Summary Safety Review - Garcinia gummi-gutta and Hydroxycitric Acid - Assessing the Potential Risk of Hepatotoxicity

• Health Canada’s review of the available information found a possible link between the use of either Garcinia gummi-gutta or hydroxycitric acid and the risk of hepatotoxicity, which, in rare cases, could lead to serious outcomes.

• Health Canada will update the monographs^a,^b for Garcinia gummi-gutta and hydroxycitric acid to include the risk of hepatotoxicity. Health Canada expects licence holders to update the risk information on product labels for all licensed Garcinia gummi-gutta- or hydroxycitric acid-containing NHPs to:

  • include information about the warning signs and symptoms of hepatotoxicity, including yellowing of the eyes or skin, dark urine, nausea, vomiting and stomach pain,

  • advise consumers to stop using these products and consult a healthcare professional if symptoms occur, and

  • advise consumers to consult a healthcare professional before use if they have a liver disorder or are taking medications.

• Health Canada will also inform healthcare professionals and consumers about these updates through a Health Product InfoWatch communication and a social media campaign.

Health Canada reviewed the potential risk of hepatotoxicity with the use of either Garcinia gummi-gutta or hydroxycitric acid. This safety review was triggered by rare, but potentially serious, cases of hepatotoxicity with the use of either Garcinia gummi-gutta or hydroxycitric acid reported to international regulatory authorities and published in the scientific literature.

Garcinia gummi-gutta, also known as Malabar tamarind and Garcinia cambogia, is a fruit that has long been used in Southeast Asia for its appetite-suppressing properties. The fruit peel contains a number of

active substances, including hydroxycitric acid, which can be extracted from the fruit or produced synthetically to be used in NHPs.

Hepatotoxicity, which can result from exposure to plant extracts and isolates, may progress to more severe complications, including liver failure.

• Garcinia gummi-gutta and hydroxycitric acid are authorized in Canada for use in NHPs to temporarily increase the feeling of fullness. They often appear alongside other weight-management or “metabolism support” supplements in health food stores, pharmacies, and online retailers.

• Since 2003, Health Canada has authorized over 600 products containing Garcinia gummi-gutta and/or hydroxycitric acid under the Natural Health Products Regulations.

• Authorized products are most commonly available in capsule form, with liquid and spray formulations also available. Most Garcinia gummi-gutta- and/or hydroxycitric acid-containing NHPs also contain other medicinal ingredients.

• Health Canada reviewed the available information provided by foreign regulatory agencies, as well as from searches of the Canada Vigilance database^c, the World Health Organization (WHO)’s adverse drug reaction database^d, and the scientific literature.

• Health Canada reviewed 1 Canadian case of hepatotoxicity in a patient using Garcinia gummi-gutta, which came from the scientific literature1. The case was found to be possibly linked to the use of Garcinia gummi-gutta. The patient, who was taking 3 different NHPs, including green tea extract, required a liver transplant. Although the other NHPs may have contributed to the occurrence of hepatotoxicity, a contributory role for either Garcinia gummi-gutta or hydroxycitric acid could not be ruled out.

• Health Canada also reviewed 93 international case reports of hepatotoxicity in persons using either Garcinia gummi-gutta or hydroxycitric acid, including from the WHO’s adverse drug reaction database and those that were published in the scientific literature.

  • In 5 cases, Garcinia gummi-gutta was the only reported ingredient. Four of these cases required liver transplantation with no alternative causes of hepatotoxicity identified.^2-6

  • Although in many cases there were confounders, such as underlying medical conditions and use of other products and/or medications that may have contributed to the occurrence of hepatotoxicity, there was evidence of a possible link between the use of either Garcinia gummi-gutta or hydroxycitric acid and the risk of hepatotoxicity under conditions similar to how these products are used in Canada.

• International regulators, such as Australia’s Therapeutic Goods Administration, have implemented a number of regulatory actions, such as label updates for either Garcinia gummi-gutta- or hydroxycitric acid-containing health products to include the risk of hepatotoxicity, and safety alerts to inform consumers of the risk.^7,8,9

• The evidence suggests that the risk of hepatotoxicity associated with Garcinia gummi-gutta or hydroxycitric acid appears to be idiosyncratic (not dependent on the dose or duration of use, and unpredictable in onset with risk factors not fully known). In most cases, the hepatotoxicity is reversible once use of the product is stopped.

• Health Canada’s review of the available information found a possible link between the use of either Garcinia gummi-gutta or hydroxycitric acid, and the risk of hepatotoxicity.

• Health Canada will update the monographs for Garcinia gummi-gutta and hydroxycitric acid, ensuring all licensed products include the risk of hepatotoxicity. Health Canada expects licence holders to update the risk information on product labels for all licensed Garcinia gummi-gutta- or hydroxycitric acid-containing NHPs to:

  • include information about the warning signs and symptoms of hepatotoxicity, including yellowing of the eyes or skin, dark urine, nausea, vomiting and stomach pain,

  • advise consumers to stop using these products and consult a healthcare professional if symptoms occur, and

  • advise consumers to consult a healthcare professional before use if they have a liver disorder or are taking medications.

