Month: October 2019

SEMINAR VENUE FOR QCDRRHR – VIS on 7-8 November 2019

Please be informed that the venue for the Center for Device Regulation, Radiation Health and Research QPIRA Seminar for Visayas Stakeholders (Course Code: QCDRRHR-Vis) on 7-8 November 2019 will be at RICHMOND PLAZA HOTEL, F. SOTTO DRIVE, GORORDO AVENUE, CEBU CITY.

All course registrants who received Course Assessment Slip for the CDRRHR QPIRA Seminar but have not received the Course Confirmation Slip are advised to come in the seminar venue on the scheduled date of seminar with the following documents:

  • Course assessment slip
  • Proof of payment

Rest assured that the stakeholders with the above documents will be accepted to the seminar. For inquiries and other concerns, please call the FDA Academy at telephone number (02) 877 0259 or email at e[email protected] and [email protected]

Attachment:-> SEMINAR VENUE FOR QCDRRHR – VIS on 7-8 November 2019

FDA Advisory No. 2019-415 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

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

  1. OMIZU Cute Natural Alkaline Water
  2. SEAFRESH Adobong Bagoong Gourmet Shrimp Paste Sweet
  3. TROPICAL BLEND NONI Pure Fruit Powder
  4. CASUBA by KLU Spices Trading and General Merchandise

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

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

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

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

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

Kindly contact the FDA Center for Food Regulation and Research through e-mail at [email protected], or call (02) 857-1900 loc. 8112 or 8105.

To report any sale or distribution of unregistered food products, 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. 2019-415

FDA Advisory No. 2019-414 || 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 consumption of the following unregistered food products:

  1. CHAM® POLO WHISTLE FRUIT FLAVOR
  2. MOMMY’S SPECIAL CANE VINEGAR-WHITE
  3. 4C SINAMAK PINAKURAT
  4. TJ BRAND CHEESE POWDER
  5. FAT & THIN® SPICES & CONDIMENTS CINNAMON POWDER

The FDA verified through post-marketing surveillance that the abovementioned food products are not registered and the Certificate of Product Registration (CPR) have not yet 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 guarantee their quality and safety. The consumption of such violative products may pose health risk to consumers.

In light of the foregoing, the public is advised not to purchase violative products in the market. Moreover, the public is advised to always check if a food product is registered with the FDA. The FDA website (www.fda.gov.phhas 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 until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a CPR for the food product.

All FDA Field Officers and Regulatory Enforcement Unit (REU) in coordination with the law enforcement agencies and Local Government Units (LGUs) are requested to ensure that violative products are not sold or made available in their localities or areas of jurisdiction.

Kindly contact the FDA Center for Food Regulation and Research through email at [email protected] or call (02)857-1900 loc. 8115 and 8112.

To report any sale or distribution of unregistered food 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. 2019-414

FDA Advisory No. 2019-411 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

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

  1. PERFECTION ™ ENHANCED Buah Merah Instant Powdered Drink Mix
  2. EDEN’S BLEND 9-in-1 Coffee Hazelnut Flavor , 21g sachet
  3. ROARGANICS BGC Blend
  4. DOC Herbs Coffee
  5. TOP Guyabano Puree

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

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

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

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

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

Kindly contact the FDA Center for Food Regulation and Research through e-mail at [email protected], or call (02) 857-1900 loc. 8112 or 8105.

To report any sale or distribution of unregistered food products, 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. 2019-411

FDA Advisory No. 2019-410 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

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

  1. FAT & THIN Icee! Pearl Shake Powder Buko Pandan Flavor
  2. FAT & THIN Icee! Pearl Shake Powder Ube Flavor
  3. FAT & THIN Icee! Pearl Shake Powder Sweet Corn Flavor
  4. FAT & THIN Icee! Pearl Shake Powder Choco Fudge Flavor
  5. FAT & THIN Icee! Pearl Shake Powder Melon Flavor

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

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

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

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

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

Kindly contact the FDA Center for Food Regulation and Research through e-mail at [email protected], or call (02) 857-1900 loc. 8112 or 8105.

