Editor's note: This decision by the FDA is probably going to negatively impact all combustible smoking alternatives requests going forward for not only IQOS but also e-cigarettes, snuff and others. We were actually hoping IQOS would be able to reach their goals to make a trail for the vaping industry.
Philip Morris had submitted findings to the FDA claiming that its IQOS (heat not burn) product exposed users to far fewer chemicals and harmful agents. Based on these findings Philip Morris wanted permission from the FDA to market its products as a safer alternative to smoking, which was also rejected for e-cigarettes in the current regulatory framework.
These studies were covered here at Vaping Scout in our articles about studies showing e-cigarettes are 99% less carcinogenic than smoking and switch from smoking can prevent early deaths.
Politicians are here to save us from ourselves
Ten U.S. senators called on the Food and Drug Administration to reject Philip Morris International Inc’s (PM.N) application to market its iQOS smoking device as being less risky than cigarettes, according to a letter to the agency’s commissioner.
The senators, all Democrats, cited remarks by an expert scientific panel that reviewed the application for the FDA and voted last month to recommend against granting Philip Morris permission to do so, according to the letter, a copy of which was seen by Reuters.
The senators also referred to a Reuters report in December that identified shortcomings in the training and professionalism of some of the lead investigators in the clinical trials submitted to the FDA by Philip Morris, the maker of Marlboro cigarettes. Former Philip Morris employees and contractors also described irregularities in those experiments.
Philip Morris International, the world’s largest publicly traded tobacco company by market value, has applied to the FDA to be able to sell iQOS in America and for permission to market it as a modified-risk tobacco product. That designation could mean that Philip Morris would be allowed to sell iQOS to consumers as presenting less harm or risk of disease than traditional tobacco.
By heating tobacco instead of burning it, the company says iQOS avoids subjecting smokers to the same levels of carcinogens and other toxic substances found in regular cigarettes. The device is part of a $3 billion-plus investment by Philip Morris in new-generation smoking platforms.
The senators’ letter, dated Feb. 7, asked FDA Commissioner Scott Gottlieb to “avoid rushing through new products, such as IQOS, to fit within this evolving FDA policy, without requiring strong evidence that any such product will reduce the risk of disease, result in a large number of smokers quitting, and not increase youth tobacco use.”
It also said: “Such thorough review is especially critical given the tobacco industry’s deceitful history of marketing products under the guise of lower risk.”
This is a strange letter, in our opinion, for politicians to send to the FDA if they actually care about the health of their constituency and not just the appearance of fighting some big foe.
"Don't let this product come to market in a way where people think that switching away from smoking cigarettes to some other product could be beneficial to them in any way!" This is how this stance comes off to some people.
We don't like Big Tobacco but we can definitely understand the situation people who are trapped by an addiction to nicotine are in when the alternatives to smoking cigarettes are being crushed. Where does someone go to get a nicotine fix if the only choice is smoking cigarettes?
First they say you can't have flavored vape juice because kids also like flavors, then you can't have any new developments in your e-cig technology, now they are saying that taking in less chemicals and harmful carcinogens shouldn't be considered less harmful.
Is this the environment that Big Tobacco wanted for vaping coming back to haunt them?
How did the panel vote?
Several issues were decided upon by the panel in a series of votes.
The FDA panel voted 8-0 stating that Philip Morris hadn't proven that switching from cigarettes to IQOS reduced the risk of contracting tobacco related illness.
In a second vote of 5-4 found that tangible harm reduction hadn't been demonstrated when compared to smoking.
A third finding in an 8-1 vote, the FDA panel did agree to Philip Morris's claim that IQOS devices did reduce exposure to harmful chemicals.
This is a weird outcome seeing as the less exposure finding seems to be at odds with the rejection of tangible harm reduction claim.
Did this outcome occur due to the anti-vaping propaganda?
Over the past year or two these huge tobacco companies have been saying things in other countries about how they are moving away from cigarette products and moving towards these heat not burn devices and e-cigarettes.
Big Tobacco seems to have created an environment over the past ten years in the way it derided vaping in an effort to prop up the sales of its primary product cigarettes which is coming back to bite them (and vaping) in a big way.
It seems to be funny that all the arguments that were made against e-cigarettes and vaping are now being used to strangle its new $3 billion dollar investment in IQOS products.
Going forward, the tobacco industry is going to be forced to fund research which shows that there is tangible harm reduction, reduced disease risk versus traditional smoking. We have already seen them put out a call to researchers and up to a billion dollars in funding but will anyone take it?
Perhaps some researcher will but will the results of any findings be tarnished due to the shady history of fake studies from the tobacco industry?