Month: April 2019

FDA Advisory No. 2019-109 || Public Health Warning Against Unregistered Food Supplements with their Unapproved and Misleading Advertisements and Promotion on Their Products:

The Food and Drug Administration (FDA) warns the public against unregistered food supplements with therapeutic claims on their brochure:

  1. ROYALE FASTRIM WITH GARCINIA CAMBOGIA DIETARY SUPPLEMENT
  2. COLLAGEN PROTEIN SOFTGELS FOOD SUPPLEMENT

The public is hereby warned that food supplements being advertised above are not registered with the FDA. 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.

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.

Accordingly, since unregistered food supplements have not gone through evaluation and testing process of the FDA, the agency cannot guarantee their quality and safety. The consumption of such violative products may pose potential health hazards to the consuming public. Food products including food supplements should not bear any misleading, deceptive, and false claims in their labels and/or any promotional materials that will provide erroneous impression on products’ character or identity.

In light of the above, the public is advised not to purchase the aforementioned violative products. Moreover, the public is advised to be vigilant against food products that might not be duly registered with FDA. Always check if a food product has been registered with FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph.

For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of the above unregistered food supplement, utilize our online reporting facility, eReport, at www.fda.gov.ph/ereport, or e-mail us via [email protected], or call us at the Center for Food Regulation and Research (CFRR) hotline (02) 857-1900 loc. 8115 and 8112.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2019-109

/ In General Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-109 || Public Health Warning Against Unregistered Food Supplements with their Unapproved and Misleading Advertisements and Promotion on Their Products:

FDA Advisory No. 2019-108 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplements:

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

  1. EVIDENT GLUTATHIONE + COLLAGEN FOOD SUPPLEMENT
  2. JM BLESS TURMERIC CURCUMIN CAPSULES
  3. JM BLESS PANAX GINSENG CAPSULE
  4. JM BLESS SERPENTINA CAPSULE
  5. NATURE’S DETOX FOOD SUPPLEMENT

FDA post-marketing surveillance (PMS) activities have verified that the abovementioned food supplements have not gone through the registration process of the agency and have not been issued the proper authorization in the form of Certificate of Product Registration. 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.

Accordingly, since unregistered food supplements have not gone through evaluation and testing process of the FDA, the agency cannot guarantee their quality and safety. The consumption of such violative products may pose potential health hazard to the consuming public.

In light of the foregoing, the public is advised not to purchase the aforementioned violative products. Moreover, the public is advised to be vigilant against food supplements that might not be duly registered with FDA. Always check if a food product has been registered with FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph.

All concerned establishments are warned not to distribute the above-identified violative food supplements until they have already been covered by the appropriate authorization (product registration), 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 the above unregistered food supplement, utilize our online reporting facility, eReport, at www.fda.gov.ph/ereport, or e-mail us via [email protected], or call us at the Center for Food Regulation and Research (CFRR) hotline (02) 857-1900 loc. 8115 and 8112.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2019-108

FDA Advisory No. 2019-107 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplements:

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

  1. PARADISE ORAC-ENERGY EARTH’S BLEND ONE DAILY SUPERFOOD MULTIVITAMIN
  2. NEW CHAPTER EVERY WOMAN’S ONE DAILY MULTI
  3. 21st CENTURY CRANBERRY PLUS PROBIOTIC URINARY TRACT SUPPORT
  4. CALIFORNIA PRODUCTS RASPBERRY KETONE ULTRA WEIGHT LOSS FORMULA
  5. FERTILAID FOR WOMEN DIETARY SUPPLEMENT

FDA post-marketing surveillance (PMS) activities have verified that the abovementioned food supplements have not gone through the registration process of the agency and have not been issued the proper authorization in the form of Certificate of Product Registration. 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.

Accordingly, since unregistered food supplements have not gone through evaluation and testing process of the FDA, the agency cannot guarantee their quality and safety. The consumption of such violative products may pose potential health hazard to the consuming public.

In light of the foregoing, the public is advised not to purchase the aforementioned violative products. Moreover, the public is advised to be vigilant against food supplements that might not be duly registered with FDA. Always check if a food product has been registered with FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph.

