vaping.com – FDA Warning Letter, Mar 11, 2025

The FDA Center for Tobacco Products issued a Warning Letter to Vapingby.com on March 7, 2025, after reviewing its website and determining that it offers electronic nicotine delivery system (ENDS) products for sale in the U.S. These products, including "Geekberg By Geekbar / Geek Bar 575 Puffs" and "Cotton Candy Ice Elf Bar 600 Puffs Disposable Vape," are considered "new tobacco products" under section 201(rr) of the FD&C Act, as amended to include nicotine from any source. The primary violation is the marketing of these new tobacco products without 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 failure to provide required notice under section 905(j). The letter emphasizes that all new tobacco products require premarket authorization to be legally marketed. The firm is required to submit a written response within 15 working days detailing actions taken to address the violations, including discontinuing sales and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, injunction, or import detention.