Author: Administrator

FDA Advisory No. 2020-1444 || Public Health Warning Against the Purchase and Use of Counterfeit Cosmetic Product “ARTISTA SCENT PERFECT WHITE CREAM SILKY”

The Food and Drug Administration (FDA) warns the public from purchasing and using the below counterfeit cosmetic product:

  1. “ARTISTA SCENT PERFECT WHITE CREAM SILKY”

The FDA has coordinated with the Market Authorization Holder (MAH), SKIN MAGICAL BEAUTY PRODUCTS TRADING, and has verified that the aforementioned cosmetic product is COUNTERFEIT. According to the company SKIN MAGICAL BEAUTY PRODUCTS TRADING, the batch number coding of the aforementioned cosmetic product does not belong to them and is a counterfeit.

Counterfeit products did not go through the required safety assessment and the FDA verification process. These products pose potential health hazards to the consuming public since their safety and purity cannot be guaranteed. Potential hazards may come from ingredients that are not allowed to be part of a cosmetic product or restricted ingredients that in excessive amount as per ASEAN Cosmetic Directive (ACD). The use of substandard and possibly adulterated cosmetic products may result to adverse reactions, including but not limited to, skin irritation, itchiness, anaphylactic shock, and organ failure.

In light of the foregoing, the public is advised not to purchase the aforementioned violative cosmetic product. Moreover, the public is advised to always check if a cosmetic product is notified with the FDA. The FDA website (ww2.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing.

All concerned establishments are warned not to distribute counterfeit cosmetic products.

All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with Law Enforcement Agencies and Local Government Units, are requested to ensure that violative products are not sold or made available in the market or areas of jurisdiction.

Kindly contact the FDA Center for Cosmetics Regulation and Research through e-mail at [email protected] or call (02) 857-1900 local 8113 or 8107.

To report any sale or distribution of unnotified cosmetic products,email us at [email protected]

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-1444

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1444 || Public Health Warning Against the Purchase and Use of Counterfeit Cosmetic Product “ARTISTA SCENT PERFECT WHITE CREAM SILKY”

FDA Advisory No. 2020-1438 || Public Health Warning Against the Purchase and Use of Counterfeit Cosmetic Product “DOVE HAIR THERAPY HAIR FALL RESCUE + CONDITIONER”

The Food and Drug Administration (FDA) warns the public from purchasing and using the below counterfeit cosmetic product:

  1. DOVE HAIR THERAPY HAIR FALL RESCUE + CONDITIONER”

The FDA has coordinated with the Market Authorization Holder (MAH), Unilever Philippines, Inc., and has verified that the aforementioned cosmetic product is COUNTERFEIT. According to the company Unilever Philippines, Inc., the aforementioned cosmetic product was not manufactured/imported and/or distributed by Unilever.

Counterfeit products did not go through the required safety assessment and the FDA verification process. These products pose potential health hazards to the consuming public since their safety and purity cannot be guaranteed. Potential hazards may come from ingredients that are not allowed to be part of a cosmetic product or restricted ingredients that in excessive amount as per ASEAN Cosmetic Directive (ACD). The use of substandard and possibly adulterated cosmetic products may result to adverse reactions, including but not limited to, skin irritation, itchiness, anaphylactic shock, and organ failure.

In light of the foregoing, the public is advised not to purchase the aforementioned violative cosmetic product. Moreover, the public is advised to always check if a cosmetic product is notified with the FDA. The FDA website (ww2.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing.

All concerned establishments are warned not to distribute counterfeit cosmetic products.

All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with Law Enforcement Agencies and Local Government Units, are requested to ensure that violative products are not sold or made available in the market or areas of jurisdiction.

Kindly contact the FDA Center for Cosmetics Regulation and Research through e-mail at [email protected] or call (02) 857-1900 local 8113 or 8107.

To report any sale or distribution of unnotified cosmetic products,email us at [email protected]fda.gov.ph.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1438

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1438 || Public Health Warning Against the Purchase and Use of Counterfeit Cosmetic Product “DOVE HAIR THERAPY HAIR FALL RESCUE + CONDITIONER”

FDA Advisory No. 2020-1404 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND CONSUME the following unregistered food products:

  1. Achuete Powder
  2. TAY SENG & HOPIA BAKERY Caycay Sesame
  3. DUNDEE’S CEBU SPECIAL Durian
  4. DUNDEE ‘S BAKESHOP Special Home-made Caycay
  5. MAYFAIR Milk Chocolate

The FDA verified through post-marketing surveillance that the abovementioned food products are not registered and no corresponding Certificates of Product Registration (CPR) have been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered food products have not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative food products until CPR are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label, if available or the name of the product.

