FDA should act on potential reduced risk tobacco products

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As a primary care physician, I will be watching closely on Jan. 24 when the Food and Drug Administration’s Tobacco Products Scientific Advisory Committee (TPSAC) meets to review the Modified Risk Tobacco Product Application of Philip Morris International IQOS product.

The agency recently announced it will convene a public hearing to examine the merits of a new heat-not-burn tobacco technology that the company claims may be much less harmful than traditional cigarettes, one and be an effective alternative for current smokers who haven’t had success quitting with electronic cigarettes and other alternatives.

{mosads}As we all know, many members of the scientific community are skeptical of any claim made by the tobacco industry, and they are right to be so. But when it comes to reduced-risk alternatives, there is a science-based argument to be made about the true cause of smoking-related disease.


While nicotine is not a harmless substance, it is not the primary cause of disease. Burning tobacco creates smoke, which is home to thousands of harmful compounds. The inhalation of smoke into the lungs is where the primary source of risk emanates. Reducing the overall use of combustible tobacco products, while recognizing that some adults will continue to use nicotine, could greatly improve the health of individuals and the population as a whole.

Almost every day, I counsel patients to quit smoking. Though they understand that smoking is an extreme hazard to their health, and despite efforts to quit cold turkey or using the variety of smoking cessation products on the market, many continue to struggle. Each day they continue smoking they put themselves at an increased risk of serious disease and premature death.

For some patients who have tried and failed to quit smoking (sometimes multiple times), I have advocated a harm-reduction method. However, given today’s regulatory environment, my toolbox for this approach is very limited. Based on my experience, I believe we need to inform smokers about alternatives that minimize their exposure to the damaging effects of tobacco smoke.

Currently, federal law provides the FDA with a regulatory tool to improve access to nicotine products that do not burn tobacco. The Family Smoking Prevention and Tobacco Control Act of 2009 empowers the agency to review, approve and bring new technologies to the market, such as vaporizers, e-cigarettes and heat-not-burn products, and permit communications to adults who smoke regarding the potential new products have for reducing risk.

While we do not yet know enough about the long-term effects of non-combustible tobacco products, we must encourage investments in new technologies. The FDA has a well-developed system for monitoring the effects of these products over time, which allows the agency to assess the impact of these products and adjust policy accordingly. Bringing reduced risk products to market would not only provide millions of people in this country with another meaningful option to reduce their risk from smoking, it could also revolutionize tobacco consumption around the world.

Philip Morris International has produced an impressive amount of data on IQOS. As a physician, I support a careful review of that data by the FDA so that I can confidently recommend these products should they be allowed to come to market, a point I emphasized in a comment I submitted to FDA as part of its review of PMI’s Modified Risk Tobacco Product Application.

To be clear, quitting cigarettes entirely is the preferred approach I recommend to my patients, but for many, this is not a likely outcome, and for those, reduced risk products can make a meaningful difference. 

America’s health professionals and their patients could benefit from the availability of products that have the potential to reduce risk. I remain hopeful that the FDA shares that straightforward goal. 

Erika Bliss, M.D. is a Seattle-based family physician and CEO of Equinox Primary Care, which serves employers, unions and individual patients with unlimited access to high functioning primary care services in an innovative medical home membership model. In 2009, she was elected to serve on the American Board of Family Medicine, the organization that oversees certification and continuing education requirements for family physicians across the U.S.


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