Month: September 2019

LIMITED SLOTS AVAILABLE FOR FDA ACADEMY SEMINAR SCHEDULE FOR 4th QUARTER 2019 

This is to inform all stakeholders that limited slots are available on the remaining Unified Licensing Seminar (ULS) and QPIRA seminars offered by the FDA for 2019. The Certificate of Completion of these seminars are required in the FDA License to Operate (LTO) application. However, in the event that the seminars are already full and no slots are available, Seminar Certificate of Completion shall be waived given the following conditions:

  1. Seminar is already full and there are no more slots available;
  2. Stakeholder has received “No Available Slot” email notice, or did not receive Course Assessment Slip in their email five (5) days prior to the seminar date; and
  3. Stakeholder has ongoing FDA License to Operate application – initial application, or renewal application within the next nine (9) months.

Stakeholders that satisfied all three conditions above are advised to prepare a Commitment Letter addressed to FDA signed by the participant and Head of the Office.  Submit the signed Commitment Letter in lieu of the Certificate of Completion required in the LTO application.

For more information, you may call the FDA Academy at telephone number (02) 877-0259, or email at [email protected]. Please be guided accordingly. Thank you very much.

Annex: 

  1. FDA Circular 2019-0001 entitled “Training Courses/Seminars and Schedule of Fees for the Trainings Offered by the Food and Drug Administration (FDA) Academy – Policy and Planning Service (PPS) for Calendar Year 2019”

Attachment:-> LIMITED SLOTS AVAILABLE FOR FDA ACADEMY SEMINAR SCHEDULE FOR 4th QUARTER 2019

SCHEDULE OF FDA ACADEMY SEMINARS FOR STAKEHOLDERS IN MINDANAO

Please be informed of the following FDA Academy Seminars for Stakeholders in Mindanao:

COURSE TITLE DATE VENUE
Unified Licensing Seminar for Region IX

(ULS-RIX)

29 October 2019 Zamboanga City
Unified Licensing Seminar for Region IX

(ULS-RIX)

30 October 2019 Zamboanga City
Unified Licensing Seminar for Region XII

(ULS-RXII)

19 November 2019 General Santos City
Unified Licensing Seminar for Region XII

(ULS-RXII)

20 November 2019 General Santos City
Good Manufacturing Practices for Food Manufacturer and Trader

(GMP-FMT-MWC)

21 November 2019 General Santos City
Center for Food Regulation and Research QPIRA Seminar (QCFRR-Min) 3 – 4 December 2019 Davao City
Good Manufacturing Practices for Food Manufacturer and Trader

(GMP-FMT-MEC)

5 December 2019 Davao City

For more information, you may call the FDA Academy at telephone number (02) 877-0259, or email at [email protected]. Please be guided accordingly.

Attachment:-> SCHEDULE OF FDA ACADEMY SEMINARS FOR STAKEHOLDERS IN MINDANAO

SCHEDULE OF FDA ACADEMY SEMINARS FOR STAKEHOLDERS IN VISAYAS

Please be informed of the following FDA Academy Seminars for Stakeholders in Visayas:

COURSE TITLE DATE VENUE
Good Manufacturing Practices for Food Manufacturer and Trader

(GMP-FMT-Vis)

15 October 2019 Iloilo City
Center for Food Regulation and Research QPIRA Seminar (QCFRR-Vis) 16 – 17 October 2019 Iloilo City
Center for Device Regulation, Radiation Health and Research QPIRA Seminar

(QCDRRHR-Vis)

7 – 8 November 2019 Cebu City

For more information, you may call the FDA Academy at telephone number (02) 877-0259, or email at [email protected]. Please be guided accordingly.

Attachment:->SCHEDULE OF FDA ACADEMY SEMINARS FOR STAKEHOLDERS IN VISAYAS

CDRR Officers of the Day for 1-2 October 2019

The Center for Drug Regulation and Research (CDRR) will be Having its Operational Planning on 1-2 October 2019. In line with this, there will be no CDRR officers on duty for the said dates at the FDA Action Center (FDAC).

We advise our clients to kindly send all queries and concerns via [email protected] and we will respond accordingly.

For your information and guidance.

