Month: March 2020

FDA approved 3 additional kits today (2 PCR, 1 RAPID), 31 March 2020. Total registered COVID-19 Test Kits for commercial use is now 26.

UPDATE as of 4PM: FDA approved 3 additional kits today (2 PCR, 1 RAPID), 31 March 2020. Total registered COVID-19 Test Kits for commercial use is now 26. Click the link below for details.

https://drive.google.com/drive/folders/1Dk8KjbCzk8g92HydWDRvg8K-ATp7gBez?fbclid=IwAR2v60QZvEV-cV18ft2ZLtvighX6oxCtn3_pWv41fUY2fxjdRo3joNxpXV0

FDA Advisory No. 2018-309-A || Lifting the Advisory of the Registered Medical Device Product “Air Life Gauze Bandage 4” x 10 yds, 40’s/40’s 19 x 10 mesh under FDA Advisory No. 2018-309 “Public Health Warning Against the Purchase and Use of Medical Device with Expired Certificate of Product Registration (CPR) “

The Food and Drug Administration (FDA) informs the public that the medical device product Air Life Gauze Bandage 4″ x 10 yds, 40’s/40’s 19 x 10 mesh with CPR No. MDR-08861, has been registered by the Market Authorization Holder (MAH), Airlife International Trading Corporation, in accordance to existing FDA rules and regulations.

Accordingly, the warning against the purchase and use of the product as mentioned in FDA Advisory No. 2018-309 is hereby lifted.

For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health, and Research through e-mail at [email protected], or call (02) 8857-1900 loc. 8301.

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

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.2018-309-A

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2018-309-A || Lifting the Advisory of the Registered Medical Device Product “Air Life Gauze Bandage 4” x 10 yds, 40’s/40’s 19 x 10 mesh under FDA Advisory No. 2018-309 “Public Health Warning Against the Purchase and Use of Medical Device with Expired Certificate of Product Registration (CPR) “

FDA Advisory No. 2020-432 || Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Products:

The Food and Drug Administration (FDA) warns the public from purchasing and consuming the following unregistered food products:

  1. MEGA Honey Lemon Candy
  2. AJL STORE Sugar
  3. EARTH’S BEST ORGANIC Chicken & Brown Rice Organic Baby Food
  4. EARTH’S BEST Organic Sweet Peas & Creamed Spinach Medley Organic Baby Food
  5. W.L. FOODS U NEED Pure Vegetable Oil

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

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

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

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

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

Kindly contact the FDA Center for Food Regulation and Research through e-mail at [email protected], or call (02) 8857-1900 loc. 8112 & 8115.

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-432

FDA Advisory No. 2020-431 || Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Supplements and Food Product:

The Food and Drug Administration (FDA) warns the public from purchasing and consuming the following unregistered food supplements and food product:

  1. THE SAINT NANO-CELL L-Glutathione Plus Antioxidant Capsules
  2. BALANCE Spirulina Tablets
  3. OTSUKA Placenta C Jelly
  4. TRANSINO White C Clear Tablets
  5. PREMIER BEET TRUTH! Beetroot Juice

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

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

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

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

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

Kindly contact the FDA Center for Food Regulation and Research through e-mail at [email protected], or call (02) 8857-1900 loc. 8112 & 8115.

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-431

/ In Food Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-431 || Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Supplements and Food Product:

FDA Advisory No. 2020-430 || Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Supplements and Food Product:

The Food and Drug Administration (FDA) warns the public from purchasing and consuming the following unregistered food supplements and food product:

  1. MAXIMUM STRENGTH Advanced Turmeric Organic Health Support Dietary Supplement Capsule
  2. LIVE GREEN Food Supplement Powder Drink
  3. CYSTINA C Food Supplement Tablets
  4. BELTA Folic Acid Supplement
  5. KENZO & KLOE’S NATURE FARM Natural Seasoning Bonggan Mix

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

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

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

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

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

Kindly contact the FDA Center for Food Regulation and Research through e-mail at [email protected], or call (02) 8857-1900 loc. 8112 & 8115.

