By Mar Supnad
Bataan 2nd District Representative Jose Enrique “Joet” S. Garcia III called on the Department of Health (DOH) to strictly implement its administrative order regulating the manufacture and distribution of electronic nicotine delivery systems (ENDS) or e-cigarettes.
In the public hearing of various proposed measures seeking to regulate the importation, manufacture, sale, distribution, use and advertisement of ENDS at the House of Representatives, it was revealed that no single importer, manufacturer, retailer or distributor of these products have applied or were granted license to operate (LTO) or certificate of product registration (CPR). It is public knowledge, however, that vaping bars, ENDS or e-cigarette outlets continue to proliferate.
Citing administrative order (AO) No. 2014-0008 issued on March 12, 2014, Garcia said the DOH classified ENDS or e-cigarettes as combination drugs and medical devices that shall be regulated as medicinal products. It directed the FDA to require LTO from manufacturers and distributors before applying for a CPR. It likewise prescribed the CPR as a mandatory market authorization before the product is used or offered for sale.
More than four years after the AO’s issuance, the FDA is yet to come up with specific guidelines and requirements for the issuance of LTO and CPR. The FDA itself has not apprehended or held to task any importer, manufacturer, or retailer of ENDS or e-cigarettes, their components and parts, despite non-compliance with the required LTO and CPR.
Garcia is calling on the DOH and the FDA to strictly implement the AO to prevent the undue exposure of the populace to potential harmful effects of e-cigarette smoking. He recommended that the DOH and the FDA tie-up with local government units and make arrangements for the denial of business permits to importers, manufacturers, distributors or retailers of e-cigarettes and their components and parts without duly approved LTO and CPR.