FDA WARNING_LETTER - King Mountain Tobacco Company, Inc.

The FDA's Center for Tobacco Products (CTP) issued a Warning Letter to King Mountain Tobacco Company, Inc. (King Mountain), identifying it as a domestic manufacturer of cigarettes and roll-your-own tobacco products subject to user fees under section 919 of the FD&C Act. The primary violation is the failure to pay assessed user fees by the last day of the applicable quarter, as required by section 919(b)(6) of the FD&C Act.

FDA determined that all regulated tobacco products manufactured by King Mountain are adulterated under section 902(4) of the FD&C Act due to this non-payment. Specific assessment invoices and due dates were provided, for which no payment has been received. The introduction or delivery into interstate commerce of adulterated tobacco products is a prohibited act under section 301(a) of the FD&C Act.

King Mountain had previously disputed its user fee obligation, but FDA reaffirmed the requirement in February 2014. The company has not responded to subsequent delinquency notices or paid the fees.

The FDA requires King Mountain to immediately correct these violations and submit a written response within 15 working days. The response must include documentation of user fee payment or contact with OFM to arrange payment, steps taken to prevent future violations, and a timetable for planned corrections. Failure to comply may result in further FDA action, including civil money penalties, criminal prosecution, seizure,