All Law Enforcement Agencies (LEAs) and Local Government Unit (LGUs) are requested to ensure that these products are not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of these unregistered products.

For more information and inquiries about this advisory, kindly contact the FDA Center for Food Regulation and Research through email [email protected] indicating on the subject the concerned Advisory, or call (02)857-1900 local 8105 and 8112.

To report any sale or distribution of unregistered product, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-1404

Procedure for the Use of the New Electronic Registration System Repealing FDA Circular No. 2016-014 “Procedure for the Use of Electronic Registration (E-Registration) System for Prepackaged Processed Food Products”

Please be informed that the subject draft contains an additional section for review/comments, Annex Dentitled Reference Guide to Stakeholders to Assess Compliance of Submitted Documents as Complete Requirements for Product RegistrationThe date of effectivity of the guidelines was moved to 15 September 2020.

This Office is therefore extending the web posting period of the subject draft for your review of Annex D, hence kindly submit your comments (if any) in MSWord (docx) format until 25 August 2020 by email to [email protected] with copy furnished to [email protected] using the format below:

Name of Organization
Contact Information

Telephone:                                                                              E-mail:

Title of draft policy (FDA Circular):

Procedure for the Use of the New Electronic Registration System Repealing FDA Circular No. 2016-014 “Procedure for the Use of Electronic Registration (E-Registration) System for Prepackaged Processed Food Products”

Section Comments Input / Recommendation
Suggested Text (if any)

Thank you.

Attachment:->Draft Procedure for the Use of the New Electronic Registration System
Attachment:->Annex D

/ In Draft for Comments / By Administrator / Comments Off on Procedure for the Use of the New Electronic Registration System Repealing FDA Circular No. 2016-014 “Procedure for the Use of Electronic Registration (E-Registration) System for Prepackaged Processed Food Products”

UPDATED CUSTOMER MOBILE HOTLINES OF FDAC AS OF 10 AUGUST 2020

Please be advised that our hotlines will still be temporarily unavailable due to our ongoing system upgrade. In the meantime, you may reach us through the following mobile numbers:

GLOBE/TM:

0956-4518268
0956-4518341
0977-6177991

SMART:

0961-6804447
0951-1311186
0961-0574926
0961-0574927

0961-770-9691

Email: [email protected]

Operating hours from 9AM to 4PM during working days. Rest assured that our team will respond to your concerns as soon as we can.

Thank you.

FDA Circular No. 2020-021 || Guidelines for the Acceptance of Certificate of Safety Evaluation (CSE) Applications for Radiofrequency Radiation (RFR) Facilities through the FDA RRD Portal

OBJECTIVES:

This Circular aims to provide implementing guidelines to all relevant stakeholders of the new process in the acceptance of applications of CSE for RFR facilities pursuant to DOH AO No. 2020-0035.

Read more:->FDA Circular No. 2020-021

/ In Circular / By Administrator / Comments Off on FDA Circular No. 2020-021 || Guidelines for the Acceptance of Certificate of Safety Evaluation (CSE) Applications for Radiofrequency Radiation (RFR) Facilities through the FDA RRD Portal

FDA Advisory No. 2020-1380 || Public Health Warning Against the Purchase and Use of Unregistered Household/Urban Pesticide (H/UP) MAPECON F3D50 TERMITE PROOFING

The Food and Drug Administration (FDA) warns the public from purchasing and using the unregistered household/urban pesticide (H/UP) product:

  1. MAPECON F3D50 TERMITE PROOFING

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Registration (CPR) as of 08 July 2020. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization from the FDA is prohibited.

Since the abovementioned unregistered household/urban pesticide product has not gone through the registration process of the FDA, the agency cannot assure their efficacy, quality and safety. The use of such violative product may pose health risks to consumers.

Potential hazards may come from harmful, toxic and banned active ingredients that pose imminent danger to human and animal health. The use of substandard and possibly adulterated household/urban pesticide products may result to adverse reactions including, but not limited to, skin irritation, itchiness, anaphylactic shock, respiratory disorders, endocrine complications, brain damage and organ failure.