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-430

/ In Food Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-430 || Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Supplements and Food Product:

FDA Advisory No. 2020-429 || Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Supplements and Food Product:

The Food and Drug Administration (FDA) warns the public from purchasing and consuming the following unregistered food supplements and food product:

  1. GNC MEGA MEN Dietary Supplement Tablets
  2. GNC WOMEN’S ULTRA MEGA ONE DAILY Dietary Supplement Caplets
  3. GNC MEGA MEN 50 PLUS Dietary Supplement Caplets
  4. LAC ACTIVATED LUNG PROTECT Vegicaps
  5. TRIM AND SLIM Herbal Coffee Mix

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

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

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

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

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

Kindly contact the FDA Center for Food Regulation and Research through e-mail at [email protected], or call (02) 8857-1900 loc. 8112 & 8115.

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-429

/ In Food Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-429 || Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Supplements and Food Product:

FDA Advisory No. 2020-428 || Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Supplements and Food Products:

The Food and Drug Administration (FDA) warns the public from purchasing and consuming the following unregistered food supplements and food products:

  1. ALASKA LIFE EFA Omega 3 Food Supplement Softgels
  2. MAHARLIKA Ampalaya Plus 3 in 1 Food Supplement Capsule
  3. SHINE L-Glutathione
  4. MERJ Chia Milk Tea Hokkaido Flavor
  5. MERJ Chia Milk Tea Okinawa Flavor

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

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

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

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

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

Kindly contact the FDA Center for Food Regulation and Research through e-mail at [email protected], or call (02) 8857-1900 loc. 8112 & 8115.

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-428

/ In Food Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-428 || Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Supplements and Food Products:

FDA Advisory No. 2020-427 || Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Supplements and Food Products:

The Food and Drug Administration (FDA) warns the public from purchasing and consuming the following unregistered food supplements and food products:

  1. CF WELLNESS CF Grapeseed Food Supplement
  2. H2W MICSWELL CAFÉ 10 in 1 Coffee Mix with Pomegranate & Trace Minerals
  3. FELOKLEAR Herbal Capsules
  4. STRONGLIFE G-DEFENSE Capsules
  5. SKY DRAGON Chopped Pork and Ham

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

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

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

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

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

Kindly contact the FDA Center for Food Regulation and Research through e-mail at [email protected], or call (02) 8857-1900 loc. 8112 & 8115.

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-427

/ In Food Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-427 || Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Supplements and Food Products:

FDA Advisory No. 2020-426 || Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Supplements:

The Food and Drug Administration (FDA) warns the public from purchasing and consuming the following unregistered food supplements:

  1. 24 SUPER HERBS 24 in 1 Organic & All Natural Health Supplement Capsules
  2. HOUSE OF HERBS Turmeric with Buah Merah, Lemon Grass & Citrus
  3. EMVI HERBAL PRODUCTS Mangosteen Food Supplement Capsule
  4. EMVI Turmeric Curcumin Capsules
  5. EMVI HERBAL PRODUCTS Sambong Blumea balsamifera Capsules

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

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

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

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

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

Kindly contact the FDA Center for Food Regulation and Research through e-mail at [email protected], or call (02) 8857-1900 loc. 8112 & 8115.

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-426

/ In Food Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-426 || Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Supplements:

FDA Advisory No. 2020-425 || Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Supplements and Food Products:

The Food and Drug Administration (FDA) warns the public from purchasing and consuming the following unregistered food supplements and food products:

  1. EMVI HERBAL PRODUCTS Guyabano Graviola Capsules
  2. DYNAMIC WEIGHT-LOSS FORMULA PURE SVETOL Green Coffee Extract Dietary Supplement Capsules
  3. ULTIMA MARKETING Graviola Capsules
  4. JOCALS GLUTA GLOW Powdered Drink Mix
  5. JOCALS Green Coffee

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

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

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

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

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

Kindly contact the FDA Center for Food Regulation and Research through e-mail at [email protected], or call (02) 8857-1900 loc. 8112 & 8115.

