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Lifestyle

E-cigarettes, vapes available in PHL do not have FDA registration


Food and Drug Administration (FDA) Director Ana Rivera, Center for Cosmetics Regulation and Research, said Thursday that all e-cigarettes advertised as smoking-cessation devices are technically illegal, as not one brand has successfully applied for a Certificate of Product Registration.

"Unfortunately, walang nag-aapply pa for CPR, because of the requirements for clinical trials, because it is considered as a part of smoking cessation," Rivera said during the Department of Health's (DOH) press briefing on World No Tobacco Day.

"Wala pa 'yong evidence that it can be used for smoking cessation. We are awaiting, we are encouraging them to do their own clinical studies, if they have, and submit it to the FDA."

Rivera said there are talks within the FDA and DOH to update their regulations to include e-cigarettes and related devices that do not claim to be smoking-cessation devices.

"Technically, they are (illegal), at ito ay pinaguusapan namin within FDA and DOH right now for us to introduce and review the current regulations.

"The current regulations are for those nicotine-containing. So 'yong mga non-nicotine containing, wala po tayong regulations as of the moment," she added. 

Studies needed before LGU regulation on vape bars

Health Secretary Francisco Duque III added that local government units would need to wait for evidence-based results from studies on e-cigarettes before they could regulate vape bars and other such establishments.

"We have to wait for those results, then that will trigger the LGU's mandate to regulate; at least there's a basis. Kasi kung sabihin mo lang bawal, bakit bawal? Huhulihin mo, bakit mo huhulihin? You get into a lot of these legal entanglements, you want to avoid that," Duque explained.

In spite of this, Rivera said the FDA put such establishments under surveillance and may carry out raids in the future if the regulations they are crafting come to pass.

"I cannot disclose kung ano 'yong operations no'ng ating regional enforcement units, but we have referred some cases of those vapings and stations, and those that are advertising in the internet," she said.

"There are moves within FDA, hindi naman pwedeng i-announce na ire-raid namin kayo today. These are under surveillance, these are within the insides of our enforcement units."

No proof that e-cigs lower tobacco use

World Health Organization (WHO) Country Representative Dr. Gundo Weiler said it was too early to say that e-cigarettes do indeed result in reduced consumption of tobacco, as often claimed by its proponents.

"(E-cigarettes are) still fairly young as devices, so there is not really sufficient research and data that would make us come to find conclusions," Weiler said.

"There are also many other factors that also have an impact on smoking," he added. "It is already clear, they are harmful, and to an extent we need to observe them very carefully. In short, e-cigarettes are not the solution to the tobacco epidemic from our perspective."

Philippine Heart Association President Dr. Nannette Rey said it was better for smokers to go cold turkey if they wish to quit, and for non-smokers not to use e-cigarettes to eliminate any chance of smoking.

"You might not taking the nicotine you usually take from the tobacco, but you take other carcinogens that may be harmful to your health," Rey said.

"We still have to have big studies to really prove it, but as of this time, if you think about it, and we're talking about stopping smoking, I think the best way to stop smoking is to not smoke at all — and that's what the young people should do." — AT, GMA News