Firms Marketing Flavored Cigarettes Get FDA Warning

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The U.S. Food and Drug Administration is enforcing the flavored cigarette ban provision that is part of the newly-enacted Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) by issuing several warning letters to companies that continue to sell illegal flavored cigarettes to consumers in the United States through Web sites.

The warning letters directed the companies to cease the marketing and sale of these products immediately or to take other appropriate action to bring the products into compliance with the law. Failure to do so may result in additional regulatory actions such as seizure or injunction. The FDA also requested a written response from each of the companies within 15 days outlining the corrective actions taken.

Enforcement of the flavored cigarette ban is FDA’s effort to remove cigarettes that contain certain candy or fruit flavors from the marketplace. Removal of these products from the market will assist in the prevention of children and adolescents from starting to smoke and in the reduction in death and disease caused by smoking. “FDA takes the enforcement of this flavored cigarette ban seriously,” said Lawrence R. Deyton, M.S.P.H, M.D., director of FDA’s Center for Tobacco Products. These actions should send a clear message to those who continue to break the law that FDA will take necessary actions to protect our children from initiating tobacco use.”

As we have previously mentioned, the ban on candy and fruit-flavored cigarettes highlights the importance of reducing the number of children who start to smoke, and who become addicted to dangerous tobacco products. “Almost 90 percent of adult smokers start smoking as teenagers. These flavored cigarettes are a gateway for many children and young adults to become regular smokers,” said FDA Commissioner Margaret A. Hamburg, M.D. at the time the ban was implemented. “The FDA will utilize regulatory authority to reduce the burden of illness and death caused by tobacco products to enhance our Nation’s public health,” she added.

Flavors make cigarettes and other tobacco products more appealing to youth. Studies have shown that 17-year-old smokers are three times likelier to use flavored cigarettes as smokers over the age of 25. “Flavored cigarettes attract and allure kids into lifetime addiction,” said U.S. Department of Health and Human Services Assistant Secretary for Health, Howard K. Koh, M.D., M.P.H. previously. “FDA’s ban on these cigarettes will break that cycle for the more than 3,600 young people who start smoking daily.”

The Tobacco Control Act, which was passed by Congress and signed by the President in June 2009, specifically called for a ban on cigarettes containing certain characterizing flavors. On September 14, 2009, FDA sent a letter to regulated industry reminding them that the ban would go into effect on September 22, 2009. FDA also stated in the letter that any company who continued to sell such products after the September 22, 2009, effective date may be subject to FDA enforcement actions.

Since the effective date of the ban, FDA has examined products offered for import and searched the Internet to identify illegal products. As a result, FDA issued several warning letters to companies and Web sites that continued to market and sell these illegal products over the Internet to consumers in the United States. The warning letters were the result of Internet searches conducted by FDA’s Office of Enforcement and the Center for Tobacco Products.

FDA posted the warning letters that detail the offending websites and flavored cigarette products on the agency’s Web site:
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm The FDA also urges the report of possible violations of the flavored cigarette ban at:
www.fda.gov/flavoredtobacco.

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