Month: March 2019

SUBMISSION OF COURSE REGISTRATION DOCUMENTS FOR WAITLISTED APPLICANTS OF FDA ACADEMY TRAINING SEMINAR

Due to intermittent email error, all waitlisted applicants of FDA Academy Trainings are advised to send their course registration documents to [email protected]. To confirm that your application is a part of the waitlisted applicants, attach the acknowledgement receipt of waitlisted from FDA Academy to your email.

Meantime, please refrain from sending email to [email protected] until further notice. Rest assured that the stakeholders with the correct and complete documents will be assessed to the seminar. For inquiries and other concerns, please call the FDA Academy at telephone number (02) 877 0259.

FOR WAITLISTED APPLICANTS

SEMINAR VENUE FOR CDRRHR QPIRA SEMINAR (QCDRRHR) ON 2-3 APRIL 2019

Please be informed that the Center for Device Regulation, Radiation Health and Research QPIRA Seminar (QCDRRHR) scheduled on 2-3 April 2019 shall be held at ACACIA HOTEL.

VENUE       :     ACACIA HOTEL

ADDRESS  :     5400 EAST ASIA DRIVE CORNER COMMERCE

AVENUE, FILIVEST CORPORATE CITY, ALABANG,  MUNTINLUPA CITY

All course registrants who received Course Assessment Slip for the Unified Licensing Seminar but have not received the Course Confirmation Slip are advised to come in the seminar venue (ACACIA HOTEL) on the scheduled date of seminar with the following documents:

  • Course assessment slip
  • Proof of payment
  • Original Copy of Notarized Affidavit of Undertaking

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 CDRRHR QPIRA SEMINAR QCDRRHR ON 2-3 APRIL 2019

FDA Advisory No. 2019-084 || Dissemination of ASEAN Post-Marketing Alert System(PMAS) Report on Cosmetic Product Containing Banned Ingredient With Reference No. FDA 1008.5 / 327 (8 February 2019)&FDA 1004.03/746(March 2019)

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FDA Advisory No. 2019-084

/ In General Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-084 || Dissemination of ASEAN Post-Marketing Alert System(PMAS) Report on Cosmetic Product Containing Banned Ingredient With Reference No. FDA 1008.5 / 327 (8 February 2019)&FDA 1004.03/746(March 2019)

FDA Advisory No. 2019-079 || Voluntary Recall of Terumo® Needle

All concerned healthcare professionals and establishments are hereby advised by the Food and Drug Administration (FDA) regarding the voluntary product recall of selected lots of Terumo® Needle with MDR No. 00802 (see photos of the affected product above), manufactured by Terumo Philippines Corporation.

Terumo Marketing Philippines Inc. received a customer complaint that the blister seals of the above-mentioned medical device are narrows or misaligned. After  the investigation, it was observed that the sealing portion (width) of the blister package was below the manufacturing standard of 1.5mm and a small opening on the package resulting to seal breach was observed.

The reason for recall is the potential loss of packaging integrity that may compromise the sterility of the subject medical device product. There have been no reported patient injuries associated to this issue.

All concerned healthcare professionals and establishments are advised to discontinue further use, sale and distribution of the said affected medical device product.

For more information and inquiries, please email us at [email protected] or call the Product Research and Standards Development Division of the FDA – Center for Device Regulation, Radiation Health and Research at 857-1900 local 8301.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2019-079

SEMINAR VENUE FOR UNIFIED LICENSING SEMINAR FOR REGION I (ULS-I) IN PANGASINAN ON 20 MARCH 2019

Please be informed that the Unified Licensing Seminar for Region I (ULS-I) scheduled on 20 March 2019 in Pangasinan shall be in LENOX HOTEL.

VENUE          : LENOX HOTEL

ADDRESS     : RIZAL STREET DAGUPAN CITY, PANGASINAN

All course registrants who received Course Assessment Slip for the Unified Licensing Seminar but have not received the Course Confirmation Slip are advised to come in the seminar venue (LENOX HOTEL) 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.

