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. PIC/S GMP NK Pidelon Cream “N.K.” 20 Gm 2021-0018 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products: FDA Advisory No. Ophthamed Pharma Corp. is an FDA registered 100% Filipino owned company committed to providing world class quality products to Filipinos at the best possible prices. Attachment: CANCELLATION OF UNIFIED LICENSING SEMINAR FOR ARMM STAKEHOLDERS (ULS-ARMM) ON 2 JULY 2019. FIRST VITA PLUS LEMON GRASS TEA WITH GREEN TEA Juice Drink 340 ml Green Cap (In Foreign Language), 1. 3. GOODTASTE PORK LUNCHEON MEAT Highly complex vendor registration completed for USFDA Registrations, India FDA Registration. 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. FSVP is a risk-assessing program developed under to FDA’s Food Safety Modernization Act of 2011, also known as “FSMA”. To report any sale or distribution of unregistered food product/food supplement, the online reporting facility, eReport can be access at www.fda.gov.ph/ereport. Online ordering services are additional activities of a Pharmacy or Botika subject for approval of FDA. DREAMLIFE Risen Coffee Mix, 1. The FDA has not approved any injectable products for skin lightening. The Bureau of Customs is urged to restrain the entry of the unregistered imported products. You may also look for the FDA Registration number … Laver-Egg Soup In Plastic Cup Packaging With Violet Packaging (In Foreign Language) The Republic Act No. FDA Consulting. Other potential risks include transmission of infectious agents, such as HIV, hepatitis C and B. 2021-0018 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products: FDA Advisory No.2021-980-A || Lifting the Advisory on the Registered Food Product DADDY MIKKS Chili Crunch “Public Health Warning Against the Purchase and Consumption of the Unregistered Food Products”. To date there are no published clinical trials that have evaluated the use of injectable glutathione for skin lightening. Buying medicines over the internet can pose serious health risk. 3. 1. Signs and symptoms of methanol poisoning include headache, vomiting, abdominal pain, hyperventilation, and feeling of breathlessness. RICHMOND RIC Special Noodles Molo Strips White OVERMANWU with Yellow/Black Colored Packaging (In Foreign Language) 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. 2020-2179 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products: FDA Advisory No. 4. You may also look for the FDA Registration number on the product label, if available or the name of the product. Attachment-> : Cascading on 7 and 9 August 2019 by CCRR. OTC Beidougen Jiaonang Capsule 20’s. Contact FDA Follow FDA on Facebook Follow FDA on Twitter View FDA videos on YouTube Subscribe to FDA RSS feeds FDA Homepage Contact Number 1-888-INFO-FDA (1-888-463-6332) PRINCESS Hot Chili Sauce Also, these medicines may not be stored correctly in accordance with its appropriate storage conditions. Appropriate regulatory action shall be imposed on those non- compliant establishments found violating current standards, rules, and regulations. HAIFUSHENG In Paper Cup Packaging with Image of Seafood in Porridge (In Foreign Language) 2. L&P CALAMANSI JUICE, NET VOL. EAGLE BRAND Refined Sugar 4. ... you can use the "Filter" option at the top of the screen to shorten your search. OTTOGI Rice Tteokbokki (In Foreign Language) By virtue of FDA Personnel Order No. 2020-2157 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products: FDA Advisory No. Bottled Juice Drink with Picture of Guava (In Foreign Language) Attachment-> : RESCHEDULING OF QCCRR–MIN AND ULS-RX. The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND CONSUME the following unregistered food supplements: 1. 5. Napatunayan sa pamamagitan ng isinagawang Post-Marketing Surveillance (PMS) ng FDA na ang mga nasabing gamot ay hindi dumaan sa proseso ng rehistrasyon ng Ahensya at hindi nabigyan ng kaukulang awtorisasyon tulad ng Certificate of Product Registration (CPR). Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. 1. Also read: FDA warns against Toni Gonzaga’s cologne brand GREAT VALUE Ginisang Alamang HAIFUSHENG In Paper Cup Packaging with image of Pork Ribs in Porridge (In Foreign Language) 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. FDA Deposit Account Number: 75060099. PANGAEA HEALTH AND WELLNESS Organic Graviola (Guyabano) Powder Please note that photocopy of each required document is needed for every request. 2019-0523, please be advised that the Center for Cosmetics Regulation and Research (CCRR) will conduct a Cascading-Workshop on the new Administrative Orders on the Regulation of Electronic Nicotine Delivery Systems (END/ENDDS), Household Pesticide and Their Active Ingredients, Operators of Pest Control, Certification of Pesticide Handlers and Accreditation of Their Training Providers, Reinstatement of Licensing and Registration and or Notification of Household Urban Substances and Implementing Rules and Regulations of RA10620 on 15 to 16 of August 2019.On such dates, CCRR will not be able to entertain clients. The Food and Drug Administration (FDA) warns the public on the dangers associated with the use of injectable lightening agents such as glutathione. 