FDA WARNING_LETTER - tendollarvapes.com - April 08, 2025

On March 28, 2025, the FDA's Center for Tobacco Products issued a Warning Letter to Tendollarvapes.com after reviewing their website and determining they offer electronic nicotine delivery system (ENDS) products for sale in the United States. These products are classified as tobacco products under section 201(rr) of the FD&C Act, as amended by the Consolidated Appropriations Act, 2022, which expanded the definition to include nicotine from any source.

The FDA identified two specific ENDS products, Funky Lands Ti7000 – Blueberry Rose Mint and Esco Bars Mesh 6000 – Berry Snow, as "new tobacco products" that lack the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act. These products were not commercially marketed in the U.S. as of February 15, 2007, and do not have FDA marketing authorization or an exemption. 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 lack of required premarket notification.

The letter mandates prompt action to address these violations and bring the products into compliance. The firm must submit a written response within 15 working days detailing actions taken, including discontinuation of violative sales and