- FDA —
- US Food and Drug Administration
- HNB —
- IQOS —
- I Quit Ordinary Smoking
Background on Heat-not-Burn
In the wake of the rapid rise of e-cigarettes over the past decade, the tobacco industry has launched its latest response to the documented harms of cigarette smoking: heat-not-burn (HNB) tobacco products. Philip Morris International created and is heavily marketing their version of these products, called the IQOS (I Quit Ordinary Smoking), which involves disposable tobacco sticks soaked in propylene glycol that are inserted into a holder in the HNB cigarette. Philip Morris markets these products as being “designed to create a flavorful and satisfying nicotine-containing vapor, without burning and without smoke.”1 Advertisements claim this product releases no smoke because the tobacco leaves are heated rather than burned, with no tobacco combustion. Claims and distracting wording, however, are no substitute for science. The authors of a recent report have shown that these tobacco products release cancer-causing chemicals.2
The IQOS is not yet sold in the United States, but in December 2016, Philip Morris submitted a modified risk tobacco product application to the US Food and Drug Administration (FDA). If its application is successful, Philip Morris will face looser restrictions in marketing HNB tobacco products than it does for conventional tobacco cigarettes. Moreover, Philip Morris seeks to make affirmative safety statements on packaging and advertising for IQOS, including “Scientific studies have shown that switching completely from conventional cigarettes to the IQOS system can reduce the risks of tobacco-related diseases.”3 The public needs more accurate and unbiased information about the potential harms of these products. The FDA, public health officials, physicians and health care providers, children and parents, and current tobacco users must understand these products and take an evidence-based approach to their regulation.
Increasing Awareness and Use
HNB tobacco products were released in sleek, futuristic IQOS flagship stores across Japan in 2014 and across Italy and Switzerland in 2015, with awareness and use of these products increasing dramatically. In February 2016, Philip Morris executives revealed that their HNB tobacco product quickly captured 2.4% of Tokyo’s market share for tobacco over 6 months. According to a recent internet survey of Japanese adolescents and adults, 48.0% of respondents were aware of HNB tobacco products and 19.8% of 15- to 19-year-olds had tried the IQOS.4
Tobacco Industry–Sponsored Publications
Although information regarding health harms and benefits should come from sources independent of the tobacco industry, the vast majority of currently PubMed-indexed publications on “heat-not-burn” are published by Philip Morris or other tobacco industry companies (19 out of 27, as of September 7, 2017). These publications include a 7-part series in Regulatory Toxicology and Pharmacology, a journal partially financed by the tobacco industry with a history of concealed proindustry bias and an editor-in-chief previously paid $30 000 by the Tobacco Institute to publish an article in the journal dismissing the scientifically proven health risks of secondhand smoke.5
Secondhand Smoke Exposure From HNB Products
The authors of independent studies have identified cancer-causing chemicals in the smoke emitted by HNB tobacco products. In 1 study, the authors compared the contents of the IQOS with the contents of conventional cigarettes by using a smoking device designed to capture the mainstream aerosol and developed to meet the standards for common cigarettes.2 The smoke released by the IQOS contains the same harmful constituents of cigarette smoke. These elements include volatile organic compounds near the levels found in cigarette smoke, polycyclic aromatic hydrocarbons at wide comparative ranges, and carbon monoxide. All of these elements, on the basis of extensive research of cigarette smoke, have been shown to cause serious harms to human health.6 Additionally, the IQOS smoke had nicotine levels similar to levels in conventional cigarette smoke.2 Nicotine, the highly addictive substance found in tobacco, is unsafe to youth and harms infant and adolescent brain development, as has been summarized in a recent report from the US Surgeon General.7 A second study revealed that the aerosol from HNB tobacco products contains nicotine and cancer-causing chemicals similar to those found in traditional cigarettes.8
Approach to Protecting Public Health
There is no reliable evidence regarding the risk reduction or health benefits of tobacco products that purport to heat rather than burn tobacco. Although the tobacco industry claims these products are safer than cigarettes, these claims are not supported as of 2017. Three major approaches to these products should be undertaken.
First, any tobacco product that produces a smoke, aerosol, vapor, and/or emission should fall under the same comprehensive smoke-free policies applied to conventional tobacco cigarettes. Scientific evidence has unequivocally revealed that there is no risk-free level of exposure to tobacco smoke. The World Health Organization convention on tobacco control emphasizes rejecting a threshold value for toxic effects from secondhand smoke.9 Smoke-free policies protect public health and protect tobacco nonusers’ rights to clean, smoke-free environments.
Second, because almost all tobacco use starts during childhood and adolescence, it is essential to prevent access and promotion of HNB tobacco products to youth. A consistent and burgeoning evidence base reveals that nonusers of tobacco products, particularly children and adolescents, could be drawn to new products and that this could lead to a subsequent transition to traditional cigarettes.10 Characterizing flavors, which appeal to youth, should be banned, and HNB tobacco products should be included in age of tobacco use purchase laws. The American Academy of Pediatrics supports raising the legal minimum sales age to 21 for all tobacco products. Tobacco 21 laws have been adopted in over 260 cities and counties in 18 states across the United States, including statewide policies in Hawaii, California, New Jersey, Maine, and Oregon.
Finally, because of the high public health stakes and potential for unintended consequences, sound scientific evidence should drive decision-making regarding these products. Tobacco, when used as intended, causes disease, disability, and death. It is the only consumer product regulated by the FDA to fall in this ignominious category. Rather than the typical standard of approving “safe and effective” products, the FDA’s regulatory approach to tobacco products is based on a “public health standard.” This standard, specified in the Family Smoking Prevention and Tobacco Control Act, Public Law 111–31 (2009), section 906(d), applies to the “risks and benefits to the population as a whole, including users and nonusers of the tobacco product” and accounts for (1) “the increased or decreased likelihood that existing users of tobacco products will stop using such products” and (2) “the increased or decreased likelihood that those who do not use tobacco products will start using such products.”11 In July 2017, the FDA articulated a new harm control approach to tobacco regulation, with emphasis placed on noncombustible tobacco products because they may be less dangerous than cigarettes. Thus, it is critical that regulation of new products is based on a dispassionate evaluation of the evidence base, not on industry statements or purported science. Accordingly, all new tobacco products, including HNB products, should be independently evaluated on their potential to entice tobacco nonusers, especially children and adolescents, and on health-related outcomes for current tobacco users, including health harms and conventional cigarette quit rates, before approving their use and marketing them to consumers.
Tobacco use is the leading preventable cause of disease and death in the United States. Until product approval and advertising are based on the results of independent evaluations, we cannot allow the tobacco industry to target cigarette smokers or the general public with misleading claims about the safety of HNB tobacco products. We cannot allow the tobacco industry, whose core strategy remains the sale of traditional cigarettes, to put their success above the lives of individuals and public health.
Thank you to Robert McMillen, Julie Gorzkowski, and Mark Gottlieb for their review of this manuscript and to the members of the American Academy of Pediatrics Tobacco Consortium (a group of scientists and pediatricians dedicated to setting a research agenda for child and adolescent tobacco prevention and cessation) for their general contributions to this piece.
- Accepted September 19, 2017.
- Address correspondence to Brian P. Jenssen, MD, MSHP, Department of Pediatrics, PolicyLab, The Children’s Hospital of Philadelphia, 2716 South St, Philadelphia, PA 19146. E-mail:
FINANCIAL DISCLOSURE: The authors have indicated they have no financial relationships relevant to this article to disclose.
FUNDING: No external funding.
POTENTIAL CONFLICT OF INTEREST: The authors have indicated they have no potential conflicts of interest to disclose.
- Phillip Morris International
- US Food and Drug Administration
- Drope J,
- Bialous SA,
- Glantz SA
- US Department of Health and Human Services
- Centers for Disease Control and Prevention
- National Center for Chronic Disease Prevention and Health Promotion
- Office on Smoking and Health
- US Department of Health and Human Services
- World Health Organization
- ↵The Family Smoking Prevention and Tobacco Control Act. Pub L No. 111–31, 123 Stat. 1776 (2009)
- Copyright © 2018 by the American Academy of Pediatrics