Month: December 2019

Food and Drug Administration Included in the ASEAN Mutual Recognition Arrangement (MRA)

PRESS RELEASE
27 DECEMBER 2019

https://www.clotstudio.com/

ASEAN Member States officially listed the Philippine Food and Drug Administration (FDA) under the ASEAN Mutual Recognition Arrangement (MRA) on Good Manufacturing Practices (GMP) for Medicinal Products during the 28th ASEAN Consultative Committee on Standards and Quality Pharmaceutical Product Working Group (ACCSQ-PPWG) Meeting held on 19-20 December 2019 in Indonesia. The endorsement was agreed upon after the ASEAN Panel of Experts’ assessment of the FDA and successful establishment of the agency’s technical competency for inclusion in the register of accepted ASEAN Inspection Services.

As listed Inspection Service of the ASEAN MRA, the (1) FDA issued GMP Certificate for manufacturers of medicinal products, and (2) FDA GMP inspection reports shall be accepted by other listed National Regulatory Agencies under the ASEAN MRA on GMP.

Undersecretary of Health and FDA’s Officer-In-Charge (OIC) Director General, Rolando Enrique D. Domingo underscored the importance of the inclusion of the FDA in the ASEAN registry for both the industry and consumers. For the industry, the inclusion will result in reduced duplication of inspections, cost reduction, facilitation of exports, enhanced market access, enhanced industry reputation, transparency in inspection standards and consistency of inspection. The inclusion will also increase confidence in the quality of medicines for consumers, increase in reliability and quality of medicines, improved consumer safety and protection, better control of counterfeit medicines, and improved access to affordable quality medicines.

USec Domingo also emphasized that the successful inclusion “is a major step and contribution of the FDA to the government’s strategy to expand economic opportunities in industry and services through Trabaho at Negosyo as mandated by Philippine Development Plan (PDP) 2017-2022 anchored on a long-term vision or AmBisyon Natin 2040.”

The Philippines is the fifth country to be listed under the ASEAN MRA on GMP for Medicinal
Products after Singapore Health Sciences Authority, Malaysia National Pharmaceutical Regulatory Authority, Indonesia National Agency of Drug and Food Control and Thailand Food and Drug Administration.

Attachment:->FDA Included in the ASEAN Mutual Recognition Arrangement (MRA)

FDA Advisory No. 2019-534 || PUBLIC HEALTH ADVISORY ON THE ISSUE ON ALLEGED METHANOL POISONING DUE TO CONSUMPTION OF ‘LAMBANOG’

In view of the on-going issue involving mass hospitalization and deaths allegedly due to methanol poisoning after drinking distilled coconut sap, locally known as “lambanog”, the Food and Drug Administration (FDA) hereby warns the public on the purchase and consumption of alcoholic beverages that have not undergone the safety evaluation of this agency.

Current investigation is being done with the assistance of the Department of Health- Epidemiology Bureau, through its Regional Epidemiology and Surveillance Unit, and the concerned Local Government Units. The FDA shall conduct laboratory testing to confirm whether the implicated products contain a high level of the substance ‘methanol’. Ingestion of product with an elevated amount of methanol poses serious adverse effects such as blindness, permanent neurologic dysfunction, and even death.

The public is hereby advised to exercise extreme caution in purchasing and consuming products such as alcoholic beverages that do not have proper labels and are not registered with the FDA. Retail outlets, and other dealers of alcoholic beverages, are warned against the sale of unregistered products which is a violation of the FDA Act of 2009 and the Food Safety Act of 2013.

All Local Government Units and Law Enforcement Agencies 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] or call us at FDA Action Center hotline (02) 821-1162, or the Center for Food Regulation & Research at (02) 857-1900. To report the sale or distribution of any product that is not registered with the FDA, kindly email us via [email protected]

Dissemination of the information to all concerned is requested.

