Inaccurate labels and claims on most “immune boosters” Original paper

The market for immunity dietary supplements has exploded since COVID-19, but because supplements are not tightly regulated, adulteration, misbranding, and misleading claims are regularly reported.^[1][2][3]

In this case-series, the researchers purchased the first 30 immune health dietary supplements featured on Amazon.com, specifically those rated at least 4 stars in May 2021, and analyzed them using liquid chromatography-mass spectrometry (LC-MS). Herbs, botanicals, vitamins, and minerals made up most of the dietary supplement ingredients. The most frequently listed ingredients were echinacea, elderberry, zinc, and vitamins C and D.

The results were compared to the ingredients listed on the product’s supplement facts label. Claims that were made on the product’s labels were also evaluated by using the Operational Supplement Safety (OPSS) Scorecard, which is an educational tool designed to help consumers quickly determine whether a supplement may be risky.

Operation Supplement Safety scorecard

Of the 30 tested products, 17 had inaccurate labels, of which 13 were misbranded (i.e., ingredients listed on the label were not found in the product) and 9 included hidden ingredients (i.e., substances that were detected but not claimed on the label). No product had a third-party certification seal, all included claims related to immune defense or support, and half claimed that the product was “scientifically proven” or “clinically studied”.

The OPSS scorecard suggested that 13 of the 30 products were “likely okay/less risky”, but only 10 of those 13 had accurate labels according to the LC-MS analysis.

Although the authors did not investigate whether the product claims are actually scientifically backed for safety and efficacy in this study, they stated that they were going to do so in a separate effort.

Lipids and elements were not analyzed in the selected products, and the analysis was not quantitative in nature.

Dietary supplements are a mixed bag of risk and uncertain quality, reliability, and benefits, as their regulation is not exactly effective.^[7] A study from 2020 determined that out of 12 supplements selected from a total sample of 650 products marketed for brain health and cognitive performance, 8 were misbranded and 10 had hidden ingredients.^[8] Most products were also labeled with scientific-sounding claims that did not appear to be supported by evidence.

According to the U.S. Food and Drug Administration (FDA) manufacturing and labeling regulations, it is the manufacturer’s responsibility to ensure truthful claims about a safe and lawful product. Only after the product is on the market will the FDA inspect manufacturing facilities to monitor product quality, labeling, adverse event reports, and request to remove adulterated or misbranded products. In other words, they ask for products to be removed. Although the FDA has stricter enforcement tools available, such as sending a warning letter, mandating a recall, or even referring the issue to the Department of Justice, these are rarely used.^[9] 

A study from 2018 reported that less than half of the 776 supplements identified by the FDA as adulterated (spiked, laced, or made less pure by the addition of another substance) with pharmaceutical ingredients (e.g., prescription medications or unapproved drugs such as steroids) from 2007 to 2016 were voluntarily recalled.^[10] That means that more than half were still available for purchase. From 2016 to 2021, 292 dietary supplements were added to the adulterated list.^[2] Most of these adulterated supplements were marketed as sexual enhancers, weight loss aids, and workout stimulants (i.e., preworkout). Some of the adulterant ingredients, such as the synthetic stimulant 1,3-dimethylamylamine (DMAA), have been associated with adverse events, including hepatotoxicity and cardiac arrest.^[11]

In 2020, Amazon.com, where a majority of ecommerce supplement sales occur, began to require quality control documentation and certificates of analysis from sellers for supplements sold on the website.^[12] Amazon.com now requires a valid good manufacturing practice certificate and a finished product certificate of analysis for the declared ingredients in a supplement or evidence of product enrollment or participation in a third-party quality certification. However, as the results from the study under review using supplements purchased via Amazon.com in May 2021 suggest, this isn’t enough to stop the sale of adulterated dietary supplements.

Because regulation and enforcement are lacking, consumers must educate themselves to protect themselves. The OPSS Scorecard is a great place to start, along with potentially contacting specific supplement companies to see their third-party certification and/or certificate of analysis. The National Institutes of Health Office of Dietary Supplements is another good resource. Claims about specific supplement ingredients can be vetted on the Examine website.