Month: January 2021

FDA Advisory No.2021-0139-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. Golden Sun Cefradine Capsules 0.25 g
2. OTC San Huang Pian
3. Refined Sea-Horse Expelling Rheumatism Plaster
4. Junmiao Tang Tong Jing Tie
5. OTC Rohto Compound Taurine Eye Drops-Fufang Niuhuang Suan Diyanye [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 info@fda.gov.ph. Upang mag-report ng patuloy na pagtitinda o pangangalakal ng mga hindi rehistradong gamot, mag-email sa ereport@fda.gov.ph. 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.2021-0139-A

FDA Advisory No.2021-0139 || Public Health Warning Against the Purchase and Use of the Following Unregistered Drug Products:

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

1. Golden Sun Cefradine Capsules 0.25 g
2. OTC San Huang Pian
3. Refined Sea-Horse Expelling Rheumatism Plaster
4. Junmiao Tang Tong Jing Tie
5. OTC Rohto Compound Taurine Eye Drops-Fufang Niuhuang Suan Diyanye [as reflected in the package insert]

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug products have not gone through the registration process of the Agency and have not been issued with proper authorization in the form of Certificate of Product Registration. Thus, the Agency cannot guarantee its quality, safety and efficacy. Therefore, consumption of such violative products may pose potential danger or injury to health.

Pursuant to Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, promotion, advertising or sponsorship of health products without proper authorization from FDA is prohibited.

All concerned establishments and/or entities are warned not to distribute the above-identified violative drug 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 these products are not sold or made available in their localities or areas of jurisdiction.

For more information and inquiries, please e-mail us at info@fda.gov.ph. To report continuous sale or distribution of unregistered health products, kindly e-mail us via ereport@fda.gov.ph. You may also call the Center for Drug Regulation and Research at telephone number (02) 8809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill out all the required fields.

Dissemination of the information to all concerned is requested.

Attachment:-> FDA-Advisory-No.2021-0139

FDA Advisory No.2021-0138-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 Tiger Balm Ointment
2. Ohta Ohta’s Isan 75g
3. Shell Stomach Ache Powder 60g

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 info@fda.gov.ph. Upang mag-report ng patuloy na pagtitinda o pangangalakal ng mga hindi rehistradong gamot, mag-email sa ereport@fda.gov.ph. 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.2021-0138-A

FDA Advisory No.2021-0138 || Public Health Warning Against the Purchase and Use of the Following Unregistered Drug Products:

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

1. OTC Tiger Balm Ointment
2. Ohta Ohta’s Isan 75g
3. Shell Stomach Ache Powder 60g

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug products have not gone through the registration process of the Agency and have not been issued with proper authorization in the form of Certificate of Product Registration. Thus, the Agency cannot guarantee its quality, safety and efficacy. Therefore, consumption of such violative products may pose potential danger or injury to health.

Pursuant to Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, promotion, advertising or sponsorship of health products without proper authorization from FDA is prohibited.

All concerned establishments and/or entities are warned not to distribute the above-identified violative drug 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 these products are not sold or made available in their localities or areas of jurisdiction.

For more information and inquiries, please e-mail us at info@fda.gov.ph. To report continuous sale or distribution of unregistered health products, kindly e-mail us via ereport@fda.gov.ph. You may also call the Center for Drug Regulation and Research at telephone number (02) 8809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill out all the required fields.

Dissemination of the information to all concerned is requested.

Attachment:-> FDA-Advisory-No.2021-0138

FDA Advisory No.2021-0137 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplements and Food Products:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND CONSUME the following unregistered food supplements and food products:

1. YSANA VIDA SANA GROWTH KIDS WITH VITAMIN C + POLLEN +QUINA EXTRACT ROYAL JELLY FOOD SUPPLEMENT
2. VEGUM MULTIVITAMIN GUMMIES FOR KIDS FOOD SUPPLEMENT
3. BIOMEGA-3 KIDS FISH OIL CAPSULES – PLEASANT LEMON FLAVOUR
4. HARVEST FROM THE SEA DRIED FISH – CS RDV BOLINAO
5. HARVEST FROM THE SEA DRIED FISH – CS RDV KATAMBAK

The FDA verified through post-marketing surveillance that the abovementioned food supplements and food products are not registered and no corresponding Certificates of Product Registration (CPR) have 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 and food products have 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 food supplements until CPR are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product 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. You may also look for the FDA Registration number on the product label, if available or the name of the product.

