Month: May 2020

FDA Circular No. 2020-009-C || EXTENSION OF EFFECTIVITY OF FDA CIRCULAR 2020-009 ENTITLED “GUIDELINES ON THE IDENTIFICATION, NOTIFICATION, EVALUATION, REGULATORY ENFORCEMENT ACTION, AND REVIEW AND MONITORING OF DONATED HEALTH PRODUCTS SOLELY INTENDED TO ADDRESS COVID-19 PUBLIC HEALTH EMERGENCY”

In the interest of service and due to the COVID-19 pandemic, the effectivity of FDA Circular No. 2020-009 entitled “Guidelines on the Identification, Notification, Evaluation, Regulatory Enforcement Action, and Review and Monitoring of Donated Health Products Solely Intended to Address Covid-19 Public Health Emergency” is hereby extended until 31 August 2020.

For your information and guidance.

Attachment:->FDA Circular No. 2020-009-C

/ In Circular / By Administrator / Comments Off on FDA Circular No. 2020-009-C || EXTENSION OF EFFECTIVITY OF FDA CIRCULAR 2020-009 ENTITLED “GUIDELINES ON THE IDENTIFICATION, NOTIFICATION, EVALUATION, REGULATORY ENFORCEMENT ACTION, AND REVIEW AND MONITORING OF DONATED HEALTH PRODUCTS SOLELY INTENDED TO ADDRESS COVID-19 PUBLIC HEALTH EMERGENCY”

FDA Advisory No. 2020-928 || Public Health Warning Against the Purchase and Use of Unnotified Cosmetic EVER BILENA LIQUID FOUNDATION

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

  1. EVER BILENA LIQUID FOUNDATION

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 14 May 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 unnotified 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 product. Moreover, 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 product before purchasing.

All concerned establishments are warned not to distribute violative cosmetic product until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a Certificate of Product Notification (CPN) for the cosmetic product.

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

To report any sale or distribution of unnotified cosmetic products, email us at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-928

FDA Advisory No. 2020-927 || Public Health Warning Against the Purchase and Use of Unnotified Cosmetic ALODERMA NATURAL ALOE HAIR TONIC

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

  1. ALODERMA NATURAL ALOE HAIR TONIC

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 14 May 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 unnotified 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 product. Moreover, 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 product before purchasing.

All concerned establishments are warned not to distribute violative cosmetic product until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a Certificate of Product Notification (CPN) for the cosmetic product.

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

To report any sale or distribution of unnotified cosmetic products, email us at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-927

FDA Advisory No. 2020-926 || Public Health Warning Against the Purchase and Use of Unnotified Cosmetic SUN KISSED ORGANIC CLAY BLUSH (ORGANIC)

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

  1. SUN KISSED ORGANIC CLAY BLUSH (ORGANIC)

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 14 May 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 unnotified 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 product. Moreover, 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 product before purchasing.

All concerned establishments are warned not to distribute violative cosmetic product until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a Certificate of Product Notification (CPN) for the cosmetic product.

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

To report any sale or distribution of unnotified cosmetic products, email us at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-926

FDA Advisory No. 2020-925 || Public Health Warning Against the Purchase and Use of Unnotified Cosmetic TONY MOLY MINIS

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

  1. TONY MOLY MINIS

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 14 May 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 unnotified 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 product. Moreover, 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 product before purchasing.

All concerned establishments are warned not to distribute violative cosmetic product until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a Certificate of Product Notification (CPN) for the cosmetic product.

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

To report any sale or distribution of unnotified cosmetic products, email us at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-925

FDA Advisory No. 2020-924 || Public Health Warning Against the Purchase and Use of Unnotified Toy and Childcare Article (TCCA) STONY ANGEL SILICONE NIPPLE 3-PACK (SIZE M)

The Food and Drug Administration (FDA) warns the public from purchasing and using the unnotified toy and childcare article (TCCA) product:

  1. STONY ANGEL SILICONE NIPPLE 3-PACK (SIZE M)

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 14 May 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 unnotified toy and childcare article 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 toy and childcare article product. The use of substandard and possibly adulterated toy and childcare article product may result to health risks including, but not limited to, endocrine disruption and reproductive or development effects; or may result to injury, choking or suffocation due to its small or broken parts.

