FDA WARNING_LETTER - Nixteria, Crafted by JuicyVapor, LLC - August 18, 2020

On August 10, 2020, the FDA's Center for Tobacco Products issued a Warning Letter to Brad McNamara after reviewing the website https://nixteria.com, which offered "Mocking Bird e-liquid" for sale. The FDA determined this e-liquid is a tobacco product subject to regulation under the FD&C Act. The primary violation identified is that "Mocking Bird e-liquid" is a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007, and lacks the required premarket marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act. As a result, the product is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act for failing to provide required notice under section 905(j). The FDA also expressed significant concern regarding the product's youth-appealing logo, which resembles "The Hunger Games Mockingjay logo," potentially encouraging unlawful sales and increasing youth use of ENDS products. The company must promptly correct these violations, ensure all tobacco products, labeling, and advertising comply with the FD&C Act, and submit a written response within 15 working days detailing corrective actions and a compliance plan. Failure to comply may lead to civil money penalties, seizure, injunction, and refusal of admission for imported products.