Month: January 2020

FDA Advisory No. 2020-055 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Devices “Condoms in foreign characters”

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

  1. Condoms in foreign characters

The FDA verified through post-marketing surveillance that the abovementioned medical devices are not registered and the Certificates of Product Registration (CPR) have not yet been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered medical devices have not gone through evaluation process of the FDA, the agency cannot assure their quality and safety.

In light of the foregoing, the public is advised not to purchase the violative products in the market.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical devices until CPR are 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 these products are not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of these unregistered products.

For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health and Research through e-mail at [email protected]da.gov.ph, or call (02) 857-1900 loc. 8301.

To report any sale or distribution of unregistered 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:-> FDAAdvisory No.2020-055

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-055 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Devices “Condoms in foreign characters”

FDA Advisory No. 2020-050 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

The Food and Drug Administration (FDA) warns the public from purchasing and consuming the following unregistered food products:

  1. BAHI TURMERIC TEA POWDER
  2. INSTANT GINGER TEA SALABAT
  3. NISHRAN’S INSTANT TURMERIC TEA LUYANG DILAW
  4. NISHRAN’S SALABAT GINGER TEA WITH TURMERIC

The FDA verified through post-marketing surveillance that the abovementioned food products are not authorized and the Certificates of Product Registration have not been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered food products have not gone through evaluation process of the FDA, the agency cannot assure their quality and safety. The use of such violative products may pose health risks to consumers.

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

All concerned establishments are warned not to distribute violative food products until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a CPR for the food product.

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

Kindly contact the FDA Center for Food Regulation and Research through e-mail at [email protected], or call (02) 8857-1900 loc. 8112 & 8104.

To report any sale or distribution of unregistered food product, 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. 2020-050

FDA Advisory No. 2020-049 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

The Food and Drug Administration (FDA) warns the public from purchasing and consuming the following unregistered food products:

  1. PRECIOUS ANGELS MANGOSTEEN TONIC SWEETENED WITH COCONUT SUGAR
  2. PRECIOUS ANGELS TURMERIC TONIC SWEETENED WITH COCONUT SUGAR
  3. PRECIOUS ANGELS LEMONGRASS TONIC SWEETENED WITH COCONUT SUGAR
  4. PRECIOUS ANGELS MALUNNGAY TONIC SWEETENED WITH COCONUT SUGAR
  5. PRECIOUS ANGELS SALABAT TONIC SWEETENED WITH COCONUT SUGAR

The FDA verified through post-marketing surveillance that the abovementioned food products are not authorized and the Certificates of Product Registration have not been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered food products have not gone through evaluation process of the FDA, the agency cannot assure their quality and safety. The use of such violative products may pose health risks to consumers.

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

All concerned establishments are warned not to distribute violative food products until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a CPR for the food product.

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

Kindly contact the FDA Center for Food Regulation and Research through e-mail at [email protected], or call (02) 8857-1900 loc. 8112 & 8104.

To report any sale or distribution of unregistered food product, 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. 2020-049

FDA Advisory No. 2020-048 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

The Food and Drug Administration (FDA) warns the public from purchasing and consuming the following unregistered food products:

  1. MSC FOOD PRODUCTS ASHITABA TEA
  2. MSC FOOD PRODUCTS GUYABANO POWDER
  3. MSC FOOD PRODUCTS GINGER TEA
  4. MSC FOOD PRODUCTS TURMERIC SALABAT

The FDA verified through post-marketing surveillance that the abovementioned food products are not authorized and the Certificates of Product Registration have not been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered food products have not gone through evaluation process of the FDA, the agency cannot assure their quality and safety. The use of such violative products may pose health risks to consumers.

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

All concerned establishments are warned not to distribute violative food products until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a CPR for the food product.

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

Kindly contact the FDA Center for Food Regulation and Research through e-mail at [email protected], or call (02) 8857-1900 loc. 8112 & 8104.

