Author: Administrator

DOH FOI Manual (As of December 2020)

Purpose: The purpose of this FOI Manual (Manual) is to provide the process to guide and assist the Department of Health Bureaus, Regional Offices and Services, and selected DOH attached agencies (DOH), in dealing with requests of information received under Executive Order (E.O.) No. 2 on Freedom of Information (FOI).

Read more:>DOH FOI Manual (As of December 2020)

RE-LAUNCHING OF FDA VERIFICATION PORTAL

In the interest of public service, the FDA will resume access to the FDA VERIFICATION PORTAL starting on 18 January 2021 at the FDA website.

The following information can be accessed in the verification portal and will be updated weekly.

DETAILS CENTER/S CONCERNED
License to Operate CCHUHSRR, CDRR, CDRRHR, CFRR
Certificate of Product Registration

Certificate of Product Notification

Special Certification

CCHUHSRR, CDRRHR, CFRR
Batch Notification

Lot Release Certificate

CSL

        The list of registered drug products will be posted soon.

For questions and clarifications on the list of approved LTOs, CPRs / Notification, and Certifications you may send an e-mail to ppsmed@fda.gov.ph with subject: Verification Portal_<Name of Center>. 

For your information and guidance.

Attachment: RE-LAUNCHING OF FDA VERIFICATION PORTAL

FDA Philippines Grants Emergency Use Authorization to Pfizer-BioNTech COVID-19 Vaccine

Today, the Food and Drug Administration (FDA) grants its first Emergency Use Authorization (EUA) to Pfizer-BioNTech COVID19 Vaccine (BNT162b2) Suspension for IM Injection (Puurs, Belgium Site).

Through Executive Order No. 121 s. 2020, vaccines under development can be granted an EUA where there is no adequate, approved and available alternative to a vaccine for preventing COVID-19 during this present public health emergency. The granting of the EUA is not a marketing authorization or a Certificate of Product Registration, hence this cannot be used to market the vaccine commercially.

Evaluation was based on current available data. The assessment ensured that the benefits outweigh the known and potential risks of the product. The safety and efficacy were reviewed by a panel of clinical experts and the quality data was reviewed by technical experts from FDA Center for Drugs Regulation and Research (CDRR). “After a thorough review of the currently available data by medical and regulatory experts, the FDA is granting Emergency Use Authorization to Pfizer-BioNTech COVID-19 vaccine. The interim data from the ongoing phase 3 trial shows that the vaccine has an efficacy of 95% in the study population and at least 92% among all racial groups”, Director General Eric Domingo said.

Adverse events following immunization shall be closely monitored. DG Domingo also said that, “The roll out of the vaccine and use in more than 5 million people worldwide has identified severe allergic reaction in a few individuals. Therefore, the vaccinations must be done by health professionals trained to recognize and manage adverse reactions and they should have resources at hand to adequately respond”. Reporting of the patient’s response to the vaccine shall be through the pharmacovigilance system that will be activated once the vaccination program is implemented.

The FDA commits to continue its job to ensure that Filipinos can have access to vaccines that hold greater benefits and outweighs the risk and possible adverse effects during this time of pandemic. “The development of these vaccines is still ongoing. We will keep track of the progress and FDA will provide our public with the correct information on the authorized products for transparency, to aid the decision making of Filipinos,” DG Domingo concluded.

Attachment: FDA Press Statement EUA Pfizer-January 14 2021

#MedSafetyWeek 2020 Day 5

Ngayong panahon ng pandemya, maging alerto sa mga posibleng side effect mula sa mga gamot at i-report ito sa FDA (https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH).

Makipagtulugan tungo sa mas ligtas na gamot para sa lahat.

#MedSafetyWeek#EveryReportCounts #bePHARMAcoVIGILANTes #PhFDA

#MedSafetyWeek 2020 Day 4

Ang gamot ay maaring mag-interact sa iba pang gamot, pagkain, at ibang mga produkto. Ugaliing basahin ang patient leaflet ng gamot at mag-report sa FDA kung ikaw ay may naranasang side effect (https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH).