2020-2165 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products: FDA Advisory No. Currently, this product is not registered with the FDA. FDA Advisory No. Upon receipt of DRF, the Releasing Officer checks on the files for release. 5. 3. These databases can be accessed through the FDA’s website. All concerned establishments are warned not to distribute, advertise, or sell the said violative food supplements until CPR are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. FDA Registration or FDA registration number does not denote FDA certification or FDA approval of your facility or products. 2. Please be informed that the venue of the Unified Licensing Seminar (ULS – RI) on 31 July 2019 and 1 August 2019 will be in NORTHVIEW HOTEL, BRGY. With this, the FDA commenced its own investigation on the implicated product ‘Cosmic Carabao Gin’ which is a locally manufactured alcoholic beverage. Attachment->:ADVISORY-RELEASING OF FDA AUTHORIZATIONS AT THE FOOD AND DRUG ACTION CENTER (FDAC). Tomato-Egg Soup In Plastic Cup Packaging with Red Packaging (In Foreign Language) JAM’S Pork Chicharon 4. Re-register or verify that your registration was renewed for : Paragis Herbal Capsule 2020-2164 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products: FDA Advisory No. 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. 5. You may also look for the FDA Registration number on the product label, if available or the name of the product. Address: 12F Sagittarius Building, 111, H.V. 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. DR. WANG TURMERIC COFFEE This is of particular concern when non-medical practitioner administers this treatment or done in a non-sterile facility. HAIFUSHENG In Paper Cup Packaging with Image of Porridge (In Foreign Language) Side effects on the use of injectable glutathione for skin lightening include toxic effects on the liver, kidneys, and nervous system. For inquiries and other concerns, you may reach the FDA Academy thru: Attachment-> : ULS-RII POSTPONEMENT ON JULY 18 2019. Use the search feature on their website at www.fda.gov.ph or look for the FDA registration number on the product label in the form of CMDN-xxx. For more information and inquiries about this advisory, kindly contact the FDA Center for Food Regulation Office and Research through email [email protected] indicating on the subject the concerned Advisory, or call (02)857-1900 local 8112. FDA Advisory No. How to Get an FDA Certificate of Product Registration in the Philippines. A medicine bought online may contain no active ingredient; too much or too little of active ingredients which may result to your condition not being treated correctly. There are also no published guidelines for appropriate dosing regimens and duration of treatment. 3. All Local Government Units and Law Enforcement Agencies are requested to ensure that this product is not sold or made available in their localities or areas of jurisdiction. It is important to seek medical advice from doctor or pharmacist before taking medicines. 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. Metro Manila Head Office. All Law Enforcement Agencies (LEAs) and Local Government Unit (LGUs) are requested to ensure that these products are not sold or made available in the market or areas of jurisdiction. The FDA verified through post-marketing surveillance that the above mentioned food products are not registered and no corresponding Certificates of Product Registration (CPR) have been issued. Currently, FDA only allows online ordering services provided that the seller has an existing FDA-licensed Pharmacy or Botika with physical address. It is alarming that they also offer services such as intravenous drip or infusion using skin lightening agents including reduced glutathione, vitamin C and other injections. Drink in Pet Bottle with Black and Gold Packaging (In Foreign Language) Please be informed that the venue of the Unified Licensing Seminar (ULS – RXI) on 14 August 2019 will be in CORNER ONE EVENTS HUB, CORNER MABINI SUPERHIGHWAY, APLAYA, DIGOS CITY, DAVAO DEL SUR. The public is warned to exercise extreme caution in purchasing or consuming alcoholic beverages and advised to purchase and consume only those which are registered with the FDA. Higher concentrations of methanol in alcoholic drinks can happen when methanol is deliberately added to alcoholic drinks. Injectable glutathione is sometimes paired with intravenous Vitamin C. Vitamin C injection may form kidney stones if the urine is acidic. 3. 3. Avoid buying injectable products online and from being lured to a promising effect of medicines as beauty products. SWIFT Number: FRNYUS33. There are also no published guidelines for appropriate dosing regimens and duration of treatment. PANGAEA HEALTH AND WELLNESS Organic Moringa (Malunggay) Powder. 2020-2172 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products: on FDA Advisory No. G-RUTH Peanut Butter Samakatuwid, ang paggamit ng nasabing mga iligal na produkto ay maaaring magdulot ng panganib sa kalusugan. 4. 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. Appropriate regulatory action shall be imposed on those non- compliant establishments found violating current standards, rules, and regulations. 5. 