FDA WARNING_LETTER - www.smokecitymichigan.com

The FDA's Center for Tobacco Products issued a Warning Letter to Mr. Lazaroff, regarding smokeless tobacco products sold on smokecitymichigan.com. The FDA determined these products are tobacco products under section 201(rr) of the FD&C Act and subject to FDA jurisdiction.

The primary violation is that the smokeless tobacco products are misbranded under section 903(a)(7)(A) of the FD&C Act because advertisements on the website fail to include required health warning label statements. Specifically, products like Jackson's Apple Jack, Kentucky Twist, and Stoker's chewing tobacco were advertised without any warnings. The Smokeless Tobacco Act, as amended, mandates specific warnings such as "WARNING: This product can cause mouth cancer" and "WARNING: Smokeless tobacco is addictive," which were absent. Additionally, the letter notes the requirement for quarterly rotation of warning labels on advertising, per section 3(b)(3) of the Smokeless Tobacco Act.

Mr. Lazaroff is required to immediately correct these violations and ensure all tobacco products and promotional materials comply with the FD&C Act. Failure to comply may result in civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. A written response detailing corrective actions, including discontinuation dates of violative promotions and a plan for maintaining compliance, must be submitted within 15 working days.