The FDA’s Center for Tobacco Products (CTP) faces mounting pressure to overhaul its pre‑market review system for nicotine‑containing products. With a new commissioner nominee, Dr. Heidi Overton, poised to take office, the agency could address longstanding barriers that have limited the availability of reduced‑harm alternatives and driven consumers toward an illicit market.
The current PMTA burden
- Application cost – The FDA originally estimated a pre‑market tobacco product application (PMTA) at roughly $333,000 for electronic cigarettes or other novel products. Industry reports indicate actual costs have risen to several million dollars per SKU, potentially exceeding $100 million for a full product line.
- SKU‑by‑SKU review – Each distinct product or flavor requires a separate application, multiplying expenses for manufacturers that offer multiple variations.
- Regulatory timeline – The law requires the CTP to render a decision within 180 days, but there are no penalties for missing this deadline, creating uncertainty for both firms and consumers.
Recent progress and remaining gaps
- In 2025, the CTP cut the backlog of pending PMTAs by about 70 % and has continued to accelerate reviews this year.
- Despite this, the agency still lacks a dedicated fast‑track for products that are demonstrably less harmful than combustible cigarettes, such as e‑cigarettes, heat‑not‑burn devices, and nicotine pouches.
Proposed reforms to the PMTA process
- Fast‑track pathway – Establish a streamlined review track for products with a clear reduced‑harm profile, applying a lower evidentiary threshold while still protecting public health.
- Conditional approval after 180 days – If the CTP has not issued a final decision within the statutory window, the product would receive a provisional market authorization, incentivizing timely action.
- Transparency and guidance – Require the CTP to publish explicit criteria for “appropriate for the protection of public health,” detail the types of studies needed, and provide written explanations for each approval or denial.
- Accountability mechanisms – Implement consequences for systematic delays or blanket denials, such as mandatory reporting to Congress or the Office of Management and Budget.
Illicit market dynamics
- Only five e‑cigarette brands currently hold FDA authorization, leaving the majority of the market unregulated.
- A recent study found that 69.4 % of e‑cigarette sales were from unauthorized products, rising to 97.6 % for disposable systems and 100 % for non‑tobacco/menthol flavors, which the FDA has categorically denied.
- Illicit products are largely smuggled from China and lack safety oversight, increasing health risks for users.
- In September 2025, the FDA announced the seizure of $86.5 million worth of illegal e‑cigarettes—the largest single seizure to date—highlighting the scale of the underground market.
Expanding the legal market would:
- Reduce the share of illicit sales, improving tax compliance and public‑health oversight.
- Provide consumers with products that meet safety standards, lowering the risk of injuries associated with unregulated manufacturing.
- Strengthen enforcement by concentrating resources on a smaller, traceable supply chain.
Youth vaping trends
- The 2025 National Youth Tobacco Survey reported that 5.2 % of middle‑ and high‑school students currently used vapor products, down from 5.9 % in 2024 and 9.4 % in 2022.
- By comparison, the 2025 National Survey on Drug Use and Health found 8.7 % of adolescents used marijuana, indicating that vaping is not the dominant substance among youth.
- Declining youth prevalence suggests that stringent restrictions aimed at preventing a perceived crisis may be disproportionate, especially when balanced against the potential public‑health gains of broader access to reduced‑harm products.
Potential public‑health impact
- Combustible smoking is linked to approximately 450,000 deaths annually in the United States.
- Facilitating the market entry of scientifically validated alternative products could shift smokers toward less harmful options, potentially saving thousands of lives each year.
- A transparent, efficient PMTA system would also encourage innovation, allowing manufacturers to iterate on safer designs and flavors that meet both adult demand and youth‑prevention goals.
Key takeaways for stakeholders
- Manufacturers should prepare robust, harm‑reduction data packages and monitor forthcoming CTP guidance to leverage any fast‑track provisions.
- Policymakers may consider legislative amendments that attach penalties to missed 180‑day deadlines and mandate public reporting of CTP decisions.
- Public‑health advocates can use the declining youth‑use data to argue for a balanced regulatory approach that prioritizes adult smokers’ transition to reduced‑risk products while maintaining youth‑prevention safeguards.
Reforming the CTP’s review and approval processes could align regulatory practice with the dual goals of protecting public health and fostering a competitive, legally compliant market for alternative tobacco products.
Source article: taxfoundation.org
