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    FDA Warns Tobacco Cos. on 'Natural' Labeling

    Three manufacturers would need to apply for modified risk status.

    SILVER SPRING, Md. — The Food and Drug Administration (FDA) issued warning letters to three tobacco manufacturers that describe their cigarettes on product labeling as "additive-free" and/or "natural."

    According to the agency, ITG Brands LLC, Santa Fe Natural Tobacco Co. Inc., and Sherman's 1400 Broadway NYC Ltd. received the letters. Santa Fe Natural Tobacco is an operating company of Reynolds American Inc.

    This action marks the first time the FDA has used 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," he added.

    According to the FDA, a manufacturer that seeks to claim that a product poses fewer risks than other tobacco products may submit a modified risk tobacco product (MRTP) application to the FDA with scientific evidence to support that claim. To date, the agency has not issued any orders permitting the introduction of MRTPs into interstate commerce.

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

    • ITG Brands LLC: Winston cigarettes with the MRTP claim "Additive-free"
    • Santa Fe Natural Tobacco Co. Inc.: Natural American Spirit cigarettes with the MRTP claims "Natural" and "Additive-free"
    • Sherman's 1400 Broadway NYC Ltd.: Nat Sherman cigarettes with the MRTP claim "Natural"

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

    The manufacturers are requested 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. If they do not believe they are in violation, they must provide reasoning and supporting information to the FDA.

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