United States Food and Drug Administration’s authorization of reduced exposure claims for IQOS^®: implications for regulation in Latin America

ABSTRACT

Philip Morris International has used the July 7, 2020 United States Food and Drug Administration’s (US FDA) modified risk tobacco product order for IQOS^®, which authorized certain reduced exposure marketing claims, as a corporate strategy to promote and normalize its heated tobacco products in Latin America. The modified risk tobacco product orders are based on the US’s unique regulatory system that is not, and should not be, replicated anywhere else in the world. Philip Morris International’s global public relations campaign largely ignored the FDA’s rejection of reduced risk claims for IQOS and other key FDA findings that are important for policy-makers, regulators, and consumers – including tobacco users and Philip Morris International’s customers – to understand the risks associated with the product. In Latin America in particular, Philip Morris International has used media outlets to promote this misleading information to the public. This company has also used the FDA ruling to lobby regulators in Latin America to relax regulations on IQOS in the region. As tobacco companies rapidly introduce new tobacco products in low- and middle-income countries, public health advocates and Parties to the World Health Organization (WHO) Framework Convention on Tobacco Control (FCTC) should take measures to prevent the promotion of misleading statements about heated tobacco products, including IQOS. As Latin American countries are at different stages in their regulation of heated tobacco products, governments should adhere to their WHO FCTC obligations and the recommendations of the Conference of the Parties by entirely prohibiting the sale of heated tobacco products or strictly applying to heated tobacco products all the relevant tobacco demand-reduction policies based on the WHO FCTC (making sure to capture both heated cigarettes and heating devices).

In June 2009, the United States (US) Congress enacted the Family Smoking Prevention and Tobacco Control Act. Section 910 of the Act requires that before marketing any new tobacco product (not on the market before February 15 2007) in the US, the Food and Drug Administration (FDA) must approve a premarket tobacco application for the product. To give approval, the FDA has to determine whether the new tobacco product would be appropriate for public health protection which requires the FDA to evaluate the tobacco product’s toxicological profile, individual and population health impacts, and labelling, among other things (1). In May 2017, Philip Morris Products S.A. (Philip Morris) submitted premarket tobacco applications seeking to sell the IQOS^® heated tobacco product in the US. IQOS is an integrated system that uses an electronic device to heat specifically designed cigarettes (heatsticks), thus generating an inhalable nicotine-containing emission. In April 2019, the FDA issued a premarket tobacco product marketing order that authorized Philip Morris to market IQOS 2.4 in the US with exclusive distribution by the US-based tobacco company, Altria. Separate from the authorization for the sale of IQOS, Philip Morris also applied for permission to advertise and label IQOS as a so-called reduced harm and reduced exposure tobacco product, which requires separate modified risk tobacco product orders. In July 2020, the FDA authorized Philip Morris to use specific reduced exposure claims on the basis that the evidence, overall, showed a substantial reduction in harmful chemicals in the aerosol produced by IQOS compared with conventional cigarette smoke. However, the FDA denied Philip Morris’s application to use “reduced risk” marketing claims, stating that Philip Morris “has not demonstrated that [IQOS] will significantly reduce harm and the risk of tobacco-related disease” (2).

The FDA’s decision to issue a reduced-exposure modified risk tobacco product order for IQOS has been criticized by many. Lempert and Glantz argue the law places the burden on the applicant to demonstrate that its product confers public health benefits but the FDA’s IQOS decision established a new, weaker de facto standard: a new tobacco product is appropriate for the protection of the public health if the FDA cannot clearly demonstrate, based on the information submitted in the application, that the proposed product is more dangerous than cigarettes (3). In addition, Lempert and Glantz highlight the difference between so-called reduced harm and reduced exposure arguing both are classified as modified risk tobacco product orders and, based on complex US law-making, it is easy to misrepresent the findings to create confusion (3). A deeper analysis into Philip Morris’s application by McKelvey and colleagues revealed design flaws and deficiencies with evidence provided to support Philip Morris´ assertions that: the proposed claims will not decrease smokers’ intentions to quit; and IQOS users will in fact “switch completely” from smoking cigarettes to using IQOS (4). These authors concluded that consumers will not understand the conditions of the claims of reduced exposure. Gilmore and Braznell, among others, have begun to document how Philip Morris is using a global public relations campaign to promote the FDA’s decision and push other governments to open their markets to or relax rules regulating IQOS (5).

