Other potential risks include transmission of infectious agents, such as HIV, hepatitis C and B. BLEACHING SKIN BY NINA – BLEACHING LIQUID In an advisory, FDA said it recently approved four PCR-based and seven antibody rapid test-kit products. 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). 2020-1422 “Public Health Warning Against the Purchase and Use of the Non-Compliant Cosmetic Product SPEAKS G ORANGE WHITENING SOAP” Dated 27 July 2020. Even if the medicines bought online looks the same; there is no guarantee that it is genuine. Product #1 was found to contain hydroquinone which is an ingredient not allowed to be part of cosmetic products as this is classified as drug product in the Philippines because of its multiple serious adverse effects, such as sensitivity to light, skin redness and permanent skin discoloration, when used indiscriminately. 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. EXECUTIVE ACTIVATED CHARCOAL SOAP Information updated monthly, and current as of November 30, 2020. Share; Tweet; Linkedin; Pin it; More sharing options. Attachment-> : ULS DAVAO VENUE on 22 August 2019. The FDA lists all of its decisions on notification applications on its website. 2020-2127 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic YUNNAN BAIYAO TOOTHPASTE, FDA Advisory No. Large doses of Vitamin C have resulted in hemodialysis in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency. Given that glutathione affects the production of melanin (the pigment that gives the human skin, hair and eyes their color) — there are theoretical concerns about the long term skin cancer risk. Inc, in accordance with existing FDA rules and regulations. POLLA SMOOTH WHITENING FACE CREAM Provisitional List. In light of the foregoing, the public is advised not to purchase the aforementioned unauthorized and adulterated product. b) After securing the CCRR user account, log in at the FDA e-Portal (https://ww2.fda.gov.ph)c) Select “New Case” and accomplish the ASEAN Notification Form.d) Download the Order of Payment and assign the task to FDA Cashier.e) Pay the fee at any Landbank Branch or thru online Bancnet payment and wait for the Result of Application.h) If approved, download and print the notice of acknowledgement. Being a prominent member of ASEAN, Philippines formally adopted the ASEAN Harmonized Regulatory Scheme and the ASEAN Common Technical Documents into the National Requirements in April 2005 and allowed the cosmetic industry a transitory period to 31 Dec 2007. By virtue of FDA Personnel Order No. Please be informed that the conduct of Center for Food Regulation and Research (CFRR) QPIRA Seminar (Course Code: QCFRR-Min) on 17-18 July 2019 within Davao City shall be rescheduled to 3-4 December 2019 and GMP-FMT Seminar (Course Code: GMP-FMT-MEC) on 19 July 2019 shall be rescheduled to 5 December 2019. ANNEX A CENTER FOR COSMETICS … 175 and RA 9711. 2020-07-01. Yes or No . Dissemination of the information to all concerned is requested. 07 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. These ingredients are not allowed to be part of a cosmetic product as per ASEAN Cosmetic Directive (ACD). 5. 1000007080976 is a notified product by the Market Authorization Holder, Evyap Sabun PH Distribution Inc., in accordance with existing FDA rules and regulations. Legal Concepts: Interstate Commerce, Adulterated & Misbranded. 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. The public is advised to always check if a Cosmetic product is notified with the FDA. No. 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. Legal Bases II. 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): FDA Advisory No. Recently, the Philippines FDA has released two circulars regarding the cosmetic products notification and the licensing of the cosmetic establishments. The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product. 4 s. 1992 III. Side effects on the use of injectable glutathione for skin lightening include toxic effects on the liver, kidneys, and nervous system. 2020-238 [DTN 20200228082225] and in FDA Advisory No. 10. MORNING GLOW GLASS SKIN GLOW SET 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. 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. However, in the Philippines, cosmetics are classified separately from drugs. 3. 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. FDA APPROVED FACE MASK – Amid the coronavirus epidemic in the Philippines, thousands of retailers have sold face masks to the general public. 4. 