PMI Promotion of IQOS Using FDA MRTP Order

This page was last edited on 10 June 2021, at 13:57.

In December 2016, Philip Morris International (PMI) applied to the U.S. Food and Drug Administration (FDA) to have IQOS, its heated tobacco product (HTP), classified as a Modified Risk Tobacco Product (MRTP) in the US.¹² The US Tobacco Products Advisory Committee (TPSAC) recommended against authorising PMI to market IQOS as a reduced risk product.³

On 7 July 2020, the US Federal Drug Administration (FDA) announced its ruling.⁴⁵⁶ It granted an ‘exposure modification’ order, which allows PMI to market IQOS in the U.S. using the following claims:⁴

“The IQOS system heats tobacco but does not burn it”
“This significantly reduces the production of harmful and potentially harmful chemicals”
“Scientific studies have shown that switching completely from conventional cigarettes to the IQOS system significantly reduces your body’s exposure to harmful or potentially harmful chemicals”

The FDA denied PMI a ‘risk modification’ order, for which PMI originally applied. A ‘risk modification’ order requires the applicant to demonstrate that products “(1) Significantly reduce harm and the risk of tobacco-related disease to individual tobacco users; and (2) Benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco products”. PMI “did not demonstrate” that IQOS met these standards. The exposure modification standard that the FDA authorised “establishes a lower standard” than that of risk modification.⁷

PMI’s press release and a statement from then CEO André Calantzopoulos hailed the ruling as a “historic public health milestone”. PMI focussed on the granted exposure modification order while limiting reference to the denied risk modification order.⁵

In July 2020, the Tobacco Control Research Group (TCRG) at the University of Bath produced a STOP briefing, summarising the evidence from academic research on IQOS, and highlighting the potential for the misrepresentation of the partial approval applying to the marketing of IQOS, which only applies in the US.⁸ In September 2020, TCRG researchers additionally published a peer-reviewed paper in BMJ highlighting how the decision increases confusion around the safety of HTPs.⁹

The FDA decision has been quoted in news media worldwide, with examples collected by TobaccoTactics from the following countries: Algeria,¹⁰ Argentina,¹¹¹²¹³ Bahrain,¹⁴ Canada,¹⁵ Colombia,¹⁶ Costa Rica,¹⁷ Croatia,¹⁸ Cyprus,¹⁹²⁰²¹ Ecuador,²² Egypt,²³²⁴²⁵²⁶ France,²⁷ Georgia,²⁸ Honduras,²⁹ Hong Kong,³⁰³¹³²³³ Indonesia,³⁴³⁵ Italy,³⁶ Jordan,³⁷ Kenya,³⁸ Lebanon,³⁹ Malaysia,⁴⁰⁴¹ Malta,⁴² Mexico,⁴³⁴⁴⁴⁵⁴⁶⁴⁷⁴⁸ Moldova,⁴⁹ Nigeria, ⁵⁰⁵¹⁵²⁵³⁵⁴⁵⁵ Palestine,⁵⁶⁵⁷ Pakistan,⁵⁸ Philippines,⁵⁹⁶⁰⁶¹⁶²⁶³⁶⁴⁶⁵ Romania,⁶⁶ Russia,⁶⁷⁶⁸ Rwanda,⁶⁹ Spain,⁷⁰ South Africa,⁷¹⁷²⁷³ South Korea,⁷⁴⁷⁵⁷⁶⁷⁷ Sweden,⁷⁸ Tanzania,⁷⁹ United Arab Emirates,⁸⁰ United States,⁸¹⁸² Uruguay,⁸³ Vietnam,⁸⁴⁸⁵⁸⁶ Zambia,⁸⁷ Zimbabwe.⁸⁸⁸⁹⁹⁰ This list it not exhaustive, and it is important to note that any inaccuracies in articles authored by international journalists do not represent violations of the granted exposure order by PMI.

Decision misconstrued in global news media

Many of these reports mimic the celebratory, but technically FDA-compliant, narrative provided in PMI’s media releases and interview statements. However, there are multiple instances of inaccurate journalistic reporting. Duty Free News International ran an article on 14 July 2020 with the headline “Milestone’ decision as FDA Approves IQOS as Modified Risk Tobacco Product”; the FDA has not “approved” IQOS (see above).⁹¹ Various other publications in trade journals (Market Watch ⁶), investor publications (The Motley Fool⁹² – later retracted) local news outlets (Honduras’ La Prensa,²⁹ Hong Kong’s The Standard,³⁰ Moldova’s KP,⁴⁹ Nigeria’s The Sun⁵⁰; and broadly, coverage across EMR in Algeria,¹⁰ Bahrain,¹⁴ Egypt,²⁴²⁵²⁶ and Jordan³⁷) and pro-tobacco industry think tanks (US-based Reason Foundation⁸¹) made similar claims about the product being “safer” than cigarettes. It is incorrect to say IQOS is “safe”, or to imply that IQOS poses a reduced risk of harm when in fact it has only been shown to reduce exposure.

