Month: August 2020

FDA has released a total of 249 COVID – 19 Test Kits (87 – PCR based, 90 – Rapid Antibody, 58 – Immunoassay and 14 – Others)

As of 11 September 2020,  FDA has released a total of 249 COVID – 19 Test Kits (87 – PCR based, 90 – Rapid Antibody , 58 – Immunoassay and 14 – Others).

Click the link below for details.

https://bit.ly/2Zd0CZ4

FDA Advisory No. 2020-1509 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic GLAM SKINCARE PRODUCTS DELICA GUAVA BLEACHING SOAP

The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product:

  1. GLAM SKINCARE PRODUCTS DELICA GUAVA BLEACHING SOAP

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 30 July 2020. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing 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 any health product without the proper authorization from the FDA is prohibited.

Since the abovementioned unauthorized cosmetic product has not gone through the notification process of the FDA, the agency cannot assure their quality and safety. The use of such violative product may pose health risks to consumers.

Potential hazards may come from ingredients that are not allowed to be part of a cosmetic product or from the contamination of heavy metals. The use of substandard and possibly adulterated cosmetic products may result to adverse reactions including, but not limited to, skin irritation, itchiness, anaphylactic shock and organ failure.

In light of the foregoing, the public is advised not to purchase the aforementioned violative cosmetic product. Moreover, the public is advised to always check if a cosmetic product is notified with the FDA through its website (ww2.fda.gov.ph). It has a Search feature which may be used by typing in the name of the product before deciding on purchasing and/or using the said product.

All concerned establishments are warned not to distribute violative cosmetic product until they have fully complied with the rules and regulation of the FDA.

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 their jurisdiction.

To report any sale, distribution, complaint and/or adverse event on the use of the violative cosmetic products, the online reporting facility, eReport can be accessed at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-1509

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1509 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic GLAM SKINCARE PRODUCTS DELICA GUAVA BLEACHING SOAP

FDA Advisory No. 2020-1508 || Public Health Warning Against the Purchase and Use of the Unnotified Medical Device Product “LUEN MAN FONG BANDAGE-AID ADHESIVE STERILE PLASTERS (IN FOREIGN CHARACTERS)”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unnotified medical device product:

  1. “LUEN MAN FONG BANDAGE-AID ADHESIVE STERILE PLASTERS (IN FOREIGN CHARACTERS)”

The FDA verified through post-marketing surveillance that the above mentioned medical device product is not notified and no corresponding Product Notification Certificate has 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 product has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device product until the Product Notification Certificate is issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been notified with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Notification number on the product label in the form of either DVR-xxx or MDR-xxx or CMDN-xxx.

All Law Enforcement Agencies (LEAs) and Local Government Units (LGUs) are requested to ensure that this product is not sold or made available in the market or areas of jurisdiction.

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

For more information and inquiries about this advisory, kindly contact the FDA CDRRHR through e-mail at [email protected] indicating on the subject the concerned Advisory, or call (02) 8857-1900 loc. 8301. 

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-1508

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1508 || Public Health Warning Against the Purchase and Use of the Unnotified Medical Device Product “LUEN MAN FONG BANDAGE-AID ADHESIVE STERILE PLASTERS (IN FOREIGN CHARACTERS)”

FDA Advisory No. 2020-1507 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product “ACCUMAX NEBULIZING KIT”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unregistered medical device product:

  1. “ACCUMAX NEBULIZING KIT”

The FDA verified through post-marketing surveillance that the above mentioned medical device product is not registered and no corresponding Product Registration Certificate has 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 product has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device product until the Product Registration Certificate is issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label in the form of either DVR-xxx or MDR-xxx.

All Law Enforcement Agencies (LEAs) and Local Government Units (LGUs) are requested to ensure that this product is not sold or made available in the market or areas of jurisdiction.

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

For more information and inquiries about this advisory, kindly contact the FDA CDRRHR through e-mail at [email protected] indicating on the subject the concerned Advisory, or call (02) 8857-1900 loc. 8301.

