News & Politics

Promising New Technology on Tobacco Harm Reduction Front Awaits FDA Approval

Eugene Odinokov / Sputnik via AP

Phillip Morris International has developed a new “heat not burn” tobacco product that claims to be less harmful than combustible tobacco (cigarettes). The IQOS device is already in key cities in 38 markets and the company estimates nearly 5 million smokers have kicked their habit using IQOS. Currently, the product is awaiting approval from the Food and Drug Administration (FDA) so the IQOS can be sold in U.S. markets.

First a little background

The science is settled regarding cigarette smoking. We know that smoking causes cancer, cardiovascular disease, systemic inflammation and many other ailments. Warnings are on cigarette packs, children are taught in schools to stay away from cigarettes and even Hollywood has reduced the visibility or glamour of smoking in their movies.  But it’s difficult to quit smoking, I know because I’m a former smoker who quit using an electronic cigarette (e-cig).

Now more than ever there are options available in the U.S. for those who want to kick their smoking habit. Big Pharma sells nicotine gum and nicotine patches, products that have been around for years. The patch and the gum work for some people but not for all. As of 2015, 70% of all smokers wanted to quit smoking. The invention and growth of the electronic cigarette industry introduced more “smoking-like” options for those looking for a way out of their habit.  Convenience stores sell a few basic products like BLU or JUUL. These products are easy to use. They involve inhaling vapor with nicotine and flavor and have enjoyed much success, especially since they provide a simple point of entry for the prospective quitter. More complicated and customizable setups are available at vape shops or by ordering through stores on the internet, but those can have a steep learning curve. Most smokers want an easy option to cease smoking and would rather not bother with carrying e-liquid and extra atomizers around with them everywhere they go like I do.

It’s not the tobacco or nicotine that is dangerous for smokers; the danger lies in inhaling the byproduct of something that was set on fire (combustible tobacco). Cigarette smoke from combustible tobacco contains thousands and thousands of toxins like formaldehyde and arsenic.

PMI’s new technology

Phillip Morris International (PMI), the cigarette company, has moved into the tobacco harm reduction (THR) space and is seeking FDA approval for their new “heat not burn” tobacco technology. Whereas e-cigs deliver nicotine to the user via the vapor of heated vegetable glycerin and propylene glycol, the IQOS device takes an innovative approach and delivers nicotine via heated, not burned tobacco. The company has invested almost $5 billion into the IQOS and other smoke-free platforms and the majority of their investment has been spent on scientifically validating the reduced risk of IQOS over combustible tobacco use.

Eugene Odinokov / Sputnik via AP

The IQOS device is targeted at smokers only. The product delivers an experience very similar to that of smoking a cigarette, which I think will make it a very successful quit option here in the United States. First, because the product uses actual tobacco to provide for a continuity of taste; and second, because the IQOS mimics the cigarette smoking experience. Each IQOS use lasts six minutes just as smoking an actual cigarette does. As someone who has been through the quitting process, getting your “nic fix” is only one part of the quit equation. The habit and ritual of smoking is equally if not more difficult to get out of your system. The IQOS product integrates the IQOS into a smoker’s pre-existing routine without a shocking disruption. A user can have an after-dinner “smoke” or take a “smoke” break just like with a combustible tobacco cigarette.

The technology behind the IQOS involves the device itself and the tobacco sticks called HEETS. The HEETS are inserted into the device where a special blade heats up the sticks within a range of 560°F to 660°F. The device keeps the temperature below the threshold where toxic compounds are generated from burning, which takes place around 750°F degrees. By contrast, cigarettes reach temperatures of between 1110°F to 1470°F, exceeding 1650°F during puffs. By keeping the temperature beneath the point of burning, IQOS generates an aerosol, but not smoke. After six minutes, the HEET stick is used up and the device shuts off. HEETS sticks are sold in packs, just like cigarettes.

Manufacturing HEET sticks in Bologna, Italy. Courtesy of PMI

The evidence

PMI has produced a substantial amount of science to back up their claims that the IQOS device is less harmful than combustible tobacco. You can read the peer-reviewed studies on the PMI website. In addition, the company has participated in eight clinical trials the public can review at ClinicalTrials.gov.  While I was visiting the PMI research and development facility (known as “The Cube”) in Neuchatel, Switzerland, the company released another study that “measured the biological response of people who switch to IQOS for six months compared with continued smoking. The study met its primary objective, demonstrating that after six months, eight measures of biological response (the primary clinical risk endpoints) improved in those who switched to IQOS.”

“The Cube” also known as Phillip Morris International’s Research and Development facility in Neuchatel, Switzerland. No pictures are allowed inside the facility but it’s equally impressive. Photo credit:PJ Media.

If you are skeptical of research coming from PMI about their own product, R Street, a nonprofit public policy research organization, has published a study on the potential for harm reduction in “heat not burn” technologies. The American Cancer Society has released a statement on eliminating the use of  combustible tobacco in the United States, saying, “Whereas complete information on all the potential risks and benefits of ENDS [electronic nicotine delivery system] is  not  yet  available, there is sufficient information to allow ACS to act now with a clear focus on the primary goal of ending deadly combustible tobacco use, which  is responsible  for  approximately  a  one-half  million deaths per year and 30% of all cancer deaths in the United States.”

The FDA

In December of 2016, PMI applied to the Food and Drug Administration to sell IQOS with a modified risk claim. If approved, the product can be advertised to the public as carrying less risk then the risk associated with combustible tobacco use. There is much disinformation associated with alternative nicotine delivery systems so this is very important for those interested in mitigating the health risks of smoking. “Many adults believe, erroneously, that ENDS [electronic nicotine delivery systems] are as harmful as combustible tobacco products, and the level of public understanding has deteriorated over time.  In 2012, only 11.5% of respondents to a national survey held this view.  By 2015, 35.7% of respondents mistakenly believed that the harm associated with electronic cigarettes (e-cigarettes) was ‘about the same’ as that of smoking conventional cigarettes.” PMI also has submitted a Pre-Market Tobacco Application (PMTA) to the FDA to sell the device and is waiting for approval from the agency.

The e-cigarette “IQOS” of the company “Philip Morris International” on March 28, 2018 in Berlin, Germany. Photo by: Robert Schlesinger/picture-alliance/dpa/AP Images

Unfortunately, the FDA’s Tobacco Products Scientific Advisory Committee (TPSAC) rejected the reduced risk claims by PMI in a January 25, 2018, hearing. However, the committee did “conclude that the product exposes users to lower levels of harmful chemicals but said the company had not shown that lowering exposure to those chemicals is reasonably likely to translate into a measurable reduction in disease or death.” It is still possible for the FDA to disregard the committee’s decision and grant the IQOS reduced risk status; only time will tell if this happens.

If you are a smoker who is interested in quitting smoking or you know someone who has not yet found a successful quit method, you will want to give the IQOS device a try.  Hopefully, the FDA will move forward swiftly to approve the IQOS to market and acknowledge it as a reduced risk option for those smokers trying to improve their health.

Disclaimer: PMI sponsored my trip to visit their research and development facility in Neuchatel, Switzerland, their production facility in Bologna, Italy.