ChemLinked is a leading provider of Asia-Pacific regulatory information and market intelligence 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. Accordingly, the warning against the purchase and use of the subject product as mentioned in FDA Advisory No. KISS BEAUTY REAL GEL TINT 9 FRUIT FLAVOR Two e-mails will be received from cosmetic@fdd.gov.la 3.1. 2020-1731 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic MAG ART NAIL FOREST GREEN, ADVISORY-RELEASING OF FDA AUTHORIZATIONS AT THE FOOD AND DRUG ACTION CENTER (FDAC), RESCHEDULE OF QPIRA FOR CFRR AND GMP-FMT SEMINAR, VENUE FOR UNIFIED LICENSING SEMINAR (ULS –RIX) ON 5 JULY 2019, CANCELLATION OF UNIFIED LICENSING SEMINAR FOR ARMM STAKEHOLDERS (ULS-ARMM) ON 2 JULY 2019, Presentation of IRR of RA10620: Toy and Game Safety Labeling Act of 2013. 1. The Food and Drug Administration (FDA) has released today a list of approved COVID-19 test kits for commercial use. Unlike other consumer products purchased over the internet, medicines have the potential to cause serious side effects and health problems if not used and stored properly. Signs and symptoms of methanol poisoning include headache, vomiting, abdominal pain, hyperventilation, and feeling of breathlessness. Injectable glutathione is approved by FDA Philippines as an adjunct treatment in cisplatin chemotherapy. GLOWING K COSMETICS DAZZLIN MIST Alphabetical List of Licensed Establishments including Product Approval Dates 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 […] 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): on FDA Advisory No. The Philippines Food and Drug Administration (FDA) list of banned cosmetics featuring mercury has expanded from 50 to 71, after the illegal products were discovered over the period of January 2010 to November of this year. CLEAN & CLEAR SUN COVER VITAMIN E ALOE CREAM Overview of Labeling Requirements: What must cosmetic labels say? AHA is often found in cosmetic products marketed as skin exfoliation, pore cleanser, anti-aging, and maintaining skin’s health in general. 6. 06 2020-1731 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic MAG ART NAIL FOREST GREEN, VENUE FOR UNIFIED LICENSING SEMINAR (ULS –RI) ON 31 JULY 2019 AND 1 AUGUST 2019, Please be informed that the venue of the Unified Licensing Seminar (ULS – RI) on 31 July 2019 and 1 August 2019 will be in, We advise our clients to kindly send all queries and concerns via, For more information and inquiries, please e-mail us at, Seek medical attention immediately if you experience any side effects and report it to FDA at, Center for Cosmetics Regulation and Research QPIRA Seminar for Mindanao (Cagayan de Oro), Unified Licensing Seminar for Region X (Iligan City), Unified Licensing Seminar for Region X (Cagayan de Oro City), For inquiries and other concerns, please call the FDA Academy at telephone number (02) 877-0259 or email at, Please be informed that the conduct of Center for Food Regulation and Research (CFRR) QPIRA Seminar (Course Code: QCFRR-Min) on, 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, Please be informed that the venue of the Unified Licensing Seminar (ULS – RIX) on 5 July 2019 will be in, Please be informed that the venue of the Unified Licensing Seminar (ULS – RV) on 19-20 June 2019 will be in, FDA Advisory No.2020-1904-A || Lifting the Advisory on the Notified Cosmetic Product “SHAWILL MAKE-UP SKIN LIGHTENING POWDER (OIL CONTROL)” under FDA Advisory No. The public is advised to always check if a Cosmetic product is notified with the FDA. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act No. The .gov means it’s official. To report any sale or distribution of the afore-mentioned cosmetic product, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport. Higher concentrations of methanol in alcoholic drinks can happen when methanol is deliberately added to alcoholic drinks. QEZIGER LUMINESSE WHITENING RECHARGING SPOT DAY 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 […] In light of the foregoing, the public is advised not to purchase the aforementioned unauthorized and adulterated products. 8113 or 8107. Avoid buying injectable products online and from being lured to a promising effect of medicines as beauty products. Side effects on the use of injectable glutathione for skin lightening include toxic effects on the liver, kidneys, and nervous system. To report any sale or distribution of the above-mentioned product, kindly e-mail us via [email protected]. 8. Annex II is a List of Substances Which Must Not Form Part of the Composition of Cosmetic Products2. 3. VENUE FOR UNIFIED LICENSING SEMINAR (ULS –RV) ON 19-20 JUNE 2019, on FDA Advisory No.2020-1904-A || Lifting the Advisory on the Notified Cosmetic Product “SHAWILL MAKE-UP SKIN LIGHTENING POWDER (OIL CONTROL)” under FDA Advisory No. 5. 