Balancing Enforcement and Innovation: CTP’s Post-RIF Strategy in Focus

As the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) adjusts to a new era of leadership and reduced staffing, a clearer regulatory direction is beginning to emerge. Following months of internal restructuring and uncertainty, the agency is now articulating a strategy that seeks to balance two priorities: strong enforcement against unauthorised products and support for the development and authorisation of reduced-risk alternatives.

Evolving Priorities from CTP Leadership

At the 2025 Food and Drug Law Institute (FDLI) Conference, key interim leaders at CTP provided insight into this dual approach.

Dr Ben Apelberg, Acting Director of the Office of Science (OS), reaffirmed CTP’s commitment to the “Appropriate for the Protection of Public Health” standard, stressing the need to consider a range of scientific evidence in evaluating products. He acknowledged the public health value of reduced-risk products, particularly for adult smokers, while also noting the continued challenge of youth initiation. His comments reflect a more balanced view, one that recognises both the potential benefits and the risks of emerging nicotine products.

Meanwhile, John Verbeteen, Acting Director of the Office of Compliance and Enforcement (OCE), detailed the agency’s increasing focus on border enforcement. CTP continues to work with the Joint Federal Task Force to seize and destroy unauthorised tobacco imports, reinforcing a no-tolerance stance on non-compliant products. However, Verbeteen also emphasised the importance of providing adult smokers with legal, regulated alternative products that have successfully navigated the PMTA pathway.

The Emergence of a Dual-Strategy Approach

The messaging from CTP suggests a shift away from a solely defensive regulatory posture. Rather than focusing exclusively on enforcement, the agency appears to be pursuing a dual-strategy: tighten enforcement against unlawful products while offering clearer, science-based pathways to authorisation for reduced-risk products.

This is a welcome development for many industry stakeholders. With the nicotine pouch and heated tobacco categories growing rapidly, a more pragmatic approach is needed, one that preserves access for adult smokers while addressing concerns about youth usage.

What This Means for PMTAs and Industry Compliance

For manufacturers, this shift underscores the importance of two parallel efforts:

• First, maintaining full regulatory compliance and aligning with evolving enforcement expectations, particularly around imports and marketing practices.
• Second, continuing to invest in robust scientific evidence to support PMTA submissions, particularly around product use, abuse liability, and consumer impact.

The FDA authorisations for ZYN and, more recently, JUUL products suggest that successful PMTAs are achievable, provided the data is comprehensive and the approach is aligned with FDA expectations.

Looking Ahead

The second half of 2025 will be critical in determining whether CTP’s dual-strategy approach delivers on its promise. If successful, it could lead to a more stable and transparent regulatory environment that supports innovation while safeguarding public health.

For now, the message is clear: enforcement and innovation are not mutually exclusive. Both must work in tandem to support a reduced-risk future.

For more information on how Broughton can support your PMTA submission, arrange a meeting with our regulatory expert here.