Navigating the Fog: PMTA, Politics, and Why Now Is NOT the Time to Wait

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The tobacco and nicotine regulatory landscape is shifting — and like many of you, we’re reevaluating how best to move forward. 

At ARAC, we’re closely monitoring the evolving political, legal, and scientific signals that affect your ability to bring products to market. Our team includes deep regulatory insiders and creative scientific thinkers who are working daily to interpret what these changes mean — and what steps you should take now to stay ahead. 

Let’s be honest: there’s a lot we don’t know. But there’s even more we DO. 

WHAT WE KNOW: 

The law hasn’t changed. The Tobacco Control Act (TCA) is still the cornerstone of U.S. tobacco regulation — and it's not going anywhere. Yes, PMTA guidance can evolve, but full legislative change is a heavy lift, especially before midterms. If anything, we're seeing adjustments within the system, not the dismantling of it. 

The recent Supreme Court ruling in FDA v. Wages and White Lion Investments signals that while reforms are possible, an overhaul of the PMTA pathway is not imminent. Any evidentiary changes would still require careful implementation and are almost certain to face litigation. 

PMTA — here to stay. Even if the FDA revises expectations for Modules 5 & 6, the PMTA’s core structure will remain — and scientific justification will still be necessary. If experimental trials become optional, descriptive or observational evidence will take center stage. 

At ARAC, we help companies navigate these shifts — advising on the best pathway based on current science and business priorities. 

Importantly: future PMTA reforms won’t necessarily favor late movers. The opposite may happen. Early applicants could benefit from what's being called a “drawbridge effect” — where those already engaged with the agency receive preferential treatment as the gate tightens. 

ON OUR RADAR: 

Recent political and judicial developments have created serious uncertainty in our space. Consider just a few questions everyone’s asking: 

• Will FDA’s capacity shrink due to RIFs at CTP, slowing down PMTA reviews? 

• Will evidentiary standards change, potentially inviting new PMTA applications? 

• Will enforcement discretion fade, particularly at the border, forcing importers into the PMTA process? 

Since January 20, ARAC has been listening to stakeholders and speaking with the FDA to understand what’s really happening — and how the second Trump administration may impact tobacco and nicotine regulation. 

THE “BIG FOUR” STILL APPLY FOR NEW PRODUCTS: 

To legally market a new tobacco or nicotine product in the U.S., manufacturers still must meet the TCA’s four cornerstones:

1. APPH (Appropriate for the Protection of Public Health) 

2. Labeling must not be false or misleading 

   1. Label comprehension, TPPI, human factors, actual use studies matter 

3. Product must be manufactured properly 

4. Product must comply with tobacco standards 

REGULATORY SCIENCE STILL REIGNS

Regardless of how evidentiary expectations evolve, the FDA will continue to expect rigorous, science-based justification for authorization. 

That means: 

• Consumer research at every stage of product innovation 

• Competitive assessments — especially with novel entrants like nicotine pouches 

• Module 6 studies — behavior, switching, risk perception, and communication 

• Post-market surveillance — demonstrating continued APPH relevance 

ARAC’s integrated regulatory, behavioral, and scientific teams deliver flexible solutions that adapt to guidance changes without losing time, credibility, or competitive edge.

REGULATORY STRATEGY & SCIENCE

Regulatory uncertainty isn’t new — but it’s manageable. With the right partner, you don’t just survive uncertainty — you leverage it. 

Connect with ARAC to learn how to move forward, smartly and strategically.