Month: November 2020

Draft for Comment of Implementing Guidelines of Joint Department of Health (DOH) and Department of Agriculture (DA) Administrative Order No. 2020-001: Re-Adoption of Joint DOH and DA Administrative Order No. 2013-0026

All comments can be sent at [email protected] Deadline of submission of comments shall
be by 3 December 2020

  1. INTRODUCTION

 

Cognizant of the authority of the Food and Drug Administration (FDA) to call upon the assistance of any department, office or agency under Section 30, paragraph 5 of Republic Act (RA) No. 3720 as amended by RA No. 9711, a partnership was forged between FDA and the Department of Agriculture-Bureau of Animal Industry (DA-BAI) in the regulation of selected veterinary establishments, drugs, and products by virtue of the Joint Department of Agriculture (DA) and Department of Health (DOH) Administrative Order (JAO) No. 2013-0026: Rules on the Regulation of Veterinary Drugs and Products, Veterinary Biological Products, and Veterinary Drug Establishments. The JAO No. 2013-0026 was effective for five years, until its expiration last September 2018. The delegation of regulation of veterinary establishments and products under the jurisdiction of the FDA began way back in late 1990 through a JAO between the DOH and DA Secretaries.

Read more:-> Draft FDA Circular Implementing Guidelines of JAO DA-DOH 2020-0001 Version 2.2

 

 

FDA Advisory No. 2020-2073 || 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. White and Yellow Cup Noodles (Brand Name and Product Name in Foreign Character) BARCODE: 6926410337250
2. Liv Zhou Lou Si Fen Blue Cup Noodles ( Brand Name and Product Name in Foreign Character), BARCODE: 6970075970836
3. UNI PRESIDENT (Product Name in Foreign Character) Yellow Green Cup Noodles, BARCODE: 6925303714208
4. White Brown Cup Noodles (Brand Name and Product Name in Foreign Character) BARCODE:6926410320214
5. White and Yellow Cup Noodle ( Brand and Product Name in Foreign Character),170gBARCODE: 6970514610887

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 the unregistered imported 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 8857-1900 local 8105 and 8112.

Attachment:-> FDA-Advisory-No.2020-2073

FDA Advisory No. 2020-2072 || 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. Braised Beef Noodle (Brand Name in Foreign Character) BARCODE : 6900873000777
2. UNI PRESIDENT (Product Name in Foreign Character) Red Cup Noodles,BARCODE: 6925303714086
3. Xiannina Pickled Pepper Beef Noodle (Brand Name in Foreign Character)Green Cup Noodles,BARCODE: 6900873002177
4. UNI PRESIDENT The King of Tomato
5. UNI PRESIDENT (Product Name in Foreign Character)BARCODE: 6925303773243

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 the unregistered imported 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 8857-1900 local 8105 and 8112.

To report any sale or distribution of unregistered product, the online reporting facility, eReport can be accessed at  www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA-Advisory-No.2020-2072

FDA Advisory No. 2020-2071 || 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. Blue Colored Cup Noodles with image of Space Rocket,BARCODE:6900873714636
2. Broad Noodle Chili Oil Flavor, Spicy and Hot (Brand name in Foreign Character), BARCODE:6926410337090
3. Orange and Yellow Colored Cup Noodles (Brand Name and Product Name in Foreign Character),
BARCODE: 6900873022953
4. Scallion Braised Ribs Noodle with Shallot Flavor (Brand Name in Foreign Character) Yellow Cup Noodles, 85g, BARCODE: 6900873713936
5. Rattan Pepper Beef Noodle(Brand Name in Foreign Character) Blue Green Cup, BARCODE:6900873097029

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 the unregistered imported 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 8857-1900 local 8105 and 8112.

To report any sale or distribution of unregistered product, the online reporting facility, eReport can be accessed at  www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

 Attachment:-> FDA-Advisory-No.2020-2071

 

 

FDA Advisory No. 2020-2070 || 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. Sachet with Brown Lining (Brand Name and Product Name in Foreign Character)
2. Sachet with Pink Lining (Brand Name and Product Name in Foreign Character) BARCODE:6972110800082
3. UNI PRESIDENT Milk Tea Drink, 500,
BARCODE: 6925303730574
4. C100, 445ml (Brand Name and Product Name in Foreign Character) BARCODE:6921168500956
5. Maroon and Black with Child Graphics Cup Noodles (Brand Name and Product Name in Foreign Character)
BARCODE: 6957427661052

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 the unregistered imported 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 8857-1900 local 8105 and 8112. 