FDA Advisory No. 2019-309 || RADIATION PROTECTION TRAINING CERTIFICATE REQUIREMENT OF THE CENTER FOR DEVICE REGULATION, RADIATION HEALTH AND RESEARCH (CDRRHR)

This is in connection with the Radiation Protection Officer (RPO) training certificate as one of the documentary requirements to be submitted by an applicant to FDA-CDRRHR in relation to the License to Operate (LTO) as radiation facility or establishment.

For clarification, please be informed that the FDA CDRRHR or the FDA Academy does not offer or conduct radiation protection training for Radiation Protection Officers. However, the FDA-CDRRHR accepts training certificates, certifications, proof of completion or participation on the said topic that are issued by a third party service provider from the sectors of the industry, academe, government or National Regulatory Authority, or non-government organization (NGO) both here and abroad that is recognized, certified or accredited by the Philippine Accreditation Board, Professional Regulatory Commission, ISO Certification bodies, Commission on Higher Education, professional or industry organizations, and other relevant international organizations, like the International Atomic Energy Agency.

For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health, and Research (CDRRHR) through e-mail at [email protected] and cc: the Policy and Planning Service-FDA Academy at [email protected].

Dissemination of this advisory by all concerned parties and stakeholders is hereby requested.

Attachment: > FDA Advisory No. 2019-309

VENUE FOR CENTER FOR COSMETICS REGULATION, AND RESEARCH QPIRA SEMINAR FOR HUHS (QCCRR-HUHS-NCR) ON 3-4 OCTOBER 2019

Please be informed that the venue for the Center for Cosmetics Regulation Research QPIRA Seminar for HUHS (Course Code: QCCRR-HUHS-NCR) on 3-4 October 2019 will be at THE BELLEVUE MANILA, NORTH BRIDGEWAY, FILINVEST CITY, ALABANG, MUNTINLUPA CITY.

All course registrants who received Course Assessment Slip for the QCCRR-HUHS-NCR  but have not received the Course Confirmation Slip are advised to come in the seminar venue on the scheduled date of seminar with the following documents:

  • Course assessment slip
  • Proof of payment

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] and [email protected]

Attachment: VENUE FOR CENTER FOR COSMETICS REGULATION, AND RESEARCH QPIRA SEMINAR FOR HUHS (QCCRR-HUHS-NCR) ON 3-4 OCTOBER 2019

SEMINAR VENUE FOR QPIRA FOR CENTER FOR DEVICE REGULATION, RADIATION HEALTH AND RESEARCH (QCDRRHR-NCR) ON 3-4 OCTOBER 2019

Please be informed that the venue for the Center for Device Regulation, Radiation Health and Research QPIRA Seminar (Course Code: QCDRRHR-NCR) on 3-4 October 2019 will be at THE BELLEVUE MANILA, NORTH BRIDGEWAY, FILINVEST CITY, ALABANG, MUNTINLUPA CITY.

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

  • Course assessment slip
  • Proof of payment

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] and [email protected]

Attachment-> : SEMINAR VENUE FOR QPIRA FOR CENTER FOR DEVICE REGULATION, RADIATION HEALTH AND RESEARCH (QCDRRHR-NCR) ON 3-4 OCTOBER 2019

VENUE FOR UNIFIED LICENSING SEMINAR (ULS-NCR) ON 1 OCTOBER 2019

Please be informed that the venue for the Unified Licensing Seminar (ULS – NCR) on 1 October 2019 will be in ACACIA HOTEL, 5400 EAST ASIA DRIVE CORNER COMMERCE AVENUE, FILIVEST CORPORATE CITY, ALABANG, MUNTINLUPA CITY

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-NCR) ON 1 OCTOBER 2019

APPLICATION GUIDELINES FOR LICENSE TO OPERATE (LTO) FOR ENDS/ENNDS PRODUCTS

This is to inform all concerned stakeholders that the following are now available online via the FDA website at ww2.fda.gov.ph.

  1. LTO Application for E–Cigarette Establishment Documentary Requirements and Other Reminders
  2. Guidelines for Manufacturers and Traders
  3. Guidelines for Distributors
  4. Guidelines for Retailers

For any concerns or inquiries, kindly contact CCRR, at (02) 857-1900 local 8107 or 8113, or through email at [email protected].

For your information and guidance.

