Month: July 2019

RELEASING OF FDA AUTHORIZATIONS AT THE FOOD AND DRUG ACTION CENTER (FDAC)

In order to have an efficient and orderly releasing of FDA Authorizations at the Food and Drug Action Center (FDAC), the following guidelines shall be strictly implemented:

A. AUTHORIZED PERSON TO PICK-UP / CLAIM THE AUTHORIZATIONS:

1. Owner/President/Manager/Head of the company. Owner must submit a photocopy of his/her valid ID.

2. Authorized Representative. The authorized representative must present and submit the following:

a.) Authorization letter in company letterhead;

b.) Photocopy of valid ID of the Company’s Owner/President/Manager/Head; and

c.) Photocopy of any of the following ID’s:

1. Company ID
2. QPIRA ID
3. Any government issued ID

B. RELEASING OF AUTHORIZATIONS

1. A Document Request Form (DRF) must be accomplished by the Client (Owner/President/Manager/Head of the company or the Authorized Representative) and submit to the Releasing Officer together with the required document/s mentioned above. Please note that photocopy of each required document is needed for every request.

2. Upon receipt of DRF, the Releasing Officer checks on the files for release. Upon validation, Releasing Officer hands-over to Client the second copy as FDA’s receiving copy indicating the printed name, signature, date and time of receipt.

3. Releasing Officer releases the Authorization/s to Client.

For information and guidance.

Attachment->: RELEASING OF FDA AUTHORIZATIONS AT THE FOOD AND DRUG ACTION CENTER (FDAC) ADVISORY-RELEASING OF FDA AUTHORIZATIONS AT THE FOOD AND DRUG ACTION CENTER (FDAC)

ANNOUNCEMENT || SEMINAR VENUE FOR QPIRA FOR CENTER FOR DRUG REGULATION AND RESEARCH (QCDRR-NCR) ON 13-14 AUGUST 2019

Please be informed that the venue of the QPIRA for Center for Drug Regulation and Research (QCDRR-NCR) on 13-14 August 2019 will be at THE BELLEVUE MANILA.

VENUE : THE BELLEVUE MANILA
ADDRESS : NORTH BRIDGEWAY, FILINVEST CITY, ALABANG,
MUNTINLUPA CITY 1781

All course registrants who received Course Assessment Slip for the QPIRA Seminar but have not received the Course Confirmation Slip are advised to come in the seminar venue (THE BELLEVUE MANILA) on the scheduled date of seminar with the following documents:

• Course assessment slip
• Proof of payment
• Original Copy of Notarized Affidavit of Undertaking

Rest assured that the stakeholders with the above documents will be accepted to the seminar. For inquiries and other concerns, please call the FDA Academy at telephone number (02) 877 0259 or email at [email protected]

Attachment->:QCDRR-NCR 13-14 August 2019

ANNOUNCEMENT || SEMINAR VENUE FOR QPIRA FOR CENTER FOR DEVICE REGULATION, RADIATION HEALTH AND RESEARCH (QCDRRHR-NCR) ON 27-28 AUGUST 2019

Please be informed that the venue of the QPIRA for Center for Device Regulation, Radiation Health and Research (QCDRRHR-NCR) on 27-28 August 2019 will be at THE BELLEVUE MANILA.

VENUE : THE BELLEVUE MANILA
ADDRESS : NORTH BRIDGEWAY, FILINVEST CITY, ALABANG,
MUNTINLUPA CITY 1781

All course registrants who received Course Assessment Slip for the QPIRA Seminar but have not received the Course Confirmation Slip are advised to come in the seminar venue (THE BELLEVUE MANILA) on the scheduled date of seminar with the following documents:

• Course assessment slip
• Proof of payment
• Original Copy of Notarized Affidavit of Undertaking

Rest assured that the stakeholders with the above documents will be accepted to the seminar. For inquiries and other concerns, please call the FDA Academy at telephone number (02) 877 0259 or email at [email protected]

Attachment-> : QCDRRHR-NCR 27-28 August 2019

ANNOUNCEMENT: || SEMINAR VENUE FOR QPIRA FOR CENTER FOR FOOD REGULATION AND RESEARCH (QCFRR-NCR) ON 15-16 AUGUST 2019

Please be informed that the venue of the QPIRA for Center for Food Regulation and Research (QCFRR-NCR) on 15-16 August 2019 will be at THE BELLEVUE MANILA.