In light of the foregoing, the public is advised not to purchase the aforementioned violative product. Moreover, the public is advised to always check if a toy and childcare article 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 product before purchasing.

All concerned establishments are warned not to distribute violative toy and childcare article product until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a Certificate of Product Notification (CPN) for the toy and childcare article product.

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

To report any sale or distribution of unnotified toy and childcare articles, email us at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-924

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-924 || Public Health Warning Against the Purchase and Use of Unnotified Toy and Childcare Article (TCCA) STONY ANGEL SILICONE NIPPLE 3-PACK (SIZE M)

FDA Advisory No. 2020-923 || Public Health Warning Against the Purchase and Use of Unnotified Toy and Childcare Article (TCCA) BROTHER MAX TRAVEL SPOONS

The Food and Drug Administration (FDA) warns the public from purchasing and using the unnotified toy and childcare article (TCCA) product:

  1. BROTHER MAX TRAVEL SPOONS

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 12 May 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 unnotified toy and childcare article 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 toy and childcare article product. The use of substandard and possibly adulterated toy and childcare article product may result to health risks including, but not limited to, endocrine disruption and reproductive or development effects; or may result to injury, choking or suffocation due to its small or broken parts.

In light of the foregoing, the public is advised not to purchase the aforementioned violative product. Moreover, the public is advised to always check if a toy and childcare article 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 product before purchasing.

All concerned establishments are warned not to distribute violative toy and childcare article product until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a Certificate of Product Notification (CPN) for the toy and childcare article product.

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

To report any sale or distribution of unnotified toy and childcare articles, email us at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-923

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-923 || Public Health Warning Against the Purchase and Use of Unnotified Toy and Childcare Article (TCCA) BROTHER MAX TRAVEL SPOONS

FDA Advisory No. 2020-922 || Public Health Warning Against the Purchase and Use of Unnotified Toy and Childcare Article (TCCA) STONY ANGEL SILICONE NIPPLE (SIZE S SLOW FLOW)

The Food and Drug Administration (FDA) warns the public from purchasing and using the unnotified toy and childcare article (TCCA) product:

  1. STONY ANGEL SILICONE NIPPLE (SIZE S SLOW FLOW)

The abovementioned product was verified by FDA through postmarketing surveillance and shows no record of valid Certificate of Product Notification (CPN) as of 12 May 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 unnotified toy and childcare article 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 toy and childcare article product. The use of substandard and possibly adulterated toy and childcare article product may result to health risks including, but not limited to, endocrine disruption and reproductive or development effects; or may result to injury, choking or suffocation due to its small or broken parts.

In light of the foregoing, the public is advised not to purchase the aforementioned violative product. Moreover, the public is advised to always check if a toy and childcare article 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 product before purchasing.

All concerned establishments are warned not to distribute violative toy and childcare article product until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a Certificate of Product Notification (CPN) for the toy and childcare article product.

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

To report any sale or distribution of unnotified toy and childcare articles, email us at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-922

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-922 || Public Health Warning Against the Purchase and Use of Unnotified Toy and Childcare Article (TCCA) STONY ANGEL SILICONE NIPPLE (SIZE S SLOW FLOW)

FDA Advisory No. 2020-921 || Public Health Warning Against the Purchase and Use of Unnotified Toy and Childcare Article (TCCA) ANIMAL ASSORTED PLASTIC TOYS

The Food and Drug Administration (FDA) warns the public from purchasing and using the unnotified toy and childcare article (TCCA) product:

  1. ANIMAL ASSORTED PLASTIC TOYS

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 12 May 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 unnotified toy and childcare article 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 toy and childcare article product. The use of substandard and possibly adulterated toy and childcare article product may result to health risks including, but not limited to, endocrine disruption and reproductive or development effects; or may result to injury, choking or suffocation due to its small or broken parts.

In light of the foregoing, the public is advised not to purchase the aforementioned violative product. Moreover, the public is advised to always check if a toy and childcare article 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 product before purchasing.

