Author: FDA Admin3

FDA Advisory No. 2019-259-A|| Lifting the Advisory on the Registered Food Supplement TGP GINKO BILOBA SOFTGEL CAPSULE” and 2019-259 “Public Health Warning Against the Purchase and Consumption of the Unregistered Food Supplement:

The Food and Drug Administration (FDA) informs the public that the food supplement GINKO BILOBA SOFTGEL CAPSULE has been registered by the Market Authorization Holder, D.B. MANIX INTERNATIONAL, INC.., in accordance to existing FDA rules and regulations.

Accordingly, the list released in FDA Advisory No. 2019-259 is hereby updated to remove the aforementioned food supplement.

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. 2019-259 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. 2019-259-A

/ In Food Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2019-259-A|| Lifting the Advisory on the Registered Food Supplement TGP GINKO BILOBA SOFTGEL CAPSULE” and 2019-259 “Public Health Warning Against the Purchase and Consumption of the Unregistered Food Supplement:

VENUE FOR UNIFIED LICENSING SEMINAR (ULS –RVI) ON 17 & 18 SEPTEMBER 2019

ANNOUNCEMENT 

Please be informed that the venue of the Unified Licensing Seminar (ULS – RVI) on 17 & 18 September 2019 will be in THE MANSION ILOILO, 101 GENERAL LUNA STREET, ILOILO 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 ULS-RVI

FDA Advisory No. 2019-257 || VOLUNTARY RECALL OF LACTUM INFANT FORMULA POWDER 0-6 MONTHS (350 grams) WITH BATCH NO. PL9GDL5B

The public is hereby advised by the Food and Drug Administration (FDA) regarding the voluntary recall of Mead Johnson Nutrition of LACTUM Instant Formula Powder 0-6 Months, with batch no. PL9GDL5B, manufacturing date 12 July 2019 and expiration date 12 January 2021 due to difference in the actual product inside the box which instead contains LACTUM Infant Formula Powder 6-12 Months.
Mead Johnson Nutrition received a report from their authorized retailer that there was a discrepancy between the product marked in their storage and the actual product. The affected batch contained LACTUM Infant Formula Powder 6-12 Months, intended for infants aged 6-12 months.

In line with this, the public is advised to stop feeding of the recalled batch to your infants aged 0-6 months as this may cause dehydration and electrolyte imbalance due to the formulation being intended for infants aged 6-12 months. Furthermore, there is a greater risk for Cronobacter sakazakii infection for infants under 2 months of age as the inappropriate formulation inside (Instant Infant Formula 6-12 Months), does not require verification testing and ingredient controls for Cronobacter spp.

Although Mead Johnson Nutrition 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. PL9GDL5B and no other Mead Johnson Nutrition products are affected by this recall.

Consumers who may have purchased the above product are advised to contact Mead Johnson Nutrition Center hotline at telephone no. (02) 841-8222 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 Mead Johnson Nutrition for proper disposal.

Dissemination of the above information to all concerned is requested.

Attachment:->FDA ADVISORY No. 2019-257

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)

RESCHEDULING OF ULS-RXI IN OBSERVANCE OF THE LOCAL HOLIDAY IN DAVAO ON 16 AUGUST 2019

Please be informed of the following change of the FDA Academy Unified Licensing Seminar   for Region XI (ULS-RXI) in observance of the local holiday in Davao City on 16 August 2019 by virtue of  Proclamation No. 774:

ACTIVITY TITLE FROM

(ORIGINAL SCHEDULE)

TO

(NEW SCHEDULE)

Unified Licensing Seminar for Region XI (Davao City) 16 August 2019 22 August 2019

 

Our apology for any inconvenience this change in seminar schedule have caused.

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

Please be guided accordingly.

 

Attachment->:ULS-RXI (16 AUGUST 2019)

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

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

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

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

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

a.) Authorization letter in company letterhead;

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

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

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

B. RELEASING OF AUTHORIZATIONS

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

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

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

For information and guidance.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

device is not registered and the Certificate of Heath Related  Device Registration (CHRDR) has not yet

been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and

Drug Administration Act of 2009″, the manufacture,importation,exportation, sale, offering for

sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health

products without the proper authorization is prohibited.

Since this unregistered health related device has not gone through evaluation process of the FDA,

the agency cannot assure its quality and safety.

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

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

health related device until CHRDR is issued, otherwise, regulatory actions and sanctions shall

be strictly pursued.

All FDA Regional Field Offices and Regulatory Enforcement units in coordination with law

enforcement agencies and Local Government Units are requested to ensure that this product is

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

The Bureau of Customs is urged to restrain the entry of this unregistered product.

For more information and inquiries, kindly contact the FDA Center for Device Regulation,

Radiation Health and Research through e-mail at [email protected],or call (02) 857-1900 loc.

8301.

To report any sale or distribution of Unregistered health device, the Online reporting Facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

ATTACHMENT: FDA-Advisory-No-2019-228

 

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

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

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

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

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

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

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

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

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

Dissemination of the information to all concerned is requested.

ATTACHEMENT:  FDA-Advisory-No-2019-229

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

FDA Advisory No. 2019-180 ||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. TRUHAIRCARE PREMIUM FORMULA
2. ON GLUTAMINE POWDER
3. 1UP NUTRITION RECHARGE PM BURNER SLEEP AID-PM FAT BURNER DIETARY SUPPLEMENT
4. BPI SPORTS ROXY LEAN MEDI-BIOLOGICAL WEIGHT LOSS DIETARY SUPPLEMENT

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

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

 

FDA Advisory No.2019-180

/ In Food Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2019-180 ||Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplements

FDA Advisory No. 2019-179 ||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. MUSCLETECH PERFORMANCE SERIES CELL TECH, ORANGE FLAVOR
2. MUSCLETECH PRO SERIES MUSCLE BUILDER DIETARY SUPPLEMENT
3. MUSCLETECH ESSENTIAL SERIES PLATINUM GARCINIA TRIPLE DOSE GARCINIA FORMULA DIETARY SUPPLEMENT
4. MUSCLETECH PERFORMANCE SERIES HYDROXYCUT HARDCORE NEXT GEN DIETARY SUPPLEMENT
5. MUSCLETECH PERFORMANCE SERIES VAPORX5, ICY ROCKET FREEZE NATURAL AND ARTIFICIAL FLAVOR

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.

 

FDA Advisory No.2019-179

 

 

/ In Food Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2019-179 ||Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplements
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