The U.S. Food and Drug Administration (FDA) has renewed its authorization, allowing Philip Morris International to market its IQOS heated tobacco system as a Modified Risk Tobacco Product (MRTP).

 

This is by extending a regulatory status that lets the company communicate reduced-exposure claims to adult smokers.

 

The renewal covers two versions of the IQOS device and three HEETS tobacco variants, and allows PMI to continue presenting information to U.S. adults aged 21 and above who currently use combustible cigarettes.

 

At the center of the decision is the FDA’s assessment that supports reduced exposure claims. 

 

In its order, the agency stated: “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”

 

The FDA also concluded that extending the authorization aligns with public health goals, stating the renewal is appropriate “to promote public health” and is expected to benefit “the health of the population as a whole,” including both current tobacco users and non-users.

 

The agency further reaffirmed its scientific position, noting that: “the scientific evidence that is available without conducting long-term epidemiological studies demonstrates that a measurable and substantial reduction in morbidity or mortality among individual tobacco users is reasonably likely.”

 

PMI leadership called the decision a validation of its long-running strategy to reposition itself as a smoke-free alternatives company.

 

“As the only company to have successfully secured and maintained MRTP authorizations for heated tobacco products in the U.S., we are confident that our science-based alternatives can help adult smokers transition away from combustible cigarettes,” said Stacey Kennedy, CEO, PMI U.S. 

 

“This decision from the FDA reflects both the rigorous scientific foundation supporting IQOS and our ongoing commitment to responsibly deliver smoke-free choices to adult consumers.”

 

PMI says its submission included extensive scientific data comparing aerosol emissions from heated tobacco to cigarette smoke, arguing substantially lower levels of harmful constituents. 

 

While acknowledging that no tobacco product is risk-free, the company pointed to real-world markets such as Japan, where heated tobacco adoption has coincided with declines in cigarette consumption.

 

The IQOS system works by heating tobacco rather than burning it, a process PMI says reduces formation of harmful chemicals while still delivering nicotine.

 

PMI estimates there are around 25 million adult smokers in the U.S. and says it is focused on offering alternatives for this group. Globally, the company claims its smoke-free products are now used by more than 43 million adults across over 105 markets.

 

Since 2008, PMI says it has invested more than $16 billion in developing smoke-free technologies, with a stated long-term ambition of eventually phasing out cigarette sales entirely.