FDA WARNING_LETTER - SRB Enterprises Inc.

The FDA's Center for Tobacco Products reviewed the website http://www.thecigarmerchant.net and determined that smokeless tobacco products offered for sale to U.S. customers are misbranded. The products, including General Snus Original, Mint, White, Mini Mint Dry, Wintergreen Portions, and Loose, are considered tobacco products under section 201(rr) of the FD&C Act.

The primary violation is the failure to include any health warning label statements on the webpage for these smokeless tobacco products. This violates section 3(b) of the Comprehensive Smokeless Tobacco Health Education Act of 1986 (15 U.S.C. § 4402), which mandates specific health warnings for smokeless tobacco advertisements. Consequently, the products are misbranded under section 903(a)(1) and/or 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(1) and § 387c(a)(7)(A)) because the advertising is false or misleading due to the omission of material facts regarding product consequences.

The letter also notes the requirement for quarterly rotation of warning label statements on advertising for each brand of smokeless tobacco, in accordance with an FDA-approved plan, as per section 3(b)(3) of the Smokeless Tobacco Act.