All concerned establishments are warned not to distribute violative toy and childcare article product until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a Certificate of Product Notification (CPN) for the toy and childcare article product.

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

To report any sale or distribution of unnotified toy and childcare articles, email us at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-921

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-921 || Public Health Warning Against the Purchase and Use of Unnotified Toy and Childcare Article (TCCA) ANIMAL ASSORTED PLASTIC TOYS

FDA Advisory No. 2020-920 || Public Health Warning Against the Purchase and Use of Unregistered Household/Urban Pesticide (H/UP) SIMPLYLIVING PERSONAL REPELLENT MOSQUITO REPELLENT SPRAY SANRIO CHARACTERS

The Food and Drug Administration (FDA) warns the public from purchasing and using the unregistered household/urban pesticide (H/UP) product:

  1. SIMPLYLIVING PERSONAL REPELLENT MOSQUITO REPELLENT SPRAY SANRIO CHARACTERS

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Registration (CPR) as of 14 May 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 unregistered household/urban pesticide product has not gone through the registration process of the FDA, the agency cannot assure their efficacy, quality and safety. The use of such violative product may pose health risks to consumers.

Potential hazards may come from harmful, toxic and banned active ingredients that pose imminent danger to human and animal health. The use of substandard and possibly adulterated household/urban pesticide products may result to adverse reactions including, but not limited to, skin irritation, itchiness, anaphylactic shock, respiratory disorders, endocrine complications, brain damage and organ failure.

In light of the foregoing, the public is advised not to purchase the aforementioned violative product. Moreover, the public is advised to always check if a household/urban pesticide product is registered with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing.

All concerned establishments are warned not to distribute violative household/urban pesticides until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a Certificate of Product Registration (CPR) for the household/urban pesticides.

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

To report any sale or distribution of unregistered household/urban pesticides,  email us at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-920

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-920 || Public Health Warning Against the Purchase and Use of Unregistered Household/Urban Pesticide (H/UP) SIMPLYLIVING PERSONAL REPELLENT MOSQUITO REPELLENT SPRAY SANRIO CHARACTERS

FDA Advisory No. 2020-919 || Public Health Warning Against the Purchase and Use of Unregistered Household/Urban Pesticide (H/UP) COMBI HERBAL BABY INSECT REPELLENT SPRAY

The Food and Drug Administration (FDA) warns the public from purchasing and using the unregistered household/urban pesticide (H/UP) product:

  1. COMBI HERBAL BABY INSECT REPELLENT SPRAY

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Registration (CPR) as of 14 May 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 unregistered household/urban pesticide product has not gone through the registration process of the FDA, the agency cannot assure their efficacy, quality and safety. The use of such violative product may pose health risks to consumers.

Potential hazards may come from harmful, toxic and banned active ingredients that pose imminent danger to human and animal health. The use of substandard and possibly adulterated household/urban pesticide products may result to adverse reactions including, but not limited to, skin irritation, itchiness, anaphylactic shock, respiratory disorders, endocrine complications, brain damage and organ failure.

In light of the foregoing, the public is advised not to purchase the aforementioned violative product. Moreover, the public is advised to always check if a household/urban pesticide product is registered with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing.

All concerned establishments are warned not to distribute violative household/urban pesticides until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a Certificate of Product Registration (CPR) for the household/urban pesticides.

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

To report any sale or distribution of unregistered household/urban pesticides,  email us at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-919

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-919 || Public Health Warning Against the Purchase and Use of Unregistered Household/Urban Pesticide (H/UP) COMBI HERBAL BABY INSECT REPELLENT SPRAY

FDA Advisory No. 2020-918 || Public Health Warning Against the Purchase and Use of Unregistered Household/Urban Pesticide (H/UP) CHICCO ANTI-MOSQUITO BABY SPRAY

The Food and Drug Administration (FDA) warns the public from purchasing and using the unregistered household/urban pesticide (H/UP) product:

  1. CHICCO ANTI-MOSQUITO BABY SPRAY

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Registration (CPR) as of 14 May 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 unregistered household/urban pesticide product has not gone through the registration process of the FDA, the agency cannot assure their efficacy, quality and safety. The use of such violative product may pose health risks to consumers.