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-425

/ In Food Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-425 || Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Supplements and Food Products:

FDA Advisory No. 2020-424 || Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Supplements and Food Products:

The Food and Drug Administration (FDA) warns the public from purchasing and consuming the following unregistered food supplements and food products:

  1. MEGA DETOXIFIER FOR INTERNAL CLEANSIING Capsules
  2. STRONGLIFE BIO ENHANCER
  3. CF WELLNESS CF MORINGA PLUS Food Supplement
  4. ESSENSA NATURALE Masters Coffee 8 in 1
  5. 777 HEALING POWER Juice

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

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

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

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

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

Kindly contact the FDA Center for Food Regulation and Research through e-mail at [email protected], or call (02) 8857-1900 loc. 8112 & 8115.

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-424

/ In Food Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-424 || Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Supplements and Food Products:

FDA Advisory No. 2020-364 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

The Food and Drug Administration (FDA) warns the public from purchasing and consuming the following unregistered food products:

  1. ENG SENG FOOD PRODUCTS Vacuum Freeze-Dried Durian
  2. RUZYL’S Salabat
  3. TAP-J FOOD PRODUCTS Ginger Brew (Salabat)
  4. PRELE’S FOODS GINTU PLUS Ginger Turmeric Tea
  5. NILDA’S 7 in 1 Salabat

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

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

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

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

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

Kindly contact the FDA Center for Food Regulation and Research through e-mail at [email protected], or call (02) 8857-1900 loc. 8112 & 8115.

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-364

FDA Advisory No. 2020-363 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

The Food and Drug Administration (FDA) warns the public from purchasing and consuming the following unregistered food products:

  1. SHAS FOOD PRODUCTS Special Dried Miki
  2. SHAS FOOD PRODUCTS Special Misua
  3. SHAS FOOD PRODUCTS Special O’dong
  4. DOLPHIN BRAND Special Quality Golden Bihon Fortified with Iodine
  5. MARCA B.M. Mili

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

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

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

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

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

Kindly contact the FDA Center for Food Regulation and Research through e-mail at [email protected], or call (02) 8857-1900 loc. 8112 & 8115.

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-363

FDA Advisory No. 2020-362 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products and Food Supplement:

The Food and Drug Administration (FDA) warns the public from purchasing and consuming the following unregistered food products and food supplement:

  1. JANNAH Mangosteen Herbal Dietary Supplement Capsule
  2. ENG SENG FOOD PRODUCTS Special Polvoron
  3. MEMER FOOD DEALER Fish Cracker
  4. LEE KUM KEE Soup Base for Satay Hot Pot
  5. EZ COOK Seafood Flavored Soup Base

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

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

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

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

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

Kindly contact the FDA Center for Food Regulation and Research through e-mail at [email protected], or call (02) 8857-1900 loc. 8112 & 8115.

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-362

/ In Food Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-362 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products and Food Supplement:

FDA Advisory No. 2020-361 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

The Food and Drug Administration (FDA) warns the public from purchasing and consuming the following unregistered food products:

  1. AMERICA’S TOP CHOICE BEST RAMEN Ramen Noodle Soup Shrimp Flavor
  2. POKKA PULPY C Orange Drink with Orange Pulps & Juice
  3. 3RD GEN GLORY’S CAFÉ Local Tablea with Muscovado Sugar
  4. 3RD GEN GLORY’S CAFÉ Native Ground Coffee Drip
  5. MOTHER’S BEST Hot Banana Sauce Spicy

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

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

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

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

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

Kindly contact the FDA Center for Food Regulation and Research through e-mail at [email protected], or call (02) 8857-1900 loc. 8112 & 8115.