Attachment-> : APPLICATION GUIDELINES FOR LICENSE TO OPERATE (LTO) FOR ENDS-ENNDS PRODUCTS

FDA Advisory No. 2019-308 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “INFECTIGUARD KID’S STERILE 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. INFECTIGUARD KID’S STERILE 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.

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. 2019-308

FDA Advisory No. 2019-307 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “DELCARE – STOMACH TUBE”

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. DELCARE – STOMACH TUBE

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. 2019-307

FDA Advisory No. 2019-306 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “Langhe Disposable Circumcision Suture Device”

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. Langhe Disposable Circumcision Suture Device

The FDA verified through post-marketing surveillance that the abovementioned medical device, advertised for sale on www.lazada.com.ph, 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. 2019-306

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-306 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “Langhe Disposable Circumcision Suture Device”

FDA Circular No. 2019-006 || GUIDELINES IN COMMERCIAL DISPLAY, SELLING, PROMOTION, AND ADVERTISING OF ALCOHOLIC BEVERAGES AND BEVERAGES THAT CONTAIN ALCOHOL

Pursuant to Article II, Section 15 of the 1987 Philippine Constitution to protect the right to health of the people and instill health consciousness among them; and in Section 15 (2), Chapter 4, Title IX, Book IV of the Administrative Code of 1987 authorizes the Food and Drug Administration (FDA) to act as the policy formulation and sector monitoring arm of the Secretary of Health on matters pertaining to food, drugs, traditional medicines, cosmetics and household products containing hazardous substances, and to formulate rules and regulations and standards in accordance with the FDA mandate in accordance with Republic Act No. 3720 as amended by Executive Order No. 175 and further amended by Republic Act No. 9711, and other allied laws for their proper and effective enforcement, this regulation is hereby promulgated for the information and compliance of all concerned.

Furthermore, Article III Section 5(f) on Food Safety Requirements under Republic Act No. 10611 or the Food Safety Act of 2013, states that “compliance of a food product with specific standards applicable to a specific food shall not prohibit the competent authorities to take appropriate measures or to impose restrictions on entry into the market or to require its withdrawal from the market, where there is reason to suspect that such food product shows food safety-related risks.”

Food packaging technology and market innovation concerning stand-up pouch, flexible, tetra pack and similar packaging materials are now evolving in both the international and local market, hence the FDA sets the following guidelines to protect the consumers, especially children:

  1. All alcoholic beverages, regardless of type of packaging, shall only be displayed in designated conspicuous area in all convenience stores, supermarkets, hypermarkets, groceries and other food retailing stores with prominent signage “ALCOHOLIC BEVERAGES.” Other beverages with alcohol regardless of level of alcohol content like alcopop (flavoured beverage with alcohol content) shall likewise be displayed in this same designated area. These beverages shall not bedisplayed together with other products like juice drinks and MUST NOT be accessible to children;
  2. Owners or operators of sari-sari stores which may not have enough space to designate an area for alcoholic beverages and other beverages with alcohol content shall be responsible to ensure that subject beverages as mentioned in Item no. 2 above are not sold to minors (below 18 years old); and
  3. Promotional and advertising materials on alcoholic beverages and beverages with alcohol content (regardless of amount) shall clearly state or inform consumers that such beverages contain alcohol, and therefore not to be promoted and advertised to be sold to and consumed by minors. Packaging and labelling materials shall not be appealing to children.Sanctions and penalties over violations of any of the provisions of this FDA Circular shall follow the Rules of Republic Act No. 10611 and its IRR, otherwise known as the Food Safety Act of 2013.The FDA is enjoining all concerned, including local government units having jurisdiction on sari-sari stores, convenience stores, groceries, hypermarkets, supermarkets and other similar food retailing stores to strictly implement these guidelines.

    This Circular shall take effect immediately.