6. C-KISS SUNSCREEN CREAM 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 FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing. c. Morning Glow Tomato Glow Toner The table below indicates the particulars of the unauthorized and adulterated cosmetic products: 1. Attachment-> : Cascading on 7 and 9 August 2019 by CCRR. Attachment:-> FDA-Advisory-No.2020-2019-A. Linkedin; Pin it; Email; Print ; Recent New and Generic Drug Approvals. The Food and Drug Administration (FDA) Philippines (formerly the Bureau of Food and Drugs) was created under the Department of Health as the regulatory and enforcement division for all food, drug, cosmetic, medical, and all related products. The FDA will also ensure that adequate coordination with the Law Enforcement Agencies shall be done to facilitate their own investigation. 2020-1904 and FDA Order No. FDA information on cosmetic soaps and lotions. The Food and Drug Administration (FDA) warns the public from purchasing and using the following unauthorized and adulterated cosmetic product, which tested positive for the presence of HYDROQUINONE, as reported in the ASEAN Post-Marketing Alert System (PMAS). 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. You may also call the Center for Drug Regulation and Research at telephone number (02) 809-5596. All companies are asked to ensure that their notified products meet the requirements of the ASEAN Cosmetic Directive, its annexes and appendices. SHE LEBRITY KIKAY TALK COSMETICS 3IN1 CAKE CLAY BLUSH 8. According to the World Health Organization (WHO), the main adverse effect of exposure to inorganic mercury (e.g. 5 NUDE. The abovementioned product was verified by FDA through postmarketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 01 December 2020. The Food and Drug Administration (FDA) warns the public against the purchase and use of the adulterated and unnotified health product “ CLINS UP ISOPROPYL ALCOHOL ”, which was tested and found to contain METHANOL. 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 MERCURY, as reported in the ASEAN Post-Marketing Alert System (PMAS). In the Philippines, online selling of medicines is NOT permitted pursuant to existing laws, rules and regulations. 6. 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). They must continuously comply with the existing requirements, regulations and standards and under the supervision of a qualified person as required by the regulations. Trace amounts of lead may occur in the foods we eat and the water we drink. 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. The abovementioned product was verified by FDA through post marketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 25 November 2020. 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 […] 8113 or 8107. Seek medical attention immediately if you experience any side effects and report it to FDA at [email protected] or via online reporting through our website: www.fda.gov.ph. Philippines FDA Releases Format For Cosmetics Label Information; May 21, 2014 The Philippines Food and Drug Administration released an information bulletin on how to read labels of cosmetics products. 2020-1733 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic LOUJENE NON ACETONE ENAMEL REMOVER, on FDA Advisory No. 2020-2124 || Public Health Warning Against the Purchase and Use of the following Unauthorized Cosmetic Products: FDA Advisory No. 3. The Food and Drug Administration (FDA) informs the public that the Cosmetic product SUU Balm Dual Cooling & Moisturising Cream Body Wash with Notification No.1000007155098, has been notified by the Market Authorization Holder, Good Pharma Dermatology Phils. 1 2 3. 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. 2020-1422-A || Lifting the Advisory on the Notified Cosmetic Product “SPEAKS G ORANGE WHITENING SOAP” under FDA Advisory No. LANXI 7 DAY WHITENING GINSENG WHITENING BEAUTY MELATONIN CREAM 2. 2020-2021-A || Lifting the Advisory on the Notified Cosmetic Product “Human Nature Balancing Facial Wash (Elemi)” under FDA Advisory No. For example, when applying for the … All registered participants to this seminar shall be automatically moved to the reschedule date of the seminar. Side effects on the use of injectable glutathione for skin lightening include toxic effects on the liver, kidneys, and nervous system. 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. FDA Advisory No. 