VENUE : THE BELLEVUE MANILA
ADDRESS : NORTH BRIDGEWAY, FILINVEST CITY, ALABANG,
MUNTINLUPA CITY 1781

All course registrants who received Course Assessment Slip for the QPIRA Seminar but have not received the Course Confirmation Slip are advised to come in the seminar venue (THE BELLEVUE MANILA) on the scheduled date of seminar with the following documents:

• Course assessment slip
• Proof of payment
• Original Copy of Notarized Affidavit of Undertaking

Rest assured that the stakeholders with the above documents will be accepted to the seminar. For inquiries and other concerns, please call the FDA Academy at telephone number (02) 877 0259 or email at [email protected]

Attachment->: QCFRR-NCR 15-16 August 2019

FDA Advisory No. 2019-228 || Public Health Warning Against the Purchase and Use of the Unregistered Health Related Device “Westinghouse 3 Stage Water Purification System”:

The Food and Drug Administration (FDA) warns the general public against the purchase and use of the unregistered health related device:

The FDA verified through post-marketing surveillance that the above mentioned health related

device is not registered and the Certificate of Heath Related  Device Registration (CHRDR) 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 health related 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 distribute, advertise the violative  product in the market.

All concerned establishments are warned not to distribute, advertise, or sell the said violative

health related device until CHRDR 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 health 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-2019-228

 

/ In Device Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2019-228 || Public Health Warning Against the Purchase and Use of the Unregistered Health Related Device “Westinghouse 3 Stage Water Purification System”:

FDA Advisory No. 2019-229 || PUBLIC WARNING ON THE PURCHASE AND CONSUMPTION OF PROCESSED PORK MEAT PRODUCT FROM THE NEW IDENTIFIED COUNTRIES SUSPECTED TO BE AFFECTED BY AFRICAN SWINE FEVER VIRUS

In the interest of consistency and coherent efforts in preventing the entry of the African Swine Fever Virus, the Food and Drug Administration (FDA) hereby expands the temporary ban on the importation, distribution and sale of ALL processed pork meat products from the following countries following Department of Agriculture Memorandum Order No. 12, 13, 15, and 18 Series of 2019:

  1. Hong Kong
  2. North Korea
  3. Laos
  4. Germany

(The FDA earlier issued FDA Order 2018-133 dated 24 September 2018 and FDA Order No. 2019-045 dated 27 May 2019 on the temporary ban of pork meat and identifying the following countries infected with the African swine fever (ASF) virus, in line with the Memorandum Orders of the Department of Agriculture: )

  1. China
  2. Hungary
  3. Latvia
  4. Poland
  5. Romania
  6. Russia
  7. Ukraine
  8. Vietnam
  9. Zambia
  10. South Africa
  11. Czech Republic
  12. Bulgaria
  13. Cambodia
  14. Mongolia
  15. Moldova
  16. Belgium

The public is advised to exercise extreme caution in purchasing and consuming processed pork meat products and is advised to only consume processed pork meat products which are sourced from countries other than the above listed countries suspected to be affected by ASF virus, and are registered with the FDA.

Further, the FDA would like to reiterate that it does not allow the registration of processed pork meat products from these ASF virus affected countries. A heightened post-marketing surveillance and audit is being conducted on all concerned and covered establishments, to ensure full compliance to the foregoing FDA Orders, and at the same time, to hold violators liable under Republic Act 9711 (Food and Drug Administration Act of 2009), Republic Act 10611 (Food Safety Act of 2013) and other pertinent laws, rules and regulations, all in the interest of protecting public health and safety.

For more information and inquiries, please e-mail us at [email protected]ph or call us at FDA Action Center hotline (02) 821-1162, or the Center for Food Regulation & Research at (02) 857-1900 local 8112/8105. To report the sale or distribution of these banned products despite the issuance of FDA Orders, kindly email us via [email protected]

Dissemination of the information to all concerned is requested.

