Author: FDA Admin3

FDA Advisory No. 2021-0062 || Public Health Warning Against the Purchase and Use of the Non-Compliant Cosmetic Product ” VITAKERATIN EXPERT SALON TREATMENT BRAZILIAN STRAIGHT FOR FRIZZY & UNRULY HAIR “

The Food and Drug Administration (FDA) warns the general public from purchasing and using the non-compliant cosmetic product, ” VITAKERATIN EXPERT SALON TREATMENT BRAZILIAN STRAIGHT FOR FRIZZY & UNRULY HAIR “

The Food and Drug Administration has verified that the abovementioned product is NON-COMPLIANT through its postmarketing surveillance (PMS) pursuant to Book I, Article II, Section 2 of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009” which provides for the relevant functions, powers and duties of the agency, including the conduct of PMS activities in the monitoring of health products.

Based on the Certificate of Product Notification issued to the company, any subsequent changes to the information previously submitted to the FDA will render the notification invalid.

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

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

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

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA-Advisory-No.2021-0062

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2021-0062 || Public Health Warning Against the Purchase and Use of the Non-Compliant Cosmetic Product ” VITAKERATIN EXPERT SALON TREATMENT BRAZILIAN STRAIGHT FOR FRIZZY & UNRULY HAIR “

FDA Advisory No. 2021-0061 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic DSS D SKIN SOLUTIONS SASSY JELLY TINT V2 LIP & CHEEK TINT – NIANA

The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product, DSS D SKIN SOLUTIONS SASSY JELLY TINT V2 LIP & CHEEK TINT – NIANA .

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 07 January 2021. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization from the FDA is prohibited.

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

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

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

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

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

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA-Advisory-No.2021-0061

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2021-0061 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic DSS D SKIN SOLUTIONS SASSY JELLY TINT V2 LIP & CHEEK TINT – NIANA

FDA Advisory No. 2021-0060 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic LA BELLE MOI MERRYSUN GLUTATHIONE WHITENING SUNSCREEN LOTION SPF 35+

The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product, LA BELLE MOI MERRYSUN GLUTATHIONE WHITENING SUNSCREEN LOTION SPF 35+ .

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 07 January 2021. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization from the FDA is prohibited.

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

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

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

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

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

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA-Advisory-No.2021-0060

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2021-0060 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic LA BELLE MOI MERRYSUN GLUTATHIONE WHITENING SUNSCREEN LOTION SPF 35+

FDA Advisory No. 2021-0059 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic HONEY NAIL POLISH REMOVER

The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product, HONEY NAIL POLISH REMOVER .

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 07 January 2021. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization from the FDA is prohibited.

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

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

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

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

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

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA-Advisory-No.2021-0059

FDA Advisory No. 2021-0058 || Public Health Warning Against the Purchase and Use of the Non-Compliant Cosmetic Product ” V GIRL IVY PLUMP EMBELLISHED COLLAGEN LIPSTICK – 001 “

The Food and Drug Administration (FDA) warns the general public from purchasing and using the non-compliant cosmetic product, ” V GIRL IVY PLUMP EMBELLISHED COLLAGEN LIPSTICK – 001 “.

The Food and Drug Administration has verified that the abovementioned product is NON-COMPLIANT through its postmarketing surveillance (PMS) pursuant to Book I, Article II, Section 2 of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009” which provides for the relevant functions, powers and duties of the agency, including the conduct of PMS activities in the monitoring of health products.

Based on the Certificate of Product Notification issued to the company, any subsequent changes to the information previously submitted to the FDA will render the notification invalid.

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

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

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

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA-Advisory-No.2021-0058

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2021-0058 || Public Health Warning Against the Purchase and Use of the Non-Compliant Cosmetic Product ” V GIRL IVY PLUMP EMBELLISHED COLLAGEN LIPSTICK – 001 “

FDA Advisory No. 2021-0057 || Public Health Warning Against the Purchase and Use of the Non-Compliant Cosmetic Product ” DIVA WHITE AHA BHA GALSS GLOW SKIN FOAM FACIAL WASH WITH TEA TREE “

The Food and Drug Administration (FDA) warns the general public from purchasing and using the non-compliant cosmetic product, ” DIVA WHITE AHA BHA GALSS GLOW SKIN FOAM FACIAL WASH WITH TEA TREE ” .

The Food and Drug Administration has verified that the abovementioned product is NON-COMPLIANT through its postmarketing surveillance (PMS) pursuant to Book I, Article II, Section 2 of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009” which provides for the relevant functions, powers and duties of the agency, including the conduct of PMS activities in the monitoring of health products.

