TPA, TechFreedom, and CEI Lead Coalition Urging FDA to Embrace Innovation
October 10, 2017
The Taxpayers Protection Alliance, along with seven other groups, have written in support of the Food and Drug Administration (FDA) approving the Modified Risk Tobacco Product Application (Docket FDA-2017-D-3001), published on June 15, 2017. By approving the sale of reduced-risk tobacco products, the FDA would signal that it values cutting edge, harm-reducing technologies that will undoubtedly offer health benefits for individual consumers and the nation at-large. As a taxpayer-funded agency, the FDA must work in the interest of consumers and taxpayers.
Read the full letter below:
September 27, 2017
Dear Commissioner Gottlieb,
We the undersigned organizations dedicated to improving public health, increasing consumer choice, and reducing taxpayers’ burden through innovation, encourage you to bring less harmful tobacco products to the market expedi- ently. By doing so, the Food and Drug Administration (FDA) would signal that it values cutting edge, harm-reducing technologies that will undoubtedly offer health benefits for individual consumers and the nation at-large.
The FDA is currently reviewing the Modified Risk Tobacco Product Application (Docket FDA-2017-D-3001), published on June 15, 2017.
Traditional cigarettes are a known hazard to health, but the risks stem mainly from chemicals produced through the process of combustion. Products that heat nicotine solutions or tobacco, such as the IQOS, deliver nicotine with- out combustion and, as a result, lack most of the harmful and potentially harmful elements of traditional tobacco.
Heat-not-burn alternatives provide substantially less hazardous options for individuals wishing to consume nico- tine with an experience similar to smoking. In 2014, the FDA’s own research determined, “the inhalation of nicotine (i.e. nicotine without the products of combustion) is of less risk to the user than the inhalation of nicotine delivered by smoke from combusted tobacco products.”
The history of technology is full of examples where innovation moves consumers toward safer, more effective, and more user-friendly options. We’ve seen innovations in public health elsewhere, as wearable tech like Fitbit and Apple Watch change the way we exercise and monitor our health. Telemedicine has increased access to medical services in remote and underserved areas. Companies like Zipline are using drones to deliver medicine in Rwanda, overcoming a lack of roads and other infrastructure challenges. These advances bypass conventional outmoded paradigms and create new ones, and they have occurred in all aspects of American life.
Even in tobacco, countries that adopted the use of existing non-combustible products have already seen the health benefits of allowing consumers access to reduced-harm options. For example, Swedish men have the highest rates of snus use (a moist tobacco chew) in the European Union. Consequently, Swedish men also have the lowest lung-cancer rates3 and one of the lowest rates of both oral and esophageal cancers in the EU.
In the market for nicotine-delivery, the latest technological innovations are inhalable, but non-combustible prod- ucts like IQOS. As with Swedish snus, research finds that these products are many orders of magnitude safer than traditional cigarettes. Such innovations within the tobacco market ought to be welcomed by the FDA as having the potential to disrupt—for the better—the “analog” approach to public health.
Over the past decade, the electronic vapor industry (aka e-cigarettes) has grown from an online novelty to a brick- and-mortar industry worth more than $8 billion a year. By 2025 it is estimated the global market will be nearer to $47 billion. As millions switch from smoking to vaping, we’re experiencing a mass movement from a harmful an- alog product—cigarettes— to demonstrably safer digitized products. This large-scale voluntary transition demon- strates a consumer desire for reduced-harm nicotine products and should be embraced by regulators as a develop- ment with the potential to improve and save millions of lives.
Given how difficult it is to quit smoking, it is imperative the FDA acknowledge that there is no single approach to cessation that works for everyone. The diversity and variety seen in vapor products is a key reason for their success in pushing smokers to safer nicotine-delivery systems. For example, adult users who were able to reduce or elimi- nate their traditional tobacco use self-report the availability of a variety of flavors as being “very important” to their success. However, e-cigarettes don’t work for everyone, especially those that prefer the taste of real tobacco to the flavors of e-vapor liquid. Heat-not-burn products provide an experience similar to smoking while still substantially reducing users’ and bystanders’ exposure to harmful and potentially harmful chemicals. While not “risk free,” both industry-funded and non-industry research indicate that heat-not-burn tobacco products like the IQOS deliver less of the known toxic chemicals, upwards of 90 percent less, than combustible cigarettes—a reduction in harm that is less than, but similar to, the reduction observed in electronic cigarettes.
Government policy has a huge impact on whether consumers understand the relative risks of various products and whether or not they adopt safer alternatives. Concerted efforts among government health organizations to raise awareness about the potential harms associated with electronic cigarettes, well-intentioned as they may be, have resulted in the growing number of consumers who fundamentally misunderstand the risks of using alternative tobacco products as compared to traditional cigarettes. Polling data from 2015 found that 35 percent of Americans viewed these demonstrably safer products as being “as harmful” as traditional cigarettes, while just 12 percent held this misinformed belief three years prior. At the same time, health authorities in other nations have adopted reduced-harm tobacco products as part of the solution to tobacco harm. While government health bodies are charged with protecting consumers from potentially harmful products, consumers deserve truthful information about rela- tive risks of various options so that they may make the important decisions that will affect their health.
In July, the British government unveiled a plan to reduce smoking rates among adults to 12 percent by the end of 2022. The plan, called “Towards a smoke-free generation: tobacco control plan for England,” notes that “Two thirds of smokers say they want to stop smoking, however long term success rates are low.” Innovative nicotine-delivery alternatives are proving successful in facilitating smoking cessation and getting smokers to adopt less harmful alternatives.
According to the U.K. report, “In 2016 it was estimated that 2 million consumers in England had used (alternative nicotine delivery system) products and completely stopped smoking and a further 470,000 were using them as an aid to stop smoking.”
As a result of this success, the U.K. Department of Health declared that they “welcome innovation that will reduce the harms caused by smoking and will evaluate whether products such as novel tobacco products have a role to play in reducing the risk of harm to smokers.” The United States, and the FDA, should follow the U.K.’s lead in em- bracing marketplace innovations and encouraging smokers to switch to those alternatives.
In Japan, where IQOS has been on the market since April 2016, a peer-reviewed research study by the Osaki Hospi- tal Tokyo Heart Center found that smokers who switched to IQOS:
Reduced their exposure to 15 harmful chemicals to levels that approached those of smokers who quit smoking;
Showed improvements in measured health indicators specific to smoking-related diseases, such as lung and heart disease. In all cases, the health indicators improved in the same direction as seen in smokers who quit; and
Found the product satisfying and were likely to completely switch to it.
For smokers that haven’t already quit using e-vapor, Nicorette, pharmaceuticals, hypnosis, or the other currently available cessation methods, the IQOS system may prove to be best option for them—a potentially effective new tool among the imperfect solutions to a difficult public health epidemic.
We encourage the FDA to reduce regulatory barriers to human progress and foster these market innovations that contribute positively to our community. The FDA has not just an opportunity, but a responsibility, to allow techno- logical progress to continue creating new options that reduce the harmful health effects of smoking by allowing heat-not-burn tobacco options to meet consumer demand. We urge the FDA to approve the MRTP application for IQOS, and we also encourage the agency to approve any future innovations that can benefit public health.
We further request a meeting with you or your designee to discuss these concerns.
Taxpayers Protection Alliance
Citizens Against Government Waste
Log Cabin Republicans
National Center for Public Policy Research
Not Blowing Smoke