To report any sale or distribution of unregistered product, the online reporting facility, eReport can be accessed at  www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA-Advisory-No.2020-2070

FDA Advisory No. 2020-2059 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products and Food Supplements:

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

1. IMMUNA Powdered Juice Mix Barley Grass with Goji Berry and Grape Seed Extract
2. HONEY-C Coffee Blend with Sakura Extract
3. CESARIO’S All Natural Crispy Garlic Bits in Oil
4. QSN UATTRO Weight Gainer Dietary Supplement
5. CLACORE Conjugated Linoleic Acid Dietary Supplement

The FDA verified through online monitoring or post-marketing surveillance that the abovementioned food products and food supplements 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 supplements 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 supplements and 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 the unregistered imported 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)8857-1900 local 8105 and 8112. 

To report any sale or distribution of unregistered product, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA-Advisory-No.2020-2059

 

/ In Food Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-2059 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products and Food Supplements:

FDA Advisory No. 2020-2058 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplenment 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 supplement and food products:

1. DR.F Pixie Dust Magnesium Dietary Supplement
2. VERMICELLI Pastel Candy
3. PETER’S KITCHEN Chicken Pastil
4. SAPPORO Misua Chinese Somen
5. ARCI’S 100% Pure Crab Paste

The FDA verified through online monitoring or post-marketing surveillance that the abovementioned food supplement and 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 supplement and 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 supplements and 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 the unregistered imported 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)8857-1900 local 8105 and 8112. 

To report any sale or distribution of unregistered product, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

 Attachment:-> FDA-Advisory-No.2020-2058

 

/ In Food Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-2058 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplenment and Food Products:

FDA Advisory No. 2020-2057 || 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. DR.F Lightning in a Bottle Dietary Supplement
2. DR. F Doctor’s Shake Dietary Supplement
3. DR.F Mega dose Vitamin C Dietary Supplement
4. Special Peanut Bar
5. OT Fullo Waffle Crunchox

The FDA verified through online monitoring or post-marketing surveillance that the abovementioned food supplements and 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 supplements and 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 supplements and 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 the unregistered imported 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)8857-1900 local 8105 and 8112.

To report any sale or distribution of unregistered product, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA-Advisory-No.2020-2057

/ In Food Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-2057 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplements and Food Products:

FDA Advisory No. 2020-2056 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplements:

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

1. G21 Chocolate Dream Aids in Weight Loss Dietary Supplement
2. HONEY C Capsules Food Supplement
3. ALSHODO PLACORO Placenta Extracts Tablets
4. NOW SPORTS ZMA Sports Recovery with Zinc, Magnesium & Vitamin B-6 Dietary Supplement
5. ULTIMATE NUTRITION Liquid Amino Amino Acid Supplement

The FDA verified through online monitoring or post-marketing surveillance that the abovementioned food supplements 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 supplements 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 supplements and 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 the unregistered imported 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)8857-1900 local 8105 and 8112. 

To report any sale or distribution of unregistered product, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

 Read more:-> FDA-Advisory-No.2020-2056

/ In Food Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-2056 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplements:

FDA Advisory No. 2020-2055 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplement 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 supplement and food products:

1. DR.F Boston C Concentrate Dietary Supplement
2. VIBRANT WELLNESS Vibrant Milk Tea Winter Melon Flavor Milktea Powder Mix
3. Longyanhuasheng Peanut In Gold and White Colored Packaging
4. MANOLO’S Chili Garlic Chicken Pastil
5. TRADITIONAL GOURMET Authentic Iloilo Spicy Bagoong

The FDA verified through online monitoring or post-marketing surveillance that the abovementioned food supplement and 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 supplement and 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 supplements and 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 the unregistered imported 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)8857-1900 local 8105 and 8112. 

To report any sale or distribution of unregistered product, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA-Advisory-No.2020-2055

 

/ In Food Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-2055 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplement and Food Products:

PUBLICATION OF IMPLEMENTING RULES AND REGULATIONS OF REPUBLIC ACT NO. 11346 AND REPUBLIC ACT NO. 11467

This is to inform all concerned stakeholders that the DOF-DOH-DBM-BIR-PHIC Joint Memorandum Circular No. 001-2020, entitled “Implementing Rules and Regulations (IRR) of Heated Tobacco Products and Vapor Products as Prescribed by Republic Acts No. 11346 and RA 11467” is now posted on the FDA website for easy reference and guidance.

