IQOS, Despite Not Meeting FDA Standards, Is Authorized as Modified Risk Tobacco Product


by Christina Matthews

Updated: July 14, 2021

FDA Approves IQOS as “Modified Risk Tobaccoo Product”, Despite No Evidence to Back It Up

Due to a recent PreMarket Tobacco Application(PMTA submissions that involved all areas of the “Electronic Nicotine Delivery Systems” market, we reminded about the preceding act regarding IQOS.

The Food and Drug Administration took the unprecedented step to authorize Philip Morris’s, heat-not-burn tobacco product, IQOS, even though it failed to meet any of the standards put forth by the agency.

In a press release announcing the agency’s decision, Mitch Zeller, the director of the Center for Tobacco Products, stated that “these particular products…could help addicted adult smokers transition away from combusted cigarettes and reduce their exposure to harmful chemicals”.

There have been multiple studies conducted that have found the contrary. The decision has only added to the belief that the federal government favors traditional tobacco products over e-cigarettes.

Fair and equal rights for everyone?

Why Did the FDA Authorize IQOS?

The decision was made in July of this year to authorize the IQOS after a lengthy, four-year process. Philip Morris had applied to have the IQOS receive both a:

Risk modification classification (which would give the company the right to claim that their product was safer than traditional tobacco)
Exposure modification classification (which would give the company the right to say that their product reduced a person’s exposure to harmful chemicals)

The company did not receive a risk modification classification but was granted an exposure modification authorization, due to the data it provided the agency. The agency wrote that the company proved the following:

  • The IQOS “significantly reduces the production of harmful and potentially harmful chemicals compared to cigarette smoke”, because it does not burn tobacco, but only heats it.
  • The IQOS “significantly reduces the body’s exposure to 15 specific harmful and potentially harmful chemicals”.
  • “IQOS aerosols contain considerably lower levels of potential carcinogens and toxic chemicals”.

All of these claims have been debunked by independent studies showing the opposite. The independent studies have also called into question PMI’s research methods and have accused the company of leaving out important data sets. The FDA did not conduct its own studies on the viability of PMI’s research.

It instead chose to accept the research PMI itself conducted without question. Despite this, Mitch Zeller also puzzlingly wrote in his statement that “that these products are not safe”, and should not be thought of as “FDA approved”, even though the agency went through with granting the company an “exposure modification” classification,

Debunking PMI’s Claims

Evidence abounds countering PMI’s claims. Researchers have not only debunked the majority of the company’s conclusions about the safety of their products, but they have also pointed out the deficiencies in their reports.

  • The model used by the company to prove IQOS’s reduced risk: “underestimates the potential impact of IQOS on the population as a whole and does not justify marketing the product as an MRTP”.
  • That “PMI failed to demonstrate that the proposed IQOS claims within their MRTP application…are consistent with the scientific evidence of actual harm and exposure”.
  • That “PMI’s proposed reduced exposure claim is false and misleading”.

– experts say
All these reports were published as a response to the company’s initial application, which was made in 2016. Aside from rejecting the PMI’s scientific claims about reduced risk and exposure, these studies — commissioned by groups as varied as the US National Cancer Institute, Stanford University, and the Campaign for Tobacco-Free Kids – found the company’s marketing was problematic.

Vague and Misleading Labelling

A central claim of PMI’s marketing is that current smokers will “switch completely” from traditional cigarettes to the heat-not-burn variety. The company pushes this belief without accounting for the fact that most people who switch do not switch completely but become poly-users, meaning they use more than one tobacco product.

The company’s research has found this to be true. In Japan – one of the first markets where the company introduced IQOS – the company’s own scientists discovered that:

36% of Japanese IQOS users also used another tobacco product, whether conventional cigarettes or e-cigarettes.

The company ignored this evidence and kept on repeating the claim that potential IQOS users would “switch completely” from cigarettes, or that IQOS would lessen users’ dependence on nicotine.

Drawing In Young People

One of the more glaring omissions in PMI’s research is that it failed to study the effect its “reduced risk” marketing claims would have on young people. Not only that, but the company purposefully tried to entice young users with the same tactics that it used before in marketing cigarettes, including:

  • “liberal use of artists, musicians, social media influencers, and celebrities in promotional roles”
  • “Promoting IQOS as an “elegantly fashionable lifestyle product”
  • And “using events, social media, and influencers and celebrities” to renormalize smoking

Nothing in the FDA’s press release about its authorization of IQOS as an “exposure modified” product took this into account. It must be said that many of these studies argued against the agency granting PMI a “modified risk tobacco product” or MRTP, which it did. But the agency opened a loophole for the company to continue with its marketing campaign, and misleading claims.

Did the FDA Play Favorites?

The FDA’s decision was heralded by PMI as a “historic opportunity for public health”. The company posted a reaction to the agency’s decision on its website, which it took as a vindication of their long-standing claims. It even took the opportunity to repeat those claims in its press release, which seems more like gloating than anything else.
With a wealth of information debunking the company’s claims, many are wondering why the FDA, which is charged with protecting the public from misleading health claims made by tobacco companies, dropped the ball by authorizing PMI to continue lying to the public.

The ham-fisted decision that denied one authorization, but granted another show that accommodations can be made for powerful, well-connected tobacco companies. None of these studies claimed that e-cigarettes were a better alternative to IQOS, but they did point out that the aerosols from e-cigarettes contained fewer carcinogens than the IQOS.

With the FDA cracking down on e-cigarettes, and talk about an outright ban increasing in light of the recent troubles, it is troubling that the agency would relax its own standards to allow a tobacco company the right to say its products are safer, even though the science says otherwise.

Published: October 1, 2020Updated: July 14, 2021

Christina Matthews

I love the written word, and in my career as a journalist, I strive to provide the facts about everything I write about. There are too many false and alarmist stories out there about life and vaping mainly. My mission is to make e-cigarettes less scary to people with informative articles and extensive research on not only the possible evils of cigarettes and Big Tobacco, but the objective side of e-cigs.