Tationil Glutathione
- Advisory # 1 October 24, 2019
- Advisory # 2 October 15, 2019
- Advisory # 3 July 10, 2019
- Advisory #4 July 5, 2019
- Advisory #5 February 18, 2019
Advisory # 1
The Food and Drug Administration (FDA) informs the public that the below cosmetic product has been notified by the Market Authorization Holder (MAH), Royale Business Club International, Inc., in accordance to existing FDA rules and regulations:
| Royale Beauty L-Gluta Power Soap with Glutathione,Alpha Arbutin, Collagen & Shea Butter | · Notification No. 1000003604525 |
Accordingly, the list released in FDA Advisory No. 2018-214 is hereby updated to remove the aforementioned cosmetic product.
The public is advised to always check if a cosmetic product is notified with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing. Kindly contact the FDA Center for Cosmetics Regulation and Research through e-mail at ccrr@fda.gov.ph, or call (02) 857-1900 loc. 8113 or 8117.
To report any sale or distribution of unnotified cosmetic products, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.
The public health warning imposed on the remaining products listed in FDA Advisory No. 2018-214 shall remain to be upheld and shall not be affected by the issuance of this advisory.
Furthermore, the issuance of this advisory shall not in any manner preclude this Office from issuing subsequent orders it may deem necessary and appropriate, should there be findings of any violation of the company to the existing laws, rules, and regulations.
Dissemination of this advisory to all concerned is hereby requested.
Attachment:-> FDA Advisory No. 2018-214-A
Advisory # 2
MANUFACTURER OF UNREGISTERED GLUTATHIONE PRODUCT FOUND GUILTY BY THE REGIONAL TRIAL COURT
Press Release 15 October 2019
On 04 September 2019, the Regional Trial Court in Mandaluyong City promulgated a Judgment against Leo Plantilla Ortiz (Ortiz), owner of JLO General Merchandise, finding him guilty of violation of Republic Act No. 9711. He was sentenced to pay the fine of One Hundred Thousand Pesos (Php100,000.00).
The accused Ortiz was found to have willfully, unlawfully and feloniously, manufactured or caused the manufacture of different health products identified as: (a) 12-in-1 Gluta Lipo with Glutathione and L- Carnitine Lemon Flavor (also referred to as Gluta Lipo 12-in-1 (Glutathione) Whitening and Slimming Juice, 12- Gluta Lipo Whitening Juice(Glutathione); (b) 12-in1 Gluta Lipo Detox Coffee (also referred to as 12-in-1 Gluta Lipo Detox Coffee (Glutathione); and (c) Gluta Lipo Ultima Plus capsules without first registering said products before the Food and Drug Administration (FDA). The agents of the Regulatory Enforcement Unit of the FDA made the arrest and filed criminal charges against the accused.
He was charged of clearly violating Section 10 (a) and (j) Republic Act No. 9711 known as the Food and Drug Administration Act (FDA) of 2009, amending Section 11 of Republic Act No. 3720, as amended, which provide:
“SEC. 10. Section 11, subsections (a), (b), (d), (g), (j), (k) and (l) of Republic Act No. 3720, as amended, are hereby further amended to read as follows:
“SEC. 11. The following acts and the causing thereof are hereby prohibited:
“(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.
“6) The manufacture, importation, exportation, sale, offering for sale, distribution,
transfer, non-consumer use, promotion, advertisement, or sponsorship of any health
product which, although requiring registration, is not registered with the FDA
pursuant to this Act.”
In a statement, Undersecretary for Health and FDA’s Director General, Rolando Enrique D. Domingo, declared that this verdict of the Court shall serve as a warning to all concerned people or entities to strictly comply with the provisions of Republic Act No. 3720, as amended, and further amended by Republic Act No. 9711, as well as, other FDA-implemented laws and secure the required appropriate licenses to operate an establishment and register their products.
“To those who continue with their illegal and nefarious activities of manufacturing, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the benefit of registration and license to operate, at the expense of the health of the people, the FDA shall be relentless in pursuing legal actions against them,” he said.