Based on the Certificate of Product Notification issued to the company, any subsequent changes to the information previously submitted to the FDA will render the notification invalid.

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

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

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

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

Attachment:-> FDA-Advisory-No.2021-0057

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2021-0057 || Public Health Warning Against the Purchase and Use of the Non-Compliant Cosmetic Product ” DIVA WHITE AHA BHA GALSS GLOW SKIN FOAM FACIAL WASH WITH TEA TREE “

FDA Advisory No. 2021-0056 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic VG POWER ACAPULCO HERBAL SOAP WITH ACAPULCO, GUAVA, LEMON GRASS EXTRACT

The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product, VG POWER ACAPULCO HERBAL SOAP WITH ACAPULCO, GUAVA, LEMON GRASS EXTRACT .

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 07 January 2021. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization from the FDA is prohibited.

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

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

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

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

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

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA-Advisory-No.2021-0056

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2021-0056 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic VG POWER ACAPULCO HERBAL SOAP WITH ACAPULCO, GUAVA, LEMON GRASS EXTRACT

FDA Advisory No. 2021-0055 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic HANMIAO

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

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 07 January 2021. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization from the FDA is prohibited.

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

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

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

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

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

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

Attachment:-> FDA-Advisory-No.2021-0055

FDA Advisory No. 2021-0054 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic VANILLA LACE REFRESHING BODY MIST (VANILLA, ORCHID, AMBER AND MUSK)

The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product, VANILLA LACE REFRESHING BODY MIST (VANILLA, ORCHID, AMBER AND MUSK).

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 07 January 2021. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization from the FDA is prohibited.

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

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

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

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

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

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA-Advisory-No.2021-0054

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2021-0054 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic VANILLA LACE REFRESHING BODY MIST (VANILLA, ORCHID, AMBER AND MUSK)

FDA Advisory No. 2020-0053 || Public Health Warning Against the Purchase and Use of the Non-Compliant Cosmetic Product ” VANIDERM VCO SHAMPOO WITH GUGO AND ALOE VERA “.

The Food and Drug Administration (FDA) warns the general public from purchasing and using the non-compliant cosmetic product, ” VANIDERM VCO SHAMPOO WITH GUGO AND ALOE VERA “.

The Food and Drug Administration has verified that the abovementioned product is NON-COMPLIANT through its postmarketing surveillance (PMS) pursuant to Book I, Article II, Section 2 of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009” which provides for the relevant functions, powers and duties of the agency, including the conduct of PMS activities in the monitoring of health products.

Based on the Certificate of Product Notification issued to the company, any subsequent changes to the information previously submitted to the FDA will render the notification invalid.

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

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

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

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA-Advisory-No.2021-0053

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-0053 || Public Health Warning Against the Purchase and Use of the Non-Compliant Cosmetic Product ” VANIDERM VCO SHAMPOO WITH GUGO AND ALOE VERA “.

FDA Advisory No. 2021-0052 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic HBWELLNESS ALL OVER WHITE WHITENING & GERMICIDAL SOAP WITH MOISTURIZER

The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product, HBWELLNESS ALL OVER WHITE WHITENING & GERMICIDAL SOAP WITH MOISTURIZER .

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 07 January 2021. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization from the FDA is prohibited.

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

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

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

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

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

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

Attachment:-> FDA-Advisory-No.2021-0052

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2021-0052 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic HBWELLNESS ALL OVER WHITE WHITENING & GERMICIDAL SOAP WITH MOISTURIZER

FDA Advisory No. 2021-0051 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic ASHLEY SHINE ALOE VERA 99% POWDER (2)

The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product, ASHLEY SHINE ALOE VERA 99% POWDER (2) .

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 07 January 2021. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization from the FDA is prohibited.

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

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

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

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

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

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA-Advisory-No.2021-0051

FDA Advisory No. 2021-0050 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic HUOHBEAUTY FOCUS GLITTER NAIL POLISH COLOR 004

The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product, HUOHBEAUTY FOCUS GLITTER NAIL POLISH COLOR 004.

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 07 January 2021. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization from the FDA is prohibited.

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

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

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

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

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

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA-Advisory-No.2021-0050

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2021-0050 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic HUOHBEAUTY FOCUS GLITTER NAIL POLISH COLOR 004

FDA Advisory No. 2021-0049 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic PEARL EXTRACT PEARL BRIGHTENING HYDRATING MASK

The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product, PEARL EXTRACT PEARL BRIGHTENING HYDRATING MASK .

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 07 January 2021. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization from the FDA is prohibited.