Given the US influence in Latin America and the emergence of IQOS in the region, this commentary piece examines how Philip Morris International is using the FDA ruling to lobby for the introduction of IQOS in Latin America. In particular, we document: 1) the obligations of Parties to the World Health Organization (WHO) Framework Convention on Tobacco Control (FCTC) to prevent misleading information to the public; 2) the current regulatory environment on heated tobacco products in Latin America; 3) Philip Morris International’s use of the FDA’s modified risk tobacco product order in its public relations; and 4) Philip Morris International’s lobbying efforts to introduce IQOS in Latin America.

OBLIGATION OF PARTIES TO THE WHO FCTC

In 2018, the WHO FCTC Conference of the Parties, made up of 182 Parties, adopted a formal decision confirming that heated tobacco products are tobacco products and that the WHO FCTC applies to heated tobacco products, reminding Parties to “regulate, including restrict, or prohibit, the manufacture, importation, distribution, presentation, sale and use of novel tobacco products” such as heated tobacco products. This includes “the devices designed for consuming the products” (6). Under the WHO FCTC, Parties to the treaty have obligations that should prevent them from adopting a regulatory regime such as in the US – which is a member but has not yet ratified the FCTC – that explicitly permits reduced risk or reduced exposure claims about products as compared to conventional cigarettes.

Parties to the WHO FCTC have recognized that consumption of any tobacco product causes death, disease, and disability (Preamble) and have adopted as a guiding principle, “the need to take measures to prevent the initiation, to promote and support cessation, and to decrease the consumption of tobacco products in any form” [emphasis added] (Article 4(2)(b)). There are no provisions, recommendations or obligations in the FCTC that allow for a different regulatory approach for some categories of tobacco product.

Second, Article 11.1(a) of the WHO FCTC requires Parties to adopt effective measures to ensure tobacco packaging and labeling do not promote a tobacco product by any means that are “misleading” or “likely to create an erroneous impression about its … health effects” or “give the false impression that a particular tobacco product is less harmful than another tobacco product.” Article 11 also prohibits the use of terms such as light, low tar and mild (7), and the Guidelines for Implementation of Article 11 prohibit the use of figures for emission yields such as tar and nicotine because “the marketing of cigarettes with stated tar and nicotine yields has resulted in the mistaken belief that those cigarettes are less harmful” (7). In the WHO FCTC context, these prohibited terms and figures can be viewed as comparable to the claims that have now been authorized for marketing IQOS in the US in that these claims are likely to create an erroneous impression about the products’ health effects and whether they actually reduce risk to users. Parties to the WHO FCTC sought to prohibit these terms and statements because no conclusive epidemiological or scientific evidence existed that so-called mild cigarettes were actually less harmful than cigarettes with higher smoke emission yields. Similarly, the FDA found that the current evidence does not demonstrate that IQOS is safer than conventional cigarettes (8).

Third, Article 13.2 of the WHO FCTC requires Parties to implement a comprehensive ban on all tobacco advertising, promotion, and sponsorship. Importantly, Article 13.4 requires Parties, at a minimum, to ban all forms of tobacco advertising, promotion and sponsorship that “promote a tobacco product by any means that are false, misleading or deceptive or likely to create an erroneous impression about its characteristics, health effects, hazards or emissions” (7).

In response to the FDA modified risk tobacco product order, WHO issued a statement that reduced exposure to certain chemicals does not “translate to reduced risk to human health” and that “claims that heated tobacco products reduce exposure to harmful chemicals relative to conventional cigarettes may be misleading” (9).

In countries that are Parties to the WHO FCTC, regulatory measures that properly align with the treaty and its implementation guidelines should prevent Philip Morris International from using the US reduced exposure claims authorized by the FDA. Given the high likelihood that consumers are unfamiliar with the specific provisions of the US FDA regulatory system, it is reasonable for consumers to infer that the rationale of US regulators for providing information about so-called reduced exposure to certain harmful chemicals is to convey that the product is less harmful. Recent research demonstrates how claims of lower exposure to chemicals misleads the public to perceive lower risk even where no lower-risk claim is made (10).

REGULATORY ENVIRONMENT FOR HEATED TOBACCO PRODUCTS IN LATIN AMERICA

The current regulatory environment in Latin America varies, with different and evolving regulatory systems for heated tobacco products in different countries. IQOS, the only heated tobacco product currently in Latin America, is officially available for sale in seven Latin American countries: Aruba, Colombia, Costa Rica, Curacao, Dominican Republic, Guatemala, and Mexico. To date, only three countries ban the commercialization of heated tobacco products: Brazil, under an existing regulation that bans “electronic smoking devices”; Panama, where a health ministry resolution followed by a law declared the commercialization of heated tobacco products inadmissible and banned their use in smoke-free public places; and Mexico through a presidential decree that bans the commercialization of these products. IQOS is officially available in Mexico despite the clear legal ban on heated tobacco products. Specialist IQOS stores established before the ban are still open. This appears to be due to a lack of enforcement by the government and/or injunctions obtained.

