FDA WARNING_LETTER - Beneva Tobacco & Beer

The FDA Center for Tobacco Products issued a Warning Letter to Mr. Nusrat regarding misbranded smokeless tobacco products advertised on ucouponbooksofsarasota.com. The FDA determined that products like Longhorn, Grizzly, Skoal, and Copenhagen were offered for sale without required health warning statements, violating Section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)).

The Comprehensive Smokeless Tobacco Health Education Act of 1986, as amended by the Tobacco Control Act, mandates specific warnings such as "WARNING: This product can cause mouth cancer" or "WARNING: Smokeless tobacco is addictive." The absence of these warnings renders the products misbranded, as advertising is considered misleading if it fails to reveal material facts about product consequences.

Additionally, the letter noted a requirement under Section 3(b)(3) of the Smokeless Tobacco Act (15 U.S.C. § 4402) for quarterly rotation of warning label statements on advertising for each brand, in accordance with an FDA-approved plan.

Mr. Nusrat is required to immediately correct these violations and ensure all tobacco products and promotional materials comply with the FD&C Act across all advertising platforms. Failure to comply may result in civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. A