To report any sale or distribution of unregistered food products, 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. 2019-410

FDA Advisory No. 2019-409 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

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

  1. ROBINSONS SUPERSAVERS White Vinegar 5% acidity
  2. JINLING YUNNAN Pu-erh Tea
  3. CELESTIAL SEASONINGS Raspberry Zinger Herbal Tea Caffeine Free
  4. FAT & THIN Icee! Pearl Shake Powder Cookies and Cream
  5. HEALTHY YOU Stevia Powder

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

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

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

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

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

Kindly contact the FDA Center for Food Regulation and Research through e-mail at [email protected], or call (02) 857-1900 loc. 8112 or 8105.

To report any sale or distribution of unregistered food products, 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. 2019-409

FDA Advisory No. 2019-408 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplements:

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

  1. DLJ HERBASEN Food Supplement
  2. POWER HERBS PLANTS GRL Pito-Pito Herbal Syrup Food Supplement
  3. PURE FORSKOLIN Dietary Supplements
  4. COUNTRY FARMS SUPER CLEANSE Organic Juice Cleanse –Pomegranate Acai Flavor Dietary Supplement
  5. COUNTRY FARMS LIVING FOODS Multi-Vitamin Whole Food Formula Dietary Supplement

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

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

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

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

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) 857-1900 loc. 8112 or 8105.

To report any sale or distribution of unregistered food products, 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. 2019-408

FDA Advisory No. 2019-407 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

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

  1. PETE SIMPLY SWEET Kaong Red Class A Palm Fruit, Sugar & Water
  2. PMS Tongkat Ali Strong Coffee
  3. GRAND KIM SARDINES in Tomato Sauce Bonus Pack
  4. CHOCOCOA GOLDEN Pure Cocoa Powder Chocolate Mix

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

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

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

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

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

Kindly contact the FDA Center for Food Regulation and Research through e-mail at [email protected], or call (02) 857-1900 loc. 8112 or 8105.

To report any sale or distribution of unregistered food products, 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. 2019-407

FDA Advisory No. 2019-406 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products: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. GOLDEN SPOON Turmeric Instant Powdered Drink Luyang Dilaw (225 grams)
  2. GREENLIFE® HOME OF COCONUT PRODUCTS Organic Virgin Coconut Oil (250mL x bottle)
  3. TUNZO Pure Native Choco Chips Quick Melting Tablea (80grams)
  4. DEKA WAFER ROLLS Mini Wafer Bites Choco Choco 200 grams (7 oz.)
  5. LASAP PATIS Fish Sauce (150mL x Pouch)

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 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 until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a CPR for the food product.

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) 857-1900 loc. 8112 & 8104.

To report any sale or distribution of unregistered food 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. 2019-406

/ In Food Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-406 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

FDA Advisory No. 2019-405 || Public Health Warning Against Unregistered Food Products with Unapproved Advertisements and Promotion on Their Products:

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

  1. SEKUSHI 10 IN 1 SLIMMING TEA WITH COLLAGEN
  2. BIGNAY HERBAL TEA
  3. INOCHI BITTER HERBS FOOD SUPPLEMENT
  4. ORGANIC VEDA MORINGA CAPSULE
  5. PARAGIS GOOSE GRASS HERBAL TEA

The FDA verified through post-marketing surveillance that the abovementioned food products/food supplements are not registered and the Certificate of Product Registration (CPR) have not yet 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

Likewise, all claims in the advertisements are false, deceptive, and misleading. As per Administrative Order 2010-0008, no person shall advertise, promote, or use in any sponsorship any food/dietary supplements unless such product is duly registered and approved by the Food and Drug Adminisration.

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

In light of the foregoing, the public is advised not to purchase violative products in the market. Moreover, the public is advised to always check if a food product is registered with the FDA. The FDA website (www.fda.gov.phhas 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 until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a CPR for the food product.

All FDA Field Officers and Regulatory Enforcement Unit (REU) in coordination with the law enforcement agencies and Local Government Units (LGUs) are requested to ensure that violative products are not sold or made available in their localities or areas of jurisdiction.

Kindly contact the FDA Center for Food Regulation and Research through email at [email protected]h or call (02)857-1900 loc. 8115 and 8112.

