Comment from Mitchell Berger
AnonymousSupportIndividual
Summary: Mitchell Berger, commenting in a personal capacity, supports the draft guidance's balanced approach to flavored ENDS but suggests several improvements. He recommends that the FDA clarify the youth risk sliding scale, consider demographic subpopulations in sensory data, and include factors like device type and adult benefits in the risk assessment.
Dear Ms. Rivera: I write to make the following suggestions concerning the above flavored ENDS draft guidance. Please note that the views expressed are mine alone and not those of an agency, organization, or other individual(s). I respectfully suggest the following improvements to the draft guidance: Consider privacy implications and consent requirements for device access restrictions; Clarify the sliding scale approach used to evaluate youth risk; Discuss that sensory appeal and other data should consider demographic subpopulations; Consider additional factors in risk assessment; Discuss factors that show a product is beneficial to adults; and Note the importance of ENDS device type (e.g., open vs. closed devices) in association with adults and youth flavor use. Full comment attached below. Sincerely, Mitchell Berger