Comment from University of California San Francisco (UCSF)
AnonymousOpposeAcademic
Summary: The University of California, San Francisco (UCSF) argues that the draft guidance fails to adequately protect youth from flavored electronic nicotine delivery systems (ENDS). They contend that the FDA underestimates the youth appeal of various flavors, fails to provide a clear methodology for quantifying the tradeoff between adult benefits and youth risks, and should prohibit unproven "novel device access technologies."
FDA’s draft guidance on the considerations related to youth risk of flavored electronic nicotine delivery systems (ENDS) premarket applications should not be finalized because it fails to protect youth or present an accurate estimate of the tradeoff between increased youth e-cigarette use vs theoretical benefits to adult smokers. Please see attached comment from University of California San Francisco (UCSF).