FDA Issues Warning Letter to Company for Marketing Unauthorized Tobacco Products
From the Center for Tobacco Products – CTP Update
FDA Issues Warning Letter to Company for Marketing Unauthorized Tobacco Products
The FDA is announcing the issuance of a warning letter to Kretek International, Inc. for importing and distributing adulterated and/or misbranded smokeless tobacco products.
Four products are adulterated because they are new tobacco products and do not have FDA marketing authorization orders in effect under section 910(c)(1)(A)(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). These products are also misbranded because a notice or other information respecting these products was not provided as required by section 905(j) of the FD&C Act.
The FD&C Act requires premarket review for any “new tobacco product,” meaning any tobacco product that was not commercially marketed in the United States as of Feb. 15, 2007, or any modification of a tobacco product where the modified product was commercially marketed in the United States after Feb. 15, 2007. A marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act is required unless the FDA issues an order finding the product to be substantially equivalent (SE) to a predicate tobacco product or to be exempt from the requirements of SE and a required submission is made under section 905(j)(1)(A)(ii) for the FD&C Act.
Additionally, nine products are misbranded because the product labels do not contain the statement, “Sale only allowed in the United States”, as required under section 920(a) of the FD&C Act.
The warning letter states that Kretek International, Inc. should respond in writing within 15 days and provide the specific steps the firm has taken to correct violations. If the company is unable to adequately respond to the charges in the warning letter, it may not continue to introduce the adulterated and misbranded tobacco products into interstate commerce in the United States.
To learn more, read the full letter in the FDA’s warning letter database.