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. NANA HAND GEL ALCOHOL 80% All registrants who received Course Assessment Slips but have not yet received their Course Confirmation Slips are advised to bring with them the following documents: The confirmed participant of this seminar will be transferred to the next available seminar schedule. These are PCR based reagent kits used in laboratories and not point-of-care or do-it-yourself kits. To report any sale or distribution of the above-mentioned product, kindly e-mail us via [email protected]. 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. b. 5. Online ordering services are additional activities of a Pharmacy or Botika subject for approval of FDA. 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, FDA Advisory No. 2020-1736 || Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic CHRISTOPHER’S PERFUME OUR VERSION OF: ISSEY MIYAKI HOMME SPORT FOR MEN, FDA Advisory No. Injectable glutathione is approved by FDA Philippines as an adjunct treatment in cisplatin chemotherapy. In order to have an efficient and orderly releasing of FDA Authorizations at the Food and Drug Action Center (FDAC), the following guidelines shall be strictly implemented: A. For more information and inquiries, please e-mail us at [email protected]. Attachment:-> FDA-Advisory-No.2020-2021-A. 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. Women planning to get pregnant or are already expecting are strongly advised to avoid using products containing tretinoin. Attachment: CANCELLATION OF UNIFIED LICENSING SEMINAR FOR ARMM STAKEHOLDERS (ULS-ARMM) ON 2 JULY 2019. This is an important milestone for … The LTO is also an essential requirement to be able to notify cosmetic products. Accordingly, the warning against the purchase and use of the subject product as mentioned in FDA Advisory No. MISS MAY FRECKLE & SPOT REMOVING MAGIC CREAM WHITE 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. The Food and Drug Administration (FDA) informs the public that the Cosmetic product SHAWILL MAKE-UP SKIN LIGHTENING POWDER (OIL CONTROL)” with Notification No. But, FDA approval is required for color additives used in cosmetics for their intended use. 2020-2019-A || Lifting the Advisory on the Notified Cosmetic Product “SUU BALM DUAL COOLING & MOISTURISING CREAM BODY WASH” under FDA Advisory No. 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. Second, you will receive the assessment form which will indicate the fees … Not all such products require FDA approval before going on the market. The Food and Drug Administration (FDA) warns the public on the dangers associated with the use of injectable lightening agents such as glutathione. No. On 30 June 2019, the Food and Drug Administration (FDA) received a report on an incident involving two (2) women who allegedly consumed ‘Cosmic Carabao Gin’ and exhibited signs and symptoms related to methanol intoxication which include headache, vomiting, abdominal pain, and affected vision. JOVILAND RITA,GMA News. To report the sale or distribution of any unnotified/unregistered health products, kindly email FDA via [email protected]. MAHAD EXITER WHITENING CREAM 2020-2021 “Public Health Warning Against the Purchase and Use of the Non-Compliant Cosmetic Product ” HUMAN NATURE BALANCING FACIAL WASH (ELEMI) “” Dated 30 October 2020, FDA Advisory No. MORNING GLOW TOMATO GLOW SET 9. 5. Attachment:-> FDA-Advisory-No.2020-1422-A. 1000005137641 has been notified by the Market Authorization Holder, Speaks G Skin Essential Products Enterprise, in accordance with existing FDA rules and regulations. By virtue of FDA Personnel Order No. Companies with correct application documentation will be issued a Notification Certificate. 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. Methanol is a widely available chemical that has many industrial applications and is also found in household products and fuel for aircraft. CHRISTOPHER’S PERFUME OUR VERSION OF: ISSEY MIYAKI HOMME SPORT FOR MEN, 1. 6. AURA WHITE BEAUTY SET 2007-013-A. 13. You may also call the Center for Drug Regulation and Research at telephone number (02) 809-5596. 1. List of Licensed Products and Establishments. 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. 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. Accordingly, the warning against the purchase and use of the subject product as mentioned in FDA Advisory No. 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. Please note the following changes in schedule: Only the first one-hundred (100) pre-registered participants (per session) who received a confirmation email shall be accommodated in the venue. 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