Letters to the Editor
Letter: retrospective reviews of liver-related case reports allegedly associated with Herbalife present insufficient and inaccurate data
Article first published online: 5 MAR 2013
© 2013 Blackwell Publishing Ltd
Alimentary Pharmacology & Therapeutics
Volume 37, Issue 7, pages 753–754, April 2013
How to Cite
Appelhans, K., Najeeullah, R. and Frankos, V. (2013), Letter: retrospective reviews of liver-related case reports allegedly associated with Herbalife present insufficient and inaccurate data. Alimentary Pharmacology & Therapeutics, 37: 753–754. doi: 10.1111/apt.12217
- Issue published online: 5 MAR 2013
- Article first published online: 5 MAR 2013
- Manuscript Accepted: 30 DEC 2012
- Manuscript Received: 14 DEC 2012
In a review article in the October 2012 issue of the journal of Alimentary Pharmacology and Therapeutics, common substances in dietary supplements were reviewed for potential hepatotoxicity. The authors cite Herbalife cases in this review, which represent a broad range of onset dates between 1998 and 2010 as if they are current cases, and Herbalife is a specific agent.
Herbalife is a brand name for many different products, including cosmetics, foods and dietary supplements and none of the case reports referenced to date have one ingredient or product in common. Some of the case reports even involve products that are no longer marketed by Herbalife.
Herbalife has raised the aforementioned concerns and objected to other misconceptions about our products through various rebuttal articles.[2-7] The authors revisit many of these same issues. However, only two of our rebuttals are referenced by the authors, reflecting an unbalanced analysis.
The authors also erroneously state that US manufacturers of dietary supplement/herbal products do not have a regulatory obligation to report adverse events to the Food and Drug Administration (US FDA). The requirement for dietary supplement manufacturers to monitor and report serious adverse event reports to FDA has been effective since 22 December 2007.
Finally, the authors cite a reference to intimate that Herbalife has not been communicative, when our attempts to establish transparency with the scientific community actually precede the date of the reference cited by these authors. In fact, Herbalife has cooperated with 27 countries to address liver-related cases and articles in the literature. After more than 30 years in business, none of the 27 agencies has taken any regulatory action affecting Herbalife products. We invite the authors from this article to engage in further review of these cases with our representatives as well.
Declaration of personal interests: Drs Kristy Appelhans, Raushanah Najeeullah and Vasilios Frankos are the employees of Herbalife International of America, Inc. Dr Kristy Appelhans and Dr Vasilios Frankos own stocks and shares in Herbalife International of America, Inc.
Declaration of funding interests: None.
- 2Revisiting acute liver injury associated with herbalife products. World J Hepatol 2011; 3: 275–7., , , .
- 5Herbal medicine hepatotoxicity revisited. J Hepatol 2011; 56: 503–5., .
- 8Federal Food, Drug, and Cosmetic Act (FDCA) Sec 761 [21 USC §379aa–1] Serious Adverse Event Reporting for Dietary Supplements. Available at: http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/pdf/USCODE-2010-title21-chap9-subchapVII-partH-sec379aa-1.pdf.