Makipagtulugan tungo sa mas ligtas na gamot para sa lahat.

#MedSafetyWeek#EveryReportCounts #bePHARMAcoVIGILANTes #PhFDA

#MedSafetyWeek 2020 Day 3

Siguraduhing tanungin ang inyong mga pasyente sa anumang side effect na maaring naranasan nila mula pag-inom ng gamot.

I-report ang mga side effect sa FDA (https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH).

Sa paggawa nito, ikaw ay nakatutulong tungo sa mas ligtas na gamot para sa lahat.

#MedSafetyWeek#EveryReportCounts #bePHARMAcoVIGILANTes #PhFDA

#MedSafetyWeek 2020 Day 2

Ang bawat report ay mahalaga. Kung sa iyong palagay ikaw ay nakararanas ng panibagong side effect mula sa inyong mga gamot, i-report ito sa FDA (https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH).

Makipagtulugan tungo sa mas ligtas na gamot para sa lahat.

#MedSafetyWeek#EveryReportCounts #bePHARMAcoVIGILANTes #PhFDA

NATIONAL SINGLE WINDOW STAKEHOLDER WEBINAR by Bureau of Customs (BOC)

The Bureau of Customs (BOC) is inviting you to join the NATIONAL SINGLE WINDOW STAKEHOLDER WEBINAR on 5 November 2020 at 1:00pm via Microsoft Teams. For more details, you may contact Ms. Joanne D. Agudo of the Public Information and Assistance Division (PIAD), at telephone numbers 0997 4555 700, (02) 527 1968 or e-mail address events@customs.gov.ph or joanne.agudo@cutoms.gov.ph.
 
Thank you.

System Maintenance Advisory for FDA e-Services Portal System and Bayanihan One Stop Shop (BOSS)

Due to the unscheduled system maintenance of  the Department of Information and Communications Technology (DICT), the FDA eServices Portal System and FDA Bayanihan One Stop Shop (BOSS) Portal System are unavailable from this day, 25 October 2020 until further notice.

Rest assured that the FDA-ICTMD is giving its full measure to coordinate with DICT to restore the said services.

We sincerely apologize for any inconvenience this may cause.

Attachment:-> System Maintenance – 25 October 2020

Temporary Suspension of the FDA Verification Portal

In the interest of public service to provide accurate and timely information, the Food and Drug Administration (FDA) is temporarily suspending access to the FDA Verification Portal.

Access to FDA Verification Portal shall resume once the system has been updated.

The existing Search feature in the FDA website may be used to check the list of licensed and registered products.

Please send an email to ppsmed@fda.gov.ph for any further questions.

Attachment:-> Temporary Suspension of the FDA Verification Portal

FDA Advisory No. 2020-894-A || Lifting the Advisory on the Notified Cosmetic Product “DASOM ANTI-WRINKLE EYE CREAM” under FDA Advisory No. 2020-894 “Public Health Warning Against the Purchase and Use of Unnotified Cosmetic DASOM ANTI-WRINKLE EYE CREAM” Dated 14 May 2020

The Food and Drug Administration (FDA) informs the public that the Cosmetic product DASOM ANTI-WRINKLE EYE CREAM with Notification No. 1000006605185 has been notified by the Market Authorization Holder, Sedeung Trading Co., Ltd., Philippine Branch, in accordance with existing FDA rules and regulations.

Accordingly, the warning against the purchase and use of the subject product as mentioned in FDA Advisory No. 2020-894 and FDA Order No. 2020-590 is hereby lifted.

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 health product before purchasing. For more information or inquiries, please email us at ccrr_prsdd@fda.gov.ph, you may also call the Center for Cosmetics Regulation and Research at telephone number (02) 8857-1900 loc. 8113 or 8107.

