FDA WARNING_LETTER - www.eacarey.com

The FDA Center for Tobacco Products issued a Warning Letter to E.A. Carey (eacarey.com) for violations related to the sale and distribution of cigarette and roll-your-own tobacco products. The FDA determined that products marketed as "pipe tobacco" were actually cigarette or roll-your-own tobacco due to their presentation alongside cigarette-making equipment and explicit statements like "Care to make your own cigarettes?".

The company's products were found to be adulterated under section 902(8) of the FD&C Act because they were sold as "modified risk tobacco products" (e.g., using descriptors like "light" or "mild") without the required FDA order under section 911(g). Examples include Vintage Estate Pipe Tobacco ("light") and Captain Black Pipe Tobacco Gold ("mild").

Additionally, several flavored cigarette and/or roll-your-own tobacco products, such as "50th Anniversary Pipe Tobacco (chocolate and vanilla)" and "Cherry Bomb Flavours Pipe Tobacco by CAO," were deemed adulterated under section 902(5) of the FD&C Act for containing characterizing flavors other than tobacco or menthol, which is prohibited for cigarettes and cigarette tobacco as per section 907(a)(1)(A). If these products do not contain characterizing flavors, they are misbranded under section 903(a)(1) or 903(a)(7)(A)