FDA WARNING_LETTER - ITG Brands, LLC - Danville Leaf Operations

The FDA Center for Tobacco Products issued a Warning Letter to ITG Brands, LLC, concerning their Winston brand cigarettes, acquired from R.J. Reynolds Tobacco Company. The FDA determined that several Winston cigarette products are adulterated under section 902(8) of the FD&C Act because they are modified risk tobacco products sold without an FDA order.

Specifically, the product labeling for Winston cigarettes uses the descriptor "Additive Free." The FDA states that this explicitly or implicitly represents that the products or their smoke do not contain or are free of a substance, and/or that they present a lower risk or are less harmful than other commercially marketed tobacco products. Under section 911(b)(2)(A)(i) of the FD&C Act, such products are considered "modified risk tobacco products."

Section 911(a) of the FD&C Act prohibits the introduction or delivery of any modified risk tobacco product into interstate commerce without an FDA order under section 911(g). The FDA noted a prior FTC consent order with R.J. Reynolds regarding "additive free" claims, but clarified that the Tobacco Control Act, enacted in 2009, grants FDA authority over modified risk tobacco products, superseding the FTC order.

The FDA requires ITG Brands, LLC to immediately correct these violations and ensure compliance with the FD&C Act. Failure to comply may result in civil money penalties, criminal prosecution, seizure, and/