FDA Authorizes IQOS as a Modified Risk Tobacco Product

SILVER SPRING, Md. — Alternative tobacco products just moved a step forward in the United States.

The Food and Drug Administration (FDA) approved Philip Morris International's (PMI) Modified Risk Tobacco Product application (MRTP) for IQOS, an electrically heated tobacco system. In doing so, the agency found that an IQOS exposure modification order is appropriate to promote the public health, according to PMI.

The decision includes the IQOS device, Marlboro Heatsticks, Marlboro Smooth Menthol Heatsticks, and Marlboro Fresh Menthol Heatsticks, according to the agency.

IQOS is the first electronic nicotine product to be granted marketing orders through the FDA's MRTP process.

"The FDA's decision is a historic public health milestone. Many of the tens of millions of American men and women who smoke today will quit — but many won't," said André Calantzopoulos, PMI's CEO, adding that the decision makes it possible to inform adult smokers that switching to IQOS is a better choice.

"FDA determined that scientific studies show that switching completely from conventional cigarettes to IQOS reduces exposure to harmful or potentially harmful chemicals," he added.

According to Calantzopoulos, IQOS is a fundamentally different product than combustible cigarettes and must be regulated differently, as the FDA has recognized.

"Now — more than ever — there is an urgent need for a fundamentally different conversation on a cooperative approach to achieve a smoke-free future," he explained. "The FDA's decision provides an important example of how governments and public health organizations can regulate smoke-free alternatives to differentiate them from cigarettes in order to promote the public health."

Philip Morris USA (PM USA), under an exclusive licensing agreement with PMI, commercializes IQOS in the U.S. PM USA is an operating companies of Richmond, Va.-based Altria Group Inc.

"We're delighted that the FDA authorized IQOS to be marketed as a modified-risk tobacco product. 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," said Billy Gifford, Altria CEO.

In April 2019, the FDA approved a Premarket Tobacco Application for IQOS, allowing the product to come on the market in the U.S. Following that decision, PM USA began rolled out marketing, sales and consumer engagement approaches in two lead markets, Atlanta and Richmond.

As of March 31, PMI estimates that approximately 10.6 million adult smokers around the world have already stopped smoking and switched to IQOS.

"We believe that this decision can help to further accelerate the transition of U.S. adults away from cigarettes. We, along with our licensee Altria, are committed to guarding against unintended use and fully support FDA's focus on protecting youth," Calantzopoulos said.

With the July 7 action, the FDA issued exposure modification orders authorizing Philip Morris Products S.A. to use the following information in their advertising and marketing of the products:

"AVAILABLE EVIDENCE TO DATE:

• The IQOS system heats tobacco but does not burn it.
• This significantly reduces the production of harmful and potentially harmful chemicals.
• Scientific studies have shown that switching completely from conventional cigarettes to the IQOS system significantly reduces your body's exposure to harmful or potentially harmful chemicals."