Month: June 2019

VENUE FOR UNIFIED LICENSING SEMINAR (ULS –RXII) ON 3 & 4 JULY 2019

Please be informed that the venue of the Unified Licensing Seminar (ULS – RXII) on 3 & 4 July 2019 will be in GREENLEAF HOTEL, SAN MIGUEL STREET CORNER J. CATOLICO AVENUE, LAGAO, GENERAL SANTOS 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 ON 3 & 4 JULY 2019

FDA Advisory No. 2019-164 || 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. SIMPLY WONDERS LEMON PLUS WITH HONEY
  2. SIMPLY WONDERS CHOCO+ 8-in-1-BLEND
  3. SIMPLY WONDERS PURPLE CORN 18-N-1 COFFEE
  4. SIMPLY WONDERS PURPLE CORN JUICE 6 IN 1

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

FDA Advisory No. 2019-164

/ In Food Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-164 || Public Health Warning Against Unregistered Food Products with Unapproved Advertisements and Promotion on Their Products:

FDA Advisory No. 2019-163 || 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. JOY PANDAN GULAMAN
  2. STAY BELOW ZERO PURIFIED TUBE ICE & WATER
  3. MOTHER’S BEST CALAMANSI PHILIPPINE LEMON EXTRACT
  4. TASTY PALAMIG POWDER MIX BLUE LEMONADE
  5. NASH WHITE COFFEE, 3in1

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.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.

FDA Advisory No. 2019-163

/ In Food Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-163 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

FDA Advisory No. 2019-162 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products and Food Supplements:

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

  1. BIOHERBS HEALING TIKI-TIKI
  2. NATURE’S BOUNTY ACIDOPHILUS PROBIOTIC 100 MILLION ORGANISMS
  3. COLLOIDAL SILVER
  4. LEMON GRASS ICED TEA CALAMANSI WITH HONEY
  5. LEMON GRASS ICED TEA STEVIA, SUGAR FREE

The FDA verified through post-marketing surveillance that the abovementioned food products 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 and 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 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 and food supplements until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a CPR for the food product and 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 product and food supplement, the online reporting facility, Report can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

FDA Advisory No. 2019-162

/ In Food Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-162 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products and Food Supplements:

FDA Advisory No. 2019-161 || 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. HI AUTOCIN HERBAL SUPPLEMENT, 300mg
  2. HI VEIN LITE HERBAL SUPPLEMENT, 500mg
  3. NOW L-CARNOSINE DIETARY SUPPLEMENT, 500mg
  4. SMARTERNUTRITION CURCUMIN DIETARY SUPPLEMENT
  5. PARADISE MILK THISTLE DIETARY SUPPLEMENT

The FDA verified through post-marketing surveillance that the abovementioned 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 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 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 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 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.

FDA Advisory No. 2019-161

/ In Food Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-161 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplements:

FDA Advisory No. 2019-160 || 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. 7GRAINS VEGETABLE BOUILLON CUBES
  2. CHOCOBAMBAM
  3. CRUSTY’S SALTED EGG FISH SKIN

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.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 (REV) 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.

FDA Advisory No. 2019-160

/ In Food Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-160 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

FDA Advisory No. 2019-159 || 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 of the following unregistered food supplements:

  1. MUSCLETECH VAPORX5, BLUE RASPBERRY
  2. DOCTOR’S BEST DIGESTIVE PROBIOTIC 20 BILLION
  3. DR. FORMULATED PROBIOTICS ONCE DAILY WOMEN’S 50 BILLION
  4. BULLSIZER SEXUAL PERFORMANCE ENHANCER FOR MEN SUPPLEMENT
  5. DHC B-MIX

The FDA verified through post-marketing surveillance that the abovementioned 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 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 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 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 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.

FDA Advisory No. 2019-159

/ In Food Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-159 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplements:

FDA Advisory No. 2019-158 || 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 consumption of the following unregistered food supplements:

  1. NATURAL STACKS CILTEP FOR MENTAL PERFORMANCE DIETARY SUPPLEMENT
  2. DRFORMULAS HAIROMEGA DHT, DHT BLOCKER WITH BIOTIN DIETARY SUPPLEMENT
  3. KETO 2000 DIETARY SUPPLEMENT
  4. BUST MAXX DIETARY SUPPLEMENT
  5. NATURES NECTAR BONE BUILDER WITH CALCIUM DIETARY SUPPLEMENT
  6. PLUMP BUST BREAST ENLARGEMENT CAPSULE NATURAL

The FDA verified through post-marketing surveillance that the abovementioned 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 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 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 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 Field Officers and Regulatory Enforcement Unit (REV) 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.

