Category: Cosmetic Advisories

FDA Advisory No. 2019-249 || Public Health Warning Against the Purchase and Use of the following Unnotified Toys and Child Care Articles (TCCAs):

The Food and Drug Administration (FDA) warns the public from purchasing and using the following Unnotified TCCAs:

  1. COLOR CLAY DIY PIZZA MANIA
  2. DISNEY PIXARS CARS SURPRISE EGG WITH SWEETS & SURPRISES
  3. ZAINI3 MILK CHOCOLATE EGGS WITH A 3D COLLECTION

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

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

Potential hazards may come from ingredients that are resticted or not allowed to be part of a TCCA product such as Phthalate and Bisphenol A. The use of substandard and possibly adulterated TCCA products may result to health risks including but not limited to endocrine disruption and reproductive or developmental effects in relation to exposure to these compounds.

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

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

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

Kindly contact the FDA Center for Cosmetics Regulation and Research through e-mail at [email protected], or call (02) 857-1900 loc. 8113 or 8107. To report any sale or distribution of unnotified TCCAs, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment-> : FDA Advisory No. 2019-249

FDA Advisory No. 2019-248 || Public Health Warning Against the Purchase and Use of the following Unnotified Toys and Child Care Articles (TCCAs):

The Food and Drug Administration (FDA) warns the public from purchasing and using the following Unnotified TCCAs:

  1. AQUATIC SUPER GOGGLES
  2. GREEN FOOTBALL ARM RING (NO. 1297-10)
  3. SWIMMING RING (SPONGEBOB)

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

Since these unnotified TCCA products have not gone through evaluation process of the FDA, the agency cannot assure their quality and safety. The use of such violative products may pose health risks to consumers. Potential hazards may come from ingredients that are resticted or not allowed to be part of a TCCA product such as Phthalate and Bisphenol A. The use of substandard and possibly adulterated TCCA products may result to health risks including but not limited to endocrine disruption and reproductive or developmental effects in relation to exposure to these compounds.

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

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

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

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

Kindly contact the FDA Center for Cosmetics Regulation and Research through e-mail at [email protected], or call (02) 857-1900 loc. 8113 or 8107.

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment-> : FDA Advisory No. 2019-248

FDA Advisory No. 2019-051-C || Lifting the Advisory of the Notified Cosmetic Product “YSA BOTANICA GREEN PAPAYA SOAP WITH WHITENING FORMULA SUITABLE FOR ACNE PRONE SKIN”under FDA Advisory No. 2019-051“Public Health Warning Against the Use of Unnotified Cosmetic Products(Batch 2)”Dated 27 February 2019

The Food and Drug Administration (FDA) informs the public that the below cosmetic product has been notified by the Market Authorization Holder (MAH), Healthwellnesslifestyle, Inc., in accordance to existing FDA rules and regulations:

YSA Botanica Green Papaya Soap with Whitening Formula Suitable for Acne Prone Skin -Notification No. 1000004891665

Accordingly, the list released in FDA Advisory No. 2019-051 is hereby updated to remove the aforementioned cosmetic product.

The public is advised to always check if a cosmetic product is notified with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing. Kindly contact the FDA Center for Cosmetics Regulation and Research through e-mail at [email protected], or call (02) 857-1900 loc. 8113 or 8117.

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

The public health warning imposed on the remaining products listed in FDA Advisory No. 2019-051 shall remain to be upheld and shall not be affected by the issuance of this advisory.