All Law Enforcement Agencies (LEAs) and Local Government Unit (LGUs) 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 the unregistered imported products.

For more information and inquiries about this advisory, kindly contact the FDA Center for Food Regulation Office and Research through email cfrr@fda.gov.ph indicating on the subject the concerned Advisory, or call (02)857-1900 local 8112.

To report any sale or distribution of unregistered food product/food supplement, the online reporting facility, eReport can be access at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

 Attachment:-> FDA-Advisory-No.2021-0137

/ In Food Advisories / By FDA Admin3 / Comments Off on FDA Advisory No.2021-0137 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplements and Food Products:

FDA Advisory No.2021-0136 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplements and Food Products:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND CONSUME the following unregistered food supplements and food products:

1. NATURE’S WAY KIDS SMART VITA GUMMIES – OMEGA-3 MULTI – RASPBERRY, ORANGE & LEMON FLAVOUR
2. NATURE’S WAY KIDS SMART VITA GUMMIES – MULTI-VITAMIN FOR FUSSY EATERS – RASPBERRY FLAVOUR
3. NATURAMORE ENRICHED WITH OMEGA 3 DHA NUTRITIONAL FOOD SUPPLEMENT – VANILLA FLAVOR
4. A’S&R’S FOOD PRODUCTS PORK TOCINO
5. M&M’S MERCHANDISE KUSINAMATE HICKORY BBQ

The FDA verified through post-marketing surveillance that the abovementioned food supplements and food products are not registered and no corresponding Certificates of Product Registration (CPR) have 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 and food products have 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 food supplements until CPR are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product 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. You may also look for the FDA Registration number on the product label, if available or the name of the product.

All Law Enforcement Agencies (LEAs) and Local Government Unit (LGUs) 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 the unregistered imported products.

For more information and inquiries about this advisory, kindly contact the FDA Center for Food Regulation Office and Research through email cfrr@fda.gov.ph indicating on the subject the concerned Advisory, or call (02)857-1900 local 8112.

To report any sale or distribution of unregistered food product/food supplement, the online reporting facility, eReport can be access at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA-Advisory-No.2021-0136

 

FDA Advisory No.2021-0135 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND CONSUME the following unregistered food products:

1. CANDY LIKE IN BLUE COLORED PACKAGING WITH IMAGE OF CHERRIES (LABELS ARE IN FOREIGN CHARACTERS)
2. CANDY LIKE IN BLUE COLORED PACKAGING WITH IMAGE OF SLICED WATERMELON (LABELS ARE IN FOREIGN CHARACTERS)
3. CANDY LIKE IN RED COLORED PACKAGING WITH IMAGE OF STRAWBERRIES (LABELS ARE IN FOREIGN CHARACTERS)
4. MORINAGA PREMIUM HI-CHEW – IN YELLOW PACKAGING WITH IMAGE OF LEMON (LABELS ARE IN FOREIGN CHARACTERS)
5. MORINAGA PREMIUM HI-CHEW –IN LIGHT GREEN PACKAGING WITH IMAGE OF PEACH (LABELS ARE IN FOREIGN CHARACTERS)

The FDA verified through post-marketing surveillance that the abovementioned food products are not registered and no corresponding Certificates of Product Registration (CPR) have 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 its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative food products until CPR are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product 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. You may also look for the FDA Registration number on the product label, if available or the name of the product.

All Law Enforcement Agencies (LEAs) and Local Government Unit (LGUs) 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 the unregistered imported products.

For more information and inquiries about this advisory, kindly contact the FDA Center for Food Regulation Office and Research through email cfrr@fda.gov.ph indicating on the subject the concerned Advisory, or call (02)857-1900 local 8112.

To report any sale or distribution of unregistered food product/food supplement, the online reporting facility, eReport can be access at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA-Advisory-No.2021-0135

/ In Food Advisories / By FDA Admin3 / Comments Off on FDA Advisory No.2021-0135 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

FDA Advisory No.2021-0134 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND CONSUME the following unregistered food products:

1. NOBEL – IN GREEN COLORED PACKAGING WITH A GLASS OF DRINK DRAWING
2. 3:15PM MILK TEA ANYTIME ANYWHERE – EARL GREY MILK TEA
3. 3:15PM OATMEAL & PEARL BARLEY POWDER
4. 3:15PM BROWN SUGAR GINGER TEA
5. 3:15PM MILK TEA ANYTIME ANYWHERE – MATCHA LATTE – TAIWAN GREEN TEA FRESH WHOLE MILK POWDER

The FDA verified through post-marketing surveillance that the abovementioned food products are not registered and no corresponding Certificates of Product Registration (CPR) have 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 its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative food products until CPR are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product 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. You may also look for the FDA Registration number on the product label, if available or the name of the product.