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-1507

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1507 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product “ACCUMAX NEBULIZING KIT”

FDA Advisory No. 2020-1506 || Public Health Warning Against the Purchase and Use of the Unnotified Medical Device Product “NITRILE DISPOSABLE GLOVES POWDER-FREE, NON-STERILE”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unnotified medical device product:

  1. “NITRILE DISPOSABLE GLOVES POWDER-FREE, NON-STERILE”

The FDA verified through post-marketing surveillance that the above mentioned medical device product is not notified and no corresponding Product Notification Certificate has 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 unnotified medical device product has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device product until the Product Notification Certificate is issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been notified with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Notification number on the product label in the form of either DVR-xxx or MDR-xxx or CMDN-xxx.

All Law Enforcement Agencies (LEAs) and Local Government Units (LGUs) are requested to ensure that this product is not sold or made available in the market or areas of jurisdiction.

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

For more information and inquiries about this advisory, kindly contact the FDA CDRRHR through e-mail at [email protected] indicating on the subject the concerned Advisory, or call (02) 8857-1900 loc. 8301.

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-1506

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1506 || Public Health Warning Against the Purchase and Use of the Unnotified Medical Device Product “NITRILE DISPOSABLE GLOVES POWDER-FREE, NON-STERILE”

FDA Advisory No. 2020-1505 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Products in Foreign Characters:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unnotified medical device products:

  1. 10 mL SYRINGE
  2. 10 mL SYRINGE
  3. 60 mL SYRINGE

The FDA verified through post-marketing surveillance that the above mentioned medical device products are not registered and no corresponding Product Notification Certificate has 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 medical device products have not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device products until the Product Registration Certificates are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label in the form of either DVR-xxx or MDR-xxx.

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

The Bureau of Customs is urged to restrain the entry of these unregistered products.

For more information and inquiries, kindly contact the FDA CDRRHR through e-mail at [email protected], indicating on the subject the concerned Advisory, or call (02) 8857-1900 loc. 8301.

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-1505

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1505 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Products in Foreign Characters:

FDA Advisory No. 2020-1478 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND CONSUME the following unregistered food products:

  1. JESTRERAS PORO CORN COFFEE POWDER
  2. (UNBRANDED) GINGER POWDER
  3. PREMIUM NAYEL’S HOME BLEND BAGOONG SAUTEED SHRIMP PASTE
  4. BENDURYA PURE ORGANIC CALAMANSI SUGARCANE
  5. KEM-KANG JAPANESE TOFU (KINO TOFU)

The FDA verified through online monitoring or post-marketing surveillance that the above mentioned food products are not registered and no corresponding Certificates of Product Registration (CPR) have 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 its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative food products until CPR are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDAwebsite accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label, if available or the name of the product.

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

The Bureau of Customs is urged to restrain the entry of these unregistered products.

For more information and inquiries about this advisory, kindly contact the FDA Center for Food Regulation Office and Research through email [email protected] indicating on the subject the concerned Advisory, or call (02)857-1900 local 8112.

To report any sale or distribution of unregistered food product/food supplement, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-1478

FDA Advisory No. 2020-1464 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND CONSUME the following unregistered food products:

  1. CHOCO BAR SNACKS THE ORIGINAL WITH REAL CHOCOLATE FLAVOR
  2. JRJ ENTERPRISES INSTANT LUY A SUPER PACK
  3. EARS REPACKING PURE SALABAT
  4. WOW GOODIES PRODUCTS SPECIAL BARQUIRON
  5. SAVERS CHOICE BUKO PANDAN POWDER

The FDA verified through online monitoring or post-marketing surveillance that the above mentioned food products are not registered and no corresponding Certificates of Product Registration (CPR) have 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 its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative food products until CPR are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDAwebsite accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label, if available or the name of the product.

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

The Bureau of Customs is urged to restrain the entry of these unregistered products.

For more information and inquiries about this advisory, kindly contact the FDA Center for Food Regulation Office and Research through email [email protected] indicating on the subject the concerned Advisory, or call (02)857-1900 local 8112.

To report any sale or distribution of unregistered food product/food supplement, email us at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1464

FDA Advisory No. 2020-1473 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product “BERTICAR ONE STEP HCG URINE TEST”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unregistered medical device product:

  1. “BERTICAR ONE STEP HCG URINE TEST”

The FDA verified through post-marketing surveillance that the above-mentioned medical device product is not registered and no corresponding product registration certificate has 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 product has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device product until the product registration certificate is issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label in the form of either DVR-xxxx or MDR-xxxx.