All concerned establishments are warned not to distribute the above-identified violative food supplements until they have already been covered by the appropriate authorization (product registration), 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 the above unregistered food supplement, utilize our online reporting facility, eReport, at www.fda.gov.ph/ereport, or e-mail us via [email protected], or call us at the Center for Food Regulation and Research (CFRR) hotline (02) 857-1900 loc. 8115 and 8112.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2019-107

FDA Advisory No. 2019-106 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

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

  1. MOICO’S BICOL TABLEA, SWEETENED
  2. FRITTERS BANANA BITES PRODUCTS BANANA CHIPS
  3. ORIZA TOASTED RICE PUTO
  4. MARICAR SPECIAL PILI TARTS
  5. TRIPLE J ALBAY SWEETS PASTILLAS

FDA post-marketing surveillance (PMS) activities have verified that the abovementioned food products have not gone through the registration process of the agency and have not been issued the proper authorization in the form of Certificate of Product Registration. 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.

Accordingly, since unregistered food products have not gone through evaluation and testing process of the FDA, the agency cannot guarantee their quality and safety. The consumption of such violative products may pose potential health hazard to the consuming public.

In light of the foregoing, the public is advised not to purchase the aforementioned violative products. Moreover, the public is advised to be vigilant against food products that might not be duly registered with FDA. Always check if a food product has been registered with FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph.

All concerned establishments are warned not to distribute the above-identified violative food products until they have already been covered by the appropriate authorization (product registration), 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 the above unregistered food supplement, utilize our online reporting facility, eReport, at www.fda.gov.ph/ereport, or e-mail us via [email protected], or call us at the Center for Food Regulation and Research (CFRR) hotline (02) 857-1900 loc. 8115 and 8112.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2019-106

FDA Advisory No. 2019-105 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplements:

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

  1. RESCURE PLUS RESVERATROL + CURCUMIN + EGCG DIETARY FOOD SUPPLEMENT
  2. AMAZING HERBAL SUPPLEMENT BANABA
  3. AMAZING FOOD SUPPLEMENT MORINGA
  4. NATURE HERB’S WITH HONEY

FDA post-marketing surveillance (PMS) activities have verified that the abovementioned food products have not gone through the registration process of the agency and have not been issued the proper authorization in the form of Certificate of Product Registration. 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.

Accordingly, since unregistered food products have not gone through evaluation and testing process of the FDA, the agency cannot guarantee their quality and safety. The consumption of such violative products may pose potential health hazard to the consuming public.

In light of the foregoing, the public is advised not to purchase the aforementioned violative products. Moreover, the public is advised to be vigilant against food products that might not be duly registered with FDA. Always check if a food product has been registered with FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph.

All concerned establishments are warned not to distribute the above-identified violative food products until they have already been covered by the appropriate authorization (product registration), 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 the above unregistered food supplement, utilize our online reporting facility, eReport, at www.fda.gov.ph/ereport, or e-mail us via [email protected], or call us at the Center for Food Regulation and Research (CFRR) hotline (02) 857-1900 loc. 8115 and 8112.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2019-105

FDA Advisory No. 2019-104 || Public Health Warning Against the Purchase and Consumption of the following Unregistered PARAGIS FOOD SUPPLEMENTS:

The Food and Drug Administration (FDA) advises the public against the purchase and consumption of the following unregistered Paragis Food Supplements:

  1. GREENSPARK PARAGIS CAPSULE
  2. PARAGIS HERBAL FOOD SUPPLEMENT
  3. PARAGIS HERBAL FOOD SUPPLEMENT
  4. PARAGIS HERBAL FOOD SUPPLEMENT BY LAUDOTO SI NI LOLO KIKO FOUNDATION, INC.
  5. PARAGIS SUPER-ANTIOXIDANT

FDA post-marketing surveillance (PMS) activities have verified that the abovementioned food supplements have not gone through the registration process of the agency and have not been issued the proper authorization in the form of Certificate of Product Registration. 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.

Accordingly, since unregistered food supplements have not gone through evaluation and testing process of the FDA, the agency cannot guarantee their quality and safety. The consumption of such violative products may pose potential health hazard to the consuming public.