To report any sale or distribution of unregistered food product, 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. 2020-048

FDA Advisory No. 2020-047 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products and Food Supplement:

The Food and Drug Administration (FDA) warns the public from purchasing and consuming the following unregistered food products and food supplement:

  1. 10 PARTY POPS, MINI LOLLIPOP
  2. NARCING’S SPICY SQUID CHIPS
  3. TUBOD’S BEST UPRIGHT BANANA KETCHUP
  4. AL RAJHI FOOD PRODUCTS SUPER TURMERIC DIETARY SUPPLEMENT CAPSULES
  5. GAB’S ROASTED CORN COFFEE WITH MALUNGGAY

The FDA verified through post-marketing surveillance that the above mentioned food product and food supplements are not authorized and the Certificates of Product Registration have not been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered food product and Food Supplements have not gone through evaluation process of the FDA, the agency cannot assure their quality and safety. The use of such violative products may pose health risks to consumers.

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

All concerned establishments are warned not to distribute violative food product and food supplements until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a CPR for the food product.

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

Kindly contact the FDA Center for Food Regulation and Research through e-mail at [email protected], or call (02) 857-1900 loc. 8112 and 8115.

To report any sale or distribution of unregistered food product/food supplement, 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. 2020-047

/ In Food Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-047 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products and Food Supplement:

FDA Advisory No. 2020-042 || Public Health Warning Against the Purchase and Use of Unnotified Toys and Child Care Article (TCCA) product Containing Restricted Ingredient Phthalate:

The Food and Drug Administration (FDA) warns the public from purchasing and using the unnotified and adulterated TCCA product, which was found to contain 8.4 percent of di-(2-ethylhexyl) phthalate (DEHP) and 0.5 percent diisononyl phthalate (DINP). Such ingredients are not allowed to have concentrations of more than 0.1 percent as per Administrative Order No. 2009-005-A s. 2011. (Please see attachment for the particulars of the adulterated TCCA: )

  1. SHRILLING CHICKEN

Potential hazards may come from ingredients that are found to contain beyond the allowable limit of an ingredient such as Phthalate to be part of TCCA products. The use of substandard and possibly adulterated TCCA products may result to health risks including but not limited to endocrine disruption and reproductive or developmental effects in relation to exposure to these compounds.

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

All concerned establishments are warned not to distribute adulterated TCCA products.

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

Kindly contact the FDA Center for Cosmetics Regulation and Research (CCRR) through e­mail at [email protected].ph, or call (02) 857-1900 loc. 8113 or 8107.

To report any sale or distribution of the afore-mentioned TCCA, 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.2020-042

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-042 || Public Health Warning Against the Purchase and Use of Unnotified Toys and Child Care Article (TCCA) product Containing Restricted Ingredient Phthalate:

FDA Advisory No. 2019-171-A || Lifting the Advisory of the Notified Cosmetic Product “PROFESSIONAL SKIN CARE FORMULA BY DR. ALVIN – KOJIC ACID SOAP” under FDA Advisory No. 2019-171 “Public Health Warning Against the Purchase and Use of Unnotified Cosmetic Products” Dated 02 July 2019

The Food and Drug Administration (FDA) informs the public that the cosmetic product Professional Skin Care Formula by Dr. Alvin – Kojic Acid Soap with Notification No. 1000005564474 and has been notified by the Market Authorization Holder (MAH), A.R.M. Skin Essentials Corporation, in accordance with the existing FDA rules and regulations.

Accordingly, the list released in FDA Advisory No. 2019-171 is hereby updated to remove the aforementioned cosmetic product.

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. Kindly contact the FDA Center for Cosmetics Regulation and Research through e-mail at [email protected], or call (02) 8857-1900 loc. 8113 or 8117.

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

The public health warning imposed on the remaining products listed in FDA Advisory No. 2019-171 shall remain to be upheld and shall not be affected by the issuance of this advisory.

Furthermore, the issuance of this advisory shall not in any manner preclude this Office from issuing subsequent orders it may deem necessary and appropriate, should there be findings of any violation of the company to the existing laws, rules, and regulations.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No. 2019-171-A

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-171-A || Lifting the Advisory of the Notified Cosmetic Product “PROFESSIONAL SKIN CARE FORMULA BY DR. ALVIN – KOJIC ACID SOAP” under FDA Advisory No. 2019-171 “Public Health Warning Against the Purchase and Use of Unnotified Cosmetic Products” Dated 02 July 2019

FDA Advisory No. 2019-116-A || Lifting the Advisory of the Notified Cosmetic Product “BREMOD PERFORMANCE SPA HAIR COLOR – 6.1 DARK ASH BLOND” under FDA Advisory No. 2019-116 “Public Health Warning Against the Use of Unnotified Cosmetic Products (Batch 3)” Dated 30 April 2019

The Food and Drug Administration (FDA) informs the public that the cosmetic product Bremod Performance Spa Hair Color – 6.1 Dark Ash Blond with Notification No. 1000003036252, has been notified by the Market Authorization Holder (MAH), Elegant Fumes Beauty Products, Inc., in accordance with existing FDA rules and regulations.

