POST-MARKETING SURVEILLANCE

(PMS) ON PROCESSED FOOD

PRODUCTS AND FOOD
ESTABLISHMENTS

PAULA RHEIN F. OPULENCIA, RND

Food-Drug Regulation Officer I
Food Safety Unit – Center for Food Regulation and Research
 POST-MARKETING SURVEILLANCE (PMS) ON PROCESSED FOOD PRODUCTS AND
FOOD ESTABLISHMENTS

Overview
FOOD SAFETY UNIT
• Mandated by the Food Safety Act of 2013
• PMS arm of the Center for Food Regulation and Research (CFRR)
• Food Safety Regulation and Coordination Board (FSRCB) Secretariat
• Philippine Rapid Alert System for Food and Feed (PhilRASFF)
National Contact Point
 POST-MARKETING SURVEILLANCE (PMS) ON PROCESSED FOOD PRODUCTS AND
FOOD ESTABLISHMENTS

OVERVIEW OF THE PROCESS

Verification Evaluation Drafting of

Receiving Referral Report

Forwarding
Issuance of Storage / Checking and
of Report to
Appropriate Disposal of Signing of OIC
the
Administrative Sample FSU and CFRR
concerned
Tools Products Director
Office
 POST-MARKETING SURVEILLANCE (PMS) ON PROCESSED FOOD PRODUCTS AND
FOOD ESTABLISHMENTS

BASIS
CFRR Annual Post Marketing Plan
 POST-MARKETING SURVEILLANCE (PMS) ON PROCESSED FOOD PRODUCTS AND
FOOD ESTABLISHMENTS

SOURCES
• Samples monitored and collected by Regional Field Inspectors
 POST-MARKETING SURVEILLANCE (PMS) ON PROCESSED FOOD PRODUCTS AND
FOOD ESTABLISHMENTS

• Advertisements and promotions monitored by Field Inspectors

As per DOH-FDA CFRR Permit No. 9999 s. 2019

SOURCES
• Consumer or Company inquiries / Reports
OTHER SOURCES
• Referrals from Different Agencies (i.e DTI, LGU, Law Enforcement
Agencies)
• Complaints
• Out-of-Specification Test Reports
• International Networks/ Notifications
PROCESS?
 RECEIVING
Referral Report Actual Sample/picture of the
monitored Advertisements/Brochure

+
 VERIFICATION

Tools Used: RECEIVING

 Food Safety Unit
Database
 CFRR Database
 E-portal
 FDA Website
 EVALUATION
If the monitored food product is registered, the labelling compliances
based on CPR Remarks and FDA Regulations will be checked.
How about on the following monitored products?
a)Not Registered
b)Registered, but not compliant with labelling regulations set by the
FDA
c) Operating of companies without License-to-Operate

Issuance of Administrative tools

 ISSUANCE OF
ADMINISTRATIVE TOOLS
 ISSUANCE OF ADMINISTRATIVE TOOLS

ADMINISTRATIVE TOOLS
• Notification Letters to Companies
• Report of Violation (ROV)
• FDA Public Health Advisory
• FDA Orders
 ISSUANCE OF ADMINISTRATIVE TOOLS

LETTERS (Notification Letter)to Companies

• FDA issues letters to implicated companies to verify the received Reports
and to request investigation as the feedback from the companies will be
used by FDA in updating the international system.

What should the companies do once they receive the letter?

Companies should respond within the stipulated time. Must submit the
following:
Official response with Corrective and Preventive Action (CAPA)
Complete documents of the process (i.e investigation result, product recall)
 ISSUANCE OF ADMINISTRATIVE TOOLS

If actions and investigation of the company is

insufficient:
Request supporting documents
For Inspection of the establishment by FDA Inspectors
Request for sample collection by FDA Inspectors
a) To verify the CAPA submitted by the company
b) To verify and confirm the claims of the company
 ISSUANCE OF ADMINISTRATIVE TOOLS

REPORT OF VIOLATION (ROV)

Shall be issued by Field Inspectors to the company with the following
non-compliances:
• Non-compliant registered food products and supplements/mislabeled/ misbranded
• Unregistered food products and food supplements
• Unlicensed establishment
• Products with unapproved claims on the advertisements
• Products with out-of-specification laboratory test reports
 ISSUANCE OF ADMINISTRATIVE TOOLS

REPORT OF VIOLATION cont.

The Legal Support Services Center (LSSC) of FDA shall evaluate the
merits of the endorsed ROV based on the completeness of the
documentation of the Field Inspectors. Should there be sufficient
merits to the case, the LSSC shall recommend a Summons to the
violating establishment or personality and will be signed by the FDA
Director General.

All legal actions shall be executed by the FDA Regulatory

Enforcement Unit.
 ISSUANCE OF ADMINISTRATIVE TOOLS

FDA ADVISORY
• Issued to warn the general public regarding unregistered food products
and food supplements being sold in the market
• Issued to products with safety and quality issues (i.e Product Recall)
• Posted at FDA Website accessible at www.fda.gov.ph and in social
media site
 ISSUANCE OF ADMINISTRATIVE TOOLS

SAMPLE FDA ADVISORIES

 ISSUANCE OF ADMINISTRATIVE TOOLS

SAMPLE FDA ADVISORIES

 ISSUANCE OF ADMINISTRATIVE TOOLS

FDA ORDER
• All monitored unregistered food products/supplements
• Issued to FDA Inspectors and Regulatory Enforcement Units to
conduct of inventory and seizure of unregistered food products and
supplements offered for sale and/or sold in the Market
 ISSUANCE OF ADMINISTRATIVE TOOLS

QUESTION
My food product/ supplement is on Advisory,
how do I lift the Public Warning
on my product?

 Once the product has been registered

and the company has submitted a letter to FDA
providing proof such as Certificate of Product
Registration and a picture of the compliant
product in commercial presentation, and also
verified by Food Safety Unit, the FDA Advisory
will be lifted and will be posted and published on
FDA Website and social media site.
 THANK YOU!
For other concerns, email us at
foodsafety@fda.gov.ph