The FDA, Safer Nicotine, and the Path Forward

Source referenced: Regulating the Tobacco and Nicotine Market in the American Public Interest: A Reform Agenda for the FDA (Satel, Bates, Kenkel, Rodu, 2025). 

A new reform agenda released this week “argues for non-marginal reform to the FDA’s authorization process, to bring at least 4,000 vaping and other safer products to market, meet the statutory 180-day requirement for complementing reviews, and lower barriers to entry by a factor of 10.”  

The report argues there’s a major public-health opportunity if adult smokers can switch to smoke-free alternatives (vapes, nicotine pouches, heated/smokeless tobacco). Today, the FDA’s premarket pathway (PMTA) is so burdensome and slow that it starves the legal market and limits choice. The authors propose pragmatic reforms—no new law required—to authorize thousands of vetted products faster, protect youth, and provide viable alternatives to combustible cigarettes. 

Key Takeaways 

• Harm reduction works: Smoke-free nicotine products displace smoking. 
• Bottleneck at FDA: New smoke-free products face years-long, expensive PMTAs, while thousands of legacy combustible products remain readily available. 
• Disposable domination: With legal options throttled, products with pending PMTAs and newer disposable vapes meet most U.S. adult vape demand. 
• Enforcement alone won’t fix it: Crackdowns are necessary but insufficient; only a competitive legal market can sustainably displace cigarettes with FDA-approved vapes.  
• What to change: Make premarket review leaner and clearer, meet the 180-day statutory deadline, and authorize a large, diverse portfolio (including flavors with adult-appropriate branding) to match real adult demand. 

The 15 Reforms 

1. Premarket focus: Product safety, quality, packaging, and marketing only; assess population effects post-market. 
2. Least-burdensome evidence aligned to the Tobacco Control Act. 
3. Clear guidance/soft standards to expedite compliant apps. 
4. Prefer emissions/chemistry over human studies. 
5. Shift population/behavioral APPH elements post-market. 
6. Build serious market surveillance  
7. Use post-market corrective actions when issues arise. 
8. Drop flavored-product comparative efficacy test; focus on safety + youth-appropriate marketing. 
9. Specify application requirements precisely. 
10. Use category-wide findings to avoid duplicative reviews. 
11. Recognize products pending >180 days; list and apply enforcement discretion. 
12. Prioritize reviews where demand is highest. 
13. Collaborate with compliant smoke-free firms. 
14. Expedite risk communication for APPH/modified-risk products. 
15. Educate clinicians & public on nicotine’s relative risks (smoke vs. smoke-free). 

Why It Matters 

• Public health: Making alternative nicotine products accessible and appealing to adults can accelerate declines in smoking. 
• Consumer protection: A larger, regulated market means accurate labeling, quality assurance, and recourse. 
• Youth protection: When adult demand is met with tight branding, packaging, and retail controls—youth-accessible channels shrink. 

Quick FAQ 

Are smoke-free products risk-free? 
 No. They’re not risk-free, but they are much safer than smoking. 

Do flavors have a place? 
 The report says yes—for adults—provided youth-appropriate marketing/labeling. Banning legal flavors has been shown to increase cigarettes sales and drives black market demand.  

Is new legislation needed? 
 Not for these reforms. The authors argue the FDA can re-interpret and streamline PMTA within current law and meet the 180-day review requirement. 

Read the full report here.