FDA WARNING_LETTER - William Tisinger

The FDA Center for Tobacco Products issued a Warning Letter to Mr. Tisinger regarding the sale of smokeless tobacco products on the eBay account "aspire40." The FDA determined these products are tobacco products under section 201(rr) of the FD&C Act.

The key violations identified are: 1. **Adulteration:** The products (Ariva Citrus, Ariva Java, and Ariva Mint) are new tobacco products requiring premarket review under section 910(a)(2) of the FD&C Act but lack a marketing authorization order under section 910(c)(1)(A)(i). FDA issued Not Substantially Equivalent (NSE) orders for these products on August 28, 2014. This violates section 902(6)(A) of the FD&C Act. 2. **Misbranding:** Subsequent to the NSE orders, no notice or other information respecting these products was provided as required by section 905(j) of the FD&C Act. This violates section 903(a)(6) of the FD&C Act.

The letter emphasizes that all new tobacco products not commercially marketed in the U.S. as of February 15, 2007, require premarket review. Products with an NSE order are adulterated and misbranded if sold without authorization or required information.

Mr. T