• Information about NHPs licensed in Canada is available through the Licensed Natural Health Products Database.

• Health Canada will also inform healthcare professionals and consumers about these updates through a Health Product InfoWatch communication and a social media campaign.

• Health Canada encourages consumers and healthcare professionals to report any side effects with the use of Garcinia gummi-gutta or hydroxycitric acid, or other health products, to the Canada Vigilance Program.

• Health Canada will continue to monitor safety information involving Garcinia gummi-gutta and hydroxycitric acid, as it does for all health products on the Canadian market, to identify and assess potential harms. Health Canada will take appropriate and timely action should new health risks be identified.

The analysis that contributed to this safety review included scientific and medical literature, Canadian and international information, as well as what is known about the use of Garcinia gummi-gutta and hydroxycitric acid both in Canada and internationally.

For additional information, contact the Marketed Health Products Directorate.

1. Ferreira V, Mathieu A, Soucy G, Giard JM, Erard-Poinsot D. Acute Severe Liver Injury Related to Long-Term Garcinia cambogia Intake. ACG Case Rep J. 2020 Aug 11;7(8):e00429. doi: 10.14309/crj.0000000000000429. Accessible at: https://journals.lww.com/acgcr/fulltext/2020/08000/acute_severe_liver_injury_related_to_long_term.7.aspx

2. Corey R, Werner KT, Singer A, Moss A, Smith M, Noelting J, Rakela J. Acute liver failure associated with Garcinia cambogia use. Ann Hepatol. 2016 Jan-Feb;15(1):123-6. doi: 10.5604/16652681.1184287. Accessible at: https://www.sciencedirect.com/science/article/pii/S1665268119307483?via%3Dihub

3. Lunsford KE, Bodzin AS, Reino DC, Wang HL, Busuttil RW. Dangerous dietary supplements: Garcinia cambogia-associated hepatic failure requiring transplantation. World J Gastroenterol. 2016 Dec 7;22(45):10071-10076. doi: 10.3748/wjg.v22.i45.10071. Accessible at: https://pmc.ncbi.nlm.nih.gov/articles/PMC5143754/

4. McCarthy RE, et al. The dangers of herbal weight loss supplements: A case report of drug-induced liver injury secondary to GARCINIA CAMBOGIA ingestion and literature review. Pathology 52 (Suppl. 1): S147 abstr. 42, Feb 2020. Available from: URL: http://doi.org/10.1016/j.pathol.2020.01.042

5. Flerova E, Ambilil M, Civan JM, Sass DA, Maley WR, Pulinthanathu R, Huang J. Striking Cholestatic Giant Cell Hepatitis Resulting in Fulminant Liver Failure After Garcinia Cambogia Use. Int J Surg Pathol. 2024 May;32(3):619-624. doi: 10.1177/10668969231186926. Epub 2023 Jul 17. PMID: 37461217. Abstract available at: https://pubmed.ncbi.nlm.nih.gov/37461217/

6. Vuppalanchi R, Bonkovsky HL, Ahmad J, Barnhart H, Durazo F, Fontana RJ, Gu J, Khan I, Kleiner DE, Koh C, Rockey DC, Phillips EJ, Li YJ, Serrano J, Stolz A, Tillmann HL, Seeff LB, Hoofnagle JH, Navarro VJ; Drug-Induced Liver Injury Network. Garcinia cambogia, Either Alone or in Combination With Green Tea, Causes Moderate to Severe Liver Injury. Clin Gastroenterol Hepatol. 2022 Jun;20(6):e1416-e1425. doi: 10.1016/j.cgh.2021.08.015. Epub 2021 Aug. Accessible at: https://www.sciencedirect.com/science/article/pii/S1542356521008715?via%3Dihub

7. Australian Government. Therapeutic Goods Administration. Final Decision: Proposed changes to requirements for listed medicine ingredients: Annual low-negligible risk changes 2024-25. Version 1.0, December 2024. Accessible at: low-negligible-risk-annual-consultation-2024-25---final-decision-document.pdf

8. Australian Government. Therapeutic Goods Administration. Proposed changes to requirements for listed medicine ingredients: Annual low-negligible risk changes 2024-25 Consultation paper Version 1.0, August 2024. Accessible at: https://consultations.tga.gov.au/medicines-regulation-division/copy-of-low-neg-risk-2024-2025/user_uploads/low-negligible-risk-annual-consultation-2024-25---consultation-document---final-v1.0.pdf

9. USP-NF. Revision Bulletin. Garcinia Cambogia. Posted on November 22, 2024. Official date: December 1, 2024. Accessible at: https://www.uspnf.com/sites/default/files/usp_pdf/EN/USPNF/revisions/garcinia-cambogia-rb-notice-20241122.pdf

1. Monographs and product monographs are a written description of particular elements on an identified topic. In the case of NHPs, a monograph is specific to an individual ingredient or a combination of ingredients that are authorized for use in NHPs sold in Canada. In the case of drugs, product monographs are specific to a particular drug product authorized for sale in Canada.

2. Monographs for NHP ingredients can be accessed through the Compendium of monographs.

3. Canadian reports can be accessed through the Canada Vigilance Online Database.

4. World Health Organization’s adverse drug reaction database