Four countries explicitly regulate heated tobacco products as tobacco products (Bolivia (Plurinational State of), Guyana, Paraguay, and Uruguay). Fifteen countries have existing tobacco control legislation that should also apply to heated tobacco products to some extent (Argentina, Chile, Colombia, Costa Rica, Cuba, Dominican Republic, Ecuador, El Salvador, Guatemala, Haiti, Honduras, Nicaragua, Peru, Suriname, and Venezuela (Bolivarian Republic of)). However, because most countries have not adopted measures to specifically address these new products, tobacco companies are finding loopholes or exploiting a lack of clarity in the existing laws. In particular, the electronic heating devices (used to heat the tobacco sticks or heated cigarettes) do not contain tobacco so may not be classed as tobacco products under a tobacco control law and have therefore often escaped effective regulation in many countries because they are packaged, branded, and sold separately from heated cigarettes (1).

PHILIP MORRIS INTERNATIONAL’S PUBLIC RELATIONS ON IQOS

Within hours of the FDA publishing the modified risk tobacco product order for IQOS, Philip Morris International issued a widely covered press release (8) published online (including videos and other social media posts); incorporated the decision into investor reports; and dispatched company executives at global and regional/country headquarters to conduct interviews and presentations around the world, among other activities (11). Highlighting elements of the decision most useful to its business, Philip Morris International’s primary talking points globally have focused on repeating several key messages (Table 1). The company likely used these key messages to confuse policy-makers, regulators, and consumers around the world about the FDA’s modified risk tobacco product order for IQOS as they published them without reference to the FDA’s denial of the reduced risk claims.

TABLE 1. Comparing the United States FDA MRTP order with Philip Morris International’s statements.

FDA MRTP order	Philip Morris International talking points/statements to press	Key omissions in Philip Morris International’s statements about the FDA MRTP order for IQOS
The FDA categorizes IQOS as a “non-combusted cigarette” not an “electronic nicotine product” which could be confused with products categorized as “electronic nicotine delivery systems,” which contain no tobacco leaf (2).	“IQOS is the first and only electronic nicotine product to be granted marketing orders through the FDA’s MRTP process” (11, 12).	The FDA acknowledged IQOS is not safe (2). Users are still exposed to many harmful chemicals, and long-term use is likely to produce significant health risks when compared with not using any tobacco products (15).
The FDA specifically prohibited messages that referred to IQOS as “safer” or “less harmful.” (2)	“IQOS is a fundamentally different tobacco product and a better choice for adults who would otherwise continue smoking” (12).	The FDA did not find that the use of IQOS reduced the user’s risk of disease or that the product was less harmful than smoking cigarettes (15).
The FDA did not find that the use of IQOS reduced the risk of disease in users, or that the product was less harmful than smoking conventional cigarettes. In addition, according to the FDA, Philip Morris is not allowed to make any statements in the US that “convey or could mislead consumers into believing” that IQOS is endorsed or approved by the FDA, or that the FDA deems the products to be safe for use by consumers (2).	Reference to IQOS as a “lower risk” (13) or “reduced risk” product (14).	The FDA did not find that IQOS could help smokers to quit (15).

FDA, Food and Drug Administration; MRTP, modified risk tobacco product.

Source: Prepared by the authors based on information and data from the July 7, 2020 FDA modified risk tobacco product order for heatsticks and IQOS system holder and charger, and press releases and media statements by Philip Morris International and its subsidiaries.

Philip Morris International’s global public relations campaign largely ignored the FDA’s denial of reduced risk claims for IQOS. The campaign also omitted several other key FDA findings about the risks and characteristics of IQOS that are important for policy-makers, regulators, and consumers – including all tobacco users, even Philip Morris International’s customers – to understand the risks and benefits associated with the product (Table 1).

In a July 2020 virtual press conference for Latin American journalists, Mario Masseroli, President of Philip Morris International for Latin America and Canada, and Dr Andrea Constantini, Scientific Affairs Leader, stated, “Products such as IQOS are prohibited in Latin America, but conventional cigarettes, which we know for sure cause more harm, are approved" (13).