ATTACHEMENT:  FDA-Advisory-No-2019-229

/ In Food Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2019-229 || PUBLIC WARNING ON THE PURCHASE AND CONSUMPTION OF PROCESSED PORK MEAT PRODUCT FROM THE NEW IDENTIFIED COUNTRIES SUSPECTED TO BE AFFECTED BY AFRICAN SWINE FEVER VIRUS

FDA Advisory No. 2019-227 ||Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “Family Care™ Digital Thermometer”

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

  1. “Family Care™ Digital Thermometer”

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], 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.2019-227

FDA Advisory No. 2019-226 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “Curad Sheer Bandage”

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

  1. “Curad Sheer Bandage”

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], 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.2019-226

FDA Advisory No. 2019-225 || Public Health Warning Against the Purchase and Use of the following Unregistered Medical Devices:

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. Digital Thermometer
  2. Baby Pacifier Thermometer

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], 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.2019-225

FDA Advisory No. 2019-224 || Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Products and Food Supplements:

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

  1. PARAGIS Capsules
  2. SAVER’S CHOICE Ultra Pure Drinking Water
  3. Dr. JAMES Advanced Glutathione Formula with Alpha-T Acids Skin Whiteners
  4. OPTIMUM NUTRITION Glutamine 1000 mg Dietary Supplement Capsule

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 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 or 8105.

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:> FDA Advisory No.2019-224

/ In Food Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-224 || Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Products and Food Supplements:

FDA Advisory No. 2019-223 || Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Products and Food Supplements:

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

  1. FRUCCY’S Ginger Tea
  2. GARDEN’S SECRET 16 in 1 Turmeric Powder
  3. ACTIVE WHITE 7 Days Whitening Slimming Coffee
  4. NU-BETA Growing Factor & HGH Nature’s Super Food

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 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 or 8105.

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:>FDA Advisory No.2019-223

/ In Food Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-223 || Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Products and Food Supplements:

FDA Advisory No. 2019-222 || 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. MUNCH A BUNCH Araro
  2. ARA’S MAMI HOUSE & RESTAURANT Gourmet Bangus Fresh Basil Pesto in Olive Oil
  3. GREENFREE Spearmint Chewing Gum
  4. GREENFREE Menthol Chewing Gum

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 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 or 8105.

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:>FDA Advisory No.2019-222

/ In Food Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-222 || Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Products:

FDA Advisory No. 2019-221 || 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. MINI POPZA Lollipop Artificial Cola Flavoured
  2. MINI POPZA Lollipop Artificial Sprite Flavoured
  3. MINI POPZA Lollipop Artificial Strawberry Flavoured
  4. FIRST COCO KIT Cocoa Flavour Confectionery

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 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 or 8105.

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:> FDA Advisory No.2019-221

/ In Food Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-221 || Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Products:

FDA Advisory No. 2019-220 || 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. GREENFREE Orange & Menthol Flavoured Candy
  2. GREENFREE Blueberry & Menthol Flavoured Candy
  3. GREENFREE Spearmint & Menthol Flavoured Candy
  4. GREENFREE Peppermint & Menthol Flavoured Candy

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 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 or 8105.

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:> FDA Advisory No.2019-220

/ In Food Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-220 || Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Products:

FDA Advisory No. 2019-219 || 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. ZOOD ZOOD Bubble Gum Grape Flavoured
  2. ZOOD ZOOD Bubble Gum Orange Flavoured
  3. ZOOD ZOOD Bubble Gum Cola Flavoured
  4. ZOOD ZOOD Bubble Gum Strawberry Flavoured

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 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 or 8105.

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:> FDA Advisory No.2019-219

/ In Food Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-219 || Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Products:

ADDITIONAL TRAINING SCHEDULE OF FDA ACADEMY FOR 2019

Please be informed of the additional FDA Academy training schedule for 2019.

COURSE TITLE

DATE VENUE
Center for Cosmetic Regulation and Research QPIRA Seminar 3-4 September 2019 NCR
Unified Licensing Seminar 21 November 2019 NCR

Unified Licensing Seminar

22 November 2019

NCR

 

For inquiries and other concerns, please call the FDA Academy at telephone number (02) 877 0259 or email at [email protected].

