What is a food supplement?
A food or dietary supplement is a processed food product intended to supplement the diet that bears or contains one or more of the following dietary ingredients: vitamin, mineral, herb, or other botanical, amino acid, and dietary substance to increase the total daily intake in amounts conforming to the latest Philippine recommended energy and nutrient intakes or internationally agreed minimum daily requirements. It usually is in the form of capsules, tablets, liquids, gels, powders, or pills and not represented for use as a conventional food or as the sole item of a meal or diet or replacement of drugs and medicines.
Food supplements must be registered with the Food and Drug Administration (FDA) before manufacturing, importing, exporting, transferring, or distributing them. Product registration is necessary as it is the only way for the FDA to ensure the product’s quality and safety. The proper office is the Center for Food Regulation and Research of the FDA.
And by registration, it means the process of approval of an application to register health products prior to engaging in the manufacture, importation, exportation, sale, offer for sale, distribution, transfer, and where applicable, the use, testing, promotion, advertisement, and/or sponsorship of health products.
A certificate of product registration shall be issued by the FDA after complying with the necessary requirements.
What are the requirements for registration of a food supplement with the Food and Drug Administration of the Philippines?
The following are the requirements for a product registration (Imported/Locally Manufactured Food Supplements)
- Valid License to Operate (Manufacturer/Exporter/Trader/Importer/ Distributor/ Wholesaler)
- Scanned copy of clear and complete loose labels or artworks as applicable, of all packaging sizes, or equivalents and picture of the product in all angles and in different packaging sizes, and from at least two different perspective allowing visual recognition of a product as the same with the one being registered. Include the artworks and/or blister packs Alu- Alu Pack and secondary packaging (i.e., paper box or cardboard box)
- For Trader/Wholesaler/Distributor of Locally manufactured Food Products (when a product is manufactured or distributed by an establishment other than the FDA Licensed Manufacturer)
Scanned copy of any of the following:
- Notarized Distribution
- Contract Agreement with FDA Licensed Food Manufacturer/ Repacker
For Importers/ Distributors, scanned copy of any of the original documents:
- Foreign Agency Agreement
- Certificate of Distributorship
- Appointment Letter
- Proforma Invoice
- Memorandum of Agreement from the Manufacturer
And scanned copy of any of the following:
- Manufacturer’s certificate of registration with GMP compliance
- Valid Phytosanitary Certificate/ Health Certificate
- Valid ISO 22000 Certification
- Valid HACCP Certificate issued in the country of origin
- Certificate of Free Sale (CFS) attested by the recognized regulatory body or Chamber of Commerce / Phil. Consulate in the country of origin
- As applicable, documents to substantiate claims, such as:
- Technical or nutrition health studies or reports
- Market research studies
- Certificate of analysis, quantitative analysis, and computations
- Scientific reports or studies published in peer-reviewed scientific journals
- Certificates or certification to support use of logo/seal on Sangkap Pinoy, Halal, Organic, Kosher and in compliance with current labeling requirements.
- Certificate of Analysis reflecting critical parameters to determine compliance to applicable standards and regulations
For medium and high risk products with standars of identity (infant formula, milk supplement, food for infants and young children, foods for special medical purposes, foods for special dietary use, food suplements, bottled water, processes meat products, etc.), the corresponding Certificates of Analysis for assessment of compliance to such standard must be submitted.
- Additional requirements for food supplement:
- Stability study of the finished product
- Safety data (e.g., LD50 or toxicity tests as applicable to products with herbs and botanical ingredients not included in the Official Pharmacopoeias and Generally Recognized as Safe (GRAS) list or other applicable test procedures or reports to assess potential toxicity) must be attached to address uncertainties on safety of the product.
- Actual representative product of sample of Food Supplement (on initial application only) in commercial presentation with labels
Representative samples must be properly labeled with the respective case numbers, packaged accordingly to protect the contents and submitted to FDA Main Office within ten (10) days upon assessing fee through delivery via commericial courier. The package must contain following information:
Food and Drug Administration
Civic Drive, Filinvetst City, Alabang, Muntinlupa City
From: Company’s Complete Name and Address
Subject: Food Product e registration application
What is the penalty for non-compliance with the product registration?
Under Republic Act No. 9711 also known as the Food and Drug Administration Act of 2009, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertisement, or sponsorship of any food supplement which, although requiring registration, is not registered is a prohibited act which is punishable by one (1) year to ten (10) years of imprisonment and/or a fine a fine ranging from Fifty thousand pesos (P50,000.00) to Five hundred thousand pesos (P500,000.00).
About Nicolas and De Vega Law Offices
If you need assistance in registration with the Food and Drug Administration, applications for Licenses to Operate, drug, cosmetic, medical device or food registration, registration of food supplements, licenses to operate or other applications with the Food and Drug Registration, or have issues in corporate law, commercial law, corporate or commercial litigation, or civil or other criminal law-related issues, we can help you. Nicolas and de Vega Law Offices is a full-service law firm in the Philippines. You may visit us at the 16th Flr., Suite 1607 AIC Burgundy Empire Tower, ADB Ave., Ortigas Center, 1605 Pasig City, Metro Manila, Philippines. You may also call us at +632 84706126, +632 84706130, +632 84016392 or e-mail us at [email protected]. Visit our website https://ndvlaw.com.