FDA WARNING_LETTER - baccycafe.com

The FDA's Center for Tobacco Products issued a Warning Letter to Baccycafe.com after reviewing their website and determining that their cigarette products are offered for sale in the United States. The FDA identified two primary violations:

Firstly, numerous cigarette products, including those labeled "Lights" or "Ultra Lights" (e.g., Marlboro Gold, Winston Blue, Pall Mall Blue, Bond Fine Selection, Camel Silver), and others described as having lower risk or reduced harmful substances (e.g., Golden Gate, Kent, Parliament), are considered "modified risk tobacco products." These products are adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)) because they are sold without an FDA order in effect as required by section 911(a) of the FD&C Act (21 U.S.C. § 387k(a)).

Secondly, several flavored cigarette products (e.g., Aroma Rich Apple, Kiss Mohito, Richmond Cherry) are adulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)) for containing a characterizing flavor other than tobacco or menthol, which is prohibited by section 907(a)(1)(A) of the FD&C Act (21 U.S.C