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-361

FDA Advisory No. 2020-360 || Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Product and Food Supplements:

The Food and Drug Administration (FDA) warns the public from purchasing and consuming the following unregistered food product and food supplements:

  1. PUREST LACTATION 10 in 1 Powdered Drink Mix
  2. CLINICAL GLUTATHIONE Stable, Oral Glutathione for Viral Support Tablets
  3. KAL URIC ACID FLUSH Dietary Supplement Capsules
  4. MONA Phyllanthus Herbal Food Supplement Capsule
  5. SOLARAY KIDNEY BLEND SP-6 Cornsilk Capsule

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

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

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

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

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

Kindly contact the FDA Center for Food Regulation and Research through e-mail at [email protected], or call (02) 8857-1900 loc. 8112 & 8115.

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-360

/ In Food Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-360 || Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Product and Food Supplements:

FDA Advisory No. 2020-359 || Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Product and Food Supplements:

The Food and Drug Administration (FDA) warns the public from purchasing and consuming the following unregistered food product and food supplements:

  1. AMBULONG SLP ASSOCIATION Banana Chips Cheese, 80g
  2. HEALTHPLUS KIDNEY CLEANSE Buchu Leaf Extract, Cranberry Extract, Turmeric Root, Coenzyme Q10 Capsules
  3. JLA Lapacho Dietary Supplement Capsule
  4. 200 SUCCESS Malunggay Moringa oleifera Herbal Food Supplement Capsules
  5. 200 SUCCESS Mangosteen Fruit Extracts Food Supplement Capsules

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

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

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

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

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

Kindly contact the FDA Center for Food Regulation and Research through e-mail at [email protected], or call (02) 8857-1900 loc. 8112 & 8115.

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-359

/ In Food Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-359 || Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Product and Food Supplements:

FDA APPROVES RAPID ANTIBODY TEST KITS FOR COVID-19

PRESS STATEMENT
30 March 2020

The Food and Drug Administration (FDA) approves the use of five (5) Rapid Test Kits for COVID-19 today, March 30, 2020. The FDA supports all efforts to address this pandemic. These point-of-care test kits are registered for use in countries with reliable regulatory agencies such as China and Singapore. “We approve kits that are registered and used in countries with advanced technology and wide experience with COVID 19. We want the people to have access to testing but of course, proper evaluation and safeguards will still be in place” Director General Eric Domingo said.

FDA has also approved the SARS Cov2 kit by Gene Xpert. This kit is PCR based. To date, FDA has approved 17 PCR based test kits for commercial use.

As a safety precaution, the FDA shall require the product inserts or label of the Rapid Test Kits to state the following: “This product is strictly for medical professional use only and not intended for personal use. The administration of the test and interpretation of results should be done by a trained health professional. Confirmatory testing is required.” 

“The rapid test kits will yield a faster result compared to PCR based kits, but it is important that a trained health professional will evaluate and interpret the results. We have to be very cautious in using these rapid test kits because they measure antibodies and not the viral load itself. The body takes time to develop antibodies and this might give a negative result for patients who have been infected but have not yet developed antibodies. A positive result due to cross reaction with other bacteria or viruses is also possible, which is why a confirmatory PCR based test is still required,” DG Domingo added.

FDA calls on the local government chief executives, heads of agencies, hospitals and private companies to be cautious in using these test kits. The agency asks doctors to help in testing and guide patients in the interpretation of the results. He also stressed the need for the Department of Health to increase the number of capable laboratories accredited to perform the PCR confirmatory tests.

FDA remains steadfast in its obligation to protect the public. Despite the global crisis we are faced with, FDA continues to safeguard public health by ensuring that health commodities, especially those related to addressing the COVID 19 emergency, are certified following regulatory standards – through streamlined processes.

