Month: August 2019

LICENSING SEMINAR FOR ENDS/ENNDS MANUFACTURERS, TRADERS, DISTRIBUTORS, AND RETAILERS

This is to inform all concerned stakeholders that the FDA shall be conducting a licensing seminar for ENDS/ENNDS manufacturers, traders, distributors, and retailers on 4 and 11 September 2019, at the DOH Convention Hall, DOH, Sta. Cruz, Manila.

Please take note of the following schedule:

4 September 2019

11 September 2019

AM Session Licensing Seminar and Workshop for ENDS/ENNDS Manufacturers and Traders Licensing Seminar and Workshop for ENDS/ENNDS Retailers and Online Sellers
8:30-12:00 NN
PM Session Licensing Seminar and Workshop for ENDS/ENNDS Distributors (Importers, Exporters, and Wholesalers)
1:00-4:00 PM

Only the first one-hundred fifty (150) pre-registered participants (per session) who received a confirmation email shall be accommodated in the venue. Furthermore, due to limited slots, only one (1) representative per company will be allowed to attend the seminar.

You can register on the link provided with this announcement. 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-> : Licensing seminar for Manufacturers, Distributors, and Retailers

VENUE FOR UNIFIED LICENSING SEMINAR (ULS –NCR) ON 5 AND 6 SEPTEMBER 2019

Please be informed that the venue of the Unified Licensing Seminar (ULS – NCR) on 5 and 6 September 2019 will be at the THE BELLEVUE HOTEL MANILA, NORTH BRIDGEWAY, FILINVEST CITY, ALABANG, MUNTINLUPA CITY.

All course registrants who received Course Assessment Slips but have not received the Course Confirmation Slip are advised to come in the seminar venue on the the schduled 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].

Attachment-> : VENUE FOR UNIFIED LICENSING SEMINAR (ULS –NCR) ON 5 AND 6 SEPTEMBER 2019

FDA Advisory No. 2019-256 || Certification of Contraceptive Products in Compliance to the Implementing Rules and Regulations of the Republic Act No. 10354, Also Known as the Responsible Parenthood and Reproductive Health Act of 2012

In compliance with Republic Act No. 10354, also known as “The Responsible Parenthood and Reproductive Health Act of 2012” and its IRR, the Food and Drug Administration (FDA) hereby invites all concerned to submit their petitions and any corresponding evidence on the mechanism of action of the following contraceptive products within ten (10) calendar days from the posting of this Advisory:

Documents and scientific evidence can be submitted to the Food and Drug Action Center (FDAC), 3™ Floor Starmall, Alabang, Muntinlupa on Mondays to Fridays, 8:00 am to 5:00 pm.

Attachment-> : FDA Advisory No.2019-256

/ In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-256 || Certification of Contraceptive Products in Compliance to the Implementing Rules and Regulations of the Republic Act No. 10354, Also Known as the Responsible Parenthood and Reproductive Health Act of 2012

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

Please be informed that the venue of the QPIRA for Center for Cosmetics Regulation and Research (QCCRR-NCR) on 3-4 September 2019 will be at THE BELLEVUE HOTEL, NORTH BRIDGEWAY, FILINVEST CITY, ALABANG, MUNTINLUPA CITY.

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 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]

Attachment-> : SEMINAR VENUE FOR QPIRA FOR CCRR (QCCRR-NCR) ON 3-4 SEPTEMBER 2019

FDA Advisory No. 2019-255 || Voluntary Product Recall of Proximate ILS Curved Intraluminal Stapler

The Food and Drug Administration (FDA) warns all healthcare professionals and establishments on the voluntary recall of affected lots of Proximate ILS Curved Intraluminal Stapler with DVR No. 4981, manufactured by Ethicon Endo-Surgery, LLC — Puerto Rico and imported by Johnson & Johnson (Phils.), Inc.:

Product Name Product Code Lot Number
Proximate ILS Curved

Intraluminal Stapler

CDH21A

CDH25A

CDH29A

CDH33A

All lots within expiration date range of December 2022 to March 2024

Through investigation of complaints and returned products, Ethicon has confirmed occurrence of uncut washers and malformed staples with the above mentioned medical device, which can compromise staple line integrity. If a problem with the staple line is not adequately addressed or is not recognized, there is a potential risk of postoperative anastomotic leak, gastrointestinal injury, hemorrhage, or hemorrhagic shock.

Based on Ethicon’s analysis of complaints received to date and estimated device usage, the predicted occurrence of complaints for malformed staples has increased but is expected to remain below 0.1%. Ethicon is implementing corrective actions to resolve the shift in product performance.

In light of the foregoing, all concerned healthcare professional, establishment, and the general public is warned to discontinue further use, sale, and distribution of the above mentioned medical device.

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

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

Any suspected adverse reaction experienced from the use of the medical device but not limited to the lot numbers stated above should be reported immediately to FDA.

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. 2019-255

FDA Advisory No. 2019-254 || Public Health Warning Against the Purchase and Use of the Medical Device “INTROCAN SAFETY IV CANNULA WITH FIXATION WING (STERILE)” with the following Unregistered Article Numbers:

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

SIZE UNREGISTERED ARTICLE NUMBER 
G16 4254570-01
G18 4254562-01, 4253604-01
G20 4254546-01
G22 4254511-01, 4253540-01
G24 4254503-01

The FDA verified through post-marketing surveillance that the medical device with the above- mentioned article numbers 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.

Furthermore, FDA has verified that the above-stated unregistered medical device product is not imported by B. Braun Medical Supplies, Inc.

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. 2019-254

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-254 || Public Health Warning Against the Purchase and Use of the Medical Device “INTROCAN SAFETY IV CANNULA WITH FIXATION WING (STERILE)” with the following Unregistered Article Numbers:

VENUE FOR UNIFIED LICENSING SEMINAR (ULS –RX) ON 29 AUGUST 2019

Please be informed that the venue of the Unified Licensing Seminar (ULS – RXI) on 29 August 2019 will be in PLAZA ALEMANIA, CORNER B. S. ONG STREET & GREGORIO T. LLUCH AVE. PALA-O, ILIGAN 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 –RX) ON 29 AUGUST 2019

FDA Advisory No. 2019-252 || Phased implementation of Administrative Order 2019-0007: “Revised Rules and Regulations on Electronic Nicotine and Non-Nicotine Delivery System (ENDS/ENNDS)”

The Food and Drug Administration (FDA) informs the consuming public and all stakeholders in the electronic cigarette industry that Administrative Order 2019-0007: “Revised Rules and Regulations on Electronic Nicotine and Non-Nicotine Delivery System (ENDS/ENNDS)” has been published in two newspapers of general circulation last 9 July 2019 and the University of the Philippines Online National Administrative Registry last 4 July 2019.

Accordingly, the FDA is allowing a three-month transitory period to implement improved infrastructure, to accommodate all transactions to comply with the Ease of Doing Business Act, and to allow all stakeholders concerned to adjust to the new regulations.

The public is advised that online services will be available to check if their electronic cigarette products are 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.

Dissemination of this advisory to all concerned is hereby requested.

Attachment-> : FDA ADVISORY No. 2019-252

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-252 || Phased implementation of Administrative Order 2019-0007: “Revised Rules and Regulations on Electronic Nicotine and Non-Nicotine Delivery System (ENDS/ENNDS)”

PRESS RELEASE 22 August 2019: Warning retailers on promoting and selling of alcoholic beverages to minors (below 18 years old)

The Department of Health – Food and Drug Administration released recently an advisory warning retailers on promoting and selling of alcoholic beverages to minors (below 18 years old). This is in light of recent reports that alcopops, sweet and often fruit-flavored or fizzy alcoholic beverages, are being sold by retailers, such as supermarkets, groceries and convenience stores to minors, alongside with juice drinks and other non-alcoholic beverages.

To ensure health and welfare of minors and to remind retailers on the ethical sale of alcoholic beverages, the DOH-FDA is sternly reminding all retailers to refrain from the promotion and selling of all alcoholic beverages, especially alcopops, to minors. Further, retailers are reminded to include appropriate prominent signage for liquors/alcoholic drinks in their respective stores and ensure the conduct of appropriate verification of age of customers.

The general public is enjoined to be vigilant from food retailers who continuously sell alcoholic beverages to minors. Please report these erring food retailers to eReport, the online reporting facility of the Food and Drug Administration, which can be accessed at www.fda.gov.ph/ereport or call 857-1900 local 8112 and 8115.

Attachment-> : Press Release 22 August 2019

VENUE FOR QCCRR-MIN ON 29-30 AUGUST 2019 AND ULS-RX ON 30 AUGUST 2019

Please be informed that the venue of the Center for Cosmetics Regulation and Research (QCCRR-Min) on 29-30 August 2019 and Unified Licensing Seminar (ULS – RX) on 30 August 2019 will be in APPLE TREE RESORT AND HOTEL, ZONE-2 TABOC, OPOL, MISAMIS ORIENTAL.

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 QCCRR-MIN ON 29-30 AUGUST 2019 AND ULS-RX ON 30 AUGUST 2019

FDA Advisory No. 2019-253 || Public Health Warning Against the Purchase and Use of the following Unnotified Toys and Child Care Articles (TCCAs):

The Food and Drug Administration (FDA) warns the public from purchasing and using the following Unnotified TCCAs:

  1. SESAME STREET SESAME BEGINNINGS FEEDING BOTTLE
  2. INTEX POOL SCHOOL DE LUXE SWIM RING
  3. INTEX FROZEN DELUXE ARM BANDS
  4. BEBETA FEEDING BOTTLE
  5. HELLO KITTY FEEDING BOTTLE WITH CHARACTER HOOD

The FDA verified through post-marketing surveillance that the abovementioned TCCA products are not authorized and the Certificates of Product Notification (CPN) 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 unnotified TCCA products have not gone through evaluation process of the FDA, the agency cannot assure their quality and safety. The use of such violative products may pose health risks to consumers.

Potential hazards may come from ingredients that are resticted or not allowed to be part of a TCCA product such as Phthalate and Bisphenol A. The use of substandard and possibly adulterated TCCA products may result to health risks including but not limited to endocrine disruption and reproductive or developmental effects in relation to exposure to these compounds.

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

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

All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that violative

products are not sold or made available in the market or areas of jurisdiction.

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

To report any sale or distribution of unnotified TCCAs, 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. 2019-253

ADDITIONAL SEMINAR/TRAINING SCHEDULE OF FDA FOR 2019

Please be informed of the additional FDA Seminar/Training schedule for 2019.

COURSE TITLE DATE VENUE
Unified Licensing Seminar for Region IV-B 28 November 2019 Oriental Mindoro
Center for Device Regulation, Radiation Health and Research QPIRA Seminar 27-28 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 SCHEDULE FOR 2019

FDA Advisory No. 2019-251 || Public Health Warning Against Unregistered Food Products with Unapproved Advertisements and Promotion on Their Products:

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

  1. Ionic Coloidal Silver
  2. Aviso Water

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.

Likewise, all claims in the advertisements are false, deceptive, and misleading. As per Administrative Order 2010-0008, no person shall advertise, promote, or use in any sponsorship any food/dietary supplements unless such product is duly registered and approved by the Food and Drug Adminisration.

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. 2019-251

/ In Food Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-251 || Public Health Warning Against Unregistered Food Products with Unapproved Advertisements and Promotion on Their Products:

FDA Advisory No. 2019-249 || Public Health Warning Against the Purchase and Use of the following Unnotified Toys and Child Care Articles (TCCAs):

The Food and Drug Administration (FDA) warns the public from purchasing and using the following Unnotified TCCAs:

  1. COLOR CLAY DIY PIZZA MANIA
  2. DISNEY PIXARS CARS SURPRISE EGG WITH SWEETS & SURPRISES
  3. ZAINI3 MILK CHOCOLATE EGGS WITH A 3D COLLECTION

The FDA verified through post-marketing surveillance that the abovementioned TCCA products are not authorized and the Certificates of Product Notification (CPN) 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 unnotified TCCA products have not gone through evaluation process of the FDA, the agency cannot assure their quality and safety. The use of such violative products may pose health risks to consumers.

Potential hazards may come from ingredients that are resticted or not allowed to be part of a TCCA product such as Phthalate and Bisphenol A. The use of substandard and possibly adulterated TCCA products may result to health risks including but not limited to endocrine disruption and reproductive or developmental effects in relation to exposure to these compounds.

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

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

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

Kindly contact the FDA Center for Cosmetics Regulation and Research through e-mail at [email protected], or call (02) 857-1900 loc. 8113 or 8107. To report any sale or distribution of unnotified TCCAs, 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. 2019-249

FDA Advisory No. 2019-248 || Public Health Warning Against the Purchase and Use of the following Unnotified Toys and Child Care Articles (TCCAs):

The Food and Drug Administration (FDA) warns the public from purchasing and using the following Unnotified TCCAs:

  1. AQUATIC SUPER GOGGLES
  2. GREEN FOOTBALL ARM RING (NO. 1297-10)
  3. SWIMMING RING (SPONGEBOB)

The FDA verified through post-marketing surveillance that the abovementioned TCCA products are not authorized and the Certificates of Product Notification (CPN) 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 unnotified TCCA products have not gone through evaluation process of the FDA, the agency cannot assure their quality and safety. The use of such violative products may pose health risks to consumers. Potential hazards may come from ingredients that are resticted or not allowed to be part of a TCCA product such as Phthalate and Bisphenol A. The use of substandard and possibly adulterated TCCA products may result to health risks including but not limited to endocrine disruption and reproductive or developmental effects in relation to exposure to these compounds.

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

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

All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that violative

products are not sold or made available in the market or areas of jurisdiction.

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

To report any sale or distribution of unnotified TCCAs, 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. 2019-248

VENUE FOR UNIFIED LICENSING SEMINAR (ULS –RXI) ON 22 AUGUST 2019

Please be informed that the venue of the Unified Licensing Seminar (ULS – RXI) on 22 August 2019 will be in GRAND REGAL HOTEL DAVAO, KM. 7 J.P LAUREL AVENUE, LANANG, DAVAO CITY, DAVAO DEL SUR.

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-> : ULS DAVAO VENUE on 22 August 2019

FDA Advisory No. 2019-250 || Warning Against Retailers on Promoting and Selling of Alcoholic Beverages, especially in Ready-to-Drink Food Packaging, to Minors (Below 18 Years Old)

In the interest of consumer protection and ethical selling of alcoholic beverages to the consuming public, all food retailers, such as supermarkets, groceries, convenience stores and sari-sari stores, are hereby warned against the promoting and selling of alcoholic beverages to minors, especially in ready-to-drink food packaging.

Food retailers, particularly supermarkets, groceries and convenience stores, are sternly reminded to sell all alcoholic beverages in respective liquor/alcoholic drinks section or shelf, with prominent signage, in store premises for restriction of access to minors.

For erring food retailers continuously selling alcoholic beverages to minors, please report them to eReport, the online reporting facility of the Food and Drug Administration, which can be accessed at www.fda.gov.plc/ereport or call 857-1900 local 8112 and 8115.

Dissemination of information to all concerned is requested.

 

Attachments>:FDA Advisory No. 2019-250 |

 

/ In Food Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2019-250 || Warning Against Retailers on Promoting and Selling of Alcoholic Beverages, especially in Ready-to-Drink Food Packaging, to Minors (Below 18 Years Old)

FDA Advisory No. 2019-110-A || Lifting the Advisory on the Following Registered Medical Devices under FDA Advisory No. 2019 -110 “HR™ Lubricating Jelly One Shot”

The Food and Drug Administration (FDA) informs the public that the HR™ Lubricating Jelly One Shot has been registered by the Market Authorization Holder (MAH), Berovan Marketing Inc., with FDA registration number MDR-06020A in accordance to existing FDA rules and regulations.

Accordingly, the warning against the purchase and use of the product as mentioned in FDA Advisory No. 2019-110 is hereby lifted.

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 products, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

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. 2019-110-A

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-110-A || Lifting the Advisory on the Following Registered Medical Devices under FDA Advisory No. 2019 -110 “HR™ Lubricating Jelly One Shot”

FDA Advisory No. 2019-247 || 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. Ximivogue Germicidal Breathable Band-Aid Set
  2. Ximivogue Band-Aid Cartoon

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. 2019-247

FDA Advisory No. 2019-246 || Public Health Warning Against False, Deceptive and Misleading Health Claims of Pantyliners/Sanitary Napkins

Reiteration of the issuance of FDA Advisory No. 2017-323 regarding the false, deceptive and misleading health claims of pantyliners/sanitary napkins.

The Food and Drug Administration (FDA) reissues this advisory to inform the general public the proliferation of pantyliners/sanitary napkins with health claims e.g. relieves tension, reduces irritation, prevents/cures diseases/infection such as UTI, Myoma, vaginal odor, hormonal imbalance etc., and releases negative ions.

While as general rule, pantyliners/sanitary napkins are not required to seek proper authorization from the FDA, pantyliners/sanitary napkins with health claims, require such authorization. The sale/marketing of such unregistered product constitutes violation of Section 10 of Republic Act No. 9711 otherwise known as the “Food and Drug Administration Act of 2009”.

On the other hand, the false, deceptive and misleading advertisement of these pantyliners/ sanitary napkins, constitutes violation of Title III, Chapter I of Republic Act No. 7394, otherwise known as the “Consumer Act of the Philippines of 1992”.

The public is thus advised to be vigilant and observe precautionary measures in purchasing unregistered pantyliners/sanitary napkins with health claims, false, deceptive and misleading health claims.

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 these products are not sold or made available in the market or areas of jurisdiction.

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

Attachment-> : FDA Advisory No. 2019-246

FDA Advisory No. 2019-245 || Public Health Warning Against the Purchase and Use of the Unregistered Health Related Device “Megafresh® Compact Alkaline Water Filtration Systems”

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

  1. Megafresh® Compact Alkaline Water Filtration Systems

The FDA verified through post-marketing surveillance that the abovementioned health related device is not registered and the Certificate of Health 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. Health related device products especially water purification device/ system shall not bear any false, deceptive and misleading claims and promotional ploys on alkaline water, oxygenated water or ionized water.

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 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 related 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. 2019-245

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-245 || Public Health Warning Against the Purchase and Use of the Unregistered Health Related Device “Megafresh® Compact Alkaline Water Filtration Systems”

FDA Advisory No. 2019-244 || 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. FRANKFURT STRONG Qianlietong Capsules 380 mg
  2. FRANKFURT STRONG Sugerolin Capsules 380 mg
  3. FRANKFURT STRONG Permolex Capsules 380 mg

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

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

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

All concerned establishments are warned not to distribute violative food supplements until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a CPR for the food 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. 2019-244

FDA Advisory No. 2019-243 || 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. Phyto-Oestrogens
  2. GERMANY FRANKFURT Potenzagy Capsules 380 mg
  3. FRANKFURT STRONG Belestone Capsules 380 mg

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

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

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

All concerned establishments are warned not to distribute violative food supplements until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a CPR for the food 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. 2019-243

FDA Advisory No. 2019-242 || 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. DEXTROSOL D-Glucose Powder Pure Dextrose
  2. NUOWEIKON Soy Lecithin Dietary Supplement Softgels
  3. Kangaroo Essence 3000 mg Capsules
  4. PHYRIC Lapiton Capsules

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

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

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

All concerned establishments are warned not to distribute violative food supplements until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a CPR for the food 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. 2019-242

FDA Advisory No. 2019-241 || 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. Easy Slim Capsule
  2. FLD HERBAL PRODUCTS Detox Cleansing for Internal Purification & Healing Food Supplement Herbal Capsule
  3. NATUFORM Beauty Breast Softgels
  4. WEIDER Creatine Dietary Supplement Capsules

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

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

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

All concerned establishments are warned not to distribute violative food supplements until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a CPR for the food 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. 2019-241

