Category: General Advisories

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

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

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

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

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

a.) Authorization letter in company letterhead;

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

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

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

B. RELEASING OF AUTHORIZATIONS

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

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

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

For information and guidance.

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

FDA Advisory No. 2019-129 || FDA Email Directory

To ensure ease of transaction and the desire to provide a more efficient customer service, the Food and Drug Administration (FDA) hereby advises the public to send specific concerns, queries, transactions and/or documents to the following email addresses:

 Type of transaction / Document / Concern   Office/s Concerned
Compliance Document, Follow-ups, Verification of Registration of Products and License of Establishments  concerning Center for Food Regulation and Research [email protected]
Compliance Document, Follow-ups, Verification of Registration of Products and License of Establishments concerning Center Drug Regulation and Research including veterinary medicine, vaccine, and biologicals [email protected]
Compliance Document, Follow-ups, Verification of Registration Of Products and License of Establishments concerning Center for Cosmetics Regulation and Research
including household hazard/urban substances
[email protected]
Compliance Document, Follow-ups, Verification of Registration of products and License of Establishments concerning Center for Device Regulation, Radiation Health and Research [email protected]
Qualified Persons in Industry Regulatory Affairs (QPIRA) Training, Licensing Seminar and other Seminars as spearheaded by FDA [email protected]
Legal related concerns/queries/follow-ups [email protected]
Request for meetings, courtesy calls and other related matter [email protected]
E-Portal Account Concerns (i.e. Requests, Change of Username, password and among others), Processes (i.e. How to Apply for FDA Certificates) [email protected]

All other concerns not cited this advisory are hereby requested to be sent to [email protected]

For your information and guidance.
FDA Advisory No. 2019-129

FDA Advisory No. 2019-051 || Public Health Warning Against the Use of Unnotified Cosmetic Products (Batch 2)

