NY Smoke Scene Corp. – FDA Warning Letter

The FDA's Center for Tobacco Products reviewed the website http://www.smokescenenyc.com and found that smokeless tobacco products offered for sale to U.S. customers lacked required health warning labels. Products like Copenhagen, Skoal, and Grizzly were identified as misbranded under sections 903(a)(1) and 903(a)(7)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The Comprehensive Smokeless Tobacco Health Education Act of 1986, as amended, mandates specific health warnings for smokeless tobacco advertisements, such as "WARNING: This product can cause mouth cancer." The absence of these warnings makes the products' advertising and labeling misleading, violating the FD&C Act. Additionally, the company is reminded of the requirement for quarterly rotation of warning statements on advertising, per a plan approved by the FDA.

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 civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, or injunction. A written response detailing corrective actions, including dates of discontinued violative practices and a compliance plan, is required within 15 working days.