What is heat-not-burn?
Ensuring That Modified Risk Tobacco Products Attract Adult Smokers, Not Nonsmokers
The U.S. Food and Drug Administration (FDA) review and authorization process for modified risk tobacco products (MRTPs) requires companies seeking to market such products in the United States to meet rigorous standards regarding the appeal of MRTPs to former smokers, nonsmokers, and youth. These products should appeal only to existing adult smokers, encourage them to switch fully from cigarettes, and significantly reduce the smoker’s exposure to hazardous chemicals that are formed when tobacco is burned. However, these products must not appeal to nonsmokers, including those that have already quit smoking, and those that are underage. How is Philip Morris International (PMI) meeting this challenge?
To address these important public health questions, PMI designed a rigorous, evidence-based premarket Perception and Behavior Assessment (PBA) research program in accordance with FDA’s Draft Guidance on Modified Risk Tobacco Product Applications. The aim of the PBA program is to measure both the extent to which an MRTP will encourage adult smokers to switch and, at the same time, evaluate the likely impact on initiation of tobacco use among nonsmokers and former smokers. In essence, the PBA provides data on how U.S. consumers – both smokers and nonsmokers – will likely react and behave once the product is on the market. In addition, once the product is introduced in a market, postmarket studies will be conducted to monitor the product’s effect on individual health as well as the health of the population as a whole.
PMI’s PBA program studies are designed in accordance with the U.S. Food and Drug Administration’s Draft Guidance on Modified Risk Tobacco Product Applications. The program investigates the following areas:
1. Behavioral Impact Among Current Adult Smokers
The likelihood that adult smokers will:
- Switch from cigarettes to an MRTP
- Use an MRTP in conjunction with cigarettes
- Switch back to cigarettes from the MRTP
- Switch to the MRTP rather than quit tobacco use altogether.
2. Tobacco Initiation
Measure new tobacco use among adult nonsmokers; specifically assess whether or not adult never-smokers and adult former smokers are likely to initiate/re-initiate nicotine use with the MRTP.
3. Consumer Perception
Assess the impact of communications that the product presents less risk than cigarettes on consumer understanding and perceptions. Specifically measuring the perceived health and addiction risks associated with the use of the MRTP in comparison to:
- Conventional cigarettes
- Nicotine replacement therapies (gum or patch)
- Cessation (risk that may remain after quitting tobacco and/or nicotine).
The PBA program included a series of qualitative and quantitative studies conducted in the U.S., which have involved a total of approximately 10,000 participants. These studies were focused on assessing the company’s first proposed MRTP, Tobacco Heating System (THS), which is a product that electronically heats, but does not burn tobacco. The studies consistently demonstrated that a significant percentage of adult smokers – between 20% and 39% – intended to use THS, depending on the type of tested materials (e.g., information brochure, product packaging, or direct mail communication) and messages (e.g., a message that the product presents less risks of harm than continued smoking, a message that the product significantly reduces exposure to harmful and potentially harmful chemicals).
On the contrary, young adults (from legal smoking age, but minimum age of 18 to 25) who have never smoked, showed virtually no interest in using THS. The data shows a range of interest between 0% and 1.1% within this sensitive section of the population, which should not be attracted by these types of products.
The figure below shows results from one study (THS-PBA-05-RRC-US) measuring, among other things, the intention to use THS among three audiences that these products should not appeal to: adult former smokers, adult never-smokers and young adult never-smokers, (total sample size of over 1,300 former and never-smokers). The study investigated the impact of THS labeling and marketing material with a hypothetical reduced-risk message. Positive intention to use ranged from 2.1 % to 6.4 % with adult former smokers, while adult never-smokers’ positive responses ranged between 0 % and 1.1 %. The intention to use throughout all tested materials was non-existent for young adult never-smokers, with none of the subjects in this group indicating a positive intention to use THS.
Abb.: FS = Adult Former Smokers; LA-25 NS = Adult Never-Smokers from legal smoking age to 25 years; NS = Adult Never-Smokers
Arm 1: THS brochure in combination with one of four possible Surgeon General’s warnings in a rotating fashion; Arm 2: THS brochure in combination with the “Important Warning” developed by PMI; Arm 3: THS tobacco stick pack and diagram card in combination with one of four possible Surgeon General’s warnings in a rotating fashion; Arm 4: THS tobacco stick pack and diagram card in combination with the “Important Warning” developed by PMI; Arm 5: THS direct mail communication in combination with the “Important Warning” developed by PMI.
These results were supported by patterns observed in an actual use study investigating the impact of THS on tobacco use among more than 1,000 adult daily smokers in the U.S. In this study, participants were provided with THS and were subsequently observed for a 6-week period in real-world conditions. At the end of the 6-week period, predominant and exclusive use was in line with similar premarket studies conducted in European countries.
The real-life results from countries outside the U.S. are encouraging and support premarket studies conducted in the U.S. In Japan, over 70% of users of THS (marketed outside the United States as IQOS) have fully switched to it as of December 2016. An additional 8% use THS predominantly (i.e., smokers who replaced 70-95% of their cigarette consumption with THS). In Italy, Switzerland, Russia, Portugal, and Romania, a full or predominant switching rate exceeded 60% among THS users. PMI estimates that almost over 1.5 million adult smokers have quit smoking and use THS exclusively.
This data has been augmented by pilot cross-sectional population studies conducted in Japan and Italy, which suggest that THS generated negligible rates of initiation among adult never-smokers and relapse among adult former smokers (around 1%).
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