FDA WARNING_LETTER - La Casa del Habano (Hava Havana)

The FDA's Center for Tobacco Products issued a Warning Letter to Mr. Patel regarding the website www.havahavana.com, which offers smokeless tobacco products for sale in the United States. The FDA determined that numerous smokeless tobacco products listed on the website are misbranded under sections 903(a)(1) and/or 903(a)(7)(A) of the FD&C Act because the website fails to include any required health warning label statements.

Specific products cited for lacking health warnings include Gawith Assorted Flavours, Kendal Jockey Club, Poschls Apricot, Red Bull Strong Snuff, and various Samuel Gawith and Wilsons products. The letter states that advertisements for smokeless tobacco products must bear one of four specific health warning statements as per Section 3(b) of the Comprehensive Smokeless Tobacco Health Education Act of 1986, as amended by the Tobacco Control Act. The absence of these warnings renders the products misbranded, as it constitutes a failure to reveal material facts concerning the consequences of product use.

The FDA also noted the requirement for quarterly rotation of warning label statements on advertising for each brand of smokeless tobacco, in accordance with an FDA-approved plan. The letter demands immediate correction of these violations and similar issues to ensure compliance with the FD&C Act. Failure to comply may result in further FDA action, including civil money penalties, no-tobacco-sale orders, criminal