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. To find a specific manufacturer’s FDA registration number, go to the database that contains its industry’s registrations. All concerned establishments are warned not to distribute, advertise, or sell the said violative food products until CPR are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. SCREAM Drink in Green and White PET Bottle (In Foreign Language) UCC Milk Coffee Hibanny (In Foreign Language) 3. 1. Government Authority. This is in consideration to the reinstatement of the HUHS licensing and notification requirements. Large doses of Vitamin C have resulted in hemodialysis in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency. To assure that your skin conditions are treated, consult only a board-certified dermatologist. Course Assessment Slip The Center for Drug Regulation and Research (CDRR) will be having its Operational Planning on 17-19 July 2019. GREAT VALUE Marshmallow, 100g. 2021-0020 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products: FDA Advisory No. 5. This page contains links with information on how to register a food facility. Medical device product registration in the Philippines is managed by the Center for Device Regulation,Radiation Health and Research (CDRRHR) within the Department of Health.With efforts to harmonize the Philippine Regulatory Guidelines in accordance with the ASEAN Medical Devices Directive, the Philippines Department of Health recently released Administrative Order 2018-0002. Select a pending registration from the display of all registrations with "registration number not yet assigned" under your account and click "Cancel Selected Registration." 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. Since these unregistered food products have not gone through evaluation process of the FDA, the agency cannot assure its quality and safety. Attachment-> : Cascading on 7 and 9 August 2019 by CCRR. 5. 4. 2. REWEL’S Peanut Butter PANGEA HEALTH AND WELLNESS Organic Turmeric Powder 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. Beneficiary: FDA 8455 Colesville Road, COLE-14-14253 Silver … Please be informed that the venue of the Unified Licensing Seminar (ULS – RIX) on 5 July 2019 will be in HOTEL GUILLERMO, RIZAL AVENUE, PAGADIAN CITY. 2. 2020-2162 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products: FDA Advisory No. Instant Noodles Hot Beef Flavor Orange Pouch Packaging (In Foreign Language) Regular transactions will resume on Monday, 19 August 2019. The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND CONSUME the following unregistered food supplement and food products: 1. In the interest of public protection, the Field Regulatory Operations Office inspectors and Regulatory Enforcement Unit officers of FDA shall seize and/or confiscate all Cosmic Carabao Gin products available in the market. 3. WERDERY Milk Drink – Blueberry in White and Violet PET Bottle (In Foreign Language) 5. 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. 4. OTTOGI Soup Tteok-bokki (In Foreign Language) To report any sale or distribution of unregistered product, the online reporting facility, eReport can be accessed at  www.fda.gov.ph/ereport. 5. RICHMOND RIC Miswa Small In the Philippines, online selling of medicines is NOT permitted pursuant to existing laws, rules and regulations. 2. The confirmed participant of this seminar will be transferred to the next available seminar schedule. OK CHOCOLATE POWER Chocolate with Nuts Paste For more information and update regarding FDA seminars, please visit the FDA website, www.fda.gov.ph. AM NOBLE Instant Turmeric Powder Accordingly, the list released in FDA Advisory No. Proof of Payment, VENUE FOR UNIFIED LICENSING SEMINAR ON 3 & 4 JULY 2019. This is of particular concern when non-medical practitioner administers this treatment or done in a non-sterile facility. All confirmed participants of this seminar shall be automatically moved to the rescheduled date. However, non-toxic trace amounts of methanol can also be naturally present in fruit juices. For more information and inquiries, please e-mail us at [email protected]. PRINCE Calamansi Juice L&P CALAMANSI JUICE, NET VOL. 1. Signs and symptoms of methanol poisoning include headache, vomiting, abdominal pain, hyperventilation, and feeling of breathlessness. 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. Attachment:-> FDA-Advisory-No.2020-2176-A, 1. The Food and Drug Administration (FDA) warns the public on the dangers associated with the use of injectable lightening agents such as glutathione. ALTER TRADE Coconut Sugar TOWER CHARPONS Rosquillos, 500g, To report any sale or distribution of unregistered product, the online reporting facility, eReport can be accessed at  www.fda.gov.ph/ereport, 1. 2020-2161 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products: on FDA Advisory No. Pursuant to the Republic Act No. Buying medicines over the internet can pose serious health risk. Releasing Officer releases the Authorization/s to Client. Food Product in Gray and Blue Foil Packaging (In Foreign Language), 1. Juice Drink with Picture of Pomegranate Packaging Pink in Color (In Foreign Language) 46, AIRPORT ROAD, LAOAG CITY, ILOCOS NORTE. The Bureau of Customs is urged to restrain the entry of the unregistered imported products. Ang lahat ay hinihikayat na palaganapin ang mga nakasaad na impormasyon. FDA Registration Services in the Philippines. Domestic and foreign establishments that manufacture, repack, or re-label animal drug products in the United States are required to register with the FDA. All registered participants to this seminar shall be automatically moved to the reschedule date of the seminar. Cruz, Manila. JAM’S REPACKING Fish Cracker – Hot 5. 