Attachment-> : ADDITIONAL TRAINING SCHEDULE OF FDA ACADEMY

RESCHEDULE OF UNIFIED LICENSING SEMINAR FOR REGION II STAKEHOLDERS TO 7 AUGUST 2019

Please be informed that the Unified Licensing Seminar for Region II Stakeholders (Course Code:ULS-RII) in Isabela originally scheduled on 18 July 2019 shall be rescheduled on 7 August 2019. Seminar location is still in Ilagan City Hotel and Convention Center.

Rest assured that all changes and concerns of the registered participants of this seminar shall be attended to by the FDA Academy. For more information and update on the Unified Licensing Seminar for Region II (ULS-RII), please visit the FDA website, www.fda.gov.ph.

For inquiries and other concerns, you may reach the FDA Academy thru:

Telephone Number: (02) 877 0259

Email Address: [email protected] and [email protected]

Please be guided accordingly.

Attachment-> : RESCHEDULE OF ULS-RII

FDA Advisory No. 2019-218 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “INTROCAN® – W (NON- SAFETY)”

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. “INTROCAN® – W (NON- SAFETY)”

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.2019-218

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-218 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “INTROCAN® – W (NON- SAFETY)”

FDA Advisory No. 2019-217 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “KOJAK® SELINGE-SYRINGE WITH NEEDLE”

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. “Coralite® Cold-Wrap Elastic Bandage”

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.2019-217

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-217 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “KOJAK® SELINGE-SYRINGE WITH NEEDLE”

FDA Advisory No. 2019-216 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “Coralite® Cold-Wrap Elastic Bandage”

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. “Coralite® Cold-Wrap Elastic Bandage”

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.2019- 216

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-216 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “Coralite® Cold-Wrap Elastic Bandage”

VENUE FOR UNIFIED LICENSING SEMINAR (ULS –RI) ON 31 JULY 2019 AND 1 AUGUST 2019

Please be informed that the venue of the Unified Licensing Seminar (ULS – RI) on 31 July 2019 and 1 August 2019 will be in NORTHVIEW HOTEL, BRGY. 46, AIRPORT ROAD, LAOAG CITY, ILOCOS NORTE.

All registrants who received Course Assessment Slips but have not yet received their Course Confirmation Slips are advised to bring with them the following documents:

  • Course Assessment Slip
  • Proof of Payment

For inquiries and other concerns, please call the FDA Academy at telephone number (02) 877 0259.

Attachment-> :  VENUE FOR UNIFIED LICENSING SEMINAR (ULS –RI) ON 31 JULY 2019 AND 1 AUGUST 2019

CASCADING OF ADMINISTRATIVE ORDERS ON THE REGULATION OF ELECTRONIC NICOTINE AND NON-NICOTINE DELIVERY SYSTEMS, HOUSEHOLD/URBAN HAZARDOUS SUBSTANCES, HOUSEHOLD/URBAN PESTICIDES, AND PEST CONTROL OPERATORS AND PESTICIDE HANDLERS, AND IMPLMENTING RULES AND REGULATIONS OF RA 10620

In the interest of the service, the Center for Cosmetics Regulation and Research (CCRR), Food and Drug Administration (FDA), shall conduct a “Cascading of the Administrative Orders on the Regulation of Electronic Nicotine and Non-Nicotine Delivery Systems (ENDS/ENNDS), Household/Urban Hazardous Substances (HUHS), Household/Urban Pesticides (HUPs), and Pest Control Operators (PCOs) and Pesticide Handlers, and Implementing Rules and Regulations of RA 10620” on the following dates:

  7 August 2019 9 August 2019

AM Session

8:30-9:00 Registration
9:00-10:00 Presentation of AO on ENDS/ENNDS Presentation of AOs on HUPs and PCOs
10:00-12:00 NN Open Forum

PM Session

1:30-2:00 Registration
2:00-2:30 Presentation of IRR of RA10620: Toy and Game Safety Labeling Act of 2013 Presentation of AO on HUHS
2:30-4:00 Open Forum

All stakeholders are invited to attend. Registration through this link is on a first-come, first-serve basis as only the first one-hundred (100) pre-registrants (per session) shall be accommodated. To maximize the number of attendees, please limit your representative to only one (1) per company/industry association.

