FDA WARNING_LETTER - Shenzhen Quawins Technology Co., Ltd - November 16, 2022

The FDA issued a Warning Letter to Quawins after reviewing their website, quawins.com, and determining that their electronic nicotine delivery system (ENDS) products are manufactured and offered for sale in the United States. As tobacco products, these ENDS are subject to FDA regulation and generally require premarket authorization as "new tobacco products" if not commercially marketed before February 15, 2007. The FDA found that Quawins' ENDS products, including specific VFUN and Cocktail D1 kits, are new tobacco products lacking the required marketing 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 FDA expressed particular concern that the product labeling and advertising for these ENDS products are likely to promote youth use by imitating children's products or featuring youth-appealing cartoons, and that some packaging conceals the products' tobacco nature. Quawins must submit a written response within 15 working days detailing actions taken to address these violations, including discontinuing violative sales and advertising, and outlining a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, product seizure, injunction, or import refusal.