Month: May 2019

SUBMISSION OF COURSE REGISTRATION DOCUMENTS FOR APPLICANTS OF FDA ACADEMY TRAINING SEMINARS

All registrants of FDA Academy Seminars who have not yet received their Course Assessment Slips are advised to resend their course registration documents to [email protected] using the specific course code indicated in FDA Circular No. 2019-001 “Training Courses/Seminars and Schedule of Fees for the Trainings Offered by the Food and Drug Administration (FDA) Academy – Policy and planning Service (PPS) for Calendar Year 2019”. This is to ensure that the correct course schedule and location (region) will be assigned to the concerned registrants.

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

For your information and guidance.

SUBMISSION OF COURSE REGISTRATION

FDA Advisory No. 2019-136 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “Yongrow Medical Infrared Forehead baby Thermometer” advertised for sale in Shopee website

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

  1. Yongrow Medical Infrared Forehead baby Thermometer

FDA post-marketing surveillance (PMS) activities have verified that the abovementioned medical device has not gone through the registration process of the agency and has not been issued with proper authorization in the form of Certificate of Product Registration (CPR). Pursuant to Republic Act 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization from FDA is prohibited.

Accordingly, since this unregistered medical device has not gone through evaluation and testing process of the FDA, the agency cannot guarantee its quality and safety. The consumption of such violative product may pose potential health hazards to the consuming public.

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

All concerned establishments and/or entities are warned not to distribute the above-identified violative medical devices product until he has already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.

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

For more information and inquiries, please e-mail us at [email protected] To report continuous sale or distribution of the above unregistered medical device, utilize our online reporting facility, eReport, at www.fda.gov.ph/ereport, or e-mail us via [email protected], or call us at the Center for Device Regulation, Radiation Health and Research (CDRRHR) hotline (02) 857-1900 local 8301.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2019-136

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-136 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “Yongrow Medical Infrared Forehead baby Thermometer” advertised for sale in Shopee website

FDA Advisory No. 2019-137 || Public Health Warning Against the Purchase and Use of Surgitech Hypo-Allergenic Surgical Gloves (Powder Free)

The Food and Drug Administration (FDA) advises all concerned healthcare professionals and the public against the purchase and use of Surgitech Hypo-Allergenic Surgical Gloves (Powder Free)

FDA post-marketing surveillance activities have verified that Surgitech Hypo-Allergenic Surgical Gloves (Powder Free) has not gone through the registration process of the agency and has not been issued with Certificate of Product Registration (CPR).

Pursuant to the provisions of Republic Act 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization are prohibited.

Since the abovementioned product did not undergo the evaluation process of the FDA, the agency cannot guarantee its quality and safety.

In this regard, the public is hereby advised not to purchase the above-mentioned violative product. All concerned establishments are warned not to advertise, sell or distribute the said product until such has been issued with the corresponding Certificate of Product Registration, otherwise, regulatory actions and sanctions shall be strictly pursued.

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

For more information and inquiries, please email us at [email protected]. To report continuous sale or distribution of the above medical device, utilize our online reporting facility, eReport, at www.fda.gov.ph/ereport, or email us via [email protected], or call the Center for Device Regulation, Radiation Health, and Research at (02) 857-1900 local 8301.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2019-137

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-137 || Public Health Warning Against the Purchase and Use of Surgitech Hypo-Allergenic Surgical Gloves (Powder Free)

FDA Advisory No. 2019-135 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “First + Aid Plastic Bandage Transparent 72 x 19mm Sterile Breathable Waterproof”

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

  1. First + Aid Plastic Bandage Transparent 72 x 19mm Sterile Breathable Waterproof

FDA post-marketing surveillance (PMS) activities have verified that the abovementioned medical device has not gone through the registration process of the agency and has not been issued with proper authorization in the form of Certificate of Product Registration (CPR). Pursuant to Republic Act 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization from FDA is prohibited.

Accordingly, since this unregistered medical device has not gone through evaluation and testing process of the FDA, the agency cannot guarantee its quality and safety. The consumption of such violative product may pose potential health hazards to the consuming public.

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

All concerned establishments and/or entities are warned not to distribute the above-identified violative medical devices product until he has already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.

