The Philippines has introduced mandatory safety certification for nicotine pouches, requiring products to meet World Health Organization reference procedures before they can be sold in the country.

The Department of Trade and Industry (DTI) imposed the requirement under Department Administrative Order (DAO) No. 26-07, signed September 2. Nicotine pouches must obtain certification under the Philippine Standard (PS) licensing scheme before they can be manufactured, imported, packaged, sold, or distributed.

What This Means for the Market

The move makes the Philippines one of the few markets to explicitly tie nicotine pouch regulation to WHO testing standards. Most countries either ban pouches outright or regulate them under existing tobacco or consumer product frameworks without specifying testing protocols.

The certification requirement creates a technical barrier to entry. Brands will need PS-certified products before distribution. Smaller brands or grey-market imports that haven't gone through formal testing may be shut out.

The Testing and Packaging Rules

Products must meet WHO reference procedures for three parameters:

• Nicotine content: Verifies the declared strength matches what's actually in the pouch.
• pH level: Affects how nicotine is absorbed through the oral mucosa. Higher pH typically means faster absorption.
• Water activity: Measures moisture availability, which impacts product stability and microbial safety.

Manufacturers must run in-plant testing or use a DTI-recognized or accredited foreign laboratory. Packaging must declare nicotine content and allergens, provide use and disposal instructions, display the PS certification mark, and carry a full-color health warning covering contraindications, medication interactions, precautions, adverse reactions, and overdose treatment.

What Happens Next

The DTI set a 12-month transition period for companies to register existing products. After that, only nicotine pouches with a valid PS license may be manufactured, imported, distributed, or sold in the Philippines.

For international manufacturers, this adds the Philippines to a growing list of markets with product-specific compliance hurdles — alongside the EU's TPD notification system, the FDA's premarket authorization in the U.S., and various national bans or flavor restrictions elsewhere.

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SOURCES: Tobacco Reporter — Philippines Requires Safety Certification for Nicotine Pouches Philippines DTI — Draft implementing guidelines on mandatory product certification of novel tobacco products