To report any sale or distribution of unregistered food 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. 2019-405

/ In Food Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-405 || Public Health Warning Against Unregistered Food Products with Unapproved Advertisements and Promotion on Their Products:

FDA Advisory No. 2019-404 || Public Health Warning Against Unregistered Food Products with Unapproved Advertisements and Promotion on Their Products:

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

  1. HEALTH TEA PARAGIS TEA
  2. VIVISCAL ADVANCED
  3. GREENSPARK REISHI MUSHROOM GANODERMA CAPSULES
  4. OPHIR HERBAL ORGANIC NATURAL GINGER TEA FOR SINGERS ZERO SUGAR
  5. AMPALAYA MORINGA BANABA 3 IN 1 CAPSULE

The FDA verified through post-marketing surveillance that the abovementioned food products are not registered and the Certificate of Product Registration (CPR) have not yet 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

Likewise, all claims in the advertisements are false, deceptive, and misleading. As per Administrative Order 2010-0008, no person shall advertise, promote, or use in any sponsorship any food/dietary supplements unless such product is duly registered and approved by the Food and Drug Adminisration.

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

In light of the foregoing, the public is advised not to purchase violative products in the market. Moreover, the public is advised to always check if a food product is registered with the FDA. The FDA website (www.fda.gov.phhas 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 until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a CPR for the food product.

All FDA Field Officers and Regulatory Enforcement Unit (REU) in coordination with the law enforcement agencies and Local Government Units (LGUs) are requested to ensure that violative products are not sold or made available in their localities or areas of jurisdiction.

Kindly contact the FDA Center for Food Regulation and Research through email at [email protected] or call (02)857-1900 loc. 8115 and 8112.

To report any sale or distribution of unregistered food 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. 2019-404

/ In Food Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-404 || Public Health Warning Against Unregistered Food Products with Unapproved Advertisements and Promotion on Their Products:

FDA Advisory No. 2019-403 || 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 consumption of the following unregistered food products:

  1. JAN WIN’S GENERAL MERCHANDISE CHEESE POWDER
  2. ADVENTIST MEDICAL CENTER SOYAMILK NON-DAIRY ALTERNATIVE TO MILK
  3. HEALTHY TIMES™ ORGANIC BROWN RICE

The FDA verified through post-marketing surveillance that the abovementioned food products are not registered and the Certificate of Product Registration (CPR) have not yet 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

In light of the foregoing, the public is advised not to purchase violative products in the market. Moreover, the public is advised to always check if a food product is registered with the FDA. The FDA website (www.fda.gov.phhas a Search feature which may be used by typing in the name of the product before purchasing.
Since these unregistered food products have not gone through evaluation process of the FDA, the agency cannot guarantee their quality and safety. The consumption of such violative products may pose health risk to consumers.

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

All FDA Field Officers and Regulatory Enforcement Unit (REU) in coordination with the law enforcement agencies and Local Government Units (LGUs) are requested to ensure that violative products are not sold or made available in their localities or areas of jurisdiction.

Kindly contact the FDA Center for Food Regulation and Research through email at [email protected] or call (02)857-1900 loc. 8115 and 8112.

To report any sale or distribution of unregistered food 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. 2019-403

FDA Advisory No. 2019-401 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplements:

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

  1. COUNTRY FARMS SUPER FRUIT & VEGGIES Natural Fruit & Vegetable Formula Dietary Supplement
  2. COUNTRY FARMS SUPER GREENS Certified Organic Whole Food Formula –Delicious Chocolate Flavor Dietary Supplement

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

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

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

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

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) 857-1900 loc. 8112 or 8105.

To report any sale or distribution of unregistered food products, 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. 2019-401

FDA Advisory No. 2019-400 || 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. GUANGCUN Assam Black Tea (500grams x pack)
  2. GUANGCUN Jasmin Green Tea (500grams x pack)
  3. GUANGCUN Oolong Tea (500 grams x pack)
  4. SEVILLA SWEETS Crunchy Mushroom Original (140 grams x pouch)
  5. RPM PILINUTS All Natural Roasted Pilinut 80 grams (2.82 oz.)

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 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 until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a CPR for the food product.

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) 857-1900 loc. 8112 & 8104.