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. DEXE® HAIR COLOR SPRAY (COFFEE)
  2. DEXE® HAIR COLOR SPRAY (YELLOW)
  3. TANAKO CC CREAM ALOE VERA REFRESHING (01)
  4. TANAKO BABY SKIN BLEMISH COVER CONCEALER (NO.128, 001)
  5. HELLO KITTY L-GLUTATHIONE MOIST WHITENING LOTION SPF 70+++ (CHANEL)
  1. GLUTATHIONE W/ TAWAS
  2. TAWAS WITH MORINGA SOAP 2 IN 1
  3. MG GLUTA TAWAS SCENTED WITH CALAMANSI OIL
  4. NEW GLUTA CALAMANSI THE ORIGINAL
  5. NEW GLUTA CALAMANSI WITH BAKING SODA
  6. ANTI-AGEING W/ APPLE STEMCELL
  7. ORANGE PEEL
  8. KOJIC W/ BLEACH
  9. GLUTA W/ LAVENDER
  10. OVERLOAD
  11. LG CARE (LABEL IS IN FOREIGN LANGUAGE)
  12. FOOT™, FOOT POWDER
  13. TIANNUO® SMOOTH SHINE MOISTURIZING BB CREAM (520)
  14. HANBEILI NON-TRACE CONCEALER (01)
  15. COLOUR DIARY PLANTS FRUITS
  16. MINGHAN COSMETIC LIPSTICK DEEP SEA FISH OIL NONSTICK CUP (04)
  1. RUORI LIANA PROFESSIONAL MAKEUP NUDE MOIST LIPSTICK (04)
  2. LIPSTICK CUICU
  3. MIDIO MINUENESS LINE EYELINER
  4. MIDIO SKIN REJUVENATING ROSE HAND CREAM
  5. COSMETIC BUFFET STRETCHMARK SOAP
  6. DERMACOL MIRACELE SHES EMBELISH PERFECT BB CREAM WATERPROOF SPF 30
  7. ANASTASIA BEVERLY HILLS® DIPBROW™ POMADE MEDIUM BROWN
  1. ANASTASIA BEVERLY HILLS® MASCARA ROUGEALEVRES LIQUIDE
  2. COSMETIC BUFFET BLEACHING LOTION SUNBLOCK SPF 15
  3. COSMETIC BUFFET BODY SCRUB
  4. PNF PEINFEN® SAEMMUL REAL TINT THE RABBIT DYE LIQUID LIP (03)
  5. LI’L TOTS BABY WIPES
  6. ZAFIRAH ALLELE WHITE 5 IN 1 INSTANT WHITE BODY LOTION SPF 35
  7. FRESHMAN WHITENING BAR WITH 8 POWERFUL WHITENING INGREDIENTS
  8. BENCH/® FIX PROFESSIONAL ROCK & RULE MATTE SCULPTING WAX
  9. ALL WHITE® PLACENTA HERBAL LIGHTENING SOAP CLASSIC
  10. PURESOFT KIDDIE WIPES (BUBBLEGUM SCENT)
  11. BURT’S BEES® NATURAL FACE ESSENTIALS PINK GRAPEFRUIT FACIAL CLEANSING TOWELETTES
  12. YADAH BE MY TINT (01 WANNABE PINK)
  13. YSA BOTANICA GREEN PAPAYA ACNE SOAP WITH WHITENING FORMULA FOR PIMPLE TREATMENT
  14. ERASE PLANTCENTA 3-IN-1 MAGIC SOAP WITH SHEA BUTTER
  15. D & J CASTOR OIL
  16. HELLO GORGEOUS PURIFYING SOAP
  17. HELLO GORGEOUS OF SHEET! FRESH MERMAID ANTI-ACNE FACIAL MASK
  18. BARBIE™ MY BEAUTY KIT BARBIE LIQUID SOAP
  19. SKINFOOD SINCE 1957 SHEA BUTTER PERFUMED HAND CREAM ROSE SCENT
  20. SKINFOOD SINCE 1957 TOMATO COOL JELLY TINT
  21. ERASE® WHITENING DEODORANT WITH HAIR RETARDANT AND ANTIPERSPIRANT
  22. ERASE® SUNBLOCK CREAM WITH MOISTURIZER SPF 40
  23. ERASE® BLACKOUT SUNBLOCK LOTION SPF 60
  24. ERASE® ORGANICS WHITENING SERUM
  25. GLUTA® BY ERASE WHITENING FACIAL CLEANSER WITH OIL CONTROL
  26. GLUTA® BY ERASE WHITENING FACIAL CLEANSER WITH KOREAN GINSENG AND TAWAS
  27. GLUTA® BY ERASE WHITENING LOTION WITH KOREAN GINSENG AND VITAMIN E
  28. GLUTA® BY ERASE WHITENING LOTION WITH KOJIC ACID & MORINGA EXTRACT

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. 2019-051

FDA Advisory No. 2019-120 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

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

  1. MILEN’S Lambanog
  2. MANILA Lambanog 80% Proof
  3. PARTY ANIMAL All Natural Flavored Lambanog Strawberry Flavor
  4. CAPISTRANO Philippine Lambanog Distilled Coconut Wine

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 are prohibited.

Accordingly, since these 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 these products may pose potential health hazards to the consuming public.

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 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 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 8112 or 8105.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2019-120

FDA Advisory No. 2019-117 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

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

  1. SUPREME GRANDE PREMIUM WHOLE ALMOND CANDY
  2. CROWN PEANUTS IN CARAMEL
  3. RIGHT CHOICE SAGO PLAIN WHITE
  4. PASTAZARA LASAGNE VERDI
  5. PERFECT NATURE’S COCONUT ACTIVATED CHARCOAL

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.

