For Immediate Release
December 9, 2016
The U.S. Food and Drug Administration today issued warning letters to four tobacco manufacturers — Swisher International Inc., Cheyenne International LLC, Prime Time International Co. and Southern Cross Tobacco Company Inc. — for selling flavored cigarettes that are labeled as little cigars or cigars, which is a violation of the Family Smoking Prevention and Tobacco Control Act. The companies received warning letters for products under the “Swisher Sweets,” Cheyenne,” “Prime Time” and “Criss-Cross” brands in a variety of youth-appealing flavors, including grape, cherry, wild cherry and strawberry.
“Flavored cigarettes appeal to kids and disguise the bad taste of tobacco, but they are just as addictive as regular tobacco products and have the same harmful health effects,” said Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products. “Because about 90 percent of adult daily smokers smoked their first cigarette by the age of 18, continued enforcement of the ban on cigarettes with characterizing flavors is vital to protect future generations from a lifetime of addiction.”
The Tobacco Control Act, which was passed by Congress and signed by the President in 2009, banned cigarettes containing certain characterizing flavors, such as candy or fruit flavors, to reduce the number of youth who start to smoke and who become addicted to dangerous tobacco products. The FDA began enforcing that provision in September 2009.
The agency has determined that, although labeled as little cigars or cigars, the products meet the definition of cigarettes in the Tobacco Control Act, because they are likely to be offered to, or purchased by, consumers as cigarettes based on their overall presentation, appearance, and packaging and labeling. Additionally, since the products meet the definition of a cigarette, the FDA determined that the products are adulterated because they contain a natural or artificial characterizing flavor, or misbranded if they only purport to do so.
The FDA has requested the manufacturers respond to the warning letters within 15 working days of receiving the letter. Failure to obey federal tobacco law may result in the FDA initiating further action, including, but not limited to, civil money penalties, criminal prosecution, seizure, and/or injunction. The agency expects many of these products to remain available for purchase by consumers at retail establishments while the FDA works with the manufacturers to ensure the products are in compliance with the requirements of the law.
Consumers and other interested parties can report a potential tobacco-related violation of the FD&C Act by using the FDA’s Potential Tobacco Product Violation Reporting Form.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.