# Herbal and Dietary Supplement Induced Liver Injury in the U.S.

> **NIH NIH U01** · THOMAS JEFFERSON UNIVERSITY · 2024 · $371,520

## Abstract

PROJECT SUMMARY
Einstein-Jefferson will continue to recruit cases for the three DILIN protocols; prospective, retrospective, and
acute, and to participate in all of its procedures and ancillary studies. At Einstein-Jefferson, our main objective
is to study liver injury due to Herbal and Dietary Supplements (HDS). Specifically, our approach will entail,
through Aim 1, ongoing recruitment of patients with drug and supplement induced liver injury, with several
alliances built to promote the enrollment of patients from under-represented minority (URM) groups. Such
enhanced enrollment of URMs will not only expand access to our study but will also support our analyses.
Related to this aim, we will validate for HDS induced liver injury (HILI) a recently published form of causality
assessment; the RECAM. In aim 2, through the DILIN HDS repository housed at Einstein, we will continue to
collect products from patients enrolled at all DILIN sites that have been implicated in liver injury for chemical
analysis at the National Center for Natural Products Research (NCNPR). Related to this aim, we will work with
the NCNPR to explore mechanisms of HILI, and also expand our collaboration on chemical analysis to include
other organizations, such as the National Toxicology Program (NTP) and the Botanical Safety Consortium
(BSC). The expanded collaboration (NCNPR, NTP, BSC) will allow us to develop new analytical techniques
that will form the foundation for the design of human safety and therapeutic trials of multi-ingredient
supplements. The critical innovation of our research is explained in aim 3, with the formation of a multi-
stakeholder panel to conduct pharmacovigilance for HILI. This panel, comprising the DILIN group, FDA, CDC,
and the NTP will focus on detecting case clusters of HILI. Detection of case clusters will, in turn, facilitate
response to improve supplement safety through the FDA's regulatory actions, support the CDC's scientific
investigations to prove the association of injury with a product, and support the development of better analytical
techniques to detect injurious products through our collaboration with the NCNPR, NTP and the BSC. Related
to this aim, our research will update our prior work which defined the incidence of drug and supplement
induced liver injury in the State of DE, a state that is demographically similar to the U.S. This is an important
study to provide context to the importance of HILI pharmacovigilance.

## Key facts

- **NIH application ID:** 10918232
- **Project number:** 5U01DK083027-18
- **Recipient organization:** THOMAS JEFFERSON UNIVERSITY
- **Principal Investigator:** Dina Halegoua-DeMarzio
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $371,520
- **Award type:** 5
- **Project period:** 2008-09-30 → 2028-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10918232

## Citation

> US National Institutes of Health, RePORTER application 10918232, Herbal and Dietary Supplement Induced Liver Injury in the U.S. (5U01DK083027-18). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10918232. Licensed CC0.

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