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

For more information and inquiries, please e-mail us at [email protected] To report continuous sale or distribution of the above unregistered medical device, utilize our online reporting facility, eReport, at www.fda.gov.ph/ereport, or e-mail us via [email protected], or call us at the Center for Device Regulation, Radiation Health and Research (CDRRHR) hotline (02) 857-1900 local 8301.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2019-135

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-135 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “First + Aid Plastic Bandage Transparent 72 x 19mm Sterile Breathable Waterproof”

FDA Advisory No. 2019-134 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “Pharmaline Monitor Infrared Thermometer” advertised for sale in Shopee website

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

  1. Pharmaline Monitor Infrared Thermometer

FDA post-marketing surveillance (PMS) activities have verified that the abovementioned medical device has not gone through the registration process of the agency and has not been issued with proper authorization in the form of Certificate of Product Registration (CPR). Pursuant to Republic Act 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization from FDA is prohibited.

Accordingly, since this unregistered medical device has not gone through evaluation and testing process of the FDA, the agency cannot guarantee its quality and safety. The consumption of such violative product may pose potential health hazards to the consuming public.

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

All concerned establishments and/or entities are warned not to distribute the above-identified violative medical devices product until he has already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.

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

For more information and inquiries, please e-mail us at [email protected] To report continuous sale or distribution of the above unregistered medical device, utilize our online reporting facility, eReport, at www.fda.gov.ph/ereport, or e-mail us via [email protected], or call us at the Center for Device Regulation, Radiation Health and Research (CDRRHR) hotline (02) 857-1900 local 8301.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2019-134

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-134 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “Pharmaline Monitor Infrared Thermometer” advertised for sale in Shopee website

FDA Advisory No. 2019-133 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device — Climaxxx™ Stimulating Gel and Lubricant

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

FDA post-marketing surveillance (PMS) activities have verified that the abovementioned medical device product has not gone through the registration process of the agency and has not been issued with proper authorization in the form of Certificate of Product Registration. Pursuant to Republic Act No. 9711 , otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization from FDA is prohibited.

Accordingly, since this unregistered medical device has not gone through evaluation and testing process of the FDA, the agency cannot guarantee its quality and safety.

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

All concerned establishments and/or entities are warned not to distribute the above-identified violative medical device product until it has already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.

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

For more information and inquiries, please email us at [email protected] To report continuous sale or distribution of the above unregistered medical device, utilize our online reporting facility, eReport, at www.fda.gov.ph/ereport, or e-mail us via [email protected], or call us at the Center for Device Regulation, Radiation Health and Research (CDRRHR) hotline (02) 857-1900 loc. 8301.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2019-133

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-133 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device — Climaxxx™ Stimulating Gel and Lubricant

FDA Advisory No. 2019-132 || Public Health Warning Against the Purchase and Use of Unregistered Health Related Devices Advertised for sale in Lazada.com.ph:

The Food and Drug Administration (FDA) advises the general public against the purchase and use of the following unregistered health related device products.

  1. High Quality 3 in 1 Alkaline Water Purifier Complete Set
  2. Central Nanyang 5-Stage Reverse Osmosis Water Filtration System Ultra Safe with Tank and Pump
  3. Global 3 in 1 Water Purifier
  4. Netwire Direct Alkaline Water Purifier with Ultraviolet Lamp
  5. Semter Sink Alkaline Water Purifier
  6. Premium 5 Stage Under Sink Water Filter System Drinking Home RO Membrane Purifier

FDA post-marketing surveillance (PMS) activities have verified that the abovementioned health related device products have not gone through the registration process of the agency and have not been issued with the proper authorization in the form of Certificate of Health Related Device Registration (CHRDR). Pursuant to Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization from FDA is prohibited.

Accordingly, since this unregistered health related device products have not gone through evaluation and testing process of the FDA, the agency cannot guarantee its quality and safety. The consumption of such violative product may pose potential health hazards to the consuming public. Health related device products especially water purification device/ system shall not bear any false, deceptive and misleading claims and promotional ploys on alkaline water, oxygenated water or ionized water (Please see FDA Advisory Nos. 2014-010-A, 2014-010 and 2011-013).

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

All concerned establishments are warned not to distribute the above-identified violative health related device product until it has already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.