 To report the sale or distribution of any unnotified/unregistered health products, kindly email FDA via ereport@fda.gov.ph.

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.2020-894-A

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-894-A || Lifting the Advisory on the Notified Cosmetic Product “DASOM ANTI-WRINKLE EYE CREAM” under FDA Advisory No. 2020-894 “Public Health Warning Against the Purchase and Use of Unnotified Cosmetic DASOM ANTI-WRINKLE EYE CREAM” Dated 14 May 2020

FDA Circular No. 2020-015-A || Amendment to FDA Circular No. 2020-015 entitled “Interim Measures to Ensure Access to Vitamin Drug Products during the Coronavirus Disease 2019 (COVID-19) Pandemic”

On 21 April 2020, FDA Circular No. 2020-015 entitled “Interim Measures to Ensure Access to Vitamin Drug Products during the Coronavirus Disease 2019 (COVID-19) Pandemic” was issued. The said Circular provided interim guidelines for the registration and certification of vitamin products in response to the shortage of supplies in the market brought upon by the limited production and supplies due to the enhanced community quarantine (ECQ).

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

In view of the foregoing, the provisions of FDA Circular No. 2020-015 shall be effective until 31 December 2020, subject for extension upon the review of this Office.

Attachment:-> FDA Circular No.2020-015-A

/ In Circular / By Administrator / Comments Off on FDA Circular No. 2020-015-A || Amendment to FDA Circular No. 2020-015 entitled “Interim Measures to Ensure Access to Vitamin Drug Products during the Coronavirus Disease 2019 (COVID-19) Pandemic”

FDA Advisory No. 2020-1540 || 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. URBANGREENS MARKET Organic Cacao Powder, Raw and Fermented 100% Pure and Natural, 150g
  2. URBANGREENS MARKET Organic Cacao Nibs, Coated with Coconut Sugar and 100% Pure and Natural, 150g
  3. URBANGREENS MARKET Bentonite Clay, 100% Pure and Natural Ultrafine and Food-grade, 150grams
  4. URBANGREENS MARKET Organic Cacao Nibs, Raw and Fermented 100% Pure and Natural, 150g
  5. URBANGREENS MARKET Organic Black Quinoa, Super Grain Gluten Free and Non-GMO, 250g

The FDA verified through 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 cfrr@fda.gov.ph 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 ereport@fda.gov.ph.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1540

FDA Advisory No. 2020-1539 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplements:

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

  1. SWANSON PREMIUM BRAND Full Spectrum Avena Sativa (Green Oat Grass) Herbal Supplement, 60 Capsules,400mg
  2. SWANSON Valerian Root, Sleep Support,475mg per capsule, Herbal Supplement,100 Capsule
  3. SWANSON PREMIUM BRAND Alcohol & Sugar-Free Oil of Oregano Herbal Supplement, 1 fl oz (29.6ml)
  4. SWANSON Full Spectrum Korean Red Ginseng Root, Brain and Nervous System Health,400mg, Herbal Supplement, 90 Capsules
  5. SWANSON Brain Essentials, Memory Support,12 Brain Boosting Nutrients, Dietary Supplement, 60 Veggie Capsule

The FDA verified through post marketing surveillance that the abovementioned food supplements 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 supplements 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 supplements 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 cfrr@fda.gov.ph indicating on the subject the concerned Advisory, or call 8857-1900 local 8105 and 8112.