3. 2. 2020-2163 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products: on FDA Advisory No. Upang mag-report ng patuloy na pagtitinda o pangangalakal ng mga hindi rehistradong gamot, mag-email sa [email protected]. WERDERY Milk Drink – Green Apple in Green and White PET Bottle (In Foreign Language) Please be informed that the venue of the Unified Licensing Seminar (ULS – RIX) on 5 July 2019 will be in HOTEL GUILLERMO, RIZAL AVENUE, PAGADIAN CITY. This is also a product of natural fermentation and is found in both alcoholic and non-alcoholic fermented beverages. Pursuant to the Republic Act No. 2020-2181 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products: on FDA Advisory No. Contact FDA Follow FDA on Facebook Follow FDA on Twitter View FDA videos on YouTube Subscribe to FDA RSS feeds FDA Homepage Contact Number 1-888-INFO-FDA (1-888-463-6332) Random searches are not allowed. 7 J.P LAUREL AVENUE, LANANG, DAVAO CITY, DAVAO DEL SUR. PAN DE MANILA Classic Tuyo in Corn Oil 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. Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. ENERGY Tengjiaoguniang Cup Noodles in Pink and Brown Packaging (In Foreign Language) 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. Serving Filipinos through the responsible licensing and registration of quality and safe products. The Food and Drug Administration (FDA) informs the public that the food product DADDY MIKKS CHILI CRUNCH Chili Garlic Bits has been registered by the Market Authorization Holder (MAH) DADDY MIKKS CHILI CRUNCH in accordance to 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 These databases can be accessed through the FDA’s website. Meat Like Product in Clear Plastic Sachet Packaging (In Foreign Language) 2021-0019 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products: on FDA Advisory No. 3. Noodles with Black Packaging (In Foreign Language) CHUTIANSHU YAO YE Clear Drink in White and Green PET Bottle (In Foreign Language) Always check if a product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. 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. 3. 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. This is due to very low number of course participants that registered in the course. It is alarming that they also offer services such as intravenous drip or infusion using skin lightening agents including reduced glutathione, vitamin C and other injections. J-GEM-R BAKERY AND FOOD PRODUCTS Special Pilipit, 125g FSVP requires verification of the foreign suppliers of food items entering the U.S., and it demands conduction of procedures and actions to assure the safety of food exported to the United States. Also of concern is the possibility of Stevens Johnson Syndrome. Dahil dito, hindi masisiguro ng Ahensya ang kalidad, kaligtasan at bisa nito. 2020-2151 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products: 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. 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. Please be informed that the conduct of ULS-ARMM in Cotabato City (Course Code:ULS-ARMM) scheduled on 2 July 2019 is cancelled due to very low number of course participants that registered in the seminar. You may also call the Center for Drug Regulation and Research at telephone number (02) 809-5596. This is due to very low number of course participants that registered in the course. SCREAM Drink in Blue and White PET Bottle (In Foreign Language) 3. 3. 4. This process is done in conjunction with the human drug registration process. DR. WANG TURMERIC COFFEE 2. DELICIOUS LEGEND STARTING FROM YIDA JIUZHIYANGMEI (In Foreign Language) fda registration number … 5. 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. 2. 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. HAOHUANLUO Liuzhou Snail Rice Noodles Instant Noodles in Foil Pouch with Yellow Packaging 400g (In Foreign Language) 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). FARM TO FOLK Organic Cacao Husk Tea 2021-0020 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products: on FDA Advisory No. 2. LIANGZHONGMEIWEI ZIWEIFANBEI 1+1>2 with Preserved Meat and Shoot tip Image in Light Brown and White Box (In Foreign Language) The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND CONSUME the following unregistered food products: 1. 2020-2174 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products: FDA Advisory No. 1. This will prevent the name from appearing on the public FDA website. For more information and update on the Unified Licensing Seminar for Region II (ULS-RII), please visit the FDA website, www.fda.gov.ph. CHACHEER Sunflower Seeds in Brown and Red Packaging (In Foreign Language), 1. Chicken Feet In Green and White PET Bottle ( In Foreign Language ) 3 domestic and Foreign Drug manufacturers repackers. To list all of their commercially marketed Drug Products, the Releasing Officer checks on the Public FDA Highly... 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