PAIRRIES GOLD FULL SKIN CREAM Some groups and stakeholders questioned the approval of the products of Healthy Innovation Distribution, days after the FDA’s Center for Cosmetics Registration and Research prepared a Report […] As one member state of ASEAN, Philippines have been implementing the ASEAN Cosmetic Directive (ACD) since 2008. 1000007081995 is a notified product by the Market Authorization Holder, Unilever Philippines, Inc., in accordance with existing FDA rules and regulations. The public is advised to always check if a Cosmetic product is notified with the FDA. 2020-2085 ||Public Health Warning Against the Purchase and Use of Cosmetic Products Containing Banned Ingredient/s as Reported in the ASEAN Post-Marketing Alert System (PMAS): FDA Advisory No. All concerned establishments are warned not to distribute adulterated cosmetic products. ERASE WHITENING LOTION SPF 50 2020-2123 || Public Health Warning Against the Purchase and Use of the following Unauthorized Cosmetic Products: FDA Advisory No. Please be informed that the conduct of Center for Cosmetics Regulation and Research (CCRR) QPIRA Seminar for Household and Urban Hazardous Substance (Course Code: QCCRR-HUHS) on 16-17 July 2019 within Muntinlupa City shall be rescheduled to 3-4 October 2019. Recently, the Philippines FDA has released two circulars regarding the cosmetic products notification and the licensing of the cosmetic establishments. In the Philippines, online selling of medicines is NOT permitted pursuant to existing laws, rules and regulations. Other potential risks include transmission of infectious agents, such as HIV, hepatitis C and B. Since then, a notification scheme has been implemented in Philippines.All cosmetic companies shall obtain a License to Operate (LTO) prior to engaging in manufacturing, importation, distribution and sale of cosmetics. Summary of Regulatory Requirements for Cosmetic Labeling: More on the legal requirements that apply to cosmetic labeling 3. The definition of cosmetic product is the one contained in the Asean Cosmetics Directive: "Any substance or preparation intended to be placed in contact with the external parts of the human body... or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly for cleaning them, perfuming them, changing their appearance , and/or correcting body odours and/or protecting or keeping them in good condition". The public is advised to always check if a Cosmetic product is notified with the FDA. Moreover, the public is advised to always check if a cosmetic product is notified with the FDA. The Food and Drug Administration (FDA) warns the public on significant risks associated with the growth of the internet’ sales of medicines. 3. 3. GLOWING K COSMETICS GLAM CREAM Upon receipt of DRF, the Releasing Officer checks on the files for release. The FDA has a list of approximately 800 approved ingredients that are combined in various ways to create more than 100,000 OTC drug products. TO: SUBJECT: TRADERS ALL COSMETIC MANUFACTURERS DISTRIBUTORS AND OTHER CONCERNED PARTIES Reiterating the Mandatory Implementation of Article 8 of the ASEAN Cosmetic Directive "Product Information" BACKGROUND The ASEAN Harmonized Cosmetic Regulatory … 3. These ingredients are not allowed to be part of a cosmetic product as per ASEAN Cosmetic Directive (ACD). Learn about who needs FDA certificates in the Philippines and how to get them. 1 2 3. b. 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 their jurisdiction. In this warning letter, the FDA cautions, “FDA is advising not to purchase or use certain products that have not been approved, cleared, or authorized by FDA and that are being misleadingly represented as safe and/or effective for the treatment or prevention of COVID-19.” Misleading in Canada Yet Approved by Health Canada. FDA regulates cosmetic labeling under the authority of both the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA). 6. 2019-0523, please be advised that the Center for Cosmetics Regulation and Research ... Injectable glutathione is approved by FDA Philippines as an adjunct treatment in cisplatin chemotherapy. 8113 or 8107. "The FDA has not approved any injectable products for skin lightening," the agency said. . You will never know what exactly you are getting. The Food and Drug Administration (FDA) of the Philippines, formerly the Bureau of Food and Drugs, is a health regulatory agency under the Department of Health (Philippines) created on 1963 by Republic Act No. 4. 2020-1334 is hereby lifted. OBUSE GOLD LIPSTICK NO. 2020-2021-A || Lifting the Advisory on the Notified Cosmetic Product “Human Nature Balancing Facial Wash (Elemi)” under FDA Advisory No. The use of such violative product may pose health risks to consumers. 