In light of the foregoing, the public is advised not to purchase the aforementioned violative products. Moreover, the public is advised to be vigilant against food products that might not be duly registered with FDA. Always check if a food product has been registered with FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph.

All concerned establishments are warned not to distribute the above-identified violative food supplements until they have already been covered by the appropriate authorization (product registration), 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 the above unregistered food supplement, utilize our online reporting facility, eReport, at www.fda.gov.ph/ereport, or e-mail us via [email protected], or call us at the Center for Food Regulation and Research (CFRR) hotline (02) 857-1900 loc. 8115 and 8112.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2019-104

FDA Advisory No. 2019-103 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

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

  1. CLASSIQUE AGARICUS FORTE WITH MULTI ORGANIC ELEMENTS
  2. COFFEE INTERCOURSE UNTIL DAWN
  3. ONECARE LACTOFERRIN PRAVENTAC
  4. NBO GLOBAL NRZ INC. TURMERIC CAPSULES W/ BIOPERINE
  5. IMMUNE BOOSTER JACAMA SUPER CEE DIETARY SUPPLEMENT  

FDA post-marketing surveillance (PMS) activities have verified that the abovementioned food product and food supplements have not gone through the registration process of the agency and have not been issued the proper authorization in the form of Certificate of Product Registration. 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.

Accordingly, since unregistered food products have not gone through evaluation and testing process of the FDA, the agency cannot guarantee their quality and safety. The consumption of such violative products may pose potential health hazard to the consuming public.

In light of the foregoing, the public is advised not to purchase the aforementioned violative products. Moreover, the public is advised to be vigilant against food supplements that might not be duly registered with FDA. Always check if a food product has been registered with FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph.

All concerned establishments are warned not to distribute the above-identified violative food products until they have already been covered by the appropriate authorization (product registration), 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 the above unregistered food supplement, utilize our online reporting facility, eReport, at www.fda.gov.ph/ereport, or e-mail us via [email protected], or call us at the Center for Food Regulation and Research (CFRR) hotline (02) 857-1900 loc. 8115 and 8112.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2019-103

FDA Advisory No. 2019-102 || Public Health Warning Against the Purchase and Use of Unnotified Toy and Child Care Article (TCCA) Products (Batch 1)

The Food and Drug Administration (FDA) advises the public against the purchase and use of the following unnotified Toy and Child Care Article (TCCA) products:

  1. J.H. Toy Lasting Friend Space Balloon
  2. Magic Balloon
  3. Zestar Plastic Balloom size 11
  4. Zestar Plastic Balloon Size 7

FDA post-marketing surveillance (PMS) activities have verified that the abovementioned TCCA products have not gone through the notification process of the agency and have not been issued the proper marketing authorization (MA). 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.

The TCCA products, prior to being placed into the local market, must be duly notified with the FDA by a licensed TCCA distributor and/or manufacturer pursuant to the Implementing Rules and Regulations (IRR) of R.A. 9711 sec. 5ii. If a TCCA product has not been evaluated by FDA, as in the case of these unnotified products, the use of such products may pose potential health hazards to the consuming public.

In light of the above, the public is advised not to purchase the aforementioned violative products. Moreover, the public is also advised to be vigilant against TCCA products that are unnotified with FDA. Always check if a TCCA product has been notified with FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph.

Consumers are further reminded to:

  • Buy TCCA products from reputable stores or dealers;
  • Read the label. Check that the TCCA product has FDA notification number indicated in the label.
  • Never buy TCCAs that do not have instructions written in Filipino or English. Strictly follow the instructions for use of the product.

All concerned establishments are warned not to distribute the above-identified violative TCCA 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 the above unnotified TCCA products, utilize our online reporting facility, eReport, at www.fda.gov.ph/ereport, or e-mail us via [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 857-1979 or (02) 857-1984.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2019-102

FDA Advisory No. 2019-101 || Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Supplements and Food Products:

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

  1. GLUTA NANO PLUS 900,000 mg plus 200,000 mg White Strawberry Extract
  2. KIRKLAND SIGNATURE Extra Strength Glucosamine 1500 mg Chondroitin 1200 mg Dietary Supplement
  3. GREENGOLD Herbal Capsule 10 Amazing Herbs Food Supplement
  4. CASINO CA VIENT D’ICI Palets Bretons
  5. ELEVATE ME Fruit & Nut Energy Bar Blueberry

FDA post-marketing surveillance (PMS) activities have verified that the abovementioned food supplements and food products have not gone through the registration process of the agency and have not been issued the proper authorization in the form of Certificate of Product Registration. 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 are prohibited.