To report any sale or distribution of unregistered food 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. 2019-400

FDA Advisory No. 2019-399 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

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

  1. VENBA Ground Nut Oil
  2. VENBA Sesame Oil
  3. VENBA Coconut Oil
  4. ALBANESE WORLD’S BEST Sour Mini Neon Gummi Worms

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

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

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

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

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

Kindly contact the FDA Center for Food Regulation and Research through e-mail at [email protected], or call (02) 857-1900 loc. 8112 or 8105.

To report any sale or distribution of unregistered food products, 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. 2019-399

FDA Advisory No. 2019-398 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplements:

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

  1. UCORP Spirulina Troche Tablet
  2. LUXCENT Luminous Caps L-Glutathione Plus Marine Collagen Dietary Supplement
  3. LZCAS GO WHITE Glutathione with Collagen, Vitamin C, Garcinia Cambogia and Alpha Lipoic Acid Dietary Supplement
  4. NATURE HOME ALASKA ALLICN POTENTIAL 100% Garlic Oil Softgels
  5. YOUTHEORY Collage Type 1 & 3 Dietary Supplement , Tablets

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

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

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

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

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) 857-1900 loc. 8112 or 8105.

To report any sale or distribution of unregistered food products, 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. 2019-398

FDA Advisory No. 2019-397 || 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 consumption of the following unregistered food products:

  1. DONNABELLE THE ORIGINAL TURMERIC TEA
  2. JHERMAN’S SUGARCANE WINE BASI
  3. BELLA’S CHOICE YELLOWFIN TUNA SPANISH STYLE IN CORN OIL
  4. GOLDBITS NATURAL CALAMANSI JUICE
  5. CORONA TEA BALL CORONA TEA

The FDA verified through post-marketing surveillance that the abovementioned food products are not registered and the Certificate of Product Registration (CPR) have not yet 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 guarantee their quality and safety. The consumption of such violative products may pose health risk to consumers.

In light of the foregoing, the public is advised not to purchase violative products in the market. Moreover, the public is advised to always check if a food product is registered with the FDA. The FDA website (www.fda.gov.phhas 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 until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a CPR for the food product.

All FDA Field Officers and Regulatory Enforcement Unit (REU) in coordination with the law enforcement agencies and Local Government Units (LGUs) are requested to ensure that violative products are not sold or made available in their localities or areas of jurisdiction.

Kindly contact the FDA Center for Food Regulation and Research through email at [email protected] or call (02)857-1900 loc. 8115 and 8112.

To report any sale or distribution of unregistered food 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. 2019-397

FDA Advisory No. 2019-396 || 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. GARDEN BOTANICALS 100% ORGANIC ALOE VERA DIETARY SUPPLEMENT
  2. DAILY PLUS 500 HERBAL FARMACY HEMP EXTRACT OIL DIETARY SUPPLEMENT
  3. BLYTHE GLUTA + VIT C DIETARY SUPPLEMENT

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

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

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

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

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) 857-1900 loc. 8112 or 8105.

To report any sale or distribution of unregistered food products, 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. 2019-396

FDA Advisory No. 2019-395-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. AM YA FENG QUIKE COMPOUND
    PARACETAMOL AND AMANTADINE
    HYDROCHLORIDE CAPSULES
  2. RYUKAKUSAN DIRECT
  3. CORIX BURNSGEL
  4.  OTC SOUTH OCEAN RIDACHE® SHEXIANG
    QUTONG QIWUJI
  5.  GMP ROSMARINUS SCHNEISKI
  6. MUHI
  7. TON PHOR SCAR OIL CROCCO
  8. MUHI MOPIDICKS®-S
  9. NEW SMELL LESS AMMELTZ® YOKOYOKO
  10. 180 [Label in Foreign Language]
  11. RYUKAKU-SAN FOR PHLEGM, COUGH,
    HUSKINESS
  12. PEPPERMINT CURE ORIGINAL RICQLES
    [as reflected in the secondary packaging]
    ALCOOL DE MINTHE DE RICQLES [as reflected in
    the primary packaging]

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

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 publiko ay pinapaalalahanang huwag bumili ng nasabing mga iligal na produkto at maging maingat laban sa mga ito. Ugaliing tingnan kung ang gamot ay rehistrado sa FDA bago bilhin, sa pamamagitan ng paggamit ng Search feature ng FDA website sa www.fda.gov.ph. Maaari ring tingnan ang FDA Registration number sa label ng produkto.