FDA Advisory No. 2019-240 || 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. ESC Slimming Formula Capsule
  2. SLIM UP Slimming & Whitening Formnula Herbs Tea
  3. S-LINE Slimming Orange Juice
  4. D.K. Active White Soft Capsule

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

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

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

All concerned establishments are warned not to distribute violative food supplements until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a CPR for the food 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. 2019-240

FDA Advisory No. 2019-239 || 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. TENTAY Vinegar Sukang Tunay Asim
  2. COCOS Cider Vinegar Plain
  3. RIKOY’S Bahalina Coco Nectar Vinegar Pure Suka Tuba Classic Sukang Puti

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, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment-> : FDA Advisory No. 2019-239

Notice of Cascading-Workshop of Center for Cosmetics Regulation and Research (CCRR) on 15 to 16 of August 2019

By virtue of FDA Personnel Order No. 2019-0523, please be advised that the Center for Cosmetics Regulation and Research (CCRR) will conduct a Cascading-Workshop on the new Administrative Orders on the Regulation of Electronic Nicotine Delivery Systems (END/ENDDS), Household Pesticide and Their Active Ingredients, Operators of Pest Control, Certification of Pesticide Handlers and Accreditation of Their Training Providers, Reinstatement of Licensing and Registration and or Notification of Household Urban Substances and Implementing Rules and Regulations of RA10620 on 15 to 16 of August 2019.On such dates, CCRR will not be able to entertain clients.

Regular transactions will resume on Monday, 19 August 2019

Attachment-> : Notice (Cascading CCRR)

FDA Advisory No. 2019-238 || VOLUNTARY RECALL OF SIMILAC TUMMICARE® ONE INFANT FORMULA (820 grams) WITH BATCH NO. 03518QU

The public is hereby advised by the Food and Drug Administration (FDA) regarding the voluntary recall of Abbott Laboratories on Similac Tummicare® One Infant Formula (820 grams), with batch no. 03518QU, manufacturing date March 2019 and expiration date March 2022 due to difference in the label instructions and preparation scoop size of the product.

Abbott Laboratories, Inc. received an inquiry from a customer regarding the inconsistency between the scoop size and preparation instructions at the label of the product. The affected batch contained a smaller red preparation scoop compared to the white preparation scoop that is shown on the label instructions. The product is safe to consume however, if the red scoop is used to prepare the formula according to the label instructions and provided to an infant as sole source of nutrition, it would not provide sufficient nutrition to support normal growth.

Although Abbott Laboratories has not received any adverse event reports for this incident, the company has decided to proceed with caution and voluntarily recalled the product from the market. This recall applies only to the product with batch no. 03518QU and no other Abbott Laboratories products are affected by this recall.

Consumers who may have purchased the above product are advised to contact Abbott Laboratories hotline at telephone no. (02) 995-1555 (Manila) or 1800-10-995-1555 (Province) or email [email protected] for information on how to obtain either a replacement product or full refund. The public may also email the FDA at [email protected] for any question or additional information regarding the recall.

All Officers of the Field Regulatory Operations Office (FROO) are hereby ordered to monitor the availability of the product with the specified batch number in the market and instruct the concerned establishment to return the sealed stocks to Abbott Laboratories for proper disposal.

Dissemination of the above information to all concerned is requested.

Attachment-> : FDA Advisory No.2019-238

FDA Advisory No. 2019-237 || 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. NORDIC NATURALS OMEGA MEMORY WITH CURCUMIN 1000mg OMEGA-3 + 400mg OPTIMIZED CURCUMIN
  2. NORDIC NATURALS NORDIC OMEGA-3 FISHIES YUMMY TUTTI FRUTTI TASTE 300mg OMEGA-3S
  3. NORDIC NATURALS DAILY OMEGA KIDS BRAIN & VISUAL FUNCTION DIETARY SUPPLEMENT, 500 mg
  4. CHILDLIFE PURE DHA NATURAL BERRY FLAVOR, CHEWABLE DIETARY SUPPLEMENT
  5. BIOGLAN KIDS SMART HI DHA-OMEGA3 FISH OIL

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 use of such violative products may pose health risks to consumers.

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

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

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

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

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. 2019-237