Month: July 2018

FDA Advisory No. 2018-231 Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

  1. MORRIS COCOA CHIPS BUTTER CRUNCH COOKIES
  2. IDAHOAN LOADED BAKED MASHED POTATOES
  3. MISS VICKIE’S SMOKEHOUSE BBQ FLAVORED
  4. BESTHEALTH MENTHOL, COUGH SUPRESSANT, ORAL ANESTHETIC, CHERRY FLAVOUR
  5. VALLEY PRODUCE CO. PLAIN CRACKERTHINS AUSTRALIAN WATERCRACKERS

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

FDA post-marketing surveillance (PMS) activities have verified that the abovementioned food products have not gone through the registration process of the agency and have not been issued the 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, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization from FDA is prohibited.

Accordingly, since unregistered food products have not gone through evaluation and testing process of the FDA, the agency cannot guarantee their quality and safety. The consumption of such violative products may pose potential health hazard to the consuming public. Food products including food supplements should not bear any misleading, deceptive, and false claims in their labels and/or any promotional materials that will provide erroneous impression on products’ character or identity.

In light of the foregoing, the public is advised not to purchase the aforementioned violative products. Moreover, the public is advised to be vigilant against food products that might not be duly registered with FDA. Always check if a food product has been registered with 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 are warned not to distribute the above-identified violative food products until they have already been covered by the appropriate authorization (product registration), otherwise, regulatory actions and sanctions shall be strictly pursued.

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 the above unregistered food supplement, utilize our online reporting facility, eReport, at www.fda.gov.ph/ereport, or e-mail us via [email protected], or call us at the Center for Food Regulation and Research (CFRR) hotline (02) 857-1900 loc. 8115 and 8112.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2018-231

FDA Advisory No. 2018-230 Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

  1. LYCA’S CHILI GARLIC IN OIL
  2. CHILLI QUEEN CHILLI-GARLIC SAUCE
  3. HEALTHY YOU ANTIOXIDANT MIX
  4. TURMERIC POWDER
  5. ULTIMATE HERS MALUNGGAY POWDER

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

FDA post-marketing surveillance (PMS) activities have verified that the abovementioned food products have not gone through the registration process of the agency and have not been issued the 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, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization from FDA is prohibited.

Accordingly, since unregistered food products have not gone through evaluation and testing process of the FDA, the agency cannot guarantee their quality and safety. The consumption of such violative products may pose potential health hazard to the consuming public. Food products including food supplements should not bear any misleading, deceptive, and false claims in their labels and/or any promotional materials that will provide erroneous impression on products’ character or identity.

In light of the foregoing, the public is advised not to purchase the aforementioned violative products. Moreover, the public is advised to be vigilant against food products that might not be duly registered with FDA. Always check if a food product has been registered with 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 are warned not to distribute the above-identified violative food products until they have already been covered by the appropriate authorization (product registration), otherwise, regulatory actions and sanctions shall be strictly pursued.

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 the above unregistered food supplement, utilize our online reporting facility, eReport, at www.fda.gov.ph/ereport, or e-mail us via [email protected], or call us at the Center for Food Regulation and Research (CFRR) hotline (02) 857-1900 loc. 8115 and 8112.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2018-230

 

FDA Advisory NO. 2018-229 Public Health Warning Against the Purchase and Consumption of the following Unregistered Supplements:

  1. GNC MEGA ACIDOPHILUS
  2. AIRBORNE ORIGINAL IMMUNE SUPPORT SUPPLEMENT, CITRUS FLAVOR, CHEWABLE TABLETS
  3. SLICE OF LIFE ORGANICS ENERGY + B12 ADULT GUMMY VITAMINS
  4. SMARTY PANTS KID COMPLETE MULTIVITAMIN OMEGA 3 FISH OIL, VITAMIN D3 AND B12

The Food and Drug Administration (FDA) advises the public against the purchase and consumption of the following unregistered food supplements:.

FDA post-marketing surveillance (PMS) activities have verified that the abovementioned food supplements have not gone through the registration process of the agency and have not been issued the 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, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization from FDA is prohibited.

Accordingly, since unregistered food supplements have not gone through evaluation and testing process of the FDA, the agency cannot guarantee their quality and safety. The consumption of such violative products may pose potential health hazard to the consuming public. Food products including food supplements should not bear any misleading, deceptive, and false claims in their labels and/or any promotional materials that will provide erroneous impression on products’ character or identity.

In light of the foregoing, the public is advised not to purchase the aforementioned violative products. Moreover, the public is advised to be vigilant against food products that might not be duly registered with FDA. Always check if a food product has been registered with 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 are warned not to distribute the above-identified violative food products until they have already been covered by the appropriate authorization (product registration), otherwise, regulatory actions and sanctions shall be strictly pursued.

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 the above unregistered food supplement, utilize our online reporting facility, eReport, at www.fda.gov.ph/ereport, or e-mail us via [email protected], or call us at the Center for Food Regulation and Research (CFRR) hotline (02) 857-1900 loc. 8115 and 8112.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2018-229

FDA Advisory No. 2018-228 Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

  1. TAIWAN EGG ROLL
  2. TAMPICO TROPICAL DRINK CHERRY ORANGE PINEAPPLE
  3. BAIRONG LEMON FLAVOR CREAM SANDWICH BISCUITS
  4. QARAMEESH BLADY HI I’M STRAWBERRY GIRL GUMMY SANDY STRAWBERRY FLAVOR
  5. QARAMEESH BLADY HI I’M GRAPE GUY GUMMY CANDY GRAPE FLAVOR

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

FDA post-marketing surveillance (PMS) activities have verified that the abovementioned food products have not gone through the registration process of the agency and have not been issued the 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, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization from FDA is prohibited.

Accordingly, since unregistered food products have not gone through evaluation and testing process of the FDA, the agency cannot guarantee their quality and safety. The consumption of such violative products may pose potential health hazard to the consuming public. Food products including food supplements should not bear any misleading, deceptive, and false claims in their labels and/or any promotional materials that will provide erroneous impression on products’ character or identity.

