FDA Permits Sale of IQOS Tobacco Heating System

However, the agency placed stringent marketing restrictions on heated tobacco products aimed at preventing youth access and exposure to the new products.

May 03, 2019

WASHINGTON – This week, the U.S. Food and Drug Administration (FDA) announced it has authorized the marketing of new tobacco products manufactured by Philip Morris Products S.A. for the IQOS “Tobacco Heating System”– an electronic device that heats tobacco-filled sticks wrapped in paper to generate a nicotine-containing aerosol. The FDA has placed stringent marketing restrictions on the products in an effort to prevent youth access and exposure.

Following a rigorous science-based review through the premarket tobacco product application (PMTA) pathway, the agency determined that authorizing these products for the U.S. market is appropriate for the protection of the public health because, among several key considerations, the products produce fewer or lower levels of some toxins than combustible cigarettes. The products authorized for sale include the IQOS device, Marlboro Heatsticks, Marlboro Smooth Menthol Heatsticks and Marlboro Fresh Menthol Heatsticks.

“Ensuring new tobacco products undergo a robust premarket evaluation by the FDA is a critical part of our mission to protect the public, particularly youth, and to reduce tobacco-related disease and death,” said Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products, in an agency press release. “While the authorization of new tobacco products doesn’t mean they are safe, the review process makes certain that the marketing of the products is appropriate for the protection of the public health, taking into account the risks and benefits to the population as a whole. This includes how the products may impact youth use of nicotine and tobacco, and the potential for the products to completely move adult smokers away from use of combustible cigarettes.”

The FDA requires all package labels and advertisements for these products to include a warning about the addictiveness of nicotine, in addition to other warnings required for cigarettes, to prevent consumer misperceptions about the relative addiction risk of using IQOS compared with combusted cigarettes.

“Importantly, the FDA is putting in place post-market requirements aimed at, among other things, monitoring market dynamics such as potential youth uptake,” Zeller said. “We’ll be keeping a close watch on the marketplace, including how the company is marketing these products, and will take action as necessary to ensure the continued sale of these products in the U.S. remains appropriate and make certain that the company complies with the agency’s marketing restrictions to prevent youth access and exposure.”

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