Will the coming change in the White House and Congress bring the much-needed reforms that smokers have literally been dying for, and allow federal agencies tasked with tobacco regulation to finally break free from bureaucratic immobilization and misinformation campaigns that have stymied smokers from being able to take advantage of remarkable new technologies in harm reduction under the guise of protecting public health?
Over the last few years, Democrats, led by Joe Biden, have harmed millions of Americans who are looking for life-saving alternatives to smoking cigarettes by allowing the dialogue to be determined by anti-smoking zealots like billionaire Michael Bloomberg who run very expensive misinformation campaigns that result in the reinforcement of a restrictive regulatory framework bogged down by shifting deadlines, legal battles, and overwhelming rejection rates.
In 2009, the tobacco harm reduction marketplace in the U.S. was still fairly new but growing rapidly. First introduced around 2003, there were less than 7 million e-cigarettes users worldwide when former President Barak Obama (D), in his first year in office, signed the Family Smoking Prevention and Tobacco Control Act (TCA), which established the Center for Tobacco Products (CTP) at the FDA. The CTP would now oversee the regulation of tobacco products as determined by the language of the TCA.
In 2016, the FDA declared that manufacturers of all new tobacco products, including tobacco harm reduction products like e-cigarettes and vape pens, would be required to submit a Premarket Tobacco Product Application (PMTA) to the CTP. This has proven to be a complicated, expensive, and very lengthy process, impeding the delivery of new smoking harm reduction technology to the marketplace.
For example, the FDA changed the deadline to submit PMTAs numerous times, under pressure from anti-tobacco groups leveraging the American judicial system to influence public health agencies. Initially, the RDA’s deeming rule set the enforcement deadline on August 8, 2018, and then extended to November 8, 2018. In 2017, under then-FDA Commissioner Scott Gottlieb, the agency announced another extension to August 8, 2022. However, in 2019, the FDA moved the date back to August 8, 2021.
Meanwhile, in 2018, Bloomberg-backed groups such as the Campaign for Tobacco-Free Kids filed a lawsuit against the FDA, challenging the 2017 guidance that set the 2022 deadline. In 2019, U.S. District Judge Paul W. Grimm ruled in favor of the anti-tobacco groups, finding that the FDA violated the Administrative Procedure Act when extending the deeming rule’s deadlines. Grimm reset the deadline to May 4, 2020, and later extended to September 9, 2020, due to the COVID-19 pandemic. Trade associations appealed the decision, but the Fourth Circuit Court of Appeals ultimately upheld Grimm’s ruling.
The FDA estimates that between 2019 and February 2023, the agency received more than 26 million PMTAs for e-cigarettes. In March 2023, the agency announced that it had made determinations on more than 99 percent of the submitted applications. Nearly all of these resulted in denial orders. In fact, the FDA has only authorized 34 e-cigarette products – just 0.00013 percent of PMTAs submitted.
This represents a catastrophic failure for an agency that is supposed to protect public health while fostering innovation to protect people’s health. Many countries around the world have embraced tobacco harm reduction products, educating their citizens on reduced-risk alternatives, and encouraging their use.
In 2023, the UK government launched an ambitious program to “swap to stop” smoking, reaching nearly one in five smokers nationally giving away one million vapes to adults. As of 2023, only 12 percent of UK adults were smoking – a 40 percent decline from 2011.
Yet, on this side of the Atlantic, public health agencies under Democratic leadership continue to fail tens of millions of American adults who still smoke. Since 2021, Biden’s FDA has authorized 5,494 tobacco products. Nearly half (47.5 percent) were for cigars. The agency issued orders for 960 combustible cigarette products, about 17 percent of total approvals. Only 34 orders were issued for e-cigarettes, just 0.6 percent.
Despite these setbacks, there is hope. Recently, the U.S. Supreme Court heard oral arguments on whether the FDA violated federal laws when issuing denials to open-system e-liquid manufacturers. The election of Donald Trump is also likely to impact the agency’s regulatory processes, as the president-elect has vowed to preserve flavored vaping products when he takes office in January. Additionally, a soon-to-be Republican-controlled Congress could enact substantive reforms through new legislation.
With a new administration on the horizon and a Republican-led Congress poised to reshape public health policy, there is a real opportunity to implement reforms that prioritize science-based regulation and consumer choice. Millions of American adults seeking safer alternatives to smoking cannot afford further delays. It’s time for policymakers to break free from the influence of special interests and focus on advancing public health through innovation, transparency, and accountability.