In 2017, Scott Gottlieb, then-commissioner of the U.S. Food and Drug Administration (FDA), conceptualized a “Comprehensive Approach to Nicotine and Tobacco.” This was an approach in which the nation’s leading health agency would “envision a world” that “recognize[s] the potential for innovation to lead to less harmful products … a world where less harmful alternative forms, efficiently delivering satisfying levels of nicotine, are available for those adults who need or want them.”
In the five years since, the FDA has lost sight of that world by shuttering and arbitrarily blocking innovation in tobacco harm reduction. On August 23, the United States Court of Appeals for the Eleventh Circuit found the agency’s recent regulatory actions of vapor products to be “arbitrary and capricious.”
It is unfortunate that adult access to tobacco harm reduction products in America has always been caught between the FDA and the courts.
In 2007, two years prior to the FDA even having authority to regulate cigarettes and other tobacco products, e-cigarettes were introduced to the U.S. market and the FDA tried to block shipments into the states, decrying that the emerging technology was a medical device and under their regulatory authority. The manufacturers sued, and in 2010, the United States Court of Appeals for the District of Columbia Circuit Court ruled that the FDA did, in fact, have authority to regulate e-cigarettes as a tobacco product.
It should be noted that FDA was only given authority to regulate tobacco products in 2009 – two years after the introduction of the e-cigarette to U.S. shores. In 2016, the agency issued deeming regulations, which among a plethora of provisions, required e-cigarette manufacturers to submit an arbitrary premarket tobacco product application (PMTA).
Vapor manufacturers are not the only ones who get to turn to the courts. Michael Bloomberg-funded nanny state organizations went to the United States District Court for the District of Maryland, which sped up the timeline for e-cigarette PMTA submissions to May 2020 and was subsequently extended until September due to the pandemic.
In September 2021, the FDA arbitrarily and capriciously denied PMTAs for nearly 1 million flavored e-liquid products, citing youth use as a reason. In response, manufacturers. including the ones in the recent Eleventh Circuit decision, took the FDA to court. While other federal courts have sided with the FDA, the latest Court agreed with manufacturers. Now, once again, adult access to less harmful smoking alternatives is being determined by judges – not public health agencies.
It is a shame that the U.S. is behind many countries in providing adult access to the vast array of tobacco harm reduction products. In the UK, the government subsidizes e-cigarettes and vape shops can be found in hospitals. In New Zealand, vape retailers are allowed to advertise that “[c]ompletely replacing your cigarette with a vape will reduce harm to your health” and that “switching completely to vaping is a much less harmful option.”
Moreover, the FDA – and seemingly the dissenting judge in the last court opinion – are hiding behind a supposed youth vaping epidemic and ignoring the very data that indicate youth e-cigarette use has drastically declined in the time since the PMTAs were submitted.
In 2020, according to the National Youth Tobacco Survey, 3.03 million high school students were current e-cigarette users, or 19.6 percent of students. In 2021, only 11.3 percent of high schoolers were currently using e-cigarettes, or 1.73 million. Essentially, between the submission of applications and the FDA’s subsequent denials, there were 1.3 million fewer high school e-cigarette users. Despite this decline, the FDA declared in their denials that there are “well-documented, alarming levels of youth use of such products.” The dissenting judge in the recent case also purported to a supposed “underage vaping problem” and that “youth vaping had reached crisis proportions.”
In the recent decision, the court found that the FDA overlooked sales plans and age-restriction requirements in place by the manufacturing companies to thwart youth purchases. Many other consumer goods (including combustible cigarettes) are permitted to be sold in the U.S. without a myriad of draconian regulations imposed by federal bureaucrats, and follow similar point-of-access restrictions.
In July, what could be a good outcome, the FDA reached out for an independent review. Perhaps outsiders can help guide the agency back to its overall responsibility to “advancing the public health by helping to speed innovations” in every step of the regulatory process – not just when federal courts order them to.
Lindsey Stroud is director of the Taxpayers Protection Alliance’s Consumer Center.