FDA Elaborates on IQOS Authorization

Not an 'approval' but allows Altria to market heat-not-burn device nationally
Photograph: Shutterstock

WASHINGTON  In light of news that U.S. Food and Drug Administration (FDA) authorized the marketing and sale of the heat-not-burn device IQOS in the United States, the agency went on to clarify that it “authorized” the product’s sale but did not “approve” device safety.

In a statement released April 30, the FDA said that “while today’s action permits the tobacco products to be sold in the United States, it does not mean these products are safe or ‘FDA approved’—there are no safe tobacco products.”

The clarification refers to the way the agency puts products through its own predescribed set of tests and vetting processes before it “approves” any individual product as “safe” for the general public.

Regarding IQOS specifically, the FDA authorized the marketing of the New York-based Phillip Morris International’s (PMI) IQOS “Tobacco Heating System,” which encompasses the device itself and the accompanying, compressed tobacco sticks branded Marlboro HeatSticks, Marlboro Smooth Menthol HeatSticks and Marlboro Fresh Menthol HeatSticks.

After what it called a “rigorous, science-based review” that lasted just over two years, the FDA brought the IQOS device through its premarket tobacco product application (PMTA) process and also placed “stringent marketing restrictions” on them to help prevent youth access and exposure.

“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,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products. “Importantly, the FDA is putting in place post-market requirements aimed at, among other things, monitoring market dynamics such as potential youth uptake.”

While PMI already markets IQOS in several countries globally, it has given Richmond, Va.-based Altria Group the license to market and sell the product in the United States. Altria said it would start introducing the product to consumers in Atlanta, indicating that it would involve 500 convenience stores in the area.

The FDA also said that PMI and Altria are required to report on data regarding the products in the field, saying that the agency “may withdraw a marketing order if it, among other reasons, determines that the continued marketing of a product is no longer appropriate for the protection of the public health.”

The FDA also released a summary of its decision as well as documentation supporting the authorization.

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