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. 2019-117

FDA Advisory No. 2019-116 || Public Health Warning Against the Use of Unnotified Cosmetic Products (Batch 3)

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. LEIANIA HOUSE OF BEAUTY CUCUMBER MELON + ALOE LOOFAH SOAP
  2. SKINMATE BODY WHITE WHITENING LOTION SPF 20
  3. AEKYUNG 2080 KIDS TOOTHPASTE STRAWBERRY
  4. MOISTURE CUCUMBER SOAP (LABEL IS IN FOREIGN LANGUAGE)
  5. LOVELY LADY BABY OIL
  6. ROSE CUTICLE REMOVER
  7. KING’S GARDEN BOOS HUGGO BOOS
  8. KING’S GARDEN HUGGO HUGGO BOOS
  9. KING’S GARDEN POLOE BLACK
  10. KING’S GARDEN TOMMI GIRL
  11. KING’S GARDEN DULCE & GABANA LIGHT BLUE
  12. KING’S GARDEN FERARI EXTREME
  13. KING’S GARDEN DAVIDOF KOHL WATER
  14. KING’S GARDEN ETERNALLY AQUA CALVIN KLINNE
  15. KING’S GARDEN ESKADA MOON SPARKLE FOR MEN
  16. TRUMAY® HANZHIXIU® PERMANENT HAIR COLORANT WITH ACTIVE VEGETABLE INGREDIENTS (T-10 PURPLE RED)
  17. HANZHIXIU® KERATIN PAPAYA ESSENCE COLOR PROTECTING HAIR MASK
  18. BREMOD® PERFORMANCE SPA HAIR COLOR (DARK ASH BLOND)
  19. LIGHTNESS SERIES HAIR COLORANT (BURGUNDY LI-1072)
  20. YASH TEMPORARY HAIR COLOR
  21. YOUNG’S HAIR SPRAY NET EXTRA SUPER HOLD
  22. QUAEVITA KOJIC ROSEHIP OIL NATURAL WHITENING SOAP WITH LICORICE EXTRACT AND ROSEHIP OIL
  23. KERATIN HAIR RECONSTRUCTOR HAIR DIRECTOR HIGH PERFORMANCE
  24. BDO HERBOSIDO™ HERBAL SHAMPOO 100% NATURAL
  25. SARAH LAUREN & LUDY AL’NAIMI SKIN WHITENING LOTION
  26. QICHUN BLUE MAGNUN MASCARA
  27. USHAS® MATTE EYESHADOW 6 COLORS PALETTE (ES2750-4)
  1. RDL BABYFACE ASTRINGENT WITH MELAWHITE®
  2. ILAHUI SMOOTH & MOISTURE BODY LOTION
  3. ILAHUI CHAMOMILE PETAL SHOWER GEL
  4. SAEMMUL WATER CANDY TINT CHERRY
  5. LIP TINT EASTERN COFFEE 01
  6. ASHLEY SHINE MINERAL POWDER CHEEK BLUSHER AS8004
  7. PINKIES COLLECTIONS BLUSHER
  8. YVES ROCHER SHAMPOOING STIMULANT ANTI-HAIRLOSS
  9. ORANGE BLOSSOM·LAVENDER·PETITGRAIN BODY BALM
  10. UNI-LOVE BABY WIPES UNSCENTED
  11. BREMOD® COLLAGEN CARE JASMINE ESSENCE COLOR CARE AND INTENSE CURL HAIR MASK
  12. DEVE SUMI SKIN CARE FACE WASH WITH NATURAL FRAGRANCE
  13. UTENA SIMPLE BALANCE HYALURONIC ACID LOTION UV SPF 5
  14. WEN® YUAN HAIR COLOR 6.86 RED BROWN
  15. HUDABEAUTY (VARIANTS: 03, 09, 10, 11)
  16. MORPHE MATTE LIPSTICK (05) VIOLET
  17. NEW XXL PENCIL SOFE LIP & EYELINER PENCIL (NO. 43 01)
  18. SASIMI® 3D
  19. ME NOW GENERATION II TRUE LIPS LIP LINER PENCIL (050)
  20. L’OREAL PARIS DERMO-EXPERTISE RE·NOURISH CLEANSING WIPES (PEACH & BLUE)
  21. PNF PEIYEN® WATER CANDY TINT (VARIANTS: CHERRY, SOFT PERSIMMON, RED MANGO)

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. 2019-116

FDA Advisory No. 2019-119 || Public Health Warning Against the Use of Cosmetic Products Containing Banned Ingredients (Batch 3)

The Food and Drug Administration (FDA) advises the public against the purchase and use of the adulterated cosmetic product THE ORIGINAL PORCELANA® ASTRINGENT IMPROVED FORMULA which tested positive for the presence of HYDROQUINONE and TRETINOIN, ingredients that are not allowed to be part of a cosmetic as per Annex II Part 1 of the ASEAN Cosmetic Directive (refer to the image for the products’ particulars/details).

Products containing Hydroquinone and/or Tretinoin (Retinoic Acid) shall be classified as home remedy, over-the-counter, or prescription drug depending on the amount present as per Administrative Order No. 13 s. 1999.

Accordingly, because these products are not compliant with the existing standards, consumers should be vigilant against their purchase and use. The use of these products can pose potential health hazards to the consuming public and 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.

To report any suspicious and/or illegal activity involving the said products, the public may contact FDA through its online reporting facility, eReport, at www.fda.gov.ph/ereport, or e-mail us at [email protected], or call the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 857-1900 local 8107/8113.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2019-119

FDA Advisory No. 2019-114 || Public Health Warning Against the Purchase and Use of Unregistered Health Related Device “Authentic Neuchi 3 in 1 Alkaline Water Purifier Complete Set”

The Food and Drug Administration (FDA) advises the general public against the purchase and use of the Authentic Neuchi 3 in 1 Alkaline Water Purifier Complete Set as unregistered health related device product.

FDA post-marketing surveillance (PMS) activities have verified that the abovementioned health related device product has not gone through the registration process of the agency and has not been issued with the proper authorization in the form of Certificate of Health Related Device Registration (CHRDR). 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 this unregistered health related device product 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. Health related device products especially water purification device/ system shall not bear any false, deceptive and misleading claims and promotional ploys on alkaline water, oxygenated water or ionized water.

In light of the above, the public is advised not to purchase the aforementioned violative products. Moreover, the public is advised to be vigilant against health related device products that might not be duly registered with FDA. Always check if a health related device 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 health related 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 localities or areas or jurisdiction.

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

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2019-114

/ In General Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-114 || Public Health Warning Against the Purchase and Use of Unregistered Health Related Device “Authentic Neuchi 3 in 1 Alkaline Water Purifier Complete Set”

FDA Advisory No. 2019-113 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “Cofoe Forehead Infrared Thermometer” advertised for sale in Shopee website

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

FDA post-marketing surveillance (PMS) activities have verified that the abovementioned medical device 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 this 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 devices product until he 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.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2019-113

/ In General Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-113 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “Cofoe Forehead Infrared Thermometer” advertised for sale in Shopee website

FDA Advisory No. 2019-112 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “Leten Pleasure Lubricant Set Aloe Muscle Moisten (60ml)” advertised for sale in Lazada Website

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

FDA post-marketing surveillance (PMS) activities have verified that the abovementioned medical device 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 this 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 devices product until he 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.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2019-112

/ In General Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-112 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “Leten Pleasure Lubricant Set Aloe Muscle Moisten (60ml)” advertised for sale in Lazada Website

FDA Advisory No. 2019-111 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product (Cobas® PCR Swab)

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 Cobas® PCR Swab:

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 are 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.

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.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2019-111

/ In General Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-111 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product (Cobas® PCR Swab)

FDA Advisory No. 2019-110 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device-HR™ Lubricating Jelly One Shot

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 HR Lubricating Jelly One Shot:

FDA post-marketing surveillance (PMS) activities have verified that the abovementioned 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. 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 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 danger or injury if administered.

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 or jurisdiction.

