Seizing the Opportunity: Reforming the FDA’s Center for Tobacco Products 5   Recently updated !

A recent shift in leadership at the Food and Drug Administration’s (FDA) Center for Tobacco Products (CTP), spurred by broader government workforce adjustments, presents a critical juncture. The new leadership inherits significant challenges, notably the growth of an illicit market and policies hindering the adoption of less harmful alternatives. These unintended consequences have come at a steep human cost. This analysis outlines key areas demanding CTP reform and proposes a path forward.

The CTP has faced mounting criticism, particularly regarding the surge in illegal markets for alternative tobacco products (ATPs), complicating tax policy and consumer safety. An independent investigation by the Reagan Udall Foundation in 2022 highlighted critical shortcomings: a nebulous regulatory and approval framework, a sluggish and inefficient review process, inadequate transparency and communication, and a troubled approach to the vaping market. We propose four core areas for CTP reform, each with actionable policy recommendations.

1. Bolstering Transparency and Accountability

A primary critique of the CTP is its opaque decision-making. Unlike typical market entry, nicotine product companies in the US require explicit FDA authorization (a Marketing Granted Order or MGO). This hinges on proving the product is “appropriate for the protection of public health.” However, the criteria for this assessment remain unclear. Applicants for reduced-harm products receive minimal insight into approval or rejection rationales, and the CTP rarely details how stakeholder feedback or oversight influences its actions.

Policy Action: Publish a Clear Product Approval Rubric

The CTP should establish transparent and well-defined standards for authorizing or denying tobacco and nicotine products, explicitly including scientific benchmarks for harm reduction. While the FDA requests extensive data, a clear rubric defining “appropriate for the protection of public health” is absent. Key questions remain unanswered: How much less harmful must a product be? How are youth usage concerns balanced against reduced smoking? How are these impacts measured without clear data parameters?

Implementing a transparent rubric would provide clear targets for innovation, allow for stakeholder input on these standards, and inject much-needed clarity into the CTP’s evaluation process.

2. Streamlining the Premarket Tobacco Product Application (PMTA) Process

The PMTA process is widely criticized as expensive (ranging from millions to potentially $100 million), slow (often exceeding the statutory 180-day review period by years), inconsistent, and overly burdensome. These issues breed market uncertainty and legal challenges.

Policy Action 1: Implement a Fast-Track PMTA Pathway for Reduced-Risk Products

Products scientifically proven to be less harmful than traditional cigarettes, such as e-cigarettes, heated tobacco products, and nicotine pouches, warrant an expedited review process. Many of these products have a history of use and study in other markets. The CTP should prioritize bringing these potentially life-saving alternatives to US consumers more swiftly.

Policy Action 2: Institute Default Marketing Authorization After 180 Days

The CTP’s consistent failure to meet statutory deadlines carries no repercussions. To rectify this, a policy of default marketing authorization approval after 180 days without a decision would incentivize timely action. To prevent arbitrary rejections, any denial should explicitly reference the defined product rubric. Conversely, to prevent application flooding, the FDA should establish non-negotiable minimum standards for product submissions.

3. Rectifying the US Vaping Market

The CTP’s approach to electronic nicotine delivery systems (ENDS) has been a significant failure, with an estimated 98 percent of the US vaping market being illicit. This black market is largely a consequence of the CTP’s slow and restrictive authorization process. Fortunately, the solutions are readily available.

Policy Action 1: Authorize a Wider Range of Legal Vaping Products

The FDA’s authorization rate for new products has been exceptionally low. From late 2019 to early 2024, out of 26.6 million PMTAs received, only a tiny fraction were reviewed, and a mere 34 unique ENDS products (including variations) were authorized. This scarcity of legal options has created a vacuum filled by illegal products meeting consumer demand. Authorizing more products, coupled with robust enforcement, would significantly curb the illicit market.

Policy Action 2: Strengthen Enforcement Against Illegal Products

Illegal tobacco and nicotine products, particularly flavored disposable vapes from China, are readily accessible. Enforcement against these products has been slow and often ineffective. The CTP needs to enhance its efforts by clearly communicating legal product status and collaborating with the Department of Justice, Customs and Border Protection, state attorneys general, and local health departments to aggressively combat illegal trade.

4. Addressing Blind Spots: The Evolving Landscape of Youth Vaping

No regulatory agency is immune to oversights, and the CTP operates in a dynamic environment. Continuous analysis of data and trends is crucial for effective regulation. A key area for reevaluation is the perceived “teen vaping crisis.”

While youth consumption has been a primary concern, driving the denial of flavored vape MGOs (excluding tobacco and mint), recent data paint a more encouraging picture. The 2024 data indicate that 5.9 percent of surveyed teens reported past-month vaping, a decrease from 7.9 percent in 2023 – the lowest level in a decade. While continued monitoring is essential, this positive trend should be considered alongside the potential of flavored alternatives to encourage adult smokers to switch to less harmful options.

With nearly 450,000 American deaths annually attributed to smoking, the CTP has a profound opportunity to reduce this toll by authorizing and effectively regulating less harmful alternatives. Meaningful CTP reform is not just necessary; it is a matter of public health imperative, capable of saving lives and restoring integrity to the legal market for reduced-risk tobacco products.