FDA WARNING_LETTER - Parallel Direct LLC d/b/a The Magic Mist - September 03, 2024

The FDA Center for Tobacco Products issued a Warning Letter on August 22, 2024, to Guru Charan, Amit Aggarwal, and Sanjay Veerkar, regarding e-liquid products sold on themagicmist.com. The FDA determined that "Magic Mist E-liquid (30ml) - Green Mint (Medium (12mg))" and "Magic Mist E-liquid (30ml) - Green Mint (High (18mg))" are tobacco products under section 201(rr) of the FD&C Act, as amended by the Consolidated Appropriations Act, 2022, 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. The FDA found that these products lack the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act, and are not otherwise exempt. Consequently, they are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The letter mandates prompt action to address these violations and bring the products into compliance. A written response is required within 15 working days, detailing actions taken, including discontinuation of violative sales and a plan for future compliance. Failure