 

Attachment:->FDA Advisory No.2019-534

FDA Advisory No. 2019-533-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng Pekeng Bersyon ng Cholecalciferol (Fern-D)

Pinapayuhan ng Food and Drug Administration (FDA) ang publiko laban sa pagbili at paggamit ng pekeng bersyon ng Cholecalciferol (Fern-D):

Ayon sa pagsusuri ng FDA kasama ang Marketing Authorization Holder (MAH), FERN Inc., at ng manufacturer, Hizon Laboratories, Inc., ang nasabing produkto ay napatunayang peke. Ang paghahambing ng nakolektang pekeng gamot at kakaibang katangian ng tunay na produkto ay ang sumusunod:

  • Counterfeit – Clear, oval, pale yellowish softgel capsule containing pale yellowish oily liquid with fishy odor which is not comparable to the odor of original Fern-D 1000 IU softgel capsule.
  • Authentic – Clear, oval, yellowish softgel capsule containing yellowish oily liquid.

Ang lahat ng healthcare professionals at publiko ay binabalaan tungkol sa paglipana ng nasabing pekeng gamot sa merkado na maaaring magdulot ng panganib sa kalusugan ng mga gagamit nito. Ang publiko ay pinapaalalahanan ring bumili lamang sa mga establisyamentong lisensyado ng FDA.

Gayundin, ang lahat ng establisyamento ay binabalaang huwag magbenta nitong produkto na nagtataglay ng mga nasabing katangian ng pekeng gamot. Ang pagaangkat, pagbebenta at pamamahagi nito ay paglabag sa Republic Act No. 9711 o ang Food and Drug Administration Act of 2009 at Republic Act No. 8203 o ang Special Law on Counterfeit Drugs. Ang sino mang mapatunayang nagbebenta ng nasabing pekeng produkto ay mapaparusahan.

Hinihiling sa lahat ng Local Government Units (LGUs) at Law Enforcement Agencies (LEAs) na tiyaking ang pekeng 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 pekeng 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) 8809-5596. Para sa mga hinihinalang hindi kanais-nais na reaksyon sa gamot, i-report agad sa FDA gamit ang link na ito: https://primaryreporting.who-umc.org/ Reporting/Reporter? OrganizationID=PH at kumpletuhin ang mga kinakailangang impormasyon.

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

Attachment:->FDA Advisory No.2019-533-A

FDA Advisory No. 2019-533 || Public Health Warning Against the Purchase and Use of the Counterfeit Version of Cholecalciferol (Fern-D)

The Food and Drug Administration (FDA) advises the public against the purchase and use of the counterfeit version of Cholecalciferol (Fern-D):

The FDA together with the Marketing Authorization Holder (MAH), FERN Inc., and the manufacturer, Hizon Laboratories, Inc., have verified that the above-mentioned sample drug product is counterfeit. The comparison of the collected counterfeit drug product and the distinguishing feature of the authentic is as follows:

  • Counterfeit – Clear, oval, pale yellowish softgel capsule containing pale yellowish oily liquid with fishy odor which is not comparable to the odor of original Fern-D 1000 IU softgel capsule.
  • Authentic – Clear, oval, yellowish softgel capsule containing yellowish oily liquid. (please see:-> FDA Advisory No.2019-533 for more details)

All healthcare professionals and the general public are hereby warned as to the availability of this counterfeit drug product in the market which poses potential danger or injury to consumers. Consumers are also reminded to purchase drug products only from FDA-licensed establishments.

Likewise, all establishments and outlets are hereby warned against selling and/or dispensing of this drug product with the abovementioned features of a counterfeit drug product. The importation, selling or offering for sale of such is in direct violation of Republic Act No. 9711 or the Food and Drug Administration Act of 2009, and Republic Act No. 8203 or the Special Law on Counterfeit Drugs. Anyone found selling the said counterfeit drug product will be penalized.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that this counterfeit product is 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 counterfeit 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) 8809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: https://primaryreporting.whoumc.org/Reporting/Reporter?OrganizationID=PH and fill out all the required fields.

