July 28th marks the one year anniversary of the FDA’s landmark announcement to embark on what it called a “new comprehensive plan for tobacco and nicotine regulation” that “places nicotine, and the issue of addiction, at the center of the agency’s tobacco regulation efforts.”
When rolling out the multi-year plan, Commissioner Scott Gottlieb said that “the overwhelming amount of death and disease attributable to tobacco is caused by addiction to cigarettes.” Never was a more obvious statement more necessary, given the recent media hysteria over e-cigarettes.
The agency unveiled a two-pronged approach to reduce smoking.
First, it said it would “begin a public dialogue about lowering nicotine levels in combustible cigarettes to non-addictive levels.” The prospect of banning cigarettes as we know them drew cheers from old-school tobacco control activists. Lowering the maximum amount of nicotine in legally available cigarettes to non-satisfying and non-addictive levels is policy candy: It gives public health groups a head-rush, but it’s going to cause deadly problems for years to come. Evidence is scant that it would help smokers quit, and it will be a boon to the already thriving black market for these highly addictive products.
The second part of the plan voiced a commitment to reform regulations to foster innovation for both recreational (e-cigarettes) and medicinal (nicotine replacement therapy) products. This component of the plan gave hope to countless former smokers who are smoke-free today because of e-cigarettes. FDA regulations already in force have put a freeze on innovation. And unless the FDA quickly makes regulatory changes, nearly all currently available e-cigarettes will be removed from the marketplace in just a few years.
Commissioner Gottlieb said that to achieve the goal of reducing smoking, “all of these steps must be done in concert and not in isolation.” A year into the plan, what has FDA achieved?
With regard to beginning a dialogue about lowering nicotine in cigarettes, the FDA made good on its promise — and quickly. The agency drafted an Advanced Noticed of Proposed Rulemaking (ANPR) and moved it through the required Office of Management and Budget review at lighting fast speed. The FDA then published the document, opened a public comment docket, briefly extended it, and closed the public comment period, in which at least 7,000 comments were submitted. It also funded a study published to coincide with the ANPR, which attempted to begin quantifying the potential public health effects of setting a maximum level of nicotine in cigarettes.
With regard to e-cigarettes, last July’s extension of timelines for manufacturers to submit product review applications gave the agency the chance to develop product standards and offer companies guidance on what must be in a successful application. On that front, the FDA has been eerily silent, even as the previously extended deadline looms. Instead, it issued a second ANPR, a precursor to a possible ban on certain e-cigarette flavors, as the agency seeks to better understand how flavors may appeal to youth as well as the crucial role they play in helping adult smokers quit. Instead of keeping its promise to foster harm-reducing innovation, the agency is contemplating a crushing blow to the most significant competitive threat to the cigarette industry in history. Even President Obama’s White House stepped in to stop FDA’s attempt to ban e-cigarette flavors during his administration.
Even a leading skeptic of the benefits of e-cigarettes for smoking cessation recently found it necessary to make a major course correction. In a caveat-rich policy statement, the American Cancer Society acknowledged that “switching to the exclusive use of e-cigarettes is preferable to continuing to smoke combustible products.” ACS’s Clinical Recommendations state that the organization supports “any smoker who is considering quitting, no matter what approach they use.” ACS now recommends “that clinicians support all attempts to quit the use of combustible tobacco and work with smokers to eventually stop using any tobacco product, including e-cigarettes.” Finally, and rather reasonably, the ACS advises that “these individuals should be encouraged to switch to the least harmful form of tobacco product possible; switching to the exclusive use of e-cigarettes is preferable to continuing smoking combustible products.” Unfortunately, the science hasn’t gotten down to ACS’s lobbyists, who continue to call for a ban on e-cigarette flavors adult smokers use to quit.
Honest voices in the public health community are beginning to observe what has been clear to those of us who have been trying to learn from real-world e-cigarette users — former smokers — for the last decade: Although other methods have helped some smokers quit, a significant portion of the adult population still smokes, even though they’d like to quit. Until e-cigarettes came along, they had few alternatives. What an ironic shame, and public health disaster it would be, if the Trump administration forgets them too.
[Originally Published at RealClearHealth]