In light of the foregoing, the public is advised not to purchase the aforementioned violative household/urban pesticide product. Moreover, the public is advised to always check if a household/urban pesticide product is registered with the FDA through its website (www.fda.gov.ph). It has a Search feature which may be used by typing in the name of the product before deciding on purchasing and/or using the said product.

All concerned establishments are warned not to distribute violative household/urban pesticides until they have fully complied with the rules and regulation of the FDA.

All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that violative products are not sold or made available in the market or areas of their jurisdiction.

To report any sale, distribution, complaint and/or adverse event on the use of the violative household/urban pesticides, email us at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-1380

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1380 || Public Health Warning Against the Purchase and Use of Unregistered Household/Urban Pesticide (H/UP) MAPECON F3D50 TERMITE PROOFING

FDA Advisory No. 2020-1402 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND CONSUME the following unregistered food products:

  1. COCO FALL IN LOVE WITH Hamburger Gummy Candy
  2. COCO FALL IN LOVE WITH Love lips
  3. INDAY ROSE Ground Black Pepper
  4. ELMAR’S Imported Raisins
  5. GENREV Sardines in Tomato Sauce-Hot & Spicy

The FDA verified through post-marketing surveillance that the abovementioned food products are not registered and no corresponding Certificates of Product Registration (CPR) have been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered food products have not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative food products until CPR are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label, if available or the name of the product.

All Law Enforcement Agencies (LEAs) and Local Government Unit (LGUs) are requested to ensure that these products are not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of these unregistered products.

For more information and inquiries about this advisory, kindly contact the FDA Center for Food Regulation and Research through email [email protected] indicating on the subject the concerned Advisory, or call (02)857-1900 local 8105 and 8112.

To report any sale or distribution of unregistered product, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1402

FDA Advisory No. 2020-1396 || Public Health Warning Against the Purchase and Use of the Following Misbranded Face Masks in Foreign Characters:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the following misbranded face masks in foreign characters:

  1. Fu Le Bang Disposable Mask
  2. Flag World Face Mask
  3. MAsk

The FDA verified through post-marketing surveillance that the abovementioned medical device products are being offered for sale in the local market.

Section 19(c) of Republic Act (RA) No. 3720 also known as the “Food, Drug, and Cosmetic Act” as amended by RA No. 9711 otherwise known as the “Food and Drug Administration (FDA) Act of 2009” states that “a device shall be deemed misbranded  if any word, statement, or other information required by or under authority of this Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use”. The above-mentioned products are considered misbranded and the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product that is misbranded is prohibited pursuant to Section 10 of RA No. 9711.

In view of the above, all concerned establishments are warned not to distribute, advertise, or sell the said violative medical device products, otherwise, regulatory actions and sanctions shall be strictly pursued.

All FDA Regional Field Offices and Regulatory Enforcement Units in coordination with law enforcement agencies and Local Government Units are requested to ensure that these products are not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of these misbranded products.

For more information and inquiries about this advisory, kindly contact the FDA – CDRRHR through e-mail at [email protected] indicating on the subject the concerned Advisory, or call (02) 8857-1900 loc. 8301. 

To report any sale or distribution of the above-mentioned products, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-1396

FDA Advisory No. 2020-1393 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND CONSUME the following unregistered food products:

  1. NEW IMAR Special Misua
  2. SUKI Bihon
  3. MOUNTAIN’S GIFT Turmeric Ginger
  4. GTF’S Durian Jam

The FDA verified through post-marketing surveillance that the abovementioned food products are not registered and no corresponding Certificates of Product Registration (CPR) have been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered food products have not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative food products until CPR are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label, if available or the name of the product.

All Law Enforcement Agencies (LEAs) and Local Government Unit (LGUs) are requested to ensure that these products are not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of these unregistered products.

For more information and inquiries about this advisory, kindly contact the FDA Center for Food Regulation and Research through email [email protected] indicating on the subject the concerned Advisory, or call (02)857-1900 local 8105 and 8112.

To report any sale or distribution of unregistered product, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-1393

FDA Advisory No. 2020-1392 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND CONSUME the following unregistered food products:

  1. JEA Natural Coffee Plus Mangustin & Malunggay
  2. AMOREN Barbeque Mix Powder
  3. NATURE’S WORLD 10-in-1 Luyang Dilaw Tea
  4. KINGLAND Small Dice Red Mongo
  5. MYLIN HERBAL PRODUCTS Instant Malunggay Powder

The FDA verified through post-marketing surveillance that the abovementioned food products are not registered and no corresponding Certificates of Product Registration (CPR) have been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered food products have not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative food products until CPR are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label, if available or the name of the product.

