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PUBLIC ADVISORY ON GLUTATHIONEAS A “SKIN WHITENING” AGENT
Philippine Dermatological Society -November 2018
Prepared by the Glutathione Advisory Committee 2018
- What is glutathione? Glutathione is a molecule composed of three amino acids (glutamine, cysteine, glycine). It is produced inside our cells (endogenous) and functions as an important antioxidant, for metabolism, and body regulation. Glutathione is naturally found in fresh food and can be man-made as glutathione-containing products (i.e. oral and injectable nutritional supplements, inhaled drug, skin products).1,2
- What are the approved uses of glutathione products in the Philippines? NONE OF THE SYSTEMIC GLUTATHIONE CONTAINING PRODUCTS AROUND THE WORLD HAVE BEEN APPROVED FOR SKIN WHITENING.3,4 The Phlippine Food and Drug Administration (FDA) has approved oral glutathione products as nutritional supplements only. Injectable (intravenous/ “drips”) glutathione has only been approved as a drug to protect cancer patients from nerve side-effects of platinum-based chemotherapy.5
- Is glutathione a proven skin whitening agent? Not yet. Current scientific evidence is not strong enough to establish glutathione-containing products as efficacious “skin whiteners” when tested on healthy volunteers. High quality clinical trials are needed to prove its efficacy as a skin whitener, its dose, how long its effect lasts, and what types of pigmentation it can work well on.3
- Is glutathione a safe product for skin whitening? Its safety as a skin whitener has not yet been firmly established. Glutathione products are “generally recognized as safe” (GRAS).4 However, various side effects, ranging from mild to severe, have been linked to glutahione-containing products when used as “skin whiteners”. 6,7 FDA warns against the use of injectable glutathione as a skin whitener because whitening is not an approved use,9 efficacy is not well-established, and there have been reported side effects (acute renal failure, severe drug reactions such as generalized morbilliform eruption with angioedema and urticaria, vasculitis, anaphylactic shock and many documented side effects based on studies on IV glutathione used as skin whitening).6,7,8, 12
- Intravenous Glutathione products’ proven and approved use is primarily for medical use ie supportive treatment for chemotherapy patients and NOT for cosmetic purposes. 5,10
- The use of any medication should be prescribed and administered by a licensed physician and intended solely for the patient’s greater benefit with significant consideration to their safety and welfare.
- The public is advised to be cautious of any marketed product for treating skin conditions (ie skin lightening) and should consult with a board certified dermatologist, member of the Philippine Dermatological Society, on products that are FDA-approved and proven to treat certain skin conditions (ie hyperpigmentation and melasma).
- Active pharmacovigilance and public reporting to the FDA is encouraged. The Public is advised to be alert and report experienced side effects to any glutathione-containing product to suspected_adverse_reactions@yahoo.com via the Philippine Dermatological Society and to FDA using the link for the report form: https://www.fda.gov.ph/industry-corner/downloadables/265-suspected-adverse-reaction-form or fda.gov.ph/adr-report-new or report through phone call at 809-5596.11
- Consumers can check the registration of any health product with the FDA by visiting the FDA website – fda.gov.ph and reporting of unregistered, banned or illegal health products can be done through email via report@fda.gov.ph.11
IN THE INTEREST OF PUBLIC SAFETY LET IT BE KNOWN THAT:
- IV GLUTATHIONE IS A DRUG AND NOT MERELY A NUTRITIONAL SUPPLEMENT
- THE UNAPPROVED US OF IV GLUTATHIONE ADMINISTERED FOR SKIN LIGHTENING AT VERY HIGH DOSES IS UNSAFE AND MAY RESULT TO SERIOUS CONSEQUENCES TO THE USERS.
