On August 22, 2023 the FDA Center for Tobacco Products held a listening session to gather public input to help it prepare it’s strategic plan. Here is what I said:
My name is Stanton Glantz. I am a retired UCSF Professor of Medicine and served as principal investigator of the UCSF TCORS until I retired. I continue to be involved with the TCORS.
As part of its Strategic Plan CTP should establish a policy to prioritize direct epidemiological population measures of health and behavior over indirect measures or assumptions.
This would represent a substantial change. To date, FDA has prioritized indirect evidence, most notably biomarkers, over population epidemiology. The rationale has been that new products have NOT been in widespread use long enough for health effects to be manifest at population levels.
This problem no longer applies to e-cigarettes, which have now been on the consumer market for 17 years (since 2006).
There is a large epidemiological literature on health effects of e-cigarettes as they are actually used in the general population. It reveals elevated risks for cardiovascular, pulmonary, and oral diseases compared to non-users. Even more important, in contrast to biomarker studies, the human disease epidemiology shows that e-cigarette risks are similar to cigarettes for cardiovascular and oral diseases, and, while e-cigarette risks are lower than smoking for pulmonary disease, e-cigarette risks are much larger than FDA has assumed. Dual use of cigarettes and e-cigarettes (versus exclusive use of either product) is associated with increased odds of disease for cardiovascular, pulmonary and oral diseases.
Likewise, there is a large literature that contradicts FDA’s assumption that e-cigarettes, when used by consumers, will result in “switching completely” from cigarettes. They do not.
To implement this policy prioritizing direct measures of health and behavioral effects over indirect measures or assumptions:
- FDA should make decisions about risks of e-cigarettes and other established products based on documented effects on disease in the population, not just short-term measures of a limited number of cigarette exposure biomarkers.
- FDA should heed its own meta-analysis and stop assuming that reducing, but not stopping, cigarette smoking substantially reduces risks.
- FDA should prioritize the effects of dual and poly product use in regulatory decision making and public communications.
- FDA should complete and publish its own assessment of the epidemiological evidence of disease risk associated with e-cigarette use compared to cigarette smoking and dual use in the general population.
- FDA should complete and publish its own assessment of the relationship between e-cigarette and other tobacco use among youth and young adults, particularly the extent to which e-cigarettes are attracting youth at low risk of nicotine initiation with cigarettes.
- FDA should stop making regulatory and public communication decisions assuming that e-cigarettes as consumer products help people stop smoking until there is strong population-based evidence that this assumption is correct.
The FDA should also prioritize direct human evidence when assessing the risks of other new tobacco products as much as possible.
Prioritizing human population evidence will ensure that FDA decision making is grounded in actual effects on members of the public who actually use these products.
NOTE: We will be submitting a written comment on this issue, including more details and supporting citations to the scientific literature.
Stanton Glantz blog 