All Law Enforcement Agencies (LEAs) and Local Government Unit (LGUs) are requested to ensure that these products are not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of these unregistered products.

For more information and inquiries about this advisory, kindly contact the FDA Center for Food Regulation and Research through email [email protected] indicating on the subject the concerned Advisory, or call (02)857-1900 local 8105 and 8112.

To report any sale or distribution of unregistered product, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-1392

FDA Advisory No. 2020-1391 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND CONSUME the following unregistered food products:

  1. FRY & POP Natural Flavor Onion & Garlic – Natural Flavor Crackers
  2. GOLDEN DUCK Egg Cracklets Galletas de Huevos
  3. JUJU BEN10 OMNIVERSE Watch Pop-Wrist Band Filled with Candy
  4. KINGLAND Small Dice Ube
  5. G.K Special O’dong

The FDA verified through post-marketing surveillance that the abovementioned food products are not registered and no corresponding Certificates of Product Registration (CPR) have been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered food products have not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative food products until CPR are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label, if available or the name of the product.

All Law Enforcement Agencies (LEAs) and Local Government Unit (LGUs) are requested to ensure that these products are not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of these unregistered products.

For more information and inquiries about this advisory, kindly contact the FDA Center for Food Regulation and Research through email [email protected] indicating on the subject the concerned Advisory, or call (02)857-1900 local 8105 and 8112.

To report any sale or distribution of unregistered product, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1391

FDA Advisory No. 2020-1390 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplements and Food Products:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND CONSUME the following unregistered food supplements and food products:

  1. SATO Suguard Dietary Supplements
  2. GREENSPARK Ampalaya 3 in 1 Capsule
  3. THE JUICERY MANILA Vital Shot
  4. FRY & POP Shrimp Crackers – Natural Flavor

The FDA verified through post-marketing surveillance that the abovementioned food products and food supplement are not registered and no corresponding Certificates of Product Registration (CPR) have been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered food products and food supplement have not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative food products until CPR are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label, if available or the name of the product.

All Law Enforcement Agencies (LEAs) and Local Government Unit (LGUs) are requested to ensure that these products are not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of these unregistered products.

For more information and inquiries about this advisory, kindly contact the FDA Center for Food Regulation and Research through email [email protected] indicating on the subject the concerned Advisory, or call (02)857-1900 local 8105 and 8112.

To report any sale or distribution of unregistered product, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-1390

/ In Food Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1390 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplements and Food Products:

WHO COVID-RELATED PUBLICATIONS

Title/Subject:

1.  Coronavirus disease (COVID-19) advice for the public: Mythbusters (IEC)

  1. Alcohol
  2. Antibiotics
  3. Bleach
  4. Drugs
  5. Hydroxychloroquine
  6. Masks, CO2 Intoxication – Video
  7. Masks, Exercise
  8. Medicines
  9. Methanol, Ethanol
  10. Pneumonia Vaccines
  11. Thermal Scanners
  12. Viruses, Bacteria, Antibiotics

2.  Q&As on COVID-19 and Related Health Topics
3.  Coronavirus disease (COVID-19) advice for the public: When and how to use masks

  1. How to Wear a Medical Mask Safely – Do’s
  2. How to Wear a Medical Mask Safely – Don’ts
  3. How to Wear a Medical Mask – Video
Date of Publication: News Release:
31 March 2020 Off-label use of medicines for COVID-19 – Scientific Brief
22 April 2020 PH Solidarity trial for COVID-19 treatments receives green light from ethics review body
6 July 2020 “Solidarity” clinical trial for COVID-19 treatments
6 July 2020 WHO: access to HIV medicines severely impacted by COVID-19 as AIDS response stalls. Countries seek innovative ways to mitigate the impact of disruptions and keep services going
15 July 2020 More than 150 countries engaged in COVID-19 vaccine global access facility
31 July 2020 Draft landscape of COVID-19 candidate vaccines

FDA Advisory No. 2020-1443 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic DAI NIER WATERPROOF FULL LASHES, NATURAL LOOK MASCARA

The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product:

  1. DAI NIER WATERPROOF FULL LASHES, NATURAL LOOK MASCARA

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 23 July 2020. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization from the FDA is prohibited.

Since the abovementioned unauthorized cosmetic product has not gone through the notification process of the FDA, the agency cannot assure their quality and safety. The use of such violative product may pose health risks to consumers.