SEMINAR VENUE FOR UNIFIED LICENSING SEMINAR FOR REGION I (ULS-I) IN PANGASINAN ON 20 MARCH 2019

SEMINAR VENUE FOR CDRR QPIRA SEMINAR (QCDRR- NCR) ON 19 – 20 MARCH 2019 AND CCRR QPIRA SEMINAR (QCCRR-NCR) ON 21-22 MARCH 2019

Please be informed that the Center for Drug Regulation and Research QPIRA Seminar (QCDRR-NCR) on 19-21 March 2019 and Center for Cosmetic Regulation and Research QPIRA Seminar (QCCRR-NCR) scheduled on 21-22 March 2019 shall be held at ACACIA HOTEL.

  • VENUE           : ACACIA HOTEL
  • ADDRESS     : 5400 EAST ASIA DRIVE CORNER COMMERCE AVENUE, FILIVEST CORPORATE CITY, ALABANG MUNTINLUPA CITY

All course registrants who received Course Assessment Slip for the Unified Licensing Seminar but have not received the Course Confirmation Slip are advised to come in the seminar venue (ACACIA HOTEL) on the scheduled date of seminar with the following documents:

  • Course assessment slip
  • Proof of payment
  • Original Copy of Notarized Affidavit of Undertaking

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 CDRR QPIRA SEMINAR (QCDRR- NCR) ON 19 – 20 MARCH 2019 AND CCRR QPIRA SEMINAR (QCCRR-NCR) ON 21-22 MARCH 2019

FDA Advisory No. 2019-077 || Voluntary Recall of PROXIMATE HCS Procedure for Prolapse and Hemorrhoids (PPH) Set, Codes PPH01 and PPH03

All are hereby advised by the Food and Drug Administration (FDA) about the voluntary recall of the following lot numbers of Proximate HCS Procedure for Prolapse and Hemorrhoids (PPH) Set, Codes PPH01 and PPH03 (see figures 1, 2 and 3), with product registration number DVR-4945. The said products were imported and distributed by Johnson & Johnson (Philippines), Inc. with office address at Edison Rd., Bo. Ibayo, Parañaque City.

PRODUCT NAME PRODUCT CODE  

PRODUCT LOTS

Proximate HCS Hemorrhoidal Circular Stapler  

PPH01

P9461W
P94K20
 
Proximate PPH Hemorrhoidal Circular Stapler PPH03 P93K95 P9420Y P94A4T
P93L1M P9420Z P94D3N
P93M3G P9441H P94F3Z
P93T35 P9450L P94G04
P93T7F P9463J P94H5F
P93W3M P94765 P94J4W
P93W3N P9487Z P94J80
P93Y58 P94901 P94K2A
P94117 P94A20 R9200Z

The above-stated medical device products are being voluntary recalled by Johnson & Johnson (Philippines), Inc. because the manufacturer, Ethicon Endo-Surgery, LLC, has confirmed that some devices contained in the affected lots may have been assembled without a washer. The medical assessment concluded that this situation may potentially cause bleeding or soft tissue injury during use as the device may not fully cut when fired.

Distributors, retailers, hospitals and all healthcare professionals/users are advised to discontinue further distribution, sale and use of the said affected medical device product.

Any suspected adverse reaction experienced from the use of the device but not limited to the lot stated above, should be reported immediately to FDA at telephone number (02) 857-1900 local 8301 or email us at [email protected]yahoo.com.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2019-077

FDA Advisory No. 2019-075 || 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. DANA NATURAL SUPPLEMENTS TAWA-TAWA CONCENTRATE DROPS
  2. COLLOIDAL SILVER WATER DIETARY SUPPLEMENT
  3. NUTREX SEARCH LIPO6 BLACK HERS ULTRA CONCENTRATE DIETARY SUPPLEMENT
  4. DOK APO PRO KIDNEY HERBAL CAPSULE
  5. LUMI GLUTATHIONE 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 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. 2019-075

FDA Advisory No. 2019-071 || Public Health Warning Against the Purchase and Consumption of the following Unregistered DOLLIE’S Food Products:

