Comment from Jeffrey Smith

Summary: Dr. Jeffrey S. Smith, representing the R Street Institute, argues that the draft guidance imposes disproportionately high evidentiary burdens on flavored ENDS products that could effectively prohibit access for adult smokers seeking to quit. He contends that flavor is a critical driver of smoking cessation and recommends that the FDA consider cross-product substitution effects and international success stories where flavor availability coexists with public health improvements.