FDA Takes Action Against Three Tobacco Companies over “Additive-Free” and “Natural” Marketing Claims

FDA Takes Action Against Three Tobacco Companies

FDA Takes Action Against Three Tobacco Companies

Three tobacco companies—ITG Brands LLC, Santa Fe Natural Tobacco Company Inc., and Sherman’s 1400 Broadway N.Y.C. Ltd.—have received warning letters from the Food and Drug Administration (FDA) over “additive-free” and/or “natural” claims on their cigarette labels.

ITG Brands LLC makes Winston cigarettes, labeled additive-free; Santa Fe Natural Tobacco Company’s Natural American Spirit cigarettes are labeled additive-free and natural; and Sherman’s 1400 Broadway N.Y.C. Ltd.’s Nat Sherman cigarettes are labeled natural, WebMD reports. The companies may not represent “implicitly or explicitly . . . that the product presents a lower risk of tobacco-related disease,” the FDA news release says.

The FDA is acting to enforce a provision in the 2009 Family Smoking Prevention and Tobacco Control Act that gave it authority to regulate marketing claims like the ones used by these companies. “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 the news release. Zeller said this action is “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.”

If a tobacco company wants to advertise that its products are less dangerous than others, the company must submit a “modified risk tobacco product” application, along with scientific evidence, the New York Times reports. The FDA has not approved any such product claims, but is currently reviewing 10 applications for smokeless products from the North American branch of the tobacco company Swedish Match.

The companies have 15 business days to respond to the letters. They may either explain the steps they will take to correct the violations or they may challenge the letters. If the companies do not respond, the FDA’s subsequent actions can include fines, injunctions, seizure, or criminal prosecution, according to WebMD.

ITG Brands, a subsidiary of the Britain’s Imperial Tobacco Group, disagrees with the FDA’s position and believes its products “comply with all applicable state and federal regulations.” Santa Fe Natural Tobacco, a subsidiary of Reynolds American, is reviewing the letter. 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 health and consumer groups have recently disputed that claim. More than two dozen groups signed a letter urging the FDA to rein in the brand’s claims. Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, a group that signed the letter, said, “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.”

In 2000, Santa Fe settled deceptive advertising charges with the Federal Trade Commission. The company agreed to print the statement “No additives in our tobacco does NOT mean a safer cigarette” on its products that make a no additives claim, the Times reports.



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