FDA WARNING_LETTER - 82nd Avenue Tobacco & Pipe LTD

The FDA issued a Warning Letter to Ms. Hood regarding her websites, http://www.82ave.com, http://www.82ndave.com, and http://www.82ndavetobaccoandpipe.com, which promote smokeless tobacco products for sale in the United States. The FDA determined these websites are affiliated with 82nd Avenue Tobacco & Pipe, LTD, located at 400 Southeast 82nd Avenue, Portland, OR 97216.

The primary violation identified is that the advertised smokeless tobacco products, including Fribourg & Treyer Dry Snuff, Gawith Hoggarth Dry Snuff, Honest Scotch Dry Snuff, Lotzbeck’s Dry Snuff, McChrystal’s Dry Snuff, Peach Dry Snuff, and W.E. Garret Dry Snuff, are misbranded under section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)). This is because the advertisements fail to include any of the required warning label statements mandated by section 3 of the Comprehensive Smokeless Tobacco Health Education Act of 1986 (15 U.S.C. § 4402), as amended. These warnings include statements about mouth cancer, gum disease/tooth loss, the product not being a safe alternative to