Accordingly, the list released in FDA Advisory No. 2019-116 is hereby updated to remove the aforementioned cosmetic product.

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. Kindly contact the FDA Center for Cosmetics Regulation and Research through e-mail at [email protected], or call (02) 8857-1900 loc. 8113 or 8117.

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

The public health warning imposed on the remaining products listed in FDA Advisory No. 2019-116 shall remain to be upheld and shall not be affected by the issuance of this advisory.

Furthermore, the issuance of this advisory shall not in any manner preclude this Office from issuing subsequent orders it may deem necessary and appropriate, should there be findings of any violation of the company to the existing laws, rules, and regulations.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No. 2019-116-A

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-116-A || Lifting the Advisory of the Notified Cosmetic Product “BREMOD PERFORMANCE SPA HAIR COLOR – 6.1 DARK ASH BLOND” under FDA Advisory No. 2019-116 “Public Health Warning Against the Use of Unnotified Cosmetic Products (Batch 3)” Dated 30 April 2019

FDA Advisory No. 2018-196-C || Lifting the Advisory of the Notified Cosmetic Product “BREMOD PERFORMANCE SPA HAIR COLOR – 6.3 DARK GOLDEN BROWN” under FDA Advisory No. 2018-196 “Public Health Warning Against the Use of Unnotified Cosmetic Products (Batch 9)” Dated 08 June 2018

The Food and Drug Administration (FDA) informs the public that the cosmetic product Bremod Performance Spa Hair Color – 6.3 Dark Golden Brown with Notification No. 1000002046904, has been notified by the Market Authorization Holder (MAH), Elegant Fumes Beauty Products, Inc., in accordance with existing FDA rules and regulations.

Accordingly, the list released in FDA Advisory No. 2018-196 is hereby updated to remove the aforementioned cosmetic product.

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. Kindly contact the FDA Center for Cosmetics Regulation and Research through e-mail at [email protected], or call (02) 8857-1900 loc. 8113 or 8117.

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

The public health warning imposed on the remaining products listed in FDA Advisory No. 2018-196 shall remain to be upheld and shall not be affected by the issuance of this advisory.’

Furthermore, the issuance of this advisory shall not in any manner preclude this Office from issuing subsequent orders it may deem necessary and appropriate, should there be findings of any violation of the company to the existing laws, rules, and regulations.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No. 2018-196-C

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2018-196-C || Lifting the Advisory of the Notified Cosmetic Product “BREMOD PERFORMANCE SPA HAIR COLOR – 6.3 DARK GOLDEN BROWN” under FDA Advisory No. 2018-196 “Public Health Warning Against the Use of Unnotified Cosmetic Products (Batch 9)” Dated 08 June 2018

FDA Advisory No. 2018-196-B || Lifting the Advisory of the Notified Cosmetic Product “BREMOD PERFORMANCE SPA HAIR COLOR – 6.5 COFFEE BROWN” under FDA Advisory No. 2018-196 “Public Health Warning Against the Use of Unnotified Cosmetic Products (Batch 9)” Dated 08 June 2018

The Food and Drug Administration (FDA) informs the public that the cosmetic product Bremod Performance Spa Hair Color – 6.5 Coffee Brown with Notification No. 1000003367332, has been notified by the Market Authorization Holder (MAH), Elegant Fumes Beauty Products, Inc., in accordance with existing FDA rules and regulations.

Accordingly, the list released in FDA Advisory No. 2018-196 is hereby updated to remove the aforementioned cosmetic product.

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. Kindly contact the FDA Center for Cosmetics Regulation and Research through e-mail at [email protected], or call (02) 8857-1900 loc. 8113 or 8117.

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

The public health warning imposed on the remaining products listed in FDA Advisory No. 2018-196 shall remain to be upheld and shall not be affected by the issuance of this advisory.