All Law Enforcement Agencies (LEAs) and Local Government Units (LGUs) are requested to ensure that this product is not sold or made available in the market or areas of jurisdiction.

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

For more information and inquiries about this advisory, kindly contact the FDA CDRRHR through e-mail at [email protected] indicating on the subject the concerned Advisory, or call (02) 8857-1900 loc. 8301.  

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-1473

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1473 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product “BERTICAR ONE STEP HCG URINE TEST”

FDA Advisory No. 2020-1466 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products and Food Supplement:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND CONSUME the following unregistered food products and food supplement:

  1. ASH KITCHEN WELLNESS PURE INSULIN Insulin Plant (Costus igneus) Herbal Supplement
  2. DIABETAHERBS Insulin Plant Powder 60 Capsules Dietary Supplement
  3. VITA HERBS Insulin Plant Coffee Mix
  4. INSULIN VITA Insulin Plant w/ Ampalaya & Banaba Dietary Supplement 500mg 30 Capsules
  5. [UNBRANDED] Insulin Plant Food Supplement 100 capsules | 500mg

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

Since these unregistered food products and food supplement have not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative food products until CPR are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label, if available or the name of the product.

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

The Bureau of Customs is urged to restrain the entry of these unregistered products.

For more information and inquiries about this advisory, kindly contact the FDA Center for Food Regulation and Research through email [email protected] indicating on the subject the concerned Advisory, or call (02)857-1900 local 8105 and 8112.

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-1466

/ In Food Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1466 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products and Food Supplement:

FDA Advisory No. 2020-1465 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products and Food Supplement:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND CONSUME the following unregistered food products and food supplement:

  1. ECOGEN Insulin Plus (Chamaecostus Cuspidatus) 100% Herbal Capsule 500 mg 100 Capsules
  2. [UNBRANDED] Insulin Plant (Costus igneus) Herbal Food Supplement 30 Capsules 500mg
  3. [UNBRANDED] Insulin Plant Tea Leaves Powder Custos Igneus (Raw/Pure/Air Dry) 45grams
  4. RLB Organics Insulin Powder 100g
  5. [UNBRANDED] Insulin Plant Herbal Capsule 90 Capsules x 500mg

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

Since these unregistered food products and food supplement have not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative food products until CPR are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label, if available or the name of the product.

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

The Bureau of Customs is urged to restrain the entry of these unregistered products.

For more information and inquiries about this advisory, kindly contact the FDA Center for Food Regulation and Research through email [email protected] indicating on the subject the concerned Advisory, or call (02)857-1900 local 8105 and 8112.

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-1465

/ In Food Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1465 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products and Food Supplement:

FDA Advisory No. 2020-1437 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product “LEELVIS NON CONTACT ELECTRONIC THERMOMETER”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unregistered medical device product:

  1. “LEELVIS NON CONTACT ELECTRONIC THERMOMETER”

The FDA verified through post-marketing surveillance that the above mentioned medical device product is not registered and no corresponding product registration certificate has 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 product has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device product until the product registration certificate is issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label in the form of either DVR-xxx or MDR-xxx.

All Law Enforcement Agencies (LEAs) and Local Government Units (LGUs) are requested to ensure that this product is not sold or made available in the market or areas of jurisdiction.

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

For more information and inquiries about this advisory, kindly contact the FDA CDRRHR through e-mail at [email protected] indicating on the subject the concerned Advisory, or call (02) 8857-1900 loc. 8301. 

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-1437

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1437 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product “LEELVIS NON CONTACT ELECTRONIC THERMOMETER”

FDA Advisory No. 2020-1435 || Public Health Warning Against the Unapproved and Misleading Health Claims for IonSpec/NanoSpec Medical Eyewear

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public against unapproved and misleading advertisements and promotion of IonSpec/ NanoSpec/ Medical Eyewear:

  1. Online advertisement for the the IonSpec/ NanoSpec Medical Eyewear with Misleading Health Claims

 https://shopee.ph/IonSpec-Medical-Eyewear-or-NanoSpec-i.12710919.2189671785

(Date last accessed: 27 July 2020)

2.  Online advertisement for the Mgi IonSpec M40 Eyeglass with Misleading Health Claims

https://www.lazada.com.ph/products/mgi-ionspec-m40-the-first-and-only-in-the-world-i439524323.html

(Date last accessed: 27 July 2020)

All concerned healthcare professionals and the general public is hereby advised to be vigilant against such deceptive marketing of medical devices. Eyeglasses should not bear any misleading, deceptive and false claims on their advertisements and/or any promotional materials that will provide erroneous impression on the product’s character or identity.