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

For more information and inquiries, please e-mail us at [email protected] To report continuous sale or distribution of the above unregistered health related device product, utilize our online reporting facility, eReport, at www.fda.gov.ph/ereport, or email us via [email protected], or call us at the Center for Device Regulation, Radiation Health, and Research (CDRRHR) hotline (02) 857-1900 local 8301.

Dissemination of the information to all concerned is requested.

Attachment: FDA Advisory No. 2019-132

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-132 || Public Health Warning Against the Purchase and Use of Unregistered Health Related Devices Advertised for sale in Lazada.com.ph:

RESCHEDULING OF FDA SEMINARS IN OBSERVANCE OF EID’L FITR HOLIDAY ON 5 JUNE 2019

Please be informed of the following changes of the FDA Academy seminars in observance of Eid’l Fitr holiday on 5 June 2019:

ACTIVITY TITLE FROM

(ORIGINAL SCHEDULE)

TO

(NEW SCHEDULE)

Unified Licensing Seminar for Region XI (Davao City) 04 June 2019 16 August 2019
Unified Licensing Seminar for Region XI (Digos City) 05 June 2019 14 August 2019
Unified Licensing Seminar for Region XIII (Surigao City) 06 and 07 June 2019 07 June 2019 only
Center for Drug Regulation and Research QPIRA Seminar  (NCR) 06 to 07 June 2019 13 to 14 June 2019

Our sincere apologies for any inconvenience this change in seminar schedule have cause.

For inquiries and other concerns, please call the FDA Academy at telephone number (02) 877-0259 or email at [email protected].

Please be guided accordingly.

ANNOUNCEMENT (RESCHEDULE OF JUNE SEMINARS)

FDA Advisory No. 2019-131-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng mga Hindi Rehistradong Gamot na PapiSTOP Natural Renewal Cream 30mL (na may therapeutic claims)

Pinapayuhan ng Food and Drug Administration (FDA) ang publiko laban sa pagbili at paggamit ng mga rehistradong gamot na:

  1. PapiSTOP Natural Renewal Cream 30mL (with therapeutic claims)

to continue reading, click the link below…

FDA Advisory No. 2019-131-A

/ In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-131-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng mga Hindi Rehistradong Gamot na PapiSTOP Natural Renewal Cream 30mL (na may therapeutic claims)

FDA Advisory No. 2019-131 || Public Health Warning Against the Purchase and Use of the Unregistered Drug Product PapiSTOP Natural Renewal Cream 30mL (with therapeutic claims)

The Food and Drug Administration (FDA) advises the public against the purchase and use of the following unregistered drug product:

  1. PapiSTOP Natural Renewal Cream 30mL (with therapeutic claims)

to continue reading, click the link below…

FDA Advisory No. 2019-131

/ In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-131 || Public Health Warning Against the Purchase and Use of the Unregistered Drug Product PapiSTOP Natural Renewal Cream 30mL (with therapeutic claims)

FDA Advisory No. 2019-130-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng mga Hindi Rehistradong Gamot na:

Pinapayuhan ng Food and Drug Administration (FDA) ang publiko laban sa pagbili at paggamit ng mga rehistradong gamot na:

1. YIGANERJING Chinese Medicine Cream
2. Ketoconazole + Clobetasol Propionate Cream SF PKW Cream (Antifungal/Antipruritic/Anti-Inflammatory)
3. Triamcinolone Acetonide Acetate + Miconazole Nitrate + Neomycin Sulfate Cream SF PKS Cream (Antifungal/Antibacterial/Anti-Inflammatory)
4. Flucinonide Acetate and Borneol Cream

to continue reading, click the link below…

FDA Advisory No. 2019-130-A

FDA Advisory No. 2019-130 || Public Health Warning Against the Purchase and Use of the following Unregistered Drug Products