All Law Enforcement Agencies (LEAs) and Local Government Unit (LGUs) 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 the unregistered imported products.

For more information and inquiries about this advisory, kindly contact the FDA Center for Food Regulation Office and Research through email cfrr@fda.gov.ph indicating on the subject the concerned Advisory, or call (02)857-1900 local 8112.

To report any sale or distribution of unregistered food product/food supplement, the online reporting facility, eReport can be access at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA-Advisory-No.2021-0134

/ In Food Advisories / By FDA Admin3 / Comments Off on FDA Advisory No.2021-0134 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

FDA Advisory No.2021-0133 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplements:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND CONSUME the following unregistered food supplements:

1. KIDS EXPERT CALIPH SUNNAH FOOD SUPPLEMENT VITAMIN A AND VITAMIN B COMPLEX + MINERALS + OMEGA 3 AND 6
2. VITREE KIDS IRON FORTE SYRUP DIETARY SUPPLEMENT
3. VITREE OMEGA-3 SYRUP – ORANGE FLAVOUR DIETARY SUPPLEMENT
4. VITREE BABY & TODDLER MULTI VITAMIN SYRUP DIETARY SUPPLEMENT – FRUITY FLAVOUR
5. AVICENNA PROVITEC PROPOLIS EKINEZYA KARISIMI

The FDA verified through post-marketing surveillance that the abovementioned food supplements are not registered and no corresponding Certificates of Product Registration (CPR) have 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 its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative food supplements until CPR are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product 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. You may also look for the FDA Registration number on the product label, if available or the name of the product.

All Law Enforcement Agencies (LEAs) and Local Government Unit (LGUs) 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 the unregistered imported products.

For more information and inquiries about this advisory, kindly contact the FDA Center for Food Regulation Office and Research through email cfrr@fda.gov.ph indicating on the subject the concerned Advisory, or call (02)857-1900 local 8112.

To report any sale or distribution of unregistered food product/food supplement, the online reporting facility, eReport can be access at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA-Advisory-No.2021-0133

 

 

 

/ In Food Advisories / By FDA Admin3 / Comments Off on FDA Advisory No.2021-0133 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplements:

FDA Advisory No.2021-0132 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplements:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND CONSUME the following unregistered food supplements:

1. NATURELO PREMIUM SUPPLEMENTS CHEWABLE MULTIVITAMIN FOR CHILDREN DIETARY SUPPLEMENT
2. VITAFUSION MULTIVITES ESSENTIAL DAILY FORMULA DIETARY SUPPLEMENT
3. NUTRICODE FOOD SUPPLEMENT VITA KIDS GUMMIES – STRAWBERRY, ORANGE, CHERRY
4. MARINOX KIDS MULTIVITAMIN DROPS WITH IRON AND ZINC FOOD SUPPLEMENT
5. NATURES AID MINI DROPS MULTIVITAMINS FOOD SUPPLEMENT – SUGAR FREE

The FDA verified through post-marketing surveillance that the abovementioned food supplements are not registered and no corresponding Certificates of Product Registration (CPR) have 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 its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative food supplements until CPR are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product 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. You may also look for the FDA Registration number on the product label, if available or the name of the product.

All Law Enforcement Agencies (LEAs) and Local Government Unit (LGUs) 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 the unregistered imported products.

For more information and inquiries about this advisory, kindly contact the FDA Center for Food Regulation Office and Research through email cfrr@fda.gov.ph indicating on the subject the concerned Advisory, or call (02)857-1900 local 8112.

To report any sale or distribution of unregistered food product/food supplement, the online reporting facility, eReport can be access at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Read more:-> FDA-Advisory-No.2021-0132

/ In Food Advisories / By FDA Admin3 / Comments Off on FDA Advisory No.2021-0132 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplements:

FDA Advisory No.2021-0131 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplements:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND CONSUME the following unregistered food supplements:

1. ESTER-C KID STIKS MULTIVITAMIN & MINERAL SUPPLEMENT DAILY DRINK MIX POWDER
2. HAPPY BABY MULTIVITAMIN DROPS WITH IRON FOOD SUPPLEMENTS
3. NATURE & NURTURE BABY & CHILD VITAMINS GENTLE LIQUID FOOD SUPPLEMENT FOR BABIES (6 MONTHS +), TODDLERS AND CHILDREN
4. APPETON MULTIVITAMIN PLUS DROPS FORTIFIED WITH LYSINE AND TAURINE
5. THE GOOD VITAMIN CO. KIDS GOOD ODOURLESS OMEGA 3 + IRON – TROPICAL ORANGE DIETARY SUPPLEMENT

The FDA verified through post-marketing surveillance that the abovementioned food supplements are not registered and no corresponding Certificates of Product Registration (CPR) have 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 its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative food supplements until CPR are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product 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. You may also look for the FDA Registration number on the product label, if available or the name of the product.