Potential hazards may come from ingredients that are not allowed to be part of a cosmetic product or from the contamination of heavy metals. The use of substandard and possibly adulterated cosmetic products may result to adverse reactions including, but not limited to, skin irritation, itchiness, anaphylactic shock and organ failure.

In light of the foregoing, the public is advised not to purchase the aforementioned violative cosmetic product. Moreover, the public is advised to always check if a cosmetic product is notified with the FDA through its website (www.fda.gov.ph). It has a Search feature which may be used by typing in the name of the product before deciding on purchasing and/or using the said product.

All concerned establishments are warned not to distribute violative cosmetic product until they have fully complied with the rules and regulation of the FDA.

All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that violative products are not sold or made available in the market or areas of their jurisdiction.

To report any sale, distribution, complaint and/or adverse event on the use of the violative cosmetic products, email us at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-1443

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1443 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic DAI NIER WATERPROOF FULL LASHES, NATURAL LOOK MASCARA

FDA Advisory No. 2020-1442 || Public Health Warning Against the Purchase and Use of the Non-Compliant Cosmetic Product “INSTAGLOW GLUTATHIONE SOAP”

The Food and Drug Administration (FDA) warns the general public from purchasing and using the non-compliant cosmetic product, “INSTAGLOW GLUTATHIONE SOAP” with details specified below:

PRODUCT PARTICULARS
Local Company Responsible for Placing the Product in the Market: Instaglow by Jean Beltran

Address: Eastwood, Brgy. Bagumbayan QC Philippines

Country of Manufacture: Not Indicated

Lot/Batch Number: Not Indicated

Manufacturing Date: Not Indicated

Expiration Date: Not Indicated

NON-COMPLIANCE/S
The ingredients listed on the label is inconsistent with the information declared in the acknowledged Product Notification.
Failure to declare the complete local company address, country of manufacture, lot/batch number, and manufacturing/expiration date on the label.

The Food and Drug Administration has verified that the abovementioned product is NON-COMPLIANT through its postmarketing surveillance (PMS) pursuant to Book I, Article II, Section 2 of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009” which provides for the relevant functions, powers and duties of the agency, including the conduct of PMS activities in the monitoring of health products.

Based on the Certificate of Product Notification issued to the company, any subsequent changes to the information previously submitted to the FDA will render the notification invalid, thus, a new notification will have to be submitted.

In light of the foregoing, the public is advised not to purchase the aforementioned violative cosmetic product. Moreover, the public is advised to always check if a cosmetic product is notified with the FDA through its website (www.fda.gov.ph). It has a Search feature which may be used by typing in the name of the product before deciding on purchasing and/or using the said product.

All concerned establishments are warned not to distribute violative cosmetic product until they have fully complied with the rules and regulation of the FDA.

All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that violative products are not sold or made available in the market or areas of their jurisdiction.

To report any sale, distribution, complaint and/or adverse event on the use of the violative cosmetic products, email us at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-1442

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1442 || Public Health Warning Against the Purchase and Use of the Non-Compliant Cosmetic Product “INSTAGLOW GLUTATHIONE SOAP”

FDA Advisory No. 2020-1441 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic DODO HOUSE MOISTURIZING CLEAR LIPSTICK YELLOW CHICKEN (A06)

The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product:

  1. DODO HOUSE MOISTURIZING CLEAR LIPSTICK YELLOW CHICKEN (A06)

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 23 July 2020. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization from the FDA is prohibited.

Since the abovementioned unauthorized cosmetic product has not gone through the notification process of the FDA, the agency cannot assure their quality and safety. The use of such violative product may pose health risks to consumers.

Potential hazards may come from ingredients that are not allowed to be part of a cosmetic product or from the contamination of heavy metals. The use of substandard and possibly adulterated cosmetic products may result to adverse reactions including, but not limited to, skin irritation, itchiness, anaphylactic shock and organ failure.

In light of the foregoing, the public is advised not to purchase the aforementioned violative cosmetic product. Moreover, the public is advised to always check if a cosmetic product is notified with the FDA through its website (www.fda.gov.ph). It has a Search feature which may be used by typing in the name of the product before deciding on purchasing and/or using the said product.

All concerned establishments are warned not to distribute violative cosmetic product until they have fully complied with the rules and regulation of the FDA.

All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that violative products are not sold or made available in the market or areas of their jurisdiction.