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

  1. YIGANERJING Chinese Medicine Cream
  2. Ketoconazole + Clobetasol Propionate Cream SF PKW Cream (Antifungal/Antipruritic/Anti-Inflammatory)
  3. Triamcinolone Acetonide Acetate + Miconazole Nitrate + Neomycin Sulfate Cream SF PKS Cream (Antifungal/Antibacterial/Anti-Inflammatory)
  4. Flucinonide Acetate and Borneol Cream

to continue reading, click the link below…

FDA Advisory No. 2019-130

FDA Advisory No. 2019-129 || FDA Email Directory

To ensure ease of transaction and the desire to provide a more efficient customer service, the Food and Drug Administration (FDA) hereby advises the public to send specific concerns, queries, transactions and/or documents to the following email addresses:

 Type of transaction / Document / Concern   Office/s Concerned
Compliance Document, Follow-ups, Verification of Registration of Products and License of Establishments  concerning Center for Food Regulation and Research [email protected]
Compliance Document, Follow-ups, Verification of Registration of Products and License of Establishments concerning Center Drug Regulation and Research including veterinary medicine, vaccine, and biologicals [email protected]
Compliance Document, Follow-ups, Verification of Registration Of Products and License of Establishments concerning Center for Cosmetics Regulation and Research
including household hazard/urban substances
[email protected]
Compliance Document, Follow-ups, Verification of Registration of products and License of Establishments concerning Center for Device Regulation, Radiation Health and Research [email protected]
Qualified Persons in Industry Regulatory Affairs (QPIRA) Training, Licensing Seminar and other Seminars as spearheaded by FDA [email protected]
Legal related concerns/queries/follow-ups [email protected]
Request for meetings, courtesy calls and other related matter [email protected]
E-Portal Account Concerns (i.e. Requests, Change of Username, password and among others), Processes (i.e. How to Apply for FDA Certificates) [email protected]

All other concerns not cited this advisory are hereby requested to be sent to [email protected]

For your information and guidance.
FDA Advisory No. 2019-129

FDA Advisory No. 2018-327-C || Amendment to FDA Advisory No. 2018-327 “Public Health Warning Against the Use of Unnotified Cosmetic Products (Batch 16)” Dated 07 December 2018

The Food and Drug Administration (FDA) hereby advises the public that the list of unnotified cosmetic products listed in FDA Advisory No. 2018-327 ” Public Health Warning Against the Use of Unnotified Cosmetic Products (Batch 16)” dated 07 December 2018 is amended to remove the following cosmetic products:

  1. MORRISON STRETCH MARK COLLAGEN BODY CREAM
  2. MORRISON COLLAGEN + WHITENING 2 IN 1 BODY LOTION

to continue reading, click the link below…

FDA Advisory No. 2018-327-C

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2018-327-C || Amendment to FDA Advisory No. 2018-327 “Public Health Warning Against the Use of Unnotified Cosmetic Products (Batch 16)” Dated 07 December 2018

FDA Advisory No. 2019-128 || Safe Information: Fluoroquinolones and risk of Aortic Aneurysm and Dissection

Introduction

The US FDA searched their adverse event reporting system database and reviewed epidemiological studies to investigate the association between fluoroquinolone antibacterial use and the risk of aortic aneurysm and dissection. The review found that fluoroquinolone antibiotics can increase the occurrence of rare but serious events of ruptures or tears in the main artery of the body, called the aorta. These tears, called aortic dissections, or ruptures of an aortic aneurysm can lead to dangerous bleeding or even death.

Scientific Discussion

Fluoroquinolones are broad-spectrum antibacterial agents. It exhibits bactericidal activity by interfering with bacterial DNA replication, specifically by inhibiting DNA gyrase or topoisomerase.

In the Philippines, there are eight systemic fluoroquinolones registered as prescription-only medicines, these include:

  • Ciprofloxacin
  • Enrofloxacin
  • Levofloxacin
  • Moxifloxacin
  • Norfloxacin
  • Ofloxacin
  • Pefloxacin
  • Prulifloxacin

Fluoroquinolones are indicated for the treatment of certain bacterial infections. Resistance to these agents should be considered before commencing therapy.

Fluoroquinolones have been associated with collagen degradation, raising safety concerns related to more serious collagen disorders with use of these antibiotics including aortic aneurysm and dissection. Collagen is a major extracellular matrix component of the aortic wall. As fluoroquinolones may induce degradation of collagen causing tendinopathy, it may cause or aggravate aortic aneurysm and dissection by a similar mechanism.

