Category: Food Advisories

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. 2019-250 || 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. 2019-244 || 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

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

FDA Advisory No. 2019-236 || 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. PURITAN’S PRIDE PREMIUM OLIVE LEAF EXTRACT,150mg
  2. PURITAN’S PRIDE PREMIUM HAWTHORN EXTRACT,150mg
  3. PURITAN’S PRIDE PREMIUM CASCARA SAGRADA, 450mg
  4. PURITAN’S PRIDE PREMIUM KOREAN GINSENG EXTRACT, 100mg
  5. PURITAN’S PRIDE PREMIUM JOINT SUPORT MSM, 1000mg

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. 2019-236

FDA Advisory No. 2019-235 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

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

  1. MAMA’S ALTERNATIVES GINGER HERBAL TONIC
  2. MAMA’S ALTERNATIVES LEMON GRASS HERBAL TONIC
  3. MAMA’S ALTERNATIVES HERBAL GRASS HERBAL TONIC
  4. DON ISABELO YEMA SPREAD, UBE
  5. DON ISABELO YEMA SPREAD, ORIGINAL

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.

Attachment-> : FDA Advisory No. 2019-235

FDA Advisory No. 2019-234 || 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. NATURE’S PLUS ANIMAL PARADE KIDS IMMUNE BOOSTER CHILDREN’S CHEWABLE ANTIOXIDANT SUPPLEMENT WITH WHOLE FOOD CONCENTRATE
  2. CARLSON KID’S CHEWABLE DHA 100mg DHA DIETARY SUPPLEMENT
  3. 21ST CENTURY ZOO FRIENDS SMART KIDS OMEGA PLUS DHA
  4. HERBS OF THE EARTH MULTIVIT+ ADULT GUMMY MUTLIVITAMINS DIETARY SUPPLEMENT
  5. ORGANIC GUMMIES MULTIVITAMINS FOR KIDS, CHERRY, STRAWBERRY, LEMON, ORANGE AND GRAPE FLAVORED 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.

Attachment-> : FDA Advisory No. 2019-234

FDA Advisory No. 2019-233 || 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. DLC HIGH Q 180 DIETARY SUPPLEMENT
  2. DLC CRANBERRY FORMULA CAPSULE DIETARY SUPPLEMENT
  3. DLC DIAMOND POWER DIETARY SUPPLEMENT
  4. DLC LUTEIN FORMULA DIETARY SUPPLEMENT
  5. DLC RED YEAST RICE 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.

Attachment-> : FDA Advisory No. 2019-233

FDA Advisory No. 2019-232 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

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

  1. S. BONTO. DESTURA ROASTED PILI SPECIAL PILINUT CANDY
  2. S. BONTO. DESTURA PILI ROLL SPECIAL PILINUT CANDY
  3. S. BONTO. DESTURA SUGAR COATED SPECIAL PILINUT CANDY
  4. S. BONTO. DESTURA TURMERIC
  5. S. BONTO. DESTURA CRISPY DE PILI SPECIAL PILINUT CANDY

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.

Attachment-> : FDA Advisory No. 2019-232

FDA Advisory No. 2019-231 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

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

  1. S. BONTO. DESTURA MAZAPAN DE PILI SPECIAL PILINUT CANDY
  2. S. BONTO. DESTURA BONBONES SPECIAL PILINUT CANDY
  3. S. BONTO. DESTURA PILI ROLL SPECIAL PILINUT CANDY
  4. S. BONTO. DESTURA BUDING SPECIAL PILINUT CANDY
  5. S. BONTO. DESTURA PILINUT CANDIES SPECIAL PILI TART

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.

Attachment-> : FDA Advisory No. 2019-231

FDA Advisory No. 2019-230 || 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. PURITAN’S PRIDE PREMIUM PASSION FLOWER EXTRACT, 1000mg
  2. PURITAN’S PRIDE PREMIUM ODORLESS GARLIC, 1000 mg
  3. PURITAN’S PRIDE ODORLESS GARLIC & PARSLEY
  4. PURITAN’S PRIDE BLACK CHERRY CONCENTRATED EXTRACT, 1000mg
  5. PURITAN’S PRIDE EVENING PRIMROSE OIL, 1000mg

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. 2019-230

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

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

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

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

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

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

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

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

Dissemination of the information to all concerned is requested.

ATTACHEMENT:  FDA-Advisory-No-2019-229

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

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

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

  1. “Family Care™ Digital Thermometer”

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

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

In light of the foregoing, the public is advised not to purchase the violative products in the market.

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

medical devices until CPR are issued, otherwise, regulatory actions and sanctions shall be strictly pursued.

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

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

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

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:> FDA Advisory No.2019-227

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

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

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

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

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

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

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

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

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

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

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:> FDA Advisory No.2019-224

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