Potential hazards may come from harmful, toxic and banned active ingredients that pose imminent danger to human and animal health. The use of substandard and possibly adulterated household/urban pesticide products may result to adverse reactions including, but not limited to, skin irritation, itchiness, anaphylactic shock, respiratory disorders, endocrine complications, brain damage and organ failure.

In light of the foregoing, the public is advised not to purchase the aforementioned violative product. Moreover, the public is advised to always check if a household/urban pesticide product is registered with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing.

All concerned establishments are warned not to distribute violative household/urban pesticides until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a Certificate of Product Registration (CPR) for the household/urban pesticides.

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

To report any sale or distribution of unregistered household/urban pesticides,  email us at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-918

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-918 || Public Health Warning Against the Purchase and Use of Unregistered Household/Urban Pesticide (H/UP) CHICCO ANTI-MOSQUITO BABY SPRAY

FDA Advisory No. 2020-917 || Public Health Warning Against the Purchase and Use of Unregistered Household/Urban Pesticide (H/UP) FUMAKILLA’S RAT KILLER (GRANULAR DORA)

The Food and Drug Administration (FDA) warns the public from purchasing and using the unregistered household/urban pesticide (H/UP) product:

  1. FUMAKILLA’S RAT KILLER (GRANULAR DORA)

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Registration (CPR) as of 14 May 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 unregistered household/urban pesticide product has not gone through the registration process of the FDA, the agency cannot assure their efficacy, quality and safety. The use of such violative product may pose health risks to consumers.

Potential hazards may come from harmful, toxic and banned active ingredients that pose imminent danger to human and animal health. The use of substandard and possibly adulterated household/urban pesticide products may result to adverse reactions including, but not limited to, skin irritation, itchiness, anaphylactic shock, respiratory disorders, endocrine complications, brain damage and organ failure.

In light of the foregoing, the public is advised not to purchase the aforementioned violative product. Moreover, the public is advised to always check if a household/urban pesticide product is registered with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing.

All concerned establishments are warned not to distribute violative household/urban pesticides until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a Certificate of Product Registration (CPR) for the household/urban pesticides.

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

To report any sale or distribution of unregistered household/urban pesticides,  email us at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-917

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-917 || Public Health Warning Against the Purchase and Use of Unregistered Household/Urban Pesticide (H/UP) FUMAKILLA’S RAT KILLER (GRANULAR DORA)

FDA Advisory No. 2020-916 || Public Health Warning Against the Purchase and Use of Unregistered Household/Urban Pesticide (H/UP) RUSH DEER PEARL BALLS (NAPHTHALENE BALLS)

The Food and Drug Administration (FDA) warns the public from purchasing and using the unregistered household/urban pesticide (H/UP) product:

  1. RUSH DEER PEARL BALLS (NAPHTHALENE BALLS)

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Registration (CPR) as of 14 May 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 unregistered household/urban pesticide product has not gone through the registration process of the FDA, the agency cannot assure their efficacy, quality and safety. The use of such violative product may pose health risks to consumers.

Potential hazards may come from harmful, toxic and banned active ingredients that pose imminent danger to human and animal health. The use of substandard and possibly adulterated household/urban pesticide products may result to adverse reactions including, but not limited to, skin irritation, itchiness, anaphylactic shock, respiratory disorders, endocrine complications, brain damage and organ failure.

In light of the foregoing, the public is advised not to purchase the aforementioned violative product. Moreover, the public is advised to always check if a household/urban pesticide product is registered with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing.

All concerned establishments are warned not to distribute violative household/urban pesticides until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a Certificate of Product Registration (CPR) for the household/urban pesticides.

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

To report any sale or distribution of unregistered household/urban pesticides,  email us at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-916

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-916 || Public Health Warning Against the Purchase and Use of Unregistered Household/Urban Pesticide (H/UP) RUSH DEER PEARL BALLS (NAPHTHALENE BALLS)

FDA Advisory No. 2020-915 || Public Health Warning Against the Purchase and Use of Unnotified Cosmetic HORTALEZA CALLUS REMOVER

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

  1. HORTALEZA CALLUS REMOVER

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 08 May 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 unnotified 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 product. Moreover, 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 product before purchasing.

