August 29, 2017
Division of Dockets Management (HFA-305)
Food and Drug Administration 5630 Fishers Lane, Room 1061
Rockville, MD 20852 Re: Docket No. FDA-2017-D-3001
Modified Risk Tobacco Product Applications for the Philip Morris International Tobacco Heating System, or IQOS.
These comments in support of the application are submitted on behalf of the Risk Analysis Division of the National Center for Public Policy Research, a think tank based in Washington, D.C.
FDA Commissioner Dr. Scott Gottlieb and Director Mitch Zeller recently laid out a new approach to help reduce American's risks from nicotine use when they announced a comprehensive tobacco regulatory plan centered on nicotine and how it is delivered.
While much of the new approach outlined in July will require many months and even years of research and rule-making before implementation, this application provides the agency with an opportunity to take action, consistent with the principles of the plan, which could quickly yield significant public health improvements.
The scientific basis for encouraging nicotine users to use less harmful products is well established. The urgency to take action to provide appealing and less harmful nicotine products is also clear.
As Gottlieb, M.D., and Zeller, J.D., wrote in the New England Journal of Medicine in August, "Despite extraordinary progress in tobacco control and prevention, tobacco use remains the leading cause of preventable disease and death in the United States. Combustible cigarettes cause the overwhelming majority of tobacco-related disease and are responsible for more than 480,000 U.S. deaths each year. Indeed, when used as intended, combustible cigarettes kill half of all long-term users.
As Dr. Gottlieb and Mr. Zeller explained, the agency's plan recognizes that "the core problem of nicotine lies not in the drug itself but in the risk associated with the delivery mechanism." In order to shift the trajectory of tobacco-related disease, regulators, industry, and consumers — who should always be the focus of our work — must all play a role.
The products under consideration represent a major contribution from industry. According to the company, nearly 3 million smokers have already switched to these non-combustible products in the few non-U.S. markets where they are available. Now is the time for the FDA to do its part. By approving this application, the agency will give smokers in the U.S. access to a lower-risk nicotine delivery system along with information about its risks as compared to cigarettes.
As the FDA considers the application, it must remember the important and often-overlooked role consumers play in tobacco and nicotine policy. No regulatory strategy would be complete— or effective— without taking consumers into account. Although some smokers have been able to quit without any nicotine replacement therapy, prescription products, or counseling, too many have not succeeded. We are now getting a clearer look at data from various sources about the role lower-risk products such as e-cigarettes have already played in helping certain smokers quit.
Last month's National Institutes of Health-funded study in the journal, BMJ, which evaluated U.S. Census Bureau data, concluded that "the substantial increase in e-cigarette use among US adult smokers was associated with a statistically significant increase in the smoking cessation rate at the population level." But although the promise of e-cigarettes should not be ignored, it must also not be overstated.Far too many smokers have not quit smoking, even after they've tried e-cigarettes, either as part of an effort to quit smoking, or simply through experimentation.
Now, policymakers have an opportunity to learn from the "Swedish Experience" with snus, the unfolding American experience with e-cigarettes, and emerging data out of Japan and other countries where heated tobacco products are already helping smokers quit.
The lessons should include the fact that, especially in a society as diverse as ours, different smokers not only smoke for different reasons and quit for different reasons, but they are also aided in quitting by a broad range of products and methods. The smoking population is not monolithic.
Indeed, FDA's recognition that products along a continuum of risk could benefit public health rests on this idea. It's not simply that a "continuum of risk" is necessary, it's that a range of different products with different risk profiles can help different smokers quit.
As Dr. Gottlieb and Mr. Zeller wrote, "To truly protect the public, the FDA's approach must take into account the continuum of risk for nicotine-containing products." Recognition of the risk continuum can help achieve sorely-needed public health gains not because of any products' risks, but because of their potential to help shift smokers to lower-risk products.
It's the products' benefits, even if those products come with different risk profiles, that is their promise. Because in areas like this there will always be unknowns, the FDA should guard against the enticing trap of the precautionary principle.
Opponents of this application claim that because this product does indeed present risks, and we can't, with certainty, quantify those risks with precision, the application should be denied. Such a feeble analysis fails to consider the issue in the context of how these products are used in the real world.
The vast majority of those who use IQOS around the world, and would use it in the U.S., are adult smokers. Yet the precautionary principle assumes a false scenario in which we live in a risk-free society, where the choice is between not using any nicotine product and using IQOS. If that were reality, surely this product would not advance public health. Potential IQOS users would have already quit smoking without even an FDA-approved nicotine replacement therapy. IQOS use would be all risk, no benefit.
However this is not the world we live in. The choice is between smoking and using a lower-risk product. Our world requires the agency to compare the risks of the use of this product against that of combustible cigarettes. Thus the only question is whether the products are combustible and as such, are less dangerous than cigarettes. The scientific basis to answer that question affirmatively already exists.
The only uncertainty is how much less harmful the product is when compared to their combustible cousins. The answer to that question is critically important to help consumers make informed choices, but it is not necessary in order to approve the application.
Before approving the application, the FDA should validate, using its own experts, the central claim of the manufacturer, that these products heat, rather than burn, tobacco. If this claim can be verified, the agency should move quickly to approve the application.
Jeff Stier Director,
Risk Analysis Division National Center for Public Policy Research