In light of the foregoing, the public is advised not to purchase the aforementioned violative products. Moreover, the public is advised to be vigilant against food products that might not be duly registered with FDA. Always check if a food product has been registered with 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 are warned not to distribute the above-identified violative food products until they have already been covered by the appropriate authorization (product registration), otherwise, regulatory actions and sanctions shall be strictly pursued.

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 the above unregistered food supplement, utilize our online reporting facility, eReport, at www.fda.gov.ph/ereport, or e-mail us via [email protected], or call us at the Center for Food Regulation and Research (CFRR) hotline (02) 857-1900 loc. 8115 and 8112.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2018-228

FDA Advisory No. 2018-227 Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Products:

  1. TO-NE’ 15% Orange Juice with Nata de Coco
  2. TO-NE’ 15% Strawberry Juice with Neta de Coco
  3. TO-NE Orange Juice 15%
  4. KANRO PURE Gummy Grape
  5. HARVEST BOX Roasted Pistachios Lightly Salted

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

FDA post-marketing surveillance (PMS) activities have verified that the abovementioned food products have not gone through the registration process of the agency and have not been issued the 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, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization from FDA is prohibited.

Accordingly, since unregistered food products and food supplements have not gone through evaluation and testing process of the FDA, the agency cannot guarantee their quality and safety. The consumption of such violative products may pose potential health hazards to the consuming public. Food products including food supplements should not bear any misleading, deceptive, and false claims in their labels and/or any promotional materials that will provide erroneous impression on products’ character or identity.

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

All concerned establishments are warned not to distribute the above-identified violative food products until they have already been covered by the appropriate authorization (product registration), otherwise, regulatory actions and sanctions shall be strictly pursued.

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 the above unregistered food products, utilize our online reporting facility, eReport, at www.fda.gov.ph/ereport, or e-mail us via [email protected], or call us at the Center for Food Regulation and Research (CFRR) hotline (02) 857-1991 to 93.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2018-227

FDA Advisory No. 2018-226 Public Health Warning Against the Use of Unnotified Cosmetic Products (Batch 12)

The Food and Drug Administration (FDA) advises the public against the purchase and use of the following unnotified cosmetic products whose particulars/details are provided in the attached annex:

  1. MAC GIAMBATTISTA VALLI PARIS MATTE LIPSTICK – KINDA SEXY
  2. HUDABEAUTY MATTE LIPSTICK 104 MATERIAL GIRL
  3. HUDABEAUTY MATTE LIPSTICK CHEERLEADER
  4. NEUTROGENA® PORE REFINING® EXFOLIATING CLEANSER
  5. NEUTROGENA® HYDRO BOOST HYDRATING CLEANSING GEL
  6. NEUTROGENA® TRIPLE MOISTURE® SILK TOUCH LEAVE-IN CREAM WITH UV SHIELD
  7. DONG BANG® BABY TENDER BABY WIPES (FRESH SCENTED-PINK)
  8. JOHNSON’S® CLEANSING FACIAL WIPES 3IN1
  9. AMPAL’S COSMECEUTICAL
  10. NÀ TING® WHITE CLEANSER
  11. JERKYS INSTANT HAND SANITIZER
  12. SAISI PERMANENT HAIR COLORANT WITH ACTIVE VEGETABLE INGREDIENTS (H-20 DIANA GOLDEN)
  13. AICHUN BEAUTY® SLIMMING AND DETOXIFYING SOAP GREEN TEA ESSENCE
  14. NICE PONPON BEAUTY PERFUMED SOAP
  15. AS ASHLEY SHINE 2IN1 MAKEUP BASE + FOUNDATION CREAM 2 (NO. AS804)
  16. AS ASHLEY SHINE 3IN1 B.B CREAM SUN DAMAGED CONTROL CREAM HIGH PROTECTION SPF 50 (NO. AS9007-1)
  17. JIGOTT ALOE SUN PROTECT BB CREAM SPF 41 PA+++
  18. SUNSTAR STRIPE PASTE
  19. KAO (LABEL IS IN FOREIGN LANGUAGE)
  20. MARI & U DOT VITA MASK WHITENING TONE UP
  21. UNI KERATIN MOROCCO ARGAN OIL HAIR REBORN TREATMENT VITAMIN E INTENSIVE REPAIR FOR SMOOTH AND STRAIGHT HAIR
  22. FRESHMAN MASCULINE WASH TEA TREE OIL
  23. PINK BLUSH SKIN ESSENTIALS BEAUMAX TONER
  24. PINK BLUSH SKIN ESSENTIALS ACNE SOAP
  25. PINK BLUSH SKIN ESSENTIALS KOJIC ACID SOAP
  26. RED SEAL® BAKING SODA TOTAL MOUTH FRESHNESS
  27. PINK BLUSH SKIN ESSENTIALS BY AMBER & PINK SUNBLOCK PINK CREAM SPF 30
  28. EB EVERA MAGIC LIPSTICK WITH VITAMIN E – ORANGE
  29. AMORE PARFUM INSPIRED PERFUMES
  30. HANZHIXIU® PERMANENT HAIR COLORANT WITH ACTIVE VEGETABLE INGREDIENTS (A-16 COFFEE)
  31. HANZHIXIU® PERMANENT HAIR COLORANT WITH ACTIVE VEGETABLE INGREDIENTS (A-21 DARK COFFEE)
  32. HANZHIXIU® PERMANENT HAIR COLORANT WITH ACTIVE VEGETABLE INGREDIENTS (A-3 BURGUNDY RED)
  33. EON SKIN CARE EON REFRESH PREMIUM BOTOX GEL
  34. EDMARK® SPLINA CHLOROPHYLL SOAP
  35. LUMINE TURMERIC + LEMON SOAP SKIN LIGHTENING AND ANTI-ACNE HERBAL BATH SOAP
  36. GEVEMIA TRI & 1™ PROFESSIONAL HAIR COLOUR NATURAL & EASY (H817 DIANA GOLDEN)
  37. GEVEMIA TRI & 1™ PROFESSIONAL HAIR COLOUR NATURAL & EASY (H823 PURPLISH RED)
  38. GEVEMIA TRI & 1™ PROFESSIONAL HAIR COLOUR NATURAL & EASY (H829 COFFEE PURPLE)
  39. GELCO HAND SANITIZER WITH VITAMIN E GREEN APPLE
  40. DERMCARE FRESH FEMININE WASH FRESHLY COOL
  41. THE FACE SHOP REAL NATURE AVOCADO FACE MASK
  42. BEAUTY WISE REJUVENATING TONER
  43. BEAUTY WISE KOJIC ACID SOAP WITH BEARBERRY EXTRACT
  44. DROPLETS OF NATURE. REJUVENATING LIFT & CORRECT KIT:
    1. DROPLETS OF NATURE. REJUVENATING LIFT & CORRECT SUNBLOCK CREAM WITH SPF
    2. DROPLETS OF NATURE. REJUVENATING LIFT & CORRECT KOJIC ACID SOAP
    3. DROPLETS OF NATURE. REJUVENATING LIFT & CORRECT REJUVENATING TONER
    4. DROPLETS OF NATURE. REJUVENATING LIFT & CORRECT REJUVENATING CREAM
  1. LOVIA PROFESSIONAL HENNA HERBAL BASED HAIR COLOUR POWDER NATURAL BLACK
  2. GARNIER SKIN NATURALS LIGHT COMPLETE WHITE SPEED™ 12 H SHINE – FREE WHITENING SERUM CREAM
  3. MOIST SKIN CARE NATURAL EXTRACT APPLE REFRESHING MASK SHEET
  4. MIR & RYVI BANANA SOAP SPOT LIGHTENING BEAUTY BAR

