Glutathione Not currently offered

Longevity

Glutathione

A natural antioxidant made by the body

Not currently offered by RiptideRx
Why it’s not available
Stylised model of the real sequence

Overview.

No FDA-approved drug has glutathione in its natural (reduced) form as its active ingredient, and FDA has approved no injectable glutathione. Glutathione is the body's main endogenous antioxidant, made inside cells from glutamate, cysteine, and glycine via an unusual gamma-peptide bond. It is sold in three very different formats with very different evidence and risk profiles: as a widely available oral dietary supplement; as a topical skin-care ingredient (in the US, products claiming to lighten skin are regulated as drugs, and no over-the-counter skin lightener is FDA-approved); and as an unapproved intravenous 'drip' or injection. The injectable form carries the most serious documented safety signals and the least standardization, including FDA alerts in 2019 and August 2026 about endotoxin reactions from injections compounded with dietary-supplement-grade glutathione.

Also known as GSH · L-Glutathione · Reduced Glutathione · gamma-glutamylcysteinylglycine

The molecule, decoded.

Sequence

gamma-Glu-Cys-Gly

Length
3 residues
Molecular weight
307.3 g/mol
Formula
C10H17N3O6S
CAS number
70-18-8
Half-life
Not established
Routes studied
oral (dietary supplement), topical (cosmetic), intravenous (off-label wellness/skin-lightening use)
Modifications
Non-standard gamma-carboxyl (isopeptide) linkage between glutamate and cysteine rather than a normal alpha-peptide bond; free reactive thiol on the cysteine residue

How it works.

Glutathione's cysteine thiol group neutralizes reactive oxygen species and free radicals directly and serves as a cofactor for glutathione peroxidase and glutathione-S-transferase in detoxification pathways. For skin lightening, it is proposed to act via direct and indirect inhibition of tyrosinase and by shifting melanin synthesis from dark eumelanin toward lighter pheomelanin.

Evidence · Early or small human studies

What the research shows

narrative review2016

A 2016 dermatology review identified three randomized controlled trials reporting skin lightening with topical or oral glutathione, and found no efficacy evidence for intravenous glutathione injections despite their popular use.

review of published RCTs of oral/topical/IV glutathione for skin lightening

Source
narrative review2025

A 2025 narrative review comparing routes of administration found that intravenous glutathione is associated with serious safety concerns, including anaphylaxis and hepatotoxicity, worsened by a lack of standardized dosing protocols; it reported melanin reduction with oral and topical forms that varied in size and durability.

narrative review across oral, topical, and IV routes

Source
narrative review2016

The same review reported that adverse effects associated with intravenous glutathione led the Food and Drug Administration of the Philippines to issue a public warning condemning its use for off-label indications such as skin lightening.

regulatory/safety literature review

Source

What to know first.

Based on: narrative reviews of skin-lightening trials and FDA safety alerts.

Reported side effects

  • IV route: anaphylaxis and hepatotoxicity have been reported
  • IV/injectable glutathione compounded from dietary-supplement-grade powder: endotoxin reactions including fever, chills, nausea, vomiting, low blood pressure, shock and sepsis-like symptoms, some requiring hospitalization (FDA alerts, Feb 2019 and Aug 2026)

Cautions

  • No standardized protocol exists for IV use
  • The Philippines FDA specifically warned against IV use for skin-whitening indications
  • WADA's M2.2 volume-limit method rule applies to large-volume IV glutathione infusions regardless of the substance's own status
  • FDA has approved no injectable glutathione, including for skin lightening. FDA (Aug 2026) tells compounders not to use dietary-supplement-grade glutathione in injectables and advises clinicians to check their compounder's glutathione source.

Checked 2026-09

Where it stands.