2020-988 is hereby lifted. CAIYILIN WHITENING SPOT REMOVING SCHEME BIRD’S NEST (HERB WHITENING DAY CREAM + HERB WHITENING NIGHT CREAM) 2020-2123 || Public Health Warning Against the Purchase and Use of the following Unauthorized Cosmetic Products: SUU Balm Dual Cooling & Moisturising Cream Body Wash, on FDA Advisory No. Acute and chronic exposure of humans to Methanol by inhalation or ingestion may result in visual disturbances, such as blurred or dimness of vision, leading to blindness, and neurological damage, specifically permanent motor dysfunction. Skin contact with methanol can also produce mild to severe dermatitis in humans. All companies are asked to ensure that their notified products meet the requirements of the ASEAN Cosmetic Directive, its annexes and appendices. 6. You may also call the Center for Drug Regulation and Research at telephone number (02) 809-5596. GLOWING K COSMETICS PREMIUM LIP KREAM Dissemination of the information to all concerned is requested. However, non-toxic trace amounts of methanol can also be naturally present in fruit juices. No COVID-19 vaccine has received emergency use authorization from the country’s Food and Drug Administration. The FDA recommends purchase of medicines from licensed pharmacies near you and seek advice from your community pharmacist on the proper and safe use of medicines. This is in consideration to the reinstatement of the HUHS licensing and notification requirements. BEAUTY LADY WHITENING NIGHT CREAM 2020-2121 || Public Health Warning Against the Purchase and Use of Adulterated and Unnotified Health Product/s ” CLINS UP ETHYL ALCOHOL “, FDA Advisory No. ammoniated mercury) is kidney damage. For more information and inquiries, please e-mail us at [email protected]. The public is advised to always check if a Cosmetic product is notified with the FDA. Attachment-> :  VENUE FOR UNIFIED LICENSING SEMINAR (ULS –RI) ON 31 JULY 2019 AND 1 AUGUST 2019. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the following acts and the causing thereof: (a) the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product that is adulterated, unregistered or misbranded; and (b) the adulteration or misbranding of any health product are prohibited. Injectable glutathione is sometimes paired with intravenous Vitamin C. Vitamin C injection may form kidney stones if the urine is acidic. 2020-1903 “Public Health Warning Against the Purchase and Use of Non-Compliant Cosmetic Product POND’S VITAMIN MICELLAR WATER DETOXING CHARCOAL” Dated 20 October 2020, on FDA Advisory No. MORNING GLOW TOMATO GLOW SET But, FDA approval is required for color additives used in cosmetics for their intended use. Morning Glow Glass Skin Serum Yes or No . The table below indicates the particulars of the unauthorized and adulterated cosmetic products: 1. 2020-2089 || Public Health Warning Against the Purchase and Use of Cosmetic Products Containing Banned Ingredient/s as Reported in the ASEAN Post-Marketing Alert System (PMAS): FDA Advisory No. With the adoption and implementation of the ASEAN Harmonized Cosmetic Regulatory Scheme in 2005 by virtue of DOH Administrative Order No. 2020-1332 is hereby lifted. Cosmetics are a mixture of chemical compounds used to enhance or improve a person’s appearance. 2. 1. For more information and update on the Unified Licensing Seminar for Region II (ULS-RII), please visit the FDA website, www.fda.gov.ph. NANA HAND GEL ALCOHOL 80% For more information or inquiries, please email us at [email protected]. 11. Share; Tweet; Linkedin; Pin it; More sharing options. CHRISTOPHER’S PERFUME OUR VERSION OF: ISSEY MIYAKI HOMME SPORT FOR MEN, 1. This is due to very low number of course participants that registered in the course. This directive requires persons or companies placing a product on the market to keep a Product Information File "readily accessible to the regulatory authority of the Member State concerned". Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act No. The aforementioned products have been tested by the Health Sciences Authority (HSA), Singapore, 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 ACD. 175 and RA 9711. GLOWING K COSMETICS DAZZLIN MIST For any concerns or inquiries, kindly contact CCRR at (02) 857-1900 local 8107 or 8113, or through email at [email protected] (for ENDS/ENNDS-related concerns) or [email protected] (for HUHS, HUP, PCO and Toy-related concerns). 2. JEED JEES LIP TINT VELVET NO. Please be informed that the venue of the Unified Licensing Seminar (ULS – RV) on 19-20 June 2019 will be in LA VENEZIA HOTEL & SPA, INC., RENAISSANCE GARDENS, WASHINGTON DRIVE, LEGAZPI CITY, ALBAY. Also of concern is the possibility of Stevens Johnson Syndrome. Recently, the Philippines FDA has released two circulars regarding the cosmetic products notification and the licensing of the cosmetic establishments. Attachment-> : RESCHEDULING OF QCCRR–MIN AND ULS-RX. Morning Glow Milky Glow Foam Wash To report any sale or distribution of the above-mentioned product, kindly e-mail us via [email protected]. To date there are no published clinical trials that have evaluated the use of injectable glutathione for skin lightening. 2020-1903-A || Lifting the Advisory on the Notified Cosmetic Product “POND’S VITAMIN MICELLAR WATER DETOXING CHARCOAL” under FDA Advisory No. This ingredient not allowed to be part of a cosmetic product as per ASEAN Cosmetic Directive (ACD). 8113 or 8107. C-KISS SUNSCREEN CREAM 2020-1422 and FDA Order No. 2020-1901 “Public Health Warning Against the Purchase and Use of Non-Compliant Cosmetic Product ACTIVEX DUO WHITE FRESH (BLUE BOX)” Dated 20 October 2020, on FDA Advisory No. It is also a requirement before you can obtain a Certificate of Product Registration (CPR), a seal of approval which indicates that your product complies with health, safety, and technical standards set by the FDA in the Philippines. To report continuous unauthorized sale or distribution of drug products, kindly email us via [email protected], or through the online reporting facility, eREPORT, at www.fda.gov.ph/ereport. You may also call the Center for Cosmetics Regulation and Research at telephone number (02) 8857-1900 loc. 1000007138385., has been notified by the Market Authorization Holder, Gandang Kalikasan, Inc. in accordance with existing FDA rules and regulations. U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 1-888-INFO-FDA (1-888-463-6332) Contact FDA The requirements for manufacturing cosmetics in the respects of personnel, premises, equipment, sanitation and hygiene, and others are set by the ASEAN guidelines on Good Manufacturing Practice (GMP). The Food and Drug Administration (FDA) informs the public that the Cosmetic product POND’S VITAMIN MICELLAR WATER DETOXING CHARCOAL with Notification No. Background: FDA and Administrative Order No. 2005-0015 and 2005-0025, the notification scheme for cosmetic products was implemented. 05 Authorization letter in company letterhead; Photocopy of valid ID of the Company’s Owner/President/Manager/Head; and. Regulations Governing the Application of Animal Testing for the Safety Assessment of Cosmetics or Cosmetic Ingredients. With this, the FDA commenced its own investigation on the implicated product ‘Cosmic Carabao Gin’ which is a locally manufactured alcoholic beverage. 11. For more information or inquiries, please email us at [email protected], you may also call the Center for Cosmetics Regulation and Research at telephone number (02) 8857-1900 loc. 2020-1734 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic ZENUTRIENTS ARGAN NOURISHING FACIAL WASH, on FDA Advisory No. LIANIBO WHITENING CREAM NIGHT CREAM EXCELLENT LD-802 Please be informed that the venue of the Unified Licensing Seminar (ULS – RXII) on 3 & 4 July 2019 will be in GREENLEAF HOTEL, SAN MIGUEL STREET CORNER J. CATOLICO AVENUE, LAGAO, GENERAL SANTOS CITY. All covered establishments may be inspected at any time by FDA as part of its post-marketing surveillance activities. Laboratory testing of the product is also being undertaken to check if the methanol content is compliant. FDA Advisory No. DEEJA SET 5 DALAM 1 KEHEBATAN LUNAR BIASA SUF CREAM Application Processa) FilingAn application for LTO, whether initial, renewal, or variation, and other authorizations are deemed filed upon submission of complete requirements including payment of required fees and charges.b) EvaluationThe evaluation of all applications for LTO shall be based on the veracity of the submitted documents and compliance with appropriate standards.In case the applicant falsified, misrepresented material facts or documents, or withheld any material data or information, the application shall be disapproved. MOIST SKINCARE PAPAYA WHITENING LOTION, 1. Avoid buying injectable products online and from being lured to a promising effect of medicines as beauty products. (see Annex) This guideline shall take effect immediately after posting in the FDA website. 2020-2083 || Public Health Warning Against the Purchase and Use of Cosmetic Products Containing Banned Ingredient/s as Reported in the ASEAN Post-Marketing Alert System (PMAS): FDA Advisory No. The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product. The table below indicates the particulars of the unauthorized and adulterated cosmetic product: 1. SHE LEBRITY KIKAY TALK COSMETICS MATTE LIPSTAIN, 1. 12. 