All Law Enforcement Agencies (LEAs) and Local Government Unit (LGUs) 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 the unregistered imported products.

For more information and inquiries about this advisory, kindly contact the FDA Center for Food Regulation Office and Research through email cfrr@fda.gov.ph indicating on the subject the concerned Advisory, or call (02)857-1900 local 8112.

To report any sale or distribution of unregistered food product/food supplement, the online reporting facility, eReport can be access at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA-Advisory-No.2021-0131

/ In Food Advisories / By FDA Admin3 / Comments Off on FDA Advisory No.2021-0131 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplements:

FDA Advisory No.2020-058-A || Lifting the Advisory on the Registered Food Product MARKY’S PRIME BAKE CORPORATION Egg Cracklets (Galletas) and 2020-058 “Public Health Warning Against the Purchase and Consumption of the Unregistered Food Product”

The Food and Drug Administration (FDA) informs the public that the food product MARKY’S PRIME BAKE CORPORATION Egg Cracklets (Galletas) has been registered by the Market Authorization Holder, MARKY’S PRIME BAKE CORPORATION, in accordance to existing FDA rules and regulations.

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. Kindly contact the FDA Center for Food Regulation and Research through e-mail at cfrr@fda.gov.ph, 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.

The public health warning imposed on the remaining product listed in FDA Advisory No. 2020-058 shall remain to be upheld and shall not be affected by the issuance of this advisory. Furthermore, the issuance of this advisory shall not in any manner preclude this Office from issuing subsequent orders it may deem necessary and appropriate, should there be findings of any violation of the company to the existing laws, rules, and regulations.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA-Advisory-No.2020-058-A

/ In Food Advisories / By FDA Admin3 / Comments Off on FDA Advisory No.2020-058-A || Lifting the Advisory on the Registered Food Product MARKY’S PRIME BAKE CORPORATION Egg Cracklets (Galletas) and 2020-058 “Public Health Warning Against the Purchase and Consumption of the Unregistered Food Product”

FDA has released a total of 366 COVID – 19 Test Kits (126 – PCR based, 105 – Rapid Antibody, 68 – Immunoassay and 67 – Others).

As of 29 January 2021, FDA has released a total of 366 COVID – 19 Test Kits (126 – PCR based, 105 – Rapid Antibody, 68 – Immunoassay and 67 – Others).

Click the link below for details.

https://bit.ly/2Zd0CZ4

FDA Advisory No.2021-329-A || Lifting FDA Advisory No. 2020-329 “Public Health Warning Against the Purchase and Use of Unnotified Cosmetic BRUNOLAB HAIRSTYLING FIBER SHINY MEDIUM HOLD” Dated 10 March 2020

The Food and Drug Administration (FDA) informs the public that the Cosmetic product BRUNOLAB HAIRSTYLING FIBER SHINY MEDIUM HOLD has been notified by the Market Authorization Holder, BRUNOLAB INC., under the product name BRUNO’S HAIRSTYLING FIBER SHINY FINISH MEDIUM HOLD with Notification No. 1000005824509 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. 2020-329 and FDA Order No. 2020-150 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 health product before purchasing. For more information or inquiries, please email us at ccrr_prsdd@fda.gov.ph, 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 ereport@fda.gov.ph.

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.2021-329-A

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No.2021-329-A || Lifting FDA Advisory No. 2020-329 “Public Health Warning Against the Purchase and Use of Unnotified Cosmetic BRUNOLAB HAIRSTYLING FIBER SHINY MEDIUM HOLD” Dated 10 March 2020

FDA Advisory No.2021-0130 || Public Health Warning Against the Purchase and Use of the following Unauthorized Cosmetic Products:

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

1. SHE LEBRITY SERUM FOUNDATION WITH ANTI-ACNE
2. SHE LEBRITY SUNBLOCK CREAM WITH SPF60

The abovementioned products were verified by FDA through post marketing surveillance and show no valid Certificate of Product Notification (CPN) as of 12 January 2021. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization from the FDA is prohibited.