For any concerns or inquiries, kindly contact CCRR at (02) 857-1900 local 8107 or 8113, or through email at [email protected].

Attachment:->Publication of Implementing Rules and Regulations of RA No. 11346 and 11467

Attachment:->  JOINT-MEMORANDUM CIRCULAR NO-003-S-2020

FDA Advisory No. 2020-2022 || REITERATION OF THE MANDATORY LABELING REQUIREMENTS FOR TOYS AND CHILD CARE ARTICLE PRODUCTS PURSUANT TO THE IRR OF RA 10620

Pursuant to the Implementing Rules and Regulation of Republic Act 10620, otherwise known as “Toy and Game Safety Labeling Act of 2013”, Toy and Game refers to an object or a number of objects clearly intended as plaything for children below fourteen (14) years of age.

Toys and Game including Childcare Articles are favorite items for gift-giving during special occasions such as birthdays, parties and Christmases.

The Food and Drug Administration (FDA) having the mandate to issue appropriate authorizations to establishments and their toy and game products reiterates the mandatory labeling requirement for Toys and Child Care Article (TCCA) products. The following information shall appear on the package, container, wrapper or protective covering of the products: (See attached infographics for easy reference)

  1. License to Operate (LTO) Number issued by FDA
  2. Age Grading
  3. Cautionary Statement/Warnings
  4. Instructional Literature
  5. Manufacturer’s markings with complete name and address of the local company
  6. Item Model / Stock Keeping Unit (SKU) number

The label shall be generally written in English, otherwise, a parallel translation in English or Filipino or both shall appear thereon. The label shall be in a visible, easily legible, understandable and indelible form.

Thus, consumers are advised to be vigilant in purchasing TCCA products as gifts for children during special occasions by checking the product label’s information if compliant to the abovementioned labeling requirement.

Consumers are also encouraged to visit the FDA website and click the Verification Portal  (https://verification.fda.gov.ph) to check the list of notified TCCA products.

For any concern, kindly contact the FDA Center for Cosmetics Regulation and Research through e-mail at [email protected], or call (02) 857-1900 loc. 8113 or 8107.

To report any sale or distribution of unnotified TCCAs, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Attachment:-> FDA Advisory No.2020-2022

/ In Device Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-2022 || REITERATION OF THE MANDATORY LABELING REQUIREMENTS FOR TOYS AND CHILD CARE ARTICLE PRODUCTS PURSUANT TO THE IRR OF RA 10620

FDA Advisory No. 2020-2054 || Pilot Implementation of Food and Drug Administration (FDA) eServices Portal System for License to Operate (LTO) Application of Medical Device Establishments

The Food and Drug Administration (FDA) is currently developing the FDA eServices Portal System – an online platform for a streamlined License to Operate (LTO) application of FDA-regulated establishments.

In this regard, FDA is issuing this Advisory to inform all stakeholders that the application for eLTO for Medical Device Establishments within National Capital Region (NCR) is now on its pilot implementation. The eServices Portal is accessible through this link eservices.fda.gov.ph/, with the scope of the application is limited for the time being:

FDA eServices Portal for LTO Application for Medical Device Establishments
Location of Establishment National Capital Region (Metro Manila)
LTO Establishment Application Distributor (Wholesaler, Importer, Exporter), and Trader of Medical Devices, in-vitro diagnostic device, reagents, equipment or devices used for treating sharps, pathological and infectious waste and water purification system
Type of LTO Application Initial, Renewal, and Variation
Fees to be Paid Based on current issuance on Fees and Charges (Reference: DOH Administrative Order No. 50 s. 2001)
Validity of Initial LTO Two (2) years
Start of Pilot Implementation 23 November 2020
End of Pilot Implementation 07 December  2020

For this Pilot Run, applications for Renewal and Variation in the LTO using the eServices Portal are only functional if the approved initial LTO is applied using the eServices Portal.

For those with existing LTO application via ePortal, you may opt to apply to the eServices Portal for a new fee. Previous payment will be forfeited as the application has already been processed.

The implementation of eServices Portal for Manufacturers, including Refurbishers of all health products shall be on November 2020.

Retailers of Medical Devices, Radiation Facilities and Installer of water treatment systems providing installation, repair and maintenance services to operators of water refilling stations and other users of water treatment systems shall be governed by separate rules and regulations.