Dissemination of the information to all concerned is requested.

Attachment:-> FDA Advisory No.2019-533

FDA Advisory No. 2019-527 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “Bio Swiss Cupcake Shaped Bandage”

The Food and Drug Administration (FDA) warns the general public against the purchase and use of the unregistered medical device:

  1. BIO SWISS CUPCAKE SHAPED BANDAGE

The FDA verified through post-marketing surveillance that the abovementioned medical device is not registered and the Certificate of Product Registration (CPR) has 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 this unregistered medical device has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

In light of the foregoing, the public is advised not to purchase the violative product in the market.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device until CPR is issued, otherwise, regulatory actions and sanctions shall be strictly pursued.

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

The Bureau of Customs is urged to restrain the entry of this unregistered product.

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

To report any sale or distribution of unregistered medical device, 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.2019-527

FDA Advisory No. 2019-526 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “Care Touch Oral Medicine Syringe”

The Food and Drug Administration (FDA) warns the general public against the purchase and use of the unregistered medical device:

  1. “CARE TOUCH ORAL MEDICINE SYRINGE”

The FDA verified through post-marketing surveillance that the abovementioned medical device is not registered and the Certificate of Product Registration (CPR) has 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 this unregistered medical device has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

In light of the foregoing, the public is advised not to purchase the violative product in the market.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device until CPR is issued, otherwise, regulatory actions and sanctions shall be strictly pursued.

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

The Bureau of Customs is urged to restrain the entry of this unregistered product.

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

To report any sale or distribution of unregistered medical device, 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.2019-526

FDA Advisory No. 2019-525 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “Surgitech Clinical Fieber Thermometer MT-101”

The Food and Drug Administration (FDA) warns the general public against the purchase and use of the unregistered medical device:

  1. “SURGITECH CLINICAL FIEBER THERMOMETER MT-101”

The FDA verified through post-marketing surveillance that the abovementioned medical device is not registered and the Certificate of Product Registration (CPR) has 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 this unregistered medical device has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

In light of the foregoing, the public is advised not to purchase the violative product in the market.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device until CPR is issued, otherwise, regulatory actions and sanctions shall be strictly pursued.

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

The Bureau of Customs is urged to restrain the entry of this unregistered product.

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

To report any sale or distribution of unregistered medical device, 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.2019-525

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-525 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “Surgitech Clinical Fieber Thermometer MT-101”

FDA Advisory No. 2019-524 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “Qinlishu Flex Freely Abacterial Flexible Fabric Bandage”

The Food and Drug Administration (FDA) advises the general public and all healthcare professionals against the purchase and use of the unregistered medical device:

  1. “Qinlishu Flex Freely Abacterial Flexible Fabric  Bandage”

FDA post-marketing surveillance (PMS) activities have verified that the abovementioned medical device has not gone through the registration process of the agency and has not been issued with proper authorization in the form of Certificate of Product Registration (CPR).Pursuant to Republic Act 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 this unregistered medical device have not gone through evaluation and testing process of the FDA, the agency cannot guarantee its quality and safety. The consumption of such violative product 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 and to be vigilant against medical device that might not be duly registered with FDA. Always check if a medical device 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.

All concerned establishments and/or entities are warned not to distribute the above-identified violative medical device 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 this product is 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 medical device, 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 Device Regulation, Radiation Health and Research (CDRRHR) hotline (02) 857-1900 local 8301.

Dissemination of the information to all concerned is requested.