- THE RISK OF HARMFUL SIDE EFFECT INCREASES WHEN NON-PHYSICIANS INJECT GLUTATHIONE
- THE PUBLIC IS STRONGLY WARNED TO REFRAIN FROM USING GLUTATHIONE PRODUCTS THAT ARE NOT PHILIPPINE FDA-APPROVED AND USED OUTSIDE THE DOSES APPROVED BY FDA
Prepared by:
Glutathione Advisory Committee 2018, Philippine Dermatological Society
Dr. Belen L. Dofitas, MD FPDS
Dr. Eleonor B. Asuncion, MD FPDS
Dr. Ma. Katrina Carmina Nisce-Anisco, MD FPDS
Dr. Ma. Angela M. Lavadia, MD FPDS
References:
- Glutathione Metabolism and Its Implications for Health. Guoyao Wu Yun, Zhong Fang Sheng Yang, Joanne R. Lupton and Nancy D. Turner ..The Journal of Nutrition, Volume 134, Issue 3, 1 March 2004, Pages 489- 492,https://doi.org/10.1093/jn/134.3.489
- Glutathione, glutathione supplements, and the skin: The basic facts. Author(s): Belen L. Dofitas Journal of the Philippine Dermatological Society. May 2009, Vol 18(1)p. 37-40 (Journal).
- Glutathione supplements and the skin: An exploratory study and review of the best current evidence. Belen L. Dofitas, Eileen Vizconde. Journal of the Philippine Dermatological Society, November 2008: Vol. 17(2): p. 98-102 (Journal).
- Food and Drug Administration, Center of Drug Regulation and Research. Data accessed June 2017 and October 2018. www.fda.gov.ph.
- Role of glutathione in the regulation of Cisplatin resistance in cancer chemotherapy. Chen HH, Kuo MT. Met Based Drugs. 2010;2010:430939.
- Glutathione for skin whitening: A systematic review and meta-analysis (Abstract). Toledo, Ma. Socorro and Dofitas, Belen. Dept. of Clinical Epidemiology, College of Medicine, University of the Philippines Manila, 2016 (unpublished).
- Glutathione for skin lightening: a regnant myth or evidence-based verity? Sonthalia, Sidharth, Abhijeet K Jha… and Deepak Jakhar. Dermatol Pract Concept. 2018 Jan; 8(1): 15-21. Published online 2018 Jan 31.
- Efficacy of intravenous glutathione vs. placebo for skin tone lightening. Zubair S, Hafeez S, Mujtaba G. J Pak Ass Dermatol. 2016;26:177–181.
- Food and Drug Administration. May 12, 2011. Public Advisory. https://ww2.fda.gov.ph/index.php/advisories-2/cosmetic-2/38960-doh-fda-advisoryno-2011-004
- Effects of Glutathione Supplementation: A Systematic Review and Meta-Analysis. Alolod M, Alonte A. and Dofitas B. St. Luke’s Medical Center, Department of Medicine,Metro Manila, Philippines, 2009 (Unpublished).
- Food and Drug Administration. November 15, 2016. Public Advisory. https://ww2.fda.gov.ph/attachments/article/381213/FDA%20Advisory%20No.%202016-133.pdf
- Adverse effects observed by Filipino-Dermatologists among patients using glutathione containing products: an exploratory study. Asuncion, Eleonor and Dofitas, Belen. Department of Dermatology, St. Luke’s Medical Center 2011 (unpublished).
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FAQs
What is the FDA warning on glutathione? ›
WARNING TO THE PUBLIC: The use of glutathione IV as a skin whitener is not approved by the FDA. The public is strongly warned to refrain from using glutathione for this purpose in light of potential harm associated with such use.
Which glutathione brand is best for skin whitening? ›Thorne Glutathione-SR
If you are looking for a skin whitener that will also offer your eyes, heart, liver, and other body organs a boost in immune function, then the Thorne Glutathione SR might be what you are looking for. It supports eye health and liver detoxification. It reduces oxidative stress and brightens skin.
A Glutathione efficacy in skin lightening works only if it is taken with Vitamin C at least equal or twice its dosage. Standard dosage is 20-40 mg/kg of body weight for 3-6 months once or twice in a day and best if taken at night 2-3 hours after last meal for better absorption.
What happens when you stop using glutathione? ›Its whitening effects are permanent only if you will maintain it (by avoiding exposure to sunlight). You won't go back to your original skin colour even if you stop taking these supplements, however, there is a tendency for you to be tan or darken your skin if you expose yourself to sunlight and other harsh elements.
