At a U.S. House Oversight Committee hearing on April 11, FDA Commissioner Robert Califf testified that “tobacco harm reduction product is an industry term.” He also said that “I saw many, many people die from the ravages of tobacco…460,000 [sic] people will die from tobacco related illness this year.” With all due respect, Commissioner Califf is wrong on all three accounts.
Tobacco harm reduction is not an industry term, it is a common sense public health strategy that would save many of the 480,000 American lives lost each year, according to the CDC, as a result of smoking cigarettes. Fifteen years ago the British Royal College of Physicians, one of the world’s oldest and most prestigious medical societies, clearly and unequivocally said “…that smokers smoke predominantly for nicotine, that nicotine itself is not especially hazardous, and that if nicotine could be provided in a form that is acceptable and effective as a cigarette substitute, millions of lives could be saved… Harm reduction is a fundamental component of many aspects of medicine and, indeed, everyday life, yet for some reason effective harm reduction principles have not been applied to tobacco smoking.”
Dr. Califf provided the reason why smoking has been immunized from harm reduction. Either Califf and the FDA are misinformed, or they are deliberately working to undermine this effective public health strategy in order to chase the government’s dream of a “tobacco-free society” and retaliate against the U.S. tobacco industry.
Harm reduction should be a key priority because it saves lives. However, U.S. public health policy remains singularly focused on prohibiting all tobacco and nicotine use, overlooking the fact that many adult smokers are unable or unwilling to quit. Commissioner Califf and other U.S. public health authorities must revise their approach, recognizing that vastly safer smoke-free nicotine and tobacco products will save lives by effectively mitigating the deadly consequences of smoking cigarettes.
The disingenuous effort to ban safer tobacco/nicotine cigarette substitutes continues while hundreds of thousands of U.S. smokers die each year. Everyone shares the concerns about limiting underage tobacco use—but what about much more dangerous alcohol and cannabis used in high numbers by U.S. teens for decades? According to the CDC, alcohol alone is responsible for more than 220,000 years of potential life lost among young adults under 21 years old. It's time for federal officials to let go of their insular focus on nicotine use and get serious about saving smokers’ lives.
Here's a violation of the popular narrative: Nicotine, when consumed without the harmful constituents of cigarette smoke, is no more harmful than caffeine. Even former FDA commissioner Scott Gottlieb, while incorrectly conflating tobacco with smoking, acknowledged that "Nicotine, though not benign, is not directly responsible for the tobacco-caused cancer, lung disease, and heart disease that kill hundreds of thousands of Americans each year."
The demonization of nicotine, perpetuated by entrenched opponents and sensationalized reports, obscures reality. Studies on American smokeless tobacco products and snus, popular in Sweden, demonstrate little to no discernible increase in smoking-related disease deaths among users. Further, the Royal College of Physicians found that "the hazard to health arising from long-term [vapor] inhalation from the e-cigarettes available today is unlikely to exceed 5% of the harm from smoking tobacco." It's time to confront the unfounded fears and baseless assumptions surrounding nicotine's health impacts.
Kneejerk bans and opposition to less risky products that could ultimately help smokers quit is not true public health policy at all. The myopic focus on prohibition and complete ignorance of the medical research around nicotine overlooks the potential for better strategies to alleviate the burden of smoking-related illnesses. Banning nicotine/tobacco alternatives only serves to perpetuate the cigarette market and undermine efforts to reduce harm. The path forward lies in recognizing the diverse needs and preferences of individuals grappling with nicotine addiction, including but not obsessed with abstinence.
Confronting the challenges posed by tobacco use requires placing a priority on saving lives. Despite the semantic debate about labels, tobacco harm reduction—or whatever else you want to call it—means giving adult smokers options to quit and to live longer and healthier lives. It means prioritizing real, actionable public health policy over the FDA's misleading rhetoric.
Dr. Brad Rodu is a Professor of Medicine at the University of Louisville and holds the Endowed Chair of Tobacco Harm Reduction Research at the UofL Brown Cancer Center.
