In a rare admission of what the tobacco harm reduction community has called a “bureaucratic nightmare,” Robert Califf, Commissioner of the U.S. Food and Drug Administration (FDA), has asked for an independent review, including “an initial assessment of the processes and procedures, resourcing and organizational structure” for the Center for Tobacco Products, as well as food programs under FDA.
The review will be conducted by the Reagan-Udall Foundation, a non-governmental organization created by Congress “to advance the mission of the FDA to modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation, and enhance product safety.”
While long overdue, it is a somewhat hopeful sign that officials at FDA can step away from rampant, alarmist public and political pressure; pressure that caused the agency to ignore science when sealing the fatal regulatory fate for hundreds of thousands of e-cigarette products.
Since at least 2018, the FDA has been under intense scrutiny over its handling of vapor products – products which the agency received regulatory authority over just two years prior, in 2016. Since then, Congressional hearings, lawmakers, and Bloomberg-funded campaigns have unfairly targeted the agency with a smear campaign to vilify the very notion of tobacco harm reduction.
In 2021, as FDA was overseeing PMTAs for nearly 6.5 million different products, Congressman Raja Krishnamoorthi (D-IL) used taxpayer funding to host a hearing urging the FDA to ban certain products without care for the underlying science, nor efficacy of e-cigarette products.
For example, Representative Katie Porter (D-CA) asked if then-acting FDA Commissioner Janet Woodcock would “commit” to denying PMTAs “for every flavored e-cigarette other than tobacco.” As Woodcock tried to explain that the FDA could not “prejudge” these devices, Porter took control of the mic and made clear she was not looking for a scientific answer, but a commitment to exert raw executive power. Porter stated the reason for her questions was simply that she wanted the “American people to understand [Woodcock has] that power.”
In the same hearing, as a witness, Senator Dick Durbin (D-IL) erroneously claimed that e-cigarette manufacturers have no proof that their products help smokers transition and he “fears” the FDA is “going to once again over-value the unproven potential benefit of cessation for adult smokers while undervaluing the clear evidence of what is happening to our kids.”
Alarmingly, it is Congress that is overvaluing the so-called youth vaping epidemic, all the while denying tobacco harm reduction products for the same constituents they claim to care about. It is Congress strong-arming a federal agency which is supposed to come to regulatory decisions based on science and facts – not cherry-picked media headlines spouted by misinformed lawmakers.
Congress has completely ignored data showing tremendous declines in youth vaping. According to the Centers for Disease Control and Prevention’s National Youth Tobacco Survey, only 11.6 percent of high school students and 2.8 percent of middle school students were “current users,” defined as having used a vapor product on at least one occasion in the 30 days prior to the survey. Among high school students, past-month vaping rates have declined by 41.8 percent since 2020 and by 58.9 percent since 2019.
Of course, naysayers claim that due to the ongoing COVID-19 pandemic and school lockdowns, that these figures need to be examined skeptically. Yet, in states with less restrictive pandemic responses, youth vaping still declined. According to the Florida Youth Tobacco Survey, in 2021, only 18.3 percent of high school students were current e-cigarette users, a 15.2 percent decrease from 2020 and a 28.5 percent decrease from 2019.
Lawmakers who continue to flout misleading statements of a supposed youth vaping epidemic to block adult access to tobacco harm reduction products are not only problematic, but this is indicative that these lawmakers just do not seem to care about helping their own constituents quit smoking. Damningly, these are generally the same lower income constituents Democrats claim to represent. In Illinois, home to both Krishnamoorthi and Durbin, of the 1.2 million adults that were current smokers in 2020, nearly half (47.5 percent) reported annual incomes of $24,999 or less.
Despite the rhetoric, e-cigarettes are significantly less harmful and have helped millions of American adults quit smoking. In fact, one randomized controlled trial found their use to be twice as effective as FDA-approved nicotine replacement therapy in helping people quit.
Perhaps an independent review of the regulatory processes at FDA can expose such issues with politicians not only refusing to listen to the science and data, but actively blocking a federal agency from using those tools to ensure adult access to less harmful alternatives to smoking.
Lindsey Stroud is Director of the Taxpayers Protection Alliance’s Consumer Center.