FDA approves marketing for IQOS Tobacco Heating System

Marketing by Philip Morris Products for the IQOS Tobacco Heating System was approved by the Food and Drug Administration.

These products produce lower levels of some toxins, which is why the FDA allowed the marketing to be approved through the premarket tobacco product application (PMTA) pathway.

The specific products authorized were the IQOS device, Marlboro Heatsticks, Marlboro Smooth Menthol Heatsticks and Marlboro Fresh Menthol Heatsticks.

The FDA warns that, while the products can be sold, they are not safe nor are they FDA approved.

“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 deat,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products.

“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.”

“Importantly, the FDA is putting in place postmarket 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. As other manufacturers seek to market new tobacco products, the FDA remains committed to upholding the vital public health standards under the law and using all the tools at our disposal to ensure the efficient and appropriate oversight of tobacco products.”

The PMTA pathway ensures that manufacturers prove to the FDA that the new tobacco product would be appropriate for all public health. Because the IQOS delivers nicotine at similar rates to cigarettes, it suggests that users can use the IQOS to stop smoking cigarettes.

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US Food and Drug Administration

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