Green Tea Extract
EFSA's 2018 opinion concluded that EGCG intake ≥800 mg/day from green tea extract supplements has been associated with statistically significant elevation of serum transaminases (signal of liver injury). EU has restricted use; case reports document acute liver injury.
What it is
Concentrated extract of Camellia sinensis leaves, typically standardized to catechins including epigallocatechin gallate (EGCG).
Antioxidant ingredient and dietary supplement.
Why it's flagged
- dose-related hepatotoxicity (≥800 mg EGCG/day)
- rare idiosyncratic liver injury
What regulators actually say
"There is evidence from interventional clinical trials that intake of doses equal or above 800 mg EGCG/day taken as a food supplement has been shown to induce a statistically significant increase of serum transaminases in treated subjects compared to control."
Regulatory status
United States — FDA
Dietary supplement ingredient; not approved for disease claims; FDA monitors adverse events
European Union — EFSA
EFSA 2018 hepatotoxicity opinion; EU restrictions on EGCG levels (Reg. (EU) 2022/2340)
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