Tag Archives: Tobacco

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

Policy, , , , ,

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 info@center4research.org or at (202) 223-4000.

References

  1. Youth and Tobacco Use. CDC.gov. https://www.cdc.gov/tobacco/data_statistics/fact_sheets/youth_data/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. https://d14rmgtrwzf5a.cloudfront.net/sites/default/files/drugfacts-mtf.pdf

NCHR Testimony on Low Nicotine Cigarette Claim

Testimony & Briefings, , ,

Nina Zeldes, National Center for Health Research, February 14, 2020

Thank you for the opportunity to speak here today. My name is Dr. Nina Zeldes and I am here as a senior fellow speaking on behalf of the National Center for Health Research. Our research center analyzes scientific and medical data and provides objective health information to patients, providers and policy makers. We do not accept funding from drug and medical device companies or tobacco companies, so I have no conflicts of interest.

We strongly oppose the approval of this modified risk application by the 22nd Century Group for their low-nicotine combusted filtered cigarette tobacco products. 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. Unfortunately, evidence is lacking to support the claim that this product significantly reduces harm for smokers. At the same time, it is likely to entice people who have never smoked, especially adolescents, to start smoking.

As the applicant has pointed out, this low nicotine cigarette poses similar risks of tobacco-related disease as conventional cigarettes. Its only advantage is that it contains much less nicotine, and could therefore be less addictive. However, the claims of reduced harm seem to be based entirely on the assumption that people would smoke less often – an assumption that was not adequately supported by the applicant’s data. For example, this product was rated as less satisfying than smokers’ usual brand of cigarettes and less likely to be used again compared to nicotine gum, raising questions about whether smokers would switch completely to this product and ultimately quit smoking.

The FDA briefing document points out that nicotine is often perceived as causing smoking-related health risks. That means that a claim of a product having “95% less nicotine” will be misunderstood as being less likely to cause cancer, when in fact it just means potentially less addictive. Although the applicant provided a voluntary warning that “less nicotine does NOT mean safer”, study participants who were shown this warning still perceived this product as safer than conventional cigarettes. Additionally, the applicant only tested the claims on packaging and not how they would be used in ads and social media. We’ve all learned that the context and imagery in these ads can vastly alter how these claims are interpreted. Tobacco companies have learned how to make very persuasive ads that go beyond the specific claims that they make.

And as we all know, smoking is a habit that is very difficult to break, and addiction to nicotine is only one of the reasons that quitting is so difficult.

Most smokers start smoking as children and adolescents, and yet adolescents were not included in any of the studies provided by the applicant. Previous studies have demonstrated that this group is likely to perceive products with a risk-mitigation claim as less harmful, but that is not proven in this case.

In conclusion, while the claim that this product contains 95% less nicotine may be factually correct, the company’s claims of health benefits are based on the implied assumption that this product would help smokers quit. If that is supposed to be the benefit, their product should have sought to market this product as a cessation aid. Moreover, the packaging does not explain how to achieve this health benefit. Because of such claims, smokers interested in reducing smoking-related health risks might start using this product, instead of quitting or using available FDA-approved cessation products. Meanwhile, non-smokers, particularly adolescents, might start using this product, thinking it is a safe alternative to other tobacco products.

If we’ve learned anything from the vaping epidemic, it is that adolescents are easy to influence, and once they start a habit like smoking or vaping, they are unlikely to stop. We encourage you to let the FDA know that you do not believe that would be an acceptable outcome.

Thank you.

NCHR Comments on FDA’s Notice on the Modified Risk Tobacco Product Application for Copenhagen Snuff Fine Cut

Policy, Testimony & Briefings, , , ,

National Center for Health Research, January 21, 2020

National Center for Health Research’s Public Comments on FDA’s Notice on the Modified Risk Tobacco Product Application for Copenhagen® Snuff Fine Cut

Thank you for the opportunity to comment on the FDA Notice on the Modified Risk Tobacco Product Application for Copenhagen Snuff Fine Cut.

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 for Copenhagen Snuff Fine Cut with the claim “IF YOU SMOKE, CONSIDER THIS: Switching completely to this product from cigarettes reduces risk of lung cancer” for the following reasons:

  • This safety claim could result in a higher number of dual users, and there is not sufficient evidence to suggest that dual use would reduce the risk of lung cancer. 
  • Even if an individual’s complete switch from combustible tobacco products to this product reduces a user’s risk of lung cancer, we agree with the FDA’s own website, which indicates that the use of smokeless tobacco products increases the risks of other types of cancers, such as oral, esophageal, and pancreatic cancer, as well as other diseases.
  • Because snuff has risks, data are needed to ensure that the marketing of this product as a modified risk product would not increase the number of non-smokers who would start using tobacco products. Increased use is likely, especially among teens and young adults, because, as with vaping, when people hear claims that a product is “safer,” they often misinterpret that to mean the product is “safe.”
  • Research has already shown that individuals who start using smokeless tobacco products, such as this product, are more likely to start using combustible tobacco products.
  • The modified risk statement could be interpreted as suggesting that Copenhagen Snuff Fine Cut can be used as a smoking cessation strategy. However, the sponsor has not provided scientific evidence that using this product helps people stop smoking. 
  • Although smoking and lung cancer deaths have both gone down in Sweden and Norway, the company has not provided evidence that these “favorable public health outcomes” are due to smokeless tobacco products. In addition, there is no evidence that additional reductions would occur in the U.S. market if this modified risk reduction application is approved, because the healthcare system, tobacco reduction campaigns, popular products and cultural influences are different than they are in Sweden and Norway.

In summary, a modified risk statement may encourage people who do not smoke to begin using this tobacco product and could lead to more dual usage, therefore, this product would not reduce the health risks for lung cancer.

For questions or more information, please contact Nina Zeldes, PhD at the National Center for Health Research at nz@center4research.org or at (202) 223-4000.

References

  1. US Food and Drug Administration. Executive Summary of USSTC MRTP Application for Copenhagen® Snuff Fine Cut. Silver Spring, MD: US Food and Drug Administration; 2020. https://digitalmedia.hhs.gov/tobacco/static/mrtpa/Copenhagen/2.3-executive%20summary%20_Redacted.pdf