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Whistleblower Reveals FDA’s Struggles Under Biden, Accuses Agency of Failing to Combat Illicit Chinese Vapes
FIRST ON FOX: A former senior staff member at the Food and Drug Administration has come forward to articulate concerns about the agency’s operations during the Biden administration. The whistleblower highlights issues surrounding diversity, equity, and inclusion while revealing key failures to address the influx of illicit vapes from China.
Calls for Change Within the FDA
David Oliveira, who departed the FDA after a six-year tenure, discussed the pressing need for reform at the agency, particularly regarding tobacco control. In reaction to the recent removal of FDA’s chief tobacco regulator Brian King, Oliveira noted, “We anticipated this for some time; change was desperately needed at the FDA regarding tobacco control due to ongoing challenges.”
He emphasized the failures in fulfilling core responsibilities, stating that a spectrum of stakeholders—including public health advocates, small business owners, and even political figures—are discontent with recent FDA actions. Oliveira referred to a previous hearing where Senator Dick Durbin admonished King, saying, “It appears you have fallen down on the job.”
The Impact of Illicit Vapes
One significant criticism Oliveira pressed revolves around the rise of illicit Chinese vapes in the U.S. market. He likened his concerns to being a “canary in a coal mine,” feeling alarmed about the potential public health dangers while witnessing little action from the agency.
Although youth smoking rates have hit an all-time low according to the CDC, the usage of Chinese vapes by young people has surged dramatically since 2020. With China emerging as a dominant player in e-cigarette production, young consumers are increasingly exposed to flavored products that appeal to minors.
Market research firm Circana reported that unauthorized flavored disposable vapes accounted for approximately $2.4 billion in sales within the United States in 2024. This figure represents 35% of all e-cigarette sales from retail outlets.
Regulatory Challenges
Oliveira criticized the FDA’s weakness in enforcing regulations against these market disruptions, arguing that the agency has transferred too much authority to external agencies like Border Patrol and the Department of Justice. He stressed that the FDA needs a stronger ground presence to counteract China’s market proliferation.
“The FDA currently approves or authorizes about two products annually,” Oliveira pointed out. This limited regulatory pace has allowed Chinese manufacturers to dominate the market, as they continue to aggressively market their products with little consequence.
Oliveira noted that under King’s leadership, many applications for flavored e-cigarettes faced rejection due to a lack of data proving they could assist adult smokers in quitting. Consequently, the FDA’s decision-making has not only resulted in backlash from industry players but has also led to multiple legal challenges, including a case presented before the Supreme Court.
DEI Initiatives Distracting FDA’s Focus
Another point Oliveira raised concerns the prominent emphasis on diversity, equity, and inclusion initiatives that he argues shifted focus away from the agency’s core responsibilities. He characterized King’s version of these initiatives as ineffective and largely superficial.
“Under King’s leadership, we noticed a concerning increase in focus on DEI at the expense of substantive progress in tobacco regulation,” Oliveira stated, criticizing the adoption of practices that he believes prioritized optics over effectiveness.
Recently, the FDA removed DEI content from its official website following directives from President Trump to eliminate such practices across federal agencies. Oliveira described the emphasis on DEI as a distraction from critical work that affects public health.
The Broader Critique of FDA Leadership
Oliveira points out that the FDA’s leadership under King has drawn scrutiny from various groups, including politicians and advocates. There have been increasing calls for the FDA to intensify efforts against unauthorized vaping products that pose risks to teenagers, especially those sourced from China. Conversely, tobacco companies express frustration over the slow approval of newer products designed for adult smokers that generally gravitate toward being less harmful compared to traditional cigarettes.
Critics, including Jim McCarthy from the American Vapor Manufacturers, have branded King’s anti-vaping campaign as damaging to public health, characterized by misleading narratives that undermine the potential benefits of vaping as a smoking cessation tool.
A Shifting Landscape for Tobacco Regulation
The complexities of tobacco regulation continue to evolve, placing the FDA at the center of a heated debate. As Oliveira asserts, the challenges faced by the FDA necessitate strong, informed leadership capable of navigating a rapidly changing landscape influenced by technological advancements and market dynamics.
The growing divide among stakeholders underscores the pressing need for the FDA to reassess its approach and prioritize effective regulations to ensure public health while considering the industry’s realities.
The Associated Press and Reuters contributed to this report.
