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The FDA's 2019 warning letter to a Nevada compounding pharmacy illustrates the enforcement trigger: the pharmacy marketed pre-mixed glutathione IV bags as 'skin lightening treatments' and 'immune boosters' on its websitedisease and cosmetic claims that crossed into unapproved drug territory

Deficiency or low levels are linked to immune dysfunction, cardiovascular risk, neurological issues, and inflammation

doi: 10.1016/j.jpeds.2006.01.011 60 SivanEFeldmanBDolitzkiMNevoNDekelNKarasikA