Accordingly, since these unregistered food supplements and food products have not gone through evaluation and testing process of the FDA, the agency cannot guarantee their quality and safety. The consumption of these products may pose potential health hazards to the consuming public.

In light of the above, the public is advised not to purchase the aforementioned violative products. Moreover, the public is advised to be vigilant against food products and food supplements that might not be duly registered with FDA. Always check if a food product has been registered with FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph.

All concerned establishments are warned not to distribute the above-identified violative food supplements and food products until they have already been covered by the appropriate authorization (product registration), 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 the above unregistered food supplements and food products, utilize our online reporting facility, eReport, at www.fda.gov.ph/ereport, or e-mail us via [email protected], or call us at the Center for Food Regulation and Research (CFRR) hotline (02) 857-1900 locals 8112 or 8105.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2019-101

/ In General Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-101 || Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Supplements and Food Products:

FDA Advisory No. 2019-100 || Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Products:

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

  1. MEIJI THE CHOCOLATE Matcha 58% Cacao
  2. RING POP Raspberry Flavour Hard Candy
  3. ESSENTIAL EVERYDAY Animal Crackers
  4. FRANKFORD WONDER BALL Milk Chocolate with Candy Inside
  5. MILKA NUSSINI

FDA post-marketing surveillance (PMS) activities have verified that the abovementioned food products have not gone through the registration process of the agency and have not been issued the proper authorization in the form of Certificate of Product Registration. 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 are prohibited.

Accordingly, since these unregistered food products have not gone through evaluation and testing process of the FDA, the agency cannot guarantee their quality and safety. The consumption of these products may pose potential health hazards to the consuming public.

In light of the above, the public is advised not to purchase the aforementioned violative products. Moreover, the public is advised to be vigilant against food products and food supplements that might not be duly registered with FDA. Always check if a food product has been registered with FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph.

All concerned establishments are warned not to distribute the above-identified violative food products until they have already been covered by the appropriate authorization (product registration), 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 the above unregistered food products, utilize our online reporting facility, eReport, at www.fda.gov.ph/ereport, or e-mail us via [email protected], or call us at the Center for Food Regulation and Research (CFRR) hotline (02) 857-1900 locals 8112 or 8105.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2019-100

FDA Advisory No. 2019-099 || Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Supplements:

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

  1. PIPINGROCK.COM Fertility Complex Dietary Supplement Capsules
  2. PIPINGROCK.COM Apple Cider Vinegar Capsule
  3. PIPINGROCK.COM Sea Kelp Dietary Supplement
  4. PIPINGROCK.COM Potassium plus Iodine Dietary Supplement
  5. PIPINGROCK.COM ULTIMATE CARB CONTROL White Kidney Bean Capsules
  6. SAM-SAMMI Pure Malunggay Powder Food Supplement

FDA post-marketing surveillance (PMS) activities have verified that the abovementioned food supplements have not gone through the registration process of the agency and have not been issued the proper authorization in the form of Certificate of Product Registration. 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 are prohibited.

Accordingly, since these unregistered food supplements have not gone through evaluation and testing process of the FDA, the agency cannot guarantee their quality and safety. The consumption of these products may pose potential health hazards to the consuming public.

In light of the above, the public is advised not to purchase the aforementioned violative products. Moreover, the public is advised to be vigilant against food products and food supplements that might not be duly registered with FDA. Always check if a food product has been registered with FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph.