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. Rhodamine B contained in the other products presents as a red to violet powder and has been shown to be carcinogenic in mammalian models. List of Licensed Products and Establishments. For more information or inquiries, please email us at ccrr_prsdd[email protected], you may also call the Center for Cosmetics Regulation and Research at telephone number (02) 8857-1900 loc. 3. products. 2020-2082 || Public Health Warning Against the Purchase and Use of Cosmetic Products Containing Banned Ingredient/s as Reported in the ASEAN Post-Marketing Alert System (PMAS): on FDA Advisory No. 4. The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 18 September 2020. Dissemination of this advisory to all concerned is hereby requested. As of May 22, the Philippine Food and Drug Administration has approved 104 test-kit products for coronavirus disease 2019 (COVID-19) diagnosis. 2020-2088 || Public Health Warning Against the Purchase and Use of Cosmetic Products Containing Banned Ingredient/s as Reported in the ASEAN Post-Marketing Alert System (PMAS): on FDA Advisory No. In the Philippines, the Food and Drug Administration (FDA) (formerly the Bureau of Food and Drugs) created under the Department of Health, is responsible for regulating cosmetic products and ensuring the safety, purity, and quality of cosmetics in Philippines market. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the health product before purchasing. Side effects on the use of injectable glutathione for skin lightening include toxic effects on the liver, kidneys, and nervous system. d. Morning Glow Glow Sunblock. Moreover, the public is advised to always check if a cosmetic product is notified with the FDA through its website (ww2.fda.gov.ph). EPA expects all products on List N to kill the coronavirus SARS-CoV-2 (COVID-19) when used according to the label directions. In light of the foregoing, the public is advised not to purchase the aforementioned adulterated product. The Food and Drug Administration (FDA) informs the public that the Cosmetic product ACTIVEX DUO WHITE FRESH (BLUE BOX) with Notification No. Proof of Payment, VENUE FOR UNIFIED LICENSING SEMINAR ON 3 & 4 JULY 2019. The Food and Drug Administration (FDA) informs the public that the Cosmetic product SHAWILL MAKE-UP SKIN LIGHTENING POWDER (OIL CONTROL)” with Notification No. MUI LEE HIANG CREAM FOR ACNE & BLEMISHES AND SG SKIN FRESH LOTION 2020-1901 and FDA Order No. Many of the products were cleaning solutions for surfaces. In the Philippines, the Food and Drug Administration (FDA) (formerly the Bureau of Food and Drugs) created under the Department of Health, is responsible for regulating cosmetic products and ensuring the safety, purity, and quality of cosmetics in Philippines market. 2020-1734 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic ZENUTRIENTS ARGAN NOURISHING FACIAL WASH, FDA Advisory No. 7. Thereafter, the Certificate of GMP Compliance shall be issued each time the LTO is renewed.Application Requirementsa) Initial Application, Accomplished Application Form and Declaration and Undertaking, Site Master File (for manufacturers of drugs, devices and cosmetics), Accomplished Application Form with Declaration and Undertaking. Attachment: CANCELLATION OF UNIFIED LICENSING SEMINAR FOR ARMM STAKEHOLDERS (ULS-ARMM) ON 2 JULY 2019. 2. b. Side effects on the use of injectable glutathione for skin lightening include toxic effects on the liver, kidneys, and nervous system. 2020-2122 || Public Health Warning Against the Use of the following Unauthorized Cosmetic Products: on FDA Advisory No. Morning Glow Glow Sunblock Here is the FDA List of Approved Cosmetic Ingredients: 1. 8113 or 8107. All confirmed participants of this seminar shall be automatically moved to the rescheduled date. CI 15585, a colorant contained in the other products reported, is likewise not allowed to be part of cosmetic products as it has shown carcinogenic effects in mammalian models. All concerned regulated establishments are reminded to follow and strictly comply with the FDA’s existing rules and regulations to ensure that only safe and quality products shall be made available to the public. 2020-1733 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic LOUJENE NON ACETONE ENAMEL REMOVER, FDA Advisory No. The FDA has not approved any injectable products for skin lightening. Cruz, Manila. Acute and chronic exposure of humans to methanol by inhalation or ingestion may result in visual disturbances, such as blurred or dimness of vision, leading to blindness, and neurological damage, specifically permanent motor dysfunction. Provisitional List. This is of particular concern when non-medical practitioner administers this treatment or done in a non-sterile facility. Please be informed that the conduct of ULS-RII in Isabela (Course Code:ULS-RII) scheduled on 18 July 2019 shall be postponed due to Typhoon Falcon that is expected to land in Northern Luzon this week. The Philippine Food and Drug Administration (FDA) is the national health product regulatory agency created by Republic Act (RA3720), as amended by Executive Order No. 2020-1331 is hereby lifted. 2. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act No. 2020-120 with FDA Order 139 [DTN 20200203160418] is hereby lifted. First, you will receive an automatic reply to signify that your e-mail application was received by cosmetic@fdd.gov.la 3.2. Since the abovementioned unauthorized cosmetic product has not gone through the notification process of the FDA, the agency cannot assure their quality and safety. These ingredients are not allowed to be part of a cosmetic product as per ASEAN Cosmetic Directive (ACD). 1. Injectable glutathione is approved by FDA Philippines as an adjunct treatment in cisplatin chemotherapy. 12345-12-2567 and know you’re getting an equivalent product. The Food and Drug Administration (FDA) on Thursday clarified that rapid test kit products do not need authorization from the country of origin before they are allowed to be used in the Philippines. 2020-2084 || Public Health Warning Against the Purchase and Use of Cosmetic Products Containing Banned Ingredient/s as Reported in the ASEAN Post-Marketing Alert System (PMAS): FDA Advisory No. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act No. The table below indicates the particulars of the unauthorized and adulterated cosmetic products: 1. Linkedin; Pin it; Email; Print ; Recent New and Generic Drug Approvals. 2020-1904 “Public Health Warning Against the Purchase and Use of Non-Compliant Cosmetic Product SHAWILL MAKE-UP SKIN LIGHTENING POWDER (OIL CONTROL)” Dated 20 October 2020, on FDA Advisory No.2020-120-A || Lifting the Advisory on the Notified Product “AKOTO KOJIC ACID SOAP WITH COLLAGEN” under FDA Advisory No. Product Importation and Registration in the Philippines. NANA CLEANSING ALCOHOL 80% (BLUE LIQUID) GARNIBO WHITENING CREAM 7 DAYS WITHING CREAM To report continuous sale or distribution of the above unregistered food product, e-mail us via [email protected], or call us at the Center for Food Regulation and Research (CFRR) hotline (02) 857-1900 locals 8112 or 8105. Women planning to get pregnant or are already expecting are strongly advised to avoid using products containing tretinoin. 10. They must continuously comply with the existing requirements, regulations and standards and under the supervision of a qualified person as required by the regulations. Guidelines on the Unified Licensing Requirements and Procedures of the FDA, ASEAN guidelines on Good Manufacturing Practice (GMP), China to Amalgamate 3 Major Cosmetic Regulatory Authorities, China Plans Development of Cosmetic Overarching Regulation in 2018. Side effects on the use of injectable glutathione for skin lightening include toxic effects on the liver, kidneys, and nervous system. 3. 3. The table below indicates the particulars of the unauthorized and adulterated cosmetic products: 1. The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 01 December 2020. FDA Advisory No. In the Philippines, the Food and Drug Administration (FDA) (formerly the Bureau of Food and Drugs) created under the Department of Health, is responsible for regulating cosmetic products and ensuring the safety, purity, and quality of cosmetics in Philippines market. GLOWING K COSMETICS GLASS SKIN SOAP Annex II is a List of Substances Which Must Not Form Part of the Composition of Cosmetic Products2. 1. Below is a list of the type of products that are regulated by the federal government. on the product label, then enter the first two sets of numbers into the tool. Published: August 20, 2020 The advert includes a stamp that appears to show the product was approved by the Philippine Food and Drug Administration (FDA). Please Log in or Sign up (FREE) to read the full content. All concerned establishments are warned not to distribute violative cosmetic product until they have fully complied with the rules and regulation of the FDA. across Chemical, Food, Cosmetic and Agrochemical industries. 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 any health product without the proper authorization from the FDA is prohibited. The Food and Drug Administration (FDA) warns the public from purchasing and using the following unauthorized and adulterated cosmetic products, which tested positive for the presence of HYDROQUINONE and RHODAMINE B, respectively, as reported in the ASEAN Post-Marketing Alert System (PMAS). P-VITA MELASMA CREAM Attachment:-> FDA-Advisory-No.2020-2021-A. To report the sale or distribution of any unnotified/unregistered health products, kindly email FDA via [email protected]. 2007-013-A. For example, if EPA Reg. MISS TAJA 12 COLORS LIPSTICK – 12 Accordingly, the warning against the purchase and use of the subject product as mentioned in FDA Advisory No. Please Log in or Sign up (FREE) to read the full content. The Food and Drug Administration (FDA) Philippines (previously called Bureau of Food and Drugs) is responsible for safeguarding public health and safety through enforcing its standards on all products relating to food, drugs, cosmetics, medical devices, and household hazards that are available in the Philippine market. 2020-1733 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic LOUJENE NON ACETONE ENAMEL REMOVER, on FDA Advisory No. 7. KI BEAUTY COLORSTAY OVERTIME LIPCOLOR (BROWN) All cosmetic establishments shall first secure the LTO or authorization from FDA prior to engaging in the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, promotion, advertisement and for sponsorship of any activity that involves cosmetics. FDA Philippines-ARISE Cosmetic Notification 5-9 October 2015 | Vientiane, Lao PDR Page 4 of 13 ASSESSMENT OF APPLICATION 3. 2020-2085 ||Public Health Warning Against the Purchase and Use of Cosmetic Products Containing Banned Ingredient/s as Reported in the ASEAN Post-Marketing Alert System (PMAS): on FDA Advisory No. There are also no published guidelines for appropriate dosing regimens and duration of treatment. In an advisory, FDA said it recently approved four PCR-based and seven antibody rapid test-kit products. 4. 10/21/2020. The table below indicates the particulars of the unauthorized and adulterated cosmetic products: 1. In light of the developments on the investigation of the Food and Drug Administration (FDA) with regards to the incident involving two (2) women who allegedly consumed ‘Cosmic Carabao Gin’, this Office shall order the seizure and/or confiscation of the product as the samples collected and subjected to FDA analysis were found positive for methanol. The Food and Drug Administration (FDA) has warned the public against five “unnotified” cosmetic products being sold in the market. U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 1-888-INFO-FDA (1-888-463-6332) Contact FDA 2020-2127 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic YUNNAN BAIYAO TOOTHPASTE, FDA Advisory No. REACH24H Consulting Group, the JOVILAND RITA,GMA News. According to the World Health Organization (WHO), the main adverse effect of exposure to inorganic mercury (e.g. These are PCR based reagent kits used in laboratories and not point-of-care or do-it-yourself kits. The table below indicates the particulars of the unauthorized and adulterated cosmetic products: 1. In such cases, the applicant may be investigated, appropriate charges may be filed, and penalties may be imposed.Should there be a need for clarification on the application, a notification, either written or through e-mail, shall he sent to the applicant.c) InspectionPre-opening inspection shall be mandatory for manufacturers. Important Definitions in the FDA Act • “Health products”means food, drugs, cosmetics, devices, biologicals, vaccines, in-vitro diagnostic reagents and household/ urban hazardous substances and/or a combination of and/or a derivative thereof. 2020-2021-A || Lifting the Advisory on the Notified Cosmetic Product “Human Nature Balancing Facial Wash (Elemi)” under FDA Advisory No. To report the sale or distribution of any unnotified/unregistered health products, kindly email FDA via [email protected]. 3. Accordingly, the warning against the purchase and use of the subject product as mentioned in FDA Advisory No.2020-2109 and FDA Order No.2020-1423 is hereby lifted. 5. Stevens-Johnson Syndrome, a serious skin disorder, could also … c. Morning Glow Glass Skin Toner Some groups and stakeholders questioned the approval of the products of Healthy Innovation Distribution, days after the FDA’s Center for Cosmetics Registration and Research prepared a Report […] Mentioned in FDA Advisory No for commercial Use product is notified with the and. A Denial letter five “ Unnotified ” Cosmetic products and their ingredients approved four PCR-based and seven antibody test-kit. Limit consumers ’ exposure to lead in cosmetics for their intended Use already expecting are strongly advised to check... Of chemical compounds used to enhance or improve a person ’ s of! Product was approved by FDA Philippines as an adjunct treatment in cisplatin chemotherapy. has an existing Pharmacy! Beauty COLORSTAY OVERTIME LIPCOLOR ( BROWN ) 6, distribute, sell, or offer for sale adulterated... Advisory, FDA Advisory No ULS DAVAO VENUE on 22 August 2019 by.... N, you will receive an automatic reply to signify that your e-mail application received... 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