PMI uses FDA decision to lobby for regulatory change

In addition to calling the decision a “historic public health milestone”,⁵ PMI is transparent in its desire to use the FDA decision to advocate for legislative change. In its press release immediately following the decision, PMI CEO Calantzopolous said:⁵

“The FDA’s decision provides an important example of how governments and public health organizations can regulate smoke-free alternatives to differentiate them from cigarettes in order to promote the public health.”

Countries are at different stages in their regulation of HTPs; some have banned them outright, many have allowed their sale under certain regulatory conditions, and in others the regulatory position remains unclear. There are also wide variations in taxation rates.⁹³ At COP 8 in 2018, parties to the WHO Framework Convention on Tobacco Control (FCTC) agreed to regulate HTPs as tobacco products.⁹⁴ For more information and links to external resources, see the main page on Heated Tobacco Products.

In some regions, local PMI directors and managers have used the FDA decision to explicitly lobby for changes to regulations of tobacco products:

Canada: Rothmans, Benson & Hedges Inc. (PMI affiliate) in Canada used the decision to advocate for “risk-based regulation” of tobacco products in the country, where it claimed “[r]egulation in Canada has not kept pace with innovation of smoke-free technologies”.¹⁵
Hong Kong: The manager of PMI Hong Kong & Macau, Brett Cooper, said that he hoped to have “dialogue” and “conversation” on the regulation of “alternative smoking products”. An article in The Harbour Times suggested that the FDA decision would encourage legislators reconsider a proposed ban on these products.³² The Standard reported, quoting CEO Calantzopolous, that PMI “urged authorities worldwide to ‘maximize adoption of these products by adult smokers,’ adding that if not, ‘we would be missing an enormous public health opportunity’”.³¹
Latin America: In an interview with Forbes in Mexico, Mario Masseroli, President of PMI Latin America and Canada, said PMI had “been in contact with the Mexican authorities trying to show the difference between IQOS and conventional cigarettes”. He also said that “We believe that it is something that cannot be ignored if you are an authority in any country seriously thinking about solving the problem of public health, such as diseases related to smoking, you cannot ignore a decision like the FDA” (translated from original Spanish).⁴⁸ HTPs were banned in Mexico in February 2020, by presidential order.⁹⁵ Masseroli made similar statements in Argentina,¹¹ Colombia,¹⁶ Honduras²⁹ and Uruguay.⁸³ On 1 September 2020, the Mexican government put out a statement in response to the FDA decision and PMI statements made in the country, which reaffirmed its decision to ban the import of HTPs and clarified that IQOS was not granted “reduced risk” status, in the US or in Mexico.⁹⁶
Nigeria: An interview with Bahman Safakish, Managing Director for PMI Sub-Saharan Africa, began to appear in Nigerian news media at the end of July. In what appears to be its first run in The Sun, the article was briefly titled “Why we can’t stop selling cigarettes – Philip Morris Int’l” (30 July) before changing to “Our plans to end cigarette smoking – Philip Morris Int’l” (31 July), and stated that ending cigarette sales “would automatically create a niche market for competitors and illicit trades who do not appreciate the need replace the combustible hazardous smoking with the electronic vapour-producing device that is much safer health-wise”, giving this as the reason why the company would not stop selling cigarettes “despite global health concerns”.⁵⁰⁵⁴⁵³⁹⁷ Note that the FDA decision did not conclude that IQOS was “safer” than traditional cigarettes, or that it reduces risk.
Philippines: An article detailing an interview with PMI Asia director Stacey Kennedy encouraged the country to adopt the US FDA decision as a “starting block” to provide “the basis of public health policymaking”.⁶⁵ The article also claimed IQOS was a “reduced risk” product, and is “less harmful than traditional cigarettes”. This is false; FDA actually denied PMI’s reduced risk application (see above).
South Africa: PMI used the FDA decision as an additional argument against the ban on tobacco products that was imposed in the country as a result of the COVID-19 pandemic. Philip Morris South Africa (PMSA) that said that the continuing ban on tobacco products was a “missed opportunity to make smoke-free alternatives available for 11-million South African smokers”, citing the FDA decision as evidence that IQOS is a “much better choice than continued smoking”.⁷¹ A comment from PMSA in the online magazine TWFLD said that it encouraged the South African government to follow a “science-based approach” in its policy-making and advised it adopt “a similar regulatory approach to the U.S. FDA”.⁷²
South Korea: An article titled “Following FDA’s decision, PMI repeats need for differentiated policies” appeared in The Korea Herald on 13 July 2020, again quoting the CEO: “Making a comparison to fossil fuels and coal, Calantzopoulos urged that governments around the world should provide differentiated policies for conventional cigarettes and heated tobacco products”.⁷⁴ PMI Korea CEO Paik Young-jay held an online news conference in September 2020, in which he said: “The FDA’s decision is an important example of how governments and public health agencies can regulate heat-not-burn products and cigarettes differently to improve public health” and recommended “rational regulation”.⁷⁵ A further article in The Korea Herald covering the conference, initially titled “Philip Morris Korea says Iqos brings ‘reduced risk’”, included both modified and reduced risk claims, misrepresenting the FDA decision.⁷⁶ Within hours, this article was corrected, instead appearing as “Philip Morris aims to acquire ‘risk modification’ nod from FDA”.⁷⁷