Fees and Requirements for FDA-Approved Food Supplements in the Philippines (Part 2)

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 [11] 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 pair@fda.gov.ph. 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.

How to Apply for FDA LTO (License to Operate) in the Philippines

Interested in FDA LTO application (License to Operate from the Philippine Food and Drug Administration) but don’t know where to start?

This new guide gives you a complete step-by-step process on how to apply for an FDA LTO in 2020.

While there are quite a few articles online on FDA LTO application, they are mostly outdated.

One major change to the process is that it is now done online via https://eportal.fda.gov.ph (the integrated application form may be found here).

Once processed and approved, the LTO will be mailed to you; no need to pick it up from regional FDA centers.

Click the links below to go directly to that part of this article:

  1. What is an LTO? Why would you need one?
  2. How to Apply for FDA eLTO User Account
  3. License to Operate Requirements
  4. Steps for FDA LTO Application
  5. Tips to make application easier and faster

What is an LTO or License to Operate? Why would you need one?

An LTO allows you to legally import, distribute, sell wholesale, and/or manufacture food, drugs, cosmetics, and medical devices. It is also a requirement before you can obtain a Certificate of Product Registration (CPR), a seal of approval which indicates that your product complies with health, safety, and technical standards set by the FDA in the Philippines.

Operating without a license can spell disaster for your business. If caught, your LTO may be suspended, revoked, canceled, or disapproved upon renewal. Likewise, existing licenses that were not renewed after one-hundred twenty (120) days from the date of expiration will be automatically canceled by the FDA. Not only that, but the company will automatically be delisted from the FDA’s list of licensed establishments, so be sure to renew on time.

Important Reminder: Only residents of the Philippines (either Filipino citizens or alien holders of resident visas) and majority Filipino-owned companies may apply for LTO.

All guidelines and penalties may be found on the FDA website: http://www.fda.gov.ph

 

How to Apply for FDA eLTO User Account

Per FDA Circular 2016-004 (Procedures on the Use of the New Application Form for License to Operate through the FDA Electronic Portal), the application process has been moved online. With the goal of increasing transparency, accessibility, and efficiency of the process, this decision has been especially beneficial for businesses based outside Metro Manila.

Before you can access the E-portal, you must first create a User Account, the application for which is not as straightforward as what you may be used to. Instead of a simple sign-up button, it instead involves sending a few emails. Here’s how to create a new User Account for the FDA E-Portal System:

Creating eLTO User Account
  • First, accomplish an authorization letter for the eLTO User Account Application. This will designate a specific individual as eLTO account holder.
  • Next, send an email to request for a User Account to the FDA’s Public Assistance, Information and Receiving (PAIR) unit via pair@fda.gov.ph with the following format:

SUBJECT: Request for eLTO User Account

BODY:

a. E-mail address (preferably company email address)
b. Name of the authorized company representative (preferably permanently employed and not merely a consultant)
c. Position in the company
d. Contact Number
e. Company Name

  • Don’t forget to attach a scanned Authorization Letter in PDF format. Be sure that it is completed (signed and notarized) and virus-free.

Below is a sample email provided by the FDA:

From: https://ww2.fda.gov.ph/attachments/article/330042/FDA%20Circular%20No.%202016-004.pdf
About the eLTO User Account

Please take note that the User Account details will be sent to the company email address provided in the body of the email, not to the original sender’s email address. User Accounts are usually issued within two (2) days upon receipt of the completed request by the FDA in the Philippines. Requests received after 5:00 pm on regular working days, holidays, Saturdays, and Sundays shall be processed on the next working day.

Each User Account is unique to one company and is valid for one (1) year. Requests for replacing the authorized company representative as well as account reactivation must be sent to pair@fda.gov.ph at least three (3) months before the expiration of the User Account.

Once you have a valid User Account in hand, the E-Portal can now be accessed. Filling up the forms and uploading the documents can now be done via the portal. The E-Portal accepts new, renewal, and variation applications.

The accomplishment of the eLTO may be done via http://www.fda.gov.ph.

License to Operate Requirements

The following are the License to Operate requirements for initial and renewal applications. Ensure that all documents are secured before applying to avoid processing delays.

Requirements for FDA LTO - Initial and Renewal Application

FDA LTO Initial Requirements:

  • Completed Application Form with Declaration and Undertaking
  • Proof of Business Name Registration
  • Risk Management Plan
  • Site Master File (for manufacturers of drugs, devices and cosmetics)
  • Fees payment

FDA LTO Renewal Requirements:

  • Completed Application Form with Declaration and Undertaking
  • Payment of fees

Now that you have all the requirements, the application for the actual license can now follow.

Steps for FDA LTO Application

Applying for an initial FDA LTO consists of the following steps: filing, evaluation, and inspection. An application is considered filed only if all necessary requirements are met, including payment of fees. After filing, the FDA will evaluate all LTO applications to determine whether to grant the license or not. Lastly, a pre-opening inspection shall be conducted for manufacturers. In addition, all establishments covered under the FDA may be inspected anytime by the agency to ensure proper compliance with its set rules and regulations.

  • Log-in to the e-Portal using the User Account provided by FDA at http://www.fda.gov.ph.
  • Click “New Case” on the upper left-hand side and select “License to Operate v2.0” which can be found under Electronic Licensing.
  • Make sure you’ve read and fully understood the “Declaration and Undertaking” and click the “I Agree” button before proceeding.
  • Under the General Information tab, select the appropriate Product Type, Primary Activity, and Type of Application from their respective drop-down menus.
  • (Each primary activity has its applicable sub-options. Accomplish the General Information appropriately).
  • Under Establishment Information, provide the complete establishment name, TIN, address, and contact details. Use the Show Map Tool and move the arrow to the exact address of the establishment and click the “Submit” button.
  • Provide needed information under “Details of the Authorized Officer” and “Details of the Applicant.”Upload the required documents (depending on LTO type). Make sure documents are in PDF format.
  • Double-check the total amount to be paid by looking at the Order of Payment section, which can be downloaded if needed.
  • Payment can be made using existing FDA mechanisms.
  • Please note: Under the “Assign Task” section, please click the “Continue” button in order for the application to be processed by the FDA.

Here are some tips to make application easier and faster:

Tips for Faster and Easier FDA LTO Application

Tip 1: Follow documentary requirements listed in Administrative Order (AO) 2016-0003 (“Guidelines on Unified Licensing Requirements and Procedures of the Food and Drug Administration”):

  • Submit files in PDF format and ensure that there are no bugs, viruses, or anything that can jeopardize the system of the FDA.
  • All documents must be scanned and compiled with 100-150 dots-per-inch (dpi).
  • All document file names must be less than 40 characters, should not contain the following characters: \ ? / : * ” > <

Tip 2: Make sure to submit all forms completely. Do not forget to attach files to emails before sending them.

Tip 3: Get assistance from DAYANAN Business Consultancy! With our FDA Consulting services, you would no longer have to stress and fret over the LTO application process.

After you’re done applying, expect your FDA License to Operate (LTO) in the mail! We hope these tips answer your queries on how to apply for an FDA LTO. If you would like to avail of our FDA consulting services, you may contact us here.

FDA Consulting Philippines