FDA WARNING_LETTER - esmokeronline.com - May 06, 2025

On April 25, 2025, the FDA's Center for Tobacco Products issued a Warning Letter to esmokeronline.com after reviewing its website and finding electronic nicotine delivery system (ENDS) products offered for sale in the United States. These products, including Elf Bar BC3500 Disposable Vapes (Lemon Mint and Sakura Grape), are classified as 'tobacco products' under section 201(rr) of the FD&C Act, a definition expanded in March 2022 to include nicotine from any source. The FDA determined that these are 'new tobacco products' as they were not commercially marketed before February 15, 2007, and lack the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, these unauthorized 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 discontinue the violative sale and distribution, and outlining a plan for future compliance. Failure to address these violations may result in regulatory actions such as civil money penalties, seizure, or injunction, and imported products may face detention or refusal.