THE Food and Drug Administration (FDA) will start accepting license applications for e-cigarette and vape businesses in December, allowing for a transition period after the July release of regulations for the industry.
FDA Officer-In-Charge Rolando Enrique D. Domingo told reporters Monday that the FDA is currently in the first month of the three-month transition period prescribed by the Department of Health’s (DoH) Administrative Order (AO) 2019-0007. The AO requires individuals and establishments involved in the manufacturing, distributing, selling, importing, and exporting of Electronic Nicotine and Non-nicotine Devices (ENDS/ENNDS) to obtain a license to operate (LTO) from the FDA.
ENDS/ENNDS businesses will also be required to register their products with the FDA.
“We’re now on the first month, so September, October and November. FDA has conducted meetings with the industry to discuss the AO, and they were given three months from the time it took effect,” he said.
He added, “By December, we will be ready to accept registrations.”
E-cigarette and vape groups have expressed opposition to the AO. The Philippine E-Cigarette Industry Association (PECIA) said in a social media post on Aug. 13 that the AO was “designed to kill the industry,” adding that some of their members have questioned the validity of the AO in court.
Mr. Domingo, who is also a DoH Undersecretary, added that the department consulted with all stakeholders prior to the release of the AO.
“We cannot do that without public consultation. I remember we had a meeting here in the DoH and it was posted in the website for comment,” he said.
Mr. Domingo described the registration as a safety measure due to incidents where e-cigarette and vape devices exploded, causing facial injuries. ENDS/ENNDS products being sold on the streets and online are also not yet regulated by the FDA. On the tax side, the government is proposing to impose tax rates on the segment on par with the tax levied on tobacco products.
“At least we will test the device to see if this does not explode or not cause fire or smoke suddenly….Hindi namin alam kung safe ito or kung saan sila ginawa (We don’t know if they are safe or where they were made) and some of them can potentially harm a person, causing injury…..They have to be regulated kasi nasa bibig ’yun eh and pwede magka-injury (because it is consumed by mouth, which makes it an injury risk),” he said.
The AO also covers liquids and refills used for ENDS/ENNDS. Enterprises are only permitted to sell a maximum of 10 milliliters (mL) of liquid per container, whether this has nicotine or not. The maximum allowable nicotine content for liquids is 20 mg/ml while nicotine shots and concentrates will be prohibited.
Mr. Domingo said the FDA will release a list of allowed flavors for liquid refills late next month, adding that food-inspired flavors that normally appeal to the young will be banned. — Gillian M. Cortez