2FIRSTS | Alan Zhao: In the Post-“Absolute Resolve” Era: Speculating on U.S.-Referenced Regulatory Alignment and the Restructuring of Order in South America’s Novel Tobacco Market

2Firsts
Alan Zhao analyzes potential U.S. regulatory influence on South America's novel tobacco market following geopolitical shifts, suggesting a move towards 'U.S.-Referenced Regulatory Alignment'.

Summary

Alan Zhao explores the possibility of 'U.S.-Referenced Regulatory Alignment' in South America’s novel tobacco market following the 'Absolute Resolve' operation in Venezuela. He argues that this alignment won’t necessarily come from formal policy changes, but through the adoption of U.S. regulatory practices, enforcement mechanisms, and algorithmic risk controls, effectively making U.S. standards a de facto market entry threshold. This shift could lead to the FDA’s PMTA framework becoming a 'digital compliance signal' and redefine competition based on compliance identity rather than scale. The analysis suggests two potential manufacturing trajectories: continued dominance of U.S. manufacturing or a gradual nearshoring of production to South America. Ultimately, Zhao emphasizes the importance of ongoing discussion and input from local practitioners to refine these observations.

(Source:2Firsts)

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