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

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

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

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

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

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->  FDA-Advisory-No.2021-0049

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2021-0049 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic PEARL EXTRACT PEARL BRIGHTENING HYDRATING MASK

FDA Advisory No. 2021-0048 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic SILK PROTEIN SOFT BRIGHT AND TENDER MOISTURIZING MASK

The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product, SILK PROTEIN SOFT BRIGHT AND TENDER MOISTURIZING MASK .

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 07 January 2021. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization from the FDA is prohibited.

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

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

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

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

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

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA-Advisory-No.2021-0048

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2021-0048 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic SILK PROTEIN SOFT BRIGHT AND TENDER MOISTURIZING MASK

FDA Advisory No. 2021-0047 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic BEAUTY KEI AQUA MOISTURE BOMB MASK BLOOD ORANGE

The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product, BEAUTY KEI AQUA MOISTURE BOMB MASK BLOOD ORANGE .

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 07 January 2021. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization from the FDA is prohibited.

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

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

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

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

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

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA-Advisory-No.2021-0047

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2021-0047 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic BEAUTY KEI AQUA MOISTURE BOMB MASK BLOOD ORANGE

FDA Advisory No. 2021-0046 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic VG POWER PAPAYA HERBAL SOAP FOR WHITENING AND SOFT SKIN

The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product, VG POWER PAPAYA HERBAL SOAP FOR WHITENING AND SOFT SKIN .

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 07 January 2021. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization from the FDA is prohibited.

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

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

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

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

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

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA-Advisory-No.2021-0046

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2021-0046 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic VG POWER PAPAYA HERBAL SOAP FOR WHITENING AND SOFT SKIN

FDA Advisory No. 2021-0045 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic SHS SIENA HERBAL SOAP COLD PROCESSED TOMATO HERBAL SOAP

The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product, SHS SIENA HERBAL SOAP COLD PROCESSED TOMATO HERBAL SOAP .

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 07 January 2021. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization from the FDA is prohibited.

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

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

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

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

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

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA-Advisory-No.2021-0045

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2021-0045 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic SHS SIENA HERBAL SOAP COLD PROCESSED TOMATO HERBAL SOAP

FDA Advisory No. 2021-0044 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic ANDREA SECRET MYSTERY CHARM P36

The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product, ANDREA SECRET MYSTERY CHARM P36 .

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 07 January 2021. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization from the FDA is prohibited.

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

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

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

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

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

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA-Advisory-No.2021-0044

FDA Advisory No. 2021-0043 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic COCO3 SOAP BAR WITH VIRGIN COCONUT OIL & RICE BRAN OIL

The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product, COCO3 SOAP BAR WITH VIRGIN COCONUT OIL & RICE BRAN OIL .

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 07 January 2021. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization from the FDA is prohibited.

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

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

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

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

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

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA-Advisory-No.2021-0043

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2021-0043 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic COCO3 SOAP BAR WITH VIRGIN COCONUT OIL & RICE BRAN OIL

FDA Advisory No. 2021-0042 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic MUSIC FLOWER FOR ATTRACTIVE LIPS LIP STICK – 109

The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product, MUSIC FLOWER FOR ATTRACTIVE LIPS LIP STICK – 109 .

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 07 January 2021. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization from the FDA is prohibited.

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

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

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

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

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

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA-Advisory-No.2021-0042

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2021-0042 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic MUSIC FLOWER FOR ATTRACTIVE LIPS LIP STICK – 109

FDA Advisory No. 2021-0041 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic TASTE BEAUTY LIP BALM – BAKED RED VELVET CAKE

The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product, TASTE BEAUTY LIP BALM – BAKED RED VELVET CAKE .

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 07 January 2021. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization from the FDA is prohibited.

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

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

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

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

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

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA-Advisory-No.2021-0041

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2021-0041 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic TASTE BEAUTY LIP BALM – BAKED RED VELVET CAKE

FDA Advisory No. 2021-0040 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic SHS SIENA HERBAL SOAP PAPAYA GREEN HERBAL SOAP

The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product, SHS SIENA HERBAL SOAP PAPAYA GREEN HERBAL SOAP.

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 07 January 2021. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization from the FDA is prohibited.

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

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

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

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

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

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA-Advisory-No.2021-0040

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2021-0040 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic SHS SIENA HERBAL SOAP PAPAYA GREEN HERBAL SOAP

FDA Advisory No. 2021-0039 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic TASTE BEAUTY TASTE POPS RASPBERRY & GRAPE FLAVORED LIP GLOSS

The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product, TASTE BEAUTY TASTE POPS RASPBERRY & GRAPE FLAVORED LIP GLOSS .

