On August 18, 2026, the Philippines Food and Drug Administration (FDA) issued the draft "Guidelines on the Classification and List of Identified Health Products under the Jurisdiction of the Food and Drug Administration (hereinafter referred to as the "Guidelines")" for public comment by stakeholders, with a feedback deadline of September 17, 2026. Comments may be sent to the FDA Policy and Planning Service. The Guidelines will take effect fifteen days after publication in the Official Gazette.
Background: The Dilemma of "Which Center Should I Go To?"
Under the Food, Drug and Cosmetics Act and Food and Drug Administration Act of 2009, the Philippines FDA regulates five categories of health products: food, drugs, medical devices, cosmetics, and household/urban hazardous substances (HUHS) .
The Guidelines seek to achieve four objectives:
- Clarify the legal definitions of food, drugs, cosmetics and devices;
- Establish attribution rules for combination health products;
- Provide examples of products with similar characteristics and their corresponding classifications;
- Set out transitional provisions for product reclassification and label digestion.
Cosmetics: Definition and Three "Red Lines"
In the Philippines, cosmetics are regulated by the FDA's Center for Cosmetics and Household/Urban Hazardous Substances Regulation and Research (CCHUHSRR). In addition to Food and Drug Administration Act of 2009, cosmetics regulation also follows the ASEAN Cosmetic Directive (ACD).
The legal definition of a cosmetic is:
‘Cosmetics’ means any substance or preparation intended to be placed in contact with the various external parts of the human body or with the teeth and the mucous membranes of the oral cavity, with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/ or correcting body odor, and/ or protecting the body or keeping them in good condition.
The Guidelines emphasize that determining whether a product is a cosmetic requires grasping two core characteristics — the route of use and the intended use — while observing three "red lines":
- It must not contain prohibited ingredients, or use restricted ingredients in excess of their limits;
- It must not be represented as capable of treating or preventing human diseases;
- It must not ordinarily produce permanent effects on the human body.
Regarding claims, the Guidelines explicitly reference the ASEAN Cosmetic Claims Guidelines, requiring that product claims comply with that Guidelines. In addition, ingredients, product presentation and physiological effects will also influence product classification.
How Are Borderline Products Classified? — A Cosmetics Perspective from the Annex Examples
The annex to the Guidelines provides 46 examples of typical product classifications, many of which are directly relevant to cosmetics. These examples clearly illustrate how the same type of product may fall under cosmetics, drugs or medical devices depending on differences in claims, ingredient concentrations or mechanisms of action.
The following are some examples:
| Product | Classified as Cosmetic (CCHUHSRR) | Classified as Drug (CDRR) / Device (CDRRHR) |
| Salicylic acid products | Concentration complies with ACD Annex III/VI limits | Contains 75% salicylic acid → Drug |
| Mouthwash | No therapeutic claims, not used for gargling | - |
| False eyelash / wig adhesive | Yes | - |
| Cosmetic contact lenses | - | Medical device |
Five-Year Transition Period
The Guidelines establish a transition period for products currently on the market that require reclassification, with the main arrangements as follows:
- Existing registered/notified products: Where a product registration certificate/notification (CPR/CPN) expires within five years after the Guidelines take effect, an initial application under the new classification may be submitted after the existing authorization expires; for products transferring across centers, the initial registration/notification procedure and requirements of the new center must be followed, and a License to Operate (LTO) corresponding to the new classification must be obtained before filing the application.
- Pending applications: Initial and renewal applications submitted before the Guidelines take effect will continue to be processed by the originally accepting center; before theauthorization expires, the holder must obtain new authorization from the appropriate center.
- Upon registration/notification of a reclassified product with the appropriate center, the original authorization must be canceled.
- Inventory digestion: For products with a remaining validity not exceeding three years, a maximum of three years' validity may be granted upon renewal to complete reclassification and digest remaining stock.
- Label digestion: During the transition between old and new authorizations, companies may apply to the FDA for label digestion, valid for up to six months from the date of approval, and must submit the corresponding inventory list; after the five-year transition period expires, label digestion will no longer be permitted.
- Failure to comply with the transitional provisions may constitute a prohibited act, subject to penalties including application rejection, license suspension or revocation.
"Self-Assessment Tool" to Be Launched Online
The FDA announced that, upon issuance of the Guidelines, it will launch a "Self-Assessment Health Product Classification Tool" on its official website (www.fda.gov.ph) to help companies determine their product classifications. However, the FDA stresses that the tool's results are not binding and shall not be interpreted or understood as an FDA regulatory decision on product classification; the risk of use rests with the user.
If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.
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