Is glutathione banned in USA? ›The FDA already warned the public that glutathione injectables are illegal in 2011 and said that no medical studies have been done to prove that they are safe to use as whitening treatments.
Do doctors recommend glutathione? ›As of yet, there is no good study of the use of glutathione in healthy people. Some nutritionists recommend increasing the intake of the amino acids cysteine and glutamate, which make glutathione, but this hasn't been studied either.
What is the most effective glutathione in the world? ›- Quicksilver Scientific Glutathione Complex. ...
- Quicksilver Scientific Liposomal Glutathione. ...
- Douglas Labs Liposomal Glutathione. ...
- Pure Encapsulations Liposomal Glutathione Softgels. ...
- Thorne Glutathione-SR.
Typically, it takes 1-3 months for people with light-medium brown skin to see some lightning effects of glutathione. For people with dark brown skin, glutathione takes 3-6 months to lighten the skin. However, people with very dark skin may see the lightning effect of glutathione in 6-12 months.
What glutathione is effective in the Philippines? ›Luxxe White offers the best glutathione in the Philippines that are readily available in the market. It also helps in clearing acne among users. For fast and better results it is recommended to be taken every four hours and 1 hour before breakfast.
How many shades lighter can glutathione make you? ›The amount of IV sessions of glutathione depends on how many shades lighter you want your skin tone to be. Typically 10 IV's will be performed twice a week for 5 weeks. Typically one round of treatment (10 IV's) can lighten the skin from 1 to 3 shades lighter.
How many times a week should I inject glutathione? ›
It is recommended to take glutathione injection 1-3 times per week for 4-8 weeks. Your response to the treatment will determine if you will continue taking the injection after this period.
How many shades can you lighten your skin with glutathione? ›Now that your body is a glutathione “factory”, you can reap the benefits of skin lightening (in some cases up to 3-4 shades lighter). It'll also be effective against freckles, age spots, acne scars, and blemishes.
What are the dangers of glutathione? ›No side effects have been reported with a high glutathione intake from diet alone. However, there's some concern that using glutathione supplements may cause cramping and bloating or allergic reactions, with symptoms like a rash.
Can glutathione damage the kidney? ›Downregulation of Glutathione Biosynthesis Contributes to Oxidative Stress and Liver Dysfunction in Acute Kidney Injury.
What toxins does glutathione remove? ›At the same time, the conjugation of glutathione with toxins helps to detoxify and eliminate fat-soluble toxins and heavy metals. It detoxifies even other environmental toxins such as many solvents, herbicides, fungicides, polycyclic aromatic hydrocarbons, and lipid peroxides.
Why glutathione is not FDA approved? ›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.
Is glutathione FDA approved for skin whitening? ›The FDA also said that it has not approved any injectables for skin lightening and that injectable glutathione is only approved as an adjunct treatment in cisplatin chemotherapy. Side effects of using injectable glutathione for skin lightening include toxic effects on the liver, kidneys, and nervous system.
Does glutathione damage the skin? ›Glutathione plays a significant role in keeping skin healthy and young. It not only acts as an astonishing skin-brightening agent but is also known to reduce wrinkles, fine lines and improve skin elasticity. All these attributes of glutathione are due to its amazing skin-protecting properties.
Who should avoid glutathione? ›Avoid taking glutathione if you're sensitive to it. Experts don't know if taking glutathione is safe during pregnancy and while breastfeeding. Interactions. Tell your doctor about any supplements you're taking, even if they're natural.
Which is better collagen or glutathione? ›Unlike collagen supplements that take care of skin aesthetics, glutathione supplements work deeper inside and work with the skin cells to promote good skin health. Glutathione, the master antioxidant of the body, fights free radicals.
Does glutathione affect the heart? ›
Glutathione peroxidase polymorphisms seem to increase the risk of developing coronary artery disease, stroke, and cerebral thrombosis. In smokers, the increased risk of coronary heart disease is related to glutathione S-transferase polymorphisms [77].
