IQOS, Despite Not Meeting FDA Standards, Is Authorized as Modified Risk Tobacco Product
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?
Table Of Contents
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:
Today, FDA issued exposure modification orders for Philip Morris Products S.A.’s IQOS System, which permits the products to be marketed with specific information about reduced exposure. Even with this action, these products are not safe nor “FDA approved.” https://t.co/Dts7v4CIny pic.twitter.com/aPXkL5CNtB
— FDA Tobacco (@FDATobacco) July 7, 2020
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 U.S. FDA determined that issuing exposure modification orders for the IQOS system, while not risk-free, is "appropriate to promote the public health".#ScientificUpdate 11 takes an in-depth look ➡️ https://t.co/T1kXGSPiNx pic.twitter.com/uTqYpG1uw1
— PMIScience (@PMIScience) October 1, 2020
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.
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.
- 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”.
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.