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 07 January 2021. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization from the FDA is prohibited.

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

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

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

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

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

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA-Advisory-No.2021-0039

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2021-0039 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic TASTE BEAUTY TASTE POPS RASPBERRY & GRAPE FLAVORED LIP GLOSS

FDA Advisory No. 2021-0038 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic TASTE BEAUTY TASTE POPS STRAWBERRY & PINEAPPLE FLAVORED LIP GLOSS

The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product, TASTE BEAUTY TASTE POPS STRAWBERRY & PINEAPPLE FLAVORED LIP GLOSS .

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 07 January 2021. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization from the FDA is prohibited.

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

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

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

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

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

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


Dissemination of this advisory to all concerned is hereby requested..

Attachment:->FDA-Advisory-No.2021-0038

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2021-0038 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic TASTE BEAUTY TASTE POPS STRAWBERRY & PINEAPPLE FLAVORED LIP GLOSS

FDA Advisory No. 2021-0037 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic GENERAL MILLS CINNAMON TOAST CRUNCH FLAVORED LIP BALM

The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product, GENERAL MILLS CINNAMON TOAST CRUNCH FLAVORED LIP BALM .

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 07 January 2021. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization from the FDA is prohibited.

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

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

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

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

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

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

Attachment:-> FDA-Advisory-No.2021-0037

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2021-0037 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic GENERAL MILLS CINNAMON TOAST CRUNCH FLAVORED LIP BALM

FDA Advisory No. 2020-0036 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic TASTE BEAUTY DELICIOUS SUGAR DADDY MILK CARAMEL POPS FLAVORED LIP BALM

The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product, TASTE BEAUTY DELICIOUS SUGAR DADDY MILK CARAMEL POPS FLAVORED LIP BALM.

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 07 January 2021. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization from the FDA is prohibited.

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

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

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

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

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

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

Attachment:-> FDA-Advisory-No.2021-0036

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-0036 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic TASTE BEAUTY DELICIOUS SUGAR DADDY MILK CARAMEL POPS FLAVORED LIP BALM

FDA Advisory No. 2021-0030 || Public Health Warning Against the Purchase and Use of the following Unauthorized Cosmetic Products:

The Food and Drug Administration (FDA) warns the public from purchasing and using the following unauthorized cosmetic products.

1. POUF! EVERYDAY BLOOM COLOGNE SPRAY
2. POUF! EVERYDAY RISE COLOGNE SPRAY
3. POUF! EVERYDAY DUSK COLOGNE SPRAY

The abovementioned product was verified by FDA through post marketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 19 October 2020. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization from the FDA is prohibited.

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

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

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

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

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

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA-Advisory-No.2021-0030

FDA Advisory No. 2020-2184-A || Lifting the Advisory of the Products under FDA Advisory No. 2020-2184 entitled Public Health Warning Against the Purchase and Use of the following Unnotified Medical Device Products: 1. Hisamitsu® Bye-Bye Fever (For Adults) 2. Hisamitsu® Bye-Bye Fever (For Babies)

The Food and Drug Administration (FDA) informs all healthcare professionals and the public that the medical device products mentioned above has Certificate of Exemption (CoE) issued to Hisamitsu Pharmaceutical Co., Inc., Marketing Authorization Holder. Based on FDA Circular No. 2020-001 all Certificate of Exemption for Class A medical devices issued from 25 February 2014 shall remain valid until 03 November 2021 or within 2 years from date of effectivity of this Circular whichever is earlier.

Accordingly, the warning against the purchase and use of the product as mentioned in FDA Advisory No. 2020-2184 is hereby lifted.

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

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

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 befindings 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.2020-2184-A

/ In Device Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-2184-A || Lifting the Advisory of the Products under FDA Advisory No. 2020-2184 entitled Public Health Warning Against the Purchase and Use of the following Unnotified Medical Device Products: 1. Hisamitsu® Bye-Bye Fever (For Adults) 2. Hisamitsu® Bye-Bye Fever (For Babies)

FDA Advisory No. 2021-0104 || Public Health Warning Against the Purchase and Use of Uncertified COVID-19 Test Kits intended for Self-Administration

The Food and Drug Administration (FDA) informs all concerned stakeholders and the general public that to date, there is no FDA Certified COVID-19 Test Kits for Self-Administration.

In light of the foregoing, all healthcare professionals and the general public are advised not to purchase and use these in-vitro devices.

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

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

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

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

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA-Advisory-No.2021-0104

 

/ In Device Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2021-0104 || Public Health Warning Against the Purchase and Use of Uncertified COVID-19 Test Kits intended for Self-Administration