FDA Advisory No. 2019-158

/ In Food Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-158 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplements:

FDA Advisory No. 2019-157 || 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 consumption of the following unregistered food supplements:

  1. CHIN LOK TUNG CAPSULES
  2. LAC ACTIVATED CORDYCEPS SINENSIS MYCELIUM
  3. LAC ACTIVATED LINGZHI PLUS
  4. SPRING VALLEY FOLIC ACID 800 MCG
  5. SNOW CRYSTAL WHITE TOMATO FOOD SUPPLEMENT
  6. NATURAL HERB BIGNAY FOOD SUPPLEMENT

The FDA verified through post-marketing surveillance that the abovementioned 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 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 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 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 Field Officers and Regulatory Enforcement Unit (REV) 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.

FDA Advisory No. 2019-157

/ In Food Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-157 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplements:

FDA Advisory No. 2019-156 || 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 consumption of the following unregistered food supplements:

  1. JEUNESSE MIND DIETARY SUPPLEMENT
  2. NATURE’S BRANCH ADVANCED BRAIN BOOSTER+ DIETARY SUPPLEMENT
  3. PURE-D PUERARIA MIRIFICA AINTEROL SUPPLEMENT
  4. SWEET DREAMS FOOD SUPPLEMENT
  5. PRIME LABS ANTI-ANXIETY DIETARY SUPPLEMENT
  6. MYCOBOTANICALS STRESS DECOMPRESS DIETARY SUPPLEMENT

The FDA verified through post-marketing surveillance that the abovementioned 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 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 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 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 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.

FDA Advisory No. 2019-156

/ In Food Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-156 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplements:

FDA Advisory No. 2019-155 || 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. VITACIO MACA ROOT EXTRACT COMPLEX, 500MG
  2. DOCTOR’S BEST, BEST PROBIOTIC 20 BILLION CFU
  3. PROBIOTIC PEARLS WOMEN’S DIGESTIVE & YEAST BALANCE
  4. PURITAN’S PRIDE CHEWABLE CHLOROPHYLL WITH NATURAL SPEARMINT FLAVOR
  5. SCIVATION XTEND BCAAs, MANGO FLAVOR

The FDA verified through post-marketing surveillance that the abovementioned 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 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 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 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 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.

FDA Advisory No. 2019-155

/ In Food Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-155 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplements:

CANCELLATION OF UNIFIED LICENSING SEMINAR FOR ARMM STAKEHOLDERS (ULS-ARMM) ON 2 JULY 2019

Please be informed that the conduct of ULS-ARMM in Cotabato City (Course Code:ULS-ARMM) scheduled on 2 July 2019 is cancelled due to very low number of course participants that registered in the seminar. The confirmed participant of this seminar will be transferred to the next available seminar schedule.

For more information and update regarding FDA seminars, please visit the FDA website, www.fda.gov.ph.

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

Please be guided accordingly.

Attachment: CANCELLATION OF UNIFIED LICENSING SEMINAR FOR ARMM STAKEHOLDERS (ULS-ARMM) ON 2 JULY 2019

“Saving lives through vigilant reporting.” #BePHARMAcoVIGILANT #CDRR #PhFDA

“Siguraduhing tama ang ibinibigay na gamot sa inyong pasyente. Ipaliwanag ang mga side effects na maaaring maranasan at ang kahalagahan sa pagsunod sa dosage at instruction sa paginom nito.”

I-report ang side effects upang makatulong sa ligtas na paggamit ng mga gamot:

https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH

“Saving lives through vigilant reporting.” #BePHARMAcoVIGILANT #CDRR #PhFDA

“Make sure the medicine is right for the parent, baby or child. Discuss the potential of side effects and the importance of following recommended dosages and instruction.”

