Month: October 2020

FDA has released a total of 303 COVID – 19 Test Kits (106 – PCR based, 99 – Rapid Antibody, 65 – Immunoassay and 33 – Others)

As of 30 October 2020, FDA has released a total of 303 COVID – 19 Test Kits (106 – PCR based, 99 – Rapid Antibody, 65 – Immunoassay and 33 – Others)

Click the link below for details.

https://bit.ly/2Zd0CZ4

FDA Advisory No. 2020-1955 || Public Health Warning Against the Purchase and Use of the Unnotified Medical Device Product “ZOCN DISPOSABLE FACE MASK FOR ADULT”

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

The FDA verified through post-marketing surveillance that the above-mentioned medical device product is not notified and no corresponding Product Notification Certificate has been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since this unnotified medical device product has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.  

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

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

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

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

To report any sale or distribution of unnotified medical device, 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.2020-1955

Guidelines on Compliance with Section 35 (b) of Republic Act No. 11223 (Universal Health Care Act) by All Drug, Medical Device, Biological and Medical Supplies Manufacturers to Submit Reports on Disclosure of Financial Relationships with Health Care Providers and Health Care Professionals

All comments can be sent at [email protected].

  1. BACKGROUND

The 1987 Philippine Constitution declares that it is the policy of the State to protect and promote the right to health of the people and instill health consciousness among them.  Consistent with the national health policy, the President of the Philippines signed into law, on February 20, 2019, Republic Act No. 11223 (RA 11223), otherwise known as the Universal Health Care Act (UHC law), which was passed by the 17th Congress of the Philippines.  The provisions of the UHC law seeks “to progressively realize universal health care in the country through a systemic approach and clear delineation of roles of key agencies and stakeholders towards better performance in the health system and to ensure that all Filipinos are guaranteed equitable access to quality and affordable health care goods and services, and protected against financial risk.”

Under item b of Section 35 on Ethics in Public Health Policy and Practice, the UHC law mandates that “all manufacturers of drugs, medical devices, biological and medical supplies registered by the FDA shall collect and track all financial relationships with health care professionals and health care providers and report these to the DOH.”  On October 10, 2019, the Secretary of Health signed the Implementing Rules and Regulation (IRR) of the RA 11223, which included the IRR for Section 35. Declaration of financial relationships between manufacturers of health products and health care providers and professionals has public health importance and value. Clinical evaluation and approval of innovative health products, including formulation of regulatory policies, are more efficient when conflicts of interest are addressed and managed through transparency and disclosures.

Read more:-> DRAFT AO Financial Relationship Manufacturer and HCPs for Posting

FDA Advisory No. 2020-1951 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic SECURE ALL IN ONE SKIN SUPPLEMENT BATH SOAP

The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product, SECURE ALL IN ONE SKIN SUPPLEMENT BATH SOAP .

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 21 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.2020-1951

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-1951 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic SECURE ALL IN ONE SKIN SUPPLEMENT BATH SOAP

FDA Advisory No. 2020-1950 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic LOVALI EXCELLENT VARSACE EROS EAU DE PARFUM NATYRAL SPRAY VAPORISATEUR (NO. 6156-17)

The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product, LOVALI EXCELLENT VARSACE EROS EAU DE PARFUM NATYRAL SPRAY VAPORISATEUR (NO. 6156-17).

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 08 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.2020-1950

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-1950 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic LOVALI EXCELLENT VARSACE EROS EAU DE PARFUM NATYRAL SPRAY VAPORISATEUR (NO. 6156-17)

FDA Advisory No. 2020-1949 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic LOVALI EXCELLENT INVITATION VIP POUR HOME 1 MILLION DEODORANT ROLLON/EFFECTIVE 24H (NO. 6015-1)

The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product, LOVALI EXCELLENT INVITATION VIP POUR HOME 1 MILLION DEODORANT ROLLON/EFFECTIVE 24H (NO. 6015-1).

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 08 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.2020-1949

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-1949 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic LOVALI EXCELLENT INVITATION VIP POUR HOME 1 MILLION DEODORANT ROLLON/EFFECTIVE 24H (NO. 6015-1)

FDA Advisory No. 2020-1948 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic DAISO JAPAN EYEBROW GEL (CLEAR)

The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product, DAISO JAPAN EYEBROW GEL (CLEAR).

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 08 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.2020-1948

FDA Advisory No. 2020-1947 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic LA ‘SEINE SKIN CARE SERIES PAPAYA BODY BAR

The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product, LA ‘SEINE SKIN CARE SERIES PAPAYA BODY BAR.

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 08 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.2020-1947

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-1947 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic LA ‘SEINE SKIN CARE SERIES PAPAYA BODY BAR

FDA Advisory No. 2020-1946 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic HAN RUI CC CREAM WHITENING SUN-SCREEN ANTI-OXIDATION MULTI EFFECT 1 (BTY-028)

The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product, HAN RUI CC CREAM WHITENING SUN-SCREEN ANTI-OXIDATION MULTI EFFECT 1 (BTY-028).