Marketing authorization holders of these medical devices are sternly warned and hereby directed to stop such misleading advertisements and promotions. Appropriate regulatory tools and sanctions shall be executed to such companies that are continuously conducting such and other similar activities upon issuance of this Advisory.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-1435

FDA Circular No. 2020-012-B || Further Amendment to FDA Circular (FC) Nos. 2020-012 and 2020-012-A entitled “Guidelines for the Registration of Drug, Products under Emergency Use (DEU) for the Coronavirus Disease 2019 (COVID-19)”

The FDA Circular (FC) Nos. 2020-012 and 2020-012-A were issued to provide DEU registration guidelines for selected drug products identified under the Philippine Society for Microbiology and Infectious Diseases (PSMID) Clinical Practice Guidelines (CPG) on COVID-19.

Due to the regular updates to the quarantine status of the different cities and municipalities and in the event that the imposed quarantine is lifted, the provisions of this Circular may still deemed be applicable and necessary by the public’s interest.

In view of the foregoing, the effectivity of FC Nos. 2020-012 and 2020-012-A shall be until 31 December 2020, subject for extension upon the review of this Office.

Read more:-> FDA Circular No.2020-012-B

/ In Circular / By Administrator / Comments Off on FDA Circular No. 2020-012-B || Further Amendment to FDA Circular (FC) Nos. 2020-012 and 2020-012-A entitled “Guidelines for the Registration of Drug, Products under Emergency Use (DEU) for the Coronavirus Disease 2019 (COVID-19)”

FDA Circular No. 2020-007-A || Amendment to FDA Circular (FC) No. 2020-007 entitled “Guidelines in the Implementation of the Use of Electronic Means of Prescription for Drugs for the Benefit of Individuals Vulnerable to COVID-19”

In ensuring the continuous access of prescription drugs to individuals vulnerable to COVID-19, the FDA Circular No. 2020-007 was issued to provide guidelines to consumers and health providers on the use of electronic prescription.

Due to the regular updates to the quarantine status of the different cities and municipalities and in the event that the imposed quarantine is lifted, the provisions of this Circular may still deemed be applicable and necessary by the public’s interest.

In view of the foregoing, the effectivity of FC No. 2020-007 shall be until 31 December 2020, subject for extension upon the review of this Office.

Attachment:-> FDA Circular No.2020-007-A

/ In Circular / By Administrator / Comments Off on FDA Circular No. 2020-007-A || Amendment to FDA Circular (FC) No. 2020-007 entitled “Guidelines in the Implementation of the Use of Electronic Means of Prescription for Drugs for the Benefit of Individuals Vulnerable to COVID-19”

FDA Circular No. 2020-025 || Implementing Guidelines for Administrative Order No. 2019-0019, “Reinstatement of Requirements of Licensing as Importers, Exporters, Manufacturers, Toll Manufacturers, Wholesalers, Distributors, Retailers, or Re-Packers of Those Engaged in Certain Household/Urban Hazardous Substances, and from the Requirement of Prior Registration and/or Notification of Said Products”

 OBJECTIVE:

This Circular aims to:

  1. Establish the guidelines for the licensing and inspection of HUHS establishments;
  2. Establish the guidelines for registration and other relevant authorizations for HUHS products;
  3. Update the categorization of HUHS products;
  4. Institutionalize the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) as the new hazard category for labeling of HUHS products; and
  5. Ensure compliance of HUHS establishments to FDA regulatory standards, such as but not limited to Good Manufacturing Practice (GSP); or Good Distribution Practice (GDP), or Good Storage Practice (GSP); or Good Labeling Practice (GLP).

