FDA WARNING_LETTER - Cyberliquids, LLC - August 02, 2022

The FDA Center for Tobacco Products issued a Warning Letter to Anthony Garcia regarding e-liquid products sold on cyberliquids.com. The FDA determined that e-liquid products, including Cereal Rounds, Gummi Yummi, and Mochi, are tobacco products under section 201(rr) of the FD&C Act, as they contain nicotine and are intended for human consumption.

The key violation is that these e-liquid products are "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007, and lack 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.

The letter requires a written response within 15 working days detailing actions taken to address violations, including discontinuing the sale and distribution of non-compliant products and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.