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Independent Panel Tells FDA Not To Allow iQOS To Be Advertised As Harm Reduction Tool Independent Panel Tells FDA Not To Allow iQOS To Be Advertised As Harm Reduction Tool

Philip Morris International was looking for approval to market their heat not burn devices as harm reduction tools in America. But is this a good or bad thing for the independent vaping community?

An independent advisory panel unanimously decided last week to deny Philip Morris International’s bid to have their iQOS device approved by the FDA as a harm reduction tool. The committee claimed that PMI hadn’t done enough to prove the reduced risk, in spite of PMI’s rebuttal of the panel’s “valid questions.” It was not all bad news for vaping, as they did concede that Heat-not-Burn devices did reduce the number of harmful substances introduced into the system. But they wouldn’t back them as deserving a special designation and label. The advisory board felt that while PMI had shown evidence that suggested and implied a harm reduction value, they just simply hadn’t shown anything clearly demonstrating it.

It was not the only time last week that an extension of the FDA had conceded that vaping reduces harm, but wouldn’t commit to fully supporting them as legitimate harm reduction tools. A comprehensive analysis of hundreds of vaping studies similarly concluded that vaping shows a distinct ability to reduce the exposure to harm, but they still had questions about their long-term efficacy. So while the FDA heads don’t have any obligation to follow the suggestions of the panel, it would seem likely that they will. But would it honestly be better for vaping as a whole if the FDA allowed Philip Morris to advertise their products as harm reduction tools legally?

The Bad

On its surface, it seems clear that the vaping industry should be in Philip Morris International’s corner for this fight, hoping to aide their own fight for legitimacy. The major health organizations in America have never formally backed vaping, so any product getting such an endorsement would be tremendous. In addition to that, it’s usually much easier for other products to receive approval after a first one sets a precedent for evidence. Many vapers also feel that any cracks in the FDA’s stance against vaping should be exploited to hopefully open the floodgates and get momentum on the vaping industry’s side.

The general public has a pathetic level of understanding regarding vaping, and the FDA blocking yet another smoke-free device is only exacerbating the issue. A poll by Action on Smoking and Health found that only 13% of people believe vaping to be much safer than smoking, while over 26% thought vaping was just as, if not more dangerous. With numbers like this, it’s no wonder why the American vaper has faced increasing taxes and bans; They’re simply an easy target.

The Good

It won’t be all bad news if the FDA does indeed block PMI’s application. The most apparent positive for vapers is that it will mean a Big Tobacco company isn’t handed a coveted legal harm reduction endorsement. With the latest news that Philip Morris is planning for a future without cigarettes, many vapers are more concerned than ever that the Big Tobacco company will attempt to steal a significant portion of the vaping market share. Mark MacGregor, PMI’s Director of Corporate Affairs in the UK recently said that the company could even stop selling traditional cigarettes as soon as 2030. While some vapers may have expected Big Tobacco to make a hard push into vaping, few could have anticipated it would happen so rapidly.

With that in mind, it becomes even more critical for the independent vaping industry that companies like PMI face as many roadblocks as possible. Given they have such a large resource pool to draw from, that last thing they need is to be handed an exclusive designation backing their harm reduction value. The continued hesitance of the FDA has traditionally been seen as a negative for vapers, but at least in this case, it’s preventing a massive advantage for Big Tobacco. The evidence is still growing for the harm reduction value of vaping after all. Public Health England originally came out in 2015 supporting vaping as at least 95% safer than smoking, but they recently went even further, now claiming that hospitals should sell vaporizers and allow vaping indoors. Trends like this show it’s only a matter of time until the evidence supporting vaping is overwhelming. Whenever that happens, most products should be able to qualify for a harm reduction label, thus negating any extra advantage for Big Tobacco.


The fact that PMI’s application for designation as a harm reduction tool will likely be denied can seem like a significant loss for smoke-free devices of all kinds. But alternatively, it may actually be giving the independently owned vaping industry the time it needs to also earn that distinction. Regardless of how accurate Mark MacGregor’s “2030” comments are, they prove that Big Tobacco companies are planning for a future in which they no longer sell combustible cigarettes at all. With that being the case, it seems rather necessary to limit the advantages for the already well-resourced tobacco companies.

There’s no way that we can stop companies like PMI from entering the smoke-free market entirely, but we can work to limit their advantages such as having the only product endorsed as a “harm reduction tool.” But this raises a massive question for the whole industry. How do we work with Big Tobacco on issues we mutually benefit from, without giving them too much of a foot in the door? Having the extra resources of Big Tobacco companies could undoubtedly lead to a faster acceptance in the general public, but that would, in turn, increase their market share faster. So the question remains, what is better for the future of vaping?

Should the panel have denied PMI’s request, or do you think it’s doing more harm than good? Should we aim for a faster public understanding of vaping or working to keep the industry mainly independent? What’s the best way to deal with Big Tobacco companies when the goals of vaping companies align with theirs? Let us know in the comments.

Dustin Erickson

Dustin Erickson - ECR.net Editor

Dustin can lay claim as one the first e-cigarette reviewers on the internet. Back in the summer of 2009 he set out on a mission to spread the word about e-cigs with this very site. Nearly 2.5 Million visitors, 1,700 Reviews collected and 5 years later, he’s still as passionate as ever and one of the leading Vaping advocates online.