How much is glutathione in the Philippines? ›A 500mg glutathione vial costs P1,500 and dermatologist consultation amounts to P500 per session.
Is glutathione better than hydroquinone? ›Glutathione is another non-hydroquinone product that is increasing in popularity. There were evidenced-based studies cited that showed that combination treatment is more effective than monotherapy with the combination of hydroquinone 4%, tretinoin 0.05%, and fluocinolone acetonide 0.01% or other variations.
What is the No 1 glutathione brand in Japan? ›During our research process, we came across Now Foods L-Glutamine 500mg 120 capsules, which made its mark at number 1 of the list of best L-Glutathione Supplements in Japan.
Can glutathione make you look younger? ›Glutathione holds many anti-ageing benefits. Since it is a natural detoxifier, it improves the health of the body's cells to reverse ageing. Like melatonin, Glutathione protects the skin against oxidative damage which leads to wrinkles - making it an excellent form of anti-ageing skincare.
What happens when you start taking glutathione? ›According to one study , glutathione helps reduce oxidative stress by either stimulating or reducing the body's immunological response. Autoimmune diseases attack the mitochondria in specific cells. Glutathione works to protect cell mitochondria by eliminating free radicals.
Does glutathione fade dark spots? ›To simply put, glutathione injections work effectively in lightening the dark spots and reducing hyperpigmentation by neutralizing free radicals, removing melanin, and fighting inflammation.
Does glutathione reduce belly fat? ›Another method of losing belly fat is supplementation, such as glutathione intake. Glutathione supplements have been found to reduce lipogenesis, improve insulin sensitivity and decrease belly fat [13].
What is the best natural source of glutathione? ›Eat Foods Naturally Rich in Glutathione
Spinach, avocados, asparagus and okra are some of the richest dietary sources ( 13 ). However, dietary glutathione is poorly absorbed by the human body. Additionally, cooking and storage conditions can decrease the amount of glutathione found in food.
Downregulation of Glutathione Biosynthesis Contributes to Oxidative Stress and Liver Dysfunction in Acute Kidney Injury.
Can glutathione cause blood clots? ›
This is where glutathione's primary role in the body comes into play. Apart from its various benefits mentioned above, it also plays the role of a natural blood thinner. It shields against abnormal blood clots and reverses the build-up of plaque.
Is glutathione capsule approved by FDA? ›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.
How long does it take for glutathione to lighten skin? ›Typically, it takes 1-3 months for people with light-medium brown skin to see some lightning effects of glutathione. For people with dark brown skin, glutathione takes 3-6 months to lighten the skin. However, people with very dark skin may see the lightning effect of glutathione in 6-12 months.
Can glutathione cause heart problems? ›When that happens, reduced glutathione is produced in such excessive levels that it harms the heart, Benjamin said. The resulting condition is called reductive stress.
Does glutathione affect the brain? ›The antioxidant glutathione (GSH) is essential for the cellular detoxification of reactive oxygen species in brain cells. A compromised GSH system in the brain has been connected with the oxidative stress occuring in neurological diseases.
Can glutathione cause tumors? ›Excess GSH promotes tumor progression, where elevated levels correlate with increased metastasis.
Can I take glutathione if I have high blood pressure? ›Glutathione can also reduce the blood pressure raising action of an important natural blood pressure raising hormone, norepinephrine. My results suggest that glutathione may lower blood pressure at least partially by reducing the ability of blood vessels to contract.
How much is glutathione injection in USA? ›Glutathione Injections Cost
It depends on the quality of the shot and how many jabs you require to achieve your goal and maintain your desired result. Glutathione injections usually range in between $200-$400 per treatment session. Glutathione, an antioxidant with so many nicknames showing its stupendous strength.
Always check if a product is registered with the FDA by using the FDA Verification Portal feature accessible at https://verification.fda.gov.ph.
How do I know if my product is FDA approved Philippines? ›Welcome to FDA Verification Portal
This online portal provides a comprehensive list of Establishments and Health Products with License to Operate (LTO) and Certificate of Product Registration/Notification (CPR/NN) respectively. This is consumer's access to safe and quality commodities in the market.