One Way the FDA Can Demonstrate It Is Serious About Saving Lives
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One Way the FDA Can Demonstrate It Is Serious About Saving Lives

Smokers deserve access to safer, noncombustible nicotine products, and the public and health professionals need information about the relative risks of different products.

Food and Drug Administration (FDA) Commissioner Dr. Scott Gottlieb recently signaled that he will lead the FDA in a new direction on regulating tobacco products.

Among other things, Gottlieb highlighted that the toxicants in smoke delivered by combustible cigarettes, not the nicotine, are the primary cause of nearly half a million smoking-related deaths every year. Most noteworthy, Gottlieb indicated, in official comments from the FDA and in the New England Journal of Medicine, that innovation and availability of noncombustible (and much safer) forms of nicotine may hold the promise of finally empowering smokers themselves to lead the way in dramatically reducing smoking-related death and disease.

FDA now has an opportunity to put Gottlieb’s words into action by approving the modified risk tobacco product (MRTP) application filed by Philip Morris related to its IQOS tobacco product. Because IQOS heats but doesn’t burn tobacco, the lethal toxicants found in cigarette smoke are reduced by 90 percent or more, massively reducing the user’s risk of smoking-related disease. This heating process delivers the nicotine smokers crave through an aerosol, but without the lethal smoke that may kill them.

It’s been well-known and widely accepted in the scientific community what late tobacco researcher Michael Russell declared decades ago – smokers smoke for the nicotine, but it’s the toxicants in the smoke itself that kills them. Gottlieb’s comments highlighting Russell’s conclusions are significant because Gottlieb is the highest-ranking U.S. government official to confirm this to be the case and he’s indicated the government’s intention to finally do something about it. Now it’s time to act.

Reason Foundation has filed a public comment with the FDA on the Philip Morris MRTP application and encourages the FDA to approve it. Doing so would demonstrate the FDA is serious about smokers getting access to information about relative risks that could empower them to make potentially life-saving personal health choices.

The MRTP process isn’t designed to approve new products for the U.S. market. Under FDA regulatory authority granted via the Family Smoking Prevention and Tobacco Control Act, the MRTP is designed to allow companies to communicate relevant and truthful information to consumers about specific products. As companies are prohibited from making explicit or implied health claims about tobacco products, the MRTP process effectively serves to provide important information to consumers that can inform personal choices about their health. Regarding the Philip Morris MRTP application for IQOS specifically, the consumers who would benefit by gaining access to more information would be adult smokers who have been unwilling or unable to quit.

According to the U.S. Centers for Disease Control (CDC), despite a comprehensive 50-year campaign against smoking from all levels of government, close to 40 million Americans still smoke. The CDC estimates that if we continue along this same “quit or die” tobacco control path, close to half a million of those smokers will continue to die prematurely every year. Many more will experience a diminished quality of life.

One of the more unfortunate (and reprehensible) aspects of this reality is that there are already tobacco and nicotine products in the U.S. market such as snus and traditional American smokeless tobacco products that provide smokers with a dramatically safer alternative to smoking, but companies are prohibited from sharing that information with adult smokers.

Additionally, government-funded “education campaigns” against smokeless tobacco and more recently, electronic cigarettes only exacerbate this ignorance. These campaigns, because they lack nuance, perspective and comparisons of risks versus smoking leave most smokers, the non-smoking public and even health professionals mistakenly believing that alternative, noncombustible products might be as dangerous, or more dangerous than traditional cigarettes. In some cases, mandated government warnings (such as those for smokeless tobacco) exacerbate such deadly ignorance.

The MRTP application from Philip Morris is the first to be considered under Gottlieb’s leadership. Since President Obama signed the Tobacco Act into law in 2009 and up until President Trump assumed office in January, the FDA has never approved a modified risk tobacco claim. While the agency’s concerns about non-smokers picking up a new habit may have some merit, the possibility of that happening in limited circumstances must be weighed against nearly half a million U.S. deaths from smoking every year.

Dr. Gottlieb’s words and perspective are welcome and long overdue from FDA. But unless accompanied by specific actions, they will ring hollow. Gottlieb’s expressed intention to utilize harm reduction strategies that have been effective fighting HIV and other diseases to fight smoking-related disease hold enormous potential.

His extension of pre-market tobacco authorization deadlines by four years was an immensely important first step. Currently, the FDA is considering two questions where Gottlieb’s decisions will indicate how seriously we should consider his words. Reason Foundation previously weighed in on an ill-conceived rule proposed in the last minutes of the Obama administration related to smokeless tobacco and the aforementioned MRTP application.

How Gottlieb’s FDA decides these cases will determine whether or not the FDA will continue along a new path focused on fighting smoking-related disease and death or be sidetracked by prohibitionist ideology that often seemed to rule the day in the past.

The consumer-driven free market has been providing alternatives than can effectively reduce lung cancer, heart disease and stroke that has been killing smokers. Those alternatives, when combined with transparency and good information from government agencies can empower individuals to choose better options, save lives and improve public health.