NCHR’s Comments on FDA’s Notice on the Modified Risk Tobacco Product Applications for IQOS System With Marlboro Heatsticks

National Center for Health Research, February 24, 2020

National Center for Health Research’s Public Comments on FDA’s Notice on the Modified Risk Tobacco Product Applications  for IQOS System With Marlboro Heatsticks

Thank you for the opportunity to comment on the FDA Notice on the Modified Risk Tobacco Product Applications for IQOS System With Marlboro Heatsticks, Marlboro Smooth Menthol Heatsticks, and Marlboro Fresh Menthol Heatsticks submitted by Philip Morris International.

The National Center for Health Research (NCHR) is a nonprofit think tank that conducts, analyzes, and scrutinizes research, policies, and programs on a range of issues related to health and safety. We do not accept funding from companies that make products that are the subject of our work.

We strongly oppose the approval of this modified risk application by Philip Morris International. According to the FDA, a modified risk tobacco product needs to demonstrate that it (1) significantly reduces harm to smokers and (2) promotes public health. However, there is insufficient evidence to support the claim that these products significantly reduce harm for smokers. Further, there are potential risks to public health because these products may be appealing to non-smokers, particularly adolescents.The products do contain nicotine, which is addictive.

The applicant claims that “switching completely from cigarettes to the IQOS system can reduce the risks of tobacco-related diseases.” They also claim that it delivers tobacco taste and nicotine satisfaction, which could promote IQOS use as an alternative to smoking cigarettes. However, there is not sufficient data that cigarette smokers would switch to complete IQOS use instead of continuing to smoke traditional cigarettes and thus engage in dual use. The study designs, for example, do not show that consumers’ actual use of the product would significantly reduce the use of traditional cigarettes or result in them switching completely from cigarette use. Without that scientific evidence, there is no proof to support the applicant’s claim that this product leads to a substantial reduction in toxicity.

Nearly 90% of smokers smoked their first cigarette before the age of 18,1 yet adolescents were not included in any of the studies provided by the applicant. The vaping epidemic among adolescents illustrates why we should be concerned about lack of data on teenagers. Research has shown that over half of 12th graders who vape reported that they do so “in order to “see what it’s like,” and one-third report that they vape “because it tastes good.”2 The interest that adolescents show in vaping suggest that adolescents who previously did not consume tobacco products may be interested in trying a novel form of smoking, particularly one with a flavor, such as menthol. Since the applicant has failed to provide any research on the likely impact on adolescents, we can’t assume that adolescents would not be enticed to try the product.

The main reason why we oppose a risk mitigation claim for these products is that they have not been proven to reduce risk. In addition, previous studies have demonstrated that adolescents are likely to perceive products with risk-mitigation claims as less harmful, and Philip Morris International has failed to demonstrate that this would not be the case for their IQOS system. To add to the public health concerns, the effects of the risk mitigation claims in advertising and marketing were not tested, despite the fact that some tobacco advertisements can increase use among youth. The increase in vaping among youth has demonstrated that adolescents are swayed by advertising, and that once they begin a habit such as vaping or smoking, they are unlikely to stop.

In summary, the data provided do not adequately support the claim that the IQOS systems 1) significantly reduce harm for smokers and 2) promote public health. A modified risk statement may encourage people, particularly adolescents, who do not smoke to begin using this tobacco product. At the same time, such a statement could lead to more dual usage among current smokers thinking that this is a safe alternative.

The National Center for Health Research can be reached at or at (202) 223-4000.


  1. Youth and Tobacco Use. Updated December 10, 2019.
  2. National Institute on Drug Abuse. Monitoring the Future Survey: High School and Youth Trends 2019. National Institute on Drug Abuse; National Institutes of Health; U.S. Department of Health and Human Services; 2019.