FDA WARNING_LETTER - El Fumador Cigars Pipes Tobacco, Inc.

The FDA Center for Tobacco Products reviewed the website http://www.elfumador.com and found that smokeless tobacco products offered for sale in the U.S. are in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Specifically, McChrystals Supermint smokeless tobacco is deemed adulterated under section 902(8) of the FD&C Act because it is marketed as "mild," classifying it as a modified risk tobacco product. Under section 911(a), such products require an FDA order for sale, which McChrystals Supermint lacks.

Additionally, McChrystals Supermint, Lotzbeck Mild Menthol, and Lotzbeck Vanilla smokeless tobacco products are misbranded under sections 903(a)(1) and/or 903(a)(7)(A) of the FD&C Act. The website's webpages for these products fail to include any of the required health warning statements mandated by section 3(b) of the Comprehensive Smokeless Tobacco Health Education Act of 1986 (15 U.S.C. § 4402). The letter also notes the requirement for quarterly rotation of warning labels on advertising.

The FDA requires immediate correction of these violations and 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