FDA WARNING_LETTER - Indian River Tobacco Traders LLC

The FDA Center for Tobacco Products issued a Warning Letter to Indian River Tobacco Traders LLC after reviewing their website, http://www.indianrivertobacco.com, which offers cigarette and/or roll-your-own tobacco products for sale in the U.S. The FDA determined that products marketed as "pipe tobacco" (Athey, Ramback, Three Sails) are actually "cigarette tobacco" and/or "roll-your-own tobacco" due to their "dual purpose" description and overall presentation, making them subject to FDA jurisdiction.

The company is in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for selling adulterated and/or misbranded tobacco products. Specifically, Athey 14 oz Bag ("mild"), Ramback 3.5 oz Cup ("light," "so mild"), and Three Sails 14 oz Bag ("light") are considered "modified risk tobacco products" under section 911(b)(2)(A)(ii) of the FD&C Act because they use descriptors like "mild" or "light." These products are adulterated under section 902(8) of the FD&C Act as they are sold without a required FDA order.

Additionally, Athey Old Timers Blend 3.5 oz Cup (whiskey) is adulterated under section 902(5) of the FD&C Act because it purports to contain a characterizing flavor