2020-2124 || Public Health Warning Against the Purchase and Use of the following Unauthorized Cosmetic Products: FDA Advisory No. Lead is an element that occurs naturally in the earth. (Official Page) This is Food and Drug Administration Philippines. 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. Injectable glutathione is approved by FDA Philippines as an adjunct treatment in cisplatin chemotherapy. First, you will receive an automatic reply to signify that your e-mail application was received by cosmetic@fdd.gov.la 3.2. 2020-1334 is hereby lifted. The FDA has not approved any injectable products for skin lightening. DEEJA COSMETIC SET 5 IN 1 – LAIKA CREAM Please be informed that the venue of the Unified Licensing Seminar (ULS – RXI) on 22 August 2019 will be in GRAND REGAL HOTEL DAVAO, KM. 2020-2021-A || Lifting the Advisory on the Notified Cosmetic Product “Human Nature Balancing Facial Wash (Elemi)” under FDA Advisory No. WHITE WAY NANO WHITE BODY LOTION 2020-1903 and FDA Order No. You may also call the Center for Cosmetics Regulation and Research at telephone number (02) 8857-1900 loc. MORNING GLOW TOMATO GLOW SET 3. We advise our clients to kindly send all queries and concerns via [email protected], and we will respond accordingly. 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. Accordingly, the warning against the purchase and use of the subject product as mentioned in FDA Advisory No 2020-2021 and FDA Order No.2020-1421 is hereby lifted. MOIST SKINCARE PAPAYA WHITENING LOTION, 1. Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION FDA 24 JAN 2018 FDA CIRCULAR No. : 2017-03 26th November 2017 3 Salicylic acid and (its salts (+) 1) 0.5% (acid) Not to be used in preparations for childr en under three y ears of age, except for shampoos - Not to be used for chil dr nu er three y ars of g (2) These ingredients are not allowed to be part of a cosmetic product as per ASEAN Cosmetic Directive (ACD). 3. "Injectable glutathione is approved by FDA Philippines as an adjunct treatment in cisplatin chemotherapy." In light of the foregoing, the public is advised not to purchase the aforementioned violative cosmetic product. GERO SKIN NATURALS WHITENING DISPEL SPOT 7 DAYS WHITING DISPEL SPORTS CREAM Accordingly, the warning against the purchase and use of the subject product as mentioned in FDA Advisory No. Methanol is a widely available chemical that has many industrial applications and is also found in household products and fuel for aircraft. The public is advised to always check if a Cosmetic product is notified with the FDA. With the adoption and implementation of the ASEAN Harmonized Cosmetic Regulatory Scheme in 2005 by virtue of DOH Administrative Order No. The FDA hereby warns the public on the consumption of the implicated product as this is currently unregistered and has been confirmed to contain a high level of methanol. The FDA hereby reiterates its previous Advisories following the casualties due to the consumption of unregistered food products including alcoholic beverages that have not gone through this agency’s registration and testing. . For initial submissions, the notification shall be valid for a period of 1 to 3 years maximum at the option of the applicant. 11. Upon validation, Releasing Officer hands-over to Client the second copy as FDA’s receiving copy indicating the printed name, signature, date and time of receipt. These ingredients are not allowed to be part of a cosmetic product as per ASEAN Cosmetic Directive (ACD). 2020-2087 || 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. You may also call the Center for Drug Regulation and Research at telephone number (02) 809-5596. AURA WHITE BEAUTY SET 4. across Chemical, Food, Cosmetic and Agrochemical industries. Hydroquinone and Tretinoin are not allowed to be part of cosmetic products as these are classified as drug products in the Philippines because of their multiple serious adverse effects, such as sensitivity to light, skin redness and permanent skin discoloration, when used indiscriminately. … Attachment->:ADVISORY-RELEASING OF FDA AUTHORIZATIONS AT THE FOOD AND DRUG ACTION CENTER (FDAC). The FDA will also ensure that adequate coordination with the Law Enforcement Agencies shall be done to facilitate their own investigation. By virtue of FDA Personnel Order No. Attachment-> : RESCHEDULE OF QPIRA FOR CFRR AND GMP-FMT SEMINAR. EPA expects all products on List N to kill the coronavirus SARS-CoV-2 (COVID-19) when used according to the label directions. To file an application, follow the procedure below:a) Secure a CCRR User Account by sending a request to info@fda.gov.ph following with the following information: Email address (preferably company email address). Releasing Officer releases the Authorization/s to Client. ammoniated mercury) is kidney damage. These are PCR based reagent kits used in laboratories and not point-of-care or do-it-yourself kits. 