All concerned establishments are warned not to distribute the above-identified violative food supplements until they have already been covered by the appropriate authorization (product registration), 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 the above unregistered food supplements, utilize our online reporting facility, eReport, at www.fda.gov.ph/ereport, or e-mail us via [email protected], or call us at the Center for Food Regulation and Research (CFRR) hotline (02) 857-1900 locals 8112 or 8105.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2019-099

FDA Advisory No. 2019-098 || Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Supplements:

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

  1. PIPINGROCK.COM Mega Strength L-Arginine HCI 1000 mg Dietary Supplement Caplet
  2. PIPINGROCK.COM Super Strength Water Pill Dietary Supplement Tablet
  3. PURITAN’S PRIDE Oil of Oregano Extract Dietary Supplement
  4. PURITAN’S PRIDE PREMIUM Zinc for Acne Dietary Supplement Tablet
  5. PMS Herbal Supplement with Collagen
  6. PIPINGROCK.COM Hydrolyzed Collagen 1000 mg Dietary Supplement Caplets

FDA post-marketing surveillance (PMS) activities have verified that the abovementioned food supplements have not gone through the registration process of the agency and have not been issued the proper authorization in the form of Certificate of Product Registration. 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 are prohibited.

Accordingly, since these unregistered food supplements have not gone through evaluation and testing process of the FDA, the agency cannot guarantee their quality and safety. The consumption of these products may pose potential health hazards to the consuming public.

In light of the above, the public is advised not to purchase the aforementioned violative products. Moreover, the public is advised to be vigilant against food products and food supplements that might not be duly registered with FDA. Always check if a food product has been registered with FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph.

All concerned establishments are warned not to distribute the above-identified violative food supplements until they have already been covered by the appropriate authorization (product registration), 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 the above unregistered food supplements, utilize our online reporting facility, eReport, at www.fda.gov.ph/ereport, or e-mail us via [email protected], or call us at the Center for Food Regulation and Research (CFRR) hotline (02) 857-1900 locals 8112 or 8105.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2019-098

FDA Advisory No. 2019-097 || Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Products and Supplements:

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

  1. RICE UP! Brown Rice Chips Cheese
  2. TANAKA Grilled Mirin Bonito
  3. MARUCHAN QTTA Seafood Ramen
  4. NATURE’S BLEND Omega-3 Fish Oil 1000 mg Dietary Supplement
  5. OLIE RENYUAN A Po Dou Chi
  6. HUAMASHI FOODSTUFF Silver Anchovy
  7. Fruit Cake (in foreign language)

FDA post-marketing surveillance (PMS) activities have verified that the abovementioned food products and food supplements have not gone through the registration process of the agency and have not been issued the proper authorization in the form of Certificate of Product Registration. 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 are prohibited.

Accordingly, since these unregistered food products and food supplements have not gone through evaluation and testing process of the FDA, the agency cannot guarantee their quality and safety. The consumption of these products may pose potential health hazards to the consuming public.

In light of the above, the public is advised not to purchase the aforementioned violative products. Moreover, the public is advised to be vigilant against food products and food supplements that might not be duly registered with FDA. Always check if a food product has been registered with FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph.

All concerned establishments are warned not to distribute the above-identified violative food products and food supplements until they have already been covered by the appropriate authorization (product registration), 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 the above unregistered food products and food supplements, utilize our online reporting facility, eReport, at www.fda.gov.ph/ereport, or e-mail us via [email protected], or call us at the Center for Food Regulation and Research (CFRR) hotline (02) 857-1900 locals 8112 or 8105.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2019-097

/ In General Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-097 || Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Products and Supplements:

FDA Advisory No. 2019-096 || Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Supplements:

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

  1. CERVIX CARE Food Supplement Capsules
  2. LIFE SOURCE Brain Power Plus Capsules
  3. GREENSPARK Cayenne Fat Burner Capsules
  4. TRENZ Purple Dave Strong Capsule
  5. TRENZ Purple Dave Detox Capsule
  6. TRENZ Gluta Camu Capsules

FDA post-marketing surveillance (PMS) activities have verified that the abovementioned food supplements have not gone through the registration process of the agency and have not been issued the proper authorization in the form of Certificate of Product Registration. 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 are prohibited.

Accordingly, since these unregistered food supplements have not gone through evaluation and testing process of the FDA, the agency cannot guarantee their quality and safety. The consumption of these products may pose potential health hazards to the consuming public.