Furthermore, the issuance of this advisory shall not in any manner preclude this Office from issuing subsequent orders it may deem necessary and appropriate, should there be findings of any violation of the company to the existing laws, rules, and regulations.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No. 2018-196-B

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2018-196-B || Lifting the Advisory of the Notified Cosmetic Product “BREMOD PERFORMANCE SPA HAIR COLOR – 6.5 COFFEE BROWN” under FDA Advisory No. 2018-196 “Public Health Warning Against the Use of Unnotified Cosmetic Products (Batch 9)” Dated 08 June 2018

FDA Advisory No. 2018-007-A || Lifting the Advisory of the Notified Cosmetic Product “BREMOD PERFORMANCE SPA HAIR COLOR – 9.37 LIGHT GOLDEN FLAXEN” under FDA Advisory No. 2018-007 “Public Health Warning Against the Use of Unnotified Cosmetic Products (Batch 68)” Dated 24 January 2018

The Food and Drug Administration (FDA) informs the public that the cosmetic product Bremod Performance Spa Hair Color – 9.37 Light Golden Flaxen with Notification No. 1000002840593, has been notified by the Market Authorization Holder (MAH), Elegant Fumes Beauty Products, Inc., in accordance with existing FDA rules and regulations.

Accordingly, the list released in FDA Advisory No. 2018-007 is hereby updated to remove the aforementioned cosmetic product.

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. Kindly contact the FDA Center for Cosmetics Regulation and Research through e-mail at [email protected], or call (02) 8857-1900 loc. 8113 or 8117.

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

The public health warning imposed on the remaining products listed in FDA Advisory No. 2018-007 shall remain to be upheld and shall not be affected by the issuance of this advisory.

Furthermore, the issuance of this advisory shall not in any manner preclude this Office from issuing subsequent orders it may deem necessary and appropriate, should there be findings of any violation of the company to the existing laws, rules, and regulations.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No. 2018-007-A

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2018-007-A || Lifting the Advisory of the Notified Cosmetic Product “BREMOD PERFORMANCE SPA HAIR COLOR – 9.37 LIGHT GOLDEN FLAXEN” under FDA Advisory No. 2018-007 “Public Health Warning Against the Use of Unnotified Cosmetic Products (Batch 68)” Dated 24 January 2018

FDA Advisory No. 2020-054 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “Whiter Smile Home Teeth Whitening Kit”

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

  1. Whiter Smile Home Teeth Whitening Kit”

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

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

In light of the foregoing, the public is advised not to purchase the violative product in the market.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device until CPR 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 areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of this unregistered 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) 857-1900 loc. 8301.                                                                   

To report any sale or distribution of unregistered 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.2020-054

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-054 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “Whiter Smile Home Teeth Whitening Kit”

FDA Advisory No. 2020-053 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “MC-246 Digital Pencil Thermometer”

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

  1. “MC-246 Digital Pencil Thermometer”

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

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

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

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

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

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

Dissemination of the information to all concerned is requested.

Attachment:-> FDA Advisory No.2020-053

FDA Advisory No. 2020-052 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplements:

The Food and Drug Administration (FDA) warns the public from purchasing and consuming the following unregistered food supplements:

  1. A-POTENE™ Beta-Carotene Dietary Supplement Softgels
  2. NATUREWISE Green Coffee Bean Extract 800mg Dietary Supplement Vegetarian Capsules
  3. SHISEIDO Habit Slimming Capsule
  4. DETOXIC8 Cascara Sagrada + Psyllium Husk/Seed + Flaxseed Food Supplement Capsules
  5. NATURE’S BOUNTY OPTIMAL SOLUTIONS Hair, Skin & Nails Gummies with Biotin 2500mcg per serving Skin & Hair Nutrients – Strawberry Flavored Gummies

The FDA verified through post-marketing surveillance that the abovementioned food supplements are not authorized and the Certificates of Product Registration have not been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered food supplements have not gone through evaluation process of the FDA, the agency cannot assure their quality and safety. The use of such violative products may pose health risks to consumers.

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

All concerned establishments are warned not to distribute violative food supplement until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a CPR for the food supplement.

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

Kindly contact the FDA Center for Food Regulation and Research through e-mail at [email protected], or call (02) 8857-1900 loc. 8112 & 8104.

