New Food and Drug Administration Commissioner Should Reform the Center for Tobacco Products

Last week, President Trump nominated White House domestic policy aide Dr. Heidi Overton to become the new Commissioner of the Food and Drug Administration (FDA). If confirmed by the Senate, Dr. Overton will step into an agency in need of serious reform, particularly in its Center for Tobacco Products (CTP).

CTP policy decisions over the past two decades have created serious problems in the industries the organization regulates. The (foreseeable) unintended consequences of these policies have precluded harm reduction by suppressing alternative tobacco products (ATPs) that are much less harmful than traditional combustible cigarettes and pushing consumers to illicit products in the absence of adequate legal options.

New leadership can and should build on recent successes. In 2025, the CTP reduced the backlog of premarket tobacco product applications (PMTAs) by about 70 percent. This year, the CTP is already accelerating PMTA reviews further and allowing some leeway for products under review but not yet officially authorized.                                                                                             

This is great progress, but much more can be made.

Reform the PMTA Process

In the US, companies that want to offer nicotine products for sale to the public must first be granted permission in the form of a marketing granted order (MGO) from the FDA. To get permission, manufacturers must demonstrate that the product they want to offer is “appropriate for the protection of public health.”

The process is burdensome for manufacturers. Each product or “SKU” requires a separate application process, which quickly multiplies total costs for a line of similar but slightly different products. The FDA first estimated the cost of a PMTA to be about $333,000 for electronic cigarettes or other novel tobacco products. The actual costs are reportedly several million per SKU, which can become over $100 million for a product line.

Even when the costs were underestimated, the FDA admitted they would burden the industry and expected “additional product exit, consolidation, and reduction in variety.” Burdening the industry for reduced-harm tobacco products doesn’t just damage businesses; it also undermines public health by suppressing the products smokers should be switching to.

The CTP has made strides in streamlining the PMTA approval process. That success should be built upon by establishing a specific fast-track process for products that are known to be less harmful than cigarettes, like e-cigarettes, heat-not-burn products, and nicotine pouches. While many of these products are relatively new to the US, many ATPs are well-established in markets abroad.

While the CTP has recently reduced the significant backlog of applications, there is no guarantee that the agency won’t backslide. The CTP is supposed to make its decision within 180 days but faces no consequences for its failure. Both manufacturers and consumers should be protected from the uncertainty and damages from heavily protracted review processes.

Any PMTA that does not receive a decision within the 180-day window should be conditionally approved. This establishes a real incentive for the CTP to act in a timely manner and helps to address the backwards default permissions. To prevent the CTP from merely pretending to conduct a review and continuing to blanket deny thousands of applications, the CTP should also be required to be more transparent in the review process and issue specific guidance on why applications are rejected or approved.

Create Transparent Processes and Criteria for Approval

One easy way to improve the review process is to increase transparency by establishing clear requirements for approval, sticking to them, and issuing guidance on why applications are accepted or denied.

What exactly does it mean to be “appropriate for the protection of public health,” and what types of studies or evidence are required to demonstrate that?

The Supreme Court recently decided that the FDA is allowed to issue guidance in soliciting applications, change its requirements after the fact, and blanket deny all applications for not meeting the new requirements. That obviously does not mean the FDA should do this.

The CTP does not need a court order to make beneficial reforms. It may still get one, however, given a recent Fifth Circuit ruling on its process.

A clearly defined set of standards for authorizing or denying new product applications should be established. Many different types of studies or trials have been requested, but little information exists on how they are evaluated. A set of standards would not only make the PMTA process less burdensome but would also help guide future new products and innovation. Some explanation for why decisions are made would have similar benefits for transparency and efficiency.

Address the Ongoing Vaping Market Disaster

To date, the FDA has authorized five brands of e-cigarettes to legally sell their products in the US. This lack of legal options has pushed consumers into the illicit market.

The CTP has historically denied almost every application to sell an electronic cigarette. However, more recently, there have been some approvals. This has enabled legal sales to gain some ground against illicit markets. A recent study estimated that “only” 69.4 percent of e-cigarette sales were unauthorized products. This rises to 97.6 percent for disposable systems and 100 percent for flavors other than tobacco or menthol—which the FDA has a blanket denial for.

Demand for illicit products is largely a result of the lack of legal options. The CTP should authorize more vapor products to allow a legal market to be built out and replace the illicit market that has longstanding dominance.

Bringing consumers into the legal market would do more than prevent widespread tax noncompliance. Illicit products are consistently more dangerous to consumers than legal ones. They avoid regulatory requirements in the manufacturing process and are largely unaccountable in the event of injury to consumers.

After allowing a legal market to compete with the illicit one, enforcement efforts against the illegal products—most of which are smuggled from China—would be more effective. The FDA and other agencies announced in September 2025 the largest ever seizure of unauthorized e-cigarettes.

The seizure contained approximately $86.5 million worth of illicit products. A significant sum in the context of a single seizure, but a drop in the bucket compared to the vast multi-billion-dollar industry of illicit products.

Enforcement efforts are important, but they remain largely futile when there is not an adequate legal market to replace illicit activity. If the CTP wants fewer dangerous illicit products in the US, it should allow legal activity by authorizing more products so enforcement efforts can be more effective.

Evaluate the Risks and Realities of Youth Use

While it is unknown exactly how the CTP evaluates product risks, one priority is discouraging youth nicotine use. This is a reasonable concern to have, and youth use is undeniably an important consideration when regulating these products, but the CTP should more realistically evaluate the risks of youth consumption.

Youth use of vapor products continues to decline. The FDA’s 2025 National Youth Tobacco Survey found only 5.2 percent of middle and high school students reported current use of vapor products. This is down from 5.9 percent in 2024 and 9.4 percent in 2022. The 2025 National Survey on Drug Use and Health found that 8.7 percent of adolescents used marijuana, a significantly higher rate of youth use than vaping. It remains possible that high school students underreport vapor usage, but the FDA used this data to justify action to curb youth usage, so it should adjust accordingly when that data changes.

The trend in youth use of tobacco products is extremely promising and indicates that youth usage of ATPs is far from a crisis. Youth usage should continue being monitored, but this trend of declining use should be incorporated into the CTP’s evaluations of product risks when reviewing applications. As the risks of youth use decline, the net benefits of harm-reducing ATPs grow.

Smoking is responsible for 450,000 deaths annually in the US. The FDA and the CTP could sharply reduce that toll by enabling the sale of less harmful alternative products. The CTP has taken undeniable steps toward desperately needed reforms, but more are necessary. New leadership at the CTP can save lives by establishing functioning markets for harm-reducing alternative products.

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