In light of the above, the public is advised not to purchase the aforementioned violative products. Moreover, the public is advised to be vigilant against food products and food supplements that might not be duly registered with FDA. Always check if a food product has been registered with FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph.

All concerned establishments are warned not to distribute the above-identified violative food supplements until they have already been covered by the appropriate authorization (product registration), 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 the above unregistered food supplements, utilize our online reporting facility, eReport, at www.fda.gov.ph/ereport, or e-mail us via [email protected], or call us at the Center for Food Regulation and Research (CFRR) hotline (02) 857-1900 locals 8112 or 8105.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2019-096

FDA Advisory No. 2019-095 || Lifting the Advisory of IMPACT MINTS SPEARMINT, SUGAR FREE under FDA Advisory No. 2019-029, Subject “Public Health Warning Against the Purchase and Consumption of the Unregistered Food Products”

The Food and Drug Administration (FDA) informs the public that the advisory on the product “Impact Mints Spearmint, Sugar Free” under FDA Advisory No. 2019-029 dated 15 February 2019 is hereby lifted pursuant to the compliance of the market authorization holder to the existing laws, rules, and regulations of this Office.

The product is REGISTERED under company BASIC BNBI SOLUTIONS INC. with Food Registration Number 4000000588708 valid until 10 June 2021.

The other provisions of FDA Advisory No. 2019-029 indicating unregistered products are still in effect.

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.

For more information and inquiries, please e-mail us at [email protected] or call us at FDA Action Center hotline (02) 821-1162. To report sale or distribution of any unregistered health products, kindly email us via [email protected]

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2019-095

/ In General Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-095 || Lifting the Advisory of IMPACT MINTS SPEARMINT, SUGAR FREE under FDA Advisory No. 2019-029, Subject “Public Health Warning Against the Purchase and Consumption of the Unregistered Food Products”

FDA backs NGO In war vs. fake cosmetics

Press Statement
26 April 2019

FDA backs NGO
In war vs. fake cosmetics

Food and Drug Administration (FDA) recently expressed support for the call made by a non-government organization (NGO) for an all-out campaign against fake and counterfeit cosmetic products in the local market.

In a statement, FDA Director-General Nela Charade Puno cited the Ecowaste Coalition for “underscoring the need for strong collaboration between government and the civic sector in the war against fake and counterfeit products”.

The NGO recently called on candidates for the Senate and Congress to craft laws that will strengthen the fight against “adulterated and counterfeit cosmetic products”.

The Ecowaste Coalition lauded the gains of the FDA in the campaign against these products. The group added that the FDA has ”made considerable efforts the illegal sale of mercury-contaminated cosmetics such as skin lightening or whitening facial creams”.

The group, however, pointed out that prevailing laws “are not sufficient to stop the sale of these dangerous products”.

Puno said the FDA has continued to step up its law enforcement operations, notching a total of an estimated P114 million worth of unregistered medicines, cosmetics, food and medical products from 2018 to March of this year.

This was accomplished “despite limited resources. ”, she pointed out.

Puno noted that the FDA Regulatory Enforcement Unit (REU) has increased its efforts by 500 percent from 2017 as of the end of last year.

“This has resulted in the seizure of illegal products amounting to hundreds of million as of the end of the first quarter of 2019” Puno said.

A total of 3,183 legal Orders were served last year with about 500 orders already served just in the 1st quarter of 2019 alone.

The FDA has seized a total of almost 9 million verified Counterfeit Products from the said operations conducted from 2018 up to the first quarter of 2019. Puno noted these dangerous Counterfeit items would have gone to unsuspecting consumers were they not confiscated by the FDA.

FDA remains vigilant in its enforcement efforts with 19 Summons with Preventive Measure Orders (SPMO), including Seizure, being implemented just in 2019 alone. It implemented 60 last year.

“The FDA has also padlocked establishments caught selling unregistered products or operating without the required FDA licenses,” Puno disclosed.

She said the seized goods included fake, counterfeit and unregistered wellness and pharmaceutical products in addition to the dangerous cosmetics cited by the EcoWaste Coalition.

Puno said the FDA is set to further intensify the campaign with the use of information technology-based applications.