To report any sale or distribution of unregistered product, email us at ereport@fda.gov.ph.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1539

FDA Advisory No. 2020-1538 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplements:

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

  1. SOLARAY DIETARY SUPPLEMENT L-LYSINE MONOLAURIN 1:1 RATIO IMMUNE SUPPORT FORMULA, 60 VEGETARIAN CAPSULES
  2. SOLARAY DIETARY SUPPLEMENT ORGANICALLY GROWN FENUGREEK TRIGONELLA FOENUM-GRAECUM 620MG PER CAPSULE WHOLE SEED
  3. SOLARAY DIETARY SUPPLEMENT SUPER DIGESTAWAY DIGESTIVE ENZYME BLEND – HELPS BREAK DOWN FATS, CARBS & PROTEIN
  4. SOLARAY DIETARY SUPPLEMENT PROSTATE BLEND SP-16 SAW PALMETTO PUMPKIN SEED WITH HOMEOPATHIC NUTRIENTS
  5. SOLARAY DIETARY SUPPLEMENT MULLEIN VERBASCUM THAPSUS 330MG PER CAPSULE WHOLE LEAF

The FDA verified through post-marketing surveillance that the abovementioned food supplements 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 supplements 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 imported products.

For more information and inquiries about this advisory, kindly contact the FDA Center for Food Regulation Office and Research through email cfrr@fda.gov.ph 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 ereport@fda.gov.ph

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1538

FDA Advisory No. 2020-1529 || 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. SWAN Special Bagoong Dilis, 400g
  2. HONEY HOUSE Honey Bee Farm, Pure Honey, 100ml”
  3. SAN NICOLAS Mr, Cheffy’s All Purpose Mayo Dressing
  4. TURMERIC Herbal Food Supplement
  5. WOBENZYM N Joint Health, Dietary Supplement, 200 Enteric-coated Tablets

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 these unregistered imported products.

For more information and inquiries about this advisory, kindly contact the FDA Center for Food Regulation and Research through email cfrr@fda.gov.ph 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 ereport@fda.gov.ph.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-1529

FDA Advisory No. 2020-1528 || 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. GREAT VALUE Distilled Drinking Water,350ml
  2. LEENOL’S PASTRIES Pastillas
  3. SWEET VALLEY Mango Puree, 2.1 L
  4. TROPI SNACK Mango 75g
  5. SWEET VALLEY Pop Beans

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 these unregistered imported products.

For more information and inquiries about this advisory, kindly contact the FDA Center for Food Regulation and Research through email cfrr@fda.gov.ph 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 ereport@fda.gov.ph.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1528

FDA Advisory No. 2020-1527 || 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. SWEET VALLEY Butong Pakwan, Salted
  2. MATUTUM SWEET Piña-Anghang Vinegar, 500ml
  3. SWEET VALLEY Golden Raisin Milk Chocolate, 66g, 12pcs
  4. SUPREME CITRIMAX 10-in1 Slimming Herbal Drink Mix

The FDA verified through 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 these unregistered imported products.

For more information and inquiries about this advisory, kindly contact the FDA Center for Food Regulation and Research through email cfrr@fda.gov.ph indicating on the subject the concerned Advisory, or call 8857-1900 local 8105 and 8112.

To report any sale or distribution of unregistered product, email us at ereport@fda.gov.ph.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1527

FDA Advisory No. 2020-1526 || 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. FOODGOD Happy Nipple, 30pcs
  2. CHAM GHOST SMOKE, Magic Smoke,Magic Magic Powder, Apple,4.5g
  3. HAPPY STAR Colored Candy
  4. CHAM Flyleaf Toy Candy,24pcs
  5. CHAM Yummy Belt Rainbow Sub, Grape Flavour, 30pcs

The FDA verified through 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 these unregistered products.

For more information and inquiries about this advisory, kindly contact the FDA Center for Food Regulation and Research through email cfrr@fda.gov.ph 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 ereport@fda.gov.ph.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1526

FDA Advisory No. 2020-1525 || 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. SWEETTY Flashlight Candy
  2. CHAM SNOWMAN Menthol Ball Candy
  3. SNS Delicious Oatmeal Chocolate
  4. CHAM JUICY Strawberry Flavour, Powder Drink, Vitamin Rich
  5. CHAM JUICY Mango Flavour, Powder Drink, Vitamin Rich

The FDA verified through 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 these unregistered products.

