The FDA Has a Golden Opportunity to Save Smokers’ Lives


The FDA Has a Golden Opportunity to Save Smokers’ Lives

Back in July, the Food and Drug Administration committed itself to a new strategy to tackling smoking.

Back in July, the Food and Drug Administration committed itself to a new strategy to tackling smoking.

Articulated by FDA Commissioner Scott Gottlieb, the new approach recognizes it’s the deadly smoke caused by setting tobacco on fire sucking into the lungs that are responsible for the deaths of 480,000 Americans each year — not nicotine.

Part of this new strategy, according to Gottlieb, is ensuring new and innovative products that are significantly less dangerous than smoking and can draw people away from cigarettes can come to market.

The FDA is now facing its first true test of this approach and has the opportunity to show its warm words for the role of innovation and consumer choice in reducing smoking-related deaths can be translated into action.

A new generation of products that heat but don’t burn tobacco is helping millions of smokers across the world kick the habit. Approximately three million smokers have switched to Philip Morris’ heat-not-burn battery-powered product IQOS.

Currently sold in cities in 26 countries but not the U.S., IQOS and the tobacco sticks that are inserted into it are flying off the shelves, with new factories being set up in Europe to cope with demand.

In Japan, the only country where IQOS is sold nationwide, it already accounts for 10 percent of the tobacco market after little more than a year on the market. Critically, 72 percent of those using IQOS in Japan are doing so exclusively, dropping regular cigarettes altogether.

Why are these new tobacco products so appealing? For one thing, they use real leaf tobacco which gives users a taste and experience that mimics smoking more closely than other reduced-risk nicotine products.

But by far their biggest appeal is the opportunity they present to smokers who have so far been unwilling or unable to quit smoking.

Because there is no combustion in IQOS, there is no smoke, which means levels of lethal chemicals found in cigarette smoke are dramatically reduced.

According to PMI Science, 18 chemicals whose concentrations the FDA deems as essential to evaluating the relative safety of tobacco products are reduced by 90-95 percent in IQOS.

While all of this research is published, the public will be forgiven for treating health claims from Big Tobacco with extreme skepticism.

Thankfully, PMI Science is not the only source of the relative risks of IQOS. Konstantinos Farsalinos, a research fellow at the Onassis Cardiac Surgery Center in Athens and world-renowned researcher on e-cigarettes, conducted investigations into the toxicity of IQOS in a non-PMI lab and found broadly the same results.

Furthermore, clinical trials carried out in Japan and the U.S. show smokers who switched exclusively to IQOS saw reductions in levels of the harmful and potentially-harmful chemicals similar to levels seen in smokers who ceased cigarette use for the duration of the study.

U.S. smokers don’t have access to IQOS at present but an application is working its way through the bowels of the FDA. But just as important as allowing IQOS onto the market in the first place is allowing consumers access to the full knowledge about its safety relative to cigarettes.

If IQOS and products like it are to going to be successful in transitioning people away from smoking it is imperative that smokers know switching exclusively to IQOS will massively reduce their exposure to lethal chemicals and could save their lives.

To that end, my colleague at the Reason Foundation, Brian Fojtik, and I filed a comment in support of PMI’s application for a Modified Risk Tobacco Product application.

Should the MRTP be granted, the full benefits of switching from cigarettes to IQOS could be communicated to consumers and therefore attract the maximum number of smokers who are interested in quitting smoking but have found other methods unsatisfactory.

If the FDA is serious about providing smokers the best possible options to quit and avoid an early grave, granting the MRTP for IQOS will be a major win for tobacco harm reduction and will provide the tools and information smokers desperately need.

This column first appeared in the Washington Examiner.