FDA post-marketing surveillance (PMS) activities have verified that the abovementioned cosmetic products have not gone through the verification process of the agency and have not been issued the proper authorization in the form of acknowledged cosmetic notifications. 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, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization from FDA is prohibited.

Accordingly, because unnotified cosmetic products have not gone through the verification process of the FDA, the agency cannot guarantee their quality and safety. The use of such violative products may pose potential health hazards to the consuming public.

Potential hazards may come from ingredients that are not allowed to be part of a cosmetic product or from the contamination of heavy metals such as mercury especially in whitening cosmetic products. The use of substandard and possibly adulterated cosmetic products may result to adverse reactions including but not limited to skin irritation, itchiness, anaphylactic shock and organ failure.

In light of the above, the public is advised not to purchase the aforementioned violative products. Moreover, the public is also advised to be vigilant against cosmetic products that might not be duly notified with FDA. Always check if a cosmetic product has been notified with 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 are warned not to distribute the above-identified violative cosmetic products until they have already been covered by the appropriate authorization (cosmetic notification), otherwise, regulatory actions and sanctions shall be strictly pursued.

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 the above unnotified cosmetic products, utilize our online reporting facility, eReport, at www.fda.gov.ph/ereport, or e-mail us via [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 857-1900 local 8113 or 8107.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2018-226

FDA Advisory No. 2018-225 Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product (MEDIPLAST WATER RESISTANT PLASTERS)

The Food and Drug Administration (FDA) advises the general public and all healthcare professionals against the purchase and use of the unregistered medical device product Mediplast Water Resistant Plasters:

FDA post-marketing surveillance (PMS) activities have verified that the above-mentioned medical device product has not gone through the registration process of the agency and has not been issued with proper authorization in the form of Certificate of Product Registration (CPR). 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 medical 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.

In light of the above, the public is advised not to purchase the aforementioned violative product and to be vigilant against medical device that might not be duly registered with FDA. Always check if a medical 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 medical device product 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 medical device, utilize our online reporting facility, eReport, 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. 2018-225

/ In General Advisories / By FDA_Admin2 / Comments Off on FDA Advisory No. 2018-225 Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product (MEDIPLAST WATER RESISTANT PLASTERS)

FDA Advisory No. 2018-223 Lifting the Advisory of SURE-GUARD DISPOSABLE VINYL GLOVES and SURE-GUARD DISPOSABLE NITRILE GLOVES  under FDA Advisory No. 2018-121, subject “Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Products (Sure-Guard Disposable Vinyl Gloves and Sure-Guard Disposable Nitrile Gloves)”

The Food and Drug Administration (FDA) informs the public that the advisory on the products “Sure-Guard Disposable Vinyl Gloves and Sure-Guard Disposable Nitrile Gloves” under FDA Advisory No. 2018-121 dated 02 April 2018 is hereby lifted pursuant to the compliance of the market authorization holder to existing and applicable laws, rules, and regulations.

The Food and Drug Administration (FDA) informs the public that the advisory on the products “Sure-Guard Disposable Vinyl Gloves and Sure-Guard Disposable Nitrile Gloves” under FDA Advisory No. 2018-121 dated 02 April 2018 is hereby lifted pursuant to the compliance of the market authorization holder to existing and applicable laws, rules, and regulations.

FDA issued Certificate of Exemption for the above-mentioned products, the intended use of the said products distributed by AMB HK Enterprises Inc is for industrial use.

The issuance of this advisory shall not in any manner preclude this Office from issuing subsequent orders it may deem necessary and appropriate, should there be findings of any violation of the company to existing laws, rules, and regulations.

For more information and inquiries, please e-mail us at [email protected] or call the Center for Device Regulation, Radiation Health, and Research at (02) 857-1900 local 8301. To report sale or distribution of any unregistered medical device products, kindly email us via [email protected].

