FDA WARNING_LETTER - Heritage Tobacco, LLC - January 16, 2020

On August 6, 2020, the FDA issued a Warning Letter to Heritage Tobacco, LLC, following a January 14-16, 2020 inspection. The FDA determined that Heritage Tobacco manufactures, distributes, and/or imports cigars, pipe tobacco, and cigarettes, which are subject to FDA regulation.

The letter identified several violations:

1. **New Tobacco Products Without Required Marketing Authorization:** Heritage Tobacco manufactured, sold, and/or distributed "HOBBY Full Flavor King Box 84mm," "HOBBY Gold King Box 84mm," and "HOBBY Menthol King Box 84mm" after receiving Not Substantially Equivalent (NSE) orders. These products are considered "new tobacco products" as they were not commercially marketed before February 15, 2007, and lack FDA marketing authorization. This renders them adulterated under section 902(6)(A) and/or misbranded under section 903(a)(6) of the FD&C Act. 2. **Unregistered Establishment:** The manufacturing establishment at 8455 Northwest 74th Street, Miami, FL 33166, was not registered as required by section 905(c) of the FD&C Act. Initial registration in December 2016 was deficient and not corrected, leading to misbranded tobacco products under section 90