THE Food and Drug Administration (FDA) now requires all establishments selling Vaporized Nicotine and Non-Nicotine Products (VNNPs) and Novel Tobacco Products (NTPs) to secure their respective Licenses to Operate (LTOs).
Based on Advisory 2025-1487, the FDA said business establishments that offer VNNPs and NTPs with medicinal and therapeutic claims are now required to secure licenses from the attached agency of the Department of Health (DOH).
"All manufacturers, traders, distributors as importers/exporters/wholesalers, and retailers of VNNPs and NTPs with medicinal or therapeutic claims shall (apply for a license) as pharmaceutical establishments," it said.
"VNNPs and NTPs with medicinal or therapeutic claims should apply for a License to Operate," added the FDA.
Similarly, the agency said all vape products with medicinal or therapeutic claims are now required to register with the health regulatory body.
"All VNNPs and NTPs with medicinal and therapeutic claims intended for manufacture, distribution, and sale shall be registered," said the FDA.
"VNNPs and NTPs with medicinal or therapeutic claims shall be registered as pharmaceutical products through the Center for Drug Regulation and Research (CDRR)," it added.
It urged all concerned stakeholders to fully comply with the new requirements of the FDA.
"Let us meet the regulatory requirements to ensure the safety, efficacy, and quality of VNNPs and NTPs with medicinal or therapeutic claims in the market," it said. (Anton Banal/SunStar Philippines)