Modified-Risk Tobacco Products


    On July 7, 2020, the FDA authorized four products manufactured by Philip Morris Products S.A., namely the IQOS system holder and charger and three heatsticks for use with that system, Marlboro Heatsticks, Marlboro Smooth Menthol Heatsticks and Marlboro Fresh Menthol Heatsticks. Although the FDA found the products to be modified-risk tobacco products, it denied the marketing of the products with reduced-risk claims at that time but authorized their marketing for four years with this reduced exposure claim.

    “Available evidence to date:

    • The IQOS system heats tobacco but does not burn it.
    • This significantly reduces the production of harmful and potentially harmful chemicals.
    • Scientific studies have shown that switching completely from conventional cigarettes to the IQOS system significantly reduces your body’s exposure to harmful or potentially harmful chemicals.”

    Currently, the FDA is reviewing three MRTP applications: On March 31, 2017, R.J. Reynolds Tobacco Company applied for Camel Snus Frost; on March 20, 2018, U.S. Smokeless Tobacco Company applied for Copenhagen Snuff Fine Cut; and on July 19, 2019, 22nd Century Group Inc. applied for two cigarette products, VLN King and VLN Menthol King. The public comment period on each of these products expired in 2020, demonstrating how long the MRTP application process can be.

    This story first appeared in the July/August 2021 issue of Tobacco Business magazine. Members of the tobacco industry are eligible for a complimentary subscription to our magazine. Click here for details.

    Contributed by Thomas Briant, Executive Director, National Association of Tobacco Outlets (NATO)