Scope of Guidelines
- Applicable to consumer complaints filed with FDA on health products, services, advertisements, and sales promotions.
- Excludes complaints under Consumer Arbitrators per RA 7394 Sec. 163, other tribunals, quasi-judicial bodies, and courts.
General Procedures for Filing Complaints
- Complainants must file complaints at the appropriate FDA Center/Office depending on product type:
- Processed foods and supplements: CFRR
- Cosmetics, household/urban hazardous substances, pesticides: CCRR
- Drugs, herbal, traditional, veterinary drugs, vaccines, biologicals: CDRR
- Medical devices and related products: CDRRHR
- Complaint Form must be completed by complainant or FDA personnel (for phone complaints).
- FDA personnel must certify accuracy for phone complaints.
- Thorough interview to establish facts based on complainant's personal knowledge.
- Complainant's signature required on Complaint Form.
- Supporting evidence such as photos, receipts, medical certificates, and product samples must be submitted.
- Products requiring laboratory analysis are referred only after evaluation and completion of Referral Form.
- Complainant informed of follow-up actions.
Specific Guidelines on Product Acceptance for Laboratory Analysis
- Only certain products accepted for physico-chemical and microbiological testing based on criteria:
- Food products must be registered, non-expired, properly labeled, and show possible adulteration or adverse effects.
- Drug products must be registered, non-expired, properly labeled, suspected counterfeit/tampered, or batch-certified antibiotics.
- Cosmetics and hazardous substances must be notified or registered, non-expired, suspected adulterated, or linked to adverse reactions.
- Microbiological analysis rejection criteria include unregistered/unlabeled products, expired products, visible filth, spoilage, improper storage, or insufficient sample size.
Categories of Complaints Outside FDA Jurisdiction
- The FDA does not handle complaints related to:
- Restaurants, hotels, hospitals, airlines, shipping lines, home-cooked foods.
- Street foods and "tingi-tingi" or small-quantity market foods.
- Fresh produce such as fruits, vegetables, meat, poultry, seafood.
- Non-bottled water (tap and refilling stations).
- Grains like rice.
- Suspected poisoning cases.
- Dangerous drugs per law.
- Agricultural pesticides and fertilizers.
- Medical malpractice-related products.
- Senior citizen discounted products.
- Price Act violations except certain drug pricing.
- Trade disputes between companies if not involving counterfeit health products.
- Processed canned and meat products.
Additional Consumer Guidelines and Recommendations
- Consumers should purchase health products only from licensed and legitimate establishments.
- Only registered health products should be bought.
- Avoid products with foreign-only labels or without Filipino/English translations.
- Always verify expiration or best-before dates.
- Avoid damaged or deformed packaging.
- Check FDA website for product registration status.
- Online reporting via FDA website or email is encouraged.
- Specific online ADR (Adverse Drug Reaction) reporting available.
- FDA contact email provided for inquiries.
Effectivity
- The Circular took effect immediately upon issuance.