FDA WARNING_LETTER - Peter M. Slutzky

The FDA's Center for Tobacco Products reviewed the eBay account "cloisman" (Mr. Slutzky) and found smokeless tobacco products offered for sale in the U.S. These products, including Ariva Citrus, Ariva Java, and Ariva Mint, are considered tobacco products under section 201(rr) of the FD&C Act.

The FDA determined these products are adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. This is because they are "new tobacco products" requiring premarket review and lack a marketing authorization order under section 910(c)(1)(A)(i). Furthermore, a notice or other information required by section 905(j) was not provided.

Specifically, FDA issued "Not Substantially Equivalent" (NSE) orders for Ariva Citrus, Ariva Java, and Ariva Mint on August 28, 2014, meaning they are subject to premarket review and lack authorization.

The letter requires immediate correction of these violations and similar issues across all sales and promotional platforms. 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 and a compliance plan, is required within 15 working days, referencing RW14