Not currently offered by RiptideRx. Glutathione can be compounded by licensed pharmacies, but RiptideRx doesn’t offer it. In August 2026 FDA warned about serious reactions to IV glutathione made from dietary-supplement-grade powder.
FDA
No FDA-approved drug has reduced glutathione as its active ingredient (its oxidized form, glutathione disulfide, is an ingredient of Alcon's BSS PLUS intraocular irrigating solution, NDA 018469). Oral glutathione is widely sold as a dietary supplement; separately, FDA raised no questions about a GRAS notice for its use in conventional foods (GRN 293, Kohjin, 2009). FDA has not approved any injectable glutathione, including for skin lightening, so US IV and injectable glutathione is compounded, not an approved drug used off-label. Glutathione is in FDA's 503A Category 1 (under evaluation) and was not reviewed at the July 2026 PCAC.
Compounding
Glutathione is in FDA's 503A Category 1, 'Bulk Drug Substances Under Evaluation' (FDA list updated 14 May 2026). Under FDA's interim policy, FDA does not intend to take action against a 503A pharmacy or physician compounding with a Category 1 substance if the policy's conditions are met, until FDA decides whether to add it to the 503A Bulks List. Glutathione is not on that list (21 CFR 216.23), is not on the Category 2 safety-risk list, and was not reviewed at the July 2026 PCAC. FDA's handling indicates the 'USP monograph' route does not apply: FDA counts only USP/NF drug-substance monographs, not dietary-supplement monographs (84 FR 4696, 2019), and its 2020 Tailor Made warning letter treated injectable glutathione as 'unrecognized in an official compendium'. For 503B outsourcing facilities it is in 503B Category 1 (list updated 21 Mar 2025). FDA warns compounders not to use dietary-supplement-grade glutathione in injectables (2019; 27 Aug 2026).
Sport (WADA)
Glutathione itself is not named in the WADA 2026 Prohibited List. However, the List's M2.2 method rule states: 'Intravenous infusions and/or injections of more than a total of 100 mL per 12-hour period [are prohibited] except for those legitimately received in the course of hospital treatments, surgical procedures or clinical diagnostic investigations.' Large-volume IV glutathione 'drips,' a common wellness-clinic delivery format, can therefore violate the Prohibited List purely on volume grounds regardless of glutathione's own status. M2.2 falls under M2 (Chemical and Physical Manipulation), prohibited at all times; M2.2 specifically is designated a Specified Method (other M2 methods are non-Specified).
Enforcement
  • FDA warning letter to Tailor Made Compounding LLC, dated 2020-04-01, cites a compounded injectable glutathione (200 mg) product for a potency/strength deficiency violation.
  • The Philippines FDA (Advisory No. 2011-004) issued a public warning about the safety of off-label use of glutathione injection for skin lightening, citing reported adverse drug reactions (as described in a 2016 review).
  • 27 Aug 2026: FDA reported at least 30 patients with adverse events (fever, chills, pain, dizziness, signs of shock and sepsis-like symptoms, some hospitalized) after IV glutathione made by several compounding pharmacies from dietary-supplement-grade glutathione (Medisca lot #229536), and told compounders not to use dietary-supplement-grade ingredients in injectables. Texas pharmacies recalled compounded glutathione 200 mg/mL vials for elevated endotoxin: Victory Medical Center Pharmacy (5 Aug 2026), Optimal Balance Pharmacy (19 Aug 2026) and Centric Compounding (9 Sep 2026).
  • 1 Feb 2019: FDA warned compounders not to use L-glutathione powder repackaged by Letco Medical (labeled 'Caution: Dietary Supplement') in sterile injectables, after patients given compounded IV glutathione had reactions including nausea, vomiting, chills, low blood pressure and a hospital admission for possible bloodstream infection; FDA testing found excessive endotoxin.
  • 25 Sep 2017: a federal court ordered Flawless Beauty LLC (New Jersey) to stop selling and to recall some of its injectable skin-whitening products, which contained glutathione among other ingredients, as unapproved new drugs (FDA consumer update, archived).
  • 2 Apr 2025: FDA warning letter to 503B outsourcing facility Empower Pharma cited sterility-assurance lapses involving its Glutathione 200 mg/mL injection, including an investigation of environmental-monitoring failures that left out a glutathione lot filled the same day Pseudomonas luteola was found in the gowning room.
References (10)
  1. PubMed · PMID 27088927
  2. PubMed · PMID 40013212
  3. U.S. FDA · certain bulk drug substances use compounding may present signifi
  4. U.S. FDA · bulk drug substances used compounding under section 503a fdc act
  5. World Anti-Doping Agency
  6. U.S. FDA · tailor made compounding llc 594743 04012020
  7. U.S. FDA · download
  8. U.S. FDA · fda reminds compounders not use dietary supplement grade glutath
  9. U.S. FDA · fda highlights concerns using dietary ingredient glutathione com
  10. Federal Register

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