FDA WARNING_LETTER - Sooner Distributor & Wholesalers International Inc - May 31, 2023

The FDA's Center for Tobacco Products issued a Warning Letter to Mohammad Sohail and Ambreen Sohail after reviewing their website, https://soonercbdstore.com. The review determined that electronic nicotine delivery system (ENDS) products, specifically "PUFF XXL Disposable Vape Stick Pina Colada" and "PUFF XXL Disposable Vape Stick Energy Drink," were offered for sale to U.S. customers. These products are classified as tobacco products under section 201(rr) of the FD&C Act, as amended to include nicotine from any source. The FDA found that these ENDS products are 'new tobacco products' because they were not commercially marketed in the U.S. as of February 15, 2007, and 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 notices under section 905(j). The firm is required to submit a written response within 15 working days, detailing actions taken to address these violations, including discontinuing sales and outlining a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, injunction, or detention of imported products.