Comment from Main Street Foundation Center for Regulatory Analysis and Engagement

Summary: The Main Street Foundation’s Center for Regulatory Analysis and Engagement (CRAE) supports the FDA's efforts to develop a transparent, evidence-based framework for evaluating flavored ENDS applications to reduce youth access. However, they urge the FDA to ensure the final guidance avoids creating de facto prohibitions through excessive evidentiary burdens, considers comparative-risk tradeoffs (such as adult smoking cessation), and accounts for unintended consequences like illicit-market expansion.