United States Pharmacopeia (USP) comprehensive review of the hepatotoxicity of green tea extracts

Hellen A. Oketch-Rabah, Amy L. Roe, Cynthia V. Rider, Herbert L. Bonkovsky, Gabriel I. Giancaspro, Victor Navarro, Mary F. Paine, Joseph M. Betz, Robin J. Marles, Steven Casper, Bill Gurley, Scott A. Jordan, Kan He, Mahendra P. Kapoor, Theertham P. Rao, Averell H. Sherker, Robert J. Fontana, Simona Rossi, Raj Vuppalanchi, Leonard B. SeeffAndrew Stolz, Jawad Ahmad, Christopher Koh, Jose Serrano, Tieraona Low Dog, Richard Ko

Research output: Contribution to journalReview articlepeer-review

104 Scopus citations


As part of the United States Pharmacopeia's ongoing review of dietary supplement safety data, a new comprehensive systematic review on green tea extracts (GTE) has been completed. GTEs may contain hepatotoxic solvent residues, pesticide residues, pyrrolizidine alkaloids and elemental impurities, but no evidence of their involvement in GTE-induced liver injury was found during this review. GTE catechin profiles vary significantly with manufacturing processes. Animal and human data indicate that repeated oral administration of bolus doses of GTE during fasting significantly increases bioavailability of catechins, specifically EGCG, possibly involving saturation of first-pass elimination mechanisms. Toxicological studies show a hepatocellular pattern of liver injury. Published adverse event case reports associate hepatotoxicity with EGCG intake amounts from 140 mg to ∼1000 mg/day and substantial inter-individual variability in susceptibility, possibly due to genetic factors. Based on these findings, USP included a cautionary labeling requirement in its Powdered Decaffeinated Green Tea Extract monograph that reads as follows: “Do not take on an empty stomach. Take with food. Do not use if you have a liver problem and discontinue use and consult a healthcare practitioner if you develop symptoms of liver trouble, such as abdominal pain, dark urine, or jaundice (yellowing of the skin or eyes).”

Original languageEnglish
Pages (from-to)386-402
Number of pages17
JournalToxicology Reports
StatePublished - 2020
Externally publishedYes


  • Camellia sinensis
  • Dietary supplements
  • Green tea
  • Green tea extract
  • Hepatotoxicity
  • Liver injury


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