FDA Advisory No. 2018-223

/ In General Advisories / By FDA_Admin2 / Comments Off on FDA Advisory No. 2018-223 Lifting the Advisory of SURE-GUARD DISPOSABLE VINYL GLOVES and SURE-GUARD DISPOSABLE NITRILE GLOVES  under FDA Advisory No. 2018-121, subject “Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Products (Sure-Guard Disposable Vinyl Gloves and Sure-Guard Disposable Nitrile Gloves)”

FDA Advisory No. 2018-221 Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Products:

  1. MORRIS Milk Chips Butter Crunch Cookies
  2. MORRIS Lemon Butter Lemon Sandwich
  3. MORRIS Orange Butter Orange Sandwich
  4. MORRIS Cream Crackers
  5. MORRIS Sugar Crackers

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

FDA post-marketing surveillance (PMS) activities have verified that the abovementioned food products have not gone through the registration process of the agency and have not been issued the 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, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization from FDA is prohibited.

Accordingly, since unregistered food products and food supplements have not gone through evaluation and testing process of the FDA, the agency cannot guarantee their quality and safety. The consumption of such violative products may pose potential health hazards to the consuming public. Food products including food supplements should not bear any misleading, deceptive, and false claims in their labels and/or any promotional materials that will provide erroneous impression on products’ character or identity.

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

All concerned establishments are warned not to distribute the above-identified violative food products until they have already been covered by the appropriate authorization (product registration), otherwise, regulatory actions and sanctions shall be strictly pursued.

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 the above unregistered food products, utilize our online reporting facility, eReport, at www.fda.gov.ph/ereport, or e-mail us via [email protected], or call us at the Center for Food Regulation and Research (CFRR) hotline (02) 857-1900 locals 8105 and 8112.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2018-221

FDA Advisory No. 2018-220 Public Health Warning Against HEALTH ZONE MARKETING for Selling Unregistered Food Supplements with their Corresponding Unapproved and Misleading Advertisements and Promotion on Their Products

The Food and Drug Administration (FDA) warns the public against HEALTH ZONE MARKETING for selling the following unregistered food supplements with therapeutic claims on their brochure:

The public is hereby warned that food supplements being advertised by HEALTH ZONE MARKETING are not registered with the FDA. 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, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization from FDA is prohibited.

Likewise, all claims advertised by the said establishment 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.

Accordingly, since unregistered food supplements have not gone through evaluation and testing process of the FDA, the agency cannot guarantee their quality and safety. The consumption of such violative products may pose potential health hazards to the consuming public. Food products including food supplements should not bear any misleading, deceptive, and false claims in their labels and/or any promotional materials that will provide erroneous impression on products’ character or identity.

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

For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of the above unregistered food supplement, utilize our online reporting facility, eReport, at www.fda.gov.ph/ereport, or e-mail us via [email protected], or call us at the Center for Food Regulation and Research (CFRR) hotline (02) 857-1900 loc. 8105 and 8112.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2018-220

/ In General Advisories / By FDA_Admin2 / Comments Off on FDA Advisory No. 2018-220 Public Health Warning Against HEALTH ZONE MARKETING for Selling Unregistered Food Supplements with their Corresponding Unapproved and Misleading Advertisements and Promotion on Their Products

FDA Advisory No. 2018-219 Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Products and Food Supplement:

  1. MARUCHAN Ramen Noodle Soup Beef Flavor
  2. TAO TI SUPREME 18 Tea
  3. FURN-YOU Braised Bambooshoot
  4. PALAWAN’S Brewed Coffee
  5. OBEY FOOD PRODUCTS Guyabano Capsules

The Food and Drug Administration (FDA) advises the public against the purchase and consumption of the following unregistered food products and food supplement:

FDA post-marketing surveillance (PMS) activities have verified that the abovementioned food products and food supplement have not gone through the registration process of the agency and have not been issued the 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, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization from FDA is prohibited.

Accordingly, since unregistered food products and food supplements have not gone through evaluation and testing process of the FDA, the agency cannot guarantee their quality and safety. The consumption of such violative products may pose potential health hazards to the consuming public. Food products including food supplements should not bear any misleading, deceptive, and false claims in their labels and/or any promotional materials that will provide erroneous impression on products’ character or identity.

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

All concerned establishments are warned not to distribute the above-identified violative food products and food supplement until they have already been covered by the appropriate authorization (product registration), otherwise, regulatory actions and sanctions shall be strictly pursued.

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 the above unregistered food products and food supplement, utilize our online reporting facility, eReport, at www.fda.gov.ph/ereport, or e-mail us via [email protected], or call us at the Center for Food Regulation and Research (CFRR) hotline (02) 857-1900 locals 8105 and 8112.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2018-219

/ In General Advisories / By FDA_Admin2 / Comments Off on FDA Advisory No. 2018-219 Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Products and Food Supplement:

FDA Advisory No. 2018-218 Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Products:

  1. ROMAKO YOKI Wafer Stick Crispy Wafer Sticks with Strawberry Flavour
  2. DRINGO Chocolate Chip Cookies with Chocolate
  3. BOBBY Chocolate Flavoured Cream Coated Biscuit (Red White Box)
  4. BOBBY Milk Flavoured Cream Coated Biscuit
  5. TO-NE’ Lychee Juice 15%

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

FDA post-marketing surveillance (PMS) activities have verified that the abovementioned food products have not gone through the registration process of the agency and have not been issued the 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, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization from FDA is prohibited.

Accordingly, since unregistered food products and food supplements have not gone through evaluation and testing process of the FDA, the agency cannot guarantee their quality and safety. The consumption of such violative products may pose potential health hazards to the consuming public. Food products including food supplements should not bear any misleading, deceptive, and false claims in their labels and/or any promotional materials that will provide erroneous impression on products’ character or identity.

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

All concerned establishments are warned not to distribute the above-identified violative food products until they have already been covered by the appropriate authorization (product registration), otherwise, regulatory actions and sanctions shall be strictly pursued.

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 the above unregistered food products, utilize our online reporting facility, eReport, at www.fda.gov.ph/ereport, or e-mail us via [email protected], or call us at the Center for Food Regulation and Research (CFRR) hotline (02) 857-1900 locals 8105 and 8112.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2018-218

FDA Advisory No. 2018-217 Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Supplements:

  1. ALONDA’S PRODUCT Moringa Capsule
  2. NATURAL HERB Tawa Tawa Food Supplement
  3. KIRKLAND SIGNATURE Calcium 600 mg + D3 Dietary Supplement Tablet
  4. Powdered Sambong Sweetened w/ Coconut Sugar 100% Pure & Natural
  5. DOK APO Healing Wonder Drops High Grade Alkaline Ionized Mineral Liquid

The Food and Drug Administration (FDA) advises the public against the purchase and consumption of the following unregistered food supplements:

FDA post-marketing surveillance (PMS) activities have verified that the abovementioned food supplements have not gone through the registration process of the agency and have not been issued the 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, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization from FDA is prohibited.

