Herbalife is a multilevel marketing company that sells nutritional and weight loss supplements in 94 countries. After many complaints, the Federal Trade Commission (FTC) investigated the company. In 2016, they described Herbalife as a scam disguised as healthy living; the company was fined $200 million and ordered to restructure its business and issue refunds to 350,000 Herbalife distributors. Herbalife has also been sued in Belgium and Israel. There have been over 50 reports of liver toxicity attributed to Herbalife products in Spain, Israel, Latin America, Switzerland, Iceland, and the US. India is fast becoming the largest growing market for Herbalife products. A recent article “Slimming to the Death” is the first case report of fatal acute liver failure from the Asia-Pacific region. The researchers also found contamination of Herbalife products with heavy metals, toxins, psychotropic substances, and pathogenic bacteria.
Supplements are used by one-third to one-half of adults in the US. They are big business, with sales rising from $9.6 billion in 1994 to $36.7 billion in 2014. 20% of hepatotoxicity cases in the US are attributed to herbal and dietary supplements, the biggest culprit being multi-ingredient nutritional supplements. Identification of the responsible component in multi-ingredient supplements is a challenge due to lack of documentation about source, dosage, and purity; and some products are contaminated or mislabeled.
The LiverTox database on the NIH website categorizes Herbalife products as “a well-established cause of clinically apparent liver injury”. Not everyone would agree with the assessment of “well-established”. A study of 53 cases of suspected Herbalife toxicity evaluated 8 cases where the assumption of toxicity was reportedly confirmed by unintentional re-exposure. They found quality problems, missing data, confounding variables, and uncertainties. They concluded causality was probable in 1 of those 8 cases, unlikely in 4, and excluded in 3.
The Asian patient in question was a 24-year-old Indian woman with hypothyroidism (treated with thyroxine) and a BMI of 32.1 but no other health problems. She had been taking three Herbalife slimming products for 2 months when she developed loss of appetite, jaundice, and transient pruritus. Her liver enzymes had skyrocketed. Her condition worsened and she died while on the waiting list for liver transplant surgery. The researchers were unable to retrieve the actual Herbalife products she had taken but were able to source one product from the same seller that she had purchased her products from; it was a nutritional club functioning without a license, and it was eventually shut down by the government of Kerala. They obtained eight similar Herbalife products from the internet and had them analyzed. High levels of multiple heavy metals were found in all of the products. There were traces of psychotropic recreational agent in 75%, bacterial DNA in 63%, including highly pathogenic species, and other potential liver-toxic agents. The products and contaminants are listed in Table 1 in the article. They pointed out that this is a growing public health concern. They recommended better regulation, with preclinical and clinical scientific studies and post-marketing vigilance.
Conclusion: Cause for concern
This was a case report, not definitive proof of causation, but along with other reports of liver toxicity from many countries, it adds to the circumstantial evidence and is clearly a cause for concern. It highlights the possible dangers of dietary supplements and the lack of purity of products on the market. Until dietary supplements are better studied and better regulated, taking products like the ones sold by Herbalife is a gamble and cannot be recommended. There is no credible scientific evidence that they improve health, so the plausible risk must be balanced against zero evidence of benefit. In the absence of proven benefit, even a suspicion of possible risk is unacceptable.
The article “Slimming to the Death” referred to in the first paragraph has been removed by Elsevier for legal reasons following a complaint from Herbalife. According to Elsevier, “The article, which was published in the March-April 2019 issue of the journal, has been removed for legal reasons. However the decision to remove the article does not imply admission of any allegation made about the article by any party.”