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". C-KISS SUNSCREEN CREAM . Blindness can also happen in severe cases. U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 1-888-INFO-FDA (1-888-463-6332) Contact FDA With this, the FDA commenced its own investigation on the implicated product ‘Cosmic Carabao Gin’ which is a locally manufactured alcoholic beverage. 2. SHE LEBRITY KIKAY TALK COSMETICS MATTE LIPSTAIN, 1. To report any sale, distribution, complaint and/or adverse event on the use of the violative cosmetic products, the online reporting facility, eReport can be accessed at [email protected], or call us at the Center for Cosmetics Regulation and Research (CCRR) hotline (02) 8857-1900 loc. The aforementioned products were found to contain methanol which is an ingredient not allowed to be part of cosmetic products. The table below indicates the particulars of the unauthorized and adulterated cosmetic products: 1. For inquiries and other concerns, please call the FDA Academy at telephone number (02) 877-0259 or email at [email protected]. This, despite the absence of regulatory approval in the Philippines. Mercury may also cause skin rashes, skin discoloration and scarring, as well as a reduction in the skin’s resistance to bacterial and fungal infections. In light of the foregoing, the public is advised not to purchase the aforementioned unauthorized and adulterated product. 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. importers and downstream users to effectively manage their responsibilities. 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. 5. FDA Republic Of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION Filinvest Corporate City Alabang, City of Muntinlupa (8) The FDA and the company shall use the revised checklist of requirements and licensing forms for Cosmetics. Attachment-> : Cascading on 7 and 9 August 2019 by CCRR. 2020-2019 “Public Health Warning Against the Purchase and Use of the Non-Compliant Cosmetic Product ” SUU BALM DUAL COOLING & MOISTURISING CREAM BODY WASH” Dated 30 October 2020, FDA Advisory No. NANA CLEANSING ALCOHOL 80% (BLUE LIQUID) Attachment:-> FDA-Advisory-No.2020-1901-A. 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. The abovementioned product was verified by FDA through post marketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 01 December 2020. No COVID-19 vaccine has received emergency use authorization from the country’s Food and Drug Administration. 4. While the rules are made and regulated by the FDA, all the risk is on the manufacturer. 2020-1332 is hereby lifted. Annex IV lists colouring agents allowed for use in cosmetic products4. Most are, however, under the regulatory authority of the FDA in the event of safety-related concerns. 4. The table below indicates the particulars of the unauthorized and adulterated cosmetic products: 1. BLEACHING SKIN BY NINA – BLEACHING LIQUID 2. However, non-toxic trace amounts of methanol can also be naturally present in fruit juices. 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. JEED JEES LIP TINT VELVET NO. By virtue of FDA Personnel Order No. Republic of the Philippines Department of Health FDA FOOD AND DRUG ADMINISTRATION 28 February 2014 FDA CIRCUL R No. List of Approved Products; Here begins the text. 2. As one member state of ASEAN, Philippines have been implementing the ASEAN Cosmetic Directive (ACD) since 2008. Attachment-> : VENUE FOR UNIFIED LICENSING SEMINAR (ULS –RI) ON 31 JULY 2019 AND 1 AUGUST 2019. 2020-1734 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic ZENUTRIENTS ARGAN NOURISHING FACIAL WASH, on FDA Advisory No. Skin contact with methanol can also produce mild to severe dermatitis in humans. The Food and Drug Administration (FDA) warns the public against the purchase and use of the adulterated and unnotified health product “ CLINS UP ETHYL ALCOHOL ”, which was tested and found to contain METHANOL. Side effects on the use of injectable glutathione for skin lightening include toxic effects on the liver, kidneys, and nervous system. To find a product, locate the EPA Reg. The confirmed participant of this seminar will be transferred to the next available seminar schedule. 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. 3. As of May 22, the Philippine Food and Drug Administration has approved 104 test-kit products for coronavirus disease 2019 (COVID-19) diagnosis. You may also call the Center for Cosmetics Regulation and Research (CCRR) at telephone number (02) 8857-1900 loc. In line with this, there will be no CDRR officers on duty for the said dates at the FDA Action Center (FDAC). All registered participants to this seminar shall be automatically moved to the reschedule date of the seminar. A Certificate of GMP Compliance shall only be issued upon demonstration of satisfactory compliance to GMP and effective up to the validity of the current LTO. Presentation Outline I. on FDA Advisory No. GLOWING K COSMETICS GLAM CREAM 2020-380 and FDA Advisory 2020-120 “Public Health Warning Against the Purchase and Use of Unnotified Cosmetic AKOTO KOJIC ACID SOAP WITH COLLAGEN” dated 11 March 2020 and 06 February 2020, FDA Advisory No. Rhodamine B contained in the other products presents as a red to violet powder and has been shown to be carcinogenic in mammalian models. 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. Drugs@FDA: FDA-Approved Drugs. Additionally, tretinoin may also cause harm to developing fetus. Accordingly, the warning against the purchase and use of the subject product as mentioned in FDA Advisory No. 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. 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. 3. Businesses involved in the importation, exportation, trading, and distribution of food, drinks, drugs, pharmaceuticals, cosmetics, or medical devices in the Philippines need to obtain a license to operate (LTO) and a certificate of product registration (CPR) from the Food and Drug Administration (FDA). The FDA has not approved any injectable products for skin lightening. This is due to very low number of course participants that registered in the course. 2020-2081 || 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. Here Is The List Of FDA Approved Medical Face Mask Brands In The Philippines. Further, the FDA has requested the assistance of the Epidemiology Bureau of the Department of Health to ensure that proper information from the patients relative to this incident is collected and verified. FDA APPROVED FACE MASK – Amid the coronavirus epidemic in the Philippines, thousands of retailers have sold face masks to the general public. 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. 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. All companies are asked to ensure that their notified products meet the requirements of the ASEAN Cosmetic Directive, its annexes and appendices. The companies have complied with the requirements as stated in the FDA Memorandum No. BIHAN GIRLY MAKEUP BSKIN CARE 3x BRIGHTENING EFFECT – TREATMENT CREAM For more information and update on the Unified Licensing Seminar for Region II (ULS-RII), please visit the FDA website, www.fda.gov.ph. Regular transactions will resume on Monday, 19 August 2019. Philippine National Drug Formulary (latest edition) R.A. 3720: Foods, Drugs, Devices & Cosmetics Act R.A. 6675: Generics Act of 1988 and Relevant Implementing Rules and Regulations professional team backing up ChemLinked, offers compliance solutions to assist global manufacturers, Those that do show that they are imported either from Taiwan, Hong Kong, or … 2020-1901-A || Lifting the Advisory on the Notified Cosmetic Product “ACTIVEX DUO WHITE FRESH (BLUE BOX)” under FDA Advisory No. Doc Adam advises against use of Dr. Farrah Agustin-Bunch’s non-FDA approved products JO-EST B. TAN. These ingredients are not allowed to be part of a cosmetic product as per ASEAN Cosmetic Directive (ACD). Many of the products were cleaning solutions for surfaces. 1000007138385., has been notified by the Market Authorization Holder, Gandang Kalikasan, Inc. in accordance with existing FDA rules and regulations. The Food and Drug Administration (FDA) warns the public from purchasing and using the following unauthorized cosmetic products. List of Preservatives in Cosmetic Products. 2020-1422-A || Lifting the Advisory on the Notified Cosmetic Product “SPEAKS G ORANGE WHITENING SOAP” under FDA Advisory No. The Philippine FDA (Food and Drug Administration, not to be confused with the US FDA), recently released a list of whitening products it banned from the Philippines because of excessive mercury content, the allowable of which is not over 1ppm. It shall also refer to products that may have an effect on health which require regulations as determined by the FDA. The aforementioned products were verified to contain Mercury, a naturally occuring heavy metal which is known to be severely hazardous to health even in small amount. This ingredient not allowed to be part of a cosmetic product as per ASEAN Cosmetic Directive (ACD). In light of the foregoing, the public is advised not to purchase the aforementioned adulterated product. 2020-1331 is hereby lifted. Pin it ; email ; Print ; Recent New and Generic Drug.. ( who ), the Public Against five “ Unnotified fda philippines list of approved cosmetics Cosmetic products ( BOX... Issey MIYAKI HOMME SPORT for MEN, 1 of any unnotified/unregistered Health products including. Whitening DESPECKLE AB SET 11 of original and supplemental applications fda philippines list of approved cosmetics the safety cosmetics. Fda has released two circulars regarding the Cosmetic products: 1 the federal government websites often in! 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