Read more:->FDA Circular No.2020-025

/ In Circular / By Administrator / Comments Off on FDA Circular No. 2020-025 || Implementing Guidelines for Administrative Order No. 2019-0019, “Reinstatement of Requirements of Licensing as Importers, Exporters, Manufacturers, Toll Manufacturers, Wholesalers, Distributors, Retailers, or Re-Packers of Those Engaged in Certain Household/Urban Hazardous Substances, and from the Requirement of Prior Registration and/or Notification of Said Products”

FDA Advisory No. 2020-1484 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND CONSUME the following unregistered food products:

  1. EVINA NATURALS Mint Fresh Instant Herbal Tea
  2. EVINA NATURALS Coco Jam
  3. LURIE’S TURMERIC PRODUCTS TANGCALUY PLUS Instant Tea
  4. NITZ & PAZ Turmeric Brew
  5. APLASCA Native Coffee

The FDA verified through online monitoring or post-marketing surveillance that the abovementioned food products are not registered and no corresponding Certificates of Product Registration (CPR) have 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 its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative food products until CPR are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label, if available or the name of the product.

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

The Bureau of Customs is urged to restrain the entry of the unregistered imported products.

For more information and inquiries about this advisory, kindly contact the FDA Center for Food Regulation and Research through email [email protected] indicating on the subject the concerned Advisory, or call (02)857-1900 local 8105 and 8112.

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1484

FDA Advisory No. 2020-1483 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND CONSUME the following unregistered food products:

  1. BOBETTE’S DELICACIES Turmeric Herbal Tea
  2. KALAWAG GRANULES Kalawag and Turmeric Powder Food Supplement
  3. KYLEN’S Barquiron
  4. PINAY BORACAY Dried Mango Snack Bites
  5. TRUDS Instant Salabat with Turmeric

The FDA verified through online monitoring or post-marketing surveillance that the abovementioned food products are not registered and no corresponding Certificates of Product Registration (CPR) have 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 its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative food products until CPR are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label, if available or the name of the product.

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

The Bureau of Customs is urged to restrain the entry of the unregistered imported products.

For more information and inquiries about this advisory, kindly contact the FDA Center for Food Regulation and Research through email [email protected] indicating on the subject the concerned Advisory, or call (02)857-1900 local 8105 and 8112.

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

Dissemination of this advisory to all concerned is hereby requested

Attachment:-> FDA Advisory No.2020-1483

FDA Advisory No. 2020-1482 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND CONSUME the following unregistered food products:

  1. HEALTHYRICH Healthy-Me Squash Noodle
  2. TIEL’S FOOD PRODUCTS Instant Salabat
  3. MEMER FOOD DEALER Sampaloc Candy
  4. NARS FOOD PRODUCTS Turmeric Tea with Lemongrass
  5. ADE’S Native Products Buko Pie

The FDA verified through online monitoring or post-marketing surveillance that the abovementioned food products are not registered and no corresponding Certificates of Product Registration (CPR) have 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 its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative food products until CPR are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label, if available or the name of the product.

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

The Bureau of Customs is urged to restrain the entry of the unregistered imported products.

For more information and inquiries about this advisory, kindly contact the FDA Center for Food Regulation and Research through email [email protected] indicating on the subject the concerned Advisory, or call (02)857-1900 local 8105 and 8112.

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-1482

FDA Advisory No. 2020-1547 || REITERATION OF DOH ADMINISTRATIVE ORDER NO. 2012-0007 AS AMENDED

All establishments dispensing medicines are directed to implement Department of Health (DOH) Administrative Order (A.O.) No. 2012-0007, entitled “Guidelines on the Grant of 20% Discount to Senior Citizens on Health-Related Goods and for Other Purposes,” as amended by A.O. No. 2012-0007-A which included vitamins and minerals supplements in the coverage thereof.

As amended, A.O. No. 2012-0007, Part IV, Section 3, Paragraph 3.1 provides that:

The 20% discount and VAT exemption shall apply to the purchase of generic or branded medicines and drugs by or for senior citizens, including the purchase of influenza and pneumococcal vaccines. The 20% discount and VAT exemption shall also be granted to the purchase of vitamins and mineral supplements which are medically prescribed by an attending physician for prevention and treatment of diseases, illness, or injury. xxx

All establishments dispensing medicines, including vitamins and minerals supplements, are reminded to honor the benefits provided under A.O. No. 2012-0007, as amended. Strict monitoring shall be conducted. Appropriate action shall be taken in coordination with other government offices against those found violating R.A. No. 9994, or the Expanded Senior Citizens Act of 2010, and its Implementing Rules and Regulations (IRR).