Please follow Annex A of this Advisory for the Guideline and Checklist of Requirements, and Annex B for the Step-by-Step Guide in applying via eServices Portal and the procedure for checking of application status.

Attachment:-> FDA-Advisory-No.2020-2054

/ In Device Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-2054 || Pilot Implementation of Food and Drug Administration (FDA) eServices Portal System for License to Operate (LTO) Application of Medical Device Establishments

FDA Order No. 2019-045-B || LIFTING THE TEMPORARY BAN OF ENTRY OF PORK MEAT PRODUCTS IMPLICATED WITH AFRICAN SWINE FEVER FROM BELGIUM

In the interest of consistency and coherent efforts in preventing the entry of African Swine Fever Virus in the country, the Food and Drug Administration (FDA) issued FDA Order No. 2019-045 dated 27 May 2019 on the temporary ban of entry of pork meat products domesticated or wild pig in nature due to African Swine Fever (ASF) in Belgium following the Department of Agriculture Memorandum Order No. 30 series of 2018.

Read more:-> FDA-Order-No.2019-045-B

FDA Advisory No. 2020-2053 || Public Health Warning Against the Purchase and Use of the Unnotified Medical Device Product “KLEAN BY LUXEORGANIX FACE MASKS 3PLY EARLOOP DISPOSABLE”

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

The FDA verified through post-marketing surveillance that the above-mentioned medical device product is not notified 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 unnotified medical device product has 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 product until the Product Notification Certificate is issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been notified 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 Notification number on the product label in the form of CMDN-xxx.

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

The Bureau of Customs is urged to restrain the entry of this unnotified product.

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 unnotified medical device, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA-Advisory-No.2020-2053

 

/ In Device Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-2053 || Public Health Warning Against the Purchase and Use of the Unnotified Medical Device Product “KLEAN BY LUXEORGANIX FACE MASKS 3PLY EARLOOP DISPOSABLE”

FDA Advisory No. 2020-2052 || PUBLIC HEALTH WARNING ON THE USE OF ULTRAVIOLET (UV) EMITTING DEVICES

The Food and Drug Administration (FDA) strongly advises against the use of UV light for COVID-19 disinfection near or on human body parts. The FDA through Republic Act 9711 or the FDA Act of 2009 is mandated to regulate radiation devices such as UV emitting devices. According to the World Health Organization (WHO), UV radiation can cause skin irritation and damage to eyes due to exposure.[1]

Additionally, the International Commission on Non-Ionizing Radiation (ICNIRP) does not recommend the use of UV lamps for consumers or personal use.[2] UV radiation is typically classified into three (3) wavebands with varying effects to human health:

UV Band Health Effects
UV-A (100 to 280 nm) Soft UV. Associated with skin aging and other effects.
UV-B (280 to 315 nm) Associated with sunburn, skin cancer, and cataracts.
UV-C (100 to 280 nm) Commonly used in ‘germicidal’ or disinfection lamps. Also associated with sunburns and eye injury (photokeratitis).

             As such, the public is advised to follow infection control protocols against COVID-19 from the Department of Health (DOH) like proper handwashing, coughing/sneezing etiquette, and social/physical distancing.

For your guidance.

Attachment:-> FDA-Advisory-No.2020-2052

FDA Advisory No. 2020-1395-A || REITERATION OF FDA ADVISORY NO. 2020-1395 TO TAKE EXTREME CAUTION ON THE PURCHASE AND USE OF UNREGISTERED VACCINES FOR COVID-19

The Food and Drug Administration (FDA) reiterates our advisory to the public to take extreme caution on the purchase and use of vaccines sold locally or online claiming to be safe and effective in preventing COVID-19.

To date, the FDA has not yet received any application for registration of COVID-19 vaccine. Thus, there is currently no registered vaccine for use against COVID-19. Selling of unregistered vaccines is prohibited. These products have not gone through the registration process of the FDA and have not been issued with proper authorization. The agency cannot guarantee their quality, safety, and efficacy.

The public is encouraged to remain vigilant on the purchase and use of health products. Report any suspicious claims, sale or advertisement claiming as vaccine for COVID-19 to the FDA through email at [email protected] or call at (02) 88095596.

