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FDA Sends Warning Letters to Three Tobacco Companies over Marketing Claims

Aug 31, 2015

The Food and Drug Administration (FDA) has sent warning letters to three tobacco companies for making "additive-free" and/or "natural" claims on cigarette labels.

The warning letters were sent to ITG Brands LLC for Winston cigarettes labeled additive-free, Santa Fe Natural Tobacco Company Inc. for Natural American Spirit cigarettes labeled additive-free and natural, and Sherman's 1400 Broadway N.Y.C. Ltd. for Nat Sherman cigarettes labeled natural, WebMD reports.

The move is the FDA's first effort to enforce a provision in the Family Smoking Prevention and Tobacco Control Act of 2009 that gave the agency authority to regulate marketing claims like the ones used by these companies promoting supposedly healthier tobacco products. "The FDA's job is to ensure tobacco products are not marketed in a way that leads consumers to believe cigarettes with descriptors like 'additive-free' and 'natural' pose fewer health risks than other cigarettes, unless the claims have been scientifically supported," Mitch Zeller, director of the FDA's Center for Tobacco Products, said in an agency news release. Zeller called the action "a milestone," and "a reminder of how we use the tools of science-based regulation to protect the U.S. public from the harmful effects of tobacco use."

The companies have 15 business days from receipt of the letters to respond to the warning letters and explain what steps they will take to correct the violations or to challenge them. If the companies do not follow federal tobacco laws, the FDA can take further action, such as fines, seizure, injunctions or criminal prosecution, WebMD explains.

Under the 2009 law, companies must submit a "modified risk tobacco product" application, along with scientific evidence, if they want to advertise that their tobacco products are less dangerous than others, the New York Times reports. The FDA has not approved any such products, according to its statement. The agency is currently reviewing 10 applications for smokeless products from the North American branch of the tobacco company Swedish Match.

ITG Brands, the United States subsidiary of the British company Imperial Tobacco Group, says it disagrees with the FDA's position, and believes its products "comply with all applicable state and federal regulations." A spokesperson for Santa Fe Natural Tobacco, a subsidiary of Reynolds American, said in an email that the company was reviewing the letter. Representatives for Sherman's 1400 Broadway N.Y.C. could not be reached for comment, the Times reports.

American Spirit's advertises that its products are made with "100 percent organic tobacco," but several health and consumer groups dispute this claim. More than two dozen groups signed a letter urging the FDA to curb the brand's claims. "The F.D.A.'s warning sends a strong message to the tobacco industry that its long history of deception about the dangers of tobacco use will no longer be tolerated," said Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, one of the groups that signed the letter. This is not the first time a cigarette company's marketing practices have run afoul of federal regulations. In 2000, Santa Fe settled deceptive advertising charges with the Federal Trade Commission. The company agreed to print a statement: "No additives in our tobacco does NOT mean a safer cigarette" on all of its products that made a no additives claim, the Times reports.

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