To report any sale or distribution of unregistered food supplement, 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. 2020-052

FDA Advisory No. 2020-051 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

The Food and Drug Administration (FDA) warns the public from purchasing and consuming the following unregistered food products:

  1. AMBULONG SLP ASSOCIATION Young Coconut Meat Bukayo Sweetened Coconut
  2. YA YAMMY DELICACIES Dilis Crispy Fried Anchovy
  3. YA YAMMY DELICACIES Ready to Eat Spicy Pusit
  4. L&T LYN’S Sweet Tamarind
  5. ALING TINDING’S Extra Crunchy Garlic Bits

The FDA verified through post-marketing surveillance that the abovementioned food products are not authorized and the Certificates of Product Registration have not been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered food products have not gone through evaluation process of the FDA, the agency cannot assure their quality and safety. The use of such violative products may pose health risks to consumers.

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

All concerned establishments are warned not to distribute violative food products until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a CPR for the food product.

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

Kindly contact the FDA Center for Food Regulation and Research through e-mail at [email protected], or call (02) 8857-1900 loc. 8112 & 8104.

To report any sale or distribution of unregistered food product, 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. 2020-051

FDA Advisory No. 2020-046 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplements:

The Food and Drug Administration (FDA) warns the public from purchasing and consuming the following unregistered food supplements:

  1. NATURE’S BOUNTY OPTIMAL SOLUTIONS Extra Strength Hair, Skin & Nails Argan Oil Infused 5000mcg Biotin per Serving Antioxidants A, C & E plus Hyaluronic Acid Multivitamin Supplement Liquid Softgels
  2. NATURE’S BOUNTY Garcinia Cambogia & Coconut Oil Dietary Supplements Coated Softgels
  3. NATURE’S BOUNTY Fish Oil 1400mg 980mg of Omega-3 Dietary Supplement Softgels
  4. NATURE’S BOUNTY Super B-Complex with Folic Acid Plus Vitamin C Vitamin Supplement Coated Tablets
  5. NATURE’S BOUNTY B-12 Methylcobalamin 2500 mcg Vitamin Supplement Quick Dissolve Tablets

The FDA verified through post-marketing surveillance that the abovementioned food supplements are not authorized and the Certificates of Product Registration have not been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered food supplements have not gone through evaluation process of the FDA, the agency cannot assure their quality and safety. The use of such violative products may pose health risks to consumers.

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

All concerned establishments are warned not to distribute violative food supplement until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a CPR for the food supplement.

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

Kindly contact the FDA Center for Food Regulation and Research through e-mail at [email protected], or call (02) 8857-1900 loc. 8112 & 8104.

To report any sale or distribution of unregistered food supplement, 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. 2020-046

FDA Advisory No. 2020-045 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplements:

The Food and Drug Administration (FDA) warns the public from purchasing and consuming the following unregistered food supplements:

  1. NATURE’S BOUNTY Evening Primrose 1000mg Herbal Supplement Softgels
  2. NATURE’S BOUNTY C 1000mg Vitamin Supplement Caplet
  3. NATURE’S BOUNTY OPTIMAL SOLUTIONS Advanced Verisol + Collagen Dietary Supplement Caplets
  4. NATURE’S BOUNTY Calcium 1200mg Plus 1000 IU Vitamin D3 Mineral Supplement Softgels
  5. NATURE’S BOUNTY D3 5000 IU Vitamin Supplement Softgels

The FDA verified through post-marketing surveillance that the abovementioned food supplements are not authorized and the Certificates of Product Registration have not been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered food supplements have not gone through evaluation process of the FDA, the agency cannot assure their quality and safety. The use of such violative products may pose health risks to consumers.

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

All concerned establishments are warned not to distribute violative food supplement until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a CPR for the food supplement.

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

Kindly contact the FDA Center for Food Regulation and Research through e-mail at [email protected], or call (02) 8857-1900 loc. 8112 & 8104.

To report any sale or distribution of unregistered food supplement, 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. 2020-045

FDA Advisory No. 2020-044 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplements:

The Food and Drug Administration (FDA) warns the public from purchasing and consuming the following unregistered food supplements:

  1. NATURE’S BOUNTY Biotin 1000mcg Vitamin Supplement Coated Tablets
  2. NATURE’S BOUNTY Ultra Strength Probiotic 10 Dietary Supplement Capsule
  3. NATURE’S BOUNTY St. John’s Wort 300mg Herbal Supplement Capsules
  4. NATURE’S BOUNTY OPTIMAL SOLUTION Women’s Multivitamins with Collagen 50mg Dietary Supplement – Raspberry Flavored Gummies
  5. NATURE’S BOUNTY B-Complex Dietary Supplement Sublingual Liquid

The FDA verified through post-marketing surveillance that the abovementioned food supplements are not authorized and the Certificates of Product Registration have not been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered food supplements have not gone through evaluation process of the FDA, the agency cannot assure their quality and safety. The use of such violative products may pose health risks to consumers.