Attachment:-> FDA Advisory No.2019-524

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-524 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “Qinlishu Flex Freely Abacterial Flexible Fabric Bandage”

FDA Advisory No. 2019-523 || Voluntary Recall of Endo GIA Articulationg Reload with Tri-Staple Technology

The Food and Drug Administration (FDA) warns all healthcare professional and the general public on the voluntary recall of Endo GIA Articulating Reload with Tri-Staple Technology with MDR No. 00768, imported and distributed by Medtronic Philippines Inc.:

Product Name Product Code Lot Number
Endo GIA Articulating Reload with Tri-Staple Technology EGIA60AMT N5G0186KX
N5J0492KX
N5J0775KX
N5M0769KX
N5M0582KX
N6C0972KX
N6E0462KX
N6E0600KX
N6F0541KX

Medtronic Philippines Inc. has conducted the voluntary recall of the aforementioned product due to the potential absence of one of the two pin components that maintains the alignment of the device jaws. This potential issue was identified during the in-process quality testing at the manufacturing facility. The use of a product with missing pin may result in incomplete staple formation. This may cause bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the potential for infection and/or sepsis. Manufacturing process improvements have been implemented to address this issue. There have been no confirmed complaints associated with this recall.

In light of the foregoing, all concerned healthcare professional, establishment, and the general public is warned to discontinue further use, sale, and distribution of the said 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 product is 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.2019-523

FDA Advisory No. 2019-522 || Public Health Warning Against the Purchase and Use of Unregistered Medical Devices that is being Advertised and Offer for Sale Online

to continue reading, click the attachment below…

Attachment:-> FDA Advisory No.2019-522

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-522 || Public Health Warning Against the Purchase and Use of Unregistered Medical Devices that is being Advertised and Offer for Sale Online

FDA Advisory No. 2019-521 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “Ethicon* Mersilk* Black Braided Silk Suture N537”

to continue reading, click the attachment below…

Attachment:->FDA Advisory No.2019-521

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-521 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “Ethicon* Mersilk* Black Braided Silk Suture N537”

FDA Advisory No. 2019-519 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “Banghaoning Flex Freely AbacteralFlexble Fabrc Bandage”

The Food and Drug Administration (FDA) advises the general public and all healthcare professionals against the purchase and use of the unregistered medical device:

  1. “Banghaoning Flex Freely Abacteralflexble Fabrc  Bandage”

FDA post-marketing surveillance (PMS) activities have verified that the abovementioned medical device has not gone through the registration process of the agency and has not been issued with proper authorization in the form of Certificate of Product Registration (CPR).Pursuant to Republic Act 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 this unregistered medical device have not gone through evaluation and testing process of the FDA, the agency cannot guarantee its quality and safety. The consumption of such violative product 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 and to be vigilant against medical device that might not be duly registered with FDA. Always check if a medical device 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.

All concerned establishments and/or entities are warned not to distribute the above-identified violative medical device 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 this product is 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 medical device, 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 Device Regulation, Radiation Health and Research (CDRRHR) hotline (02) 857-1900 local 8301.

Dissemination of the information to all concerned is requested.

Attachment:-> FDA Advisory No.2019-519

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-519 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “Banghaoning Flex Freely AbacteralFlexble Fabrc Bandage”

FDA Advisory No. 2019-532 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products & Food Supplements:

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

  1. GARCINIA CAMBOGIA Food Supplement (100 capsules)
  2. B.C SERPENTINA Andrographis paniculata (600 mg)
  3. TINTOY’S FOOD PRODUCT ITOY’S ORIGINAL Chili Garlic Sauce (4 oz.)
  4. BICOL DELICACY REGALADO Pili Peanut Butter
  5. SHYKERA Pilinut Brittle

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

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

In light of the foregoing, the public is advised not to purchase the aforementioned violative products. Moreover, the public is advised to always check if a food product & 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 & food supplement until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a CPR for the food product & food supplement.

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

Kindly contact the FDA Center for Food Regulation and Research through e-mail at [email protected], or call (02) 857-1900 loc. 8112 & 8104.