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 22 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.2020-1946

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-1946 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic HAN RUI CC CREAM WHITENING SUN-SCREEN ANTI-OXIDATION MULTI EFFECT 1 (BTY-028)

FDA Advisory No. 2020-1945 || Public Health Warning Against the Purchase and Use of the Non-Compliant Cosmetic Product ” TOV CH HAIR COLOR CREAM PERMANENT HAIR COLOR 7.33 GOLD YELLOW “

The Food and Drug Administration (FDA) warns the general public from purchasing and using the non-compliant cosmetic product, ” TOV CH HAIR COLOR CREAM PERMANENT HAIR COLOR 7.33 GOLD YELLOW “.

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, thus, a new notification will have to be submitted.

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.2020-1945

 

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-1945 || Public Health Warning Against the Purchase and Use of the Non-Compliant Cosmetic Product ” TOV CH HAIR COLOR CREAM PERMANENT HAIR COLOR 7.33 GOLD YELLOW “

FDA Advisory No. 2020-1944 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic ANDREA SECRET FRAGRANCE MIST PEAR TEMPTATION

The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product, ANDREA SECRET FRAGRANCE MIST PEAR TEMPTATION

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 21 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.2020-1944

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-1944 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic ANDREA SECRET FRAGRANCE MIST PEAR TEMPTATION

FDA Advisory No. 2020-1943 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic Product “JESSY & CO. LIP TINT”

The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product “JESSY & CO. LIP TINT”.

The abovementioned product was verified by FDA through post marketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 23 September 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.

Read more:-> FDA-Advisory-No.2020-1943

FDA Advisory No. 2020-1942 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic ELEGANT SKIN BY DP SKIN TOUCH GEL TONER AND MAKE-UP REMOVER

The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product, ELEGANT SKIN BY DP SKIN TOUCH GEL TONER AND MAKE-UP REMOVER .

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 20 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.

Attachment:->  FDA-Advisory-No.2020-1942

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-1942 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic ELEGANT SKIN BY DP SKIN TOUCH GEL TONER AND MAKE-UP REMOVER

FDA Advisory No. 2020-1941 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic ELEGANT SKIN BY DP SKIN TOUCH INSTANT MAGIC LOTION

The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product, ELEGANT SKIN BY DP SKIN TOUCH INSTANT MAGIC LOTION .

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 20 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.

Attachment:->  FDA-Advisory-No.2020-1941

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-1941 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic ELEGANT SKIN BY DP SKIN TOUCH INSTANT MAGIC LOTION

FDA Advisory No. 2020-1940 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic ELEGANT SKIN BY DP SKIN TOUCH MASCULINE SOAP

The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product, ELEGANT SKIN BY DP SKIN TOUCH MASCULINE SOAP .

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 13 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.

Attachment:->  FDA-Advisory-No.2020-1940

FDA Advisory No. 2020-1939 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic ELEGANT SKIN BY DP SKIN TOUCH WHITE SKIN BRIGHTENING LOTION

The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product, ELEGANT SKIN BY DP SKIN TOUCH WHITE SKIN BRIGHTENING LOTION .

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 20 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.

Attachment:->  FDA-Advisory-No.2020-1939

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-1939 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic ELEGANT SKIN BY DP SKIN TOUCH WHITE SKIN BRIGHTENING LOTION

FDA Advisory No. 2020-1938 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic FEET BLACK HAIR SHAMPOO

The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product, FEET BLACK HAIR SHAMPOO .

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 20 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.

Attachment:->  FDA-Advisory-No.2020-1938

FDA Advisory No. 2020-1937 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic CHARM LIMIT NAIL POLISH REMOVER

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

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 20 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.

Attachment:->  FDA-Advisory-No.2020-1937

FDA Advisory No. 2020-1936 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic VERDON NE SILKY NATURAL ORGANIC 1 MINUTE MILK KERATIN

The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product, VERDON NE SILKY NATURAL ORGANIC 1 MINUTE MILK KERATIN .

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 20 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.

Attachment:->  FDA-Advisory-No.2020-1936

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-1936 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic VERDON NE SILKY NATURAL ORGANIC 1 MINUTE MILK KERATIN

FDA Advisory No. 2020-1935 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic VERDON NE SILKY NATURAL ORGANIC 1 MINUTE ARGAN OIL KERATIN

The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product, VERDON NE SILKY NATURAL ORGANIC 1 MINUTE ARGAN OIL KERATIN .

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 20 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.

Attachment:->  FDA-Advisory-No.2020-1935

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-1935 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic VERDON NE SILKY NATURAL ORGANIC 1 MINUTE ARGAN OIL KERATIN

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

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

FDA Advisory No. 2020-1934 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic SKIN EXPERTS SECRETS GLOWING NIGHT CREAM PREMIUM

The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product, SKIN EXPERTS SECRETS GLOWING NIGHT CREAM PREMIUM .

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 20 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.