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

All concerned establishments are warned not to distribute violative food supplement until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a CPR for the food supplement.

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

Kindly contact the FDA Center for Food Regulation and Research through e-mail at [email protected], or call (02) 8857-1900 loc. 8112 & 8104.

To report any sale or distribution of unregistered food supplement, 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. 2020-044

FDA Advisory No. 2020-043 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplements:

The Food and Drug Administration (FDA) warns the public from purchasing and consuming the following unregistered food supplements:

  1. NATURE’S BOUNTY Ginkgo Biloba 60mg Herbal Supplement Capsules
  2. NATURE’S BOUNTY Maximum Strength Folic Acid 800mcg Vitamin Supplement Tablet
  3. NATURE’S BOUNTY Iron 65mg (325mg Ferrous Sulfate) Mineral Supplement Tablets
  4. NATURE’S BOUNTY Vitamin E-Oil 30,000 IU Vitamin Supplement
  5. NATURE’S BOUNTY Cranberry Fruit 4200mg with Vitamin C Herbal Supplement Softgels

The FDA verified through post-marketing surveillance that the abovementioned food supplements are not authorized and the Certificates of Product Registration have not been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered food supplements have not gone through evaluation process of the FDA, the agency cannot assure their quality and safety. The use of such violative products may pose health risks to consumers.

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

All concerned establishments are warned not to distribute violative food supplement until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a CPR for the food supplement.

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

Kindly contact the FDA Center for Food Regulation and Research through e-mail at [email protected], or call (02) 8857-1900 loc. 8112 & 8104.

To report any sale or distribution of unregistered food supplement, 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. 2020-043

Department Circular No. 2019-0319 || Adoption of Food Category System and Descriptor of the General Standard for Food Additives (Codex Stan 192-1995, Rev 2018 or Latest)

to continue reading, click the attachment below…

Attachment:-> Department Circular No. 2019-0319

/ In General Announcements / By Administrator / Comments Off on Department Circular No. 2019-0319 || Adoption of Food Category System and Descriptor of the General Standard for Food Additives (Codex Stan 192-1995, Rev 2018 or Latest)

FDA CIRCULAR NO. 2020-001 || Initial Implementation of Administrative Order No. 2018-0002 “Guidelines Governing the Issuance of an Authorization for a Medical Device Based on the ASEAN Harmonized Technical Requirements”

to continue reading, click the attachment below…

Attachment:-> FDA CIRCULAR NO.2020-001

/ In Circular / By Administrator / Comments Off on FDA CIRCULAR NO. 2020-001 || Initial Implementation of Administrative Order No. 2018-0002 “Guidelines Governing the Issuance of an Authorization for a Medical Device Based on the ASEAN Harmonized Technical Requirements”

FDA Advisory No. 2020-041 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplements:

The Food and Drug Administration (FDA) advises the public from purchasing and consuming the following unregistered food supplements:

  1. BOWTROL PROBIOTICS 9 BILLION MICROORGANISMS HERBAL SUPPLEMENT
  2. ROCHWAY BIO-FERMENTED PAPAYA LEAF EXTRACT
  3. BIO SCWARTZ TURMERIC CURCUMIN WITH BIOPERINE
  4. PURE SYNERGY STRESS REMEDY DAILY SUPPORT FOR STRESS RELIEF DIETARY SUPPLEMENT
  5. HERBAL PHARMACY AMAZING GC GARCINIA CAMBOGIA 100% PURE

The FDA verified through post-marketing surveillance that the abovementioned food supplements are not authorized and the Certificates of Product Registration (CPR) have not been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered food supplements have not gone through evaluation process of the FDA, the agency cannot assure their quality and safety. The consumption of such violative products may pose health risks to consumers.

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

All concerned establishments are warned not to distribute violative food supplements until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a CPR for the food supplements.

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

Kindly contact the FDA Center for Food Regulation and Research through e-mail at [email protected], or call (02) 857-1900 loc. 8112 or 8105.

