Cronyism Is Killing Tobacco Harm Reduction Innovations
FDA’s regulation of electronic cigarettes and vaping devices underscore the agency’s unwillingness to promote, or even acknowledge, tobacco harm reduction (THR) products.
In 2012, Charles Koch argued “to end cronyism we must end government’s ability to dole out favors and rig the market.” Koch knows government goodies harm consumers by decreasing economic competition and innovation. Unfortunately, the U.S. Food and Drug Administration (FDA), a federal regulatory body that might as well be renamed the Pharmaceutical Department of America, has refused to heed Koch’s sage advice.
FDA’s regulation of electronic cigarettes and vaping devices underscore the agency’s unwillingness to promote, or even acknowledge, tobacco harm reduction (THR) products—unless they are manufactured by pharmaceutical companies, such as GlaxoSmithKline.
In 2016, unelected and unaccountable FDA bureaucrats used regulatory authority to “deem” e-cigarettes “tobacco products.” Because of this rule, e-cigarette producers must now submit arduous premarket tobacco applications (PMTA) presenting data and scientific research on the potential health hazards and benefits associated with electronic cigarettes and vaping devices.
Beginning in August 2022, unless PMTAs are approved, e-cigarette manufacturers won’t be able to sell their products. PMTAs are estimated to cost $350,000 for a single application. Since August 2016, FDA has prohibited the introduction of any new vaping products without an approved PMTA. These misguided FDA polices thwart THR product innovations that could improve the safety of current products.
Since 2017, FDA has allowed for public comments on heat-not-burn products, smokeless tobacco, guidelines for nicotine levels, and the use of flavors in tobacco products. Hopefully, these comment periods signal the Trump administration’s FDA recognizes the potential health benefits of e-cigarettes in a way the Obama-era FDA did not.
Consumers shouldn’t celebrate just yet, however. Many of the FDA officials in charge of tobacco regulation are outspoken advocates and beneficiaries of companies that produce nicotine replacement therapy (NRT) products, such as Nicorette gum and the NicodermCQ patch.
For instance, in 2013, Mitch Zeller was named director of the Center for Tobacco Products at FDA. Two months prior to beginning his FDA position, Zeller wrote a piece reflecting on an “endgame” for tobacco control. Zeller noted the continuum of risk strategy, stating cigarettes were the most hazardous of nicotine products and alleging NRTs are the least harmful. Zeller paid little attention to electronic cigarettes and smokeless tobacco, claiming “less is known about their population-level health impacts.”
Zeller left PinneyAssociates, a pharmaceutical research firm that “provides consulting services to GlaxoSmithKline Consumer Healthcare on issues related to the treatment of tobacco dependence,” for his FDA job. GlaxoSmithKline just happens to be the patent holder for many NRT products, including Nicorette and NicoDermCQ.
Since 2014, GlaxoSmithKline has lobbied against vaping devices, stating “e-cigarettes have not been proven to help smokers quit” and that their [NRT] products “can double a smoker’s chance of quitting.”
Unfortunately for the vaping community, FDA is profoundly tied to the pharmaceutical industry, notably manufacturers of NRT products, and the conflict of interests extend beyond Zeller’s office.
Despite the widespread support they have received from many influential people at FDA, NRTs’ impact on tobacco cessation is disputable. A 2013 study found the perceived efficacy of an electronic cigarette to be greater than NRTs, with participants noting “undesirable side-effects and many attempts using NRTs that resulted in relapse to cigarette use.” A 2009 study found only 6.75 percent of NRT participants had sustained smoking abstinence after six months, with the authors concluding that “it is unclear whether [NRT] without regular contact would be as effective.”
Unlike NRTs, there is substantial evidence available showing electronic cigarettes help countless smokers quit using combustible tobacco cigarettes. A 2017 study found “e-cigarette users were more likely than non-users to attempt to quit smoking … and more likely to succeed in quitting.” Overall, 8 percent of participants reported cessation.
Other notable public health agencies, such as the Royal College of Physicians and Public Health England are also promoting electronic cigarettes as alternatives to combustible tobacco and other harmful products.
These reports have yet to persuade top officials at FDA, however, which has continued to unjustly treat these non-tobacco products as though they are tobacco.
Unless unelected and unaccountable officials remove their ties from NRT products, which directly compete with electronic cigarettes, smokers in the United States will only be able to find relief to their nicotine addictions by using a pharmaceutical product.
[Originally Published at the Daily Caller]