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Glutathione Benefits Outweigh Potential Risks

The majority of new prescription medications, vitamins and nutritional supplements involve controversy, mainly fueled by medical and legal professionals. Once the controversy surrounding a new product is discovered, the mainstream media begins to release negative reports. Many countries including Europe, Asia, Australia and Canada actively promote patient rights in choosing their specific medical treatment. In the United States, however, the Food and Drug Administration (FDA) regulates medications and supplements before they are approved for consumer use. While people should be able to maintain control of their personal health and nutritional needs, there are always groups attempting to downplay the positive effects of certain medications, such as dietary supplements. To date, serious side effects have not been linked to the use of glutathione.

Glutathione, naturally produced by our bodies and found in every living cell, is vital to cell growth, function and activity. Glutathione is described as a protein molecule consisting of three essential amino acids: cysteine, glutamate and glycene. As a natural detoxifier, glutathione helps protect bodily cells from damage or destruction from harmful toxins, metals, oxidants, viruses, bacteria and microorganisms. Some people choose to increase their normal levels of glutathione by eating foods rich in amino acids and carbohydrates found in fresh fruits and vegetables, pasta, grains and garlic. The levels of glutathione derived from a healthy diet are depleted by the digestive process. For this reason, people choose to take glutathione supplements or vitamins that help boost cellular health.

FDA Issues Warning to Glutathione Manufacturer

Back in April 2013, the FDA's Inspections, Compliance, Enforcement and Criminal Investigations unit issued a warning letter addressed to a glutathione manufacturer following a routine inspection of the company's dietary supplement. Following its inspection, the FDA determined that glutathione products were "adulterated" under the Federal Food, Drug and Cosmetic Act. In essence, the inspectors determined that glutathione supplements were prepared, packaged and maintained under conditions that do not meet FDA regulations for dietary supplements.

The FDA essentially concluded that the company was in violation of packaging and labeling requirements. The agency stated that the company failed to publish specifications concerning each component used in the manufacturing of its dietary supplements. The agency specifically cited the L-Glutathione Reduced supplement, which is the primary ingredient in most of the company's supplements. The FDA also stated that the manufacturer failed to provide the agency with documentation proving the "characteristic structure" of the supplements and also failed to provide clinical test results verifying the ingredients contained in the supplements. The most important violation cited by the FDA is that the company mislabeled or misrepresented the safety and effectiveness of glutathione and promoted it as a treatment for certain medical conditions. Under this scenario, the FDA requires a manufacturer to submit a new drug application, since glutathione was promoted as a drug rather than a dietary supplement.

The majority of the language used in the FDA warning letter is "boilerplate," as it is used routinely when new drugs or supplements are submitted for approval. The FDA warned the company against promotional claims that the supplement can be effective in treating conditions not approved by the agency including respiratory infections, arthritis, Alzheimer's disease, cystic fibrosis, Parkinson's disease and high blood pressure.

The FDA routinely conducts facility inspections and drug surveillance investigations to insure that manufacturers are following proper agency guidelines. The warnings are issued to encourage manufacturers to maintain strict quality control before drugs are released for public use. Once a warning letter is issued, the pharmaceutical company is given a certain amount of time to rectify the issues. In this specific case, results of the warning have not been made available.

Incomplete Labeling of Glutathione May Cause People to Self-Diagnose Medical Conditions

After the FDA warning letter was issued, media reports began surfacing about the danger of consumers self-diagnosing medical conditions and turning to supplements to find the answer and cure to problems. As pointed out by one national news outlet, people have been using a glutathione-based whitening product to lighten skin. A glutathione based "Skin Whitening" product came under intense FDA scrutiny in June 2014, as the product was not registered with the agency as a drug or a dietary supplement. The company involved in the 2014 investigation was charged with unlawful marketing by promoting uses not proven by scientific studies or approved by the agency. The results of the investigation are ongoing and have not been released to the public.

Advertising campaigns promote glutathione as an effective treatment to cleanse internal organs, detoxify the body, destroy free radicals that can cause cancer and protect healthy cells in the body. Advertising spots also claim that glutathione is "FDA approved" and "Halal approved" and that it has earned "Global Brands" and "Top Brands" awards. None of this information has been substantiated. The director of the FDA stated that glutathione "carries unacceptable claims as a food supplement."

The Effects of Low Glutathione Levels

As the popularity of glutathione spreads worldwide, it has become the subject of discussion among healthcare professionals, as well as consumers. According to a noted biochemistry professor at Emory University, people who exercise and maintain healthy diets have sufficient glutathione in their bodies. He stated that under normal circumstances, many people do not require glutathione supplements, and that it is strictly a personal choice.

Research studies indicate that people with low levels of glutathione have been diagnosed with diabetes, hypertension, HIV/AIDS, male infertility and some types of cancer. Scientists indicate that even people suffering from serious diseases do not have a glutathione deficiency. Researchers have found that only people who have been diagnosed with low levels of glutathione should take supplements. Glutathione deficiency can be detected by a simple blood test.

Glutathione and Cancer

To date, there are no published scientific studies to support the claims made by manufacturers that glutathione is effective in the prevention or cure of cancer. Recent media reports have surfaced concerning scientific evidence that the use of glutathione actually aggravates cancer by promoting tumor growth. A study published in the April 2013 issue of the journal Oxidative Medicine and Cellular Longevity studied the effects of glutathione deficiency on the progression of cancer. It was shown that high levels of glutathione can increase cellular antioxidant activity and cellular resistance to chemotherapy treatment. Results of the study indicated that elevated glutathione levels have been discovered in various types of tumors, causing cells to become resistant to chemotherapy. Although a correlation between high levels of glutathione and metastatic cancer is known to exist, further studies are indicated. Researchers suggested that additional studies be conducted to help scientists and medical professionals understand the functions of glutathione in fighting cancer progression and minimizing cellular resistance to chemotherapy drugs

It is important to remember that self-diagnosis and treatment of any medical condition can lead to devastating effects. If you think you are suffering from any condition that may be helped by increasing glutathione levels, it is important to speak with your healthcare professional before starting a supplementation regimen. Most of us are in tune with are bodies and are aware of unusual symptoms or irregular health conditions. Vitamins, amino acids and nutritional supplements can certainly help build the immune system and help prevent cellular damage, but should not be used to cure or treat conditions that have not been diagnosed by a healthcare professional. In some instances, the use of dietary supplements may cause organ damage or the progression of a medical condition, such as cancer, cardiovascular disease or diabetes.

If you decide to take glutathione or other dietary supplements, it is important that you purchase a brand manufactured by a reputable company. It is also recommended that you speak with your pharmacist to make sure that glutathione will not cause adverse reactions with other medications or supplements you are taking.

 

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Reference Links

http://www.fda.gov/ICECI/EnforcementActions?WarningLetters/2013/ucm345968.htm

http://www.gmanetwork.com/news/story/364256/news/nation/fda-warns-vs-unregistered-glutathione-products-sold-via-fb

http://globalnation.inquirer.net/cebudailynews/opinion/view/20110221-321447/Is-glutathione-safe

http://www.hindawi.com/journals/omcl/2013/972913/