To report any sale or distribution of unregistered food products, 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. 2020-041

FDA Advisory No. 2020-039 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplements:

The Food and Drug Administration (FDA) advises the public from purchasing and consuming the following unregistered food supplements:

  1. LEANHEALTH GARCINIA CAMBOGIA ULTRA SLIM
  2. NUTRI HERBS GINGKO BILOBA DIETARY SUPPLEMENT
  3. NUTRI HERBS DETOX DIETARY SUPPLEMENT
  4. MALUNGGAY (MORINGA) CAPSULES
  5. HERB’S CENTRAL GRAPE SEED OIL EXTRACT

The FDA verified through post-marketing surveillance that the abovementioned food supplements are not authorized and the Certificates of Product Registration (CPR) have not been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered food supplements have not gone through evaluation process of the FDA, the agency cannot assure their quality and safety. The consumption of such violative products may pose health risks to consumers.

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

All concerned establishments are warned not to distribute violative food supplements until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a CPR for the food supplements.

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

Kindly contact the FDA Center for Food Regulation and Research through e-mail at [email protected], or call (02) 857-1900 loc. 8112 or 8105.

To report any sale or distribution of unregistered food products, 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. 2020-039

FDA Advisory No. 2020-037 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

The Food and Drug Administration (FDA) advises the public from purchasing and consuming the following unregistered food products:

  1. NONI 100%  NONI JUICE
  2. CREME DE MENTHE GREEN WALSH LIQUEUR
  3. VICENTE GANDIA WHITE WINE, VINO BLANCO 12.5% VOLUME
  4. RICHMAN-C PURE CALAMANSI JUICE

The FDA verified through post-marketing surveillance that the abovementioned food products are not authorized and the Certificates of Product Registration (CPR) have not been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered food products have not gone through evaluation process of the FDA, the agency cannot assure their quality and safety. The consumption of such violative products may pose health risks to consumers.

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

All concerned establishments are warned not to distribute violative food products until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a CPR for the food products.

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

Kindly contact the FDA Center for Food Regulation and Research through e-mail at [email protected], or call (02) 857-1900 loc. 8112 or 8105.

To report any sale or distribution of unregistered food products, 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. 2020-037

FDA Advisory No. 2020-036 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplement and Food Products:

The Food and Drug Administration (FDA) warns the public from purchasing and consuming the following unregistered food supplement and food products:

  1. AMPALAYA BITTER MELON DIETARY FOOD SUPPLEMENT
  2. JADE ROEL SEVEN IN ONE POWDER
  3. TIEL’S FOOD PRODUCTS INSTANT SALABAT
  4. CRAFTS OF BORACAY BANANA CRACKERS
  5. GERBERTS PURE AND FRESH KALAMANSI JUICE

The FDA verified through post-marketing surveillance that the above mentioned food product and Food Supplements are not authorized and the Certificates of Product Registration have not been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered food product and Food Supplements have not gone through evaluation process of the FDA, the agency cannot assure their quality and safety. The use of such violative products may pose health risks to consumers.

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

All concerned establishments are warned not to distribute violative food product and food supplements until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a CPR for the food product.

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

Kindly contact the FDA Center for Food Regulation and Research through e-mail at [email protected], or call (02) 857-1900 loc. 8112 and 8115.

To report any sale or distribution of unregistered food product/food supplement, 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. 2020-036

/ In Food Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-036 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplement and Food Products:

FDA Advisory No. 2020-032 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplement and Products:

The Food and Drug Administration (FDA) warns the public from purchasing and consuming the following unregistered food supplement and food products:

  1. FARMITY APPLE CIDER VINEGAR POWDER DIETARY SUPPLEMENT
  2. KOREAN GINSENG TEA
  3. SEMPIO GREEN TEA WITH BROWN RICE
  4. GOLDYFOODS DELICIOUS SAMPALOC
  5. AMAZING DRAGON FRUIT SUPER MIX JUICE

The FDA verified through post-marketing surveillance that the above mentioned food products and Food Supplement are not authorized and the Certificates of Product Registration have not been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered food product and Food Supplements have not gone through evaluation process of the FDA, the agency cannot assure their quality and safety. The use of such violative products may pose health risks to consumers.

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

All concerned establishments are warned not to distribute violative food product and food supplements until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a CPR for the food product.

