E-CIGARETTE and vaporizer (vape) businesses will have until October to register their establishments and products before the Food and Drug Administration (FDA) or face possible seizure of their goods.

Speaking to reporters, FDA Officer-in-Charge Rolando Enrique D. Domingo said that businesses who currently involved in the sale, distribution, manufacture, import, and export of Electronic Nicotine and Non-nicotine Devices, the government acronym for which is END/ENNDS, will have to register with the FDA in order to obtain a license to operate. The agency will be giving these businesses a three-month transition period to do so since the Department of Health (DoH) issued DoH Administrative Order (AO) 2019-0007 last week.

“After the grace period, kailangan na ’yung nagtitinda, nagma-manufacture, nag-i-import, at nagtitinda ng retail ay may license to operate at kailangan ang products nila i-register (those who sell, manufacture, import, and sell at retail need to have a license to operate and also have their products registered),” he said.

The DoH AO 2019-0007 provides guidelines on the conduct of business for the ENDS/ENNDS industry. According to the guidelines, the sale of nicotine shots and concentrates is prohibited.

If businesses fail to follow the AO, Mr. Domingo said that the FDA will issue warnings ordering the establishments to comply. If these businesses continue to be non-compliant despite the warning and advisory, the FDA will issue a seizure order to remove all their products from the market.

As part of the AO, the DoH will also release rules that will govern refills for ENDS/ENNDS products. Mr. Domingo, who is also a Health Undersecretary, said, “Within the next three months we are going to have a complete list. What we don’t want are flavors that appeal to children.”

In a separate statement, the Health department said that there are studies affirming that e-liquids used for ENDS/ENNDS have some ingredients that put users at risk. The Health department also rejected the argument that ENDS/ENNDS products are a healthier alternative to tobacco products since more long-term studies need to be produced in order to prove these claims.

“The Department cautions the public regarding harmful chemicals in these devices such as nicotine, ultra-fine particles, carcinogens, heavy metals, and volatile organic compounds. Results generated from peer-reviewed studies show that e-cig juices contain high levels of addictive nicotine, which can result in acute or even fatal poisoning through ingestion and other means, “ DoH said in a statement on Monday. — Gillian M. Cortez

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