Pharma-Backed Study: Herbs Are Destroying Your Liver!

Another slanted study is part of larger, ongoing efforts to eliminate your supplements. Action Alert!

THE TOPLINE

• A recent study, coincidentally released after anti-supplement legislation was introduced, claims that certain herbal supplements like turmeric and green tea cause liver damage. The study argues that supplements should face stricter regulation, similar to pharmaceuticals, following a pattern seen in European markets.
• The study cites national survey data to highlight potential risks from supplements but admits that the sample size is inadequate for determining any causal relationship between supplement use and liver damage. The authors have disclosed ties to pharmaceutical companies, raising questions about bias.
• The article appears to be intended to justify more regulation for botanicals, likely following the incredibly restrictive European model, and proposes “increasing regulatory oversight on how botanicals are produced, marketed, tested, and monitored in the general population.”

Your vitamins are under attack once again. Coincidentally released days after the introduction of Senator Dick Durbin’s (D-IL) anti-supplement legislation, a new botanical-bashing study in JAMA Network Open plays all the hits: according to the authors, supplements are an unregulated, disease-causing public health menace. The implicit solution is that we need to treat supplements more like drugs, a project that the likes of Sen. Durbin and the FDA have been working on for some time. This follows the blueprint developed by European regulators years ago—with the results being a severely restricted market for supplements where you will struggle to get anything but the most basic products. We cannot let that happen.

What the study said

The authors cite data showing an increase in reports of liver injuries among supplement users, with the most “commonly implicated” herbs being turmeric, green tea, Garcinia cambogia, black cohosh, red yeast rice, and ashwagandha. Using national survey data, the authors then investigate how many Americans use these six “potentially hepatotoxic” botanicals (while ignoring the numbers that consume definitely hepatotoxic sugar and alcohol).

Along the way, the authors trot out the familiar supplement-bashing tropes: because supplements aren’t FDA-approved, we don’t know if they’re safe and/or effective; they’re sold via “unregulated retail outlets”; there are “frequent discrepancies between product labels and detected ingredients”; and US Health Department data show supplements cause 23,000 emergency room visits a year!

We should also mention that the authors disclosed connections to Pharma giants AstraZeneca and Takeda Pharmaceutical.

Severe limitations

It’s interesting to read the author’s doom and gloom story about hepatotoxicity and supplements, only to reach the “Limitations” section of the study, where the authors admit:

this survey sample size was not adequate to detect hepatotoxic effects from botanicals or other adverse events since these arise in less than 1% of exposed individuals. Thus, our study was not designed to identify any causal relationship between consumption of the 6 botanicals of interest and the development of liver injury over time. 

In short, then, this study found that, according to a survey with a low response rate, 4.7 percent of US adults reported “exposure” to the six botanicals mentioned above—the study reveals nothing about supposed liver-damaging effects of these botanicals.

“It’s déjà vu all over again”

We’ve rebutted the thrust of the study’s other arguments many times over the years. To sum up briefly:

• No, supplements are neither unregulated nor are they unsafe—they are regulated in a similar manner to foods (where the burden of safety is placed on the manufacturer) and their safety record is actually impeccable, especially compared to drugs but even to conventional foods. The idea that supplements are a threat to public health is a zombie myth that just won’t die.
• No, supplements are not, nor should they be, FDA approved. If they had to be, supplements would probably disappear entirely. FDA approval requires controlled, randomized clinical trials (RCTs), and as we’ve explained countless times, RCTs, which are exorbitantly expensive, are not practical for supplements that generally share ingredients found in conventional foods. Supplements are not strongly patentable, so the costs of those trials can’t be recouped. Only drugs can afford those trials, and that’s the whole point. Calling for pre-approval of supplements is a backhanded way of banning them.
• Yes, bad actors exist, and sometimes they sell fraudulent products that are mislabeled. The FDA knows this and does nothing. NOW Foods submitted independent testing to the FDA finding widespread fraud and mislabeling among supplements sold on e-commerce platforms—the company even got Representative Jeff Duncan (R-SC) to send a letter to the agency asking why they refused to follow up on that testing. We think the FDA allows mislabeling to continue to bolster its case for more power to restrict supplements.

To conclude the study, the authors “urge government authorities to consider increasing the regulatory oversight on how botanicals are produced, marketed, tested, and monitored in the general population.” You take it from here, Sen. Durbin!

European blueprint

Sen. Durbin is leading us down the path laid down by European regulators—a path that leads to a severely restricted supplement market where the options available to you are slashed. In the European Union (EU), a very narrow list of permitted supplement ingredients has been created for vitamins and minerals, while many other ingredients are only allowed following pre-market approval where reams of data are required, and therapeutic doses are disallowed for all supplements. That’s before you look at the extreme difficulties of getting science-backed health claims approved or bringing any product to market that is considered ‘novel’ (akin to the FDA’s interpretation of ‘new dietary ingredients’).  

Call to action

We cannot let momentum build behind Sen. Durbin’s anti-supplement legislation. Let’s keep up the pressure on lawmakers to protect our supplement access!