For more information and inquiries, please email 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 loc. 8301.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2019-110

/ In General Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-110 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device-HR™ Lubricating Jelly One Shot

FDA Advisory No. 2014-010-A || Public Health Warning Against False, Deceptive and Misleading Claims and Promotion Ploys on “Alkaline Water” and “Oxygenated Water”

Relative to the issuance of the FDA Advisory No. 2014-010 regarding the false, deceptive and misleading claims and promotional ploy on “Alkaline Water” and “Oxygenated Water”.

The Food and Drug Administration (FDA) reissues this advisory to inform the general public that any distributors that are promoting and offering for sale or use equipment or devices that would change tap water or bottled water into “alkaline” or “oxygenated” water shall be substantiated through valid clinical trials. It is a violation of RA 9711, otherwise known as the FDA Act of 2009, to sell or offer for sale or use purification devices that allegedly produce water known as “alkaline water” or “oxygenated water” and make therapeutic claims without a Certificate of Product Registration (CPR). Vendo-type outlets or refilling stations, and those engaged in the manufacture, importation and distribution of water with therapeutic claims shall secure a License to Operate from FDA before applying for a CPR.

Consumers are advised not to fall prey to these unscrupulous vendors and peddlers. Drinking alkaline, oxygenated or ionized water does not change the blood pH level.

The FDA warns all companies engaged in the business of supplying drinking waters in containers with specific claims, such as “alkaline water” or “oxygenated water” to secure LTO from FDA and apply for a CPR. The FDA Act of 2009 (RA 9711) prohibits selling, offering for sale, distribution, advertisement, and promotion, among other marketing and advertisement activities, of unregistered health products.

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

To check if a health product is registered with FDA, please log in at www.fda.gov.ph and type in the name of the product in the Search bar.

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

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2014-010-A

/ In General Advisories / By Administrator / Comments Off on FDA Advisory No. 2014-010-A || Public Health Warning Against False, Deceptive and Misleading Claims and Promotion Ploys on “Alkaline Water” and “Oxygenated Water”

FDA Advisory No. 2019-109 || Public Health Warning Against Unregistered Food Supplements with their Unapproved and Misleading Advertisements and Promotion on Their Products:

The Food and Drug Administration (FDA) warns the public against unregistered food supplements with therapeutic claims on their brochure:

  1. ROYALE FASTRIM WITH GARCINIA CAMBOGIA DIETARY SUPPLEMENT
  2. COLLAGEN PROTEIN SOFTGELS FOOD SUPPLEMENT

The public is hereby warned that food supplements being advertised above 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 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.

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. 8115 and 8112.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2019-109

/ In General Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-109 || Public Health Warning Against Unregistered Food Supplements with their Unapproved and Misleading Advertisements and Promotion on Their Products:

FDA Advisory No. 2019-108 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplements:

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

  1. EVIDENT GLUTATHIONE + COLLAGEN FOOD SUPPLEMENT
  2. JM BLESS TURMERIC CURCUMIN CAPSULES
  3. JM BLESS PANAX GINSENG CAPSULE
  4. JM BLESS SERPENTINA CAPSULE
  5. NATURE’S DETOX FOOD SUPPLEMENT

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.

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 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 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 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 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. 2019-108

FDA Advisory No. 2019-107 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplements:

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

  1. PARADISE ORAC-ENERGY EARTH’S BLEND ONE DAILY SUPERFOOD MULTIVITAMIN
  2. NEW CHAPTER EVERY WOMAN’S ONE DAILY MULTI
  3. 21st CENTURY CRANBERRY PLUS PROBIOTIC URINARY TRACT SUPPORT
  4. CALIFORNIA PRODUCTS RASPBERRY KETONE ULTRA WEIGHT LOSS FORMULA
  5. FERTILAID FOR WOMEN DIETARY SUPPLEMENT

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.

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 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 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 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 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. 2019-107

FDA Advisory No. 2019-106 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

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

  1. MOICO’S BICOL TABLEA, SWEETENED
  2. FRITTERS BANANA BITES PRODUCTS BANANA CHIPS
  3. ORIZA TOASTED RICE PUTO
  4. MARICAR SPECIAL PILI TARTS
  5. TRIPLE J ALBAY SWEETS PASTILLAS

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.

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. 2019-106

FDA Advisory No. 2019-105 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplements:

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

  1. RESCURE PLUS RESVERATROL + CURCUMIN + EGCG DIETARY FOOD SUPPLEMENT
  2. AMAZING HERBAL SUPPLEMENT BANABA
  3. AMAZING FOOD SUPPLEMENT MORINGA
  4. NATURE HERB’S WITH HONEY

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.

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. 2019-105

FDA Advisory No. 2019-104 || Public Health Warning Against the Purchase and Consumption of the following Unregistered PARAGIS FOOD SUPPLEMENTS:

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

  1. GREENSPARK PARAGIS CAPSULE
  2. PARAGIS HERBAL FOOD SUPPLEMENT
  3. PARAGIS HERBAL FOOD SUPPLEMENT
  4. PARAGIS HERBAL FOOD SUPPLEMENT BY LAUDOTO SI NI LOLO KIKO FOUNDATION, INC.
  5. PARAGIS SUPER-ANTIOXIDANT

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.

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 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 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. 2019-104

FDA Advisory No. 2019-103 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

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

  1. CLASSIQUE AGARICUS FORTE WITH MULTI ORGANIC ELEMENTS
  2. COFFEE INTERCOURSE UNTIL DAWN
  3. ONECARE LACTOFERRIN PRAVENTAC
  4. NBO GLOBAL NRZ INC. TURMERIC CAPSULES W/ BIOPERINE
  5. IMMUNE BOOSTER JACAMA SUPER CEE DIETARY SUPPLEMENT  

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 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.

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 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 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. 2019-103

FDA Advisory No. 2019-102 || Public Health Warning Against the Purchase and Use of Unnotified Toy and Child Care Article (TCCA) Products (Batch 1)

The Food and Drug Administration (FDA) advises the public against the purchase and use of the following unnotified Toy and Child Care Article (TCCA) products:

  1. J.H. Toy Lasting Friend Space Balloon
  2. Magic Balloon
  3. Zestar Plastic Balloom size 11
  4. Zestar Plastic Balloon Size 7

FDA post-marketing surveillance (PMS) activities have verified that the abovementioned TCCA products have not gone through the notification process of the agency and have not been issued the proper marketing authorization (MA). 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.

The TCCA products, prior to being placed into the local market, must be duly notified with the FDA by a licensed TCCA distributor and/or manufacturer pursuant to the Implementing Rules and Regulations (IRR) of R.A. 9711 sec. 5ii. If a TCCA product has not been evaluated by FDA, as in the case of these unnotified products, the use of such products may pose potential health hazards to the consuming public.

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 TCCA products that are unnotified with FDA. Always check if a TCCA 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.

Consumers are further reminded to:

  • Buy TCCA products from reputable stores or dealers;
  • Read the label. Check that the TCCA product has FDA notification number indicated in the label.
  • Never buy TCCAs that do not have instructions written in Filipino or English. Strictly follow the instructions for use of the product.

All concerned establishments are warned not to distribute the above-identified violative TCCA products until they have 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 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 TCCA 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) 857-1979 or (02) 857-1984.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2019-102

FDA Advisory No. 2019-101 || Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Supplements and Food Products:

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

  1. GLUTA NANO PLUS 900,000 mg plus 200,000 mg White Strawberry Extract
  2. KIRKLAND SIGNATURE Extra Strength Glucosamine 1500 mg Chondroitin 1200 mg Dietary Supplement
  3. GREENGOLD Herbal Capsule 10 Amazing Herbs Food Supplement
  4. CASINO CA VIENT D’ICI Palets Bretons
  5. ELEVATE ME Fruit & Nut Energy Bar Blueberry

FDA post-marketing surveillance (PMS) activities have verified that the abovementioned food supplements and 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 are prohibited.

