FDA WARNING_LETTER - Sherman's 1400 Broadway, N.Y.C. Ltd.

The FDA Center for Tobacco Products issued a Warning Letter to Mr. Sherman regarding Nat Sherman cigarette products. The FDA determined these products are tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction.

The primary violation is that several Nat Sherman cigarette products are adulterated under section 902(8) of the FD&C Act because they are modified risk tobacco products sold or distributed without an FDA order. Specifically, the product labeling uses the descriptor "Natural," which 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. This violates section 911(a) of the FD&C Act, which prohibits introducing modified risk tobacco products into interstate commerce without an FDA order.

The FDA requires immediate correction of these violations and any similar issues to ensure compliance with the FD&C Act. Failure to comply may result in further FDA action, including civil money penalties, criminal prosecution, seizure, and/or injunction. Adulterated and misbranded tobacco products imported into the U.S. are subject to detention and refusal. A written response detailing corrective actions, including dates of discontinued violative activities and a plan for maintaining compliance, is required within 15 working days.