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

Kindly contact the FDA Center for Food Regulation and Research through e-mail at [email protected], or call (02) 857-1900 loc. 8112 and 8115.

To report any sale or distribution of unregistered food product/food supplement, 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. 2020-032

/ In Food Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-032 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplement and Products:

FDA Advisory No. 2020-040 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

The Food and Drug Administration (FDA) advises the public from purchasing and consuming the following unregistered food products:

  1. CANDY BOY® Strawberry Fruity Flavor Stick
  2. DUKE’S Curvy Cups Premium Milk Chocolate
  3. MINIONS Bubble gum with Tattoo inside
  4. SUGARKING™ Pencil Stick Candy
  5. OK® Meteor Garden Mix Snack – Spicy Barbeque Flavor

The FDA verified through post-marketing surveillance that the abovementioned food products are not authorized and the Certificates of Product Registration (CPR) have not been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered food products have not gone through evaluation process of the FDA, the agency cannot assure their quality and safety. The consumption of such violative products may pose health risks to consumers.

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

All concerned establishments are warned not to distribute violative food products until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a CPR for the food products.

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

Kindly contact the FDA Center for Food Regulation and Research through e-mail at [email protected], or call (02) 857-1900 loc. 8112 or 8105.

To report any sale or distribution of unregistered food products, 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. 2020-040

FDA Advisory No. 2020-038 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

The Food and Drug Administration (FDA) advises the public from purchasing and consuming the following unregistered food products:

  1. MASIRAM Instant Salabat with Turmeric
  2. MASIRAM Instant Salabat
  3. BRICS 7 in 1 Turmeric Brew Plus
  4. HEALTHY TROPICS Philippine Sambong & Banaba Leaf Tea with Stevia Leaves
  5. DETOXYLITE SweetLeaf Café Trim

The FDA verified through post-marketing surveillance that the abovementioned food products are not authorized and the Certificates of Product Registration (CPR) have not been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered food products have not gone through evaluation process of the FDA, the agency cannot assure their quality and safety. The consumption of such violative products may pose health risks to consumers.

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

All concerned establishments are warned not to distribute violative food products until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a CPR for the food products.

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

Kindly contact the FDA Center for Food Regulation and Research through e-mail at [email protected], or call (02) 857-1900 loc. 8112 or 8105.

To report any sale or distribution of unregistered food products, 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. 2020-038

FDA Advisory No. 2020-035 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

The Food and Drug Administration (FDA) advises the public from purchasing and consuming the following unregistered food products:

  1. ROMEO & JULIET Native Coffee Bee
  2. POPTOYS Lollipop and Toy
  3. CB Candy Mix
  4. CANDY LAND Egg Toy with Candy
  5. YA YAMMY DELICACIES Watermelon Seeds

The FDA verified through post-marketing surveillance that the abovementioned food products are not authorized and the Certificates of Product Registration (CPR) have not been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered food products have not gone through evaluation process of the FDA, the agency cannot assure their quality and safety. The consumption of such violative products may pose health risks to consumers.

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

All concerned establishments are warned not to distribute violative food products until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a CPR for the food products.

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

Kindly contact the FDA Center for Food Regulation and Research through e-mail at [email protected], or call (02) 857-1900 loc. 8112 or 8105.

To report any sale or distribution of unregistered food products, 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. 2020-035

FDA Advisory No. 2020-034 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplements:

The Food and Drug Administration (FDA) advises the public from purchasing and consuming the following unregistered food supplements:

  1. VIMERSON HEALTH Natural Sleep Aid Dietary Supplement
  2. RESTORE Mineral Supplement
  3. NUTRICOLOGY Pancreas Natural Glandular Dietary Supplement
  4. PUREST VANTAGE D-Mannose with Cranberry and Dandelion Extract Dietary Supplement

The FDA verified through post-marketing surveillance that the abovementioned food supplements are not authorized and the Certificates of Product Registration (CPR) have not been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered food supplements have not gone through evaluation process of the FDA, the agency cannot assure their quality and safety. The consumption of such violative products may pose health risks to consumers.

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

All concerned establishments are warned not to distribute violative food supplements until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a CPR for the food supplements.

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

Kindly contact the FDA Center for Food Regulation and Research through e-mail at [email protected], or call (02) 857-1900 loc. 8112 or 8105.

To report any sale or distribution of unregistered food products, 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. 2020-034