The US Food and Drug Administration (FDA) issued orders in July 2020 authorising Philip Morris Products S.A. to market its heated tobacco product (HTP) IQOS inside the USA with claims that it reduces exposure to some dangerous substances. FDA's 'reduced-exposure' orders explicitly prohibit the marketing of IQOS with claims that IQOS will reduce harm or the risk of tobacco-related diseases. Under US law, FDA's IQOS orders are problematic because FDA disregarded valid scientific evidence that IQOS increases exposure to other dangerous toxins and that Philip Morris Products S.A. failed to demonstrate that consumers understand the difference between reduced-exposure and reduced-harm claims. Unfortunately, both 'reduced-exposure' and 'reduced-harm' are classified as 'modified risk tobacco products' under US law. Exploiting this confusion, Philip Morris International used the FDA decision as the basis for marketing and public relations campaigns outside the USA to press governments to reverse policies that ban or regulate the sales and marketing of HTPs, including IQOS. Parties to the WHO Framework Convention on Tobacco Control should reject tobacco companies' unsubstantiated explicit or implied claims of reduced harm associated with HTPs and resist Philip Morris International's and other companies' calls to relax HTP regulations based on the FDA's actions. Instead, parties should adopt policies aligned with the Framework Convention on Tobacco Control when dealing with HTPs and other novel tobacco products.

Objective

This study examined differences in the availability and advertising of flavored tobacco products before and after flavored tobacco sales restrictions were enacted in Alameda and San Francisco Counties in California.

Main outcome measures

Data were collected from a sample of tobacco retailers in Alameda and San Francisco Counties at two time points: 2015, before flavored tobacco policies were enacted, and in 2019-2020, after some cities had enacted policies. Retailers were separated by city into Category 1 (n = 442)-retailers in cities that enacted a flavored tobacco policy between the two data collection periods, and Category 2 (n = 89), those that had not. Means comparison tests were conducted to evaluate significant differences over time and by category.

Results

There was significantly reduced availability of menthol cigarettes, flavored little cigars, smokeless tobacco, vape pens, and Blu brand menthol e-cigarettes between 2015 and 2020 in Category 1 retailers. Category 2 retailers had reduced availability only for Blu menthol e-cigarettes and demonstrated an increase in smokeless tobacco availability. Exterior store advertising for cigarettes, little cigars, cigars, and e-cigarettes also decreased significantly in Category 1 cities relative to Category 2 cities; 8.1% of Category 1 stores were advertising flavored tobacco products in 2019-2020 compared to 36.2% of Category 2 stores. There was also a 78% reduction in flavored ads between 2015-2019 in Category 1 cities compared to a 38% decrease in Category 2 cities. Tobacco advertising inside Category 2 stores increased. Finally, Category 2 cities had significantly greater availability of cigalikes, mod or tank vapes, flavored e-cigarettes, and e-liquids compared to Category 1 cities.

Conclusions

Comprehensive flavored sales restriction policies reduce flavored tobacco availability and tobacco advertising, which may help prevent youth tobacco initiation and exposure.

Background

Philip Morris International (PMI) continually expands and diversifies their nicotine product portfolio, which includes IQOS, a heated tobacco product. In December 2016, PMI filed a modified risk tobacco product (MRTP) application with the US Food and Drug Administration (FDA), seeking authorisation to market IQOS in USA with three claims of reduced harm: 'switching completely from conventional cigarettes to the IQOS system…' (1) 'can reduce the risks of tobacco-related diseases;' (2) 'significantly reduce[s] your body's exposure to harmful or potentially harmful chemicals;' and (3) 'presents less risk of harm than continuing to smoke cigarettes.' Consumers may misunderstand what is meant by 'switching completely'.

Methods

We critically reviewed study reports submitted to FDA by PMI in support of proposed marketing claims in its MRTP application for IQOS and focused on the statement that switching completely to IQOS reduces risk.

Results

We found deficiencies with evidence provided by PMI supporting their assertions that: current smokers will understand what is meant by the phrase 'switching completely'; the proposed claims will not decrease smokers' intentions to quit; and IQOS users will in fact 'switch completely' from smoking cigarettes to using IQOS. The studies and measurement instruments employed by PMI suffer from design flaws and their reporting of associated findings is misleading.

Conclusion

Consumers will not understand the condition of the claims-that they must quit using cigarettes completely to achieve the inferred health benefits of IQOS. Rather, they are likely to misunderstand the unsupported claims of reduced risks to mean IQOS are harm-free.