All concerned establishments are warned not to distribute violative cosmetic product until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a Certificate of Product Notification (CPN) for the cosmetic product.

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

To report any sale or distribution of unnotified cosmetic products, email us at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-915

FDA Advisory No. 2020-914 || Public Health Warning Against the Purchase and Use of Unnotified Cosmetic MUMUSO LONG LASTING LIPSTICK 03 BARBIE POWDER

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

  1. MUMUSO LONG LASTING LIPSTICK 03 BARBIE POWDER

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 08 May 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 unnotified 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 product. Moreover, 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 product before purchasing.

All concerned establishments are warned not to distribute violative cosmetic product until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a Certificate of Product Notification (CPN) for the cosmetic product.

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

To report any sale or distribution of unnotified cosmetic products, email us at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-914

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-914 || Public Health Warning Against the Purchase and Use of Unnotified Cosmetic MUMUSO LONG LASTING LIPSTICK 03 BARBIE POWDER

FDA Advisory No. 2020-913 || Public Health Warning Against the Purchase and Use of Unnotified Cosmetic LOVELY LOOK MINERAL OIL

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

  1. LOVELY LOOK MINERAL OIL

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 08 May 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 unnotified 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 product. Moreover, 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 product before purchasing.

All concerned establishments are warned not to distribute violative cosmetic product until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a Certificate of Product Notification (CPN) for the cosmetic product.

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

To report any sale or distribution of unnotified cosmetic products, email us at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-913

FDA Advisory No. 2020-912 || Public Health Warning Against the Purchase and Use of Unnotified Cosmetic BENCH/ BRATSPLASH INSTANT HAND SANITIZER GEL WITH MOISTURIZING ALOE (GREEN APPLE)

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

  1. BENCH/ BRATSPLASH INSTANT HAND SANITIZER GEL WITH MOISTURIZING ALOE (GREEN APPLE)

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 08 May 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 unnotified 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 product. Moreover, 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 product before purchasing.

All concerned establishments are warned not to distribute violative cosmetic product until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a Certificate of Product Notification (CPN) for the cosmetic product.

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

To report any sale or distribution of unnotified cosmetic products, email us at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-912

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-912 || Public Health Warning Against the Purchase and Use of Unnotified Cosmetic BENCH/ BRATSPLASH INSTANT HAND SANITIZER GEL WITH MOISTURIZING ALOE (GREEN APPLE)

FDA Advisory No. 2020-911 || Public Health Warning Against the Purchase and Use of Unnotified Cosmetic DAISO JAPAN ELLEFAR MAGICAL EYELINER A BLACK [WATERPROOF]

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

  1. DAISO JAPAN ELLEFAR MAGICAL EYELINER A BLACK [WATERPROOF]

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 08 May 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 unnotified 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 product. Moreover, 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 product before purchasing.

All concerned establishments are warned not to distribute violative cosmetic product until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a Certificate of Product Notification (CPN) for the cosmetic product.

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

To report any sale or distribution of unnotified cosmetic products, email us at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-911

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-911 || Public Health Warning Against the Purchase and Use of Unnotified Cosmetic DAISO JAPAN ELLEFAR MAGICAL EYELINER A BLACK [WATERPROOF]

FDA Advisory No. 2020-910 || Public Health Warning Against the Purchase and Use of Unnotified Cosmetic MIAO SOAP HEALTHY SOAP LEMON MINT

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

  1. MIAO SOAP HEALTHY SOAP LEMON MINT

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 08 May 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 unnotified 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 product. Moreover, 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 product before purchasing.

All concerned establishments are warned not to distribute violative cosmetic product until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a Certificate of Product Notification (CPN) for the cosmetic product.

