PhotoITG Brands LLC, Santa Fe Natural Tobacco Company Inc., and Sherman’s 1400 Broadway N.Y.C. Ltd. — three brands that describe their cigarettes on product labeling as “additive-free” and/or “natural” – have all received warning letters from the Food and Drug Administration (FDA).

That description violates section 911 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA said.

This is the first time the FDA has exercised its authority under the Family Smoking Prevention and Tobacco Control Act of 2009 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,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products. “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.”

2009 law

Congress moved in 2009 to give the FDA the power to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. At the same time, the law created channels for companies to use if they wanted to make claims of modified risk for their products.

Under the law, a “modified risk tobacco product” is “any tobacco product sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products.”

Companies that make this claim have to go through an approval process with the FDA and be prepared to back it up. The companies getting the warning letters, the agency says, did not do this.

Specific infractions

Specifically, ITG Brands was cited for marketing its Winston cigarettes with the MRTP claim “Additive-free.”

Santa Fe Natural Tobacco was cited for its Natural American Spirit cigarettes with the MRTP claims "Natural” and “Additive-free.”

The FDA said Sherman’s 1400 Broadway N.Y.C. has been marketing its Nat Sherman cigarettes with the MRTP claim “Natural.”

To make any of those claims, the FDA has determined that these products need an FDA modified risk tobacco product order before they can be legally introduced as such into interstate commerce.

As we reported Thursday, several anti-smoking groups have petitioned the FDA to crack down on such labeling. In particular, these groups said the FDA should look into Reynolds American's Natural American Spirit cigarette brand, which uses phrases like "additive free" and "organic tobacco," making it seem like the cigarettes might be less harmful than other brands.

The groups, in a letter to the FDA, say the tobacco may be “additive free” but smoking it is still a health hazard.

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