For any concerns or inquiries, kindly contact CCRR at (02) 857-1900 local 8107 or 8113, or through email at [email protected] (for ENDS/ENNDS-related concerns) or [email protected] (for HUHS, HUP, PCO and Toy-related concerns).For your information and guidance.

Attachment-> : FDA Announcement re. Cascading of New Policies

/ In Cosmetic Announcements / By Administrator / Comments Off on CASCADING OF ADMINISTRATIVE ORDERS ON THE REGULATION OF ELECTRONIC NICOTINE AND NON-NICOTINE DELIVERY SYSTEMS, HOUSEHOLD/URBAN HAZARDOUS SUBSTANCES, HOUSEHOLD/URBAN PESTICIDES, AND PEST CONTROL OPERATORS AND PESTICIDE HANDLERS, AND IMPLMENTING RULES AND REGULATIONS OF RA 10620

FDA Advisory No. 2019-215 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “Assured® Colored Bandages”:

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.  “Assured® Colored Bandages”

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.

Furthermore, the FDA, in coordination with Johnson & Johnson (Philippines), Inc. verified that the above-stated medical device product is not part of their registered portfolio and there is no transaction history of the product concerned.

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 their 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.2019-215

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-215 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “Assured® Colored Bandages”:

FDA Advisory No. 2019-214 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “ETHICON” HOSPITAL PACK CHROMIC STERILE CATGUT SUTURE”

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.  “ETHICON” HOSPITAL PACK CHROMIC STERILE CATGUT SUTURE”

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.

Furthermore, the FDA, in coordination with Johnson & Johnson (Philippines), Inc. verified that the above-stated medical device product is not part of their registered portfolio and there is no transaction history of the product concerned.

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 their 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.2019-214

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-214 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “ETHICON” HOSPITAL PACK CHROMIC STERILE CATGUT SUTURE”

FDA Advisory No. 2018-297-A || Termination of the Voluntary Product Recall of the following medical device products:

This is to inform the public and concerned healthcare professionals that the Voluntary recall order issued on specific batch/es of Novosyn® Violet Dyed Suture with Needle and Safil® Violet Surgical Suture as shown in the table below is hereby terminated by the Food and Drug Administration (FDA).

Article Number Article Name Batch
C0068029 Novosyn® Violet 4/0 (1.5) 70cm HR22 (M) 718043
718042
718064
C0068595 Novosyn® Violet 2/0 (3) 90cm HR 37S (M) 717526
717525
C1048540 Safil® Violet 4/0 (1.5) 90cm HR 26 (M) 717445

 

As stated in the FDA Advisory No. 2018-297 dated 05 October 2018, B. Braun Medical Supplies, the Marketing Authorization Holder (MAH), conducted a voluntary recall of the above-stated medical device products as a Field Safety Corrective Action in response to the report received from the manufacturer. In the course of routine quality audits at the production site, the manufacturer detected that some units of the abovementioned batches have damaged packaging, which may have compromised the sterility of the product.

After due and thorough evaluation of the submitted documents by the MAH, FDA has determined that reasonable efforts had been made to recall and properly destroy the affected product batch in accordance with FDA Circular No. 2016-012, known as the Guidelines on Product Recall.

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 subsequent findings of any violation of existing FDA laws, rules and regulations.

All FDA Regional Field Offices and Regulatory Enforcement Units in coordination with law enforcement agencies and Local Government Units are requested to monitor and seize the cited product batches if still found available in the market.

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.

Dissemination of this advisory to all concerned is hereby requested.

