Professor Ken Warner's reaction to FDA plan to reduce tobacco-related disease

FDA announces comprehensive plan to reduce the burden of tobacco-related disease and death.

Ken Warner, July 29, 2017

On July 28th, new FDA Commissioner Scott Gottlieb issued a remarkable news release calling for a "comprehensive regulatory plan to shift [the] trajectory of tobacco-related disease, death." Since 2009, when President Obama signed the Family Smoking Prevention and Tobacco Control Act, FDA has had the authority to regulate cigarettes and certain other tobacco products, recently extended to a wide range of products, including novel ones like e-cigarettes. To date, the agency has done little to impact the ongoing saga of death-by-smoking that continues to plague our country and the rest of the world. (Smoking is responsible for one of every five deaths of Americans and one of every eight deaths worldwide.) Today's announcement could be a game-changer.

The proposed plan entails a major philosophical shift in how FDA – and, it hopes, by extension the rest of the country – thinks about nicotine and tobacco. Specifically, it focuses on the essential reality that it is not the nicotine in cigarettes that kills people, but rather scores if not hundreds of toxins among the 7,000 chemical compounds found in cigarette smoke. (They include arsenic, formaldehyde, hydrogen cyanide, and radioactive every puff.) Nicotine is the substance that sustains smoking. Logically, therefore, dissociating nicotine from the poisons that kill people could have an enormous impact on the burden of disease and death produced by smoking. This implies contemplating the idea of providing nicotine-addicted smokers with alternatives to cigarettes that can satisfy their addiction without exposing them to the toxic substances in cigarette smoke. E-cigarettes could be one such type of product.

FDA's plan includes developing methods to regulate such alternative products that will encourage innovation will still protecting the public, and especially children, from the entry of dangerous new products in the marketplace. The most radical component of the plan, however, calls for consideration of requiring the reduction of nicotine in cigarettes and other combusted tobacco products to levels incapable of sustaining addiction. While the 2009 law prohibits FDA from banning cigarettes, it does permit the agency to require the reduction of substances in cigarette smoke. Combined with the availability of consumer-attractive alternative nicotine delivery products, this measure would give nicotine-addicted smokers the opportunity, and incentive, to relinquish their dependence on cigarettes. (Multiple surveys have found smokers supportive of a regulation requiring the removal of nicotine from cigarettes.) And it would make it far less likely that youthful experimentation with smoking would lead to adult dependence on cigarettes.

The plan is a first step, an attempt to engage the public in a thoughtful discussion, and debate, about tobacco and nicotine policy. We aren't likely to see major new regulations resulting from the statement in the immediately foreseeable future. But for those of us who have toiled in the tobacco (control) fields for decades, the press release is truly an exciting development.

Altria, manufacturer of Marlboro, saw its stock price drop by 10% on issuance of the press release.