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment-> : FDA Advsisory No.2019-051-C

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-051-C || Lifting the Advisory of the Notified Cosmetic Product “YSA BOTANICA GREEN PAPAYA SOAP WITH WHITENING FORMULA SUITABLE FOR ACNE PRONE SKIN”under FDA Advisory No. 2019-051“Public Health Warning Against the Use of Unnotified Cosmetic Products(Batch 2)”Dated 27 February 2019

FDA Advisory No. 2019-205 || Public Health Warning Against the Purchase and Use of the following Unnotified Cosmetic Products:

The Food and Drug Administration (FDA) warns the public from purchasing and using the following unnotified cosmetic products:

  1. MAYBELLINE NEW YORK THE COLOSSAL GO EXTREME POWER (03)
  2. MAYBELLINE NEW YORK THE COLOSSAL GO EXTREME VOLUM MASCARA
  3. MAYBELLINE NEW YORK THE COLOSSAL GO EXTREME EYELINER
  4. LIP GLOSS MATTE, LIP GLOSS STAR (03)
  5. MORPHE EYELINER WATERPROOF

The FDA verified through post-marketing surveillance (PMS) that the abovementioned cosmetic products are not authorized and the Certificates of Product Notification have not been issued. 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.

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

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 Antimony (Sb) and Lead (Pb) especially in eye cosmetic products. Antimony (Sb) exposure can result to damages to the lung, heart muscle and liver. Symptoms of antimony toxicity includes skin irritation, headache, nausea, vomiting, insomnia and abdominal pain among others. Lead (Pb) exposure may cause anaemia, hypertension, renal impairement, immunotoxicity and toxicity to the reproductive organs.

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

All concerned establishments are warned not to distribute violative cosmetic products until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a Certificate of Product Notification (CPN) for the cosmetic product.

All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with Law Enforcement Agencies and Local Government Units, are requested to ensure that violative products are not sold or made available in the market or areas of jurisdiction.

Kindly contact the FDA Center for Cosmetics Regulation and Research through e-mail at [email protected] or call (02) 857-1900 local 8113 or 8107.

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment-> : FDA Advisory No.2019-205

FDA Advisory No. 2019-204 || Public Health Warning Against the Purchase and Use of the following Unnotified Cosmetic Products:

The Food and Drug Administration (FDA) warns the public from purchasing and using the following unnotified cosmetic products:

  1. POPA SMOOTH INTERNATIONAL WITH VITAMIN E POWDER FOUNDATION WITH UVA & UVB PROTECTION
  2. CHROMA CELLOSHINE TREATMENT CHOCO BROWN
  3. PEIYEN® LIPS TINT THE LURE OF LIP (01)
  4. WOW LONG LASTING LIP COLOR (LOVELY PEACH)
  5. EXCEK PARIS LONG LASTING 24 HOURS

The FDA verified through post-marketing surveillance (PMS) that the abovementioned cosmetic products are not authorized and the Certificates of Product Notification have not been issued. 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.

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

Potential hazards may come from ingredients that are not allowed to be part of a cosmetic product such as Rhodamine B or from the contamination of heavy metals such as Lead (Pb) especially in lip cosmetic products. Rhodamine B is a fluorescent dye used as a tracer in water and air flow studies and in molecular and cell biology studies. It presents as a red to violet powder and has been shown to be carcinogenic in mammalian models. Lead (Pb) exposure may cause anaemia, hypertension, renal impairement, immunotoxicity and toxicity to the reproductive organs.

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

All concerned establishments are warned not to distribute violative cosmetic products until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a Certificate of Product Notification (CPN) for the cosmetic product.

All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with Law Enforcement Agencies and Local Government Units, are requested to ensure that violative products are not sold or made available in the market or areas of jurisdiction.

Kindly contact the FDA Center for Cosmetics Regulation and Research through e-mail at [email protected] or call (02) 857-1900 local 8113 or 8107.

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment-> : FDA Advisory No.2019-204

FDA Advisory No. 2019-203 || Public Health Warning Against the Purchase and Use of the following Unnotified Cosmetic Products:

The Food and Drug Administration (FDA) warns the public from purchasing and using the following unnotified cosmetic products:

  1. SHINE SILK SALON EXPERT ADVANCED BIO-EXTENSEO CHOCOLATE KERATIN REPAIR THERAPY
  2. VERDON LIGHTNESS GREEN TEA KERATIN BLOW-OUT
  3. VERDON LIGHTNESS COCO KERATIN BLOW-OUT
  4. KOLIES FOOT BLUSH
  5. LADY QUEEN 24 COVER ALL LONG-WEAR FULL COVERAGE HIGHLIGHT AND CONTOUR (01)

The FDA verified through post-marketing surveillance (PMS) that the abovementioned cosmetic products are not authorized and the Certificates of Product Notification have not been issued. 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.