Dissemination of this Advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-1547

Draft Guidelines on Facilitated Registration of Drugs Products, Vaccines and Biologicals: Abridged Review, Verification Review, and Collaborative Procedure

All comments can be sent at [email protected]. Deadline of submission of comments shall be by 28 August 2020.

  1. OBJECTIVES

The general objective of this Administrative Order is to provide facilitated registration procedure and review process of drug products, including vaccines and biologicals.

Specifically, this Administrative Order aims to:

  1. Provide registration procedures for market authorization holders (MAH) of drug products holding current approval from reference drug regulatory agencies and prequalification/ registration;
  2. Participate in the global or regional collaborative procedures for accelerated registration;
  3. Identify the reference drug regulatory agencies as the basis for an abridged and verification review registration procedure; and
  4. Establish strategic assessment and evaluation process of drug products that already passed stringent regulatory approvals from foreign drug regulatory agencies.
  1. SCOPE AND COVERAGE

This Order shall apply to all MAH of drug products holding current approval/s from reference drug regulatory agencies and/or registered under the collaborative registration procedures.

Read more:->Draft AO on Facilitated Registration Procedure v1.3.1

FDA Advisory No. 2020-1481 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND CONSUME the following unregistered food products:

  1. ISLAND JAM Pineapple Jam
  2. SOFTEE Chocomint Candy
  3. JUNG Durian Candy
  4. PUREBLENDS Mango Powder
  5. PUREBLENDS Strawberry Powder

The FDA verified through online monitoring or post-marketing surveillance that the abovementioned food products are not registered and no corresponding Certificates of Product Registration (CPR) have 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 its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative food products until CPR are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label, if available or the name of the product.

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

The Bureau of Customs is urged to restrain the entry of the unregistered imported products.

For more information and inquiries about this advisory, kindly contact the FDA Center for Food Regulation and Research through email [email protected] indicating on the subject the concerned Advisory, or call (02)857-1900 local 8105 and 8112.

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1481

FDA Advisory No. 2020-1480 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND CONSUME the following unregistered food products:

  1. REYLEN’S Pancit Canton Egg Noodles
  2. THE HERBAL SHOP Bignay Powder
  3. SUNBEAM California Sun-Made Raisins
  4. DRAGON BRAND Special O’Dong
  5. MISTER CHEF’S Sandwich Spread Original

The FDA verified through online monitoring or post-marketing surveillance that the abovementioned food products are not registered and no corresponding Certificates of Product Registration (CPR) have 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 its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative food products until CPR are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label, if available or the name of the product.

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

The Bureau of Customs is urged to restrain the entry of the unregistered imported products.

For more information and inquiries about this advisory, kindly contact the FDA Center for Food Regulation and Research through email [email protected] indicating on the subject the concerned Advisory, or call (02)857-1900 local 8105 and 8112.

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1480

FDA Advisory No. 2020-1546 || Regulation of Face Shield

The Food and Drug Administration (FDA) informs all concerned stakeholders and the general public that face shield is not regulated by the FDA. Thus, no FDA authorization or certification is required for the importation and distribution of face shield.

For more information and inquiries, kindly contact the FDA — Center for Device Regulation, Radiation Health, and Research through e-mail at [email protected].

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1546

FDA Circular No. 2020-027 || Conduct of Risk-Based Local Inspections in Light of the COVID-19 Pandemic

OBJECTIVES

This Circular aims to provide guidelines on the conduct of risk-based local inspections to carry out the FDA’s regulatory mission while protecting the health, safety, and well-being of the inspectors and the public.

Read more:->FDA Circular No. 2020-027

FDA Advisory No. 2020-1479 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplement and Food Products:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND CONSUME the following unregistered food supplement and food products:

  1. NEOCELL Super Collagen Hair, Skin, Nails, Joints, & Bones 6600 mg Collagen Type 1 & 3 Dietary Supplement
  2. DESA Spanish Style Sardines
  3. GOLD SEASON Corn Starch
  4. OMOR Pimientos
  5. W.L. LOTTO Coated Green Peas Beef Flavor

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

Since these unregistered food supplement and food products have not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative food products until CPR are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label, if available or the name of the product.

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

The Bureau of Customs is urged to restrain the entry of the unregistered imported products.

For more information and inquiries about this advisory, kindly contact the FDA Center for Food Regulation and Research through email [email protected] indicating on the subject the concerned Advisory, or call (02)857-1900 local 8105 and 8112.

