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Invested in Advancing Science

What’s the problem?
Smoke.

 

The data are clear: Smoking remains the leading cause of preventable deaths in the United States, according to public health data. But it doesn’t have to be that way. Scientifically validated smoke-free alternatives can help change this reality and improve public health. 

 

When we eliminate combustion, we dramatically reduce the production of harmful chemicals. This scientific fact is at the heart of our smoke-free product development. To be clear, smoke-free products are not risk-free. They contain nicotine, which is addictive, but they’re designed to satisfy consumer preferences and are a far better option for 21+ adults who would otherwise smoke. 

Championing a smoke-free future 

PMI U.S. is a leader in smoke-free innovation, helping America’s 45 million nicotine consumers—30 million of whom smoke—leave cigarettes and other traditional tobacco products behind. 

First premarket tobacco
application (PMTA¹) authorization
(General snus)

2015

First modified risk tobacco product
(MRTP²) authorization
(General snus)  

2019

First and only PMTA heated tobacco product (HTP) authorization (IQOS)

2019

First and only MRTP
HTP authorization 

(IQOS)

2020

First and only MRTP
authorization renewal 

(General snus)

2024

First and only PMTA nicotine
pouch authorization 

(ZYN) 

2025

As of June 1, 2025, PMI is proud to have the largest share of both PMTA and MRTP authorizations from the U.S. Food and Drug Administration (FDA).

1When a company receives an authorization in response to its premarket tobacco product application (PMTA), it means the U.S. Food and Drug Administration (FDA) has conducted a rigorous review of the scientific data submitted about the product and determined that the product is appropriate for the protection of public health. 

 

2Receiving a modified risk tobacco product (MRTP) exposure order means the FDA has determined that the product is appropriate to promote public health and is expected to benefit the health of the population as a whole. 

U.S. Chief Science & Regulatory Strategy Officer

Matt Holman

Clearing up confusion around smoke-free products can create huge benefits for public health. The fact is that FDA-authorized smoke-free products do exist, and they have the power to drive real change toward accelerating an end to smoking.

Nicotine
facts

Nicotine is addictive and not risk-free. But it’s the smoke from traditional cigarettes, not nicotine, that is the primary cause of smoking-related diseases. 


Scientific studies conducted by government health agencies and independent third parties consistently conclude that it is the high levels of harmful chemicals generated by burning tobacco—not nicotine—that are principally responsible for smoking-related diseases. 

 

The U.S. FDA states, “It’s the thousands of chemicals contained in tobacco and tobacco smoke that make tobacco use so deadly. […] This toxic mix of chemicals—not nicotine—cause the serious health effects among those who use tobacco products, including fatal lung diseases, like chronic obstructive pulmonary disease (COPD) and cancer.”

People—even doctors and other medical experts—often misunderstand this distinction. A 2020 report showed that more than 80 percent of physicians mistakenly thought that nicotine contributes directly to the development of lung cancer and COPD (chronic obstructive pulmonary disease). 

A 2025 survey fielded by Povaddo LLC and funded by PMI U.S. has found that misconceptions about nicotine persist. The survey of more than 1,500 U.S. healthcare practitioners found that nearly half of these providers (47 percent) mistakenly believed nicotine is a carcinogen, despite scientific consensus that the harms of smoking primarily stem not from nicotine but from the burning of tobacco. Another 19 percent were unsure. More than two-thirds of medical professionals want the U.S. Food and Drug Administration to share clinical evidence that demonstrates the role of smoke-free products in harm reduction (69 percent) and clear guidance on counseling patients about transitioning to smoke-free alternatives as part of harm reduction strategies (68 percent).

 

 

In the interest of public health, government agencies and health organizations must provide science-grounded education on tobacco harm reduction.

 

The roughly 30 million U.S. adults who smoke need to know the facts about nicotine and the role of smoke in tobacco-related disease. Their physicians need to know it, too. 

Choice and the need
for better alternatives

The best choice a person can make is never to start smoking. For people who smoke, the best choice is to quit tobacco and nicotine completely. Every year, while any smoker can quit, most don’t. For those adults who choose to continue consuming nicotine, switching to a smoke-free alternative, backed by science, is a far better choice than continuing to smoke. 

 

In the past few decades, PMI and other companies have introduced better alternatives to smoked tobacco products such as cigarettes, cigars, and pipe tobacco. PMI U.S.’s heated tobacco products, snus, and oral nicotine pouches all offer a better option to adults who would otherwise smoke. 

By offering a wide range of smoke-free options, we give adults better alternatives to continuing to smoke. 

Policy and action need to
follow science’s lead

The U.S. Food and Drug Administration has the power to improve public health by prioritizing the review of smoke-free product applications. 

 

But regulation isn’t the agency’s only responsibility. The FDA has an obligation to share accurate, science-based information about smoke-free products 1) so legal-age nicotine consumers can make better decisions for their health and 2) to help keep unauthorized products out of the hands of consumers. 

 

Learn more on our Policy & Engagement page.