If you are interested to sell, import, and distribute FDA-approved food supplements in the Philippines, then the Food and Drug Administration (FDA) is your first stop. This article, Part 2 of this series, discusses the detailed requirements you need to prepare to get FDA approval as well as the corresponding fees and charges.
What kind of supplements need to be registered with the FDA?
All types of processed foods, including food supplements that contain no additional pharmacologically active ingredients, must receive approval first from the FDA. It must be noted that per FDA Circular 2016-014, the registration process applies to low-risk, medium-risk, and high-risk food products (refer to our previous article for a discussion on these categories).
How many kinds of FDA registrations do I need for my product?
One registration may satisfy different packaging sizes for the same product as long as they share the same brand and product names. They must also have exactly similar formulation and proportion of ingredients. When it comes to the label information, everything must also be the same except for net weight.
If you are a manufacturer, trader, or distributor (whether importer, exporter, or wholesaler), you need to get a License to Operate (LTO) before you can obtain a certificate of product registration (CPR).
To get prioritized in food registrations, you must attend and complete the Qualified Person in Industry Regulatory Affairs (QPIRA) Training organized by the Center for Food Regulation and Research (CFRR). Before availing the services of a Liaison Officer to help you transact with the FDA, check for their names in the FDA website first.
What are the requirements for FDA approval in the Philippines?
FDA-approved food supplements in the Philippines present these documents first:
- Notarized and completed Integrated Application Form
- Proof of payment of fees
- Clear and complete loose labels or artworks of all packaging sizes
- Sticker of importer for imported food supplements.
- Pictures of the product from all different angles for all packaging sizes
- For food supplements, a sample in actual commercial presentation needs to be submitted
- Certificate of analysis to demonstrate compliance with Codex, national and other standards – Physical, Chemical and Microbiological Analysis, stability data of the finished product and Safety Data
- Documentation to substantiate the use of claims in the given case
- Certification to support use of logo’s (e.g. Halal, Kosher, Organic)
- Certificate of analysis to determine compliance with applicable standards (e.g. Codex, Philippine National, etc.)
- Relevant scientific studies to support the use of products for specific purposes
- Certificate of analysis to determine compliance with FDA circular No. 2013
- Quantitative analysis and computations to support nutrition facts/nutrient content claims
- Scientific researches or studies published in peer-reviewed scientific journals to support declaration of health and nutrition claims
- Other relevant supporting documents to substantiate claims other than health and nutrition
- Additional requirements to address uncertainties on safety as deemed necessary
For more detailed information on these requirements, check out FDA Circular 2016-014 here.
How do I process my registration with FDA Philippines?
- Download the Integrated Application Form  from the FDA website and fill-in the required details.
- After filling up the document, it will generate a worksheet email which you have to send to email@example.com. A maximum of 10 applications with the FDA may be forwarded in a single email.
- Your application will then be scheduled through a Document Tracking Log (DTL) sent to your email within two days.
- After receiving the DTL, make sure to pay the fees. You can submit your application via soft copy (USB device). Note that only applications scheduled for the day will be accommodated.
What fees and charges do I need to pay for an FDA Philippines registration of my supplements?
This schedule of fees is based on FDA Administrative Order 2001-50
1) Product classification = PhP 500.00
2) Initial Registration for Food Supplements = PhP 1,000.00 (Valid for up to 2 years)
3) Renewal of Registration for Food Supplements = PhP 5,000.00 (Valid for up to 3 years)
4) Amendment of CPR = PhP 200.00
5) Re-application Fees = PhP 200.00
Please note that payment of fees cannot exceed ten applications. Manufacturing and distribution licenses require the payment of a separate fee. Such a license is initially valid for 1 year and 2 years upon renewal.