FDA WARNING_LETTER - Upper Limits

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to Upper Limits on December 11, 2025, after reviewing inspection records, identifying the company as selling and distributing electronic nicotine delivery system (ENDS) products in the United States. The primary violation centers on Upper Limits marketing a "new tobacco product," specifically "NEXA PIX 35000 PUFFS Sun Slush 50mg/ml," without the required premarket authorization. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), products introduced after February 15, 2007, or modified products commercially marketed thereafter, require an FDA marketing order or an exemption, such as a substantial equivalence determination. The FDA determined this specific ENDS product lacked authorization, rendering it both adulterated and misbranded under the FD&C Act. The agency also noted the expanded definition of "tobacco product" to include nicotine from any source. Upper Limits must submit a written response to the FDA within 15 working days, detailing actions taken to cease the violative sale and distribution, bring products into compliance, and outline a plan for maintaining ongoing adherence to the FD&C Act. Failure to comply may lead to further regulatory enforcement.