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FDA issues warning letters to tobacco manufacturers

December 09, 2016 Silver Spring, Md. — The Food and Drug Administration Dec. 9 issued warning letters to four manufacturers for violating the Family Smoking Prevention and Tobacco Control Act.

The four tobacco manufacturers — Swisher International Inc., Cheyenne International LLC, Prime Time International Co. and Southern Cross Tobacco Company Inc. — received the warning letters for selling flavored cigarettes labeled as little cigars or cigars, the FDA said in a news release. The companies have 15 working days to respond to the letters.

In May, the FDA expanded its authority to regulate any product it deems to be covered by the Family Smoking Prevention and Tobacco Control Act of 2009, including e-cigarettes, cigars, pipe tobacco, snus, hookah, and other tobacco and tobacco-related products. In this instance, the agency determined that even though the products were labeled as little cigars or cigars, they 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.”

For more information about the ADA’s involvement in tobacco issues, visit