FDA WARNING_LETTER - Sugar Vapor Company - February 12, 2021

The FDA Center for Tobacco Products issued a Warning Letter to Ryon Calhoun of Sugar Mountain Drive, Banner Elk, NC, on February 12, 2021. The letter states that a review of the website https://www.sugarvapor.net revealed the manufacture and sale of e-liquid products, including "Smurfberry Yum," "Carnival Crack," and "Cap’n’s Berries," to U.S. customers.

These e-liquid products are classified as "tobacco products" under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction. The FDA determined that these products are "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007. Consequently, they require a premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act, which they lack.

Therefore, 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 absence of required marketing authorization and failure to provide necessary information under section 905(j). The firm, a registered manufacturer with over 1,100 listed products, is responsible for ensuring compliance. Failure to address these violations may result in civil money penalties, seizure