By Timothy S. Donahue

Top Takeaways:

• Certification required: The Philippines introduced mandatory product certification for nicotine pouches under a new order.
• Testing and labeling: Manufacturers must meet requirements covering nicotine content, pH, water activity, ingredient disclosures and warnings.
• One-year deadline: Companies have 12 months to obtain certification before uncertified products are barred from the market.

Nicotine pouches in the Philippines now need more than shelf space. They need a government seal of approval.

The Philippines Department of Trade and Industry (DTI) has introduced mandatory product certification for nicotine pouches, requiring manufacturers and importers to obtain a Philippine Standard (PS) license to continue selling their products in the country.

Department Administrative Order No. 26-07, signed on Sept. 2 and made public in early October, establishes technical, manufacturing, and labeling requirements for the category. Companies have a 12-month transition period to comply, after which uncertified products can no longer be manufactured, imported, packaged, distributed, or sold.

Unlike other regulated imported products, nicotine pouches will not qualify for certification under the Import Commodity Clearance (ICC) scheme. Instead, the order requires certification under the PS licensing system, which evaluates manufacturing facilities and their ability to consistently produce compliant products.

The requirements apply to domestic and overseas manufacturers serving the Philippine market.

Product testing must cover nicotine content, pH, and water activity. Manufacturers must demonstrate suitable testing capabilities or use laboratories recognized under the country’s certification framework.

Nicotine-content testing verifies the declared strength of each product, while pH affects nicotine release and absorption. Water activity is used to evaluate product stability and the conditions that affect microbial growth.

Manufacturers must also provide a written declaration confirming that their products contain no substances classified as dangerous drugs under the Philippines’ Comprehensive Dangerous Drugs Act of 2002.

The order introduces extensive packaging requirements. Retail packs must identify the product and variant, disclose nicotine content in milligrams per pouch, specify the number of pouches, and list ingredients in descending order of weight.

Labels must also include manufacturing dates, batch or lot numbers, allergen information, manufacturer and importer details, and instructions for use and disposal.

Products must display the PS certification mark and license number, along with prescribed health warnings covering contraindications, potential medication interactions, precautions, adverse reactions, and treatment for nicotine overdose.

The information must be presented clearly and durably in either English or Filipino.

DTI’s requirements apply to manufacturing and toll-packing facilities, which may be subject to inspections, audits and ongoing surveillance. Companies conducting in-house testing must demonstrate adequate equipment, qualified personnel and technical capabilities. Those using outside laboratories must meet the applicable accreditation and recognition requirements.

The certification framework also limits changes to products and packaging that could compromise quality, safety, or traceability.

DTI first circulated proposed certification requirements in April to solicit stakeholder feedback before issuing the final administrative order.

The new rules build on the Philippines’ existing regulation of vaporized nicotine, non-nicotine, and novel tobacco products under Republic Act No. 11900, which established a broader regulatory framework for the country’s emerging nicotine market.

Nicotine pouches are addressed separately from electronic vaping devices and heated tobacco systems because their product characteristics and testing requirements differ. The 12-month transition period gives existing manufacturers, importers, and distributors time to complete testing, obtain facility certification, and update packaging.