Accordingly, since unregistered food products and food supplements have not gone through evaluation and testing process of the FDA, the agency cannot guarantee their quality and safety. The consumption of such violative products may pose potential health hazards to the consuming public. Food products including food supplements should not bear any misleading, deceptive, and false claims in their labels and/or any promotional materials that will provide erroneous impression on products’ character or identity.

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

All concerned establishments are warned not to distribute the above-identified violative food supplements until they have already been covered by the appropriate authorization (product registration), otherwise, regulatory actions and sanctions shall be strictly pursued.

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 the above unregistered food supplements, utilize our online reporting facility, eReport, at www.fda.gov.ph/ereport, or e-mail us via [email protected], or call us at the Center for Food Regulation and Research (CFRR) hotline (02) 857-1900 locals 8105 and 8112.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2018-217

/ In General Advisories / By FDA_Admin2 / Comments Off on FDA Advisory No. 2018-217 Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Supplements:

FDA Advisory No. 2018-216 Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Products:

  1. MORRIS ALEO Chocolate Sandwich Cookies Chocolate Flavour Cream
  2. VIKI BOY Original Wafer Rolls Chocolate Flavour 10% Full Chocolate Cream
  3. ROMAKO CITA Creamy Roll Crispy Creamy Roll with Double Chocolate Flavour
  4. ROMAKO CITA Creamy Roll Crispy Creamy Roll with Strawberry Flavour
  5. ROMAKO YOKI Wafer Stick Crispy Wafer Sticks with Chocolate Flavour

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

FDA post-marketing surveillance (PMS) activities have verified that the abovementioned food products have not gone through the registration process of the agency and have not been issued the 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, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization from FDA is prohibited.

Accordingly, since unregistered food products and food supplements have not gone through evaluation and testing process of the FDA, the agency cannot guarantee their quality and safety. The consumption of such violative products may pose potential health hazards to the consuming public. Food products including food supplements should not bear any misleading, deceptive, and false claims in their labels and/or any promotional materials that will provide erroneous impression on products’ character or identity.

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

All concerned establishments are warned not to distribute the above-identified violative food products until they have already been covered by the appropriate authorization (product registration), otherwise, regulatory actions and sanctions shall be strictly pursued.

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 the above unregistered food products, utilize our online reporting facility, eReport, at www.fda.gov.ph/ereport, or e-mail us via [email protected], or call us at the Center for Food Regulation and Research (CFRR) hotline (02) 857-1900 locals 8105 and 8112.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2018-216

FDA Advisory No. 2018-215 Lifting the Advisory of BERYL’S GOURMET MILK under FDA Advisory No. 2018-211, Subject “Public Health Warning Against the Purchase and Consumption of the Unregistered Food Products”

The Food and Drug Administration (FDA) informs the public that the advisory on the product “BERYL’S GOURMET Milk Compound” under FDA Advisory No. 2018-211 dated 28 June 2018 is hereby lifted pursuant to the compliance of the market authorization holder to the existing laws, rules, and regulations of this Office.

The product is REGISTERED, under company GLOBAL PACIFIC DISTRIBUTION NETWORK CORP., with Food Registration Number 123917 valid until 04 November 2019.

Other provisions of FDA Advisory No. 2018-211 indicating unregistered products are still in effect.

The issuance of this advisory shall not in any manner preclude this Office from issuing subsequent orders it may deem necessary and appropriate, should there be findings of any violation of the company to the existing laws, rules, and regulations.

For more information and inquiries, please e-mail us at [email protected] or call us at FDA Action Center hotline (02) 821-1162. To report sale or distribution of any unregistered health products, kindly email us via [email protected].

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2018-215

/ In General Advisories / By FDA_Admin2 / Comments Off on FDA Advisory No. 2018-215 Lifting the Advisory of BERYL’S GOURMET MILK under FDA Advisory No. 2018-211, Subject “Public Health Warning Against the Purchase and Consumption of the Unregistered Food Products”

FDA Advisory No. 2018-222 Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Product and Food Supplements:

  1. MORRIS Cocoa Chips Butter Crunch Cookies
  2. All Natural Organic Spirulina Blue-Green Algea
  3. All Natural Grapeseed Extract Extra Strength
  4. FISH COLLAGEN + HA
  5. COLLAGEN 500mg

The Food and Drug Administration (FDA) advises the public against the purchase and consumption of the following unregistered food product and food supplements:

FDA post-marketing surveillance (PMS) activities have verified that the abovementioned food product and food supplements have not gone through the registration process of the agency and have not been issued the 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, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization from FDA is prohibited.

Accordingly, since unregistered food products and food supplements have not gone through evaluation and testing process of the FDA, the agency cannot guarantee their quality and safety. The consumption of such violative products may pose potential health hazards to the consuming public. Food products including food supplements should not bear any misleading, deceptive, and false claims in their labels and/or any promotional materials that will provide erroneous impression on products’ character or identity.

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

All concerned establishments are warned not to distribute the above-identified violative food products until they have already been covered by the appropriate authorization (product registration), otherwise, regulatory actions and sanctions shall be strictly pursued.

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 the above unregistered food product and food supplements, utilize our online reporting facility, eReport, at www.fda.gov.ph/ereport, or e-mail us via [email protected], or call us at the Center for Food Regulation and Research (CFRR) hotline (02) 857-1900 locals 8105 and 8112.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2018-222

/ In General Advisories / By FDA_Admin2 / Comments Off on FDA Advisory No. 2018-222 Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Product and Food Supplements:

Seminar Venue for CDRR QPIRA Seminar on 26-27 July 2018

Please be informed that the conduct of CDRR QPIRA Seminar on 26-27 July 2018, shall be held at The Bellevue Manila.

