FDA WARNING_LETTER - Online Guru, LLC d/b/a Vapor Puffs - November 09, 2023

The FDA Center for Tobacco Products issued a Warning Letter to Akob Akopyan and Nataliia Zharynina regarding ENDS products sold on vaporpuffs.com. The FDA determined that products like "Elf Bar BC5000 – Frozen Edition – Pineapple Orange Mint" and "Elf Bar BC5000 – EB Design – Strawberry Ice" are new tobacco products under section 201(rr) of the FD&C Act, as amended by the Consolidated Appropriations Act, 2022, which expanded the definition to include nicotine from any source.

These products are considered "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007. They lack the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act and are not exempt. 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 or information under section 905(j).

The FDA requires a written response within 15 working days detailing actions taken to address violations, including discontinuation of sales and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, or injunction. The letter also notes that imported