Read more:-> FDA-Advisory-No.2020-1934

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-1934 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic SKIN EXPERTS SECRETS GLOWING NIGHT CREAM PREMIUM

FDA Advisory No. 2020-1775-A || Lifting the Advisory on the Notified Cosmetic Product “MEDIHEAL R:NA BRIGHTENING MASK PROATIN MASK (CREAMY SERUM BRIGHTENING MASK)” under FDA Advisory No. 2020-1775 “Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic MEDIHEAL R:NA PROATIN MASK” Dated 28 SEPTEMBER 2020

The Food and Drug Administration (FDA) informs the public that the Cosmetic product MEDIHEAL R:NA BRIGHTENING MASK PROATIN MASK (CREAMY SERUM BRIGHTENING MASK with Notification No. 1000002604739 and 1000006903452, has been notified by the Market Authorization Holder, Genson Distribution Inc., in accordance with existing FDA rules and regulations.

Accordingly, the warning against the purchase and use of the subject product as mentioned in FDA Advisory No. 2020-1775 and FDA Order No. 2020-1239 is hereby lifted.

The public is advised to always check if a Cosmetic product is notified with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing. For more information or inquiries, please email us at [email protected] or [email protected]. You may also call the Center for Cosmetics Regulation and Research at telephone number (02) 8857-1900 loc. 8113 or 8117.

To report the sale or distribution of any unnotified/unregistered health products, kindly email FDA via [email protected].

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.2020-1775-A

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-1775-A || Lifting the Advisory on the Notified Cosmetic Product “MEDIHEAL R:NA BRIGHTENING MASK PROATIN MASK (CREAMY SERUM BRIGHTENING MASK)” under FDA Advisory No. 2020-1775 “Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic MEDIHEAL R:NA PROATIN MASK” Dated 28 SEPTEMBER 2020

 System Maintenance 29 October 2020

The Food and Drug Administration (FDA) Policy and Planning Service- Information and Communication Technology Management Division (PPS-ICTMD) will conduct a scheduled system maintenance on 30 October 2020, 7:00 PM.

With this, we regret to inform you that the ePortal and eServices systems will be temporarily unavailable and will be restored on 03 November 2020,7:00 AM for regular business operations.

We sincerely apologize for any inconvenience this may cause.

Attachment:->  System Maintenance 29 October 2020

Full Implementation of Eservices Portal System for License to Operate (LTO) Application of Drug Distributor, Drug Trader, Drugstore, RONPD, CRO, and Sponsor

Read more:-> Full Implementation of Eservices Portal System for License to Operate (LTO) Application of Drug Distributor, Drug Trader, Drugstore, RONPD, CRO, and Sponsor

FDA Advisory No. 2020-1730-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng mga Hindi Rehistradong Gamot na:

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

1. OTC 111 Yishen Wan [as reflected in the package insert and primary packaging]
2. BAILI PHARM CO. Ribavirin Granules 50mg
3. Miejun Zhusheyong Shui 5ml
4. OTC Weitai “999” granule Sanjiu Weitai Keli [as reflected in the package insert]

Napatunayan sa pamamagitan ng isinagawang Post-Marketing Surveillance (PMS) ng FDA na ang mga nasabing gamot ay hindi dumaan sa proseso ng rehistrasyon ng Ahensya at hindi nabigyan ng kaukulang awtorisasyon tulad ng Certificate of Product Registration (CPR). Dahil dito, hindi masisiguro ng Ahensya ang kalidad, kaligtasan at bisa nito. Samakatuwid, ang paggamit ng nasabing mga iligal na produkto ay maaaring magdulot ng panganib sa kalusugan.

Alinsunod sa Republic Act No. 9711, o ang Food and Drug Administration Act of 2009, ang paggawa, pag-angkat, pagbenta, pamamahagi, paglipat, promosyon, pagpapatalastas o sponsorship ng produktong pangkalusugan nang walang kaukulang awtorisasyon mula sa FDA ay ipinagbabawal.

Ang lahat ng establisyamento at/o entidad ay binabalaang huwag mamahagi ng nasabing mga iligal na produkto hanggang sa ito ay mabigyan ng kaukulang awtorisasyon. Karampatang parusa ay mahigpit na ipatutupad sa mga lalabag.

Hinihiling sa lahat ng Local Government Units (LGUs) at Law Enforcement Agencies (LEAs) na tiyaking ang mga produktong ito ay hindi maibebenta o magagamit sa kanilang mga nasasakupan.

Para sa karagdagang impormasyon at katanungan, maaaring mag-email sa [email protected]. Upang mag-report ng patuloy na pagtitinda o pangangalakal ng mga hindi rehistradong gamot, mag-email sa [email protected]. Maaari ring tumawag sa Center for Drug Regulation and Research (CDRR) sa numerong (02) 8809-5596.  Para sa mga hinihinalang hindi kanais-nais na reaksyon sa gamot, i-report agad sa FDA gamit ang link na ito: https://primary reporting.who-umc.org/Reporting/Reporter?OrganizationID=PH at kumpletuhin ang mga kinakailangang impormasyon.

Ang lahat ay hinihikayat na palaganapin ang mga nakasaad na impormasyon.

Attachment:-> FDA-Advisory-No.2020-1730-A