    Attachment-> :  FDA Circular No. 2019-006

/ In Circular / By Administrator / Comments Off on FDA Circular No. 2019-006 || GUIDELINES IN COMMERCIAL DISPLAY, SELLING, PROMOTION, AND ADVERTISING OF ALCOHOLIC BEVERAGES AND BEVERAGES THAT CONTAIN ALCOHOL

FDA Advisory No. 2019-305 || INFORMATION ON THE ANTI-RED TAPEAUTHORITY (ARTA) ORDER OF AUTOMATIC RENEWAL DATED 09 SEPTEMBER 2019

The Food and Drug Administration (FDA) fully supports the implementation of the Republic Act (RA) No. 11032, otherwise known as the Ease of Doing Business and Efficient Government Service Delivery Act of 2018. Since its enactment into law, multiple initiatives and reforms are being undertaken by the FDA in order to deliver quality and efficient services to its clients and the public it protects.

In light of the ARTA Order of Automatic Renewal issued on 09 September 2019 by ARTA Director General Atty. Jeremiah B. Belgica, REB, EnP, the FDA shall implement the said Order, as stated:

“By virtue of Section 10 of R.A. 11032 or the Ease of Doing Business and Efficient Government Service Delivery Act of 2018, in relation to Section 4 of Rule VIII of its Implementing Rules and Regulations, the Authority hereby DECLARES THE COMPLETENESS of all the pending applications, which have submitted the complete documentary requirements pursuant to the above rules and have paid the required fees until 08 August 2019 or twenty (20) working days immediately prior to the issuance of this Order, classified as follows:

A. CFRR  
Kind of Application Total
  1.    E-Registration  
  1.2. Renewal 1081
  2.    Licensing  
  2.2. Renewal 27
B. CDRR  
  Automatic Renewal 1818
  PCPR 199

Consequently, the foregoing applications are deemed AUTOMATICALLY APPROVED and/or AUTOMATICALLY RENEWED by operation of law, as the case may be. In view thereof the Food and Drug Administration is hereby ORDERED to ISSUE the corresponding permits, licenses, or any other certification for the foregoing applications.”

The following conditions for Automatic Renewal of License to Operate (LTO) and Certificate of Product Registration (CPR) shall be met, as stated in the RA No. 9711 otherwise known as the Food and Drug Administration (FDA) Act of 2009 and its Implementing Rules and Regulations:

  1. The application is filed before the expiration date of the license;
  2. The prescribed renewal fee is paid upon filing of the application; and
  3. Sworn statement indicating no change or variation whatsoever in the establishment is attached to the application.

However, this does not preclude FDA from conducting Post-Marketing Surveillance activities on establishments and health products.

For public health reasons, any company found to have committed misrepresentations, false entries or claims against the Affidavit of Undertaking submitted in the Automatic Renewal application shall be subject to administrative and criminal liabilities, provided for by the RA No. 9711, which includes but not limited to suspension, cancellation, or revocation of their License to Operate and/or Certification.

Attachment-> : FDA Advisory No. 2019-305

FDA Advisory No. 2019-304 || 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 consumption of the following unregistered food products:

1. MARLO’S SPECIAL PORK CHICHARON
2. AYCOCHO’S FOOD PRODUCT CHICHARON MANOK CHICKEN CRACKLING ORIGINAL
3. CAFE JUVI 8 in 1 PREMIUM HERBAL COFFEE MIX
4. LEXVIC ENTERPRISE 100% NATURAL PARAGIS COFFEE SUGAR FREE

The FDA verified through post-marketing surveillance that the above mentioned food products are not registered and the Certificate 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 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 in the market. Moreover, the public is advised to always check if a food product is registered with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing.

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

All FDA Field Officers and Regulatory Enforcement Unit (REU) in coordination with the law enforcement agencies and Local Government Units (LGUs) are requested to ensure that violative products are not sold or made available in their localities or areas of jurisdiction.

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

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment-> : FDA Advisory No. 2019-304

FDA Advisory No. 2019-303 || ADVISORY ON THE USE OF RAW PORK MEAT IN THE PROCESSING OF PORK MEAT PRODUCTS

With reference to the confirmation of the outbreak of African Swine Fever (ASF) in the country, the Food and Drug Administration (FDA) hereby enjoins all concerned establishments, especially manufacturers of processed pork meat products, to ensure that only carcass/ meat from National Meat Inspection Service (NMIS) accredited slaughterhouses or abattoirs shall be utilized in the manufacturing of pork meat products.

Likewise, those establishments acquiring raw pork meats from wet markets, meat shops, groceries, and other meat outlets are reminded to purchase only those that have been inspected and permitted by NMIS inspectors, veterinary inspectors or Meat Control Officers.

Although ASF virus is not considered a zoonotic disease (disease of animal transferable to humans), all establishments are ordered to support the government’s efforts on ASF disease detection, surveillance, and control measures in order to prevent the further spread of the disease that poses a great impact to the swine industry.

Dissemination of the above information to all concerned is requested.

Attachment-> : FDA Advisory No. 2019-303

FDA Advisory No. 2019-302 || 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 consumption of the following unregistered food products:

1. PEZ SOURZ SOUR WATERMELON CANDY
2. PEZ SOURZ SOUR BLUE RASPBERRY CANDY
3. PEZ SOURZ SOUR GREEN APPLE CANDY
4. PEZ SOURZ SOUR GREEN PINEAPPLE CANDY

The FDA verified through post-marketing surveillance that the above mentioned food products are not registered and the Certificate 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 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 in the market. Moreover, the public is advised to always check if a food product is registered with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing.

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

All FDA Field Officers and Regulatory Enforcement Unit (REU) in coordination with the law enforcement agencies and Local Government Units (LGUs) are requested to ensure that violative products are not sold or made available in their localities or areas of jurisdiction.

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

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment-> :FDA Advisory No. 2019-302

FDA Advisory No. 2019-301 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Product and Food Supplements:

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

1. PERFECTION Cafe Cappuccino Coffee Mix
2. CELLFOOD Oxygen + Nutrient Dietary Supplement
3. Nano Silver Colloidal
4. Aviso Water

The FDA verified through post-marketing surveillance that the above mentioned food product and food supplements are not registered and the Certificate 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 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 in the market. Moreover, the public is advised to always check if a food product is registered with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing.

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

All FDA Field Officers and Regulatory Enforcement Unit (REU) in coordination with the law enforcement agencies and Local Government Units (LGUs) are requested to ensure that violative products are not sold or made available in their localities or areas of jurisdiction.

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

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment-> : FDA Advisory No. 2019-301

/ In Food Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-301 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Product and Food Supplements:

FDA Advisory No. 2019-300 || 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. HEALTH INSIGHT NUTRIMAX PLUS
  2. HEALTH INSIGHT FECAL BUSTER COLONIC BIODETOX TOTAL BODY CLEANSING
  3. HEALTH INSIGHT NERVO-SAVER PROANTHOCYANIDIN GRAPESEED OIL EXTRACT
  4. HEALTH INSIGHT 100% PURE SPIRULINA SUPER FOOD
  5. HEALTH INSIGHT VCO EXTRA VIRGIN COCONUT OIL

The FDA verified through post-marketing surveillance that the abovementioned food supplements 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 food supplements 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 in the market. Moreover, the public is advised to always check if a food supplement is registered with the FDA. The FDA website (www.fda.gov.phhas 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 supplement.

All FDA Field Officers and Regulatory Enforcement Unit (REU) in coordination with the law enforcement agencies and Local Government Units (LGUs) are requested to ensure that violative products are not sold or made available in their localities or areas of jurisdiction.

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

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment-> :  FDA Advisory No. 2019-300

FDA Advisory No. 2019-299 || 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 consumption of the following unregistered food products:

  1. SUNDRY DRIED MANGOES
  2. FARM DELIGHT MALUNGGAY CHIPS (Moringa Oelifera)
  3. FARM DELIGHT AMPALAYA CHIPS (BITTER GOURD)
  4. OH YUMMY SUNFLOWER CHOCOLATE SEED

The FDA verified through post-marketing surveillance that the abovementioned food products are not registered and the Certificate 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 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 in the market. Moreover, the public is advised to always check if a food product is registered with the FDA. The FDA website (www.fda.gov.phhas 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 Field Officers and Regulatory Enforcement Unit (REU) in coordination with the law enforcement agencies and Local Government Units (LGUs) are requested to ensure that violative products are not sold or made available in their localities or areas of jurisdiction.

