Vivian Juarez – FDA Warning Letter

The FDA Center for Tobacco Products issued a Warning Letter to Ms. Juarez regarding her eBay account "vvjuare" for offering smokeless tobacco products for sale in the U.S. The FDA determined these products are tobacco products under section 201(rr) of the FD&C Act.

Specifically, the products Ariva Java and Ariva Mint were identified as new tobacco products that are adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. This is because they require premarket review under section 910(a)(2) and lack a marketing authorization order under section 910(c)(1)(A)(i). Furthermore, a notice or other information was not provided as required by section 905(j). FDA had issued Non-Substantially Equivalent (NSE) orders for these products on August 28, 2014.

Ms. Juarez is required to immediately correct these violations and ensure all tobacco products and promotional materials comply with the FD&C Act. Failure to comply may result in civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. A written response detailing corrective actions, including discontinuation dates of violative activities and a compliance plan, must be submitted within 15 working days to the FDA Center for Tobacco Products.