FDA WARNING_LETTER - Smokers Outlet Online

The FDA Center for Tobacco Products reviewed Smokers Outlet's website, smokersoutlet.com, and determined their products are manufactured and sold in the U.S., falling under FDA jurisdiction as tobacco products. The website promotes loose tobacco products, labeled as "pipe tobacco," for "multi-use" or "RYO/MYO," including Criss Cross Smooth, Direct Buy Blue, Direct Buy Silver, Golden Harvest Silver, Criss Cross Mint, Golden Harvest Mint, and Smokers Outlet Mint. These products are deemed "cigarette tobacco" and "roll-your-own tobacco" under the FD&C Act.

Several products are adulterated under section 902(8) of the FD&C Act because they are modified risk tobacco products (e.g., Criss Cross Smooth, Direct Buy Blue, Direct Buy Silver, Golden Harvest Silver) sold without an FDA order, using descriptors like "light," "ultra light," or "mild." Additionally, Criss Cross Mint, Golden Harvest Mint, and Smokers Outlet Mint are adulterated under section 902(5) of the FD&C Act for containing a characterizing flavor (mint), violating the prohibition on flavored cigarettes and RYO tobacco. If these products do not contain a characterizing flavor, they are misbranded under section 903(a)(1) or 903(a)(7)(A) for false or misleading labeling.

Smokers Outlet must immediately correct these