Accordingly, since these unregistered food supplements and food products have not gone through evaluation and testing process of the FDA, the agency cannot guarantee their quality and safety. The consumption of these products may pose potential health hazards to the consuming public.

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 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 supplements and 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 supplements and 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 8112 or 8105.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2019-101

/ In General Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-101 || Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Supplements and Food Products:

FDA Advisory No. 2019-100 || Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Products:

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

  1. MEIJI THE CHOCOLATE Matcha 58% Cacao
  2. RING POP Raspberry Flavour Hard Candy
  3. ESSENTIAL EVERYDAY Animal Crackers
  4. FRANKFORD WONDER BALL Milk Chocolate with Candy Inside
  5. MILKA NUSSINI

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 are prohibited.

Accordingly, since these 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 these products may pose potential health hazards to the consuming public.

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 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 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 8112 or 8105.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2019-100

FDA Advisory No. 2019-099 || Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Supplements:

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

  1. PIPINGROCK.COM Fertility Complex Dietary Supplement Capsules
  2. PIPINGROCK.COM Apple Cider Vinegar Capsule
  3. PIPINGROCK.COM Sea Kelp Dietary Supplement
  4. PIPINGROCK.COM Potassium plus Iodine Dietary Supplement
  5. PIPINGROCK.COM ULTIMATE CARB CONTROL White Kidney Bean Capsules
  6. SAM-SAMMI Pure Malunggay Powder Food Supplement

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 are prohibited.

Accordingly, since these 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 these products may pose potential health hazards to the consuming public.

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 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 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 8112 or 8105.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2019-099

FDA Advisory No. 2019-098 || Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Supplements:

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

  1. PIPINGROCK.COM Mega Strength L-Arginine HCI 1000 mg Dietary Supplement Caplet
  2. PIPINGROCK.COM Super Strength Water Pill Dietary Supplement Tablet
  3. PURITAN’S PRIDE Oil of Oregano Extract Dietary Supplement
  4. PURITAN’S PRIDE PREMIUM Zinc for Acne Dietary Supplement Tablet
  5. PMS Herbal Supplement with Collagen
  6. PIPINGROCK.COM Hydrolyzed Collagen 1000 mg Dietary Supplement Caplets

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 are prohibited.

Accordingly, since these 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 these products may pose potential health hazards to the consuming public.

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 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 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 8112 or 8105.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2019-098

FDA Advisory No. 2019-097 || Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Products and Supplements:

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

  1. RICE UP! Brown Rice Chips Cheese
  2. TANAKA Grilled Mirin Bonito
  3. MARUCHAN QTTA Seafood Ramen
  4. NATURE’S BLEND Omega-3 Fish Oil 1000 mg Dietary Supplement
  5. OLIE RENYUAN A Po Dou Chi
  6. HUAMASHI FOODSTUFF Silver Anchovy
  7. Fruit Cake (in foreign language)

FDA post-marketing surveillance (PMS) activities have verified that the abovementioned food products 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 are prohibited.

Accordingly, since these 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 these products may pose potential health hazards to the consuming public.

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 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 and 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 products 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 8112 or 8105.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2019-097

/ In General Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-097 || Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Products and Supplements:

FDA Advisory No. 2019-096 || Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Supplements:

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

  1. CERVIX CARE Food Supplement Capsules
  2. LIFE SOURCE Brain Power Plus Capsules
  3. GREENSPARK Cayenne Fat Burner Capsules
  4. TRENZ Purple Dave Strong Capsule
  5. TRENZ Purple Dave Detox Capsule
  6. TRENZ Gluta Camu Capsules

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 are prohibited.

Accordingly, since these 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 these products may pose potential health hazards to the consuming public.

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 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 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 8112 or 8105.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2019-096