Smokers Need Choices, Doctors Need Tools, and the FDA Needs to Act

As a primary care physician, I go to work every day to help people lead better, healthier lives.  Some of my patients, however, are addicted to cigarettes. They understand that smoking presents an extreme hazard to their health, yet they continue to smoke.

The reality is that many attempt to quit but fail because quitting an addiction can go beyond mere willpower. Addiction changes brain pathways, so quitting often requires a more scientific approach.

My duty is to help my patients bridge this gap. Simply quitting is not a realistic solution for many of them, making it necessary to switch to a harm-reduction approach to minimize the negative effects of this habit. Unfortunately, the toolbox for such an approach is very limited and needs more alternatives and strategies to help patients reduce the harmful effects of smoking cigarettes.

The Food and Drug Administration has taken steps to re-evaluate its approach to tobacco and nicotine regulation, investigating non-combustible tobacco products like the tobacco-heating system IQOS. In an article published in the New England Journal of Medicine, the FDA indicated its understanding that while nicotine itself is not good for you, smoking-related death and disease stem from the smoke when tobacco is burned.

There is a law called the Family Smoking Prevention and Tobacco Control Act of 2009, which allows the FDA to bring new nicotine and tobacco technologies to market prior to formally designating them as safer alternatives to smoking. The FDA is currently reviewing the IQOS for this purpose through a premarket tobacco application. However, the application has been pending far longer than the law’s 180-day review period.

While we don’t yet know enough about the long-term effects of non-combustible tobacco products, we do know that smoking is by far the most dangerous way of consuming nicotine, and we also know that eliminating combustion can significantly reduce the amount of toxins that smokers inhale with each and every puff. This point was driven home by a recent public health statement from the American Cancer Society. ACS wrote that “[P]ublic misunderstanding underscores the urgent need for consumer education about the absolute and relative risks posed by different tobacco products and to reinvigorate smokers’ understanding of the importance of quitting combustible tobacco.”

The FDA also has a well-developed system for monitoring the effects of these products over time to ensure they continue to benefit public health as we continue to learn more about these new products.

Philip Morris International has produced an alternative for the toolbox. The IQOS, a heat-not-burn tobacco system, warms the tobacco rather than burning it. It tastes like a standard cigarette, but releases 90 to 95 percent less harmful toxins than cigarette smoke, according to the company and independent studies. Though it is a relatively new technology, it may offer a much-less risky option.

As a physician, I support a careful review of data submitted to the FDA, so that doctors everywhere can best inform patients concerning their medical recommendations. Quitting will continue to be the best option, but for those who continue to smoke, products such as IQOS need to be expeditiously approved by the FDA.

Across the globe, over 5 million smokers have switched to IQOS and quit smoking cigarettes.  The sooner these products can be brought to market in the United States, the sooner they can be used to save lives here, too. This is particularly important now, given the recent proliferation of new products with flavors that appear to be an obvious attempt to attract new smokers, many of whom are youth. Such products have not faced the rigorous FDA approval process that the IQOS product is going through.  


Dr. Erika Bliss, M.D., is a family physician from Seattle with Equinox Primary Care.

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