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

To report any sale or distribution of unnotified cosmetic products, email us at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-910

FDA Advisory No. 2019-541-A || Lifting the Advisory on the Registered Food Supplement NUTRAWELL Collagen with Astaxanthin and Hyaluronic Acid Food Supplement Powder under FDA Advisory No. 2019-541 with Subject “Public Health Warning Against the Purchase and Consumption of the Unregistered Food Products and Food Supplements”

The Food and Drug Administration (FDA) informs the public that the food supplement NUTRAWELL Collagen with Astaxanthin and Hyaluronic Acid Food Supplement Powder has been registered by the Market Authorization Holder (MAH) AIRLIFE INTERNATIONAL TRADING CORPORATION, in accordance to existing FDA rules and regulations.

Accordingly, the list released in FDA Advisory No. 2019-541 is hereby updated to remove the aforementioned food supplement.

The public is advised to always check if a food product or food supplement is registered with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing.

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

The public health warning imposed on the remaining products listed in FDA Advisory No. 2019-541 shall remain to be upheld and shall not be affected by the issuance of this advisory. Furthermore, the issuance of this advisory shall not in any manner preclude this Office from issuing subsequent orders it may deem necessary and appropriate, should there be findings of any violation of the company to the existing laws, rules, and regulations.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA-Advisory-No.2019-541-A

/ In Food Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-541-A || Lifting the Advisory on the Registered Food Supplement NUTRAWELL Collagen with Astaxanthin and Hyaluronic Acid Food Supplement Powder under FDA Advisory No. 2019-541 with Subject “Public Health Warning Against the Purchase and Consumption of the Unregistered Food Products and Food Supplements”

FDA Advisory No. 2020-909 || Public Health Warning Against the Purchase and Use of Unnotified Cosmetic SEXXY MAKE – UP KIT TWO – WAY CAKE NO:9161X (2)

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

  1. SEXXY MAKE – UP KIT TWO – WAY CAKE NO:9161X (2)

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 08 May 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 unnotified 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 product. Moreover, 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 product before purchasing.

All concerned establishments are warned not to distribute violative cosmetic product until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a Certificate of Product Notification (CPN) for the cosmetic product.

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

To report any sale or distribution of unnotified cosmetic products, email us at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-909

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-909 || Public Health Warning Against the Purchase and Use of Unnotified Cosmetic SEXXY MAKE – UP KIT TWO – WAY CAKE NO:9161X (2)

FDA Advisory No. 2020-908 || Public Health Warning Against the Purchase and Use of Unnotified Cosmetic DAISO JAPAN WL LAME EYESHADOW (PURPLE)

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

  1. DAISO JAPAN WL LAME EYESHADOW (PURPLE)

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 08 May 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 unnotified 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 product. Moreover, 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 product before purchasing.

All concerned establishments are warned not to distribute violative cosmetic product until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a Certificate of Product Notification (CPN) for the cosmetic product.

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

To report any sale or distribution of unnotified cosmetic products, email us at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-908

FDA Advisory No. 2020-907 || Public Health Warning Against the Purchase and Use of Unnotified Cosmetic BOBBIE COSMETICS WILDLY PINK

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

  1. BOBBIE COSMETICS WILDLY PINK

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 08 May 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 unnotified 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 product. Moreover, 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 product before purchasing.

All concerned establishments are warned not to distribute violative cosmetic product until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a Certificate of Product Notification (CPN) for the cosmetic product.

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

To report any sale or distribution of unnotified cosmetic products, email us at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-907

FDA Advisory No. 2020-906 || Public Health Warning Against the Purchase and Use of Unnotified Cosmetic KAXIER WATER COLOR COLOR LIPSTICK (NO.221) (ORANGE)

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

  1. KAXIER WATER COLOR COLOR LIPSTICK (NO.221) (ORANGE)

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 11 May 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 unnotified 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 product. Moreover, 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 product before purchasing.

All concerned establishments are warned not to distribute violative cosmetic product until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a Certificate of Product Notification (CPN) for the cosmetic product.

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

To report any sale or distribution of unnotified cosmetic products, email us at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-906

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-906 || Public Health Warning Against the Purchase and Use of Unnotified Cosmetic KAXIER WATER COLOR COLOR LIPSTICK (NO.221) (ORANGE)

FDA Advisory No. 2020-905 || Public Health Warning Against the Purchase and Use of Unnotified Cosmetic NXTSKIN REJUV CREAM

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

  1. NXTSKIN REJUV CREAM

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 11 May 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 unnotified 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 product. Moreover, 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 product before purchasing.

