FDA WARNING_LETTER - Star Distribution Inc. d/b/a Vape Star USA - May 01, 2024

The FDA issued a Warning Letter to Naina Panjwani regarding the sale and distribution of unauthorized electronic nicotine delivery system (ENDS) products on vapestarusa.com. The FDA's Center for Tobacco Products reviewed the website and determined that certain ENDS products are offered for sale in the U.S. These products are classified as tobacco products under section 201(rr) of the FD&C Act, as amended by the Consolidated Appropriations Act, 2022, to include nicotine from any source.

The identified violations involve "new tobacco products" lacking required premarket authorization. Specifically, Elf Bar EB Design TE6000 Puff Disposable – Lemon Drop, Funky Republic Fi3000 Puff Disposable – Malaysian Mango, and Lost Mary MO5000 5000 Puff Disposable Vape – Plum Rose Mint were found to be new tobacco products not commercially marketed before February 15, 2007, and without FDA marketing authorization orders or exemptions. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The letter requires a written response within 15 working days detailing actions taken to address violations, including discontinuing sales and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.