No analysis is complete without examining what could go wrong for the consolidation thesis:

• Legal challenges: The Campaign for Tobacco-Free Kids and other groups have pending lawsuits that could invalidate FDA enforcement guidance, slowing the squeeze on unauthorized products.
• PMTA streamlining: If the accelerated review process lowers costs enough for mid-size companies, the oligopoly could become more competitive. The FDA could create a "small business pathway" with reduced requirements.
• Black market resilience: If enforcement is too aggressive, the market could go underground — making products more dangerous, not less. The prohibition parallel is imperfect but instructive.
• Political reversal: A new administration could reverse the enforcement posture. However, the Schumer demand shows that enforcement isn't purely partisan — both parties support cracking down on illicit vapes.
• Technology disruption: A new product category (e.g., nicotine pouches, heated tobacco) could shift consumer demand away from e-cigarettes entirely, making the oligopoly irrelevant.