To report any sale or distribution of unregistered food product & food supplement, 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.2019-532

/ In Food Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-532 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products & Food Supplements:

FDA Advisory No. 2019-531 || 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 consuming the following unregistered food products:

  1. JAS SWEETS Special Pastillas de Leche
  2. GOLD EAGLE Food Product
  3. OCEAN DELIGHTS Ginisang Alamang (Sauteed Shrimp Fry/ Sweet Chili Flavor)
  4. DEGUSO Mangosteen Guyabano with Honey

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.2019-531

FDA Advisory No. 2019-530 || 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 consuming the following unregistered food products:

  1. TESCO Italian Chopped Tomatoes with Olive Oil (1.5%) & Garlic in rich tomato juice
  2. TESCO Red Kidney Beans in Water Mild & Versatile
  3. TESCO Shorties – Light & Crumbly
  4. TESCO Italian Peeled Plum Tomatoes, Vine-Ripened
  5. MIGHTY MOUSE Watermelon Candy

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.2019-530

FDA Advisory No. 2019-529 || 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 FOOD PRODUCTS Chia Seeds (100 grams)
  2. CHAM CHOCO STICK (4 grams)
  3. SWAN MINDANAO Pure Raw Honey Wild (375 mL)
  4. HEALTHWEALTH OH! TOMATO Coffee Lycopene Drink
  5. FINI Sour Tornadoes with Sour Filling Twisted Flavors Soft and Chewy Candy (70 grams)

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.2019-529

FDA Advisory No. 2019-514 || 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. PIPING ROCK MAGNESIUM GLYCINATE
  2. PIPING ROCK ODORLESS GARLIC
  3. PIPING ROCK TRIPLE STRENGTH ACAI SUPREME
  4. PIPING ROCK MEGA T1000 TRIBULUS TERRESTRIS
  5. PIPING ROCK ULTRA TART CHERRY

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

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

In light of the foregoing, the public is advised not to purchase the aforementioned violative products. Moreover, the public is advised to always check if a food supplements 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 8104.

To report any sale or distribution of unregistered food supplements, 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.2019-514

FDA Advisory No. 2019-511 || 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. EMMARENS SWEET DELIGHTS 100% NATURAL BANANA CHIPS
  2. WOWIE FOOD PRODUCTS TURMERIC ORANGE GINGER TEA
  3. WOWIE SALABAT RED GINGER TEA
  4. GREAT HARVEST VINAIGRETTE SPICY
  5. GREAT HARVEST PASSION FRUIT & MANGO VINAIGRETTE

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 or 8104.

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.2019-511

FDA Advisory No. 2019-508 || 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. PIPING ROCK VITAMIN K-2 ULTRA
  2. PIPING ROCK BACOPA
  3. PIPING ROCK URINARY TRACT COMPLEX + D-MANNOSE CAPSULE
  4. PIPING ROCK L-METHYLFOLATE
  5. PIPING ROCK COLD PRESSED FLAXSEED OIL

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

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

In light of the foregoing, the public is advised not to purchase the aforementioned violative products. Moreover, the public is advised to always check if a food supplements 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 8104.

To report any sale or distribution of unregistered food supplements, 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.2019-508

FDA Advisory No. 2019-507 || 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. PIPING ROCK OIL OF OREGANO, 1500MG
  2. PIPING ROCK CHILDREN’S PROBIOTIC-10
  3. PIPING ROCK MAGNESIUM CHLORIDE
  4. PIPING ROCK KIDNEY CARE CAPSULES
  5. PIPING ROCK B-COMPLEX + B-12 TABLET

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

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

In light of the foregoing, the public is advised not to purchase the aforementioned violative products. Moreover, the public is advised to always check if a food supplements 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 8104.

To report any sale or distribution of unregistered food supplements, 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.2019-507

FDA Advisory No. 2019-504 || 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. PIPING ROCK GORGEOUS HAIR, SKIN & NAILS GUMMIES
  2. PIPING ROCK ZINC PICOLINATE
  3. PIPING ROCK VITAMIN D3 250MCG 10000 IU SOFTGEL
  4. PIPING ROCK CALCIUM MAGNESIUM PLUS D3 COATED CAPLET
  5. PIPING ROCK BOSWELLIA SERRATA

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

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

In light of the foregoing, the public is advised not to purchase the aforementioned violative products. Moreover, the public is advised to always check if a food supplements 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 8104.