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

Potential hazards may come from hair-smoothing products containing formaldehyde. Formaldehyde have been associated with reactions such as eye problems, nervous system problems (headaches, and dizziness), respiratory tract problems, nausea, chest pain, vomiting and rash. Skin sensitivy can develop after repeated contact with formaldehyde-related ingredients.

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

All concerned establishments are warned not to distribute violative cosmetic products until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a Certificate of Product Notification (CPN) for the cosmetic product.

All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with Law Enforcement Agencies and Local Government Units, are requested to ensure that violative products are not sold or made available in the market or areas of jurisdiction.

Kindly contact the FDA Center for Cosmetics Regulation and Research through e-mail at [email protected] or call (02) 857-1900 local 8113 or 8107.

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment-> : FDA Advisory No.2019-203

FDA Advisory No. 2019-202 || Public Health Warning Against the Purchase and Use of the following Unnotified Cosmetic Products:

The Food and Drug Administration (FDA) warns the public from purchasing and using the following unnotified cosmetic products:

  1. MAGIC TOUCH SUPER STRAIGHT SEMI REBOND SUPER HAIR STRAIGHTENING
  2. USHAS HEAVY METAL FINGERTIP EYELINER (06)
  3. JIE GE® MATTE LONGLASTING LIPGLOSS
  4. LIDANXIU CORRECTOR DE OJERAS FOUNDATION
  5. XIAZHIMEI® CONCEALER NON-GREASY SUPER SILKY COVER (01)

The FDA verified through post-marketing surveillance (PMS) that the abovementioned cosmetic products are not authorized and the Certificates of Product Notification have not been issued. 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.

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

Potential hazards may come from ingredients that are not allowed to be part of a cosmetic product such as Rhodamine B or from the contamination of heavy metals such as Lead (Pb) and Antimony (Sb) especially in eye and lip cosmetic products, and from hair-smoothing products containing formaldehyde. Rhodamine B is a fluorescent dye used as a tracer in water and air flow studies and in molecular and cell biology studies. It presents as a red to violet powder and has been shown to be carcinogenic in mammalian models. Antimony (Sb) exposure can result to damages to the lung, heart muscle and liver. Symptoms of antimony toxicity includes skin irritation, headache, nausea, vomiting, insomnia and abdominal pain among others. Lead (Pb) exposure may cause anaemia, hypertension, renal impairement, immunotoxicity and toxicity to the reproductive organs. Formaldehyde have been associated with reactions such as eye problems, nervous system problems (headaches, and dizziness), respiratory tract problems, nausea, chest pain, vomiting and rash. Skin sensitivy can develop after repeated contact with formaldehyde-related ingredients.

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

All concerned establishments are warned not to distribute violative cosmetic products until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a Certificate of Product Notification (CPN) for the cosmetic product.

All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with Law Enforcement Agencies and Local Government Units, are requested to ensure that violative products are not sold or made available in the market or areas of jurisdiction.

Kindly contact the FDA Center for Cosmetics Regulation and Research through e-mail at [email protected] or call (02) 857-1900 local 8113 or 8107.

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment-> : FDA Advisory No.2019-202

FDA Advisory No. 2019-201 || Public Health Warning Against the Purchase and Use of the following Unnotified Cosmetic Products:

The Food and Drug Administration (FDA) warns the public from purchasing and using the following unnotified cosmetic products:

  1. HASAYA GIRL CONTOURING PALETTE CONTOUR (03)
  2. LIP AND CHEEK TINT PEACH
  3. LIP CHEEK TINT RED
  4. DARK RED OLD NO. 7 BRAND LIP AND CHEEK TINT
  5. M.A.G GENTA LIP AND CHEEK TINT

The FDA verified through post-marketing surveillance (PMS) that the abovementioned cosmetic products are not authorized and the Certificates of Product Notification have not been issued. 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.

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

Potential hazards may come from ingredients that are not allowed to be part of a cosmetic product such as Rhodamine B or from the contamination of heavy metals such as Lead (Pb) especially in lip cosmetic products. Rhodamine B is a fluorescent dye used as a tracer in water and air flow studies and in molecular and cell biology studies. It presents as a red to violet powder and has been shown to be carcinogenic in mammalian models. Lead (Pb) exposure may cause anaemia, hypertension, renal impairement, immunotoxicity and toxicity to the reproductive organs.

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

All concerned establishments are warned not to distribute violative cosmetic products until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a Certificate of Product Notification (CPN) for the cosmetic product.

All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with Law Enforcement Agencies and Local Government Units, are requested to ensure that violative products are not sold or made available in the market or areas of jurisdiction.

Kindly contact the FDA Center for Cosmetics Regulation and Research through e-mail at [email protected] or call (02) 857-1900 local 8113 or 8107.

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment-> : FDA Advisory No.2019-201

FDA Advisory No. 2019-200 || Public Health Warning Against the Purchase and Use of the following Unnotified Toys and Child Care Articles (TCCAs):

The Food and Drug Administration (FDA) warns the public from purchasing and using the following Unnotified Toys and Child Care Articles (TCCAs):

  1. BESTWAY DOLPHIN ARMBANDS
  2. SWIMMING AID/ARMBAND (HELLO KITTY DESIGN)
  3. WEI BRAND SWIM SET MASK/SNORKEL/DIVE STICK
  4. MIAOFENG TOY SWIM RING
  5. SAINTEVE® SWIM VEST

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

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

Potential hazards may come from ingredients that are restricted or not allowed to be part of a TCCA product such as Phthalate and Bisphenol A. The use of substandard and possibly adulterated TCCA products may result to health risks including but not limited to endocrine disruption and reproductive or developmental effects in relation to exposure to these compounds.

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

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

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

Kindly contact the FDA Center for Cosmetics Regulation and Research through e-mail at [email protected], or call (02) 857-1900 loc. 8113 or 8107.

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment-> : FDA Advisory No.2019-200

FDA Advisory No. 2019-199 || Public Health Warning Against the Purchase and Use of the following Unnotified Toys and Child Care Articles (TCCAs):

The Food and Drug Administration (FDA) warns the public from purchasing and using the following Unnotified TCCAs:

  1. CHILD CARE WATER FILLED SILICONE TEETHER
  2. CHILD CARE FEEDING BOTTLE
  3. XIMIVOUGE FEEDING BOTTLE EXPLOSION-PROOF
  4. CHICCO FRESH RELAX TEETHING RING

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

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

Potential hazards may come from ingredients that are resticted or not allowed to be part of a TCCA product such as Phthalate and Bisphenol A. The use of substandard and possibly adulterated TCCA products may result to health risks including but not limited to endocrine disruption and reproductive or developmental effects in relation to exposure to these compounds.

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

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

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

Kindly contact the FDA Center for Cosmetics Regulation and Research through e-mail at [email protected], or call (02) 857-1900 loc. 8113 or 8107.

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment-> : FDA Advisory No.2019-199

FDA Advisory No. 2019-182 || UNSAFE USE OF GLUTATHIONE AS SKIN LIGHTENING AGENT

The Food and Drug Administration (FDA) warns the public on the dangers associated with the use of injectable lightening agents such as glutathione.

In the Philippines, several health and beauty salons, wellness spa and beauty clinics are offering all kinds of beauty enhancements, services and skin treatments. It is alarming that they also offer services such as intravenous drip or infusion using skin lightening agents including reduced glutathione, vitamin C and other injections.

To date there are no published clinical trials that have evaluated the use of injectable glutathione for skin lightening. There are also no published guidelines for appropriate dosing regimens and duration of treatment. The FDA has not approved any injectable products for skin lightening. Injectable glutathione is approved by FDA Philippines as an adjunct treatment in cisplatin chemotherapy.

Side effects on the use of injectable glutathione for skin lightening include toxic effects on the liver, kidneys, and nervous system. Also of concern is the possibility of Stevens Johnson Syndrome. Injectable glutathione is sometimes paired with intravenous Vitamin C. Vitamin C injection may form kidney stones if the urine is acidic. Large doses of Vitamin C have resulted in hemodialysis in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency.

Given that glutathione affects the production of melanin (the pigment that gives the human skin, hair and eyes their color) — there are theoretical concerns about the long term skin cancer risk.

Other potential risks include transmission of infectious agents, such as HIV, hepatitis C and B. This is of particular concern when non-medical practitioner administers this treatment or done in a non-sterile facility.

To assure that your skin conditions are treated, consult only a board-certified dermatologist. Avoid buying injectable products online and from being lured to a promising effect of medicines as beauty products.

Seek medical attention immediately if you experience any side effects and report it to FDA at [email protected] or via online reporting through our website: www.fda.gov.ph. You may also call the Center for Drug Regulation and Research at telephone number (02) 809-5596.

FDA Advisory No.2019-182

FDA Advisory No. 2019-173 || Public Health Warning Against the Purchase and Use of the following Unnotified Cosmetic Products:

The Food and Drug Administration (FDA) warns the public from purchasing and using the following unnotified cosmetic products:

  1. CHANLEEVI WHITENING LOTION MOIST SKINCARE NATURAL EXTRACT MILK AND ROSE ESSENCE
  2. MA·C A MERMAID MOMENT POWDER BLUSH (ROUGE 06)
  3. ZD® 3 COLOR EYEBROW PALETTE (04)
  4. NAKED URBAN DECAY 6 COLOR CONCEALER PROFESSIONAL MAKEUP (SHADE 03)
  5. 16 BRAND BY CHOSUNGAH SIXTEEN BRAND 16 EYE MAGAZINE EVERYDAY

The FDA verified through post-marketing surveillance (PMS) that the abovementioned cosmetic products are not authorized and the Certificates of Product Notification have not been issued. 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.

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

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

All concerned establishments are warned not to distribute violative cosmetic products until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a Certificate of Product Notification (CPN) for the cosmetic product.

All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with Law Enforcement Agencies and Local Government Units, are requested to ensure that violative products are not sold or made available in the market or areas of jurisdiction.

Kindly contact the FDA Center for Cosmetics Regulation and Research through e-mail at [email protected] or call (02) 857-1900 local 8113 or 8107.

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

Dissemination of this advisory to all concerned is hereby requested.

FDA Advisory No.2019-173

FDA Advisory No. 2019-172 || Public Health Warning Against the Purchase and Use of the following Unnotified Cosmetic Products:

The Food and Drug Administration (FDA) warns the public from purchasing and using the following unnotified cosmetic products:

  1. GLUTA KOJIC ACID DOUBLE WHITENING +
  2. PINK BLUSH SKIN ESSENTIALS REJUVENATING SET:
  • REJUVENATING CREAM
  • SUNBLOCK PINK CREAM SPF 30
  • REJUVENATING TONER
  • KOJIC ACID SOAP

The FDA verified through post-marketing surveillance (PMS) that the abovementioned cosmetic products are not authorized and the Certificates of Product Notification have not been issued. 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.

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

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

All concerned establishments are warned not to distribute violative cosmetic products until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a Certificate of Product Notification (CPN) for the cosmetic product.

All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with Law Enforcement Agencies and Local Government Units, are requested to ensure that violative products are not sold or made available in the market or areas of jurisdiction.

Kindly contact the FDA Center for Cosmetics Regulation and Research through e-mail at [email protected] or call (02) 857-1900 local 8113 or 8107.

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

Dissemination of this advisory to all concerned is hereby requested.

FDA Advisory No.2019-172

FDA Advisory No. 2019-171 || Public Health Warning Against the Purchase and Use of the following Unnotified Cosmetic Products:

The Food and Drug Administration (FDA) warns the public from purchasing and using the following unnotified cosmetic products:

  1. PROFESSIONAL SKIN CARE FORMULA® BY DR. ALVIN KOJIC ACID SOAP
  2. MAGIC POTIONS WHITE ALLURE AGE DEFYING DIMINISHING MOUSSE CREAM
  3. WHITE ALLURE MICRODERMABRASION WITH ARGAN OIL
  4. BEAUOXIWHITE DAY AND NIGHT SERUM ANTI-AGING FORMULA
  5. 7 SELECT™ ANTI BACTERIAL WIPES

The FDA verified through post-marketing surveillance (PMS) that the abovementioned cosmetic products are not authorized and the Certificates of Product Notification have not been issued. 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.

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

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

All concerned establishments are warned not to distribute violative cosmetic products until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a Certificate of Product Notification (CPN) for the cosmetic product.

All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with Law Enforcement Agencies and Local Government Units, are requested to ensure that violative products are not sold or made available in the market or areas of jurisdiction.

Kindly contact the FDA Center for Cosmetics Regulation and Research through e-mail at [email protected] or call (02) 857-1900 local 8113 or 8107.

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment-> : FDA Advisory No.2019-171

FDA Advisory No. 2019-051-B || Lifting the Advisory of the following Notified Cosmetic Products under FDA Advisory No. 2019-051 “Public Health Warning Against the Use of Unnotified Cosmetic Products (Batch 2)” Dated 27 February 2019

The Food and Drug Administration (FDA) informs the public that the following cosmetic products have been notified by the Market Authorization Holder (MAH), Jaoming Marketing Corp., in accordance to existing FDA rules and regulations:

1. Erase® Whitening Deodorant –     Notification No. 1000015244320
2. Gluta® By Erase Whitening Facial Cleanser with Korean Ginseng and Tawas –     Notification No. 1000004397701
3. Gluta® By Erase Whitening Lotion with Kojic Acid & Moringa Extract –     Notification No. 1000001923286
4. Gluta® By Erase Whitening Lotion with Korean Ginseng & Vitamin E –     Notification No. 1000002845309

Accordingly, the list released in FDA Advisory No. 2019-051 is hereby updated to remove the aforementioned cosmetic products.

The public is advised to always check if a cosmetic product is notified with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing. Kindly contact the FDA Center for Cosmetics Regulation and Research through e-mail at [email protected], or call (02) 857-1900 loc. 8113 or 8117.

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

The public health warning imposed on the remaining products listed in FDA Advisory No. 2019-051 shall remain to be upheld and shall not be affected by the issuance of this advisory.

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment-> : FDA Advisory No.2019-051-B

Please see FDA Advisory No. 2019-051 for your reference.

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-051-B || Lifting the Advisory of the following Notified Cosmetic Products under FDA Advisory No. 2019-051 “Public Health Warning Against the Use of Unnotified Cosmetic Products (Batch 2)” Dated 27 February 2019

FDA Advisory No. 2019-051-A || Lifting the Advisory of the following Notified Cosmetic Products under FDA Advisory No. 2019-051 “Public Health Warning Against the Use of Unnotified Cosmetic Products (Batch 2)” Dated 27 February 2019

The Food and Drug Administration (FDA) informs the public that the following cosmetic products have been notified by the Market Authorization Holder (MAH), Jaoming Marketing Corp., in accordance to existing FDA rules and regulations:

  1. Gluta® By Erase Whitening Facial Cleanser with Oil Control
–     Notification No. 1000003008486
2.  Erase® Organics Whitening Serum –     Notification No. 1000002576494
3. Erase Plantcenta Soap with Shea Butter –     Notification No. 1000001885357
4. Erase® Blackout Sunblock Lotion –     Notification No. 1000001591591
5. Erase® Sunblock Cream –     Notification No. 1000002829703

Accordingly, the list released in FDA Advisory No. 2019-051 is hereby updated to remove the aforementioned cosmetic products.

The public is advised to always check if a cosmetic product is notified with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing. Kindly contact the FDA Center for Cosmetics Regulation and Research through e-mail at [email protected], or call (02) 857-1900 loc. 8113 or 8117.

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

The public health warning imposed on the remaining products listed in FDA Advisory No. 2019-051 shall remain to be upheld and shall not be affected by the issuance of this advisory.

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

Dissemination of this advisory to all concerned is hereby requested.

Attachment:>FDA Advisory No.2019-051-A

Please see FDA Advisory No. 2019-051 for your reference.

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-051-A || Lifting the Advisory of the following Notified Cosmetic Products under FDA Advisory No. 2019-051 “Public Health Warning Against the Use of Unnotified Cosmetic Products (Batch 2)” Dated 27 February 2019

FDA Advisory No. 2019-143 || Dissemination of ASEAN Post-Marketing Alert System(PMAS) Report on Adulterated Cosmetic Products with Reference No. 1007/702 (07 March 2019), 1004.03./983(19 March 2019)

to continue reading, click the attachment below…

FDA Advisory No. 2019-143

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-143 || Dissemination of ASEAN Post-Marketing Alert System(PMAS) Report on Adulterated Cosmetic Products with Reference No. 1007/702 (07 March 2019), 1004.03./983(19 March 2019)

FDA Advisory No. 2019-142 || Public Health Warning Against the Purchase and Use of Counterfeit Cosmetic Products (Batch 9)

The Food and Drug Administration (FDA) hereby advises the public against the purchase and use of POND’S PURE WHITE MINERAL CLAY MASK D-TOXX TREATMENT:

FDA, in coordination with the Market Authorization Holder (MAH), Unilever Philippines, Inc., has verified that the aforementioned cosmetic product is COUNTERFEIT. According to the MAH, prior to distribution of all imported cosmetic products in the local market, the company revises the product label in compliance to FDA and ASEAN Cosmetic Labeling Requirements.

Counterfeit products, not having gone through the required safety assessment and the verification process of the FDA, pose potential health hazards to the consuming public since their safety and purity cannot be guaranteed. The dangers/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 lead and mercury. 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 to be vigilant against buying and using the aforementioned counterfeit cosmetic product. 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 product, otherwise, regulatory actions and sanctions shall be strictly pursued.

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

To report any suspicious and/or illegal activity involving the said product, 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. 2019-142

FDA Advisory No. 2019-141 || Dissemination of ASEAN Post-Marketing Alert System (PMAS) Report on Adulterated Cosmetic Products With Reference No. 8-9/2019/K

The Food and Drug Administration (FDA) hereby issues this public health warning to inform the public on the report from ASEAN Post-Marketing Alert System (PMAS) on the following Cosmetic Products which are found to contain DIPHENHYDRAMINE:

BRAND / PRODUCT NAME

1. Bao Fu Ling Snow Lotus Cream 15g
2. Bao Fu Ling Skincare Cream

*Attached is a copy of the Malaysia PMAS Report with Reference No. 8-9/2019/K

The aforementioned products have been tested by the National Pharmaceutical Regulatory Agency, Ministry of Health, Malaysia as part of their post-marketing surveillance activities and results of the laboratory analyses show that these products are not compliant with the technical standards set forth by the ASEAN Cosmetic Directive (ACD).

The aforementioned products were found to contain Diphenhydramine, an antihistamine that is not allowed to be part of a cosmetic product based on the ACD. Adverse effects associated with topical application of Diphenhydramine include mild stinging, allergic reactions such as rash, hives, itching, swelling of the mouth, face, lips, tongue, or throat, and skin irritation. Side effects common to all antihistamines include nausea, dizziness, anxiety, dry mouth, blurred vision, difficulty urinating, and constipation.

Because of the hazards posed by the aforementioned products, the public is strongly advised to be vigilant and report to FDA, through any of the following channels, any encounter with these products:

  1. Send an e-mail via [email protected]
  2. Call the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 857-1900 local 8107 or 8113
  3. Utilize the agency’s online reporting facility, Report, at www2.fda.gov.ph/ereport.

Civic Drive, Filinvest City, Alabang 1781 Muntinlupa, Philippines Trunk Line +63 2 857 1900 Fax +63 2 8070751 Website: www.fda.gov.ph Email: [email protected]

Furthermore, the public is also advised to only buy cosmetic products that have been notified with FDA. If unsure of a product’s notification status, consumers may verify whether the product is authorized by FDA through the Search engine embedded in the FDA website accessible at www2.fda.gov.ph. For more information and inquiries, please e-mail us at [email protected] or call the CCRR hotline.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2019-141

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-141 || Dissemination of ASEAN Post-Marketing Alert System (PMAS) Report on Adulterated Cosmetic Products With Reference No. 8-9/2019/K

FDA Advisory No. 2019-140 || Dissemination of ASEAN Post-Marketing Alert System (PMAS) Report on Adulterated Cosmetic Products With Reference No. (12)/MOH/DPS/PMAS/05/2019

The Food and Drug Administration (FDA) hereby issues this public health warning to inform the public on the report from ASEAN Post-Marketing Alert System (PMAS) on the following Cosmetic Products which were found to contain MERCURY:

BRAND / PRODUCT NAME

1. Glow Skin White French Technology Smart Pack — Whitening Cleanser

2. Glow Skin White French Technology Smart Pack — Whitening Cream
3. Glow Skin White French Technology Smart Pack — SPF 50 Cream

*Attached is a copy of the Brunei PMAS Report with Reference No. (12)/MOH/DPS/PMAS/05/2019

The aforementioned products have been tested by the Department of Pharmaceutical Services, Ministry of Health, Brunei Darussalam as part of their post-marketing surveillance activities and results of the laboratory analyses show that these products are not compliant with the technical standards set forth by the ASEAN Cosmetic Directive (ACD).

The aforementioned products have been verified to contain Mercury, a naturally occuring heavy metal which is known to be severely hazardous to health even in small amount. People exposed to mercury exhibits symptoms including but not limited to tremors, numbness and tingling in hands and feet, gingivitis or inflammation of the gums, pink discolouration of the hands and feet especially in children, irritability, and photophobia or sensitivity to light. Nursing mothers are doubly vulnerable because mercury are passed on to nursing babies through breast milk which can affect the baby’s development.

Because of the hazards posed by the aforementioned products, the public is strongly advised to be vigilant and report to FDA, through any of the following channels, any encounter with these products:

  1. Send an e-mail via [email protected]
  2. Call the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 857-1900 local 8107 or 8113
  3. Utilize the agency’s online reporting facility, eReport, at www2.fda.gov.ph/ereport.

Civic Drive, Filinvest City, Alabang 1781 Muntinlupa, Philippines Trunk Line +63 2 857 1900 Fax +63 28070751 Website: www.fda.gov.ph Email: [email protected]

Furthermore, the public is also advised to only buy cosmetic products that have been notified with FDA. If unsure of a product’s notification status, consumers may verify whether the product is authorized by FDA through the Search engine embedded in the FDA website accessible at www2.fda.gov.ph. For more information and inquiries, please e-mail us at [email protected] or call the CCRR hotline.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2019-140

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-140 || Dissemination of ASEAN Post-Marketing Alert System (PMAS) Report on Adulterated Cosmetic Products With Reference No. (12)/MOH/DPS/PMAS/05/2019