Seminar: The Bellevue Manila

Address: North Bridgeway, Filinvest Corporatte City, Alabang Muntinlupa City, Metro Manila

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

Seminar Venue for CDRR QPIRA Seminar on 26-27 July 2018

FDA Chief Orders Clean-Up Of Backlog

The Food and Drug Administration (FDA) is set to take drastic moves to address the backlog in the processing of various applications which the agency has inherited from the past.

According to the FDA, this is part of its efforts to create more efficient systems and to get rid of so-called “nuisance applications”.

FDA Director-General Nela Charade Puno announced that she is issuing a directive which will lead to the immediate disposition of all applications for food and drug products that have been pending with the FDA for a period of six months or more.

“Starting September this year, applications for license to operate and product registration pending with the FDA for a period of six months or more will be approved provided they have fully complied with the requirements, including the payment of fees,” Puno said. “This will clear the way for the implementation of a better system for filing and processing of applications and the claiming of approved permits and certificates of product registration (CPR),” she explained.

Puno announced that permits and CPRs granted through this initiative will still be subjected to back-end checks “following safety nets we have put in place to protect public health and well-being”.

She clarified that this is a “one-time procedure” and will be completed by the last quarter of this year.

“I want to make it clear that this is not a policy, but just an intermediate step to the implementation of a more efficient system,” Puno said.

“Future applicants should not expect automatic approvals just because their applications were not completed within six months,” she pointed out.

She also warned that the FDA will set stricter requirements for future applications “to weed out the nuisances and to enable the FDA to attend to the needs of serious and legitimate applicants”.

Puno pointed out that the current backlog “appears to have been at the FDA for close to a decade and have been left unattended”. She said the backlog involves some 80,000 applications that have not been completed in the past. With the move, she said she expects to clear the longstanding backlog by 80 percent.

A large percentage of the backlog is the result of the inability of applicants to submit product registration requirements, she explained.

“Under the new system we shall put in place, the failure the submit all requirements within a period of time shall mean automatic disapproval,” Puno said. “This means that a new application will have to be filed and the requirements must be complied with within a specified period,” she warned.

Puno said the moves are in line with commitments made by the FDA at the beginning of the current administration. “This follows the directive of President Duterte that the agency should be rid of inefficient and corrupt elements and that the public should be given higher standards of service,” she explained.

Puno said the backlog in the processing of applications she inherited “is also responsible for the proliferation of unregistered food and drug products in the black market”. “Because of the slow process, manufacturers and distributors in the past had opted to skip registration and just brought their products to the market right away,” she explained.

“This poses risks to the public since unregistered products have not been properly evaluated for safety and efficacy,” Puno added.

The FDA head also warned that she will not allow delays in the processing of applications “that are caused by internal human factors, such as the inefficiency and corruption on the part of our personnel”.

She called on applicants to report any unwarranted actions on the part of any FDA personnel that may jeopardize the efficiency and integrity of the FDA processes.

Creation of Technical Working Group for the Effective Implementation of the PICS/GMP Guide for Medicinal Products

FDA MEMORANDUM CIRCULAR NO. 2018-003

13 July 2018

TO : All Drug Establishments and concerned Offices, Officers, and Personnel within Food and Drug Administration

SUBJECT : Creation of Technical Working Group for the Effective Implementation of the PICS/GMP Guider for Medicinal Products

 

The Pharmaceutical Inspection Cooperation Scheme (PIC/S) Good Manufacturing Guide for Medicinal Products was officially adopted and implemented by virtue of the issuance of Administrative Order No. 2012-008 dated 25 June 2012. For capability building purposes, Paragraph 5, Item VI of the Administrative Order specifically authorizes the FDA and industry to provide trainings and workshops and may create technical working group/s for the effective implementation of the PIC/S Guide.

 

Hence, a Technical Working is hereby established composed of the following:

 

  1. FIELD REGULATORY OPERATIONS OFFICE, as Lead
  2. CENTER FOR DRUG REGULATION AND RESEARCH, as Co-Lead
  3. Two representatives from the industry representing local manufacturers and distributors (importers).

 

The TWG shall perform the following:

 

  1. Undertake impact analysis concerning the implementation of the PIC/S guides or requirements and recommend to FDA and industry appropriate actions;
  2. Coordinate with the FDA and industry for the provision of trainings, workshops, dissemination of information to stakeholders, and other appropriate action for the smooth implementation of the PIC/S guides or requirements including supplements or revisions thereto;

 

All materials, food, transportation, equipment, and other financial requirements that may be needed by the TWG during meetings shall be sourced out from available funds of the FDA, subject to the usual accounting and auditing rules and regulations.

 

This Order shall take effect immediately and shall be valid until revoked.

 

NELA CHARADE G. PUNO, RPh

Director-General

 

ATTACHMENTS:

/ In Drugs-GMP / By FDA_Admin1 / Comments Off on Creation of Technical Working Group for the Effective Implementation of the PICS/GMP Guide for Medicinal Products

Cloud Migration

Please be advised that ICTMD will conduct migration activity (from FDA Server to  Cloud System) starting today 13-July- 2018, from 1pm to 12 midnight. Due to this activity, we regret to inform you that the FDA Inventory System (FIS), e-portal, Zimbra (FDA Email System), and the FDA Inventory System (FIS) will not be available during this period.

Once again, we do apologize for the inconvenience and please rest assured that ICTMD is doing its best to serve you better.

Thank you very much for your kind understanding.

FDA Circular No. 2018-009 || Updates and Amendments of the ASEAN Cosmetic Directives (ACD) as Adopted During the 28th ASEAN Cosmetic Committee (ACC) Meetings and Its Related Meetings

I. Background and Rationale

In 2005, the Department of Health (DOH) – Food and Drug Adminstration (FDA), then called Bureau of Food and Drugs (BFAD), has adopted and implemented the ASEAN Harmonized Cosmetic Regulatory Scheme and the ASEN Common Technical Documents through Administrative Orders No. 2005-0015 and 2005-0025, respectively. The harmonization scheme involves the conduct of alignment meetings for the purpose of eliminating trade barriers and enhancing cooperation within the ASEAN Members States (AMS) in ensuring the safety, quality and claimed benefits of cosmetic products.