“Let us remain vigilant and hopeful as we protect each other’s welfare against those who seem to take advantage of this vulnerable situation. During this rapid increase of COVID-19 cases in the country, the agency continues to serve the people by giving them access to testing without compromising our mandate of ensuring the safety, efficacy and quality of every health product for the public,” DG Domingo concluded.

FDA Advisory No. 2020-483 || FDA APPROVES RAPID ANTIBODY TEST KITS FOR COVID-19

In line with the ongoing response to the increasing number of COVID-19 cases in the Philippines, the Food and Drug Administration (FDA)- Philippines hereby provides an initial list of approved Rapid Antibody Test Kits.

PRODUCT NAME MANUFACTURER
1. NANJING VAZYME 2019-nCoV IgG/IgM DETECTION KIT Biolidics Limited. – 37 Jalan Pemimpin, #02-07, Mapex, Singapore
2. NOVEL CORONAVIRUS (2019-NCOV) IgM/IgG ANTIBODY DETECTION KIT (COLLOIDAL GOLD METHOD) Nanjing Vazyme Medical Technology Co., Ltd – Level 1-3, Bldg. C2, Red Maple Sci-Tech Park, Kechuang Road, Nanjing China
3. DIAGNOSTIC KIT FOR IgM/IgG ANTIBODY TO CORONAVIRUS (SARS-CoV-2) (COLLOIDAL GOLD) Zhuhai Livzon Diagnostic Inc. – 1st Building, No. 266, Tongchang Road, Xiangzhou District, Zhuhai, Guangdong Province, People’s Republic of China
4. 2019-nCoV ANTIBODY TEST (COLLOIDAL GOLD) Innovita (Tangshan) Biological Technology Co., Ltd. – No. 699 Juxin Street, High-Tech Industrial Development Zone, Qian’an 064400, Hebei, China
5. SARS-CoV-2 ANTIBODY TEST (LATERAL FLOW METHOD) Guangzhou Wondfo Biotech Co., Ltd. – No. 8 Lizhishan Road, Science City, Luogang District, 510663, Guangzhou, People’s Republic of China

This list shall be regularly updated. For reference please click the link.

https://drive.google.com/open?id=1Dk8KjbCzk8g92HydWDRvg8K-ATp7gBez

To report any sale or distribution of COVID-19 rapid test kits not included in the list, you may email us at [email protected].

Attachment:->FDA Advisory No.2020-483

FDA Advisory No. 2020-358 || Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Products:

The Food and Drug Administration (FDA) warns the public from purchasing and consuming the following unregistered food products:

  1. AMBULONG SLP ASSOCIATION Bukayo Sweetened Coconut
  2. TINA’S Ginger Tea with Luyang Dilaw, Guyabano, Pandan & Mangosteen
  3. 7 Days Slimming Coffee
  4. MAMA’S Organic Virgin Coconut Oil
  5. MAMA’S Organic Tablea Praline

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

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

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

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

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

Kindly contact the FDA Center for Food Regulation and Research through e-mail at [email protected], or call (02) 8857-1900 loc. 8112 & 8115.

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-358

FDA Advisory No. 2020-357 || Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Products:

The Food and Drug Administration (FDA) warns the public from purchasing and consuming the following unregistered food products:

  1. MAMA’S Organic Sweetened Cacao Nibs
  2. MAMA’S Organic Spicy Cacao Nibs
  3. MAMA’S Organic Pure Cacao Nibs
  4. MAMA’S Organic Mountain Honey
  5. MAMA’S Organic Coconut Blossom Sugar

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

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

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

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

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

Kindly contact the FDA Center for Food Regulation and Research through e-mail at [email protected], or call (02) 8857-1900 loc. 8112 & 8115.