There are also numerous examples of in-country media outlets within Latin American countries misconstruing the FDA’s modified risk tobacco product order, including with direct quotes attributed to Philip Morris International executives, which contain highly misleading information about IQOS being a “better choice” or even being “a safer product” (Table 1). Latin American media coverage has focused on the US being a precedent for other governments to follow. In Uruguay, in July 2020, an article in a leading newspaper emphasizing “the importance of the FDA decision”, stated that “despite the fact that the FDA decision has no direct impact on the decisions made by Latin American governments, it sets prestigious precedent regarding the system” (16). Some months later, in March 2021, Uruguay lifted the ban on heated tobacco products through Decree 87/21 and now regulates them as tobacco products (17). A Uruguayan national legislator requested information from the health ministry on the evidence used to lift the Uruguayan ban on heated tobacco products and the ministry responded highlighting the FDA’s modified risk tobacco product order.

In February 2020, Mexico issued a decree that prohibited the import and export of electronic nicotine delivery systems (ENDS), e.g. electronic cigarettes and heated tobacco products. In July 2020, media articles raised the question of whether the FDA decision was a “precedent for Mexico” and stated that FDA authorization for the marketing of IQOS in the US “could set a precedent in countries that maintain strong regulations for alternative tobacco products” (Figure 1) (14). In July 2021, the import/export decree was amended to keep the ban on ENDS but exclude heated tobacco products from the ban. However, the President publicly mentioned that he would reverse this decree and, on October 22, 2021, a new presidential decree banning the import and exports of heated tobacco products was adopted (18). The ban on imports and exports was later reinforced by law in June 2022, and the President issued a decree to ban the commercialization of these products in May 2022 (18).

FIGURE 1. Mexican newspaper headline on the precedent set by the United States Food and Drug Administration in issuing the modified risk tobacco product order for IQOS.

Note: Translation – FDA says yes to Philip Morris’s IQOS.

Source: Expansión (14).

PHILIP MORRIS INTERNATIONAL’S LOBBYING OF IQOS IN LATIN AMERICA

Philip Morris International’s lobbying is also visible in the language used for draft legislation regulating heated tobacco products in Latin America. Draft bills contain references to the supposed harm reduction attributes of these products. For example, in Panama, while the commercialization of heated tobacco products and ENDS is banned, draft bills have been introduced to the Congress intended to soften this ban in order “… to provide current adult smokers with a smoke-free and lower-risk alternative” (19). In Colombia, a draft bill that was approved in its first debate in the Chamber of Deputies on June 16, 2021, established as an objective to “implement harm reduction and reduced risks public policies” and refers to purported evidence that supports ENDS, heated tobacco products, and other products as “reduced risk products” (20). In Chile, a draft bill at the Congress states that “public institutions have published several studies at the international level and with international recognition, which refer to the effectiveness of these devices in anti-smoking therapies and are used as part of their public policies for risk reduction” (21). Statements such as these attempt to introduce the idea that these products are less harmful than traditional tobacco products and they use industry-funded research, which has a clear conflict of interest.

CONCLUSIONS

As misleading and even erroneous claims about the FDA’s modified risk tobacco product order for IQOS continue in the international media and are pushed forward in legislative bills, public health advocates should contact media outlets that are reporting on such claims to request corrections and consider reaching out to decision-makers, regulators, and journalists to offer critical and accurate facts about the FDA’s modified risk tobacco product order. Indeed, consumer protection laws and regulations in some countries could be relied on to demand correct information and to publicly denounce any misleading information.

Governments and civil society in Latin America should anticipate that Philip Morris International will continue to misrepresent the FDA-authorized claims about IQOS, which are specific to the complex US regulatory structure, in its global lobbying efforts to weaken regulation of heated tobacco products. As the global tobacco companies rapidly introduce new tobacco and nicotine products into more markets, WHO FCTC Parties must adhere to their obligations under the treaty and the recommendations of the Conference of the Parties, including the obligation to prevent misleading information to the public (5). Parties can best meet their WHO FCTC obligations by prohibiting entirely the sale of heated tobacco products such as IQOS, or strictly applying all the relevant tobacco demand-reduction policies to heated tobacco products (ensuring that relevant legislation applies to both heated cigarettes and devices) including: comprehensively prohibiting all tobacco advertising, promotion, and sponsorship; banning non-tobacco flavors in products; ensuring smoke-free laws include use of heated tobacco products in covered places; applying all packaging and labeling requirements including pictorial health warnings; prohibiting misleading claims and adopting plain packaging; and taxing the tobacco sticks at the same rate as conventional cigarettes.

Disclaimer.

The authors hold sole responsibility for the views expressed in the manuscript, which may not necessarily reflect the opinion or policy of the RPSP/PAJPH or the Pan American Health Organization (PAHO).

Funding Statement

RE, GS, AB, EMS and MEM received funding from the Bloomberg Initiative to Reduce Tobacco Use. EC was supported by the University of Nevada, Reno. Neither the university nor the Bloomberg Initiative played a role in the conduct of the research or the preparation of this article.