OPINION:
Less than a year into his second term, President Trump has his hands full reversing the poor decision-making of the Biden years. Perhaps nowhere is this trend more evident than in the illicit nicotine market crisis.
Today, up to 85% of the vaping devices sold in the U.S. are illegal, having not received authorization by the Food and Drug Administration, whose Center for Tobacco Products oversees the manufacturing, marketing and distribution of tobacco products and their smoke-free alternatives.
That means nearly 9 in 10 vaping devices have never received FDA review, let alone market authorization, or they are caught in an FDA backlog of products waiting for action. The ingredients and manufacturing of the parts used in devices that avoid FDA oversight are a mystery.
Still, the vast majority come from the People’s Republic of China, including many intentionally marketed to underage users with youth-appealing features, such as gaming device screens. A recent federal seizure coordinated by the Department of Justice and Department of Health and Human Services uncovered $86.5 million worth of illegal product, nearly all with roots in communist China.
How did America reach this tipping point? Two primary drivers are the Biden administration’s failure to authorize legal, smoke-free nicotine alternatives to cigarettes, which Chinese manufacturers then exploited. They drove the mass importation of illegal nicotine products into the U.S., which the Biden administration failed to prevent and enforce against. Combined, the FDA’s obstruction created a dangerous concoction that endangers the well-being of the millions seeking less harmful alternatives to combustible cigarettes.
Let’s unpack the Biden administration’s failures on each.
Mr. Biden’s pick to run the Center for Tobacco Products, Brian King, failed to establish or implement a comprehensive enforcement regime to address the illicit vape marketplace. When Mr. King took the reins of the center in 2022, public health advocates, the regulated industry and bipartisan members of Congress sounded the alarm on the growing crisis. Rather than respond to the concerns, Mr. King adopted a prohibitionist approach to authorizing smoke-free nicotine alternatives, allowing illicit products to flood the U.S. marketplace.
Two years ago, a coalition of regulated manufacturers, distributors and retailers sent him a joint letter again urging him to take the illicit market crisis seriously and enhance the FDA’s enforcement plan. Still, the Center for Tobacco Products fell short of the enforcement needed to address the rapidly growing illicit vape marketplace.
Rather than collaborate on areas of common ground, Mr. King sowed confusion on the legal status of certain nicotine products, refusing to help retailers and consumers identify the full range of illicit vaping products. It was the worst of both worlds.
Simultaneously, the FDA’s opaque authorization approach lacked intellectual consistency and left nearly 20 million adult vapor consumers, as well as millions more adult pouch consumers, with few smoke-free alternatives in the legal marketplace.
The FDA is required to review and make decisions on premarket tobacco product applications within 180 days. However, the agency has never met this deadline, and a growing backlog of products has accumulated, with many waiting five years for an FDA decision.
A recent publication by experts at the American Enterprise Institute notes that the FDA “routinely violates its legal obligation to process applications” within the six-month deadline. Should the FDA provide timely reviews and authorize diverse products for adults seeking less harmful alternatives? “Such reforms would crowd out illicit traders and protect youth.”
The Biden administration’s inaction failed the millions of adult consumers seeking to move away from combustible cigarettes to less-harmful, smoke-free nicotine products and simultaneously squandered innovative technological advancements that have resulted in improved quality.
As applications collected dust on desks in government offices, adult consumers were denied regulated options, despite Mr. King’s acknowledgment that vapor products have “markedly less risk” than cigarettes.
Many other independent public health authorities had already reached this same conclusion. Independent studies have estimated vaping to be 95% less harmful than cigarette smoking. Thankfully, smoking levels have sunk to all-time lows for adults and have been cut in half during the past decade alone. The progress is encouraging, but there is more to be done.
Fortunately, both the Trump administration and Congress are acting to reverse the damage of the Biden years. In addition to the recent raid on illicit nicotine products, FDA Commissioner Martin Makary has been clear-eyed about the challenge.
Under Mr. Trump’s leadership, meaningful enforcement action has proved effective at holding accountable and deterring those importing illicit nicotine products and seeking to avoid FDA regulation. Even amid a laundry list of competing priorities, the early progress is a hopeful sign of the FDA’s modernizing its approach, with increased enforcement actions and the acceleration of authorization for more options for adults seeking legal, smoke-free alternatives.
• Richard Burr served as a U.S. senator from North Carolina from 2005 to 2023. He is the chairman of the Coalition for Smarter Regulation of Nicotine.
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