FDA Circular No. 2018-009

/ In Circular / By FDA_Admin2 / Comments Off on FDA Circular No. 2018-009 || Updates and Amendments of the ASEAN Cosmetic Directives (ACD) as Adopted During the 28th ASEAN Cosmetic Committee (ACC) Meetings and Its Related Meetings

Seminar Venue for QPIRA CFRR in Cebu CIty on 12-13 July 2018

Please be informed that the QPIRA for Center for Food Regulation and Research (CFRR) Seminar scheduled on 12-13 July 2018 at Cebut City shall be at Cebu Parklane International Hotel.

Venue: Cebu Parklane International Hotel.

ADDRESS: Cor. Kamagong-Escario Sts., Lahug, Cebu City

All course registrants who received Course Assessment Slip for QPIRA CFRR but have not received the Course Confirmation Slip are advised to come in the seminar venue (Cebu Parklane International Hotel) on the scheduled dates of seminar with the following documents:

  • Course assessment slip
  • Proof of payment
  • Original notarized affidavit of undertaking

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

Seminar Venue for QPIRA in Cebu City

FDA Advisory No. 2018-214 || Public Health Warning Against the Use of Unnotified Cosmetic Products (Batch 11)

The Food and Drug Administration (FDA) advises the public against the purchase and use of the following unnotified cosmetic products whose particulars/details are provided in the attached annex:

  1. VAPORISING RUB MANGOSTEEN
  2. SAM-SAMMI SPF 35+++ SUNBLOCK FACE CREAM
  3. SAM-SAMMI MERIAM CEBO DE MACHO
  4. ROYALE BEAUTY® L-GLUTAPOWER® FACIAL SOAP
  5. FAIRY SKIN GLOWING FACIAL SET:
    1. FAIRY SKIN FACIAL TONER
    2. FAIRY SKIN BLEACHING SOAP
    3. FAIRY SKIN WHITENING CREAM
    4. FAIRY SKIN SUNBLOCK CREAM SPF 45
  6. LOVIA PROFESSIONAL PREMIUM HAIR COLOUR CREAM (NATURAL BLACK 2.0)
  7. MYCHOICE® BUBBLE SCRUB SHOWER SALT HIGH CONCENTRATE (CUCUMBER) 2-IN-1 REFRESHING
  8. MYCHOICE® RED CROWN CREAM PUFF (5)
  9. EPIELLE™ HAIR COLOR DARK BROWN
  10. PERSONAL CARE VITAMIN E SKIN OIL 1500 IU
  11. EAD SUNSCREEN BROAD SPECTRUM LOTION SPF15
  12. SANTEE® USA MAGIC SKIN BEAUTIFIER BB SPF20 (6)
  13. MYCHOICE® ANTI-ACNE FACIAL FOAM
  14. HENGFANG® CUSHIOM CARESSE (NO. 9047)
  15. ASHLEY SHINE HAIR COLOR SPRAY CHESTNUT RED
  16. INFINITE BEAUTY SKIN AND BEYOND RADIANCE SERUM
  17. BEAUTY LUSH SKIN ESSENTIALS PERFECT FIRMING SOAP
  18. MYUNGIN FARMSTAY GRAPE STEM CELL TONER
  19. GEVEMIA TRI&1™ PROFESSIONAL HAIR COLOUR (H819 GRAPE-PURPLE)
  20. BEAUTY HOST PAPAYA WHITENING PEELING GEL
  21. HIMALAYA® HERBALS PROTECTING NEEM & TURMERIC SOAP
  22. LACTO CARROT SOAP WITH LACTOBACILLUS PAFI
  23. NEW YAKI BABY SOAP BLOSSOMS
  24. COSMETIC BUFFET REJUVENATING SET KIT 1:
    1. COSMETIC BUFFET BLEACHING CREAM
    2. COSMETIC BUFFET REJUVENATING TONER
    3. COSMETIC BUFFET KOJIC ACID SOAP
    4. COSMETIC BUFFET DAY CREAM
  25. JARFUL OF GOODNESS CHOCO SOAP
  26. JARFUL OF GOODNESS GENTLE CLAY & CHARCOAL SOAP
  27. JARFUL OF GOODNESS PURE CASTILE ALL-NATURAL SOAP
  28. BAZ’A GALAXDOR MAKEUP CLEANSING WIPES
  29. ULTRA COMSOFT WET WIPES (MANGO)
  30. ULTRA COMSOFT WET WIPES (GREEN APPLE)
  31. HP HILTON PACKARD 5 IN 1 ACTION WIPES (YELLOW)
  32. ULTRA SOFT SENSITIVE COMSOFT WITH ALOE VERA BABY WIPES
  33. DONG BANG® 123 KID’S BABY WIPES
  34. MB MISS BEAUTY MAKE-UP KIT (MB6464) (1)
  35. ADS FASHION BLUSHER (A8408) (3)
  36. LADY BELLE SKIN ENHANCERS BY OSEUR LADY BELLE NIGHT TIME CRÈME
  37. MERIAM GLUTA CREAM LOTION CHERRY BLOSSOM SCENT
  38. LP MIRACLE CREAM WITH ARGAN AND VITAMIN SPF 55
  39. SUNBLOCK CREAM SPF 30
  40. WELLCHECK™ VALUESCENT™ EXTRA STRENGTH WITH VITAMIN E

FDA post-marketing surveillance (PMS) activities have verified that the abovementioned cosmetic products have not gone through the verification process of the agency and have not been issued the proper authorization in the form of acknowledged cosmetic notifications. 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, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization from FDA is prohibited.

