FDA Holds IQOS Heat-Not-Burn Hostage, As Market Forces & Smoke-Free Products Slash Japan Cigarette Sales

The media has been silent about an unprecedented decline in cigarette consumption.  Japan Tobacco International reports (here) that cigarette sales in Japan declined 12% in 2018, largely due to sales of reduced-risk products.  The dominant reduced-risk product in Japan is Philip Morris International’s IQOS heat-not-burn HeatStick.

David Sweanor, a veteran tobacco harm reduction advocate in Canada, observed: “Japan provides a great lesson in how tobacco control groups ‘doing nothing’ and ‘staying out of the way’ has led to outperformance in reducing cigarette smoking.  A key question is what could be accomplished if these groups actively facilitated transitions away from combustibles.  Japan has reduced cigarette sales dramatically in just three years, Iceland reduced prevalence of cigarette smoking by 40% in three years, Norway reduced the cigarette market by half in a decade, Sweden achieved by far the lowest rates of smoking in Europe, and the U.S. appears to have tripled the rate of decline in cigarettes sales. All this largely despite, not because, of, actions by mainstream tobacco control. That should be a wake-up call.”

Clive Bates, another veteran THR advocate from the U.K., remarked: “The only mystery is why the skies over Tokyo are not dark with chartered planes bringing officials from WHO, FDA, Truth Initiative, the Campaign for Tobacco-Free Kids, the European Commission and others on an emergency mission to learn about this most extraordinary shift.  What is the secret they would find? ‘Do nothing, stay out of the way....’  There was very little involvement from tobacco control – the demise of cigarettes in Japan has been driven by the market and consumer preference.” 

Meanwhile, in the U.S., smokers can’t buy IQOS because the FDA has not approved PMI’s marketing application (known as an PMTA), which was submitted in March 2017.  Approval requires the company to demonstrate “that the new tobacco product is beneficial to the population as a whole.”  Nothing benefits a population more than the rapid deterioration of cigarette sales, as seen in Japan.

An FDA official recently indicated that a decision on IQOS will be issued by the end of this year.  That would mark the passing of 2.75 years from submission, and the untimely deaths of 1.3 million American smokers.

The FDA took eight months (335,000 dead smokers) to grant Swedish Match a PMTA for eight snus products in 2015 (here).  What will happen in 2022, when the FDA receives thousands of PMTAs from vapor manufacturers and retailers?