Philippines FDA Reinforces Ban on Therapeutic Claims for Dietary Supplements, Highlights Labeling Compliance

The Philippines FDA has issued a strict warning against marketing food and dietary supplements as medicines, reaffirming mandatory labeling requirements regarding therapeutic claims. The agency specifically highlighted violations involving Serpentina products being illegally promoted for unapproved indications, such as abortifacients, citing significant safety risks.

On November 25, 2025, the Philippines Food and Drug Administration (FDA) issued FDA Advisory No. 2025-1552, titled "Public Health Warning Against the Advertisement, Promotion, Marketing and Use of Food/Dietary Supplements for Therapeutic Purposes and Indications." This advisory addresses the growing concern over the misleading marketing of processed food products as drugs intended to treat, cure, or prevent diseases.

1. Regulatory Definition and Scope

In the Philippines, food/dietary supplements are defined as processed food products intended to supplement the diet. These may contain ingredients such as vitamins, minerals, amino acids, herbs, or other dietary substances, presented in forms like capsules, tablets, liquids, gels, or powders.

The FDA emphasizes that these products are regulated by the Center for Food Regulation and Research (CFRR). They are distinct from pharmaceutical drugs and serve only as adjunct nutritional substances to support food intake. They must not replace prescribed maintenance medicines for conditions such as hypertension, diabetes, or cancer.

2. Mandatory Labeling and Advertising Requirements

To ensure compliance and consumer safety, the FDA strictly enforces specific labeling and advertising mandates for all food and dietary supplements. Manufacturers and distributors must adhere to the following:

Standard Disclaimer: Product labels must bear the statement "NO APPROVED THERAPEUTIC CLAIMS."
Precautionary Statement: Where applicable based on the product's safety profile, labels must include "NOT RECOMMENDED FOR CHILDREN, PREGNANT, AND LACTATING WOMEN."
Advertising Mandate: All advertisements, promotions, and sponsorships for these products must include the specific Filipino warning statement: "MAHALAGANG PAALALA: ANG [NAME OF PRODUCT] AY HINDI GAMOT AT HINDI DAPAT GAMITING PANGGAMOT SA ANUMANG URI NG SAKIT." (Important Reminder: [Name of Product] is not a medicine and should not be used to treat any type of illness.)

3. Specific Safety Violations: Serpentina

The advisory explicitly flags recent reports of violations involving supplements containing Serpentina (Andrographis paniculata; Rauvolfia serpentina). The FDA notes these products are being illegally promoted for unapproved therapeutic indications, specifically as abortifacients.

Scientific literature and World Health Organization (WHO) data indicating that both Rauvolfia serpentina and Andrographis paniculata are contraindicated for pregnant women due to risks of uterine stimulation, embryotoxicity, and neonatal complications. The FDA is actively gathering data on these reports to validate the public health impact.

4. Verification Obligations

The FDA instructs all stakeholders to verify the registration status of food/dietary supplements. Brand owners and consumers can validate products by searching the brand name, product name, or registration number via the FDA Verification Portal.