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

  1. DOLLIE’S SPICY PEANUTS
  2. DOLLIE’S SPECIAL PEANUT BUTTER
  3. DOLLIE’S PURE TURMERIC POWDER, SUGAR FREE
  4. DOLLIE’S PURE TURMERIC TEA (BAG)
  5. DOLLIE’S GROUND COFFEE, IRISH CREAM
  6. DOLLIE’S GROUND COFFEE, HAZELNUT CREAM
  7. DOLLIE’S GROUND COFFEE, AMARETTO

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. 2019-071

FDA Advisory No. 2019-070 || 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. BOURBON GRACEFUL BISCUITS SERIES
  2. CALBEE CEREALS
  3. KELLOGG’S CEREALS
  4. WONDER KIDS CANDY
  5. JGM LAMBANOG (FLORIDA COCOWINE)
  6. L.I. EXCELSIOR’S IODIZED SALT

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. 2019-070

FDA Advisory No. 2019-069 || Public Health Warning Against False, Deceptive, and Misleading Advertisement of the following Unregistered Food Products and Food 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. SUCCESS 200 TURMEIRC CURCUMA LONGA CAPSULES
  2. CHRO-PLUS HERBAL DIETARY SUPPLEMENT
  3. FIT & GROW HERBAL DIETARY SUPPLEMENT
  4. CHLOROXYGEN CHLOROPHYLL CONCENTRATE

The public is hereby warned that the food products and food supplements 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 advertisments are false, deceptive, and misleading. As per a
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 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 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 product. 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) 857-1900loc. 8115 and 8112.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2019-069

/ In General Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-069 || Public Health Warning Against False, Deceptive, and Misleading Advertisement of the following Unregistered Food Products and Food Supplements:

FDA Advisory No. 2019-067 || 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. AMY’S CASHEW ROASTED CASHEW
  2. MORINGA Q
  3. PALAWAN’S BEST TITA HILDZ MALUNGGAY POWDER
  4. IJ TURMERIC PRODUCTS TURMERIC INSTANT HERBAL TEA
  5. TURMERIC FORTIFIED WITH 95% CURCUMIN C3 COMPLEX DIETARY SUPPLEMENT

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. 2019-067

FDA Advisory No. 2019-006-A || Clarification on the FDA Advisory No. 2019-006 re:Public Health Warning Against the Purchase and Use of Counterfeit Medical Device Product (Freshlook Colorblends (phemfilcon A) Contact Lenses)

to continue reading, click the attachment below…

FDA Advisory No. 2019-006-A

/ In General Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-006-A || Clarification on the FDA Advisory No. 2019-006 re:Public Health Warning Against the Purchase and Use of Counterfeit Medical Device Product (Freshlook Colorblends (phemfilcon A) Contact Lenses)

FDA Advisory No. 2019-066 || Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Products and Food 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. MARUMIYA NORITAMA
  2. RYI Spirulina Troche
  3. NATURE’S DETOX Food Supplement
  4. Premium Alkaline Water
  5. BARE NATURE Vitamin Iced Tea Peach Naturally Flavored

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 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 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. 2019-066

/ In General Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-066 || Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Products and Food Supplements:

FDA Advisory No. 2019-065 || Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Products and Food 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. WONDER KIDS WONDER INSIDE
  2. DAILY MULTI Vitamins & Minerals
  3. SUPER B COMPLEX
  4. G STUFF PURE ILOCANO Sea Salt
  5. G STUFF Turmeric and Ginger Tea
  6. G STUFF AMAZING Tea

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 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 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. 2019-065

/ In General Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-065 || Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Products and Food Supplements:

FDA Advisory No. 2019-064 || 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 in which labels are in foreign characters:

  1. VIVA MIXED NUTS
  2. A XIONG FOODS FEITIANSUOGU
  3. BOSS GAZUI PICKLE
  4. WEI-LONG MEAT PICKLE
  5. JINMOFANG FOODS TOFU WITH FISH
  6. 99 EGG FLAVOR
  7. GO GO CORN BAR

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. 2019-064