It’s Time for the Government to Refocus on Respiratory Health

Americans have historically applied science and technology to advance the nation and its public health. We developed advanced diagnostic tools, removed lead from gasoline, limited harmful substances in our food and drink and countless other examples. There is, however, one tragic exception to such success: cigarettes.

Despite the obvious harm of smoking, the staggering public health costs and the millions of lives lost, we have never mustered the fortitude to enact policies that would make cigarettes less addictive and end this public health disaster. This is the perfect time to take that step.

The COVID-19 pandemic has brought into sharp focus the importance of respiratory health: We all need air that is not harmful. For people addicted to the nicotine in cigarettes, this pandemic brings yet another specter related to their already compromised respiratory health.

The serious direct and indirect harm caused by cigarette addiction is irrefutable. Smoking causes almost half a million deaths a year or 1,300 deaths per day. Compare that to COVID-19, which tragically takes about 1,200 lives per day, and there’s little doubt that smoking is a never-ending pandemic.

Further, 16 million Americans are currently living with smoking-related disease, leading to about $300 billion in annual economic costs. The outlook remains truly horrific; the Centers for Disease Control and Prevention estimates 5.6 million children alive today will die from smoking-related diseases.

The U.S. Food and Drug Administration responded to these alarming statistics by developing the landmark Comprehensive Plan for Tobacco and Nicotine Regulation in 2017. The plan was straightforward: create a roadmap to better protect youth and help addicted adult smokers quit, significantly reducing tobacco-related disease and death in the United States in the years to come.

At the time, then-FDA Commissioner Dr. Scott Gottlieb called it an opportunity to save millions of lives. “The overwhelming amount of death and disease attributable to tobacco is caused by addiction to cigarettes – the only legal product that, when used as intended, will kill half of all long-term users,” Gottlieb said at the time.

Then, late last year, without warning or significant explanation, the FDA abruptly removed the proposed rule-making to reduce nicotine levels in cigarettes from its regulatory agenda. Even before the COVID-19 pandemic struck, policymakers decided there were more immediate priorities than cigarette addiction and the roughly half-million Americans who die from it each year.

And so, here we are still; the cycle continues. The tobacco industry promotes an addictive product and gains financially from smokers’ life-long compulsive consumption, the costs of which are largely borne (like COVID-19) by individuals and families in lower socio-economic communities and regions. Deaths are offset by “replacement smokers” – our children.

But the facts remain. There are approximately 34 million smokers in the United States, 70 percent of whom have expressed a desire to quit. In fact a recent survey found that 8 in 10 adult smokers favor requiring cigarette makers to lower nicotine levels in cigarettes so that they are less addictive.

By mandating the reduction of nicotine levels in cigarettes to minimally or non-addictive levels and by introducing a pragmatic regulatory approach to alternative methods of nicotine delivery, we have the opportunity to reduce the harm caused by addiction and to save millions of lives. But we continue to delay the steps needed to make that a reality.

This is where science comes in. Companies like the one where I work have developed technology to decrease the chances that future generations become addicted to cigarettes and to provide alternatives for smokers of highly addictive cigarettes. Our product, based on years of research by the FDA, the National Institutes of Health and the CDC, dramatically reduces the amount of nicotine in tobacco. The FDA has already authorized our product for sale as “appropriate for the protection of public health” in 2019. Yet we continue to wait almost a year for a further authorization to allow us to communicate this breakthrough to adult smokers. The faster this can be achieved, the sooner and greater the public health benefit in the United States.

Too many Americans pay a fatal price for cigarette addiction and for too long; the global pandemic has accelerated the need to promote and protect respiratory health. The FDA’s comprehensive plan on tobacco and nicotine deserves and demands to be a national priority. The FDA should revisit their plan and accelerate its own actions. But even before that, the agency should provide authorizations to those products that can begin to change the trajectory of disease and death in the United States. The impact of these actions will go a long way towards protecting public health and the lives of individual Americans now and for generations to come.

We have the science. Now, we just need the will.

John Pritchard is vice president of regulatory science at 22nd Century Group Inc., a leading plant biotechnology company focused on technologies that alter the level of nicotine in tobacco plants and the level of cannabinoids in hemp/cannabis plants through genetic engineering, gene-editing and modern plant breeding.

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