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

To report any sale or distribution of unregistered food product/food supplement, email us at ereport@fda.gov.aph.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1525

FDA Advisory No. 2020-1524 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplements:

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

  1. SOLARAY DIETARY SUPPLEMENT FEMALE HORMONE BLEND SP-7C BLACK COHOSH DONG QUAI WITH ROMEOPATHIC NUTRIENTS
  2. SOLARAY DIETARY SUPPLEMENT PANTOTHENIC ACID 500MG WITH ALOE VERA
  3. SOLARAY DIETARY SUPPLEMENT VITEX (VITEX ANGUS-CASTUS) 400MG PER CAPSULE WHOLE BERRY
  4. SOLARAY DIETARY SUPPLEMENT TOTAL CLEANSE URIC ACID VEGETARIAN CAPSULE
  5. SOLARAY DIETARY SUPPLEMENT MAGNESIUM GLYCINATE 400MG VEGETARIAN CAPSULE

The FDA verified through online monitoring or post-marketing surveillance that the abovementioned food supplements 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 supplements 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 imported products.

For more information and inquiries about this advisory, kindly contact the FDA Center for Food Regulation Office and Research through email cfrr@fda.gov.ph 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 ereport@fda.gov.ph.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1524

FDA Advisory No. 2020-1523 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplements:

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

  1. SOLARAY DIETARY SUPPLEMENT VITAMIN K-2 MENAQUINONE-7 50MCG VEGCAPS
  2. SOLARAY DIETARY SUPPLEMENT OREGANO OIL 70% CARVACROL SOFTGELS
  3. SOLARAY DIETARY SUPPLEMENT REISHI MUSHROOM GANODERMA LUCIDUM 600MG EASY TO SWALLOW CAPSULE
  4. SOLARAY DIETARY SUPPLEMENT NATURAL COCONUT SOURCE MONOLAURIN 500MG VEGETARIAN CAPSULE
  5. SOLARAY DIETARY SUPPLEMENT TART CHERRY CELERY SEED 620MG VEGCAPS

The FDA verified through online monitoring or post-marketing surveillance that the abovementioned food supplements 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 supplements 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 imported products.

For more information and inquiries about this advisory, kindly contact the FDA Center for Food Regulation Office and Research through email cfrr@fda.gov.ph 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 ereport@fda.gov.ph.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1523

FDA Advisory No. 2020-1522 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplements:

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

  1. SOLARAY DIETARY SUPPLEMENT OIL OF OREGANO EXTRA VIRGIN OLIVE OIL BASE 150MG VEGAN SOFTGELS
  2. SOLARAY DIETARY SUPPLEMENT PQQ COQ-10 WITH NAC & GLUTATHIONE VEGCAPS
  3. SOLARAY DIETARY SUPPLEMENT BEET 605MG VEGCAPS
  4. SOLARAY DIETARY SUPPLEMENT GUARANTEED POTENCY DIM SUPREME 100MG DIINDOLYMETHANE 100MG BROCCOLI SEED EXT 10% SULFORAPHANE
  5. SOLARAY DIETARY SUPPLEMENT LIVER BLEND SP-13 MILK THISTLE + DANDELION WITH HOMEPATHIC NUTRIENTS

The FDA verified through online monitoring or post-marketing surveillance that the abovementioned food supplements 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 supplements 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 imported products.

For more information and inquiries about this advisory, kindly contact the FDA Center for Food Regulation Office and Research through email cfrr@fda.gov.ph 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 ereport@fda.gov.ph.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-1522

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 ereport@fda.gov.ph, 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 cdrrhr@fda.gov.ph 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 ereport@fda.gov.ph.

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 cdrrhr@fda.gov.ph 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 ereport@fda.gov.ph.

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 cdrrhr@fda.gov.ph 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 ereport@fda.gov.ph.

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 cdrrhr@fda.gov.ph, 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 ereport@fda.gov.ph.

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: