Category: Cosmetic Advisories

FDA Advisory No. 2019-346-A || Lifting the Advisory of the Notified Cosmetic Product “SUNBRIGHT SERIES KERATIN & COLLAGEN HAIR COLOR 9.91 (SILVER ASH)” under FDA Advisory No. 2019-346 “Public Health Warning Against the Purchase and Use of Unnotified Cosmetic Products” Dated 09 October 2019

The Food and Drug Administration (FDA) informs the public that the cosmetic product Sunbright Series Keratin & Collagen Hair Color 9.91 (Silver Ash) with Notification No.  1000002547393 and has been notified by the Market Authorization Holder (MAH), Elegant Fumes Beauty Products, Inc., in accordance with the existing FDA rules and regulations.

Accordingly, the list released in FDA Advisory No. 2019-346 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. 2019-346 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.2019-346-A

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-346-A || Lifting the Advisory of the Notified Cosmetic Product “SUNBRIGHT SERIES KERATIN & COLLAGEN HAIR COLOR 9.91 (SILVER ASH)” under FDA Advisory No. 2019-346 “Public Health Warning Against the Purchase and Use of Unnotified Cosmetic Products” Dated 09 October 2019

FDA Advisory No. 2019-517 || Public Health Warning Against the Purchase and Use of the following Unregistered Household Urban Pesticides:

The Food and Drug Administration (FDA) warns the public from purchasing and using the following unregistered household urban pesticides:

  1. PIF PAF LIQUID MOSQUITO KILLER
  2. BEN KILL RAT BAIT
  3. BYE BYETM MOSQUITO STICKER
  4. YUANMENG READ A DREAM FLY REPELLENT INCENSE
  5. COBRA FLY ERADICATION

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

Since these unregistered household urban pesticide 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 harmful, toxic and banned active ingredients that pose imminent danger to human and animal health. The use of substandard and possibly adulterated household/urban pesticide products may result to adverse reactions such as skin irritation, itchiness, anaphylactic shock, respiratory disorders, endocrine complications, brain damage 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 household urban pesticide is registered with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing.

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

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 unregistered household urban pesticide, 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.2019-517

FDA Advisory No. 2019-516 || Public Health Warning Against the Purchase and Use of the following Unregistered Household Urban Pesticides:

The Food and Drug Administration (FDA) warns the public from purchasing and using the following unregistered household urban pesticides:

  1. MAPECON TOTAL INSECT KILLER WITH BIG-R SPRAY
  2. MIE HAI LING AEROSOL INSECTICIDE

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

Since these unregistered household urban pesticide 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 harmful, toxic and banned active ingredients that pose imminent danger to human and animal health. The use of substandard and possibly adulterated household/urban pesticide products may result to adverse reactions such as skin irritation, itchiness, anaphylactic shock, respiratory disorders, endocrine complications, brain damage 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 household urban pesticide is registered with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing.

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

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 unregistered household urban pesticide, 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.2019-516

FDA Advisory No. 2019-249-A || Lifting the Advisory of the Notified Toys and Child Care Articles (TCCA) “DISNEY PIXAR CARS SURPRISE EGGS WITH SWEETS & SURPRISES” under FDA Advisory No. 2019-249 “Public Health Warning Against The Purchase and Use of Unnotified TCCA products Dated 16 August 2019

The Food and Drug Administration (FDA) informs the public that the Toys and Child Care Article (TCCA) product Disney Pixar Cars Surprise Eggs with Sweets & Surprises with Notification No. TC-5000005535797, has been notified by the Market Authorization Holder (MAH), Resourceful International Marketing, Inc., in accordance to existing FDA rules and regulations.

Accordingly, the list released in FDA Advisory No. 2019-249 is hereby updated to remove the aforementioned Toys and Child Care Articles (TCCAs).

The public is advised to always check if a TCCA 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. 2019-249 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.2019-249-A
Please see FDA Advisory No. 2019-249 for your reference.

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-249-A || Lifting the Advisory of the Notified Toys and Child Care Articles (TCCA) “DISNEY PIXAR CARS SURPRISE EGGS WITH SWEETS & SURPRISES” under FDA Advisory No. 2019-249 “Public Health Warning Against The Purchase and Use of Unnotified TCCA products Dated 16 August 2019

FDA Advisory No. 2019-502 || Public Health Warning Against the Purchase and Use of the following Unregistered Household Urban Pesticides:

The Food and Drug Administration (FDA) warns the public from purchasing and using the following unregistered household urban pesticides:

  1. TEMOX MULTI-INSECT KILLER LIQUID
  2. GREEN LEAF POWDER COCKROACH KILLING BAIT
  3. GUARD INSECT REPELLENT LIQUID SPRAY

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

Since the unregistered household urban pesticides 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 harmful, toxic and banned active ingredients that pose imminent danger to human and animal health. The use of substandard and possibly adulterated household/urban pesticide products may result to adverse reactions such as skin irritation, itchiness, anaphylactic shock, respiratory disorders, endocrine complications, brain damage 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 household urban pesticide is registered with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing.

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

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 unregistered household urban pesticide, 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.2019-502

FDA Advisory No. 2019-501 || Gentle reminder for all physicians connected with public hospitals pertaining to DOH-CSC Joint Memorandum Circular 2910-01 and urging them to avoid all interaction with the tobacco/e-cigarette industry

The Food and Drug Administration (FDA) informs heads of hospitals that e-cigarette companies are currently engaging physicians, from both the public and private sector, in an attempt to recruit them in disinformation campaigns that promote electronic cigarette use as viable harm reduction options. Please understand that e–cigarettes (electronic nicotine and non-nicotine delivery systems, heated tobacco products, and hybridizations and modifications thereof) have been proven to introduce new risks above and over those already present in traditional combustible cigarettes. Both reduced exposure and reduced risk claims in favor of e-cigarettes have been debunked, leading to a call from the American Medical Association to BAN these products until approved and regulated by the US FDA.

In addition, these products have been demonstrated to be gateway options for subsequent tobacco and illicit drug use, especially for the youth, blunting any purported public health benefit from e-cigarette implementations compliant with the relevant public health standards.

In compliance with DOH-CSC Joint Memorandum Circular 2010-01, please advise all physicians, especially in the rank of Medical Officer, Medical Specialist, and Scientist, to DENY ALL requests to engage with the tobacco industry. Such engagements are inimical to the concord of medicine and public health, and reflect poorly on our commitment to protect the Filipino people from harm.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2019-501

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-501 || Gentle reminder for all physicians connected with public hospitals pertaining to DOH-CSC Joint Memorandum Circular 2910-01 and urging them to avoid all interaction with the tobacco/e-cigarette industry

FDA Advisory No. 2019-500 || Updated contact information for DOH surveillance injuries and illness arising from the use of electronic nicotine and non-nicotine delivery systems (ENDS/ENNDS)

The Food and Drug Administration (FDA) informs heads of hospitals that all DOH-retained hospitals shall report all probable and confirmed cases of Electronic Cigarette or Vaping Product-Associated Lung Injury (EVALI) to [email protected].

To capture all the necessary epidemiologic and clinical data, please complete the EVALI case report form enclosed in this advisory.

Private hospitals and public hospitals not retained by the DOH are likewise strongly encouraged to use the same reporting tools to standardize case reporting communication processes.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2019-500

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-500 || Updated contact information for DOH surveillance injuries and illness arising from the use of electronic nicotine and non-nicotine delivery systems (ENDS/ENNDS)

FDA Advisory No. 2019-486 || CONSUMER INFORMATION ON THE PURCHASE AND USE OF TOYS AND CHILD CARE ARTICLES (TCCA) DURING HOLIDAY SEASON

The Food and Drug Administration (FDA) is reminding the general public, especially the parents, to be more careful and vigilant in buying Toys and Child Care Articles (TCCAs) during the holiday season as these products are often purchased as Christmas gifts for children.

Pursuant to the Implementing Rules and Regulation of Republic Act 10620, otherwise known as “Toy and Game Safety Labeling Act of 2013” Title II sec.1, the following information shall appear on the package, container, wrapper or protective covering to guide consumers on how to use a toy, what ages the toy is safe for and to know how to use the toy in the right way: (See attached infographics for easy reference)

  1. License to Operate number issued by FDA
  2. Age grading
  3. Cautionary Statement/Warnings
  4. Instructional Literature
  5. Manufacturer’s markings (name and address of the local company)
  6. Item Model / Stock Keeping Unit (SKU) number

Failure to declare the above labeling information is considered as misbranded or banned hazardous substances and shall not be allowed to be distributed or sold in the market.

Further, consumers are encouraged to check the website (https://ww2.fda.gov.ph/index.php/consumers-corner/toys-and-childcare-artiles-notification) for the list of notified TCCA products for information on toy safety and to purchase only notified Toys and Child Care Articles (TCCAs) distributed by FDA licensed manufacturer/trader/distributor.

For more information or clarification, kindly email us at [email protected].

Attachment:-> FDA Advisory No.2019-486

FDA Advisory No. 2019-473 || 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. NIVEA® CRÈME SMOOTH BODY WASH SHEA BUTTER
  2. TEAL’S® PINK HIMALAYAN FOAMING BATH
  3. WHITE BODY ALL SKIN DEEP SEA MUD NATURAL
  4. MUZ WHITENING PLUS FACIAL SHEET MASK WHITENING + COLLAGEN
  5. MEDIHEAL W.H.P. WHITE HYDRATING BLACK MASK EX

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 as listed in the Annex II, Part I of the ASEAN Cosmetic Directive (ACD). 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.2019-473

FDA Advisory No. 2019-453 || 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. MISTINE NATURAL MUD FACIAL MASK
  2. NEXXUS® NEW YORK SALON CARE PROMEND SPLIT END REPAIRING SYSTEM FLAX SEED OIL SHAMPOO
  3. SCALPKLENS ANTI-DANDRUFF SHAMPOO HAIR CLEANSING TREATMENT
  4. 3W CLINIC FRESH COENZYME Q1 MASK SHEET

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 as listed in the Annex II, Part I of the ASEAN Cosmetic Directive (ACD). 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. 2019-453

FDA Advisory No. 2019-452 || 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 cosmetic following unnotified cosmetic products:

  1. VERY FASHION VERDON SERIES COFFEE HAIR REBOND PRO-HERBAL FORMULA (1)
  2. VERY FASHION VERDON SERIES COFFEE HAIR REBOND PRO-HERBAL FORMULA (2)
  3. VERDON®  NE SILKY ARGAN OIL KERATIN CARE REBONDING (2)
  4. FASHIONNATE VERDON NE SILKY SERIES KERA,TIN AVOCADO REBONDING FOR PROFESSIONAL USE ONLY
  5. VERDON®  NE SILKY NATURAL ORCANIC 1 MINUTE KERATIN BLOW OUT HAIR SPA TREATMENT

The FDA verified though 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 ofthe 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 as listed in the Annex II, Part I of the ASEAN Cosmetic Directive (ACD). 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 puchasing.

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. 2019-452.

FDA Advisory No. 2018-327-E || Lifting the Advisory of the Notified Cosmetic Product “DROPLETS OF NATURE KOJIC ACID LOTION” under FDA Advisory No. 2018-327 “Public Health Warning Against the Use of Unnotified Cosmetic Products (Batch 16)” Dated 07 December 2019

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

Droplets of Nature Kojic Acid Lotion with SPF                –Notification No. 1000001861278

Accordingly, the list released in FDA Advisory No. 2018-327 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. 2018-327 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.2018-327-E

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2018-327-E || Lifting the Advisory of the Notified Cosmetic Product “DROPLETS OF NATURE KOJIC ACID LOTION” under FDA Advisory No. 2018-327 “Public Health Warning Against the Use of Unnotified Cosmetic Products (Batch 16)” Dated 07 December 2019

FDA Advisory No. 2019-394 || U.S. Food and Drug Administration (USFDA) Safety Alert on Certain Cosmetic Products that Tested Positive for Asbestos

Last October 18, 2019, the U.S. Food and Drug Administration (USFDA) has issued a safety alert warning for consumers not to use certain cosmetic products that tested positive for asbestos. Accordingly, a voluntary recall was undertaken by Johnson and Johnson Consumer Inc. (JJIC) for Johnson’s Baby Powder solely in the United States, relative to a single batch of products (lot #22318RB), as a precautionary move. This was in response to USFDA test indicating the presence of trace levels of chrysotile asbestos contamination in a sample taken from a single bottle purchased from an online retailer. Another sample from another lot of the product, tested negative for asbestos. The Philippine Food and Drug Administration (FDA) was informed by the company that the aforementioned lot number was only distributed in the United States and that further investigation is on-going regarding the tests and results conducted. The recall does not affect Johnson’s Baby Powder in markets outside of the U.S.A., including the Philippines.

Talc, otherwise known as talcum or hydrated magnesium silicate, is a naturally occurring mineral mined from the earth used in the manufacture of plastics, ceramics, paint, paper, roofing materials and other consumer products like cosmetics. It is allowed for use as an ingredient under the ASEAN Cosmetic Directive (ACD) and European Union (EU) Cosmetic Regulation. Cosmetic-grade talc must not contain contaminants such as asbestos, a prohibited substance under the ACD. Cosmetic-grade talc is generally regarded to be a safe ingredient in cosmetic products worldwide.

Cosmetic products which are sold or supplied in the ASEAN countries must comply with the applicable prohibitions or restrictions on cosmetic ingredients as well as product labeling stipulated under the ACD which has been adopted by all the ASEAN Member States.

At present, talcum powders used in children must be labeled with a warning that states “Keep powder away from children’s nose and mouth” to avoid inhalation. This is in line with the product labeling requirements in the EU and Canada.

Accordingly, to protect the public health and safety, Philippine FDA will undertake the following public health interventions:

  1. Conduct audit/inspection to check the product information file (PIF) of cosmetic product manufacturers, traders, distributor/importers and distributor/wholesalers to provide proof/certifications of asbestos-free products including laboratory test results that are sold in the market.
  2. Intensify post-marketing surveillance for talc-containing cosmetic powders (e.g. loose powder) in the market including laboratory tests when necessary.
  3. Implement the ASEAN Cosmetic Directive (ACD), adopted and implemented through the issuance of Administrative Orders 2005-0015 and 2005-0025, which required product owners or local companies placing talc-containing cosmetic powders intended to be used for children under three (3) years of age in the market to indicate a warning in the product label — “keep powder away from children’s nose and mouth.”
  4. Advise the general public to use cosmetic products in accordance with the written instructions/directions for use found in the immediate and/or secondary packaging label.

Dissemination of the information to all concerned is requested.

Attachment:-> FDA Advisory No. 2019-394

FDA Advisory No. 2019-392 || 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. TIFANNY CLAIRE’S CONCEAL INSTANT GRAY HAIR TOUCH-UP SOLUTION (DARK MOCHA BROWN)
  2. SALLY HANSEN EXTRA STRENGTH EXTRA FAST NAIL POLISH REMOVER WITH VITAMIN E
  3. ANDREA SECRET CAT WINK (3)
  4. KAXIER BB EFFECTIVE GENTLE BB CREAM (04)
  5. MEIYA HAND AND BODY LOTION PAPAYA WITH SPF 30+ (ME-5081)

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 as listed in the Annex II, Part I of the ASEAN Cosmetic Directive (ACD), and from the contamination of heavy metals such as Mercury (Hg), Lead (Pb) and Antimony (Sb) especially in eye and face 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. Mercury salts in cosmetic products inhibits the formation of skin melanin which will result to lighter skin tone. Adverse health effects brought about by highly toxic mercury in cosmetics products include kidney damage, skin rashes, skin discoloration and scarring. Chronic use reduces the skin’s normal resistance against bacterial and fungal infections. Other effects include anxiety, depression or psychosis and peripheral neuropathy. The transfer of mercury to fetuses of pregnant women may manifest as neurodevelopment deficits later in life.

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. 2019-392

FDA Advisory No. 2019-391 || 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. LITTLE PALS UNSCENTED SOFT BABY WIPES ENRICHED WITH ALOE VERA
  2. ACT® KIDS ANTICAVITY FLUORIDE RINSE OCEAN BERRY®
  3. VICTORIA’S SECRET FRAGRANCE OIL ELECTRIC BEACH
  4. MARCUS STYLING GEL STRONG HOLD
  5. JOHNSON’S® BE FRESH & RETREAT SHOWER GEL WITH PINEAPPLE & LILY AROMA

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 as listed in the Annex II, Part I of the ASEAN Cosmetic Directive (ACD). 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. 2019-391

FDA Advisory No. 2018-214-A || Lifting the Advisory of the Notified Cosmetic Product “ROYALE BEAUTY L-GLUTA POWER SOAP WITH GLUTATHIONE, ALPHA ARBUTIN, COLLAGEN & SHEA BUTTER” under FDA Advisory No. 2018-214 “Public Health Warning Against the Use of Unnotified Cosmetic Products (Batch 11)” Dated 02 July 2018

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

Royale Beauty L-Gluta Power Soap with Glutathione, Alpha Arbutin, Collagen & Shea Butter
  • Notification No. 1000003604525

Accordingly, the list released in FDA Advisory No. 2018-214 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. 2018-214 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. 2018-214-A

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2018-214-A || Lifting the Advisory of the Notified Cosmetic Product “ROYALE BEAUTY L-GLUTA POWER SOAP WITH GLUTATHIONE, ALPHA ARBUTIN, COLLAGEN & SHEA BUTTER” under FDA Advisory No. 2018-214 “Public Health Warning Against the Use of Unnotified Cosmetic Products (Batch 11)” Dated 02 July 2018

FDA Advisory No. 2019-356 || 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. AS ANDREA SECRET SMOOTH CREAM BLUSHER (3)
  2. AS ASHLEY SHINE LIPSTICK (#9)
  3. FRESH HANDMADE COSMETICS MINT JULIPS LIP SCRUB LUSH
  4. SHAWILL MAKE-UP SHINY COLOR LIP GLOSS (004)
  5. SHAWILL MAKE-UP PREMIUM MINERAL MATTE LIPGLOSS (5)

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. 2019-356

FDA Advisory No. 2019-355 || 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. THE RETRO HEALING BENTONITE CLAY SOAP
  2. M CALAMANSI SOAP
  3. ELITE SKIN INTERNATIONAL KOJIC SOAP
  4. 3W CLINIC CHARCOAL SOAP
  5. BUMEBIME MASK NATURAL 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 as listed in the Annex II, Part 1 of the ASEAN Cosmetic Directive (ACD). 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. 2019-355

FDA Advisory No. 2019-354 || Public Health Warning Against the Purchase and Use of Counterfeit Cosmetic Product “VAGISIL® DAILY INTIMATE WASH PH BALANCE”

The Food and Drug Administration (FDA) warns the public from purchasing and using the below counterfeit cosmetic product:

  1. VAGISIL® DAILY INTIMATE WASH PH BALANCE

The FDA has coordinated with the Market Authorization Holder (MAH), MYIMPORT, Inc., and has verified that the aforementioned cosmetic product is COUNTERFEIT. According to the company MYIMPORT, Inc., they are not responsible for the importation nor distribution of the aforementioned cosmetic product with Batch No. R17E055.

Counterfeit products did not go through the required safety assessment and the FDA verification process. These products pose potential health hazards to the consuming public since their safety and purity cannot be guaranteed. Potential hazards may come from ingredients that are not allowed to be part of a cosmetic product or restricted ingredients that in excessive amount as per ASEAN Cosmetic Directive (ACD). 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 counterfeit cosmetic 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 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. 2019-354

FDA Advisory No. 2019-353 || 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. WILD EARTH™ SIGNATURE POTIONS BY SHABIA WALIA NATURAL BROWN HENNA
  2. DEXE® HAIR COLOR SPRAY BLUE
  3. DEXE® HAIR COLOR SPRAY ORANGE
  4. DEXE® HAIR COLOR SPRAY COFFEE
  5. EPSA® PRO-HAIR KERATIN CHOCOLATE HAIR THERAPHY TREATMENT

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 as listed in the Annex II, Part I of the ASEAN Cosmetic Directive (ACD), such as heavy metals like Lead (Pb) and 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. 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. 2019-353

FDA Advisory No. 2019-352 || 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. TOV HAIR COLOR WAX VARIANT: T-1601
  2. PROFESSIONAL DECOLOR POWDER FLOWERY RED
  3. DARK SECRET HERBAL BLACK BROWN COLORING SHAMPOO
  4. PALAWAN HENNA POWDER
  5. CHROMA CELLOSHINE COLOR TREATMENT (PURPLE)

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 as per ASEAN Cosmetic Directive (ACD), such as heavy metals like Lead (Pb) or 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. 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. 2019-352

FDA Advisory No. 2019-351 || 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. LS BL TRANSPARENT BABY SOAP
  2. MIKAELA KOJIC ACID AND GLUTATHIONE LIGHTENING SOAP
  3. SEOUL SKIN JINJU WHITE SOAP
  4. KINIS™ CARROT SOAP
  5. SOFTSOAP® ANTIBACTERIAL HANDS SOAP WITH MOISTURIZERS GENTLY CLEANS & PROTECTS FRESH CITRUS

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 as listed in the Annex II, Part 1 of the ASEAN Cosmetic Directive (ACD). 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. 2019-351

FDA Advisory No. 2019-350 || 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. VERDON® NE SILKY NATURAL ORGANIC 1 MINUTE KERATIN BLOWOUT HAIR SPA TREATMENT MILK
  2. VERDON® NE SILKY NATURAL ORGANIC 1 MINUTE KERATIN BLOWOUT HAIR SPA TREATMENT POMEGRANATE
  3. VERDON® NE SILKY NATURAL ORGANIC 1 MINUTE KERATIN BLOWOUT HAIR SPA TREATMENT VERDON
  4. EPSA® MORE LIGHT AND BEAUTY SALON EXPERT WAVE LOTION
  5. MAGIC KERATIN GOLD INFUSION 4 POST-TREATMENT AMINO MOISTURIZING CONDITIONER PROFESSIONAL HAIR CARE

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 as per ASEAN Cosmetic Directive (ACD), or 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. 2019-350

FDA Advisory No. 2019-349 || 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. CO™ LAB DRY SHAMPOO NEW YORK SHEER + INVISIBLE
  2. WILD EARTH™ SIGNATURE POTIONS BY SHABIA WALIA ORANGE BERGAMOT SHAMPOO
  3. PANTENE PRO-V SHEER VOLUME 2 IN 1 SHAMPOO + CONDITIONER
  4. BIOTIN & COLLAGEN SHAMPOO THICKENING SHAMPOO
  5. CPS PERMANENT HAIR STRAIGHTENING

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 as listed in the Annex II, Part I of the ASEAN Cosmetic Directive (ACD), like 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. 2019-349

FDA Advisory No. 2019-348 || 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. DAPHNIE BEAUTY SOAP AHA WHITENING BOOSTER WITH MOISTURIZER
  2. HONEY NATURAL SKIN CARE MASK
  3. UTENA PREMIUM PURESA FACIAL SHEET MASK
  4. THE RETRO HEALING BENTONITE CACAO CLAY FACE MASK
  5. OLIVE NATURAL SKIN CARE MASK

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 as listed in the Annex II, Part 1 of the ASEAN Cosmetic Directive (ACD). 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. 2019-348

FDA Advisory No. 2019-347 || 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. KAXIER B.B CREAM WHITE CRYSTALIN PERFECT CONCEALER (04)
  2. IVY BEAUTY LIGHT SILK BLUSHER (4)
  3. JIALIQI 24 HOURS WATERPROOF LASTING EYELINER (BLACK)
  4. JIALIQI PRECISION EYELINER
  5. USHAS® EYESHADOW PALETTE (3)

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 as listed in the Annex II, Part I of the ASEAN Cosmetic Directive (ACD), and from the contamination of heavy metals such as Lead (Pb) and Antimony (Sb) especially in eye and face 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. 2019-347

FDA Advisory No. 2019-346 || 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. SUNBRIGHT SERIES KERATIN & COLLAGEN HAIR COLOR 9.91 (SILVER ASH)
  2. ELLIPS™ VITAMIN HAIR MASK NUTRI COLOR WITH TRIPLE CARE
  3. SOFTSOAP® SOOTHING ALOEVERA MOISTURIZING HAND SOAP
  4. ENZO PROFESSIONAL HAIR CARE HAIR SERUM KERATIN
  5. ROUSHUN KERATIN & COLLAGEN CARE HAIR MASK STRONG REPAIR & NOURISH HAIR

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 as listed in the Annex II, Part I of the ASEAN Cosmetic Directive (ACD), like 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. 2019-346

FDA Advisory No. 2018-327-D || Lifting the Advisory of the Notified Cosmetic Product “DROPLETS OF NATURE SUNBLOCK LOTION WITH SPF” under FDA Advisory No. 2018-327 “Public Health Warning Against the Use of Unnotified Cosmetic Products (Batch 16)” Dated 07 December 2018

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

Droplets of Nature Sunblock Lotion with SPF             – Notification No. 1000001861627

Accordingly, the list released in FDA Advisory No. 2018-327 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. 2018-327 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. 2018-327-D

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2018-327-D || Lifting the Advisory of the Notified Cosmetic Product “DROPLETS OF NATURE SUNBLOCK LOTION WITH SPF” under FDA Advisory No. 2018-327 “Public Health Warning Against the Use of Unnotified Cosmetic Products (Batch 16)” Dated 07 December 2018

FDA Advisory No. 2016-122-A || Lifting the Advisory of the Notified Cosmetic Product “SWEET CARESS MASSAGE OIL PEPPERMINT” under FDA  Advisory No. 2016-122 “Public Health Warning Against the Use of Unnotified Cosmetic Products (Batch 15)” Dated 28 October

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

Sweet Caress Massage Oil Peppermint                         – Notification No. 1000001577005

Accordingly, the list released in FDA Advisory No. 2016-122 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) 8571900 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. 2016-122 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. 2016-122-A

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2016-122-A || Lifting the Advisory of the Notified Cosmetic Product “SWEET CARESS MASSAGE OIL PEPPERMINT” under FDA  Advisory No. 2016-122 “Public Health Warning Against the Use of Unnotified Cosmetic Products (Batch 15)” Dated 28 October

FDA Advisory No. 2019-286 || 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. KOMIKU BABY SHOWER GOOD PARTNER
  2. BABYJOY SILICONE NIPPLE (X)
  3. BABYJOY SILICONE NIPPLE (M)
  4. BABYJOY SILICONE NIPPLE (S)

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. 2019-286