To report any sale, distribution, complaint and/or adverse event on the use of the violative cosmetic products, email us at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-1441

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1441 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic DODO HOUSE MOISTURIZING CLEAR LIPSTICK YELLOW CHICKEN (A06)

FDA Advisory No. 2020-1440 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic WEDO SHOP NUT ESSENTIAL MOISTURIZING NOURISHING MASK NO. WD5088

The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product:

  1. WEDO SHOP NUT ESSENTIAL MOISTURIZING NOURISHING MASK NO. WD5088

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 23 July 2020. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization from the FDA is prohibited.

Since the abovementioned unauthorized cosmetic product has not gone through the notification process of the FDA, the agency cannot assure their quality and safety. The use of such violative product may pose health risks to consumers.

Potential hazards may come from ingredients that are not allowed to be part of a cosmetic product or from the contamination of heavy metals. The use of substandard and possibly adulterated cosmetic products may result to adverse reactions including, but not limited to, skin irritation, itchiness, anaphylactic shock and organ failure.

In light of the foregoing, the public is advised not to purchase the aforementioned violative cosmetic product. Moreover, the public is advised to always check if a cosmetic product is notified with the FDA through its website (www.fda.gov.ph). It has a Search feature which may be used by typing in the name of the product before deciding on purchasing and/or using the said product.

All concerned establishments are warned not to distribute violative cosmetic product until they have fully complied with the rules and regulation of the FDA.

All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that violative products are not sold or made available in the market or areas of their jurisdiction.

To report any sale, distribution, complaint and/or adverse event on the use of the violative cosmetic products, email us at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-1440

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1440 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic WEDO SHOP NUT ESSENTIAL MOISTURIZING NOURISHING MASK NO. WD5088

FDA Advisory No. 2020-1439 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic V GIRL IVY COLLAGEN BB CREAM 002 (NO. IV10008)

The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product:

  1. V GIRL IVY COLLAGEN BB CREAM 002 (NO. IV10008)

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 23 July 2020. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization from the FDA is prohibited.

Since the abovementioned unauthorized cosmetic product has not gone through the notification process of the FDA, the agency cannot assure their quality and safety. The use of such violative product may pose health risks to consumers.

Potential hazards may come from ingredients that are not allowed to be part of a cosmetic product or from the contamination of heavy metals. The use of substandard and possibly adulterated cosmetic products may result to adverse reactions including, but not limited to, skin irritation, itchiness, anaphylactic shock and organ failure.

In light of the foregoing, the public is advised not to purchase the aforementioned violative cosmetic product. Moreover, the public is advised to always check if a cosmetic product is notified with the FDA through its website (www.fda.gov.ph). It has a Search feature which may be used by typing in the name of the product before deciding on purchasing and/or using the said product.

All concerned establishments are warned not to distribute violative cosmetic product until they have fully complied with the rules and regulation of the FDA.

All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that violative products are not sold or made available in the market or areas of their jurisdiction.

To report any sale, distribution, complaint and/or adverse event on the use of the violative cosmetic products, email us at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-1439

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1439 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic V GIRL IVY COLLAGEN BB CREAM 002 (NO. IV10008)

FDA Advisory No. 2020-1354 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

The Food and Drug Administration (FDA) advises the public from purchase and consumption of the following unregistered food products:

  1. TSAA LAYA Java Banaba Herbal Tea
  2. MANA Matcha Bar
  3. MANA Plant Protein Bar
  4. MANA Nutty Professor
  5. TAKE ROOT Energy Bar Apple Pie

The FDA verified through post-marketing surveillance that the abovementioned food products are not authorized and the Certificates of Product Registration (CPR) have not been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered food products have not gone through the evaluation process of the FDA, the agency cannot assure their quality and safety. The consumption of such violative products may pose health risks to consumers.

In light of the foregoing, the public is advised not to purchase the aforementioned violative products. Moreover, the public is advised to always check if a food product or food supplement is registered with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing.

All concerned establishments are warned not to distribute violative food products and food supplements until they have been issued the appropriate authorization, a License to Operate for the establishment, and a CPR for the food supplement and food products.

All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that violative products are not sold or made available in the market or areas of jurisdiction.

To report any sale or distribution of unregistered food products and food supplements, kindly contact us through email at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-1354

EXTENSION OF DEADLINE OF COMMENTS OF DRAFT FDA CIRCULAR ON IMPLEMENTING RULES AND REGULATIONS ON REVISED APPLICATION PROCESS AND REQUIREMENTS FOR POST-APPROVAL CHANGES OF PHARMACEUTICAL PRODUCTS, AND INSTITUTIONALIZATION OF THE PHILIPPINE VARIATION GUIDELINES, AND PHILIPPINE VARIATION GUIDELINES VERSION 1.0

To provide sufficient time for comments on the subject draft FDA Circular, submission of comments is hereby extended from 5 August 2020 to 14 August 2020.

All comments shall be sent at [email protected].

For your information and compliance.

Attachment:->Philippine Variation Guidelines V.1.0 with fees and charges
Attachment:->Draft Circular for Post Approval Changes and PVG

/ In Draft for Comments / By Administrator / Comments Off on EXTENSION OF DEADLINE OF COMMENTS OF DRAFT FDA CIRCULAR ON IMPLEMENTING RULES AND REGULATIONS ON REVISED APPLICATION PROCESS AND REQUIREMENTS FOR POST-APPROVAL CHANGES OF PHARMACEUTICAL PRODUCTS, AND INSTITUTIONALIZATION OF THE PHILIPPINE VARIATION GUIDELINES, AND PHILIPPINE VARIATION GUIDELINES VERSION 1.0

RRD-CDRRHR ANNOUNCEMENT 03 August 2020

Please be informed that due to COVID-19, the Radiation Regulation Division of the Center for Device Regulation, Radiation Health, and Research – Food and Drug Administration will temporarily shift to online transaction from August 3, 2020 to August 18, 2020 for the following transactions:

  1. License to Operate (LTO)/Certificate of Compliance (COC)/Certificate of Registration (COR) of radiation facilities
  2. Clearance for Customs Release (CFCR) of radiation devices

All official communications and applications regarding radiation facilities are hereby requested to be sent to [email protected].

For your information and guidance.

FDA Citizen’s Charter for Comments

Please see the following Drafts for Comments of FDA Citizen’s Charter:

Please email your comments at [email protected].

Deadline for accepting comments will be on 18 August 2020.

DRAFTS FOR COMMENTS OF ADMINISTRATIVE ORDER “ADOPTION OF THE COLLABORATIVE PROCEDURE FOR THE ACCELERATED REGISTRATION OF WORLD HEALTH ORGANIZATION (WHO) – PREQUALIFIED DRUG PRODUCTS AND VACCINES”

Please see the following drafts for industry comments:

All comments can be sent at [email protected]. Deadline of submission of comments shall be by 14 August 2020.

/ In Draft for Comments / By Administrator / Comments Off on DRAFTS FOR COMMENTS OF ADMINISTRATIVE ORDER “ADOPTION OF THE COLLABORATIVE PROCEDURE FOR THE ACCELERATED REGISTRATION OF WORLD HEALTH ORGANIZATION (WHO) – PREQUALIFIED DRUG PRODUCTS AND VACCINES”

FDA has released a total of 214 COVID – 19 Test Kits (75 – PCR based, 79 – Rapid Antibody, 53 – Immunoassay and 7 – Others)

As of  today, 30 July 2020, FDA has released a total of 214 COVID – 19 Test Kits (75 – PCR based, 79 – Rapid Antibody, 53 – Immunoassay and 7 – Others)

Click the link below for details.

https://bit.ly/2Zd0CZ4

FDA Advisory No. 2020-1385 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unnotified medical device product:

  1. INFUSION SET WITH NEEDLE – 0.6mm
  2. INFUSION SET WITH NEEDLE – 0.55mm
  3. INFUSION SETS FOR SINGLE-USE WITH NEEDLES

The FDA verified through post-marketing surveillance that the above mentioned medical device products are not registered and no corresponding Product Notification Certificates have been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered medical device products have not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device products until CMDR are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label in the form of either DVR-xxx or MDR-xxx.

All Law Enforcement agencies (LEAs) and Local Government Units (LGUs) are requested to ensure that these products are not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of these unregistered products.

For more information and inquiries, kindly contact the FDA CDRRHR through e-mail at [email protected], indicating on the subject the concerned Advisory, or call (02) 8857-1900 loc. 8301. 

