The AAFP recently signed on to a letter(4 page PDF) to Mitchell Zeller, J.D., director of the FDA's Center for Tobacco Products, that calls on the agency to take enforcement action against the Santa Fe Natural Tobacco Co. (a subsidiary of Reynolds American Inc.) for its national advertising campaign suggesting its Natural American Spirits cigarettes are less hazardous than other cigarettes.
According to the Aug. 24 letter, which was crafted by the Campaign for Tobacco-Free Kids and signed by about 30 health care and public health-related organizations, the recently launched campaign promotes the cigarettes using terms such as "natural," "additive-free" and "organic," thus clearly conveying a message of reduced risk or reduced exposure to harmful substances and representing them as what the FDA terms "modified-risk tobacco products."
Section 911 of the Food, Drug & Cosmetic Act, as amended by the 2009 Family Smoking Prevention and Tobacco Control Act (TCA), prohibits the introduction of modified-risk tobacco products without an FDA marketing order, said the groups in their letter.
No such order exists for the products in question.
"Premarket FDA review of modified risk products is critical for the agency to determine whether the product, as used by consumers, will significantly reduce the risk of disease to individual users and to assess whether its marketing, with the claim of reduced risk, will benefit the health of the population as a whole," the groups said.
- Three days after the AAFP called on the FDA's Center for Tobacco Products to take enforcement action against the Santa Fe Natural Tobacco Co. for making misleading claims about its cigarettes, the FDA issued a warning letter to the company.
- The FDA's action marks the first time it has used its authority under the 2009 Family Smoking Prevention and Tobacco Control Act to pursue regulatory action regarding the use of "additive-free" or "natural" claims on tobacco product labeling.
- The company's Natural American Spirit cigarettes are of particular interest to anti-tobacco groups because the brand is experiencing significant growth, with sales rising 86 percent between 2009 and 2014.
"The potential for irreparable damage to public health from the marketing of tobacco products with modified-risk claims is well illustrated by the industry's years of deceptive advertising of 'light' and 'low-tar' cigarettes to persuade health-conscious consumers to continue smoking, when in fact, such cigarettes, as actually used by smokers, were no less hazardous than other cigarettes."
On Aug. 27, the FDA issued warning letters(www.fda.gov) to three tobacco manufacturers, including Santa Fe Natural Tobacco Co., for using the "additive-free" and "natural" language in promoting their cigarettes.
"Tobacco manufacturers that try to trick the American public by slapping 'additive-free' and 'natural' claims on their cigarette labels just received a reality check, courtesy of the Food and Drug Administration," said AAFP President Robert Wergin, M.D., of Milford, Neb., in a statement. "Today, the FDA called three tobacco manufacturers out on the carpet, and the American Academy of Family Physicians couldn't be happier."
FDA Breaks New Regulatory Ground
The FDA's action marks the first time the agency has used its authority under the TCA to pursue regulatory action regarding the use of "additive-free" or "natural" claims on tobacco product labeling.
"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," Zeller said in a news release(www.fda.gov) about the agency's action. "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."
The other two tobacco manufacturers cited were ITG Brands LLC for using "additive-free" to describe its Winston cigarettes and Sherman's 1400 Broadway N.Y.C. Ltd. for saying its Nat Sherman cigarettes were "natural."
Natural American Spirit cigarettes are of particular interest to anti-tobacco groups because the brand is experiencing significant growth. From 2009 to 2014, U.S. sales of Natural American Spirit cigarettes soared by 86 percent, while overall sales of cigarettes declined 17 percent.
In a recent earnings call with investors, industry analysts and the media, Reynolds CEO Susan Cameron said that Santa Fe Natural Tobacco Co. had experienced volume growth of 25 percent during the second quarter of 2015. She added that the company's products are gaining market share in every state and have achieved "a loyal and growing franchise, and the brand strength is based on its distinctive additive-free style, including those made with organic tobacco."
"There is every reason to believe that Natural American Spirit is growing in popularity because consumers are being misled to believe that the brand offers a healthier alternative to other cigarettes," said the health care groups in their letter.
FDA Lays Out Next Steps
The FDA directed the three manufacturers to respond to the warning letters within 15 working days and explain what actions they plan to take to remedy the violation and come into compliance with the law, or, if they do not think they are in violation, to provide reasoning and supporting information to the agency.
If these companies fail to obey federal tobacco law, the FDA can initiate further action, including, but not limited to, imposing monetary penalties or pursuing criminal prosecution, seizure and/or injunction.
Wergin said the FDA's action is an important step in the continued fight against tobacco use.
"These tobacco manufacturers are trying to convince the American public that their product is a healthier alternative to other cigarettes," he said in the statement. "This isn’t the tobacco industry's first lie, and it won't be its last, but right now, I'd like to thank the FDA for taking action on this critical public health issue."
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