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

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

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

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

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

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA-Advisory-No.2021-0130

 

FDA Advisory No.2021-0129 || Public Health Warning Against the Purchase and Use of the Non-Compliant Cosmetic Product ” COCOBODY GUGO VIRGIN COCONUT SHAMPOO “

The Food and Drug Administration (FDA) warns the general public from purchasing and using the non-compliant cosmetic product, ” COCOBODY GUGO VIRGIN COCONUT SHAMPOO “.

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

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

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

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

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

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA-Advisory-No.2021-0129

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No.2021-0129 || Public Health Warning Against the Purchase and Use of the Non-Compliant Cosmetic Product ” COCOBODY GUGO VIRGIN COCONUT SHAMPOO “

FDA Advisory No.2021-0128 || Public Health Warning Against the Purchase and Use of the Non-Compliant Cosmetic Product ” VENUS CHARM SEBO DE MACHO “

The Food and Drug Administration (FDA) warns the general public from purchasing and using the non-compliant cosmetic product, ” VENUS CHARM SEBO DE MACHO “.

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

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

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

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

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

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA-Advisory-No.2021-0128

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No.2021-0128 || Public Health Warning Against the Purchase and Use of the Non-Compliant Cosmetic Product ” VENUS CHARM SEBO DE MACHO “

FDA Advisory No.2021-0127 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic RYXSKINCERITY SUN SHIELD SPF 60 SUNSCREEN

The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product, RYXSKINCERITY SUN SHIELD SPF 60 SUNSCREEN.

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 18 January 2021. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization from the FDA is prohibited.

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

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

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

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

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

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA-Advisory-No.2021-0127

FDA Advisory No.2021-0126 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic SHS SIENA HERBAL SOAP COLD PROCESSED CARROT HERBAL SOAP

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

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 19 January 2021. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization from the FDA is prohibited.

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

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

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

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

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

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA-Advisory-No.2021-0126

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No.2021-0126 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic SHS SIENA HERBAL SOAP COLD PROCESSED CARROT HERBAL SOAP

FDA Advisory No.2021-0125 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic SECRET CHARM REFRESHING BODY MIST (HONEYSUCKLE, GALA APPLE AND STEPHANOTIS)

The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product, SECRET CHARM REFRESHING BODY MIST (HONEYSUCKLE, GALA APPLE AND STEPHANOTIS) .

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 19 January 2021. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization from the FDA is prohibited.

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

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

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

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

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

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA-Advisory-No.2021-0125

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No.2021-0125 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic SECRET CHARM REFRESHING BODY MIST (HONEYSUCKLE, GALA APPLE AND STEPHANOTIS)

FDA Advisory No.2021-0124 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic COCO RUBUS COREANUS & BLUEBERRY PEELING SOAP

The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product, COCO RUBUS COREANUS & BLUEBERRY PEELING SOAP .

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 19 January 2021. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization from the FDA is prohibited.

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

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

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

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

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

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA-Advisory-No.2021-0124

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No.2021-0124 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic COCO RUBUS COREANUS & BLUEBERRY PEELING SOAP

FDA Advisory No.2021-0123 || Public Health Warning Against the Purchase and Use of the Non-Compliant Cosmetic Product ” FOLIAGED TAWAS WITH CALAMANSI ROLL-ON DEODORANT “

The Food and Drug Administration (FDA) warns the general public from purchasing and using the non-compliant cosmetic product, ” FOLIAGED TAWAS WITH CALAMANSI ROLL-ON DEODORANT “.

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

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

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

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

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

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

Attachment:-> FDA-Advisory-No.2021-0123

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No.2021-0123 || Public Health Warning Against the Purchase and Use of the Non-Compliant Cosmetic Product ” FOLIAGED TAWAS WITH CALAMANSI ROLL-ON DEODORANT “

FDA Advisory No.2021-0122 || Public Health Warning Against the Purchase and Use of the Non-Compliant Cosmetic Product ” MERRY SUN OLIVE ANTI DANDRUFF SHAMPOO “

The Food and Drug Administration (FDA) warns the general public from purchasing and using the non-compliant cosmetic product, ” MERRY SUN OLIVE ANTI DANDRUFF SHAMPOO “.

