FDA WARNING_LETTER - Whitelightning USA LLC - March 10, 2020

The FDA's Center for Tobacco Products issued a Warning Letter to Andy Lee regarding products offered on https://www.whitelightningusa.com. The FDA determined that Electronic Nicotine Delivery System (ENDS) products, specifically the SNIC Starter Kit (with Magma Blast, Tropical Freeze, and Mega Fruit refillable tanks), White Lightning Starter Kit (with Aqua Fruit, Cafe Latte, Mega Fruit, and Spearmint Gum refillable tanks), and Strawberry Cheesecake refillable tanks, are manufactured and sold in the U.S. and are considered tobacco products under section 201(rr) of the FD&C Act.

These ENDS products are deemed "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 marketing authorization orders under section 910(c)(1)(A)(i) of the FD&C Act and are not otherwise exempt. Consequently, these products are adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. The failure to provide a required report under section 905(j) is also a prohibited act under section 301(p).

The letter requires a written response within 15 working days detailing corrective actions, including dates of discontinued sales and a