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 firstname.lastname@example.org or at (202) 223-4000.
- 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