Now that he has triumphed over the confirmation process, Gottlieb’s real challenge—streamlining the FDA for the benefit of consumers—begins. Though a number of hot-button issues await him in his first days in office, one in particular deserves his immediate attention. Though the Trump administration delayed Obama-era regulations on electronic cigarettes, without swift action from the newly-minted FDA commissioner, consumers will lose a demonstrably safer alternative to cigarettes and be left with no alternative to their deadly habit.
In 2009 when Congress enacted the Tobacco Control Act (TCA), it granted the FDA authority to regulate tobacco products. Electronic cigarettes, however, were not included in the TCA until last year when the FDA unilaterally decided to deem electronic cigarettes—which contain no tobacco—to be tobacco products. While some public health advocates and members of Congress insist the change just gives FDA oversight power over these novel devices, in reality it lumps in demonstrably safer nicotine-delivering products in with far more deadly tobacco cigarettes and will ultimately result in e-cigarettes being wiped from the market.
A handful of rational lawmakers who are aware of the massively positive impact these reduced-harm products can have on public health, sought to amend the TCA. Their goal was not—as has been widely misreported—to exempt e-cigarettes from FDA scrutiny. Rather, the proposed change simply hoped to afford e-cigarettes the same leniency granted to traditional cigarettes by the TCA.
When enacted, the TCA “grandfathered in” cigarettes already on the market, bringing them under FDA scrutiny, but exempting them from the costly prior-approval process. Because e-cigarettes didn’t exist when TCA was written, they—unlike traditional tobacco—would not benefit from the same grandfathering exclusion. And even though TCA explicitly gives the FDA “flexible enforcement authority” in order to assist in efforts to develop, introduce, and promote less harmful tobacco products the agency insisted that it didn’t have “the authority to alter or amend this grandfathering date, which is set by statute.”
It is this technicality a bipartisan bill, proposed by Reps. Tom Cole (R-OK) and Sanford Bishop (D-GA) sought to address. Rather than limiting FDA’s ability to regulate e-cigarettes, the proposal would have merely altered the “grandfather” date to 2017; allowing existing e-cigarettes to stay on the newly regulated market. Just as it did for regular old cancer sticks.
But the proposal was killed by Democrats in Congress who gleefully chalked it up as a win over “big tobacco.” In reality, they have given a gift to the traditional tobacco industry since they are the only ones who will be able to afford the $400,000 per application cost of getting approval from the FDA; if they choose to do this. And, should any of their cigarette-alternatives be approved by the FDA, they will have almost no competitors—since the thousands of small e-cigarette and e-liquid companies are already shuttering their businesses—so these offerings will be massively more expensive and far less attractive to smokers.
This should gravely concern Dr. Gottlieb since almost every single study investigating e-cigarette’s safety have found them to be significantly less harmful than traditional tobacco products and effective as a means for people to quit smoking. In 2015, for example, an independent study performed by Public Health England estimated that e-cigarettes were about 95 percent less harmful than cigarettes. Just last year the Royal College of Physicians recommended physicians encourage patients who smoke to switch to electronic cigarettes.
Just this year, a study funded by Cancer Research UK found that smokers who switch to e-cigarettes reduced their exposure to known carcinogens as much as those who switched to other FDA-approved nicotine replacement therapies like nicotine gums or patches. This is because, unlike traditional cigarettes, the nicotine-containing vapor from an e-cigarette is not produced by burning tobacco. It is this burning that creates most of the carcinogens in smoking.
Even Mitch Zeller, the current director of the FDA’s Center for Tobacco Products, admitted that “if we could get all those people [who smoke] to completely switch all of their cigarettes to noncombustible cigarettes, it would be good for public health.” Yet, he allowed zealots within his center to ignore their duty to encourage the development of lower risk tobacco alternatives and instead create new regulations that, by the agency’s own admission, will eliminate 99% of the e-cigarette market.
Gottlieb, who thankfully already understands the importance of moving Americans away from combustible tobacco products, told senators in his confirmation hearing that his decisions would be “guided by science.” Reversing the FDA’s asinine e-cigarette rule before it destroys the entire vaping market would be a great place to start.