FDA WARNING_LETTER - Kretek International, Inc.

The FDA's Center for Tobacco Products (CTP) issued a Warning Letter to Kretek International Inc. for importing and distributing adulterated and misbranded smokeless tobacco products. The FDA determined that products including Dry Snuff Silver Dollar Scotch, Snus Thunder Pouch Wintergreen Extra Strong, Snus Thunder Pouch Frosted Extra Strong, and Snus Thunder Pouch Original Extra Strong were introduced into U.S. interstate commerce without required marketing authorization orders, making them adulterated under section 902(6)(A) of the FD&C Act and misbranded under section 903(a)(6) due to lack of required premarket notification.

Additionally, several Dry Snuff Silver Dollar products (Cherry, Spearmint, Apricot, Original, Blueberry, Raspberry, Natural, Vanilla, and Scotch) were found misbranded under section 903(a)(2)(D) because their labels lacked the mandatory statement "Sale only allowed in the United States," as required by section 920(a) of the FD&C Act.

The letter states that introducing or receiving adulterated or misbranded tobacco products in interstate commerce constitutes prohibited acts under sections 301(a) and 301(c) of the FD&C Act. Kretek International Inc. is required to respond within fifteen working days, detailing corrective actions taken, steps to prevent recurrence, and supporting documentation. Failure to comply may result in