FDA WARNING_LETTER - Ecig.com - April 22, 2025

The FDA's Center for Tobacco Products issued a Warning Letter to Hoosier E-Cig, Inc. on April 11, 2025, following a website review (hoosierecig.com). The FDA determined that the company is illegally marketing "new tobacco products," specifically Elf VPR 7000 Ultra Disposable – Kiwi Strawberry and Elf VPR 7000 Ultra Disposable – Miami Mint, to U.S. customers. These ENDS products, which fall under the expanded definition of "tobacco product" (21 U.S.C. § 321(rr)), 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 notice under section 905(j). The letter mandates a written response within 15 working days detailing corrective actions, including discontinuing the sale and distribution of the violative products, and a plan for maintaining compliance. Failure to address these violations may lead to regulatory actions such as civil money penalties, seizure, injunction, or detention of imported products.