The Food and Drug Administration (FDA) of the Philippines has issued a significant new directive targeting the vaporized nicotine and tobacco industry. The agency now mandates that all businesses involved with Vaporized Nicotine and Non-Nicotine Products (VNNPs) and Novel Tobacco Products (NTPs) that make health-related claims must obtain official Licenses to Operate (LTOs).
New Licensing Requirements for Businesses
According to the official Advisory 2025-1487 released by the FDA, this new rule is immediately in effect. The regulation specifically targets establishments that market or sell VNNPs and NTPs with any assertions of medicinal or therapeutic benefit. These businesses are now classified under the purview of the FDA, which is an attached agency of the Department of Health (DOH).
The advisory clearly states that all manufacturers, traders, distributors, importers, exporters, wholesalers, and retailers of such products must apply for a license. These entities will be regulated as pharmaceutical establishments, a move that significantly raises the compliance bar for the industry.
Mandatory Product Registration
Beyond business licensing, the FDA has also imposed a strict product registration mandate. The agency declared that all VNNP and NTP items which carry medicinal or therapeutic claims and are intended for manufacture, distribution, or sale must undergo formal registration.
This process will be handled through the FDA's Center for Drug Regulation and Research (CDRR). Products must be registered as pharmaceutical products, ensuring they meet stringent standards for safety, quality, and efficacy before they can be legally marketed with health claims.
Call for Industry Compliance
The FDA has issued a strong call to action for all stakeholders in the sector. The agency urges full and prompt compliance with these updated regulatory requirements. The stated goal is to safeguard public health by ensuring that any VNNP or NTP product presented as having health benefits is proven to be safe, effective, and of high quality.
This regulatory shift represents a major step by Philippine health authorities to tighten control over an evolving market. It places products making health promises under the same scrutiny as traditional medicines and pharmaceuticals.
