On July 28, 2017, the United States Food and Drug Administration (FDA), under the leadership of a newly appointed Commissioner, Scott Gottlieb, announced that the agency would chart a bold new course on regulating nicotine products and tobacco. He laid out two guiding principles. First, smoke from a tobacco cigarette is by far the most dangerous form of nicotine consumption and more must be done to help smokers quit. Second, nicotine is not a major source of harm when delivered without smoke.

Adopting less harmful smokeless products could rapidly save countless lives from premature death and burdensome suffering. While this is a watershed moment, Commissioner Gottlieb’s voice is not enough.

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The FDA said there is “a continuum of risk.” Tobacco cigarettes are at most hazardous end. Medicinal nicotine products like over-the-counter gums, patches, and lozenges are at the other. In between, but at the much lower end of harm, are emerging products delivering nicotine without the smoke. These include e-cigarettes, products that heat but do not burn tobacco, and smokeless tobacco products like snus.

All are far safer for those who cannot or do not want to give up nicotine use but don’t want to die from smoking

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Unfortunately, misinformation about nicotine abounds. The majority of Americans wrongly believe that e-cigarettes are at least as harmful as cigarettes. While nicotine makes it hard to stop smoking, it is the tars, toxins, and carbon monoxide in smoke from the burning of tobacco that are overwhelmingly responsible for the massive burden of death. E-cigarettes can help smokers to switch and quit smoking cigarettes. In the U.S., adolescent and adult smoking rates have dropped to record lows since the mid-1960s.

Still, more than half a million smokers a year will die prematurely if more is not done. Millions more will suffer from smoking caused disability. Among those who continue to smoke, 70 percent say they want to quit. More smokers are now trying e-cigarettes to quit than FDA-approved medicines like nicotine gum, patches, or lozenges. If smokers switched exclusively to e-cigarettes over the next 10 years, estimates project as many as 6.6 million deaths could be averted and cigarettes could become obsolete.

The FDA statements are an important first corrective. While Commissioner Gottlieb opened a door to a massive shift in American tobacco and nicotine policy, the FDA is fundamentally a regulatory agency. He must now guide the FDA to creating appropriate product safety standards and fill a void that has persisted for too long.

What the nation needs now is a candid and resolute champion to cross the threshold and deliver a clear message about less harmful tobacco products.

The Centers for Disease Control and Prevention officially acknowledges that e-cigarettes are safer than tobacco cigarettes, yet has undercut that message by stressing concerns about e-cigarettes. The Office of the Surgeon General has raised alarm about use by youth, with no balanced recommendations for adult smokers who want to switch.

America needs a candid smoking control champion — a figure like C. Everett Koop, Surgeon General during the first eight years of the AIDS epidemic — to get out the information that could save millions of smokers’s lives. Surgeon General Koop shifted the debate about AIDS by giving Americans the facts, even when harm reduction options conflicted with his personal values. Dr. Koop recognized that every American deserved forthright health information about prevention, devoid of stigmatizing messages and insistence on total abstinence. He acted fearlessly at a moment of enormous misinformation regarding the transmission and ways of preventing a disease that amounted to a virtual death sentence.

What, then, would a Koop moment look like today, on the 100-year anniversary of his birth?

It would, at a minimum, involve a leading health official — if not the Surgeon General or the head of the CDC, then a new Health and Human Services Secretary—and the leading tobacco control advocates like the American Cancer Society and the American Public Health Associations making candid statements.

The only way to avoid all risks is not to consume any product. Youth, without question, have to be protected. This demands preventing sales and predatory advertising to underage youth. But current and future smokers, who are the ones in immediate peril, must also be able to make decisions based on truthful information about how new smokeless products differ in their relative harms from smoked tobacco.

A Koop moment, finally, would require the courage to brave blistering attacks from those who cling to the uncompromising message that there is no safe tobacco product. A purist stance misleads the public into thinking that all tobacco products are equally harmful.

Ten years after e-cigarettes became available, governments and scientists know enough to assure smokers that e-cigarettes are safe enough for smokers to switch. Each year of delay endangers half a million lives in the U.S and over 7 million globally. We must follow Dr. Koop’s example and add harm reduction to our smoking prevention and cessation efforts. Ethics, evidence, and common sense demand it.



Dr. Amy Fairchild is an associate dean of academic affairs, professor, Texas A&M University, School of Public Health. Dr. Ray Niaura is a professor of social and behavioral sciences, New York University College of Global Public Health. Dr. David Abrams is a professor of social and behavioral sciences, New York University College of Global Public Health.