Philippines: Regulation of E-Cigarettes Proposed

Source from:  Manila Bulletin 12/03/2013

Electronic cigarettes or Electronic Nicotine Delivery System (ENDS) will be classified as medicinal product and will be regulated by the Food and Drug Administration (FDA) under a proposed administrative order.

"Electronic cigarettes or ENDS are combination drugs and medical device and are not tobacco products and shall be regulated as medicinal product," according to the draft order posted on the FDA website.

The administrative order by the Department of Health (DOH) will be tackled in a public hearing.

The draft order was issued four months after the FDA conducted a public hearing on e-cigarettes.

Health experts and authorities called for a ban or the enforcement of strict regulations governing the sale of e-cigarettes in the country while advocates of the product opposed, saying that it would only harm the health of tobacco smokers who have resorted to using e-cigarettes.

Under the proposed AO, e-cigarettes need to "pass the safety, efficacy and quality evaluation of the FDA before a market authorization is issued as health product and health-related device."

Manufacturers and distributors of the products will be required to get a License to Operate (LTO) before they can apply for a Certificate of Product Registration (CPR), which is needed before a product can be sold.

The FDA will assess the safety, efficacy and quality of the device and ingredient cartridge of e-cigarettes using standards for drugs and drug products.

In addition, the cartridge containing the "electronic juice" also needs to pass FDA standards including the mixture of the ingredients in the cartridge and the quality and delivery of the nicotine dose. Enditem