Month: December 2020

FDA Advisory No. 2020-2182 || 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. PRIMEBLEND SAKTO Cheesedog
2. HAIFUSHENG In Paper Cup Packaging with Image of Porridge (In Foreign Language)
3. HAIFUSHENG In Paper Cup Packaging with Image of Seafood in Porridge (In Foreign Language)
4. HAIFUSHENG In Paper Cup Packaging with image of Pork Ribs in Porridge (In Foreign Language)
5. Vegetable-Egg Soup In Plastic Cup Packaging With Orange Packaging (In Foreign Language)

The FDA verified through online monitoring or 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 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 cfrr@fda.gov.ph 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.2020-2182

 

FDA Advisory No. 2020-2181 || 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. REWEL’S Peanut Butter
2. RICHMOND RIC Miswa Small
3. RICHMOND RIC Canton Small
4. RICHMOND RIC Special Noodles Molo Strips White
5. REMIL’S Turmeric Tea Perfect Seven

The FDA verified through online monitoring or 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 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 cfrr@fda.gov.ph 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.2020-2181

FDA Advisory No. 2020-2180 || 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. ALTER TRADE Coconut Sugar
2. Drink in Pet Bottle with Black and Gold Packaging (In Foreign Language)
3. Tea (Orange) 480ml (In Foreign Language)
4. G-RUTH Peanut Butter
5. BJ DELICACIES Home Made Peanut Butter

The FDA verified through online monitoring or 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 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 cfrr@fda.gov.ph 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.2020-2180

FDA Advisory No. 2020-2179 || 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. Fruits Blend 30% 500ml Juice with Picture of Fruits (In Foreign Language)
2. Juice Drink with Picture of Pomegranate Packaging Pink in Color (In Foreign Language)
3. Enle 500ml Green Bottle with Aloe Vera Picture (In Foreign Language)
4. Bottled Juice Drink with Picture of Guava (In Foreign Language)
5. Juice Drink 340 ml Green Cap (In Foreign Language)

The FDA verified through online monitoring or 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 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 cfrr@fda.gov.ph 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.2020-2179

FDA Advisory No. 2020-2178 || 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. WENCHONG Green Pack Color with Meat and Noodles Picture (In Foreign Language)
2. OVERMANWU with Yellow/Black Colored Packaging (In Foreign Language)
3. YALIDA Watermelon Seeds with Red Packaging (In Foreign Language)
4. Noodles with Black Packaging (In Foreign Language)
5. Glass Bottle with Yellow Plastic Cup (In Foreign Language)

The FDA verified through online monitoring or 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 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 cfrr@fda.gov.ph 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.2020-2178

FDA Advisory No. 2020-2183 || Delisted Companies with Issued Special Certification for COVID-19 Test Kits

The Food and Drug Administrative (FDA) informs all concerned stakeholders and the general public that the following companies with issued Special Certification for COVID-19 Test Kits have voluntarily surrendered their authorization to market the product:

Company’s Name Product Name SC Control Number Classification
 

1.

MDX

Netherlands Diagnostics, Inc.

FOSUN COVID-19 RT-PCR DETECTION KIT SC-COVID19- 2020-183  

PCR

 

2.

MDX

Netherlands Diagnostics, Inc.

Real-Time Flourescent RT-PCR Kit for Detecting SARS-2019 nCoV SC-COVID19- 2020-148  

PCR

 

3.

Clearbridge Medical

Philippine

NANJING VAZYME 2019- nCoV IgG/IgM DETECTION

KIT

SC-COVID19- 2020-029  

RAPID

4. UC Biosciences Inc. ORIGHT COVID-19 IgG/IgM RAPID TEST KIT SC-COVID19- 2020-250 RAPID
5. UC Biosciences Inc. Cellex Qsars-CoV-2 IgG/IgM Cassette Rapid Test SC-COVID19- 2020-104 RAPID
6. UC Biosciences

Inc.

2019-nCoV-2 ANTIBODY

TEST (COLLOIDAL GOLD)

SC-COVID19-

2020-102

RAPID
 

7.

Biopharma Medical Solutions, Inc. SARS-CoV-2 FLOURESCENT PCR SC-COVID19- 2020-079  

PCR

 

8.

Biopharma

Medical Solutions, Inc.

SOLGENT DiaPlexQ™

NOVEL CORONAVIRUS (2019-nCoV) DETECTION KIT

SC-COVID19- 2020-090  

PCR

 

9.