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

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

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

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

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

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA-Advisory-No.2021-0122

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No.2021-0122 || Public Health Warning Against the Purchase and Use of the Non-Compliant Cosmetic Product ” MERRY SUN OLIVE ANTI DANDRUFF SHAMPOO “

FDA Advisory No.2021-0121 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic PAJIANI HAIR COLOR LONG LASTING AND SHINE 8.4 MEDIUM CHESNUT

The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product, PAJIANI HAIR COLOR LONG LASTING AND SHINE 8.4 MEDIUM CHESNUT .

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 13 January 2021. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization from the FDA is prohibited.

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

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

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

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

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

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA-Advisory-No.2021-0121

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No.2021-0121 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic PAJIANI HAIR COLOR LONG LASTING AND SHINE 8.4 MEDIUM CHESNUT

FDA Advisory No.2021-0120 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic COCO3 FACIAL WASH WITH VIRGIN COCONUT OIL AND MARULA OIL

The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product, COCO3 FACIAL WASH WITH VIRGIN COCONUT OIL AND MARULA OIL .

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 13 January 2021. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization from the FDA is prohibited.

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

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

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

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

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

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA-Advisory-No.2021-0120

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No.2021-0120 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic COCO3 FACIAL WASH WITH VIRGIN COCONUT OIL AND MARULA OIL

FDA Advisory No.2021-0119 || Public Health Warning Against the Purchase and Use of the Non-Compliant Cosmetic Product ” DR.MORITA HYALURONIC ACID ESSENCE MASK “

The Food and Drug Administration (FDA) warns the general public from purchasing and using the non-compliant cosmetic product, ” DR.MORITA HYALURONIC ACID ESSENCE MASK “.

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

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

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

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

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

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA-Advisory-No.2021-0119

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No.2021-0119 || Public Health Warning Against the Purchase and Use of the Non-Compliant Cosmetic Product ” DR.MORITA HYALURONIC ACID ESSENCE MASK “

FDA Advisory No.2021-0118 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic NATURE’S INFINITY LIP BALM – FRESH MINT

The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product, NATURE’S INFINITY LIP BALM – FRESH MINT .

The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 13 January 2021. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization from the FDA is prohibited.

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

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

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

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

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

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA-Advisory-No.2021-0118

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No.2021-0118 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic NATURE’S INFINITY LIP BALM – FRESH MINT

FDA Advisory No.2021-0117 || Public Health Warning Against the Purchase and Use of the Non-Compliant Cosmetic Product ” NATURES INFINITY LUSCIOUS COCONUT LIP BALM WITH VIRGIN COCONUT OIL “

The Food and Drug Administration (FDA) warns the general public from purchasing and using the non-compliant cosmetic product, ” NATURES INFINITY LUSCIOUS COCONUT LIP BALM WITH VIRGIN COCONUT OIL “.

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

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

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

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

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

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA-Advisory-No.2021-0117

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No.2021-0117 || Public Health Warning Against the Purchase and Use of the Non-Compliant Cosmetic Product ” NATURES INFINITY LUSCIOUS COCONUT LIP BALM WITH VIRGIN COCONUT OIL “

FDA Advisory No.2021-0116 || Public Health Warning Against the Purchase and Use of the Non-Compliant Cosmetic Product ” FOOT ACCENT BY CHIC ANTIBACTERIAL FOOT BLUSH “

The Food and Drug Administration (FDA) warns the general public from purchasing and using the non-compliant cosmetic product, ” FOOT ACCENT BY CHIC ANTIBACTERIAL FOOT BLUSH “.

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

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

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

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

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

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA-Advisory-No.2021-0116

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No.2021-0116 || Public Health Warning Against the Purchase and Use of the Non-Compliant Cosmetic Product ” FOOT ACCENT BY CHIC ANTIBACTERIAL FOOT BLUSH “

FDA Advisory No.2021-0115 || Public Health Warning Against the Purchase and Use of the Non-Compliant Cosmetic Product ” HELLO KITTY WET WIPES – REFRESHING FRAGRANCE “

The Food and Drug Administration (FDA) warns the general public from purchasing and using the non-compliant cosmetic product, ” HELLO KITTY WET WIPES – REFRESHING FRAGRANCE “.

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

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

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

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

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

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

Dissemination of this advisory to all concerned is hereby requested.

FDA-Advisory-No.2021-0115

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No.2021-0115 || Public Health Warning Against the Purchase and Use of the Non-Compliant Cosmetic Product ” HELLO KITTY WET WIPES – REFRESHING FRAGRANCE “