“With the use of technology, the FDA can track and trace the presence of counterfeits in the medical supply chain,” she explained. She added that the technology has raised the level of public participation in tracking and reporting entities that are selling counterfeits and unregistered products online.

“Because of these measures, more than ever, drug retail businesses importing or selling pharmaceutical products are compelled to comply strictly with the requirements of the FDA for product registration,” Puno pointed out.

“The FDA has also intensified the training of its law enforcement agents in intelligence, surveillance and case build-up skills to ensure that we raise the level of our success in combating the distribution of these dangerous products,” Puno said.

“However, we cannot totally succeed without the support of civic groups like EcoWaste and of our legislators,” Puno added.

-end

SEMINAR VENUE FOR 13 ASEAN MODULES AND GMP MODULES FOR COSMETICS MANUFACTURERS AND TRADERS (GMP-CMT) SEMINAR ON 24-25 APRIL 2019

Please be informed that the 13 ASEAN Modules and GMP Modules for Cosmetics Manufacturers and Traders (GMP-CMT) scheduled on 24-25 April 2019 shall be held at CRIMSON HOTEL.

  • VENUE          : CRIMSON HOTEL
  • ADDRESS     : 2609 Civic Drive Filinvest City Alabang, Muntinlupa City

All course registrants who received Course Assessment Slip for the 13 ASEAN Modules and GMP Modules for Cosmetics Manufacturers and Traders but have not received the Course Confirmation Slip are advised to send their proof of payment and bank validated Training Assessment Slip until Friday, 12 April 2019 to confirm their slot for the training.

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.

SEMINAR VENUE FOR 13 ASEAN MODULES AND GMP MODULES FOR COSMETICS MANUFACTURERS AND TRADERS (GMP-CMT) SEMINAR ON 24-25 APRIL 2019

FDA Advisory No. 2019-094 || Initiative ni DTI-DOH Operation: Livelihood (IDOL) Program (a Pilot Program) Launch

The Department of Trade and Industry (DTI) and the Department of Health – Food and Drug Administration (DOH-FDA) will officially launch today, 3 April 2019, the Initiative ni DTI-DOH Operation: Livelihood or IDOL Program.

The IDOL Program is a DTI-DOH-FDA pilot program that is designed to capacitate micro enterprises/entrepreneurs to comply with the regulatory requirements of the FDA, and to streamline the processing of their applications (for authorizations) – without compromising the quality and safety of their products.  To be qualified under the Program, the applicant must be:

  1. Classified as a micro enterprise per Republic Act No. 9501 (single proprietorship, cooperative, partnership or corporation whose total assets, inclusive of those arising from loans but exclusive of the land on which the particular business entity’s office, plant and equipment are situated, not more than PhP3,000,000.00);
  2. Engaged in the business of manufacturing of low-risk food products as classified per DOH AO No. 2014-0029 (see attached [non-exclusive] list of low-risk food products);
  3. Doing business in the NCR; and
  4. Able to submit the registration requirements of the DTI-DOH-FDA for the Program (see attached process flow with list of documentary requirements)

Qualified applicants must submit the required documents to the DTI Business / Negosyo Centers (DTI BC/NC) in their area for the processing of their application/s for FDA-authorization/s.

The DTI BC/NC and the DOH-FDA will facilitate the processing of all applications pursuant to existing laws, rules and regulationsparticularly focusing on food safety, and will release the approved authorizations through the DTI BC/NCs where the application was filed.

Inquiries regarding the IDOL Program may be emailed to [email protected].

FDA Advisory No. 2019-094

FDA Advisory No. 2019-091 || Public Health Alert on the sale/administration/consumption of Nicardipine Hydrochloride 1mg/mL (10mg/10mL) Solution for IV Injection with brand names, Cardilon, Cardimed, & Nicaright, Imported by MedEthix Inc.

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FDA Advisory No. 2019-091

/ In General Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-091 || Public Health Alert on the sale/administration/consumption of Nicardipine Hydrochloride 1mg/mL (10mg/10mL) Solution for IV Injection with brand names, Cardilon, Cardimed, & Nicaright, Imported by MedEthix Inc.