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, sapagkat kaukulang parusa ay mahigpit na ipatutupad.

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

Para sa karagdagang impormasyon at katanungan, maaaring mag-email sa [email protected] Upang mag-report ng patuloy na pagtitinda o pangangalakal ng mga Hindi rehistradong gamot, mag-email sa [email protected], o mag-report gamit ang aming online reporting facility, eReport, sa www.fda.gov.ph/ereport. Maaari ring tumawag sa Center for Drug Regulation and Research (CDRR) sa numerong (02) 809- 5596. Para sa mga hinihinalang hindi kanais-nais na reaksyon sa gamot, i-report agad sa FDA gamit ang link na ito: www.fda.gov.ph/adr-report-new at kumpletuhin ang mga kinakailangang impormasyon.

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

Please see attachment for the photos:-> FDA Advisory No. 2019-395-A

FDA Advisory No. 2019-395 || 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. AM YA FENG QUIKE COMPOUND
    PARACETAMOL AND AMANTADINE
    HYDROCHLORIDE CAPSULES
  2. RYUKAKUSAN DIRECT
  3. CORIX BURNSGEL
  4.  OTC SOUTH OCEAN RIDACHE® SHEXIANG
    QUTONG QIWUJI
  5.  GMP ROSMARINUS SCHNEISKI
  6. MUHI
  7. TON PHOR SCAR OIL CROCCO
  8. MUHI MOPIDICKS®-S
  9. NEW SMELL LESS AMMELTZ® YOKOYOKO
  10. 180 [Label in Foreign Language]
  11. RYUKAKU-SAN FOR PHLEGM, COUGH,
    HUSKINESS
  12. PEPPERMINT CURE ORIGINAL RICQLES
    [as reflected in the secondary packaging]
    ALCOOL DE MINTHE DE RICQLES [as reflected in
    the primary packaging]

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug products have not gone through the registration and testing 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 their quality and safety. The consumption of such violative products may pose potential danger or injury if administered.

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.

In light of the above, the public is advised not to purchase the aforementioned violative products and to be vigilant against it. Always check if a drug 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.

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

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

For more information and inquiries, please e-mail us at [email protected] To report continuous sale or distribution of unregistered health products, kindly e-mail us via [email protected], or through the online reporting facility, eReport, at www.fda.gov.ph/ereport. You may also call the Center for Drug Regulation and Research at telephone number (02)809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: www.fda.gov.ph/adr-reportnew and fill out all the required fields.

Dissemination of the information to all concerned is requested.

 Please see attachment for the photos:-> FDA Advisory No. 2019-395

FDA Advisory No. 2019-394 || U.S. Food and Drug Administration (USFDA) Safety Alert on Certain Cosmetic Products that Tested Positive for Asbestos

Last October 18, 2019, the U.S. Food and Drug Administration (USFDA) has issued a safety alert warning for consumers not to use certain cosmetic products that tested positive for asbestos. Accordingly, a voluntary recall was undertaken by Johnson and Johnson Consumer Inc. (JJIC) for Johnson’s Baby Powder solely in the United States, relative to a single batch of products (lot #22318RB), as a precautionary move. This was in response to USFDA test indicating the presence of trace levels of chrysotile asbestos contamination in a sample taken from a single bottle purchased from an online retailer. Another sample from another lot of the product, tested negative for asbestos. The Philippine Food and Drug Administration (FDA) was informed by the company that the aforementioned lot number was only distributed in the United States and that further investigation is on-going regarding the tests and results conducted. The recall does not affect Johnson’s Baby Powder in markets outside of the U.S.A., including the Philippines.

Talc, otherwise known as talcum or hydrated magnesium silicate, is a naturally occurring mineral mined from the earth used in the manufacture of plastics, ceramics, paint, paper, roofing materials and other consumer products like cosmetics. It is allowed for use as an ingredient under the ASEAN Cosmetic Directive (ACD) and European Union (EU) Cosmetic Regulation. Cosmetic-grade talc must not contain contaminants such as asbestos, a prohibited substance under the ACD. Cosmetic-grade talc is generally regarded to be a safe ingredient in cosmetic products worldwide.

