The Department of Trade and Industry (DTI) has begun soliciting views from industry players and other stakeholders on a draft administrative order that would set the quality and certification rules for nicotine pouches, a category covered under novel tobacco products. The draft, released for public consultation, lays out the proposed mandatory product certification framework that will govern how these products may be imported, distributed, and sold in the Philippines.
The proposed order is anchored on Republic Act No. 11900, or the Vaporized Nicotine and Non-Nicotine Products Regulation Act, which gives the DTI exclusive jurisdiction over matters involving vaporized nicotine, non-nicotine, and novel tobacco products. It also builds on earlier DTI issuances on mandatory certification and adopts PNS BSI PAS 8877:2024 as the applicable Philippine standard for nicotine pouches.
Under the draft rules, nicotine pouches would be allowed in the local market only if they come from a manufacturing facility holding a valid Philippine Standard (PS) license. The draft explicitly says the Import Commodity Clearance (ICC) route will not apply to nicotine pouches; instead, only the PS Licensing Scheme would be recognized for these products.
The proposed technical requirements are specific. Nicotine content must not exceed 20 milligrams per pouch, with a permitted deviation of plus or minus 10 percent from the declared value. The product’s pH level must stay within the oral-use range of 6.0 to 10.0. Manufacturers would also have to certify in writing that the product does not contain any substance classified as a dangerous drug under Republic Act No. 9165.
The draft also sets out detailed labeling and packaging requirements. Retail packs would need to show the product name, nicotine content per pouch, quantity, manufacturing and expiration dates, batch or lot number, manufacturer and importer information, usage and disposal instructions, and health warnings stating that the product contains nicotine and is for adult use only. PS license holders would likewise be required to use the updated PS Certification Mark together with the corresponding license number.
For compliance, the order proposes both in-plant and independent testing. Manufacturers would conduct in-plant tests for nicotine content and pH, while independent verification of all required parameters must be done by a DTI-recognized testing laboratory. If no local DTI-recognized laboratory is available, applicants may nominate a foreign laboratory accredited under the International Laboratory Accreditation Cooperation Mutual Recognition Arrangement, subject to DTI approval.
Sampling rules are also spelled out in the draft, using one retail pack of nicotine pouches as the basic unit. Lots of 100 would require 5 samples, lots of 500 would require 10, and lots of more than 1,000 would require 50. The measure also includes a one-year transition period from effectivity to give stakeholders time to comply, with products manufactured or imported before the order takes effect allowed to remain on sale during the transition if a valid PS license application has already been filed.
For businesses in the category, the consultation marks an important regulatory step. If finalized, the order would tighten quality control, standardize product information, and formalize the certification path for nicotine pouches in the Philippine market—signaling DTI’s move to put novel nicotine products under a more defined technical and consumer-safety regime.
