Tobacco giant asks the FDA to approve ‘less risky’ cigarette  

Philip Morris International wants to move smokers away from conventional cigarettes to a new product that’s heated rather than burned — but first it needs a green light from the government.

It has petitioned the Food and Drug Administration (FDA) for approval to sell IQOS, which it calls a “less risky” smoke-free tobacco product, in the United States.

The rechargeable, electronic device is already on the market in 25 countries, including Japan, and heats a tobacco stick enough to release a nicotine vapor without burning the tobacco. 

Because the tobacco is heated instead of burned, the company says it cuts the harmful cancer-causing chemicals found in a combustible cigarette by 90 to 95 percent.

Health advocates are skeptical.

Given the tobacco industry’s history of questionable scientific practices over the years, Dave Dobbins, chief operating officer at Truth Initiative, said the FDA should review the company’s toxicology tests and replicate them before approving this alternative product.

“For example, the tobacco industry knew for years tobacco was addictive and deadly before they would admit it,” he said. “It’s not impossible they could do something good; I’m more saying it’s important to verify their data.”

Corey Henry, a spokesman for Philip Morris International, said the company welcomes scrutiny of the product.

“You don’t have to trust or believe us. You don’t have to take our word for it. But what we ask is that people have an open mind,” he said in an email to The Hill.

“Look at the science we’ve done and base your decision on that. We’ve submitted a substantive package of science to the FDA for their review and welcome the opportunity for FDA to scrutinize our research.”

Philip Morris International has two applications pending before the FDA. One is a Premarket Tobacco Application (PMTA) that was submitted on March 31 for its IQOS System with Marlboro Heatsticks, Marlboro Smooth Menthol Heatsticks and Marlboro Fresh Menthol Heatsticks. The FDA has to approve the application before the products can be legally marketed and sold in the U.S. 

The other, a Modified Risk Tobacco Product (MRTP) application, was submitted in December to market the products as lower-risk.

If approved, the products will be marketed and sold by Altria Group, the parent company of Philip Morris USA, via a commercial agreement between the two companies.

According to agency guidance, the FDA aims to act on PMTAs within 180 days of completing a review of an application. MRTPs, meanwhile, are reviewed and decided on within 360 days. 

Even as Phillip Morris International awaits U.S. approval for the product it invested $3 billion to develop, IQOS is already taking off overseas. By the end of the second quarter, it held 10 percent of the tobacco market in Japan, where the device retails for about $98 and a little over $4 for the heat sticks.

Unlike an electronic cigarette that use liquid laced with nicotine, IQOS uses actual tobacco. A “heat stick,” which looks like a mini cigarette that’s sold in cartons like the company’s regular Marlboros, is inserted into an electronic holder and heated to 662 degrees to give smokers the taste of tobacco without the smoke or ash. Each heat stick lasts for about 14 puffs and the device has a mechanism that turns it off to protect it from overheating.

“3 million smokers globally have already switched to IQOS and completely quit smoking conventional cigarettes and 8,000 more are making that switch each day,” Henry said. “Clearly there is a demand from consumers for a heat-not-burn alternative.” 

An independent study conducted by researchers in Switzerland, however, found IQOS produced some of the same dangerous chemicals as a combustible cigarette.

The study, published in May in the peer-reviewed medical journal JAMA Internal Medicine, found the volatile organic compounds polycyclic aromatic hydrocarbons and carbon monoxide were present in IQOS smoke. 

In an editor’s note, Dr. Mitchell Katz, director of the Los Angeles County Health Agency, said these heat-not-burn products “threaten the progress that has been made on decreasing the harms of second-hand smoke because existing bans may not apply to these heat-not-burn products.”

A spokeswoman for the University of Lausanne, a school one of the study’s authors is affiliated with, could not be reached for comment.

Philip Morris International says it has never claimed its product is completely free of harmful and potentially harmful compounds. 

“Our research shows IQOS reduces the formation of such compounds on average more than 90 percent,” Henry said. “However, we have also been clear that IQOS is not risk free and the best way to reduce tobacco related risks is to quit tobacco use all together.”

Though the product might truly be a safer alternative, Truth Initiative worries it will be marketed alongside Marlboro cigarettes instead of as an alternative for smokers who are concerned about their health.

Dobbins said it will be clear from the ads what Philip Morris International’s intentions are.

– This story was updated at 9:44 a.m.