To date, FDA has not received any adverse drug reactions reports of aortic aneurysm or dissection with fluoroquinolones.

Safety Advisory

Healthcare professionals are advised to avoid prescribing fluoroquinolones to patients who have aortic aneurysm or at risk for an aortic aneurysm, such as patients with peripheral atherosclerotic vascular disease, hypertension, certain genetic conditions such as Marfan syndrone and Ehlers-Danlos syndrome, and elderly patients. The benefit of using fluoroquinolones to these patients should be assessed by the prescribers prior to initiation of therapy. It should be prescribed to these patients only when no other treatment options are available.

Advise all patients to seek immediate medical treatment for any symptoms associated with aortic aneurysm and stop the fluoroquinolone therapy immediately if suggestive of aotic aneurysm or dissection.

Information for Market Authorization Holders

The Market Authorization Holders of systemic fluroquinolones containing active pharmaceutical ingredients as listed above shall update their respective package inserts to appear the information on risk of aortic aneurysm and dissection on the use of systemic fluoroquinolone antibiotics. This information shall be discussed under Warnings and Precautions. MAHs shall submit a variation application within 3 months after this issuance.

FDA Advisory No. 2019-128

FDA Advisory No. 2019-127 || Public Warning on the Purchase and Consumption of Processed Pork Meat Product from Identified Countries Suspected to be affected by African Swine fever virus

to continue reading, click the link below…

FDA Advisory No. 2019-127

/ In Food Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-127 || Public Warning on the Purchase and Consumption of Processed Pork Meat Product from Identified Countries Suspected to be affected by African Swine fever virus

FDA Advisory No. 2019-126 || Public Health Warning Against the Purchase and Use of Counterfeit Cosmetic Products (Batch 7)

The Food and Drug Administration (FDA) hereby advises the public against the purchase and use of M·N® MENOW GENERATION-II LONG LASTING LIP GLOSS (VARIANT 34) whose particulars/details are provided below:

PRODUCT DETAILS:

  • Local Company Name as Reflected on the Label: Not Indicated
  • Address: Not Indicated
  • Country of Manufacture: Not Indicated

FDA, in coordination with the Market Authorization Holder (MAH), Ever Bilena Cosmetics, Inc. (EBCI), has verified that the aforementioned cosmetic product is COUNTERFEIT. According to the MAH, the said cosmetic product was not marketed nor distributed by their company in the Philippine market.

Counterfeit products, not having gone through the required safety assessment and the verification process of the FDA, pose potential health hazards to the consuming public since their safety and purity cannot be guaranteed. The dangers/hazards may come from ingredients that are not allowed to be part of a cosmetic product or from the contamination of heavy metals such as lead and mercury. 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 above, the public is advised to be vigilant against buying and using the aforementioned counterfeit cosmetic product. Moreover, the public is also advised to be vigilant against cosmetic products that might not be duly notified with FDA. Always check if a cosmetic product has been notified with FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph.

All concerned establishments are warned not to distribute the above-identified violative cosmetic product, otherwise, regulatory actions and sanctions shall be strictly pursued.

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

To report any suspicious and/or illegal activity involving the said product, the public may contact FDA through its online reporting facility, eReport, at www.fda.gov.ph/ereport, or e-mail us at [email protected], or call the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 857-1900 local 8107/8113.

For more information and inquiries regarding EBCI cosmetic products, consumers may contact the MAH through any of the following channels:

  1. Website – http://www.everbilena.com.ph
  2. Email – [email protected]

Dissemination of the information to all concerned is requested

FDA Advisory No. 2019-126

FDA Advisory No. 2019-125 || Public Health Warning Against the Purchase and Use of Counterfeit Cosmetic Products (Batch 6)

The Food and Drug Administration (FDA) hereby advises the public against the purchase and use of MAYBELLINE NEW YORK THE MAGNUM VOLUM’ EXPRESS WATERPROOF MASCARA whose particulars/details are provided below:

PRODUCT DETAILS:

Local Company Name as Reflected on the Label: Not Indicated

Address: Not Indicated

Country of Manufacture: China

Batch/Lot No: Not Indicated

Expiry Date: Not Indicated

FDA, in coordination with the Market Authorization Holder (MAH), L’Oreal Philippines, Inc., has verified that the aforementioned cosmetic product is COUNTERFEIT. According to the MAH, the compliant product bears the following information:

  1. The Formula Reference are clear and readable positioned on the top portion (shrink wrap)

of the cap.

  1. The Batch Code and Manufacturing Date is directly engraved on the bottom portion of

the primary packaging.

Counterfeit products, not having gone through the required safety assessment and the verification process of the FDA, pose potential health hazards to the consuming public since their safety and purity cannot be guaranteed. The dangers/hazards may come from ingredients that are not allowed to be part of a cosmetic product or from the contamination of heavy metals such as lead and mercury. 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 above, the public is advised to be vigilant against buying and using the aforementioned counterfeit cosmetic product. Moreover, the public is also advised to be vigilant against cosmetic products that might not be duly notified with FDA. Always check if a cosmetic product has been notified with FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph.

All concerned establishments are warned not to distribute the above-identified violative cosmetic product, otherwise, regulatory actions and sanctions shall be strictly pursued.

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

To report any suspicious and/or illegal activity involving the said product, the public may contact FDA through its online reporting facility, eReport, at www.fda.gov.ph/ereport, or e-mail us at [email protected], or call the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 857-1900 local 8107/8113.

For more information and inquiries regarding Maybelline New York products, consumers may contact the MAH through any of the following contact information:

  1. Email: [email protected]
  2. Consumer Hotline No.: (02) 672-7200
  3. Official Brand Website: https://www.maybelline.com.ph
  4. Authorized Stores Reference: https://www.maybelline.com.ph/store-locator
  5. Brand’s Facebook Page: https://www.facebook.com/maybellinephilippines/

Dissemination of the information to all concerned is requested

FDA Advisory No. 2019-125

FDA Advisory No. 2019-124 || Public Health Warning Against the Purchase and Use of Counterfeit Cosmetic Products (Batch 5)

The Food and Drug Administration (FDA) hereby advises the public against the purchase and use of the following counterfeit cosmetic products whose particulars/details are provided in the attached annex:

  1. 3W CLINIC FRESH LEMON MASK SHEET
  2. 3W CLINIC FRESH ALOE MASK SHEET

FDA, in coordination with the Market Authorization Holder (MAH), BROSNEP CORP., has verified that the aforementioned cosmetic products are COUNTERFEIT. According to the MAH, the company does not distribute the said cosmetic products which are not compliant and aligned with the ASEAN Cosmetic Labeling Requirements.

Counterfeit products, not having gone through the required safety assessment and the verification process of the FDA, pose potential health hazards to the consuming public since their safety and purity cannot be guaranteed. The dangers/hazards may come from ingredients that are not allowed to be part of a cosmetic product or from the contamination of heavy metals such as lead and mercury. 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 above, the public is advised to be vigilant against buying and using the aforementioned counterfeit cosmetic product. Moreover, the public is also advised to be vigilant against cosmetic products that might not be duly notified with FDA. Always check if a cosmetic product has been notified with FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph.

All concerned establishments are warned not to distribute the above-identified violative cosmetic product, otherwise, regulatory actions and sanctions shall be strictly pursued.

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

To report any suspicious and/or illegal activity involving the said product, the public may contact FDA through its online reporting facility, eReport, at www.fda.gov.ph/ereport, or e-mail us at [email protected], or call the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 857-1900 local 8107/8113.

Dissemination of the information to all concerned is requested

FDA Advisory No. 2019-124

FDA Advisory No. 2019-123 || Public Health Warning Against the Purchase and Use of Counterfeit Cosmetic Products (Batch 4)

The Food and Drug Administration (FDA) hereby advises the public against the purchase and use of the following counterfeit cosmetic products whose particulars/details are provided in the attached annex:

  1. RDL BABYFACE WHITENING CREAM NIGHT CREAM 5 IN 1
  2. RDL FACE OFF FADE-OUT CREAM DAY CREAM

FDA, in coordination with the Market Authorization Holder (MAH), RDL Pharmaceutical Laboratory, has verified that the aforementioned cosmetic products are COUNTERFEIT. According to the MAH, the company does not manufacture, distribute nor export the said cosmetic products.