To report any sale or distribution of unregistered medical device, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1385

FDA Advisory No. 2020-1384 || Public Health Warning Against the Purchase and Use of the Unnotified Medical Device Product “NATURAL LATEX RUBBER CONDOM IN FOREIGN CHARACTERS”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unnotified medical device product:

  1. “NATURAL LATEX RUBBER CONDOM IN FOREIGN CHARACTERS”

The FDA verified through post-marketing surveillance that the above mentioned medical device products is not registered and no corresponding Product Notification Certificate has been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since this unregistered medical device products have not gone through evaluation process of the FDA, the agency cannot assure their quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device products until CMDR are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label in the form of either DVR-xxx, MDR-xxx.

All Law Enforcement agencies (LEAs) and Local Government Units (LGUs) are requested to ensure that these products are not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of these unregistered products.

For more information and inquiries, kindly contact the FDA CDRRHR through e-mail at [email protected], indicating on the subject the concerned Advisory, or call (02) 8857-1900 loc. 8301.  

To report any sale or distribution of unregistered medical device, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1384

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1384 || Public Health Warning Against the Purchase and Use of the Unnotified Medical Device Product “NATURAL LATEX RUBBER CONDOM IN FOREIGN CHARACTERS”

FDA Advisory No. 2020-1383 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product “HD® SYRINGE WITH NEEDLE FOR SINGLE USE 50 mL 1.6 x 32mm (IN FOREIGN CHARACTERS)”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unnotified medical device product:

  1. “HD® SYRINGE WITH NEEDLE FOR SINGLE USE 50 mL 1.6 x 32mm (IN FOREIGN CHARACTERS)”

The FDA verified through post-marketing surveillance that the above mentioned medical device products is not registered and no corresponding Product Notification Certificate has been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since this unregistered medical device products have not gone through evaluation process of the FDA, the agency cannot assure their quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device products until CMDR are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label in the form of either DVR-xxx, MDR-xxx.

All Law Enforcement agencies (LEAs) and Local Government Units (LGUs) are requested to ensure that these products are not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of these unregistered products.

For more information and inquiries, kindly contact the FDA CDRRHR through e-mail at [email protected], indicating on the subject the concerned Advisory, or call (02) 8857-1900 loc. 8301.      

To report any sale or distribution of unregistered medical device, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-1383

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1383 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product “HD® SYRINGE WITH NEEDLE FOR SINGLE USE 50 mL 1.6 x 32mm (IN FOREIGN CHARACTERS)”

FDA Advisory No. 2020-1381 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product “ELECTRONIC THERMOMETER TD138”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unnotified medical device product:

  1. “ELECTRONIC THERMOMETER TD138”

The FDA verified through post-marketing surveillance that the above mentioned medical device products is not registered and no corresponding Product Notification Certificate has been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since this unregistered medical device products have not gone through evaluation process of the FDA, the agency cannot assure their quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device products until CMDR are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label in the form of either DVR-xxx, MDR-xxx.

All Law Enforcement agencies (LEAs) and Local Government Units (LGUs) are requested to ensure that these products are not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of these unregistered products.

For more information and inquiries, kindly contact the FDA CDRRHR through e-mail at [email protected], indicating on the subject the concerned Advisory, or call (02) 8857-1900 loc. 8301.

To report any sale or distribution of unregistered medical device, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1381

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1381 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product “ELECTRONIC THERMOMETER TD138”

FDA Advisory No. 2020-1378 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND CONSUME the following unregistered food products:

  1. TRADITIONAL MEDICINALS Organic Tulsi with Ginger Herbal Supplement, Tea Bags
  2. TRADITIONAL MEDICINALS Gypsy Cold Care Herbal Supplement, Tea Bags
  3. TRADITIONAL MEDICINALS Organic Stress Ease Cinnamon Herbal Supplement, Tea Bags
  4. TRADITIONAL MEDICINALS Healthy Cycle Herbal Supplement, Tea Bags
  5. TRADITIONAL MEDICINALS Organic Rose Hips with Hibiscus Herbal Supplement, Tea Bags

The FDA verified through online monitoring that the abovementioned food products are not registered and no corresponding Certificates of Product Registration (CPR) have been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered food products have not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative food products until CPR are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label, if available or the name of the product.

All Law Enforcement Agencies (LEAs) and Local Government Unit (LGUs) are requested to ensure that these products are not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of these unregistered products.

For more information and inquiries about this advisory, kindly contact the FDA Center for Food Regulation and Research through email [email protected] indicating on the subject the concerned Advisory, or call (02)857-1900 local 8105 and 8112.

To report any sale or distribution of unregistered food products, kindly contact us through email at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1378

/ In Food Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1378 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:
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