Reporting side effects helps the safe use of medicines:

https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH

“Saving lives through vigilant reporting.” #BePHARMAcoVIGILANT #CDRR #PhFDA

“Ang mga gamot na iniinom ng buntis o nagpapasuso ay maaring may epekto rin sa kanilang mga anak. Ugaliin ang pagkonsulta sa doktor bago uminom ng gamot.”

I-report ang side effects upang makatulong sa ligtas na paggamit ng mga gamot:

https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH

“Saving lives through vigilant reporting.” #BePHARMAcoVIGILANT #CDRR #PhFDA

“Medicines taken when pregnant or breastfeeding means they may reach your baby. Always speak to a doctor. Reporting side effects helps the safe use of medicines for babies and children”

Reporting side effects helps the safe use of medicines:

https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH

“Saving lives through vigilant reporting.” #BePHARMAcoVIGILANT #CDRR #PhFDA

“Alam mo ba na maaring iba ang epekto ng gamot sa mga bata? Laging siguraduhin na ang inyong mga anak ay nabibigyan ng tamang gamot na may tamang sukat at paraan ng paginom.”

I-report ang side effects upang makatulong sa ligtas na paggamit ng mga gamot:

https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH

“Saving lives through vigilant reporting.” #BePHARMAcoVIGILANT #CDRR #PhFDA

“Did you know that medicines affect your baby and children in different ways? Make sure you’re giving your baby or child the right medicine in the right dose, using the right spoon, syringe or device.”

Reporting side effects helps the safe use of medicines:

https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH

 

VENUE FOR UNIFIED LICENSING SEMINAR  (ULS –RV) ON 19-20  JUNE 2019

Please be informed that the venue of the Unified Licensing Seminar (ULS – RV) on 19-20 June 2019 will be in LA VENEZIA HOTEL & SPA, INC., RENAISSANCE GARDENS, WASHINGTON DRIVE, LEGAZPI CITY, ALBAY.

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.

VENUE FOR UNIFIED LICENSING SEMINAR (ULS –RV) ON 19-20 JUNE 2019

 

FDA Advisory No. 2019-115 || Public Health Warning Against the Purchase and Use of Unregistered Health Related Device (Water Purification Device) “Wellohas Active Hydrogen Alkaline Water System”

The Food and Drug Administration (FDA) advises the public against the purchase and use of the unregistered health related device Wellohas Active Hydrogen Alkaline Water System:

FDA post-marketing surveillance (PMS) activities have verified that the abovementioned health related device has not gone through the registration process of the agency and has not been issued the proper authorization in the form of Certificate of Health Related Device Registration (CHRDR). Pursuant to Republic Act 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization from FDA is prohibited.

Accordingly, since this unregistered health related device has not gone through evaluation and testing process of the FDA, the agency cannot guarantee its quality and safety. The consumption of such violative product may pose potential health hazards to the consuming public. Water purification device/system should not bear any false, deceptive and misleading claims and promotional ploys on alkaline water, oxygenated water or ionized water.

Furthermore, the FDA has already issued two advisory (FDA Advisory Numbers 2011-013 and 2014-010) warning the general public against false, deceptive and misleading non-certified therapeutic claims and promotional ploys of water purification devices producing water labeled as alkaline, ionized, pi, oxygenated or energized water.

In light of the above, the public is advised not to purchase the aforementioned violative product and to be vigilant against health related device that might not be duly registered with FDA. Always check if a health related device has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph.

All concerned establishments and/or entities are warned not to distribute the above-identified violative health related device until it has already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that this product is not sold or made available in their localities or areas of jurisdiction.

For more information and inquiries, please e-mail us at [email protected] To report continuous sale or distribution of the above unregistered health related device, utilize our online reporting facility, Report, at www.fda.gov.ph/ereport, or e-mail us via [email protected], or call us at the Center for Device Regulation, Radiation Health and Research (CDRRHR) hotline (02) 857-1900 local 8301.

