FDA WARNING_LETTER - Tobacco Inn

The FDA Center for Tobacco Products reviewed tobaccoinn.com and found that smokeless tobacco products offered for sale in the U.S. were misbranded. The products, including General Snus Mint, Jakobsson’s Wintergreen Strong Portion, Oden’s Extreme Portion, Offroad Frosted Portion, and Thunder Portion, lacked required health warning statements on their webpage.

This violates Section 903(a)(1) and/or 903(a)(7)(A) of the FD&C Act, which state that a tobacco product is misbranded if its labeling or advertising is false or misleading. The Comprehensive Smokeless Tobacco Health Education Act of 1986, as amended, mandates specific health warnings (e.g., "WARNING: This product can cause mouth cancer") on smokeless tobacco product labeling and advertisements. The absence of these warnings on tobaccoinn.com's webpage constitutes a failure to reveal material facts, rendering the products misbranded.

The letter also notes the requirement for quarterly rotation of warning label statements on advertising, per Section 3(b)(3) of the Smokeless Tobacco Act, which necessitates an FDA-approved plan.

Tobaccoinn.com must immediately correct these violations and ensure all tobacco products, labeling, and advertising comply 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