September 12, 2017
To: Division of Dockets Management
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
From: Brandon Arnold, Executive Vice President
National Taxpayers Union
25 Massachusetts Ave, NW, Suite 140
Washington, DC 20001
Subject: Modified Risk Tobacco Product Applications for the Philip Morris International Tobacco Heating System called IQOS
Docket ID: FDA-2017-D-3001
Dear Commissioner Gottlieb,
I write to you on behalf of National Taxpayers Union (NTU), a Washington-based nonprofit research and advocacy organization dedicated to the protection of free-markets, limited government, and pro-taxpayer policies. Since 1969, NTU has been a leading voice against undue tax and regulatory burdens that hinder activity in the economy. While some level of regulation is often appropriate to protect the general public, excessive regulation increases costs to businesses, delays availability of new products, raises prices for consumers, and, in the docket before you, could have a substantially detrimental impact on public health. It is for these reasons I urge the Food and Drug Administration (FDA) to allow the IQOS system be made available to the market as a Modified Risk Tobacco Product.
Unfortunately for millions of smokers across the nation, delay of this product could have serious negative health consequences. Responsible for nearly 500,000 deaths a year, cigarette use remains the leading preventable causes of death in the United States. In fact, a government study finds almost 70 percent of American smokers want to quit, yet, last year, only 6 percent were successful in doing so. Heat-not-burn (HNB) products have the potential to offer a new and more appealing alternative for smokers who have been unsuccessful in quitting or for those who might not have tried to quit smoking.
Smoking is the most common means to use nicotine, and the most harmful as well. In fact, combustion releases nearly 90 percent of the 7,000 chemicals that are inhaled. HNB products, on the other hand, reduce harmful carcinogenic chemicals by 90-95 percent compared to cigarette smoke, thus reducing the risk of negative health effects. Without the availability of less harmful products, by the middle of the century, over 17 million Americans will suffer a premature and preventable death.
Absence of less harmful alternatives will also harm the health of the U.S. economy and strain taxpayer funds. Cigarette use leads to more than $156 billion in lost annual productivity, including $5.6 billion in lost productivity due to secondhand smoke exposure. Further, smokers report about 2.5 fewer workdays each year compared to their counterparts who do not smoke.
U.S. adults enrolled in Medicaid or are uninsured smoke at rates more than double than that of people who have private insurance. Diseases and health implications from smoking increases Medicare outlays by $45 billion; Medicaid by $40 billion; and government-sponsored insurance programs by $24 billion annually. In essence, taxpayers are subsidizing the use of cigarettes for those receiving health care from the government. Combined, private insurance and government programs pay out nearly $170 billion per year, or 8.7 percent of all health care costs, on tobacco-related illnesses and diseases.
However, people still smoke regardless of the known health consequences and monetary costs, and the best alternative for many current smokers are tobacco harm reduction products. The FDA plays a critical role in allowing certain types of products to be allowed to remain on, or enter into the marketplace. By regulating how products can be researched, developed, marketed, and sold in the U.S., any action the agency takes will determine the type of information available to consumers as well as their ability to purchase tobacco products that are less harmful.
The IQOS product developed by Philip Morris International (PMI) is an innovative product that heats tobacco opposed to burning it like typical cigarettes. Cigarettes typically burn tobacco at 1600 degrees fahrenheit, causing the release of toxic chemicals that are inhaled by the smoker. IQOS heats tobacco to a temperature that is over 1000 degrees fahrenheit less than normal cigarettes. Instead of emitting a smoke, an aerosol is created that consists mainly of water vapor and glycerol. Importantly, many of the chemical reactions that result from combustion do not occur due to considerably lower temperatures, creating a much safer experience than smoking cigarettes.
While a thorough review of the application is important, it is also important for the FDA to craft a ruling in an expeditious manner. To that end, it should be noted that this product has previously gone under intense review from governments across the globe. Today, IQOS is readily available for purchase in 27 nations around the world, including Germany, Japan, and the United Kingdom. According to PMI, nearly 3 million people have switched to the healthier alternative that is IQOS.
It is crucial that the examination of HNB products be evidence-based and demonstrate significant reductions in risk for cigarette-smokers making the transition. Clinical trials in both the United States and Japan have showed similar, positive results. Smokers who switched to heat-not-burn products were exposed to significantly lower carcinogenic and toxic chemicals than standard cigarettes. In one study, smokers who transitioned to heat-not-burn products for a three-month period had levels of harmful chemicals that were similar to those of smokers who quit for the same duration.
Approving the IQOS application is an important step towards permitting innovation that could lead to dramatic improvements in public health. This promising new technology is backed by strong scientific evidence and clinical trials that suggest tobacco harm reduction products like heat-not-burn are an acceptable, less-harmful option for smokers. Thus, I respectfully ask that the FDA approve the IQOS Tobacco Heating System as a Modified Risk Tobacco Product available for sale in the United States.
Brandon Arnold, Executive Vice President, National Taxpayers Union