Cautionary labeling recommendation for USP turmeric and curcuminoid monographs

Presenter Information

• Amy Roe, USP Dietary Supplement Admission Evaluation and Labeling Expert CommitteeFollow
• Deval Patel, USP Dietary Supplement Admission Evaluation and Labeling Expert CommitteeFollow
• Jo Barnes, USP Dietary Supplements Admission Evaluation and Labeling Expert CommitteeFollow
• Paula Gardiner, USP Dietary Supplement Admission Evaluation and Labeling Expert CommitteeFollow
• Bill Gurley, USP Dietary Supplement Admission Evaluation and Labeling Expert CommitteeFollow
• Zehra Kilic, USP Dietary Supplement Admission Evaluation and Labeling Expert CommitteeFollow
• Richard Ko, USP Dietary Supplement Admission Evaluation and Labeling Expert CommitteeFollow
• Igor Koturbash, USP Dietary Supplement Admission Evaluation and Labeling Expert CommitteeFollow
• Richard Van Breemen, USP Dietary Supplement Admission Evaluation and Labeling Expert CommitteeFollow
• Nadeem Akhtar, USP Dietary Supplement Admission Evaluation and Labeling Expert CommitteeFollow

Document Type

Poster Presentation

Location

Oxford Conference Center

Event Website

https://oxfordicsb.org/

Start Date

22-4-2026 2:00 PM

End Date

22-4-2026 2:20 PM

Description

In December 2025, the USP DSAEL EC conducted a safety evaluation of turmeric (Curcuma longa L.) and curcuminoids monographs. Recent reports of hepatotoxicity potentially associated with turmeric and/or curcuminoid products and increasing global regulatory concerns prompted a formal review. The admission evaluation was conducted according to the USP Guideline for the Admission of Dietary Supplement Ingredients to the USP-NF Monograph Development Process. Summarizing all individual clinical trials related to curcumin and turmeric was not feasible for this admission evaluation due to the large number of studies available. To ensure scientific and comprehensive synthesis, only systematic-, safety-, umbrella reviews and meta-analyses were included. Over 30 liver injury case reports exist in the literature. As a result, there have been numerous regulatory alerts from global agencies issuing warnings for liver injury. Generally, clinical studies conducted with turmeric or curcumin have reported no serious adverse effects (up to 12 g/day) with only mild GI symptoms noted at higher doses. Liver and kidney functions have been mostly unaffected in these studies. Despite the lack of liver-related findings in clinical studies, numerous authorities recommend or require cautionary labeling regarding potential hepatotoxicity. After completing an admission evaluation for turmeric and curcuminoids, the USP DSAEL EC recommended the following cautionary label be added to the monographs: Liver problems have been reported very rarely in people taking supplements containing turmeric or curcumin. Consult your health care practitioner before using this product if you have a history of liver problems. Stop using this product if you develop symptoms such as abdominal pain, dark urine, or jaundice (yellowing of the skin or eyes), and seek medical advice.

Recommended Citation

Roe, Amy; Patel, Deval; Barnes, Jo; Gardiner, Paula; Gurley, Bill; Kilic, Zehra; Ko, Richard; Koturbash, Igor; Van Breemen, Richard; and Akhtar, Nadeem, "Cautionary labeling recommendation for USP turmeric and curcuminoid monographs" (2026). Oxford ICSB. 28.
https://egrove.olemiss.edu/icsb/2026_ICSB/Schedule/28

Publication Date

April 2026

Accessibility Status

Screen reader accessible, Searchable text