Cosmetic products which are sold or supplied in the ASEAN countries must comply with the applicable prohibitions or restrictions on cosmetic ingredients as well as product labeling stipulated under the ACD which has been adopted by all the ASEAN Member States.

At present, talcum powders used in children must be labeled with a warning that states “Keep powder away from children’s nose and mouth” to avoid inhalation. This is in line with the product labeling requirements in the EU and Canada.

Accordingly, to protect the public health and safety, Philippine FDA will undertake the following public health interventions:

  1. Conduct audit/inspection to check the product information file (PIF) of cosmetic product manufacturers, traders, distributor/importers and distributor/wholesalers to provide proof/certifications of asbestos-free products including laboratory test results that are sold in the market.
  2. Intensify post-marketing surveillance for talc-containing cosmetic powders (e.g. loose powder) in the market including laboratory tests when necessary.
  3. Implement the ASEAN Cosmetic Directive (ACD), adopted and implemented through the issuance of Administrative Orders 2005-0015 and 2005-0025, which required product owners or local companies placing talc-containing cosmetic powders intended to be used for children under three (3) years of age in the market to indicate a warning in the product label — “keep powder away from children’s nose and mouth.”
  4. Advise the general public to use cosmetic products in accordance with the written instructions/directions for use found in the immediate and/or secondary packaging label.

Dissemination of the information to all concerned is requested.

Attachment:-> FDA Advisory No. 2019-394

SEMINAR VENUE FOR UNIFIED LICENSING SEMINAR (ULS-NCR) ON 21 & 22 NOVEMBER 2019

Please be informed that the venue for the Unified Licensing Seminar for NCR and Region IV-A Stakeholders (Course Code: ULS-NCR) on 21 & 22 November 2019 will be at THE BELLEVUE MANILA, NORTH BRIDGEWAY, FILINVEST CITY, ALABANG, MUNTINLUPA CITY.

All course registrants who received Course Assessment Slip for the ULS-NCR but have not received the Course Confirmation Slip are advised to come in the seminar venue on the scheduled date of seminar with the following documents:

  • Course assessment slip
  • Proof of payment

Rest assured that the stakeholders with the above documents will be accepted to the seminar. For inquiries and other concerns, please call the FDA Academy at telephone number (02) 877 0259 or email at [email protected] and [email protected]

Attachment:-> SEMINAR VENUE FOR UNIFIED LICENSING SEMINAR (ULS-NCR) ON 21 & 22 NOVEMBER 2019

SEMINAR VENUE FOR QPIRA FOR CENTER FOR DEVICE REGULATION, RADIATION HEALTH AND RESEARCH (QCDRRHR-NCR) ON 27-28 NOVEMBER 2019

Please be informed that the venue for the Center for Device Regulation, Radiation Health and Research QPIRA Seminar (Course Code: QCDRRHR-NCR) on 27-28 November 2019 will be at THE BELLEVUE MANILA, NORTH BRIDGEWAY, FILINVEST CITY, ALABANG, MUNTINLUPA CITY.

All course registrants who received Course Assessment Slip for the CDRRHR QPIRA Seminar but have not received the Course Confirmation Slip are advised to come in the seminar venue on the scheduled date of seminar with the following documents:

  • Course assessment slip
  • Proof of payment

Rest assured that the stakeholders with the above documents will be accepted to the seminar. For inquiries and other concerns, please call the FDA Academy at telephone number (02) 877 0259 or email at [email protected] and [email protected]

Attachment:-> SEMINAR VENUE FOR QPIRA FOR CENTER FOR DEVICE REGULATION, RADIATION HEALTH AND RESEARCH (QCDRRHR-NCR) ON 27-28 NOVEMBER 2019

SEMINAR VENUE FOR QPIRA FOR CENTER FOR FOOD REGULATION AND RESEARCH (QCFRR-NCR) ON 7-8 NOVEMBER 2019

Please be informed that the venue for the Center for Food Regulation and Research QPIRA Seminar (Course Code: QCFRR-NCR) on 7-8 November 2019 will be at THE BELLEVUE MANILA, NORTH BRIDGEWAY, FILINVEST CITY, ALABANG, MUNTINLUPA CITY.