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

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment-> : FDA Advisory No. 2019-299

FDA Advisory No. 2019-298 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

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

  1. VJB FOOD PRODUCTS Spicy Sampalok Candy
  2. AV PASALUBONG PRODUCTS Fried Peanut
  3. PALAWAN ESSENTIALS Dried Mangoes
  4. CATALO Turmeric Tea

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

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

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

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

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

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

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment-> : FDA Advisory No. 2019-298

FDA Advisory No. 2019-261-A || Lifting the Advisory on the Registered Food Product HEALTHY YOU CHAMOMILE & HONEY INFUSION” under 2019-261 “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 HEALTHY YOU CHAMOMILE & HONEY INFUSION has been registered by the Market Authorization Holder, MANILA UNI-GLOBAL IMPORT EXPORT CORP.., in accordance to existing FDA rules and regulations.

Accordingly, the list released in FDA Advisory No. 2019-261 is hereby updated to remove the aforementioned food productt.

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 [email protected], or call (02) 857-1900 loc. 8112 or 8105.

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

The public health warning imposed on the remaining product listed in FDA Advisory No. 2019-261 shall remain to be upheld and shall not be affected by the issuance of this advisory. Furthermore, the issuance of this advisory shall not in any manner preclude this Office from issuing subsequent orders it may deem necessary and appropriate, should there be findings of any violation of the company to the existing laws, rules, and regulations.

Dissemination of this advisory to all concerned is hereby requested.

Attachment-> : FDA Advisory No. 2019-261-A

/ In Food Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-261-A || Lifting the Advisory on the Registered Food Product HEALTHY YOU CHAMOMILE & HONEY INFUSION” under 2019-261 “Public Health Warning Against the Purchase and Consumption of the Unregistered Food Product”

National Consciousness Week Against Counterfeit Medicines 2019

Heads Up Poster Makers!

Be part of the National Consciousness Week Against Counterfeit Medicines 2019 Poster Making Contest with a THEME:

” PAMBANSANG REGULASYON PAGTIBAYIN, PEKENG GAMOT SUGPUIN “

For the Registration Form, kindly download the attachment below…

Attachment-> : Registration Form

FDA Advisory No. 2019-297 || 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. CALIFORNIA GOLD NUTRITION DAIRY ENZYMES BROAD SPECTRUM ENZYMES FOR DAIRY PROTEIN & LACTOSE  SENSITIVE INDIVIDUALS DIETARY SUPPLEMENT
  2. NOW ALOE 10,000 & PROBIOTICS
  3. ZENWISE HEALTH DAILY DIGESTIVE ENZYMES WITH PREBIOTICS AND PROBIOTICS DIETARY SUPPLEMENT
  4. SWANSON GINGER ROOT DIGESIVE HEALTH DIETARY SUPPLEMENT
  5. PARADISE COLLAGEN EXTREME WITH BIOCELL COLLAGEN DIETARY SUPPLEMENT

The FDA verified through post-marketing surveillance that the abovementioned food supplements 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 food supplements 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 in the market. 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 products 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 Field Officers and Regulatory Enforcement Unit (REU) in coordination with the law enforcement agencies and Local Government Units (LGUs) are requested to ensure that violative products are not sold or made available in their localities or areas of jurisdiction.

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

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment-> : FDA Advisory No. 2019-297

FDA Advisory No. 2019-296 || 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 consumption of the following unregistered food products:

  1. FORTUNE PINOY SNACKS BANANA SLICES
  2. CALIFORNIA SEEDLESS RAISINS
  3. FUN CRAVINGS SWEET TAMARIND
  4. CRUNCHIES BANANA CHIPS
  5. FERRER PEANUT BRITTLE

The FDA verified through post-marketing surveillance that the abovementioned food products are not registered and the Certificate 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 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 in the market. Moreover, the public is advised to always check if a food product is registered with the FDA. The FDA website (www.fda.gov.phhas 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 Field Officers and Regulatory Enforcement Unit (REU) in coordination with the law enforcement agencies and Local Government Units (LGUs) are requested to ensure that violative products are not sold or made available in their localities or areas of jurisdiction.