FDA Advisory No. 2019-115

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-115 || Public Health Warning Against the Purchase and Use of Unregistered Health Related Device (Water Purification Device) “Wellohas Active Hydrogen Alkaline Water System”

VENUE FOR UNIFIED LICENSING SEMINAR (ULS-NCR) ON 18 AND 21 JUNE 2019 AND CENTER FOR DEVICE REGULATION, RADIATION HEALTH AND RESEARCH QPIRA SEMINAR (QCDRRHR – NCR) ON 19-20 JUNE 2019

Please be informed that the venue for the Unified Licensing Seminar (ULS – NCR) on 18 & 21 June 2019 and Center for Device Regulation, Radiation Health and Research QPIRA Seminar (QCDRRHR-NCR) on 19-20 June 2019 will be in ACACIA HOTEL, 5400 EAST ASIA DRIVE CORNER COMMERCE AVENUE, FILIVEST CORPORATE CITY, ALABANG, MUNTINLUPA CITY.

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

Attachment-> : VENUE FOR UNIFIED LICENSING SEMINAR ON 18-21 JUNE 2019 AND 19-20 JUNE 2019

/ In Academy Announcements / By Administrator / Comments Off on VENUE FOR UNIFIED LICENSING SEMINAR (ULS-NCR) ON 18 AND 21 JUNE 2019 AND CENTER FOR DEVICE REGULATION, RADIATION HEALTH AND RESEARCH QPIRA SEMINAR (QCDRRHR – NCR) ON 19-20 JUNE 2019

FDA Advisory No. 2019-154 || INTERNET SALES AND ACCESS TO SAFE MEDICINE

The Food and Drug Administration (FDA) warns the public on significant risks associated with the growth of the internet’ sales of medicines.

Unlike other consumer products purchased over the internet, medicines have the potential to cause serious side effects and health problems if not used and stored properly. It is important to seek medical advice from doctor or pharmacist before taking medicines.

Buying medicines over the internet can pose serious health risk. You will never know what exactly you are getting. Even if the medicines bought online looks the same; there is no guarantee that it is genuine. A medicine bought online may contain no active ingredient; too much or too little of active ingredients which may result to your condition not being treated correctly. Also, these medicines may not be stored correctly in accordance with its appropriate storage conditions.

In the Philippines, online selling of medicines is NOT permitted pursuant to existing laws, rules and regulations. Currently, FDA only allows online ordering services provided that the seller has an existing FDA-licensed Pharmacy or Botika with physical address. Online ordering services are additional activities of a Pharmacy or Botika subject for approval of FDA.

The FDA recommends purchase of medicines from licensed pharmacies near you and seek advice from your community pharmacist on the proper and safe use of medicines.

To report continuous unauthorized sale or distribution of drug products, kindly email us via [email protected], or through the online reporting facility, eREPORT, at www.fda.gov.ph/ereport. You may also call the Center for Drug Regulation and Research at telephone number (02) 809-5596.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2019-154

FDA Advisory No. 2019-151-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng Napatunayang Pekeng Bersyon ng Gamot na Co-Amoxiclav (Augmentin) Powder for Oral Suspension.

Pinapayuhan ng Food and Drug Administration (FDA) ang publiko laban sa pagbili at paggamit ng napatunayang pekeng bersyon ng gamot na Co-Amoxiclav (Augmentin) Powder for Oral Suspension.

Ayon sa pagsusuri ng FDA kasama ang Marketing Authorization Holder (MAH), GlaxoSmithKline (GSK) Philippines, Inc., ang nasabing produkto  ay napatunayang peke.(please see attachment for further details).

Ang Batch No. 217883A na may expiry date na Dec. 2020 ay hindi inangkat ng GSK sa ating bansa.

Ang lahat ng healthcare professionals, local health centers, health institutions at publiko ay binabalaan tungkol sa nasabing pekeng gamot sa merkado na maaaring magdulot ng panganib sa kalusugan ng mga gagamit nito. Ang publiko, distributor at retailer ay pinapaalalahanan ring bumili lamang sa mga establisyamentong lisensyado ng FDA.

Gayundin, ang lahat ng establisyamento ay binabalaang huwag magbenta nitong napatunayang pekeng gamot na may nasabing mga katangian. Ang pag-aangkat, pagbebenta, brokering, pamamahagi at pagtataglay ng walang patunay ng lehitimong transaksyon nito ay tahasang paglabag sa Republic Act No. 9711 o ang Food and Drug Administration Act of 2009 at Republic Act No. 8203 0 ang Special Law on Counterfeit Drugs, samakatuwid ay may kaukulang parusang ipapataw.

