FDA WARNING_LETTER - Boosted LLC - August 02, 2022

The FDA Center for Tobacco Products issued a Warning Letter to Katharine J. York after reviewing boostedejuice.com and identifying e-liquid products, including Dragon Fruit Coconut Milkshake, Horchata Milkshake, and Raspberry Milkshake, as "tobacco products" under section 201(rr) of the FD&C Act. This includes products containing nicotine from any source, following expanded jurisdiction effective March 15, 2022. The FDA determined these e-liquid products are "new tobacco products" because they were not commercially marketed in the U.S. prior to February 15, 2007. The firm is manufacturing and selling these products without the required premarket marketing 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 lack of required notice or information under section 905(j). The FDA requires a written response within 15 working days detailing actions taken to address these violations, including discontinuation of violative sales and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, or injunction.