The Nicotine Regulatory Paralysis: Why the FDA Can't Decide—and What It's Costing

As of early 2024, the FDA's Center for Tobacco Products had received applications for over 26 million products and had made final decisions on fewer than 30,000. The math is brutal: a decision rate well below one percent. The vast majority of those undecided applications—over 99%—are for vaping products that were on the market when the PMTA deadline hit in September 2020, that have been sold in the United States for years, that millions of former smokers are using to stay off cigarettes, and that exist in a legal limbo that satisfies no one. The companies that submitted applications have no idea when—or whether—the FDA will rule on them. The consumers who use the products have no idea whether what they're buying is legal, illegal, or somewhere in between. The state attorneys general who are supposed to enforce the law have no idea which products to target. **The FDA has created a regulatory system so slow, so complex, and so risk-averse that it has effectively stopped functioning—and the paralysis is not a bureaucratic inconvenience. It is a public health emergency hiding in plain sight.**

**The root cause of the paralysis is not incompetence. It's structural.** The Tobacco Control Act requires the FDA to evaluate each product application against the 'appropriate for the protection of public health' standard—a standard that demands a population-level risk-benefit analysis for every individual product, weighing the potential for adult smokers to switch against the risk of youth initiation. For a single product from a major manufacturer, this analysis is complex but feasible: the company submits its evidence, the FDA reviews it, a decision is made. For a million products from thousands of manufacturers—the reality that the pre-2020 vaping market created—the analysis is impossible. The FDA simply does not have the staff, the budget, or the analytical infrastructure to conduct a million population-level risk-benefit analyses. Congress, when it wrote the Tobacco Control Act in 2009, did not anticipate a market of a million vaping products. The FDA, when it implemented the PMTA rule in 2016, did not design a process scaled to the market it was regulating. The paralysis is the result of a mismatch between the regulatory framework and the market reality that the framework was supposed to govern.

**The FDA's response to the paralysis has been to prioritize the applications it can process and defer the rest indefinitely.** The agency has focused its resources on the products with the largest market share—primarily the pod systems and disposables from major manufacturers—and has largely ignored the thousands of smaller products that collectively represent a significant share of the market. The enforcement discretion the FDA has exercised—announcing that it will prioritize enforcement against certain categories of products (flavored cartridge-based products, products attractive to youth) while deferring enforcement against others—is a pragmatic response to an impossible situation, but it creates a de facto regulatory system in which the law-on-the-books (all unauthorized products are illegal) bears no resemblance to the law-in-practice (most unauthorized products are tolerated, some are targeted). **A regulatory system in which the law is not enforced is a regulatory system that has lost legitimacy**—and the FDA's legitimacy is eroding with every month that the PMTA backlog remains unresolved.

**The public health cost of the paralysis is measurable and growing.** Every product that the FDA has not authorized is a product that exists in regulatory uncertainty—uncertainty that deters retailers from stocking it, that deters investors from funding the companies that make it, that deters smokers from switching to it (because they don't know if it will still be available next month). Every month of delay is a month in which smokers who might have switched to a reduced-risk product continue to smoke—and some of them will die as a result. The modeling studies that have attempted to quantify this cost suggest that the PMTA backlog, if it persists for years, will result in tens of thousands of preventable deaths—deaths that would not have occurred if the regulatory system had been capable of processing applications at a pace commensurate with the size of the market it regulates. The FDA's paralysis is not a neutral state. It is a decision—the decision to accept the deaths caused by delay rather than the political risk of authorizing products more quickly.

**The solution requires statutory reform.** The 'appropriate for the protection of public health' standard, as currently applied, is too demanding, too individualized, and too slow for the market it governs. A tiered review system—with a streamlined pathway for products that are substantially equivalent to already-authorized devices, a moderate-review pathway for products with established safety profiles, and a full-review pathway for genuinely novel products—would allow the FDA to process the backlog while maintaining scrutiny of the highest-risk products. A 'provisional authorization' mechanism—allowing products to remain on the market with post-market surveillance requirements while the full PMTA review proceeds—would eliminate the regulatory limbo that is currently suppressing the market. Both reforms would require congressional action—and the political environment for tobacco regulatory reform is, to put it mildly, not conducive to nuance. But the alternative is the status quo: a regulatory system that has stopped functioning, that is costing lives, and that is eroding the legitimacy of the agency it was designed to empower.

**The FDA's paralysis is, in the end, a story about institutional risk-aversion.** The agency is more afraid of authorizing a product that later turns out to cause harm (the 'false positive' risk) than of failing to authorize a product that would have prevented harm (the 'false negative' risk). The asymmetry is rational from the perspective of the agency—a false positive generates Congressional hearings, media investigations, and career consequences, while a false negative generates none of these—but it is catastrophic from the perspective of public health. Every product that sits in the PMTA backlog, neither authorized nor denied, is a product that could be helping smokers quit—and the agency that is supposed to be protecting public health has made the institutional calculation that the risk of acting is greater than the risk of not acting. The calculation is understandable. It is also wrong.

**💬 What do you think?** Is the FDA's caution justified—better to move slowly and carefully when people's health is at stake? Or has the precautionary impulse become a form of institutional self-protection that is causing more harm than it prevents?