Joseph Anderson d/b/a Smokin Joes – FDA Warning Letter, Dec 20, 2018

On April 30, 2019, the FDA issued a Warning Letter to Joseph Anderson, owner of Joseph Anderson, d/b/a Smokin Joes, located at 4900 Indian Hill Road, Lewiston, NY. The letter states that Smokin Joes manufactures and distributes cigarette products for commercial distribution in the United States, which are considered tobacco products under the FD&C Act.

The FDA determined that Smokin Joes manufactured, sold, and/or distributed numerous cigarette products without the required marketing authorization orders, despite receiving Not Substantially Equivalent (NSE) orders for these products. A list of 34 specific "Smokin Joes" brand cigarette products, including various sizes, colors (Blue, Gold, Red, Natural), and menthol/non-menthol varieties, along with their NSE order dates and STNs, was provided.

These products were deemed "new tobacco products" that were commercially marketed after their respective NSE orders, without the necessary FDA marketing authorization under section 910(c)(1)(A)(i) of the FD&C Act. This renders them adulterated under section 902(6)(A) and/or misbranded under section 903(a)(6) of the FD&C Act, as required notices or information were not provided per section 905(j). The introduction of adulterated or misbranded tobacco products into interstate commerce is a