The Food and Drug Administration (FDA) informs all heads of hospitals retained by the Department of Health that “electronic cigarettes,” or ENDS/ENNDS, through definitions supplied by Republic Act 9711, are under the purview of the Food and Drug Administration. Per relevant legislation, “‘[h]ealth products” means food, drugs, cosmetics, devices, biologicals, vaccines, in-vitro diagnostic reagents and household/urban hazardous substances and/or a combination of and/or a derivative thereof.[…
In the interest of evidence-based policy development, and in line with emerging report of electronic cigarette-related injury and illnesses from Europe and North America, the Food and Drug Administration [FDA] requests all DOH-retained hospitals to immediately communicate relevant case reports of injuries and illnesses documented arising from the use of these devices.
In compliance with the Data Privacy Act of 2012, it is expected that the information provided will be anonymized in as much as they are thorough and extensive.
Please communicate the requested case reports to the FDA Center for Cosmetics Regulation and Research ([email protected]).
Dissemination of this advisory to all concerned is hereby requested.
Attachment-> : FDA Advisory No. 2019-258