Attachment-> : FDA Advisory No.2018-297-A

FDA Advisory No. 2019-051-C || Lifting the Advisory of the Notified Cosmetic Product “YSA BOTANICA GREEN PAPAYA SOAP WITH WHITENING FORMULA SUITABLE FOR ACNE PRONE SKIN”under FDA Advisory No. 2019-051“Public Health Warning Against the Use of Unnotified Cosmetic Products(Batch 2)”Dated 27 February 2019

The Food and Drug Administration (FDA) informs the public that the below cosmetic product has been notified by the Market Authorization Holder (MAH), Healthwellnesslifestyle, Inc., in accordance to existing FDA rules and regulations:

YSA Botanica Green Papaya Soap with Whitening Formula Suitable for Acne Prone Skin -Notification No. 1000004891665

Accordingly, the list released in FDA Advisory No. 2019-051 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) 857-1900 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. 2019-051 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 Advsisory No.2019-051-C

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-051-C || Lifting the Advisory of the Notified Cosmetic Product “YSA BOTANICA GREEN PAPAYA SOAP WITH WHITENING FORMULA SUITABLE FOR ACNE PRONE SKIN”under FDA Advisory No. 2019-051“Public Health Warning Against the Use of Unnotified Cosmetic Products(Batch 2)”Dated 27 February 2019

FDA Advisory No. 2019-213 || 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. DROGHERIA ALIMENTARI Chilli Mill
  2. KHONG GUAN Durian Shortcake
  3. HOUSE Ground Chilli Pepper (in foreign characters)
  4. DAISO SELECT Plum Kelp Tea

The FDA verified through post-marketing surveillance that the abovementioned food products are not registered, hence authorization in the form of Certificate of Product Registration (CPR) has not yet been issued. 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, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization from FDA is prohibited.

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

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

All concerned establishments are warned not to distribute violative food products until they have been issued the appropriate authorizations, License to Operate (LTO) for the establishment and CPR for the product, otherwise, regulatory actions and sanctions shall be strictly pursued.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that violative products are 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 any sale or distribution of unregistered food product, the public can access the online reporting facility, eReport through www.fda.gov.ph/ereport, or call us at the Center for Food Regulation and Research (CFRR) hotline (02) 857-1900 loc. 8115 and 8112.

Dissemination of the information to all concerned is requested.

Attachment-> : FDA Advisory No.2019-213

/ In Food Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-213 || Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Products:

FDA Advisory No. 2019-212 || 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. HERBAL SECRETS Maca 500 mg Natural Dietary Supplement
  2. RCP Mangosteen Food Supplement
  3. CLINICAL GLUTATHIONE Stable, Oral Glutathione for Vital Support Dietary Supplement Slow Melt Tablets
  4. NATURE’S KIND Fertility Aid Plus
  5. GLUTAX 200GS Diamond Bright Glutathione Softgel

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 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 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) 857-1900 loc. 8112 or 8105.

To report any sale or distribution of unregistered food supplements, 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.2019-212

/ In Food Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-212 || Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Supplements:

FDA Advisory No. 2019-211 || Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Supplements and Food Products:

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

  1. GARDEN’S SECRET 16 in 1 Turmeric
  2. Turmeric Miracle Herb
  3. GERRY’S Mangosteen Tea
  4. PARADISE Vitamin D3 5000 IU Dietary Supplement
  5. 21st Century Sandardized Saw Palmetto Extract Dietary Supplement
  6. Laci le Beau Super Dieter’s Tea Lemon Mint Herbal Dietary Supplement
  7. Laci le Beau Super Dieter’s Tea Acai Berry Herbal Dietary Supplement
  8. CALIFORNIA GOLD NUTRITION COLLAGEN UP 5000 Marine Sourced Collagen Peptides + Hyaluronic Acid + Vitamin C Dietary Supplement

The FDA verified through post-marketing surveillance that the abovementioned food products and 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 products and 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 products 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 or 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) 857-1900 loc. 8112 or 8105.

To report any sale or distribution of unregistered food products and food supplements, 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.2019-211

/ In Food Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-211 || Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Supplements and Food Products:

FDA Advisory No. 2019-210 || 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. ESSENTIAL EVERYDAY Garlic Powder
  2. ESSENTIAL EVERYDAY Chili Powder
  3. WHITE HAT Lemon & Pepper Seasoning
  4. DASH ORIGINAL BLEND Seasoning Blend Salt Free
  5. ECOSLIM Dietary Supplement

The FDA verified through post-marketing surveillance that the abovementioned food products and food supplement 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 and food supplement 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 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 or 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) 857-1900 loc. 8112 or 8105.

To report any sale or distribution of unregistered food products and food supplements, 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.2019-210

/ In Food Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-210 || Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Products and Food Supplement: