Comment from Clark Esposito Law Firm, P.C.
AnonymousSupportBusiness
Summary: A law firm representing an anonymous industry stakeholder supports the FDA's efforts to address youth risk in flavored ENDS products but argues that the draft guidance lacks sufficient clarity regarding evidentiary expectations. They request specific benchmarks, study designs, and quantitative criteria to help applicants understand how to demonstrate "added benefit" to adult smokers relative to youth risk.
Please be advised that our firm represents an industry stakeholder who prefers to remain anonymous, hereinafter “the Stakeholder.” On their behalf we submit the attached comment in response to the U.S. Food and Drug Administration’s (FDA) request for public input regarding the Agency’s draft guidance addressing premarket tobacco product applications (PMTAs) for flavored electronic nicotine delivery systems (ENDS) and considerations related to youth risk.