Counterfeit products, not having gone through the required safety assessment and the verification process of the FDA, pose potential health hazards to the consuming public since their safety and purity cannot be guaranteed. The dangers/hazards may come from ingredients that are not allowed to be part of a cosmetic product or from the contamination of heavy metals such as lead and mercury. The use of substandard and possibly adulteratedcosmetic products may result to adverse reactions including but not limited to skin irritation, itchiness, anaphylactic shock and organ failure.

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

All concerned establishments are warned not to distribute the above-identified violative cosmetic product, otherwise, regulatory actions and sanctions shall be strictly pursued.

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

To report any suspicious and/or illegal activity involving the said product, the public may contact FDA through its online reporting facility, eReport, at www.fda.gov.ph/ereport, or e-mail us at [email protected], or call the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 857-1900 local 8107/8113.

Dissemination of the information to all concerned is requested

FDA Advisory No. 2019-123

FDA Circular No.2012-007-A || Amending FDA Circular No. 2012-007: Reduction of Turn-Around-Time for the Regulatory Review of Clinical Trials and Revised Procedure for the Application of Import License for Investigational Products

to continue reading, click the attachment below…

FDA Circular No.2012-007-A

/ In Circular / By Administrator / Comments Off on FDA Circular No.2012-007-A || Amending FDA Circular No. 2012-007: Reduction of Turn-Around-Time for the Regulatory Review of Clinical Trials and Revised Procedure for the Application of Import License for Investigational Products

Center for Food Regulation and Research (CFRR) Strategic Plan on 29-31 May 2019

Please be informed that the Center for Food Regulation and Research (CFRR) will conduct its Strategic Planning on 29-31 May 2019 within CALABARZON area.

All transactions will be entertained until 28 May 2019 and will resume on June 2019.

Center for Food Regulation and Researh (CFRR) Strategic Plan on 29-31 May 2019

FROO Operational Planning and Team Building on 28-31 May 2019

Field Regulatory Operations Office (FROO)-South Luzon Cluster will conduct its Operational Planning and Team Building on 28-31 May 2019 within Calabarzon area.

In this regard, skeletal workforce is maintained on the said period. Regular operations will resume on MONDAY, 03 June 2019.

For information and guidance of all concerned stakeholders.

FROO operational Planning and Team Building on 28-31 May 2019

Designation of MERLITO Y. AGUIHAP as Officer-in-Charge of Information Communication and Technology Management Division (ICTMD).

FPO2019-0314-Designation of MERLITO Y. AGUIHAP as Officer-in-Charge of Information Communication and Technology Management Division (ICTMD).

For your information and guidance.

Thank you.

Designation of DR. OSCAR GUTIERREZ,Chief of Policy Formulation and Program Division as Officer-in Charge of Policy Planning Service (PPS).

FPO2019-0313-Designation of DR. OSCAR GUTIERREZ,Chief of Policy Formulation and Program Division as Officer-in Charge of Policy Planning Service (PPS).

For your information and guidance.

Thank you.

Press Release dated May 21, 2019

May 21, 2019

Press Release

The Philippine Nuclear Research Institute- Department of Science and Technology (PNRI-DOST) recently reported that as many as eight out of ten vinegar products are not made from natural sources. According to the report, such products did not undergo the natural process of fermentation of acetic acid, which is the usual process of making vinegar.

Natural vinegar is a product made from the conversion of ethyl alcohol to acetic acid. Synthetic or “fake” vinegar, however, reportedly uses glacial acetic acid, which shortens the production process.

The FDA classifies vinegar as a low risk product, which means that these products are unlikely to contain pathogenic microorganisms and will not normally support their growth because of food characteristics. There is also no evidence that synthetic acetic acid is harmful to health.

While considered low risk, FDA standards consider vinegar a natural product that should have undergone the natural process of alcoholic or acetous fermentation of natural raw materials. If the product contains artificial matter, such as synthetic acetic acid or cloudifying agent, it is considered adulterated.

“The FDA is coordinating with the PNRI for the submission of the results of the analysis, while continuously subjecting vinegar products for testing. Synthetic acetic acid may not be harmful per se, but products using such chemicals shall have their registration with the FDA revoked for misdeclaration,” OIC-FDA Director General Rolando Enrique Domingo said.