All course registrants who received Course Assessment Slip for the CFRR QPIRA Seminar but have not received the Course Confirmation Slip are advised to come in the seminar venue on the scheduled date of seminar with the following documents:

  • Course assessment slip
  • Proof of payment

Rest assured that the stakeholders with the above documents will be accepted to the seminar. For inquiries and other concerns, please call the FDA Academy at telephone number (02) 877 0259 or email at [email protected] and [email protected]

Attachment:-> SEMINAR VENUE FOR QPIRA FOR CENTER FOR FOOD REGULATION AND RESEARCH (QCFRR-NCR) ON 7-8 NOVEMBER 2019

SEMINAR VENUE FOR PHARMACOVIGILANCE AND GUIDELINES FOR PV OFFICER COURSE CODE:QPPV ON 29 NOVEMBER 2019

Please be informed that the venue for the Pharmacovigilance Regulations and Guidelines for PV Officer (Course Code: QPPV) on 29 November 2019 will be at THE BELLEVUE MANILA, NORTH BRIDGEWAY, FILINVEST CITY, ALABANG, MUNTINLUPA CITY.

All course registrants who received Course Assessment Slip for the QPPV but have not received the Course Confirmation Slip are advised to come in the seminar venue on the scheduled date of seminar with the following documents:

  • Course assessment slip
  • Proof of payment

Rest assured that the stakeholders with the above documents will be accepted to the seminar. For inquiries and other concerns, please call the FDA Academy at telephone number (02) 877 0259 or email at [email protected] and [email protected]

Attachment:-> SEMINAR VENUE FOR PHARMACOVIGILANCE AND GUIDELINES FOR PV OFFICER COURSE CODE QPPV ON 29 NOVEMBER 2019

FDA SYSTEM MAINTENANCE

Please be informed that the IT System of the Information and Communication Technology Management Division of the Policy and Planning Services (PPS-ICTMD) will be undergoing check and maintenance in order to migrate from a local server to Cloud on October 31 at (6PM) to November 4, 2019 at (5AM).

We regret to inform you that all ICTM system will be temporarily unavailable.

We sincerely apologize.

Thank you for your cooperation and understanding.

Attachment:-> FDA SYSTEM MAINTENANCE from October 31 to November 4 2019

FDA Advisory No. 2019-393 || Voluntary Recall of BD Microtainer

The Food and Drug Administration (FDA) warns all healthcare professionals on the voluntary recall of the following BD Microtainer® blood collection tubes manufactured by BD Caribe:

 

Product Name Product Code Lot Number
BD Microtainer® Capillary Blood Collection Tube with K2EDTA-Tube Micro w/ Microgard EDTA LAV 21041362 8243545
8247628
8288904
8121979
8120851
BD Microtainer® Z Capillary Blood Collection Tube  (No Additives)- Tube Micro w/ Microgard PLN RD 21041356 8223778
8268514
 

BD Microtainer® SST Capillary Blood Collection Tube-Tube Micro w/ Microgard SST GLD

 

21041357 8170911
8282848
8165884
8117697
BD Microtainer® Amber Capillary Blood Collection Tube-Tube Micro w/ Microgard SST GLD/AMB 21041358 8233967

BD is conducting a voluntary recall for the aforementioned BD Microtainer® products based on the confirmation that these products may have damaged tube reservoirs.

A damaged reserviors may caused insufficient blood sample collection and non-proportional blood-to-additive ratio, hence producing inaccurate results. Moreover, a patient may be required to undergo a repeat blood sample collection and testing on the event that any of theaforementioned BD Microtainer® with damaged reservoir was used during blood collection.

In light of the foregoing, all concerned healthcare professionals, and establishments is warned to discontinue further use, sale, and distribution of the medical device.

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

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

Any suspected adverse reaction experienced from the use of the medical device but not limited to the lot numbers stated above should be reported immediately to FDA.

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) 857-1900 loc. 8301.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No. 2019-393

Cancellation of Regional Cascading in Pampanga on 29-30 October 2019

This is to inform all concerned stakeholders that the “Regional Cascading of Administrative Orders on the Regulation of Household/Urban Hazardous Substances (HUHS), Household/Urban Pesticides (HUPs), and Pest Control Operators (PCOs) and Pesticide Handlers, and Implementing Rules and Regulations (IRR) of RA 10620” Pampanga will not push through on 29-30 October 2019 due to low number of registered participants.

The new schedule and confirmed venue will be announced accordingly.

For your information and guidance.

Thank you.

Attachment:-> Cancellation of Regional Cascading in Pampanga on 29-30 October 2019

FDA Advisory No. 2019-392 || Public Health Warning Against the Purchase and Use of the following Unnotified Cosmetic Products:

The Food and Drug Administration (FDA) warns the public from purchasing and using the following unnotified cosmetic products:

  1. TIFANNY CLAIRE’S CONCEAL INSTANT GRAY HAIR TOUCH-UP SOLUTION (DARK MOCHA BROWN)
  2. SALLY HANSEN EXTRA STRENGTH EXTRA FAST NAIL POLISH REMOVER WITH VITAMIN E
  3. ANDREA SECRET CAT WINK (3)
  4. KAXIER BB EFFECTIVE GENTLE BB CREAM (04)
  5. MEIYA HAND AND BODY LOTION PAPAYA WITH SPF 30+ (ME-5081)

The FDA verified through post-marketing surveillance (PMS) that the abovementioned cosmetic products are not authorized and the Certificates of Product Notification have not been issued. 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, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization from FDA is prohibited.

Since these unnotified cosmetic 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.

Potential hazards may come from ingredients that are not allowed to be part of a cosmetic product as listed in the Annex II, Part I of the ASEAN Cosmetic Directive (ACD), and from the contamination of heavy metals such as Mercury (Hg), Lead (Pb) and Antimony (Sb) especially in eye and face cosmetic products. Antimony (Sb) exposure can result to damages to the lung, heart muscle and liver. Symptoms of antimony toxicity includes skin irritation, headache, nausea, vomiting, insomnia and abdominal pain among others. Lead (Pb) exposure may cause anaemia, hypertension, renal impairement, immunotoxicity and toxicity to the reproductive organs. Mercury salts in cosmetic products inhibits the formation of skin melanin which will result to lighter skin tone. Adverse health effects brought about by highly toxic mercury in cosmetics and hair extension products include kidney damage, skin rashes, skin discoloration and scarring. Chronic use reduces the skin’s normal resistance against bacterial and fungal infections. Other effects include anxiety, depression or psychosis and peripheral neuropathy. The transfer of mercury to fetuses of pregnant women may manifest as neurodevelopment deficits later in life.

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 cosmetic product is notified with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing.

All concerned establishments are warned not to distribute violative cosmetic products until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a Certificate of Product Notification (CPN) for the cosmetic product.

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

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

To report any sale or distribution of unnotified cosmetic products, 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. 2019-392

FDA Advisory No. 2019-391 || Public Health Warning Against the Purchase and Use of the following Unnotified Cosmetic Products:

The Food and Drug Administration (FDA) warns the public from purchasing and using the following unnotified cosmetic products:

  1. LITTLE PALS UNSCENTED SOFT BABY WIPES ENRICHED WITH ALOE VERA
  2. ACT® KIDS ANTICAVITY FLUORIDE RINSE OCEAN BERRY®
  3. VICTORIA’S SECRET FRAGRANCE OIL ELECTRIC BEACH
  4. MARCUS STYLING GEL STRONG HOLD
  5. JOHNSON’S® BE FRESH & RETREAT SHOWER GEL WITH PINEAPPLE & LILY AROMA

The FDA verified through post-marketing surveillance (PMS) that the abovementioned cosmetic products are not authorized and the Certificates of Product Notification have not been issued. 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, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization from FDA is prohibited.

Since these unnotified cosmetic 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.

Potential hazards may come from ingredients that are not allowed to be part of a cosmetic product as listed in the Annex II, Part I of the ASEAN Cosmetic Directive (ACD). The use of substandard and possibly adulterated cosmetic products may result to adverse reactions, including but not limited to, skin irritation, itchiness, anaphylactic shock, and organ failure.

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

All concerned establishments are warned not to distribute violative cosmetic products until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a Certificate of Product Notification (CPN) for the cosmetic product.

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

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

To report any sale or distribution of unnotified cosmetic products, 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. 2019-391