New Regulations for E-cigarette and Non-Nicotine Products in Philippines

On January 2nd, the Special Authority Office for Aerosolized Nicotine and Non-Nicotine Products (OSMV) under the Department of Trade and Industry (DTI) of the Philippines issued Supplemental Technical Regulations Administrative Order No. 24-11, aimed at standardizing mandatory product certification for e-cigarette and non-nicotine products.

New regulations require that all e-cigarette and heated tobacco products (HTP) obtain a Philippines Standard (PS) license as the main certification for market access. The PS license must include the entire process of production, quality testing, and distribution of the products. Products with a valid PS license are allowed to be sold, and new applications for Import Commodity Clearance (ICC) licenses will no longer be accepted.

International standards application: Recognition of ISO, IEC, and other international standards as the basis for testing and certification; introduction of specific technical standards for battery safety (PNS IEC 62133:2015) and e-cigarette e-liquid (AFNOR XP D90-300-1:2019).

Product testing and assessment: internal testing and independent testing; allowing different factories of the same manufacturer to conduct internal testing, but outsourcing is prohibited; testing results must be submitted directly to the Ministry of Trade and Industry's OSMV office to prevent intermediary interference.

Sampling and batch testing: Each model must submit 10 devices, 66 batteries, and corresponding e-cigarette liquid samples for testing according to the standard. Products that do not pass the test must submit a rectification plan and undergo re-evaluation, otherwise their PS license will be revoked.

PS Certification Logo: All products in circulation in the market must be labeled with the PS logo to ensure consumers can identify compliant products; the new certification logo design should quickly replace the old logo.

Sales and distribution restrictions: Uncertified products are prohibited from entering the Philippine market, including online sales platforms; the compliance deadline is December 31, 2024.

Law enforcement agency functions: The OSMV office is responsible for law enforcement and supervision, including setting standards, issuing permits, and conducting inspections; further empowering the OSMV to independently exercise the legal powers granted.

Transitional arrangements: Products that have obtained ICC (Import Commodity Clearance) permits can be sold until existing stock is depleted; all PS permits must be converted by the end of 2024.

The new regulations will go into effect immediately after being published in the official gazette and two widely circulated newspapers.