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1479

/ In Food Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1479 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplement and Food Products:

FDA Advisory No. 2020-1472 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND CONSUME the following unregistered food products:

  1. Chia 8 in 1 Health Drink
  2. REGAL SASAS Prawn Crackers
  3. LORETA Boneless Bagoong
  4. ALLEGRO Biscone Durian
  5. COLUMBIA’S Cioco Luv-Lov Choco Balls Milk Chocolate Coated Vanilla Wafer Balls

The FDA verified through online monitoring or post-marketing surveillance that the abovementioned food products are not registered and no corresponding Certificates of Product Registration (CPR) have 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 its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative food products until CPR are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label, if available or the name of the product.

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

The Bureau of Customs is urged to restrain the entry of the unregistered imported products.

For more information and inquiries about this advisory, kindly contact the FDA Center for Food Regulation and Research through email [email protected] indicating on the subject the concerned Advisory, or call (02)8857-1900 local 8105 and 8112.

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1472

FDA Advisory No. 2020-1471 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND CONSUME the following unregistered food products:

  1. ROYAL FANTA-SEA Crunchy Fish Cracker
  2. SPICES ACD FLAVORINGS Ground Pepper Pamintang Pino
  3. SPICES ACD FLAVORINGS Curry Powder
  4. SPICES ACD FLAVORINGS Cracked Pepper Pamintang Durog
  5. SPICES ACD FLAVORINGS Atsuete

The FDA verified through online monitoring or post-marketing surveillance that the abovementioned food products are not registered and no corresponding Certificates of Product Registration (CPR) have 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 its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative food products until CPR are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label, if available or the name of the product.

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

The Bureau of Customs is urged to restrain the entry of the unregistered imported products.

For more information and inquiries about this advisory, kindly contact the FDA Center for Food Regulation and Research through email [email protected] indicating on the subject the concerned Advisory, or call (02)8857-1900 local 8105 and 8112.

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1471

FDA Circular No. 2020-026 || Food and Drug Action Center (FDAC) New Normal Operational Guidelines of the Food and Drug Administration (FDA)

1.     RATIONALE

Pursuant to DOH AO No. 2020-0015 known as “Guidelines on the Risk-Based Public Health Standards for COVID-19 Mitigation”, the FDA has been strictly implementing minimum health standards and health safety protocols to prevent the transmission of COVID-19 and other infectious diseases.

The alarming increase in the number of infections due to COVID-19 poses a threat to the health and safety of employees and clients of FDA.  With the recent developments and consultation with internal and external stakeholders, the following guidelines shall be enforced to safely continue serving our clients and to ensure the safety of everyone.

2.     OBJECTIVE

The objective for the issuance of this Order is to provide clear and consistent guidelines for the safety of FDA employees and clients in order to prevent infection and the spread of COVID-19 and other infectious diseases at the FDAC.

3.     SCOPE

This Order shall cover all FDA clients from the industries transacting business at the FDAC and FDA employees or staff providing regulatory services at the FDA.

Read more:-> FDA Circular No. 2020-026
Attachment:-> Annex C – Notification Form for Minor Variation/s of Registered Pharmaceutical Product

/ In Circular / By Administrator / Comments Off on FDA Circular No. 2020-026 || Food and Drug Action Center (FDAC) New Normal Operational Guidelines of the Food and Drug Administration (FDA)

FDA Advisory No. 2020-1470 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products and Food Supplement:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND CONSUME the following unregistered food products and food supplement:

  1. ARCE CHEF JAKE’S Adobo Pork Chunks
  2. PVL Green Banana Chips Slightly Salted
  3. JAM’S REPACKING Barbeque Chichacorn
  4. L. YAAHOO Peanut Butter Sandwich
  5. PLUS Herbal Capsule

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

Since these unregistered food products and food supplement have not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative food products until CPR are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label, if available or the name of the product.

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

The Bureau of Customs is urged to restrain the entry of the unregistered imported products.

For more information and inquiries about this advisory, kindly contact the FDA Center for Food Regulation and Research through email [email protected] indicating on the subject the concerned Advisory, or call (02)8857-1900 local 8105 and 8112.

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1470

/ In Food Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-1470 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products and Food Supplement: