Should the Senate confirm Scott Gottlieb, President Trump’s nominee to head the Food and Drug Administration, he will face an in-tray bursting with important issues the minute he takes up post. One of the most important is reforming the FDA’s regulatory approach toward e-cigarettes and other reduced risk tobacco products to make it easier, rather than harder, for millions of Americans to quit smoking.
Left unchanged, the FDA’s controversial deeming rule finalized Aug. 8, 2016, could remove up to 99 percent of vapor products from the market giving a major boost to big tobacco companies, according to Wells Fargo analyst Bonnie Herzog.
This is because the rule requires all vapor products that came on the market after Feb. 15, 2007, to undergo an extremely expensive pre-approval process. These applications can run into the millions of dollars and need thousands of hours of paperwork.
The e-cigarette business in the U.S. prior to 2007 was nonexistent, so all vapor products currently on the market will be subject to this process. Since the vast majority of e-cigarette businesses are small and medium-sized companies, most will not be able to comply with the FDA’s rule. That is with the exception of tobacco companies.
The consequence of the rule is that regular cigarettes will remain on the market, but vastly safer options like e-cigarettes, new smokeless tobacco, and heat not burn products may be kept off the market. This would cripple the ability of smokers across the country to switch to products that could save their lives.
There is a bill in the House that would serve as a stopgap measure preventing the near total destruction the vapor business. The Deeming Authority Clarification Act of 2017 would amend the Federal Food, Drug, and Cosmetics Act to change the predicate date from Feb. 15, 2007, to when the deeming regulations came into effect.
But preventing the de facto prohibition of e-cigarettes should be but the first step in what needs to be a fundamental re-think of federal tobacco policy.
It’s not just FDA rules stemming from the misconceived Tobacco Control Act of 2009 that threatens reduced risk options for smokers, innovation and a flowering of harm reduction.
There is a cottage industry of activists and campaigners who cling to an abstinence-only approach when it comes to nicotine and tobacco. These advocates often appear more concerned with destroying tobacco companies than reducing the risk of death to smokers and their influence looms large in public health policy.
Abstinence is a one-size fit all approach that fails to take account of the full spectrum of circumstances and preferences that make up tobacco consumers. Faced with a choice of going cold turkey or continuing to smoke many smokers will and do opt for the latter.
But thanks to a decade of innovation and entrepreneurship there is an alternative to the out-of-date abstinence-only approach. Tobacco harm reduction and consumer choice are now the essential ingredients to a modern effective federal tobacco policy.
Rather than hectoring smokers, policy makers should allow those who want to quit smoking to choose from new and better options that suit them so they can actually enjoy quitting while massively reducing their risk of death and disease.
There are reasons to be optimistic that Gottlieb recognizes the value of harm reduction, while not being tied to any particular ideological dogma. In an article for Forbes in 2013, Gottlieb pointed to the potential benefits of reduced risk products.
“If the industry was earnest about transitioning away from the manufacture of smoked cigarettes, and getting into the development of new products that would still satisfy peoples’ taste for nicotine (with hopefully much lower risks) there could be public health virtue,” wrote Gottlieb.
The article highlighted the inevitable clash between anti-tobacco activists and the producers of reduced risk products in the wake of the Tobacco Control Act. “The compromise the two parties struck in Washington was supposed to satisfy both sides’ aspirations. But in the end, only one party may win,” wrote Gottlieb.
Since the Trump administration took office, there has been a chorus of voices calling for reform of the FDA’s out of date and counterproductive tobacco policies.
Reports from the R-Street Institute, the Heritage Foundation, and the Heartland Institute have all made the case that the interests of public health are best served by re-focusing tobacco policy toward harm reduction and innovation allowing new reduced risk alternatives to smoking to remain and enter the market.
Changing the direction and culture of an institution such as the FDA is difficult even at the best of times, but if Gottlieb takes the helm, he will have the power to alter the tobacco landscape in a way that would benefit the health of millions of Americans.