Attachment:-> FDA-Advisory-No.2020-1395-A

/ In Drugs Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-1395-A || REITERATION OF FDA ADVISORY NO. 2020-1395 TO TAKE EXTREME CAUTION ON THE PURCHASE AND USE OF UNREGISTERED VACCINES FOR COVID-19

FDA Advisory No. 2020-1718-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng mga Hindi Rehistradong Gamot na:

Pinapayuhan ng Food and Drug Administration (FDA) ang publiko laban sa pagbili at paggamit ng mga hindi rehistradong gamot na:

1. Cefdinir Capsules 0.1g
2. OTC YUNPENG® Compound Aluminum Hydroxide Tablets
3. OTC Eloson® Mometasone Furoate Cream 0.1% (5g:5mg)
4. OTC Terbinafine Hydrochloride Cream
5. Sanofi Clopidogrel Bisulfate Tablets (Plavix®) 75mg

Napatunayan sa pamamagitan ng isinagawang Post-Marketing Surveillance (PMS) ng FDA na ang mga nasabing gamot ay hindi dumaan sa proseso ng rehistrasyon ng Ahensya at hindi nabigyan ng kaukulang awtorisasyon tulad ng Certificate of Product Registration (CPR). Dahil dito, hindi masisiguro ng Ahensya ang kalidad, kaligtasan at bisa nito. Samakatuwid, ang paggamit ng nasabing mga iligal na produkto ay maaaring magdulot ng panganib sa kalusugan.

Alinsunod sa Republic Act No. 9711, o ang Food and Drug Administration Act of 2009, ang paggawa, pag-angkat, pagbenta, pamamahagi, paglipat, promosyon, pagpapatalastas o sponsorship ng produktong pangkalusugan nang walang kaukulang awtorisasyon mula sa FDA ay ipinagbabawal.

Ang lahat ng establisyamento at/o entidad ay binabalaang huwag mamahagi ng nasabing mga iligal na produkto hanggang sa ito ay mabigyan ng kaukulang awtorisasyon. Karampatang parusa ay mahigpit na ipatutupad sa mga lalabag.

Hinihiling sa lahat ng Local Government Units (LGUs) at Law Enforcement Agencies (LEAs) na tiyaking ang mga produktong ito ay hindi maibebenta o magagamit sa kanilang mga nasasakupan.

Para sa karagdagang impormasyon at katanungan, maaaring mag-email sa [email protected]. Upang mag-report ng patuloy na pagtitinda o pangangalakal ng mga hindi rehistradong gamot, mag-email sa [email protected]. Maaari ring tumawag sa Center for Drug Regulation and Research (CDRR) sa numerong (02) 8809-5596.  Para sa mga hinihinalang hindi kanais-nais na reaksyon sa gamot, i-report agad sa FDA gamit ang link na ito: https://primary reporting.who-umc.org/Reporting/Reporter?OrganizationID=PH at kumpletuhin ang mga kinakailangang impormasyon.

Attachment:->FDA Advisory No.2020-1718-A

FDA Advisory No. 2020-2051-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng mga Hindi Rehistradong Gamot na:

Pinapayuhan ng Food and Drug Administration (FDA) ang publiko laban sa pagbili at

paggamit ng mga hindi rehistradong gamot na:

1. OTC Calamine Lotion
2. OTC Cimetiden Tablets
3. Hydrogen Peroxide Disinfectant H2O2 100mL
4. OTC Berberine Hydrochloride Tablets

Napatunayan sa pamamagitan ng isinagawang Post-Marketing Surveillance (PMS) ng FDA na ang mga nasabing gamot ay hindi dumaan sa proseso ng rehistrasyon ng Ahensya at hindi nabigyan ng kaukulang awtorisasyon tulad ng Certificate of Product Registration (CPR). Dahil dito, hindi masisiguro ng Ahensya ang kalidad, kaligtasan at bisa nito. Samakatuwid, ang paggamit ng nasabing mga iligal na produkto ay maaaring magdulot ng panganib sa kalusugan.

Alinsunod sa Republic Act No. 9711, o ang Food and Drug Administration Act of 2009, ang paggawa, pag-angkat, pagbenta, pamamahagi, paglipat, promosyon, pagpapatalastas o sponsorship ng produktong pangkalusugan nang walang kaukulang awtorisasyon mula sa FDA ay ipinagbabawal.

Ang lahat ng establisyamento at/o entidad ay binabalaang huwag mamahagi ng nasabing mga iligal na produkto hanggang sa ito ay mabigyan ng kaukulang awtorisasyon. Karampatang parusa ay mahigpit na ipatutupad sa mga lalabag.

