Altria’s tobacco heating system approved as ‘modified risk’ product

FDA says IQOS will be allowed to be marketed as having fewer health risks than cigarettes

Published July 7, 2020 by Kate Andrews

Henrico County-based Altria Group Inc.’s IQOS tobacco heating system will be allowed to be marketed as a “modified risk” product, the U.S. Food and Drug Administration ruled Tuesday.

IQOS is available in 53 countries, and more than 10 million people have purchased the system, which is marketed to adult smokers seeking to quit cigarettes. According to Philip Morris USA, the Altria affiliate that markets IQOS in the United States, the product will be able to be marketed in the U.S. as a lower risk alternative to combustible cigarettes.

“Our 10-year vision is to responsibly lead the transition of adult smokers to a non-combustible future,” Altria CEO Billy Gifford said in a statement Tuesday. “IQOS is a key part of that future as we develop our portfolio of FDA-authorized, non-combustible products and actively switch adult smokers to them.”

The IQOS line of products, which heats but does not burn tobacco like cigarettes, was launched commercially in April 2019 after two years of research and development, and an initial authorization by the FDA. The electronic device heats a Marlboro HeatStick (limited by law to tobacco and menthol flavors) filled with tobacco, and is recharged like a cell phone, with a charging device and plug. The system, which includes 10 packets of 20 HeatSticks, retails for $80.

In a release from the FDA on Tuesday, Mitch Zeller, director of the FDA’s Center for Tobacco Products, wrote, “Data submitted by the company shows that marketing these particular products with the authorized information could help addicted adult smokers transition away from combusted cigarettes and reduce their exposure to harmful chemicals, but only if they completely switch. The FDA will closely monitor how IQOS is used by consumers to determine if these products meet this potential and do not cause increased use among youth.”

The FDA ruled that available evidence shows that heating tobacco rather than burning it reduces the production of 15 harmful and potentially harmful chemicals, although the agency cautions, “these products are not safe nor ‘FDA approved,'” and the company is not allowed to make any other claims of modified risk in its marketing. Altria’s Philip Morris Products S.A. also is required to conduct post-market surveillance and studies to “determine the impact of these orders on consumer perception, behavior and health…. The company must also keep the FDA apprised of efforts to prevent youth access and exposure.” The authorization will expire after four years, and the company must renew authorization to continue marketing the product as “modified exposure.”

In the past two years, the FDA and other officials have raised alarm over the number of teenagers using e-cigarettes and suffering serious and occasionally deadly lung ailments when using black-market drugs in vaping devices, although those products are different from the IQOS system. Last year, all vape flavors except tobacco and mint were banned — including fruit and candy, which were blamed for part of the appeal to underage vapers.

R.J. Reynolds’ parent company, British American Tobacco, sued Philip Morris International Inc. in April for patent infringement in the U.S. District Court for the Eastern District of Virginia, alleging PMI had used copyrighted technology in its IQOS product and Marlboro HeatSticks, which leads the heat-not-burn market. Altria’s e-cigarette and smokeless tobacco divisions, in turn, filed suit in May against Reynolds for patent infringement on Juul Labs Inc.’s e-cigarettes, in which Altria owns a 35% stake.

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