Herbal and dietary supplement mislabeling is common and should be evaluated as a potential cause for liver damage, according to research presented this week at The Liver Meeting® - held by the American Association for the Study of Liver Diseases.
The herbal and dietary supplements industry is a multi‐billion‐dollar‐per‐year enterprise in the United States. Over 20 percent of cases of liver injury reported to the U.S. Drug Induced Liver Injury Network (called DILIN) are attributed to herbal and dietary supplements.
"Since herbal and dietary supplements are not required by the FDA to be tested for safety or effectiveness, the DILIN has focused on various factors that could explain their potential for harm," says Victor Navarro, MD, chair of Hepatology for Einstein Medical Center in Philadelphia.
There is a growing concern that potentially mislabeled products may contain ingredients that can be highly toxic, and damaging, to the liver. To assess this, Dr. Navarro's team of researchers used samples of herbal and dietary supplements collected by DILIN to analyze the contents of these products and determine the frequency of mislabeling.
Between 2003 and March 2016, DILIN collected 341 herbal and dietary supplement products from 1,268 patients enrolled in DILIN. The National Center for Natural Products Research at the University of Mississippi conducted a chemical analysis on 229 of these products. The ingredients, as they were determined by the chemical analysis, where then compared to the ingredients listed on the 203 analyzed products that contained a label.
As determined through the chemical analysis, Dr. Navarro's team found only 90 of 203 products contained labels that accurately reflected their contents. Mislabeling – defined by the researchers as when the chemical analysis did not confirm the ingredients listed on the label – occurred in 80 percent of products used for body building and performance enhancement, and 72 percent of products used for weight loss. "Based on these findings, the DILIN will embark upon a more detailed analysis of the chemical ingredients, to determine the precise cause of the liver injury".