Advisory # 3
The Food and Drug Administration (FDA) informs the public that the food supplement NUWHITE PREMIUM Glutathione, Collagen & Vitamin E Food Supplement Capsule has been registered by the Market Authorization Holder, OXINA NUTRICOSMETICS CO., in accordance to existing FDA rules and regulations.
Accordingly, the list released in FDA Advisories No. 2017-226 and 2017-245 are hereby updated to remove the aforementioned food supplement.
The public is advised to always check if a food product is registered with the FDA. The FDA website (www. fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing. Kindly contact the FDA Center for Food Regulation and Research through e-mail at cfrr@fda.gov.ph, or call (02) 857-1900 loc. 8112 or 8105.
To report any sale or distribution of unregistered food products, the online reporting facility, report can be accessed at www.fda.gov.ph/ereport.
Attachment-> : FDA Advisory No. 2019-187
Advisory # 4
FDA Advisory No. 2019-182 || UNSAFE USE OF GLUTATHIONE AS SKIN LIGHTENING AGENT
The Food and Drug Administration (FDA) warns the public on the dangers associated with the use of injectable lightening agents such as glutathione.
In the Philippines, several health and beauty salons, wellness spa and beauty clinics are offering all kinds of beauty enhancements, services and skin treatments. 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.
To date there are no published clinical trials that have evaluated the use of injectable glutathione for skin lightening. There are also no published guidelines for appropriate dosing regimens and duration of treatment. The FDA has not approved any injectable products for skin lightening. Injectable glutathione is approved by FDA Philippines as an adjunct treatment in cisplatin chemotherapy.
Side effects on the use of injectable glutathione for skin lightening include toxic effects on the liver, kidneys, and nervous system. Also of concern is the possibility of Stevens Johnson Syndrome. Injectable glutathione is sometimes paired with intravenous Vitamin C. Vitamin C injection may form kidney stones if the urine is acidic. 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.
Other potential risks include transmission of infectious agents, such as HIV, hepatitis C and B. This is of particular concern when non-medical practitioner administers this treatment or done in a non-sterile facility.
To assure that your skin conditions are treated, consult only a board-certified dermatologist. Avoid buying injectable products online and from being lured to a promising effect of medicines as beauty products.
Seek medical attention immediately if you experience any side effects and report it to FDA at pharmacovigilance@fda.gov.ph or via online reporting through our website: www.fda.gov.ph. You may also call the Center for Drug Regulation and Research at telephone number (02) 809-5596.
18FEB
Advisory # 5
The Food and Drug Administration (FDA) warns the public from purchasing and consuming the following food supplements:
- MG SQUALENE SHARK LIVER OIL FOOD SUPPLEMENT,500mg
- SHIROI HADA SLIMMING JELLY
- SHIROI HADA GLUTATHIONE JELLY
- NUTRI HERBS JAMUN EXTRACT FOR SUGAR CONTROL
- HEALTH AND NATURALS MANGOSTEEN POWER HERBAL VEGGIE CAPSULES XANTHONE FOOD SUPPLEMENT
The FDA verified through post-marketing surveillance that the abovementioned food supplements are not authorized and the Certificates of Product Registration have not been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.
Since these unregistered food supplements have not gone through evaluation process of the FDA, the agency cannot assure their quality and safety. The use of such violative products may pose health risks to consumers.
In light of the foregoing, the public is advised not to purchase the aforementioned violative products. Moreover, the public is advised to always check if a food supplement is registered with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing.
All concerned establishments are warned not to distribute violative food supplement until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a CPR for the food supplement.
All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that violative products are not sold or made available in the market or areas of jurisdiction.
Kindly contact the FDA Center for Food Regulation and Research through e-mail at cfrr@fda.gov.ph, or call (02) 857-1900 loc. 8112 and 8105.
To report any sale or distribution of unregistered food supplement, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.
Dissemination of this advisory to all concerned is hereby requested.
Attachment:-> FDA Advisory No.2020-159
14FEB
