FDA Says PM USA Can Market IQOS as Modified Risk Tobacco Products

Heated tobacco system reduces exposure to harmful chemicals compared to conventional cigarettes, FDA says
Tobacco Products
Photograph courtesy of Altria Group

RICHMOND, Va. — Philip Morris Products SA can market its heat-not-burn device, IQOS, as a modified risk tobacco product (MRTP), the U.S. Food and Drug Administration (FDA) announced July 7.

IQOS is a heated tobacco system that allows adult smokers to use tobacco by heating instead of burning it. Altria Group, Richmond, Va., is under an exclusive licensing agreement with Philip Morris International, New York, to commercialize IQOS and its accompanying compressed-tobacco HeatSticks in the United States. Altria subsidiary Philip Morris USA is adding IQOS to the Altria companies’ portfolio of products for adult smokers looking for an alternative to cigarettes.

“We’re delighted that the FDA authorized IQOS to be marketed as a modified-risk tobacco product,” said Billy Gifford, CEO of Altria. "This authorization gives PM USA an opportunity to communicate additional benefits of switching to IQOS and this decision is an important step for adult smokers. Our 10-year vision is to responsibly lead the transition of adult smokers to a non-combustible future. 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."

This is the second set of products the FDA authorized as MRTPs and the first to received exposure modification orders, which allows Philip Morris to market the product "as containing a reduced level of or presenting a reduced exposure to a substance or as being free of a substance when the issuance of the order is expected to benefit the health of the population," the agency said.

Switching completely from conventional cigarettes to the IQOS system significantly reduces exposure to harmful or potentially harmful chemicals, the FDA said, citing scientific studies; however, this does not mean the products are safe or FDA approved.

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

Zeller said the FDA will monitor how IQOS is used by consumers to determine if the MRTP orders continue to be appropriate for IQOS, including assessing the potential for increased use among youth.

“It is important to note that these products are not safe, so people, especially young people, who do not currently use tobacco products should not start using them or any other tobacco product,” Zeller said.

The FDA’s authorization requires Philip Morris to conduct postmarket surveillance and studies to determine the impact of these orders on consumer perception, behavior and health. The requirements also include a rigorous toxicity study using computer models to help predict potential adverse effects in users and requires the company to monitor youth awareness and use of the products. The initial orders will expire in four years, according to the FDA.

In March, Philip Morris USA closed its Atlanta and Richmond IQOS stores temporarily and paused its IQOS in-person marketing efforts. The company also delayed the launch of IQOS in Charlotte, N.C., due to COVID-19 concerns. Its HeatSticks, or compressed tobacco sticks that are inserted into the IQOS device, remained available for sale in more than 500 retail stores across Atlanta and Richmond. 

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