Philippine FDA Issues Public Health Warning Against Unregistered “OTOKI Fluffy Cooked White Rice”

The Philippine Food and Drug Administration (FDA) has issued FDA Advisory No. 2025-1607, warning healthcare professionals and the general public not to purchase or consume the unregistered food product “OTOKI Fluffy Cooked White Rice.”

Based on online monitoring and post-marketing surveillance activities, the FDA confirmed that the product is not registered and has not been issued a Certificate of Product Registration (CPR). Under Republic Act No. 9711, also known as the Food and Drug Administration Act of 2009, the manufacture, importation, exportation, sale, distribution, promotion, or advertising of health products without proper FDA authorization is strictly prohibited.

As the product has not undergone FDA evaluation, the Authority stated that it cannot guarantee the quality, safety, or compliance of the product with applicable food safety standards.

Regulatory Actions and Market Controls

The FDA has directed all concerned establishments to immediately cease the distribution, sale, promotion, and advertising of “OTOKI Fluffy Cooked White Rice” until a valid CPR is obtained. Failure to comply may result in regulatory enforcement actions and sanctions.

Relevant government authorities have been requested to ensure that the product is not sold or made available within their jurisdictions. The Bureau of Customs has likewise been instructed to restrain the importation and exportation of this product, as well as other unregistered food products.

Process for Lifting the Advisory

The Market Authorization Holder may petition for the lifting of the advisory by submitting a formal written request to the FDA, accompanied by:

A copy of the valid CPR,

Clear and comprehensive photographic evidence of the compliant product in its final commercial presentation, and

A copy of FDA Advisory No. 2025-1607 for verification.

Consumer and Stakeholder Guidance

The FDA encourages stakeholders and consumers to verify the registration status of food products through the FDA Verification Portal and the FDA Advisories Issuances Database. Reports of sale or distribution of unregistered food products may be submitted via the FDA’s designated reporting channels.