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FDA Warns Tobacco Companies Over ‘Modified-Risk’ Claims

WASHINGTON — The U.S. Food & Drug Administration (FDA) has issued warning letters to three tobacco manufacturers—ITG Brands LLC, Santa Fe Natural Tobacco Co. Inc., and Sherman’s 1400 Broadway N.Y.C. Ltd.—which describe their cigarettes on product labeling as “additive-free” or “natural.” The action marks the first time the FDA has used its authority under the Family Smoking Prevention & Tobacco Control Act to pursue regulatory action regarding the use of “additive-free” or “natural” claims on tobacco product labeling.

The warning letters are for violations of the Federal Food, Drug & Cosmetic Act.

“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 (CTP). “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 FD&C Act, amended by the Tobacco Control Act, gives the FDA the authority to regulate cigarettes, cigarette tobacco, roll-your-own (RYO) tobacco and smokeless tobacco. It also created a process for the FDA to evaluate requests from companies seeking to market their products as “modified risk.”

Under the FD&C Act, a modified-risk tobacco product (MRTP) is “any tobacco product that is sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products.” This includes products, the label, labeling or advertising of which represents implicitly or explicitly that the product or its smoke does not contain or is free of a substance and/or that the product presents a lower risk of tobacco-related disease or is less harmful than one or more other commercially marketed tobacco products.

A manufacturer who seeks to claim that a product poses fewer risks than other tobacco products may submit an MRTP application to the FDA with scientific evidence to support that claim. To date, the FDA has not issued any orders permitting the introduction of MRTP into interstate commerce.

The companies received warning letters for the following products and their related modified-risk claims:

  • ITG: Winston cigarettes with the MRTP claim “additive-free.”
  • Santa Fe: Natural American Spirit cigarettes with the MRTP claims “natural” and “additive-free.”
  • Sherman: Nat Sherman cigarettes with the MRTP claim “natural.”

The FDA has determined that these products, described as “natural” and “additive-free” on their labeling, need an FDA MRTP order before they can be legally introduced as such into interstate commerce.

The manufacturers must 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 believe that they are in violation, to provide reasoning and supporting information to the FDA. Failure to obey federal tobacco law may result in the FDA initiating further action, including, but not limited to, civil money penalties, criminal prosecution, seizure or injunction.

In a statement obtained by The New York Times, ITG, the U.S. subsidiary of the British company Imperial Tobacco Group, said that it disagreed with the FDA’s position and believed its products “comply with all applicable state and federal regulations.”

A spokesperson for Santa Fe, a subsidiary of Reynolds American Inc. (RAI), told the newspaper that the company was reviewing the letter.

Representatives for Sherman could not be reached for comment, the paper said.


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