Hinihiling sa lahat ng Local Government Units (LGUs) at Law Enforcement Agencies (LEAs) na tiyaking ang mga produktong ito ay hindi maibebenta o magagamit sa kanilang mga nasasakupan.

Para sa karagdagang impormasyon at katanungan, maaaring mag-email sa [email protected]. Upang mag-report ng patuloy na pagtitinda o pangangalakal ng mga hindi rehistradong gamot, mag-email sa [email protected]. Maaari ring tumawag sa Center for Drug Regulation and Research (CDRR) sa numerong (02) 8809-5596.  Para sa mga hinihinalang hindi kanais-nais na reaksyon sa gamot, i-report agad sa FDA gamit ang link na ito: https://primary reporting.who-umc.org/Reporting/Reporter?OrganizationID=PH at kumpletuhin ang mga kinakailangang impormasyon.

Ang lahat ay hinihikayat na palaganapin ang mga nakasaad na impormasyon.

Attachment:-> FDA-Advisory-No.2020-2051-A

FDA Advisory No. 2020-2051 || Public Health Warning Against the Purchase and Use of the Following Unregistered Drug Products:

The Food and Drug Administration (FDA) advises the public against the purchase and use of the following unregistered drug products:

1. OTC Calamine Lotion
2. OTC Cimetiden Tablets
3. Hydrogen Peroxide Disinfectant H2O2 100mL
4. OTC Berberine Hydrochloride Tablets

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug products have not gone through the registration process of the Agency and have not been issued with proper authorization in the form of Certificate of Product Registration. Thus, the Agency cannot guarantee its quality, safety and efficacy. Therefore, consumption of such violative products may pose potential danger or injury to health.

Pursuant to 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, promotion, advertising or sponsorship of health products without proper authorization from FDA is prohibited.

All concerned establishments and/or entities are warned not to distribute the above-identified violative drug products until they have already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.

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

For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of unregistered health products, kindly e-mail us via [email protected]. You may also call the Center for Drug Regulation and Research at telephone number (02) 8809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill out all the required fields.

Dissemination of the information to all concerned is requested.

Attachment:->FDA-Advisory-No.2020-2051

FDA Advisory No. 2020-1737 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic TOV HAIR COLOR WAX

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

1. TOV HAIR COLOR WAX

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 18 September 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 (ww2.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, the online reporting facility, eReport can be accessed at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

FDA-Advisory-No.2020-1737

FDA Advisory No. 2020-1736 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic CHRISTOPHER’S PERFUME OUR VERSION OF: ISSEY MIYAKI HOMME SPORT FOR MEN

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

1. CHRISTOPHER’S PERFUME OUR VERSION OF: ISSEY MIYAKI HOMME SPORT FOR MEN

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 18 September 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 (ww2.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, the online reporting facility, eReport can be accessed at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Attachment:-> FDA-Advisory-No.2020-1736

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-1736 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic CHRISTOPHER’S PERFUME OUR VERSION OF: ISSEY MIYAKI HOMME SPORT FOR MEN

FDA Advisory No. 2020-1735 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic MOIST SKINCARE PAPAYA WHITENING LOTION

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

1. MOIST SKINCARE PAPAYA WHITENING LOTION

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 18 September 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 (ww2.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, the online reporting facility, eReport can be accessed at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Attachment:-> FDA-Advisory-No.2020-1735

FDA Advisory No. 2020-1734 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic ZENUTRIENTS ARGAN NOURISHING FACIAL WASH

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

1.  ZENUTRIENTS ARGAN NOURISHING FACIAL WASH

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 18 September 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 (ww2.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, the online reporting facility, eReport can be accessed at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Attachment:-> FDA-Advisory-No.2020-1734

FDA Advisory No. 2020-1733 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic LOUJENE NON ACETONE ENAMEL REMOVER

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

1. LOUJENE NON ACETONE ENAMEL REMOVER.

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 18 September 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 (ww2.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, the online reporting facility, eReport can be accessed at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Attachment:->FDA-Advisory-No.2020-1733

FDA Advisory No. 2020-1732 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic MIO PICCOLO TOKYO EYEBROW MASCARA

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

1. MIO PICCOLO TOKYO EYEBROW MASCARA

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 18 September 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 (ww2.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, the online reporting facility, eReport can be accessed at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Attachment:->FDA-Advisory-No.2020-1732

 

FDA Advisory No. 2020-1731 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic MAG ART NAIL FOREST GREEN

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

  1.  MAG ART NAIL FOREST GREEN.

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 18 September 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 (ww2.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, the online reporting facility, eReport can be accessed at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Attachment:-> FDA-Advisory-No.2020-1731

FDA Advisory No. 2020-2013 || Pilot Implementation of Food and Drug Administration (FDA) eServices Portal System for Compassionate Special Permit (CSP) Application for Drug Products

The Food and Drug Administration (FDA), in its commitment to provide stakeholders with streamlined and improved government services, is developing the FDA eServices Portal System – an online platform for FDA marketing authorization applications.

The FDA wishes to invite stakeholders to use the FDA eServices Portal System through eservices.fda.gov.ph for the applications for Compassionate Special Permit. The eServices Portal is in its Pilot Implementation; hence the scope of the application is limited for the time being:

FDA eServices Portal Pilot Implementation

for Compassionate Special Permit

Transactions Compassionate Special Permit (Named Patient Use)

Compassionate Special Permit (Institutional Use)

Fees to be Paid Based on Current Issuance on Fees and Charges
(DOH Administrative Order No. 50, s. 2001)
Start of Pilot Implementation 19 November 2020
End of Pilot Implementation 19 December 2020

Please follow Annex A of this Advisory for the Guideline and Checklist of Requirements, Annex B for step-by-step guide, and Annex C for checking of application status via FDA eServices Portal System.

For any feedback and comments for the FDA eServices Portal System, please send it to [email protected].

Read more:->FDA ADVISORY NO. 2020-2013

/ In Drugs Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-2013 || Pilot Implementation of Food and Drug Administration (FDA) eServices Portal System for Compassionate Special Permit (CSP) Application for Drug Products

FDA Advisory No. 2020-2050 || Public Health Warning Against the Purchase and Use of the Non-Compliant Cosmetic Product ” RYXSKINCERITY DAY AND NIGHT REJUVENATING FACIAL WASH “

The Food and Drug Administration (FDA) warns the general public from purchasing and using the non-compliant cosmetic product, ” RYXSKINCERITY DAY AND NIGHT REJUVENATING FACIAL WASH “.

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 (ww2.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 product, the online reporting facility, eReport can be accessed at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Attachment:-> FDA-Advisory-No.2020-2050

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-2050 || Public Health Warning Against the Purchase and Use of the Non-Compliant Cosmetic Product ” RYXSKINCERITY DAY AND NIGHT REJUVENATING FACIAL WASH “

FDA Advisory No. 2020-1048-A || Lifting the Advisory on the Notified Product “FACE REPUBLIC CRYSTAL GLOW WHITENING CREAM” under FDA Advisory No. 2020-1048 “Public Health Warning Against the Purchase and Use of the Non-Compliant Cosmetic Product FACE REPUBLIC CRYSTAL GLOW WHITENING CREAM” Dated 08 June 2020

The Food and Drug Administration (FDA) informs the public that the Cosmetic product FACE REPUBLIC CRYSTAL GLOW WHITENING CREAM with Notification No. 1000007026561 has been notified by the Market Authorization Holder, More-Ning Sun Packaging Corp., in accordance with existing FDA rules and regulations.

Accordingly, the warning against the purchase and use of the subject product as mentioned in FDA Advisory No. 2020-1048 is hereby lifted.

The public is advised to always check if a Cosmetic product is notified 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 health product before purchasing. For more information or inquiries, please email us at [email protected], you may also call the Center for Cosmetics Regulation and Research at telephone number (02) 8857-1900 loc. 8113 or 8117.

To report the sale or distribution of any unnotified/unregistered health products, kindly email FDA via [email protected].

Furthermore, the issuance of this advisory shall not in any manner preclude this Office from issuing subsequent orders it may deem necessary and appropriate, should there be findings of any violation of the company to the existing laws, rules, and regulations.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA-Advisory-No.2020-1048-A

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-1048-A || Lifting the Advisory on the Notified Product “FACE REPUBLIC CRYSTAL GLOW WHITENING CREAM” under FDA Advisory No. 2020-1048 “Public Health Warning Against the Purchase and Use of the Non-Compliant Cosmetic Product FACE REPUBLIC CRYSTAL GLOW WHITENING CREAM” Dated 08 June 2020