SILVER SPRING, Md. – Four tobacco manufacturers—Swisher International Inc., Cheyenne International LLC, Prime Time International Co. and Southern Cross Tobacco Co. Inc.—are under the FDA’s microscope for allegedly selling flavored cigarettes that are labeled as little cigars or cigars.
The U.S. Food and Drug Administration, Silver Spring, Md., issued warning letters to the companies because the alleged activity would be a violation of the Family Smoking Prevention and Tobacco Control Act. The products involved were under the Swisher Sweets, Cheyenne, Prime Time and Criss-Cross brands in a variety of flavors, including grape, cherry, wild cherry and strawberry.
Two companies out of four responded to the allegations by press time. “Prime Time adamantly disagrees with the FDA’s mischaracterization of any of our products as ‘cigarettes,’ ” said a spokesperson for the Phoenix-based company in a statement. “Prime Time does not distribute cigarettes, flavored or unflavored. Flavored cigars, like those apparently targeted by the FDA, have been manufactured, marketed and sold in the United States over many decades, and the fact that the FDA has authority to regulate cigars as of Aug. 8, 2016, does not change the fact that flavored cigars remain lawful products under federal law. We will, of course, respond to the warning letter, and we fully expect to prevail.”
For its part, Grover, N.C.-based Cheyenne emailed a response: “The FDA Center for Tobacco Products (CTP) has issued a warning letter to Cheyenne and three other manufacturers regarding a filtered-cigar product, stating its belief that because of the shape, size and packaging of the product, it is likely offered to, or purchased by, consumers as a cigarette, and as such, is in violation of the Tobacco Control Act. Cheyenne strongly disagrees with the position taken by CTP and is actively engaged in the legal analysis and formulation of an appropriate response to CTP within the required time period. We believe we will prevail in establishing with CTP that our product is in fact a filtered cigar and not a cigarette, and that the warning letter has been issued in error.”
Darien, Conn.-based Swisher and Richmond, Va.-based Southern Cross did not respond by press time.
“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, director of the FDA’s Center for Tobacco Products, Rockville, Md. “Because about 90% 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.
In a press release, the agency said it 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. Also, because the products allegedly meet the definition of a cigarette, the FDA determined that the products are adulterated because they contain a natural or artificial characterizing flavor, or are 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 letters, which were sent in mid-December. 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 injunction, officials said. 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.
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