The Philippines requires two separate FDA approvals before a food supplement can be sold — one for the company doing the importing, and one for the product itself — and a label statement that has to appear in an exact, prescribed form. Missing either approval, or getting the label wording wrong, is enough to stop a shipment at customs or trigger an FDA advisory.
This guide covers who regulates a Japan-made supplement in the Philippines, what the importer’s licence and the product’s registration each require, and the mandatory label statement.
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Who regulates a food supplement in the Philippines
The Philippine Food and Drug Administration (FDA), through its Center for Food Regulation and Research, regulates food supplements as a category distinct from both ordinary food and from drugs.
A food supplement in the Philippines sits under FDA’s food-regulation function rather than its drug-regulation function, but it still requires its own registration route separate from ordinary packaged food — closer in rigour to a health product filing than to a standard food notification.
Two separate FDA approvals: LTO and CPR
The importer needs a License to Operate (LTO) before it can act at all, and each product needs its own Certificate of Product Registration (CPR) before it can be sold.
| Approval | Who holds it | What it covers |
|---|---|---|
| License to Operate (LTO) | The Philippine importer, distributor or wholesaler | Authorises the company to import, distribute or sell FDA-regulated products, including food supplements, in the Philippines |
| Certificate of Product Registration (CPR) | The Philippine importer/registrant, per product | Confirms the specific product is authorised for sale; serves as evidence of the registrant’s marketing authority for that product |
A company must first hold a valid LTO before it can even apply for a CPR. Food supplement products in the Philippines “are required to be registered and shall have a valid Certificate of Product Registration (CPR) before they can be legally sold, imported, exported, [or] distributed” in the country. Because both approvals are issued to a Philippine-registered entity, the Japanese factory cannot hold either directly — your Philippine importer or distributor is the party that files for and holds both.
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The mandatory “No Approved Therapeutic Claims” statement
A Philippine food supplement label must carry the exact caption “NO APPROVED THERAPEUTIC CLAIMS,” printed prominently, and the product must not be marketed for treating, preventing or curing any illness.
FDA requires the caption “NO APPROVED THERAPEUTIC CLAIMS” to appear on the principal display panel of the label. The purpose, as FDA states, is to inform consumers that a food supplement has “no approved curative effects” and that “the product should not have claims to cure, prevent, mitigate, or treat any diseases.” FDA has issued advisories reinforcing this rule and warning specifically against advertising, promotion or marketing of food/dietary supplements for therapeutic purposes or indications — this applies to advertising and marketing claims, not only the printed label.
Health supplements are foods, not medicines, and are not a substitute for medical treatment. A Japanese domestic label’s claim wording, including anything drawn from Japan’s Foods with Function Claims or Foods with Nutrient Function Claims systems, has no standing in the Philippines and must be reassessed by your Philippine registrant against FDA’s own rules before it appears on any Philippine label or advertisement.
Before you ask for a quotation
- Confirm your Philippine importer holds, or is applying for, a valid LTO
- Plan for a per-product CPR application, filed by your Philippine registrant, before the product goes on sale
- Confirm the label will carry the “NO APPROVED THERAPEUTIC CLAIMS” caption on the principal display panel
- Review any intended marketing or advertising wording against FDA’s ban on therapeutic claims, not just the printed label
- List supporting documents your importer will need: specification sheet, Certificate of Analysis, Certificate of Free Sale
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Frequently asked questions
1. Can our Japanese factory register the product directly with Philippine FDA?
No. Both the License to Operate and the Certificate of Product Registration must be held by a Philippine-registered company. The factory instead supplies the specification, Certificate of Analysis and Certificate of Free Sale that support your Philippine importer’s filing.
2. What is the difference between the LTO and the CPR?
The LTO authorises the company itself to import, distribute or sell FDA-regulated products; the CPR authorises the specific product. A company needs a valid LTO before it can apply for a CPR.
3. Does every food supplement label need the “NO APPROVED THERAPEUTIC CLAIMS” statement?
Yes. FDA requires this exact caption on the principal display panel of a food supplement label, to make clear the product has no approved curative effect and is not authorised to treat, prevent, mitigate or cure disease.
4. Can we describe a health benefit on the label at all?
Only within what FDA’s rules for food supplements permit, and never combined with disease-treatment language. The mandatory no-therapeutic-claims statement applies regardless of any other wording used.
5. Does the therapeutic-claims restriction apply only to the printed label, or also to advertising?
Both. FDA has issued advisories specifically warning against advertising, promotion, marketing and sponsorship of food/dietary supplements for therapeutic purposes, not only against label wording.
Sources: Philippine Food and Drug Administration, “FDA Advisory No.2025-1552: Public Health Warning Against the Advertisement, Promotion, Marketing and Use of Food/Dietary Supplements for Therapeutic Purposes and Indications,” fda.gov.ph; Philippine FDA Center for Food Regulation and Research, Certificate of Product Registration requirements for food supplements, fda.gov.ph / eservices.fda.gov.ph. Checked on 25 September 2026.