FDA WARNING_LETTER - Fountain Valley Smoke Shop

The FDA Center for Tobacco Products issued a Warning Letter to Mr. Patel regarding his website, http://www.fvcigarsandtobacco.com, which distributes smokeless tobacco products in the United States. The FDA determined that products like Kodiak, Copenhagen, and Skoal are misbranded under sections 903(a)(1) and/or 903(a)(7)(A) of the FD&C Act because their webpages fail to include required health warning label statements.

The Comprehensive Smokeless Tobacco Health Education Act of 1986, as amended, mandates specific health warnings for smokeless tobacco product labeling and advertising, such as "WARNING: This product can cause mouth cancer." The absence of these warnings renders the products misbranded, as it constitutes a failure to reveal material facts about product use consequences, making the labeling and/or advertising false or misleading.

The letter also notes the requirement for quarterly rotation of warning label statements on advertising, in accordance with an FDA-approved plan. Mr. Patel is required to immediately correct these violations and ensure all tobacco products, labeling, and advertising on his website and other media comply with the FD&C Act and FDA regulations. 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 and a compliance plan is required within 15 working days.