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Updated: Jun 19, 2026

High Content Screening Analysis to Evaluate the Toxicological Effects of Harmful and Potentially Harmful Constituents (HPHC)
Published on: May 10, 2016
Herbal and dietary supplement hepatotoxicity
1Division of Gastroenterology and Hepatology, Thomas Jefferson University, Philadelphia, Pennsylvania 19107, USA. victor.navarro@jefferson.edu
Herbal and dietary supplements (HDS) pose risks for liver injury (hepatotoxicity). Ensuring HDS safety requires better regulation, increased reporting, and improved awareness among consumers and healthcare providers.
Area of Science:
- Hepatology
- Pharmacology
- Public Health
Background:
- Herbal and dietary supplements (HDS) are widely consumed globally.
- Existing regulations like the Dietary Supplement Health and Education Act aim to ensure HDS safety.
- HDS-associated liver injury (hepatotoxicity) presents with variable clinical patterns and severity.
Purpose of the Study:
- To review the challenges in assessing causality for HDS-induced hepatotoxicity.
- To highlight the variability in HDS-associated liver injury.
- To propose measures for preventing HDS-induced hepatotoxicity.
Main Methods:
- Review of existing literature on HDS and hepatotoxicity.
- Analysis of regulatory frameworks for HDS in the United States.
- Discussion of factors confounding causality assessment in suspected HDS hepatotoxicity cases.
Main Results:
- Causality assessment is complicated by under-reporting, HDS ubiquity, complex formulations, and adulteration.
- Clinical presentation and severity of HDS hepatotoxicity are highly variable.
- Current regulations provide a framework but challenges remain in ensuring HDS safety.
Conclusions:
- Preventing HDS-induced liver injury necessitates enhanced consumer and provider awareness.
- Increased spontaneous reporting of adverse events is crucial.
- Reassessment of regulations governing HDS manufacturing, distribution, and marketing is recommended.
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