FDA Panel Unanimously Decides To Block Harm Reduction Labels On Philip Morris International’s iQOS Devices

PMI had been seeking approval to advertise their Heat-not-Burn technology as lower risk than tobacco. But is their failure a good thing for the independent vaping industry?

Philip Morris International’s push into the American smoke-free market took a severe blow last week as an FDA advisory panel unanimously decided PMI hadn’t done enough to prove the safety of their heat-not-burn product. Although Philip Morris representatives immediately agreed to counter the “valid questions” posed by the panel, the original recommendation stood. The advisory panel did concede that Heat-not-Burn devices do limit the exposure to harmful chemicals, but they wouldn’t commit to the fact that this reduces harm. According to the panel, the evidence suggests and implies that Heat-not-Burn technology is safer, but they weren’t convinced it quite “demonstrated” this harm reduction.

This sentiment echoes the findings of the comprehensive vaping study analysis published last week by the National Academies of Sciences, Engineering, and Medicine. That report, also commissioned by the FDA, concluded that vaping does appear to have some legitimate harm reduction value, but they’re unsure if it’s enough to grant it the approval of other harm reduction tools. The FDA doesn’t have to follow the advisory panel’s suggestion, but it’s more than likely they do. Regardless of what happens, it’ll surely have a significant impact on the independent vaping industry. But will it be overall positive or negative?

Negative Effects

It may seem obvious why it would be in the whole vaping industry’s favor for someone to get approval as a legal harm reduction tool. This would give a level of legitimacy to vaping that has been missing since it first exploded onto the scene in the late 2000s. Not only that, but as soon as one product gets approval, it theoretically should become easier for other products to get a similar label, knowing precisely what was shown to gain support the first time. It can also be argued that since the FDA has remained so staunch in their stance on vaping, that any shift in status quo could lead to a domino effect, significantly accelerating the expansion of vaping rights.

If the FDA does indeed follow the panel’s suggestion to not acknowledge the harm reduction value of smoke-free products, it will only bolster the societal attitude equating vaping with smoking. Some polls have found that only around 13% of adults understand that vaping is much safer than smoking, with over double that number believing that e-cigarettes are just as, if not more harmful. It’s exactly this mindset that has lead vaping to be endlessly taxed and banned as if it was merely another high-risk tobacco product.

Positive Effects

If the FDA does, in fact, deny PMI’s request, it’s by no means all bad news for vapers. First and foremost, it’ll prevent a Big Tobacco company from receiving a massive leg up on the competitors, at least until other products could secure the same label. This could prove even more critical than ever with Big Tobacco companies like PMI seemingly reading the writing on the wall for traditional cigarettes. PMI’s Director of Corporate Affairs for the UK, Mark MacGregor said in a recent interview with the Daily Star that they are preparing for a world without cigarettes, even going as far as to claim that PMI would aim to stop making cigarettes altogether by as early as 2030. If this is true, it could mean that PMI and other Big Tobacco companies are planning on overtaking the vaping industry as combustible cigarettes stop being viable.

That would make limiting the advantages of the already much more powerful tobacco companies even more decisive to the continued existence of a thriving independent vaping industry. So although it may take a bit longer to become fully accepted as a harm reduction tool, it’s likely we’ll eventually get there since the science still points to the extreme harm reduction value of vaping. Public Health England famously reported back in 2015 that vaping is at least 95% safer than smoking. They doubled down on this stance earlier this year when they said that hospitals should allow vaping indoors and even in single patient rooms. If a reputable public health institution such as PHE has been so supportive of vaping through the years, it may be that one day we could see the same in America.


At first glance, it may seem that this was a loss for vapers, with another smoke-free device failing to secure that harm reduction label. But when you take a deeper look, it is quite possible that this was ultimately a positive thing for the independent vaping industry. If you’re to believe PMI about their future within the industry, it seems that a meteoric shift is right on the horizon. Philip Morris and companies like them have near limitless amounts of money from which to seize control of what has thus far been an ideal image of a strong, mainly independently owned industry.

While it’s unlikely that we could ever do anything to stop them from getting involved whatsoever, we can try to limit their influence over this industry moving forward. Unfortunately, vapers are still just fighting for acceptance by public health agencies and the extra capital wielded by Big Tobacco could prove vital. So the question is, do we more value faster societal acceptance of vaping, or maximizing the continued independence of the industry?

Do you think it’s a good or bad thing that the FDA panel denied PMI’s request? What’s more important to you, faster acceptance or continued independence? How do you think we should treat Big Tobacco companies in issues where our goals align with theirs? Let us know in the comments.

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