Pinapakiusap sa Bureau of Customs na harangin ang napatunayang pekeng produkto sa lahat ng port of entry ng bansa.

Hinihiling sa lahat ng Local Government Units (LGUs) at Law Enforcement Agencies (LEAs) na tiyaking ang pekeng produktong ito ay hindi maibebenta o magagamit sa kanilang mga nasasakupan.

Para sa karagdagang impormasyon at katanungan, maaaring mag-email sa [email protected] Upang mag-report ng patuloy na pagtitinda o pangangalakal ng mga peke o hindi rehistradong gamot, mag-email sa [email protected], o mag-report gamit ang aming online reporting facility, eReport, sa www.fda.gov.ph/ereport. Maaari ring tumawag sa Center for Drug Regulation and Research (CDRR) sa numerong (02) 809-5596. Para sa mga hinihinalang hindi kanais-nais na reaksyon sa gamot, i-report agad sa FDA gamit ang link na ito: www.fda.gov.ph/adr-report-new at kumpletuhin ang mga kinakailangang impormasyon.

Ang lahat ay hinihikayat na palaganapin ang mga nakasaad na impormasyon.

Attachment-> :  FDA Advisory No. 2019-151-A

/ In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-151-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng Napatunayang Pekeng Bersyon ng Gamot na Co-Amoxiclav (Augmentin) Powder for Oral Suspension.

FDA Advisory No. 2019-151 || Public Health Warning Against the Purchase and Use of the Verified Counterfeit Version of Drug Product Co-Amoxiclav (Augmentin) Powder for Oral Suspension

The Food and Drug Administration (FDA) advises the public against the purchase and use of the verified counterfeit version of drug product Co-Amoxiclav (Augmentin) Powder for Oral Suspension.

The FDA, together with the Marketing Authorization Holder (MAH), GlaxoSmithKline (GSK) Philippines, Inc., have verified that the above mentioned product is counterfeit(please see attachment for further details).

The Batch No. 217883A having the expiry date Dec. 2020 was not imported by GSK.

All healthcare professionals, local health centers, health institutions and the general public are hereby warned of this counterfeit drug product in the market which pose potential danger or injury to consumers. Consumers, distributors and retailers are also reminded to purchase drug products only from FDA-licensed establishments.

Likewise, all establishments and outlets are hereby warned against selling and/or dispensing this verified counterfeit drug product with the foregoing features. The importation, selling or offering for sale, brokering, donating or possession without proof of legitimate purchase of such is in direct violation of Republic Act No. 9711, or the Food and Drug Administration Act of 2009, and Republic Act No. 8203, or the Special Law on Counterfeit Drugs, therefore a penalty shall be imposed.

The Bureau of Customs is urged to restrain the importation or entry of this counterfeit product.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that this counterfeit product is not sold, made available or used in their localities or areas of jurisdiction.

For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of unregistered or counterfeit health products, kindly e-mail us via [email protected], or through the online reporting facility, eReport, at www.fda.gov.ph/ereport. You may also call the Center for Drug Regulation and Research at telephone number (02)809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: www.fda.gov.ph/adr-report-new and fill out all the required fields.

Dissemination of the information to all concerned is requested

Attachment-> :  FDA Advisory No. 2019-151

/ In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-151 || Public Health Warning Against the Purchase and Use of the Verified Counterfeit Version of Drug Product Co-Amoxiclav (Augmentin) Powder for Oral Suspension

FDA Advisory No. 2019-150-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng mga Hindi Rehistradong Gamot na:

Pinapayuhan ng Food and Drug Administration (FDA) ang publiko laban sa pagbili at paggamit ng mga hindi rehistradong gamot na:

  1. Keteling Jiaonang
  2. YANYAN PIAN Tablet
  3. YIN HUANG JIAO NANG
  4. QINGFEI YIHUO PIAN Tablets
  5. PE MIN KAN WAN (Nasal Clear) 50’s Tablets
  6. KEEPFIT REDUCING & WHITENING Capsule 50’s

Napatunayan sa pamamagitan ng isinagawang Post-Marketing Surveillance (PMS) ng FDA na ang mga nasabing gamot ay hindi dumaan sa proseso ng rehistrasyon ng ahensya at hindi nabigyan ng kaukulang awtorisasyon tulad ng Certificate of Product Registration (CPR).