To report any sale or distribution of unregistered food supplements, 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.2019-504

FDA Advisory No. 2019-503 || 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. PURELY BENEFICIAL RESVERATROL 1450 DIETARY SUPPLEMENT
  2. SOLNUTRA ADVANCE TURMERIC CURCUMIN C3 COMPLEX MSM, DHA/EPA AND ANTIOXIDANTS WITH BIOPERINE DIETARY SUPPLEMENT
  3. NATROGIX RASPBERRY KETONE ULTRA WITH AFRICAN MANGO DIETARY SUPPLEMENT
  4. AGELESSBOUNTY RESVERATROL 1000MG ADVANCE
  5. FAIRHAVEN HEALTH FERTILAID FOR MEN DIETARY SUPPLEMENT

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

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

In light of the foregoing, the public is advised not to purchase the aforementioned violative products. Moreover, the public is advised to always check if a food supplements 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 8104.

To report any sale or distribution of unregistered food supplements, 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.2019-503

 

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FDA Advisory No. 2019-346-A || Lifting the Advisory of the Notified Cosmetic Product “SUNBRIGHT SERIES KERATIN & COLLAGEN HAIR COLOR 9.91 (SILVER ASH)” under FDA Advisory No. 2019-346 “Public Health Warning Against the Purchase and Use of Unnotified Cosmetic Products” Dated 09 October 2019

The Food and Drug Administration (FDA) informs the public that the cosmetic product Sunbright Series Keratin & Collagen Hair Color 9.91 (Silver Ash) with Notification No.  1000002547393 and has been notified by the Market Authorization Holder (MAH), Elegant Fumes Beauty Products, Inc., in accordance with the existing FDA rules and regulations.

Accordingly, the list released in FDA Advisory No. 2019-346 is hereby updated to remove the aforementioned cosmetic product.

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 hair wigs product before purchasing. Kindly contact the FDA Center for Cosmetics Regulation and Research through e-mail at [email protected], or call (02) 857-1900 loc. 8113 or 8117.

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

The public health warning imposed on the remaining products listed in FDA Advisory No. 2019-346 shall remain to be upheld and shall not be affected by the issuance of this advisory.

Furthermore, the issuance of this advisory shall not in any manner preclude this Office from issuing subsequent orders it may deem necessary and appropriate, should there be findings of any violation of the company to the existing laws, rules, and regulations.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2019-346-A

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-346-A || Lifting the Advisory of the Notified Cosmetic Product “SUNBRIGHT SERIES KERATIN & COLLAGEN HAIR COLOR 9.91 (SILVER ASH)” under FDA Advisory No. 2019-346 “Public Health Warning Against the Purchase and Use of Unnotified Cosmetic Products” Dated 09 October 2019

FDA Advisory No. 2019-517 || Public Health Warning Against the Purchase and Use of the following Unregistered Household Urban Pesticides:

The Food and Drug Administration (FDA) warns the public from purchasing and using the following unregistered household urban pesticides:

  1. PIF PAF LIQUID MOSQUITO KILLER
  2. BEN KILL RAT BAIT
  3. BYE BYETM MOSQUITO STICKER
  4. YUANMENG READ A DREAM FLY REPELLENT INCENSE
  5. COBRA FLY ERADICATION

The FDA verified through post-marketing surveillance that the abovementioned household urban pesticides 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 household urban pesticide 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 harmful, toxic and banned active ingredients that pose imminent danger to human and animal health. The use of substandard and possibly adulterated household/urban pesticide products may result to adverse reactions such as skin irritation, itchiness, anaphylactic shock, respiratory disorders, endocrine complications, brain damage 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 household urban pesticide 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 household urban pesticides until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a CPR for the household urban pesticide.

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 loc. 8113 or 8107.

To report any sale or distribution of unregistered household urban pesticide, 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.2019-517

 

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