All concerned establishments are warned not to distribute violative cosmetic product until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a Certificate of Product Notification (CPN) for the cosmetic product.

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

To report any sale or distribution of unnotified cosmetic products, email us at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-905

FDA Advisory No. 2020-904 || Public Health Warning Against the Purchase and Use of Unnotified Cosmetic DHEELUXE COSMETICS GLUTA CALAMANSI WITH BAKING SODA HAND & BODY LOTION

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

  1. DHEELUXE COSMETICS GLUTA CALAMANSI WITH BAKING SODA HAND & BODY LOTION

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 11 May 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 unnotified 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 product. Moreover, 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 product before purchasing.

All concerned establishments are warned not to distribute violative cosmetic product until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a Certificate of Product Notification (CPN) for the cosmetic product.

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

To report any sale or distribution of unnotified cosmetic products, email us at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-904

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-904 || Public Health Warning Against the Purchase and Use of Unnotified Cosmetic DHEELUXE COSMETICS GLUTA CALAMANSI WITH BAKING SODA HAND & BODY LOTION

FDA Advisory No. 2020-903 || Public Health Warning Against the Purchase and Use of Unnotified Cosmetic NATURE BEAUTY® COLLAGEN & GLUTATHIONE PERFECT MAGIC PEELING CREAM

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

  1. NATURE BEAUTY® COLLAGEN & GLUTATHIONE PERFECT MAGIC PEELING CREAM

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 11 May 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 unnotified 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 product. Moreover, 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 product before purchasing.

All concerned establishments are warned not to distribute violative cosmetic product until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a Certificate of Product Notification (CPN) for the cosmetic product.

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

To report any sale or distribution of unnotified cosmetic products, email us at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-903

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-903 || Public Health Warning Against the Purchase and Use of Unnotified Cosmetic NATURE BEAUTY® COLLAGEN & GLUTATHIONE PERFECT MAGIC PEELING CREAM

FDA Advisory No. 2020-902 || Public Health Warning Against the Purchase and Use of Unnotified Cosmetic SKIN GENIE WORTH A SHOT ANTI AGING BAR

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

  1. SKIN GENIE WORTH A SHOT ANTI AGING BAR

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 11 May 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 unnotified 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 product. Moreover, 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 product before purchasing.

All concerned establishments are warned not to distribute violative cosmetic product until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a Certificate of Product Notification (CPN) for the cosmetic product.

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

To report any sale or distribution of unnotified cosmetic products, email us at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. 8113 or 8107.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-902

FDA Advisory No. 2020-757-A || Lifting the Advisory of the Registered Food Product VICTORIAS Food Luncheon Meat under FDA Advisory No. 2020-757 Subject “Public Health Warning Against the Purchase and Consumption of the Unregistered Food Product”

The Food and Drug Administration (FDA) informs the public that the food product VICTORIAS Food Luncheon Meat is registered by the Market Authorization Holder, VICTORIAS FOODS CORPORATIONunder the National Meat Inspection Service (NMIS).

The aforementioned company has submitted its Certificate of Product from NMIS with Registration Number 12-LM-0250 valid until 11 July 2021. Following the FDA-NMIS Joint Administrative Order No. 02 s. 2016, the FDA shall recognize the validity of the CPR issued by NMIS hence the FDA Advisory No. 2020-757 is hereby updated to remove the aforementioned food product.

The public is advised to always check if a food product is registered with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing.

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

The public health warning imposed on the remaining product listed in FDA Advisory No. 2020-757 shall remain to be upheld and shall not be affected by the issuance of this advisory. Furthermore, the issuance of this advisory shall not in any manner preclude this Office from issuing subsequent orders it may deem necessary and appropriate, should there be findings of any violation of the company to the existing laws, rules, and regulations.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-757-A

/ In Food Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-757-A || Lifting the Advisory of the Registered Food Product VICTORIAS Food Luncheon Meat under FDA Advisory No. 2020-757 Subject “Public Health Warning Against the Purchase and Consumption of the Unregistered Food Product”