FDA WARNING_LETTER - Lite-Up Anywhere Ltd. - September 29, 2022

The FDA Center for Tobacco Products issued a Warning Letter to Faruck Adama Valli Yusuf and Siraz Yusuf, owners of lite-up.co.uk, on September 29, 2022. The FDA reviewed the website and determined that e-liquid products, including "Lite Up Anywhere Blueberry Flavour," "Lite Up Anywhere Raspberry Flavour," and "Lite Up Anywhere Vanilla Custard Flavour," are manufactured and offered for sale or distribution to U.S. customers.

These e-liquids are classified as tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction. Effective August 8, 2016, e-liquids require premarket authorization to be legally marketed in the U.S. A "new tobacco product" is defined as any product not commercially marketed in the U.S. as of February 15, 2007, or any modified product marketed after this date.

The identified e-liquid products are considered new tobacco products because they were not commercially marketed in the U.S. by February 15, 2007, and lack the required FDA 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(