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-357

FDA Advisory No. 2020-356 || Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Products:

The Food and Drug Administration (FDA) warns the public from purchasing and consuming the following unregistered food products:

  1. CATALO Herbal Tea
  2. DAGI Banana Chips
  3. PALAWAN ESSENTIALS Mango Tamarind Candy
  4. ROVILLA’S Turmeric Powder
  5. GLAY’S DELI Bagoong Alamang Guisado (Sauteed Shrimp Paste)

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

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

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

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

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

Kindly contact the FDA Center for Food Regulation and Research through e-mail at [email protected], or call (02) 8857-1900 loc. 8112 & 8115.

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-356

FDA Advisory No. 2020-355 || Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Products:

The Food and Drug Administration (FDA) warns the public from purchasing and consuming the following unregistered food products:

  1. MAMA’S Organic Blossom Nipa Sugar
  2. MAMA’S Natural Native Coffee
  3. NATURE’S FRESH VERDANT Pure Drinking Water
  4. AKRISHNA AGRI FARM OYSTER MUSHROOM Crispy Mushroom Chicharon Strawberry Flavor
  5. FLORA’S Sweet Spicy Pusit

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

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

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

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

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

Kindly contact the FDA Center for Food Regulation and Research through e-mail at [email protected], or call (02) 8857-1900 loc. 8112 & 8115.

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-355

FDA Advisory No. 2020-452 || Baseless Claims of “Prodex-B” as Anti-Viral Treatment for COVID-19

The Food and Drug Administration (FDA) reiterates to all health facilities and health professionals to follow the recommended treatment guidelines endorsed by the Department of Health (DOH) and the medical societies. This is in reference to the baseless claims on drug combination for the treatment and prevention of COVID-19.

The drug combination of Procaine and Dexamethasone with Vitamin B called “Prodex-B” is circulating in various media platforms and claims that it has promising effects against viral infections and diseases. However upon verification, the drug product “Prodex-B” is unregistered in this Office.

Procaine is an anesthetic used to reduce pain on injections, while Dexamethasone is a corticosteroid which must be used cautiously due to its side effects including immunosuppression or weaker immune system leading to vulnerability to infections. Furthermore, unregistered drug products have no guaranteed quality, safety and efficacy data which may lead to patient harm.

All consumers who have received the aforementioned drug are advised to monitor for any adverse reactions. For any observed adverse reaction, the individuals are advised to seek medical attention immediately and report to this Office at [email protected] and at E-Report at [email protected].

Attachment:-> FDA Advisory No.2020-452

FDA Advisory No. 2020-354 || Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Products:

The Food and Drug Administration (FDA) warns the public from purchasing and consuming the following unregistered food products:

  1. SWEET-O Mango with Vitamin-C
  2. ORORAMA SAVINGS Vegetable Oil
  3. MAGICTIME Apple Cider Vinegar
  4. HEALTH & BEAUTY Coffee Blend 11 n’ 1 Latte

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

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

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

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

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

Kindly contact the FDA Center for Food Regulation and Research through e-mail at [email protected], or call (02) 8857-1900 loc. 8112 & 8115.

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-354

FDA Circular No. 2020-009-A || AMENDMENT TO INCLUDE VENTILATORS,RESPIRATORS AND THEIR RESPECTIVE ACCESSORIES TO THE LIST OF MEDICAL DEVICES COVERED BY FDA CIRCULAR NO. 2020-009

The listing of health products enumerated under Section IV- Scope of FDA Circular No. 2020­-009, or Guidelines on the Identification, Notification, Evaluation, Regulatory Enforcement Action, and Review and Monitoring of Donated Health Products Solely Intended to Address COVID-19 Public Health Emergency is hereby amended to include ventilators, respirators and their respective accessories.

Hence, the listing provided under said Section of the subject Circular shall be amended to read as follows:

  1. Face Masks including N-95 Masks,
  2. Shoe Covers,
  3. Gloves,
  4. Head Covers,
  5. Gowns,
  6. Goggles/ Face Shields,
  7. COVID-19 Diagnostic Test Kits,
  8. Alcohol, Hand Sanitizers, etc.,
  9. Ventilators, Respirators and their respective Accessories, and
  10. Other health products that may hereinafter be identified and listed by the FDA.

