Herbal supplements–unproven, unregulated, unsafe

One of the more ironic memes on the internet is how pharmaceutical companies make so much money (and they do), with the false conclusion that somehow all that money means that they’re not really interested in providing drugs that are safe and efficacious. Then, those same memes will claim that “natural supplements” are healthier and better, while they ignore the profit motive of supplement pushers (henceforth called Big Herbal).

The National Center for Complementary and Alternative Medicine (NCCAM), an abomination that pushes fraudulent science, reported that in 2007, US adults spent $33.9 billion on visits to complementary and alternative medicine (CAM) providers and for purchases of CAM products, classes, and materials. About $14.8 billion of that spending was on non-vitamin, non-mineral, natural products, such as fish oil, glucosamine (no evidence of effectiveness), and Echinacea (no evidence of effectiveness). What is surprising is that this $14.8 billion is about ⅓ of what is spent on prescription drugs. Finally, about $4.4 billion was spent on herbal supplements, which are supplements that use botanical products based on some historical or current belief that the products have some ability to treat some disease or symptom. Of course, sometimes these beliefs are myths, or even errors, like when a Swiss CAM products company misunderstood someone and believed that Native Americans used Echninacea for treating colds. They didn’t.

Part of the problem with these herbal supplements is that many consumers think that they are safe because someone must be regulating them. And they also think that the claims made by Big Herbal must be factual because someone must  be regulating them. Except, in the USA, regulation barely exists. The Dietary Supplement Health and Education Act (DSHEA), passed by the US Congress in 1994, specifically removed supplements from being regulated like pharmaceuticals. According to the US Food and Drug Administration (FDA), “the dietary supplement or dietary ingredient manufacturer is responsible for ensuring that a dietary supplement or ingredient is safe before it is marketed. FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market. Generally, manufacturers do not need to register their products with FDA nor get FDA approval before producing or selling dietary supplements.”

In other words, the supplement manufacturer doesn’t really have to prove anything to anyone before marketing the product. A pharmaceutical company has to spend tens or hundreds of million of dollars in clinical trials to show safety, efficacy, shelf life, interactions with other drugs, and then wait several years to gain FDA clearance to bring the drug to patients. Because Big Herbal doesn’t have to pay that huge cost to prove that those supplements are safe and that they actually work, the profit margin of supplements is probably quite a bit higher than pharmaceuticals.

In a recent article in the Archives of Internal Medicine (a respected peer-reviewed journal), DM Marcus and AP Grollman stated that “Even when the agency [FDA] identifies an unsafe product, it lacks authority to mandate its removal from the market because it must meet the very high legal requirement to demonstrate a ‘significant or unreasonable’ risk. That is why it took FDA more than 10 years to remove from the market ephedra-containing herbal weight-loss products that had caused hundreds of deaths and thousands of adverse events.”

According to an article by Geoffrey Kabat in Slate Magazine

Marcus and Grollman point to a number of major deficiencies in the regulation of herbal supplements: There is a lack of standardization to guard against adulteration and ensure a consistent level of the active ingredients. Herbal supplements can interact adversely with prescribed drugs. Herbal supplements do not need to be tested before marketing, as is required for prescription and over-the-counter drugs. Producers of dietary supplements engage in deceptive marketing and do not adequately label products to inform consumers about their nature and regulation. Finally, there is no requirement to report all adverse effects promptly to the FDA.

People seem to conflate “natural” as good and safe, a great example of an Appeal to Nature logical fallacy. But, as Marcus and Grollman state, herbal supplements aren’t tested to be shown that they are safe (let alone useful). 

This may just be non-issue, except that there are real-world consequences to lax oversight of these supplements. The Slate Magazine article describes a terrible situation with a traditional herbal supplement in Europe:

The most dramatic instance of the potential for harm from the unregulated use of botanicals occurred in Brussels, Belgium. Women attending a weight-loss clinic participated in a program that involved taking a combination of Chinese herbs. The program had been in operation for 15 years with no ill effects. However, in the early 1990s, the company that supplied the herbs substituted Aristolochia for another, benign, herb with a similar sounding name in Chinese.  Aristolochia has been widely used in herbal medicine, but it contains aristolochic acid—a powerful kidney toxin and a carcinogen. As a result of including Aristolochia in the regimen (for a period of two years), 105 women attending the clinic developed rapidly progressing kidney failure and had to go on dialysis or have kidney transplants. Many of the women went on to develop cancer of the upper urinary tract. Cases of kidney failure due to the ingestion of herbal products containing aristolochic acid have also been reported in the United States, Europe, and Asia.

As a result of the case, many countries banned the products. Eventually, the FDA issued a warning about the supplement. What is troubling is that if the kidney failure wasn’t clustered in the one clinic in Belgium, no one would have noticed the adverse events, and many more people would have been injured. This point alone illustrates why drug trials are so critical to bringing new drugs to the market–they are tested in randomized clinical trials which uncover issues like this. A real drug with real testing would have been withdrawn from a clinical trial if this many kidney failures happened so quickly. 

This supplement has been used for centuries by cultures in Europe, Asia, and South America, which adds value to the beliefs held by the herbalists. They’ll say “it’s been used safely for hundreds of years.” But the problem is that sometimes it’s difficult to link the adverse event to the supplement use, especially if the event is relatively uncommon, or the time period between its use and the adverse event is long. And people would be taking Aristolochia without worrying about their failing kidneys.

If this were the only story, maybe we could say “lesson learned.” But it’s not the only one. A recent study in Italy showed that pregnant women who took herbal supplements had a higher rate of pre-term births than those who didn’t. Another study provided evidence that energy supplements, popular with young males, can increase the risk of liver damage. There are literally hundreds of published articles that presents evidence of dangers from herbal supplements.

Real pharmaceuticals, for all of their faults, must go through a difficult and long set of clinical trials before they ever make it to the market. And except for very aggressive diseases, like certain types of cancers, the drug must show a benefit that far exceeds its risks. And even after a drug is on the market, it is constantly monitored for its safety and efficacy. Usually, after a few years, there are additional clinical trials that either dispute the efficacy, uncover adverse effects, or support both. We get distracted by the massive failures of some drugs, ignoring the fact that hundreds of other drugs are simply lifesaving.

Unfortunately, Big Herbal doesn’t have to prove its stuff are safe or effective. It just sells its potions and pills without investing in an effort to show anything. You don’t know what’s in that supplement. You don’t know if it was manufactured safely with no contaminants. You don’t know if it’s going to work. And you don’t know if it’s going to injure you. But if you want to believe in some claim that some medieval alchemist used some herb to cure some disease, go for it. But, buyer beware.

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The Original Skeptical Raptor
Chief Executive Officer at SkepticalRaptor
Lifetime lover of science, especially biomedical research. Spent years in academics, business development, research, and traveling the world shilling for Big Pharma. I love sports, mostly college basketball and football, hockey, and baseball. I enjoy great food and intelligent conversation. And a delicious morning coffee!