Network for Principled Nicotine Policy Applauds FDA Fast-Track Pilot, Emphasizes Timely Review as Essential to Public Health

The Network for Principled Nicotine Policy (Network) commends the U.S. Food and Drug Administration’s initiative to pilot expedited reviews of certain nicotine pouch applications in the face of significant delays and mounting public interest. As reported by Reuters on September 8, 2025, the FDA is taking steps to complete reviews for several nicotine pouch products by December (Reuters).

Under federal law, FDA’s premarket tobacco product application (PMTA) reviews are required to be concluded within 180 calendar days, a standard that balances thorough scientific assessment with timely action. The Network applauds any effort to uphold that statutory deadline, ensuring that decisions are both prompt and grounded in rigorous review.

We strongly welcome steps that reaffirm the FDA’s commitment to completing its PMTA reviews within 180 days. This not only helps bring safer, potentially reduced-harm alternatives to market without undue delay, but also maintains the agency’s accountability to legislative benchmarks and public health mandates.

The Network urges the FDA to:

• Extend the fast-track pilot to include other products that have been under review well-beyond the 180-day timeframe.

• Generalize successful process changes during the pilot project to its broader review practices to help ensure alignment with the 180-day statutory requirement.

• Use post-market surveillance to monitor outcomes to ensure that swifter reviews do not compromise product safety or risk assessment, or public health objectives.

Timely and principled regulation is essential to both embrace innovation that helps adults quit smoking and safeguard youth. The Network stands ready to support the FDA’s efforts toward a balanced, effective, and transparent review framework.