As instructed in Section 911 of the FSPTCA, on Thursday, February 3, FDA's Director for Tobacco Products Lawrence Deyton assigned the National Academies Institute of Medicine (IOM) Committee on Scientific Standards for Studies on Reduced Risk Tobacco Products to advise the FDA on the minimum standards for scientific studies to allow the marketing of modified risk tobacco products, and for post-market studies of marketed products.
After Introductions, Deyton's presentation and Q&A with committee members,
Committee: Scientific Standards for Studies on Reduced Risk Tobacco Products
Public comments were presented by eight interested parties. Mine is below.
William T. Godshall, MPH
1926 Monongahela Avenue
Pittsburgh, PA 15218
I’m Bill Godshall, founder and executive director of Smokefree Pennsylvania, a nonprofit organization that since 1990 has been advocating local, state and federal policies to reduce indoor tobacco smoke pollution, reduce tobacco marketing to youth, hold cigarette companies accountable for past misdeeds, increase cigarette tax rates, fund tobacco education and smoking cessation services, and inform smokers that all smokefree tobacco/nicotine products are far less hazardous alternatives to cigarettes.
For disclosure, neither Smokefree Pennsylvania nor I have ever received any direct or indirect funding from any tobacco, drug or electronic cigarette company or trade association.
There appear to be three different types of modified risk or reduced exposure applications that will be submitted to the FDA via Section 911 of the FSPTCA:
- those comparing a smokefree tobacco product to cigarettes,
- those comparing a cigarette to other cigarettes, and
- those comparing a smokefree product to other smokefree products.
Existing scientific evidence indicates that all cigarettes pose similar morbidity and mortality risks, and that all smokeless tobacco products marketed in the US pose similar morbidity and mortality risks. So additional evidence is needed before one cigarette can be determined to be less hazardous than another, and more evidence is needed before one smokeless tobacco product can be determined to be less hazardous than another.
In sharp contrast, many decades of scientific evidence confirms that daily use of smokefree tobacco products marketed in the US and Sweden pose about 99% fewer mortality risks than cigarette smoking, and that switching to smokefree tobacco products reduces a smoker’s mortality risks nearly as much as quitting all tobacco/nicotine. Nonsmokers are also exposed to less tobacco smoke when smokers switch to smokefree alternatives.
Since >99% of all tobacco attributable deaths in the US are caused by the repeated inhalation of tobacco smoke, while <1% are caused by the use of noncombustible tobacco products, it is vitally important for this committee to acknowledge these exponential differences of risk and encourage the FDA to incorporate this into the establishment of criteria for evaluating modified risk and reduced exposure tobacco product applications.
In the absence of reduced risk marketing claims, population surveys confirm that several million smokers have already switched to smokeless tobacco products even though the vast majority of smokers inaccurately believe that smokeless tobacco is just as hazardous as cigarettes. So smokeless tobacco products have already saved more lives (of smokers) than could be offset even if every non-tobacco user in America begins to use smokeless tobacco.Even if many more non-tobacco users begin using smokeless tobacco products, the truthful marketing of smokefree tobacco products as lower risk or reduced exposure alternatives to cigarettes can only further reduce tobacco morbidity and mortality (to a meaningful degree).
Therefore, this committee should encourage the FDA to not require new costly studies for a smokefree tobacco product to claim it is less hazardous than cigarettes. But post-market surveillance would be helpful.
Requiring additional scientific studies before a company can make these types of modified risk or reduced exposure claims would be a “truth tax” for far less hazardous smokefree alternatives, would unfairly protect cigarettes from market competition by lower risk alternatives, and would threaten instead of improve public health.
Once the FDA begins approving truthful modified risk or reduced exposure claims for smokeless tobacco products compared to cigarettes, the agency also will be prompted to evaluate and eliminate the 25 year old intentionally misleading Congressionally mandated warning on smokeless tobacco products and advertisements stating: “This product is not a safe alternative to cigarettes,” which has confused most smokers to believe that smokefree products are just as hazardous as cigarettes.
Please remember that smokers have a human right to accurate and relevant health information and legal access to far less hazardous alternatives. The IOM and FDA should ensure that.