Accordingly, because unnotified cosmetic products have not gone through the verification process of the FDA, the agency cannot guarantee their quality and safety. The use of such violative products may pose potential health hazards to the consuming public.

Potential hazards may come from ingredients that are not allowed to be part of a cosmetic product or from the contamination of heavy metals such as mercury especially in whitening cosmetic products. The use of substandard and possibly adulterated cosmetic products may result to adverse reactions including but not limited to skin irritation, itchiness, anaphylactic shock and organ failure.

In light of the above, the public is advised not to purchase the aforementioned violative products. Moreover, the public is also advised to be vigilant against cosmetic products that might not be duly notified with FDA. Always check if a cosmetic product has been notified with 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 are warned not to distribute the above-identified violative cosmetic products until they have already been covered by the appropriate authorization (cosmetic notification), otherwise, regulatory actions and sanctions shall be strictly pursued.

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 the above unnotified cosmetic products, utilize our online reporting facility, eReport, at www.fda.gov.ph/ereport, or e-mail us via [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 857-1900 local 8113 or 8107.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2018-214

Asean Medical Device Committee – Pharmaceutical Device Agency

The CDRRHR will attend the Asean Medical Device Committee – Pharmaceutical Device Agency (AMDC-PMDA) Japan’s Individual in-Country Training/Workshop on 11-12 July 2018. Therefore, receiving of applications for Thursday, 12 July 218 will be cancelled. Receiving of application will resume on Friday, 13 July 2018, following the schedule of submission of applications as per FDA Circular No. 2016-010.

Announcement CDRRHR

FDA Advisory No. 2018-204 || Public Health Warning Against the Use of Unnotified Cosmetic Products (Batch 10)

The Food and Drug Administration (FDA) advises the public against the purchase and use of the following unnotified cosmetic products whose particulars/details are provided in the attached annex:

  1. SIVANNA COLORS® LIPSTICK 12H MAKEUP WATERPROOF
  2. YOKO SOYBEAN Q10 CREAM
  3. BB CREAM FAIRY BLINK NATURAL & NUDE MAKEUP 01: IVORY
  4. MEILINDA KISS KISS LIQUID LIPSTICK LOVE ME TENDER (05)
  5. HASK® MACADAMIA OIL MOISTURIZING DEEP CONDITIONER
  6. BIHAKU WONDER SOAP
  7. MILEA BATH & BODY NATURALLY FOR YOU® NATURAL DEODORANT BLUE
  8. LA BELLE NAIL POLISH FRENCH LAVANDER
  9. OPTIMA™ COLLAGEN CREAM
  10. OPTIMA™ GLUTATHIONE + SOYA SOAP
  11. GLUTAMAX® PEARL WHITENING MOISTURIZING CREAM
  12. TEEN’S INTIMATE COLOR FRAGRANCE POWDER (GREEN AVILON)
  13. TEEN’S INTIMATE COLOR FRAGRANCE POWDER (MILK FRESH)
  14. TEEN’S INTIMATE COLOR FRAGRANCE POWDER (SIMPLY PINK)
  15. UZANA REFRESHING FACIAL WIPES (SANDAL)
  16. UZANA REFRESHING FACIAL WIPES (JASMINE)
  17. UZANA REFRESHING FACIAL WIPES (ROSE)
  18. NEVADA NATURAL PRODUCTS NNP ROSES PRE-MOISTENED TISSUES
  19. RXS SKIN RENEWAL TONER #2
  20. RXS SKIN RENEWAL CREAM 2
  21. RXS BLACK CHARCOAL SOAP
  22. PERFECT PURITY® SKIN BLEMISH BODY WASH WITH SALICYCLIC ACID
  23. XTRACARE SIGNATURE® BB BODY LOTION MULTI-ACTION BEAUTIFYING SKIN CARE LIGHT TO MEDIUM SKIN TONES
  24. PERSONAL CARE® MOISTURIZING VITAMIN E SKIN CREAM
  25. GOREE® WHITENING BODY LOTION VITAMIN E WITH LYCOPENE AVOCADO & ALOEVERA

FDA post-marketing surveillance (PMS) activities have verified that the abovementioned cosmetic products have not gone through the verification process of the agency and have not been issued the proper authorization in the form of acknowledged cosmetic notifications. 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, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization from FDA is prohibited

Accordingly, because unnotified cosmetic products have not gone through the verification process of the FDA, the agency cannot guarantee their quality and safety. The use of such violative products may pose potential health hazards to the consuming public.

Potential hazards may come from ingredients that are not allowed to be part of a cosmetic product or from the contamination of heavy metals such as mercury especially in whitening cosmetic products. The use of substandard and possibly adulterated cosmetic products may result to adverse reactions including but not limited to skin irritation, itchiness, anaphylactic shock and organ failure.

In light of the above, the public is advised not to purchase the aforementioned violative products. Moreover, the public is also advised to be vigilant against cosmetic products that might not be duly notified with FDA. Always check if a cosmetic product has been notified with 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 are warned not to distribute the above-identified violative cosmetic products until they have already been covered by the appropriate authorization (cosmetic notification), otherwise, regulatory actions and sanctions shall be strictly pursued.

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 the above unnotified cosmetic products, utilize our online reporting facility, eReport, at www.fda.gov.ph/ereport, or e-mail us via [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 857-1900 local 8113 or 8107.

Dissemination of the information to all concerned is requested

FDA Advisory No. 2018-204

Reschedule of the Conduct of CCRR QPIRA Seminar for HUHS (QCCRR-HUP) for 2018

Please be informed that the Center for Cosmetics Regulation and Research (CCRR) QPIRA Seminar for Household and Urban Hazardous Chemicals (Course Code: QCCRR-HUHP) that was postponed last 8-9 may 2018 due to low number of participants, shall be rescheduled on 6-7 November 218. Seminar location is still within Muntinlupa City, NCR.

For inquiries and other concernes, please call the FDA Academy at telephone number (02) 877 0259 or email at [email protected]. please be guided accordingly.

Reschedule of Conduct of CCRR QPIRA Seminar for HUHS (QCCRR-HUP) for 2018