued a Warning Letter to Virtue Vapes after reviewing their website, virtuevapes.com, and identifying electronic nicotine delivery system (ENDS) products offered for sale in the U.S. These products, including Virtue Bar Slapple Fusion 6000 Puffs, Virtue Plus Strawberry Lemon Mint 2800 Puffs, and Virtue HI9000 Grapefruit Pomegranate Ice, are considered 'new tobacco products' under section 201(rr) of the FD&C Act, as amended to include nicotine from any source. The FDA determined that these ENDS products lack the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required information under section 905(j). Virtue Vapes is required to submit a written response within 15 working days detailing actions taken to address these violations, including discontinuing sales and distribution of the non-compliant products, and outlining a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, or injunction, and imported products may be detained.