This Order shall take effect immediately.

For your information and guidance.

Attachment:-> FDA Circular No.2020-009-A

/ In Circular / By Administrator / Comments Off on FDA Circular No. 2020-009-A || AMENDMENT TO INCLUDE VENTILATORS,RESPIRATORS AND THEIR RESPECTIVE ACCESSORIES TO THE LIST OF MEDICAL DEVICES COVERED BY FDA CIRCULAR NO. 2020-009

FDA approved 3 additional kits today, 27 March 2020. Total registered COVID-19 Test Kits for commercial use is now 18.

UPDATE as of 4PM: FDA approved 3 additional kits today, 27 March 2020. Total registered COVID-19 Test Kits for commercial use is now 18. Click the link below for details.

https://drive.google.com/drive/folders/1Dk8KjbCzk8g92HydWDRvg8K-ATp7gBez?fbclid=IwAR2v60QZvEV-cV18ft2ZLtvighX6oxCtn3_pWv41fUY2fxjdRo3joNxpXV0

FDA Advisory No. 2020-178-A || Lifting the Advisory of the Registered Medical Device under FDA Advisory No. 2020-178. Subject “Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Alaris® Secondary Syringe Adapter”

The Food and Drug Administration (FDA) informs all healthcare professionals and the public that the medical device product “Alaris® Secondary Syringe Adapter” has been registered by the Market Authorization Holder (MAH), KSM Healthcare Inc., with FDA registration number MDR-04674 in accordance to existing FDA rules and regulations

Accordingly, the warning against the purchase and use of the product as mentioned in FDA Advisory No. 2020-178 is hereby lifted.

For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health, and Research through e-mail at [email protected], or call (02) 8857-1900 loc. 8301.

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

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. 2020-178-A

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-178-A || Lifting the Advisory of the Registered Medical Device under FDA Advisory No. 2020-178. Subject “Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Alaris® Secondary Syringe Adapter”

FDA Advisory No. 2020-451-A || FDA EMAIL HOTLINE PARA SA MGA SUMBONG SA PRODUKTO NA MAY KINALAMAN SA COVID-19

Ang Food and Drug Administration (FDA) ay patuloy na nagbibigay serbisyo sa publiko sa pamamagitan ng pagtiyak ng kaligtasan, kalidad, at pagiging epektibo ng mga produktong pangkalusugan tulad ng pagkain, gamot, kosmetiko, at medical devices sa kabila ng banta ng COVID-19.

Bilang sagot sa dumaraming sumbong ng mataas na pagpresyo, labis na pagiimbak (hoarding), at paglaganap ng mga hindi rehistrado, peke, at mababang kalidad na produkto sa merkado, ang FDA hotline na [email protected]  ay bukas upang tumanggap at tumugon sa mga sumbong mula sa publiko.

Maari kayong mag-report sa hotline kung may nakitang:

  1. Pagbebenta (online man o pisikal) ng mga hindi rehistradong produktong pagkalusugan;
  2. Masyadong mataas na presyo na mga gamot at gamit medical;
  3. Hinihinalang peke at mababang kalidad na produktong pangkalusugan;
  4. Kaduda-dudang kaligtasan ng pagkain at gamot; at
  5. Iba pang mga katulad na sumbong

Maari kayong maglagay ng detalye at impormasyon tulad ng pinanggalingan ng produkto, pangalan ng produkto, naranasang epekto, manufacturer, code, numero, o petsa na makikita sa balot ng produkto upang mas mapabilis ang pagresponde sa inyong mga sumbong.

Ang mga report rid ito ay makakatulong upang mapanatili ng FDA ang pag-aksyon sa mga isyu na may kinalaman sa mga banta laban sa kalusugan ng publiko.

Attachment:-> FDA Advisory No.2020-451-A