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

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment-> : FDA Advisory No. 2019-296

 

FDA Circular No. 2019-005 || Updates and Amendments of the ASEAN Cosmetic Directive (ACD) as Adopted During the 30th ASEAN Cosmetic Commitee (ACC) Meeting and Its Related Meetings

to continue reading, click the attachment below…

Attachment-> : FDA Circular No.2019-005

/ In Circular / By Administrator / Comments Off on FDA Circular No. 2019-005 || Updates and Amendments of the ASEAN Cosmetic Directive (ACD) as Adopted During the 30th ASEAN Cosmetic Commitee (ACC) Meeting and Its Related Meetings

FDA Advisory No. 2019-294 || 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 consumption of the following unregistered food products:

  1. KOPIMO 6 in 1 COFFEE WITH MANGOSTEEN & SEAWEED
  2. SKINNY ORANGE DETOX INSTANT DRINK MIX WITH L-CARNITINE, GARCINIA CAMBOGIA, GREEN TEA EXTRACT, GLUTATHIONE & COLLAGEN
  3. CHOCOLIZ 80% CACAO BAR
  4. ORION JELLYDAY
  5. OK WACKIE! CORN CHIPS, WASABI FLAVOR

The FDA verified through post-marketing surveillance that the abovementioned food products are not registered and the Certificate 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 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 in the market. Moreover, the public is advised to always check if a food product is registered with the FDA. The FDA website (www.fda.gov.phhas 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 Field Officers and Regulatory Enforcement Unit (REU) in coordination with the law enforcement agencies and Local Government Units (LGUs) are requested to ensure that violative products are not sold or made available in their localities or areas of jurisdiction.

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

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment-> :  FDA Advisory No. 2019-294

FDA Advisory No. 2019-293 || 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. DIVINE BOUNTY DIGESTIVE ENZYMES WITH PROBIOTICS + PREBIOTICS DIETARY SUPPLEMENT
  2. NATURE’S WAY DIM-PLUS ESTROGEN METABOLISM DIETARY SUPPLEMENT
  3. NOW PANCREATIN 10X-200mg DIETARY SUPPLEMENT
  4. BENDURYA MANGOSTEEN PLUS TURMERIC CAPSULE, 500mg
  5. HONEY-C

The FDA verified through post-marketing surveillance that the abovementioned food supplements 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 food supplements 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 in the market. Moreover, the public is advised to always check if a food supplement is registered with the FDA. The FDA website (www.fda.gov.phhas 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 supplement.

All FDA Field Officers and Regulatory Enforcement Unit (REU) in coordination with the law enforcement agencies and Local Government Units (LGUs) are requested to ensure that violative products are not sold or made available in their localities or areas of jurisdiction.

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

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment-> : FDA Advisory No. 2019-293

FDA Advisory No. 2019-292 || 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 consumption of the following unregistered food products:

  1. ROBINSONS CORNIKS SPICY
  2. HEALTH INSIGHT CHOCO DRINK 15 IN 1 HERBAL CHOCODRINK WITH TAURINE
  3. HEALTH INSIGHT HEALTHY BLEND 15 IN 1 HERBAL COFFEE
  4. SAKTO SPECIAL SWEET KAONG
  5. BEBS SPPECIAL SWEET KAONG

The FDA verified through post-marketing surveillance that the abovementioned food products are not registered and the Certificate 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 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 in the market. Moreover, the public is advised to always check if a food product is registered with the FDA. The FDA website (www.fda.gov.phhas 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 Field Officers and Regulatory Enforcement Unit (REU) in coordination with the law enforcement agencies and Local Government Units (LGUs) are requested to ensure that violative products are not sold or made available in their localities or areas of jurisdiction.

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

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment-> : FDA Advisory No. 2019-292

FDA Advisory No. 2019-291 || 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 consumption of the following unregistered food products:

  1. CECILLE’S SWEET BUKAYO
  2. CECILLE’S SPECIAL SHING-ALING CHIPS
  3. CECILLE’S SPECIALS PEANUT BRITTLE
  4. CECILLE’S SPECIAL URARO COLORED MEDIUM
  5. SWEET HONEY

The FDA verified through post-marketing surveillance that the abovementioned food products are not registered and the Certificate 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 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 in the market. Moreover, the public is advised to always check if a food product is registered with the FDA. The FDA website (www.fda.gov.phhas 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 Field Officers and Regulatory Enforcement Unit (REU) in coordination with the law enforcement agencies and Local Government Units (LGUs) are requested to ensure that violative products are not sold or made available in their localities or areas of jurisdiction.

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

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment-> : FDA Advisory No. 2019-291