Clearbridge

Medical Philippines, Inc.

SAVANT™ New Coronavirus (SARS-CoV-2) N Protein SC-COVID19- 2020-657  

RAPID

 

10.

 

Indoplas Philippines, Inc.

SARS-CoV-2 Antibody Test (Lateral Flow Method) – Guangzhou Wondfo Biotech Co., Ltd.  

SC-COVID19- 2020-091

 

RAPID

 

11.

Crestline Scientific Corporation Cellex qSARS-CoV-2 IgG/IgM Cassette Rapid Test SC-COVID19- 2020-161  

RAPID

 

12.

Murex Diagnostic Products Specialists  

SARS-CoV-2 Flourescent PCR

 

SC-COVID19- 2020-182

 

PCR

 

 

13.

Adamson Medtex International Corp. DIAGNOSTIC KIT FOR IgM/IgG ANTIBODY TO CORONAVIRUS (SARS-CoV-

2) (COLLOIDAL GOLD) – Zhuhau Livzon Diagnostic Inc.

 

SC-COVID19- 2020-032

 

 

RAPID

 

14.

Aglobal Care Inc. 2019-nCoV ANTIBODY TEST

(COLLOIDAL GOLD) – INNOVITA

SC-COVID19- 2020-099  

RAPID

15. St. Tyke, Inc. PCL COVID19 IgG/IgM RAPID GOLD SC-COVID19- 2020-396 RAPID

For more information and inquiries, kindly contact the FDA-Center for Device Regulation, Radiation Health, and Research through email address at cdrrhr@fda.gov.ph or call (02) 8857-1900 loc. 8301.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA-Advisory-No.2020-2183

FDA Advisory No. 2020-1691-A || Lifting of the FDA Advisory No. 2020 – 1691 entitled: Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product:

The Food and Drug Administration (FDA) informs all healthcare professionals and the general public that the following medical device products have been registered by the Market Authorization Holder, OMM Healthcare Philippines Corporation, in accordance to existing FDA rules and regulations:

1. NIPRO SYNTHETIC HOLLOW FIBER DIALYZER ELISIO™ 190HR
2. NIPRO ELISIO™ – 17H SYNTHETIC HOLLOW FIBER POLYNEPHRON

Accordingly, the warning against the purchase and use of the subject medical device products as mentioned in FDA Advisory No. 2020-1691 is hereby lifted.

For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health, and Research through e-mail at cdrrhr@fda.gov.ph, or call (02) 8857-1900 loc. 8301.

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

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.2020-1691-A

/ In Device Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-1691-A || Lifting of the FDA Advisory No. 2020 – 1691 entitled: Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product:

FDA Advisory No. 2020-2174 || 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. Instant Noodles Yellow and Green Pouch Packaging (In Foreign Language)
2. Instant Noodles in Bluegreen Pouch Packaging (In Foreign Language)
3. Instant Noodles Hot Beef Flavor Orange Pouch Packaging (In Foreign Language)
4. ENERGY Tengjiaoguniang Cup Noodles in Pink and Brown Packaging (In Foreign Language)
5. ENERGY Cup Noodles in Blue and Brown Packaging (In Foreign Language)

The FDA verified through online monitoring or 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 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 cfrr@fda.gov.ph 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.2020-2174

 

 

FDA Advisory No. 2020-2173 || 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. Q10 Fertility Gel Food Supplement
2. Cup Noodles Black and White Packaging 180g (In Foreign Language)
3. Instant Noodles in Plastic Bowl with Violet and Gold Packaging (In Foreign Language)
4. Instant Noodles in Plastic Bowl with Red and Gold Packaging (In Foreign Language)
5. Instant Noodles Green Pouch Packaging (In Foreign Language)

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 cfrr@fda.gov.ph 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.2020-2173

 

/ In Food Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-2173 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplement and Food Products:

FDA Advisory No. 2020-2172 || 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. HAOHUANLUO Liuzhou Snail Rice Noodles Instant Noodles in Foil Pouch with Violet Packaging 300g (In Foreign Language)
2. ZHENGLE Cola Candy with Foil Pouch Packaging Inside Carton Box (In Foreign Language)
3. HI Rice Meal Cup Orange Packaging (In Foreign Language)
4. DELICIOUS LEGEND STARTING FROM YIDA JIUZHIYANGMEI (In Foreign Language)
5. Cup Noodles Purple and White Packaging 180g (In Foreign Language)

The FDA verified through online monitoring or 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 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 cfrr@fda.gov.ph 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.2020-2172

FDA Advisory No. 2020-2171 || 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. HAOHUANLUO Liuzhou Snail Rice Noodles Instant Noodles in Foil Pouch with Yellow Packaging 400g (In Foreign Language)
2. Meat Like Product in Clear Plastic Sachet Packaging (In Foreign Language)
3. HSIA HSIA CHAIO Noodle Snack in Yellow Foil Packaging (In Foreign Language)
4. Ultra Spicy Peanut Snack in Red Foil Packaging (In Foreign Language)
5. Food Product in Gray and Blue Foil Packaging (In Foreign Language)

The FDA verified through online monitoring or 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 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 cfrr@fda.gov.ph 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.2020-2171

FDA Advisory No. 2020-2170 || 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. Laver-Egg Soup In Plastic Cup Packaging With Violet Packaging (In Foreign Language)
2. Pakchoi-Egg Soup In Plastic Cup Packaging With Green Packaging (In Foreign Language)
3. Tomato-Egg Soup In Plastic Cup Packaging with Red Packaging (In Foreign Language)
4. YOU & ME Super Bars in Yellow Foil Pack Packaging (In Foreign Language)
5. SINZLY Chocolate Stick In White Foil Packaging (In Foreign Language)

The FDA verified through online monitoring or 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 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 cfrr@fda.gov.ph 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.2020-2170

 

 

FDA Advisory No. 2020-2177-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. Madame Pearl’s Cough Syrup F2 for Children 60 ml
2. Uni-Febrin Syrup 120 mL
3. Ching On Tong Cold Syrup for Children Natural Herbs Preparation 120 ml
4. GMP Qualimol 125mg / 5 ml Syrup 120 ml
5. 2019 NEW Xiao Shi Tong Niao Pian Tablets 100’s

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 info@fda.gov.ph. Upang mag-report ng patuloy na pagtitinda o pangangalakal ng mga hindi rehistradong gamot, mag-email sa ereport@fda.gov.ph. 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.2020-2177-A

FDA Advisory No. 2020-2177 || 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. Madame Pearl’s Cough Syrup F2 for Children 60 ml
2. Uni-Febrin Syrup 120 mL
3. Ching On Tong Cold Syrup for Children Natural Herbs Preparation 120 ml
4. GMP Qualimol 125mg / 5 ml Syrup 120 ml
5. 2019 NEW Xiao Shi Tong Niao Pian Tablets 100’s

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 info@fda.gov.ph. To report continuous sale or distribution of unregistered health products, kindly e-mail us via ereport@fda.gov.ph. 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.2020-2177

FDA Advisory No. 2020-2176-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 Qumixin Rugao
2. PIC/S GMP NK Pidelon Cream “N.K.” 20 Gm
3. OTC Qingkailing Jiaonang Capsule 24’s
4. OTC Beidougen Jiaonang Capsule 20’s

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 info@fda.gov.ph. Upang mag-report ng patuloy na pagtitinda o pangangalakal ng mga hindi rehistradong gamot, mag-email sa ereport@fda.gov.ph. 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.2020-2176-A

FDA Advisory No. 2020-2176 || 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 Qumixin Rugao
2. PIC/S GMP NK Pidelon Cream “N.K.” 20 Gm
3. OTC Qingkailing Jiaonang Capsule 24’s
4. OTC Beidougen Jiaonang Capsule 20’s

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 info@fda.gov.ph. To report continuous sale or distribution of unregistered health products, kindly e-mail us via ereport@fda.gov.ph. 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.2020-2176

FDA Advisory No. 2020-2175-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. Armadillo Antipyretic Pills 48’s
2. Hieng Hok® Quick Rheumatism Capsule Tiger Wang Biaod 20’s
3. Qianbai Biyan Pian Tablets 100’s

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 info@fda.gov.ph. Upang mag-report ng patuloy na pagtitinda o pangangalakal ng mga hindi rehistradong gamot, mag-email sa ereport@fda.gov.ph. 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.2020-2175-A

Press Statement || Caution on Use of Unauthorized Vaccines

Following reports that certain individuals have received vaccines against COVID-19, the Food and Drug Administration (FDA) reiterates its public advisory (FDA 2020-1395-00-A) on taking extreme caution on the purchase and use of vaccines claiming to be safe and effective in preventing COVID-19.

Director General Eric Domingo stated that “As of date the FDA has not issued any Emergency Use Authorization to any vaccine for COVID-19. Without the proper authorization, there is no guarantee on the safety, quality and efficacy of said vaccine as the same has not undergone the required technical evaluation by the FDA.”

The manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertisement, or sponsorship of any unauthorized vaccine is prohibited. Commission of such prohibited acts may lead to possible liabilities provided under the law. The FDA will coordinate with other agencies and take appropriate regulatory action involving any unauthorized vaccines.

“Rest assured that the FDA is observing utmost diligence in the regulation of vaccines. Vaccines will only be approved if there is reasonable scientific evidence to show that benefit outweighs risk.” Domingo said. “We will concentrate on making sure that only vaccines that pass standards will be made available to the public” he added.

Attachment:-> CAUTION ON USE OF UNAUTHORIZED VACCINES

FDA Advisory No. 2020-2175 || 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. Armadillo Antipyretic Pills 48’s
2. Hieng Hok® Quick Rheumatism Capsule Tiger Wang Biaod 20’s
3. Qianbai Biyan Pian Tablets 100’s

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 info@fda.gov.ph. To report continuous sale or distribution of unregistered health products, kindly e-mail us via ereport@fda.gov.ph. 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.2020-2175

FDA Advisory No. 2020-2121 || Public Health Warning Against the Purchase and Use of Adulterated and Unnotified Health Product/s ” CLINS UP ETHYL ALCOHOL “

The Food and Drug Administration (FDA) warns the public against the purchase and use of the adulterated and unnotified health product “ CLINS UP ETHYL ALCOHOL ”, which was tested and found to contain METHANOL.

An adulterated health product is composed, in whole or in part of, or contains any poisonous or deleterious substance which may render the contents injurious to health.

Acute and chronic exposure of humans to Methanol by inhalation or ingestion may result in visual disturbances, such as blurred or dimness of vision, leading to blindness, and neurological damage, specifically permanent motor dysfunction. Skin contact with methanol can also produce mild to severe dermatitis in humans. Furthermore, Methanol is not allowed to be part of a cosmetic product as per the Association of Southeast Asian Nations (ASEAN) Cosmetic Directive.

In light of the foregoing, the public is advised not to purchase the aforementioned adulterated product. Always check if a health product has been notified and/or registered with the FDA before purchasing it by making use of the embedded Search feature at the FDA website (ww2.fda.gov.ph).

All concerned establishments and/or entities are warned not to manufacture, distribute, sell, or offer for sale the adulterated health product/s. Pursuant to Section 11, subsections (a) and (b) of Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the following acts and the causing thereof: (a) the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product that is adulterated, unregistered or misbranded; and (b) the adulteration or misbranding of any health product are prohibited.

All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and local government units, are requested to ensure that this product is not sold or made available in their localities or areas of jurisdiction.

For more information or inquiries, please e-mail us at ccrr@fda.gov.ph. To report any sale or distribution of the above-mentioned product, kindly e-mail us via covidresponse@fda.gov.ph. You may also call the Center for Cosmetics Regulation and Research (CCRR) at telephone number (02) 8857-1900 loc. 8113 or 8107.

Attachment:-> FDA-Advisory-No.2020-2121

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-2121 || Public Health Warning Against the Purchase and Use of Adulterated and Unnotified Health Product/s ” CLINS UP ETHYL ALCOHOL “

FDA Advisory No. 2020-2165 || 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. Dried Fruits and Nuts in Red and Silver Packaging (In Foreign Language)
2. DA CHENG PAO YA ZHUA Preserved Spiced Chicken Feet with Star Anise and Chili Image in Red and Silver Vacuum Sealed Packaging (In Foreign Language)
3. CHUTIANSHU YAO YE Clear Drink in White and Green PET Bottle (In Foreign Language)
4. Probiotic Drink, 4 bottles in 1 pack (In Foreign Language)
5. Instant Tea Drink with Flower Image in PET Bottle (In Foreign Language)

The FDA verified through post-marketing surveillance that the above mentioned 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 cfrr@fda.gov.ph 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, 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.2020-2165

FDA Advisory No. 2020-2164 || 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. HA MI Spicy Peanuts with Red Design in Clear Packaging (In Foreign Language)
2. Preserved Food in Clear Packaging inside a Box with Orange and Red Design (In Foreign Language)
3. GUAI XIFU FOOD Preserved Chicken Feet in Green Vacuum Sealed Packaging (In Foreign Language)
4. DAHAODA SERIES FOOD Sunflower Seeds in Yellow and Light Brown Packaging (In Foreign Language)
5. CHACHEER Sunflower Seeds in Brown and Red Packaging (In Foreign Language)

The FDA verified through post-marketing surveillance that the above mentioned 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 cfrr@fda.gov.ph 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, 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.2020-2164

 

FDA Advisory No. 2020-2163 || 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. LIVE ENHANCE Drink with Peach Image in Blue and Green PET Bottle (In Foreign Language)
2. SCREAM Drink in Blue and White PET Bottle (In Foreign Language)
3. SCREAM Drink in Green and White PET Bottle (In Foreign Language)
4. WERDERY Milk Drink – Blueberry in White and Violet PET Bottle (In Foreign Language)
5. MING SHA Fruit and Nut Bar in Brown and Black Box (In Foreign Language)

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 cfrr@fda.gov.ph 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, 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.2020-2163

FDA SYSTEM MAINTENANCE ON 29 DECEMBER 2020, 7:00PM UNTIL 4 JANUARY 2021, 7:00AM

Please be informed that the FDA ePortal and eServices System will be unavailable from 29 December 2020 at 7:00PM until 4 January 2021, 7:00AM.

The Information and Communication Technology Management Division will be conducting a system maintenance.

We sincerely apologize for any inconveniences this may cause.

Attachment:-> ANNOUNCEMENT 23 December 2020 and 29 December 2020

 

FDA SYSTEM MAINTENANCE ON 23 DECEMBER 2020, 7:00PM UNTIL 28 DECEMBER 2020, 7:00AM

Please be informed that the FDA ePortal and eServices System will be unavailable from 23 December 2020 at 7:00PM until 28 December 2020, 7:00AM.

The Information and Communication Technology Management Division will be conducting a system maintenance.

We sincerely apologize for any inconveniences this may cause.

Attachment:-> ANNOUNCEMENT 23 December 2020 and 29 December 2020

 

 

FDA Advisory No. 2020-2162 || 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. Instant Drink with Sunflower Image in Yellow Tetra Brik Packaging (In Foreign Language)
2. Live Enhance Drink in Blue and Pink PET Bottle (In Foreign Language)
3. WERDERY Milk Drink – Green Apple in Green and White PET Bottle (In Foreign Language)
4. NESCAFE Smoovlatte in Green and Light Brown PET Bottle (In Foreign Language)
5. LIVE ENHANCE Drink with Calamansi Image in Blue and Green PET Bottle (In Foreign Language)

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 cfrr@fda.gov.ph 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, 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.2020-2162

FDA Advisory No. 2020-2161 || 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. PANGAEA HEALTH AND WELLNESS Organic Mangosteen Pericarp Powder
2. PANGAEA HEALTH AND WELLNESS Organic Graviola (Guyabano) Powder
3. FARM TO FOLK Organic Turmeric Powder
4. LIANGZHONGMEIWEI ZIWEIFANBEI 1+1>2 with Preserved Meat and Shoot tip Image in Light Brown and White Box (In Foreign Language)
5. Energy Drink in Gold and Red Easy Open Can (In Foreign Language)

The FDA verified through post-marketing surveillance that the above mentioned 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 cfrr@fda.gov.ph 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, 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.2020-2161

FDA Advisory No. 2020-2160 || 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. JOSH’S Greaseless Peanuts
2. JOSH’S Garlic Chips
3. PATSY’S Spicy Peanut
4. LOLIT’S Appetizer Bagoong
5. LOLIT’S Sinamak

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 cfrr@fda.gov.ph 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, 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.2020-2160

FDA Advisory No. 2020-2159 || 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. ALEXANDRA’S Tingi Tipid Pack Peanut Butter, 110g
2. TOWER CHARPONS Special Biscocho, 500g
3. ELAINE’S Banana Chips, 100g
4. J-GEM-R BAKERY AND FOOD PRODUCTS Special Pilipit, 125g
5. TOWER CHARPONS Rosquillos, 500g

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 cfrr@fda.gov.ph 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, 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.2020-2159

FDA Advisory No. 2020-2158 || 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. POKKA Melon Milk Drink
2. GENREV PRODUCTS Canola Oil
3. OK CHOCOLATE POWER Chocolate with Nuts Paste
4. SAMYANG U-Dong Oriental Seafood Flavor Noodle Soup, 120g

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 cfrr@fda.gov.ph 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, 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.2020-2158