Alinsunod sa Republic Act No. 9711, 0 ang Food and Drug Administration Act of 2009, ang paggawa, pag-angkat, pagbenta, pamamahagi, paglipat, promosyon, pagpapatalastas 0 sponsorship ng produktong pangkalusugan nang walang kaukulang awtorisasyon mula sa FDA ay ipinagbabawal.

Gayundin, dahil ang mga hindi rehistradong produktong ito ay hindi dumaan sa proseso ng pagsusuri at pageeksamin ng FDA, hindi masisiguro ng ahensya ang kanilang epekto, kalidad at kaligtasan. Ang mga nasabing iligal na produkto ay maaring magdulot ng panganib sa kalusugan ng mga gagamit ng mga ito.

Ang publiko ay pinapaalalahanang huwag bumili ng mga nasabing iligal na produkto at maging maingat laban sa mga gamot na maaring hindi rehistrado sa FDA. Maaaring malaman kung ang gamot ay rehistrado sa FDA sa pamamagitan ng paggamit ng Search feature ng FDA website sa www.fda.gov.ph. Maaari ring tingnan ang FDA Registration number sa label ng produkto.

Ang lahat ng establisyamento at/o entidad ay binabalaang huwag mamahagi ng mga nasabing iligal na produkto hanggang sa ang mga ito ay mabigyan ng kaukulang awtorisasyon, sapagkat kaukulang parusa ay mahigpit na ipatutupad.

Pinapakiusap sa Bureau of Customs na harangin ang mga napatunayang hindi rehistradong gamot sa lahat ng port of entry ng bansa.

Hinihiling sa lahat ng Local Government Units (LGUs) at Law Enforcement Agencies (LEAs) na tiyaking ang mga produktong ito ay hindi maibebenta o magagamit sa kanilang mga nasasakupan.

Para sa karagdagang impormasyon at katanungan, maaaring mag-email sa [email protected] . Upang mag-report ng patuloy na pagtitinda o pangangalakal ng mga hindi rehistradong gamot, mag-email sa [email protected], o mag-report gamit ang aming online reporting facility, eReport, sa www.fda.gov.ph/ereport . Maaari ring tumawag sa Center for Drug Regulation and Research (CDRR) sa numerong (02) 809- 5596. Para sa mga hinihinalang hindi kanais-nais na reaksyon sa gamot, i-report agad sa FDA gamit ang link na ito: www.fda.gov.ph/adr-report-new at kumpletuhin ang mga kinakailangang impormasyon.

Ang lahat ay hinihikayat na palaganapin ang mga nakasaad na impormasyon.

FDA Advisory No. 2019-150-A

FDA Advisory No. 2019-150 || Public Health Warning Against the Purchase and Use of the Following Unregistered Drug Products:

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

  1. Keteling Jiaonang
  2. YANYAN PIAN Tablet
  3. YIN HUANG JIAO NANG
  4. QINGFEI YIHUO PIAN Tablets
  5. PE MIN KAN WAN (Nasal Clear) 50’s Tablets
  6. KEEPFIT REDUCING & WHITENING Capsule 50’s

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug products have not gone through the registration process of the agency and have not been issued with proper authorization in the form of Certificate of Product Registration.

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

Accordingly, since these unregistered drug products have not gone through evaluation and testing process of the FDA, the agency cannot guarantee their efficacy, quality and safety. These violative products may pose potential danger or injury if administered.

In light of the above, the public is advised not to purchase the aforementioned violative products and to be vigilant against drug products that might not be duly registered with the FDA. To check if a drug product has been registered with the FDA, use the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label.

All concerned establishments and/or entities are warned not to distribute the above- identified violative drug products until these have already been covered by the appropriate authorization, otherwise regulatory actions and sanctions shall be strictly pursued.

The Bureau of Customs is urged to restrain the importation or entry of these unregistered products.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that these products are not sold or made available in their localities or areas of jurisdiction.

For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of unregistered health products, kindly e-mail us via [email protected], or through the online reporting facility, eReport, at www.fda.gov.ph/ereport. You may also call the Center for Drug Regulation and Research at telephone number (02)809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: www.fda.gov.ph/adr-report-new and fill out all the required fields.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2019-150