SILVER SPRING, Md., May 25, 2011 /PRNewswire-USNewswire/ --The U.S. Food and Drug Administration today announced it issued 11 warning letters last week to online retailers for illegally marketing tobacco products with misleading or unsubstantiated claims or descriptors indicating that they can be used to reduce harm or the risk of tobacco-related disease.

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"There is no known safe tobacco product. It is illegal for tobacco companies or retailers, including internet sellers, to make unsubstantiated claims or statements that imply tobacco products reduce health risks," said Lawrence R. Deyton, M.S.P.H., M.D., director of the FDA's Center for Tobacco Products. "FDA will pursue enforcement actions to protect the public health."

The FDA cited the online retailers for a variety of illegal marketing claims that violate the Federal Food, Drug and Cosmetic Act, including use of terms such as: "Light"; "Low"; "Mild"; "Less toxic"; or "Safer."

These claims are not permitted unless a company has received an order from the FDA allowing it to market a product with these claims based on scientific evidence. The agency has issued no such orders to date.

In the past, some tobacco products were marketed with descriptors that indicated they were safer or had a modified risk. Those products were never proven to reduce health risk. Those deceptive marketing practices may actually have led to continued or increased tobacco use and harm to consumers who incorrectly thought they were using a product that might be less risky. This kind of marketing is now illegal under the Federal Food, Drug, and Cosmetic Act.

In addition to these marketing violations, other cited violations included the illegal sale of flavored cigarettes.

The FDA's Center for Tobacco Products conducts routine monitoring and surveillance of tobacco product marketing, advertising and promotion to assess compliance with the law. The agency will consider additional sanctions for failure to correct the violations cited in warning letters, which may include civil money penalties, no-tobacco-sale orders, seizure, injunction and/or criminal prosecution.

For more information:

FDA Warning Letters: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm

Tobacco-Related Health Fraud: http://www.fda.gov/TobaccoProducts/ResourcesforYou/ucm255658.htm

Letter to Industry on Cigarettes Containing Certain Characterizing Flavors: http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm182186.htm

CDC Vital Signs: Tobacco Use: http://www.cdc.gov/vitalsigns/TobaccoUse/Smoking/

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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.

The FDA Center for Tobacco Products' mission is to protect public health by issuing and enforcing tobacco product regulations and educating the public about the dangers of tobacco product use. Tobacco is the leading cause of preventable disease, disability and death in the United States. Tobacco products are responsible for approximately 443,000 deaths and $193 billion in medical expenditures and lost productivity each year in the U.S.(1) The Center's priorities are to prevent youth from using tobacco, help those who use to quit, provide accurate information about tobacco products, enhance the science base for tobacco product regulation, and use regulatory tools to reduce the public health burden of tobacco in the United States. To report a violation, call the FDA Center for Tobacco Products call center at 877-287-1373, option #3 or send an email to CTPcompliance@fda.hhs.gov. Visit www.fda.gov/tobacco for more information.

(1) Centers for Disease Control and Prevention. Smoking-Attributable Mortality, Years of Potential Life Lost, and Productivity Losses—United States, 2000–2004. Morbidity and Mortality Weekly Report 2008;57(45):1226–8 [accessed 2011 Mar 11].

Media Inquiries: Jeffrey Ventura, 301-796-2807, jeffrey.ventura@fda.hhs.gov
Consumer Inquiries: 877.CTP.1373

SOURCE U.S. Food and Drug Administration