Supplement Roulette

The Shocking Truth About What's Really in Your Products

Imagine you needed a can of black beans for a recipe, but when you brought the can home and opened it, there was corn instead of black beans. You might be annoyed, more so if you needed those black beans for dinner that night. Now imagine if this wasn’t a one-off; rather, 40% of the time, a can of black beans contained something else. You would probably be pissed, and you might wonder why the hell this wasn’t a major news story? And maybe also about what exactly was going on at that factory. Was no one checking the shipments from farmers to see what exactly they were delivering? Was the system for sorting corn from beans that bad? Or were they purposely substituting corn for black beans because it was cheaper? And if their quality control was this bad, maybe you would start to wonder about the product's cleanliness. 

If 40% of black beans sold in the United States contained corn, that would almost certainly be a major news story. In fact, this is the actual state of affairs with many supplements in the United States, and it seems to just be business as usual, with buyer beware in teeny tiny print. 

Anyone who has read my writing for any length of time probably knows that I am extremely skeptical of supplements. Not only are these products rarely, if ever, tested in a meaningful way, so physicians like me can’t advise people on their use, but they often don’t even declare what they contain. And this week, there was yet another study showing us the extent and seriousness of the problem. 

Researchers tested 57 products that were marketed as “sports enhancers” that either claimed to have stimulant or muscle-building effects, often advertised with nebulous claims such as “fat burners,” “thermogenic,” “preworkout”, or “metabolism booster.” The researchers focused on supplements that claimed to contain one of the following active ingredients: Rauwolfia vomitoria, methylliberine, halostachine, turkesterone, and octopamine, and they tested the products to see if the supplements contained the advertised ingredients and if the dose matched the labeling. They also tested for banned ingredients. The results are shocking but unsurprising to anyone who follows the supplement industrial complex.  

Of the 57 products evaluated, here’s what was found:

• 40% didn’t contain the active ingredient listed on the label. Yes, 40%.

• Of the 60% that did contain the active ingredient, the amount ranged from 0.02% to 334% of the dose listed on the label. 

• Only 11% had accurate labeling and contained the active ingredient and the advertised amount within a 10% margin of error. Another way to look at this is that 89% had inaccurate labeling in some manner. 

• 12% contained an ingredient banned by the Food and Drug Administration (FDA). One supplement contained four banned ingredients, and one contained a substance that has never been approved for human use in any country! This is also not the first time that experimental substances not approved for use in humans have been identified in supplements!!!! Sadly, sometimes you need four exclamation marks.

Yes, the number of products labeled corrected was about the same as the number that contained a banned ingredient. Not exactly a confidence-inspiring industry.

This study came out on the heels of another one that tested 25 melatonin gummy products marketed for sleep, some of which also advertised that they contained cannabidiol or CBD, even though CBD is not approved by the FDA for use in dietary supplements. One contained no melatonin at all (although it had CBD), and among those that did have melatonin, the amount ranged from 74 to 347 percent of what the labeling stated the product contained. In fact, only three products contained the appropriate amount of melatonin (meaning a plus or minus 10% margin of error compared with the label). 

I often hear that Canada is safer for supplements, and while it’s true there are more regulations, in a recent study also looking at melatonin, just over 71% of products tested didn’t contain the amount they should based on the labeling, and 26% contained serotonin, which they most definitely should not have contained. Whether the serotonin was there because of contamination during manufacturing, purposeful adulteration, or was somehow the result of the melatonin breaking down into serotonin wasn’t known. 

In another slightly older study from Canada, 44 supplements from 12 companies were studied. All the supplements were purchased in Toronto, although some originated in the United States; a shocking 30 products did not contain the active ingredient they claimed to have, and many had fillers not identified on the label. For example, black walnut was identified in a Ginko biloba supplement but did not appear on the label. This obviously poses a risk for people with allergies. The study couldn’t determine if the contamination was the nut (which seems unlikely) or perhaps from leaves or bark accidentally harvested with the target plant, which raises other concerns as black walnut leaves and bark contain juglone, a substance that can cause irritant reactions and may promote the growth of tumors. 

In this study, several of the products contained substitutions with known toxicity or that risked drug interactions. One product that was labeled as St. John’s wort instead contained Senna alexandrina, a laxative, and several products contained Parthenium hysterophorus or feverfew, which can cause nausea, vomiting, abdominal pain, and diarrhea and can interact with blood thinners. Only two of the 12 companies had supplements that contained what they claimed with no unlabeled additives.

And lest you think this is limited to weight loss, bodybuilding, or sleep, several studies, including the one from Toronto, have found black cohosh supplements (often promoted for hot flashes) that don’t contain any black cohosh at all. In one study, 25% of the products tested had no black cohosh and instead contained a different, potentially toxic plant. 

The supplement industry in the United States is a hot mess, and consumers pay the price. Picamilon, a drug that has never been approved in the United States, BMPEA (a synthetic amphetamine-like drug banned by the World Anti-Doping Association), anabolic steroids, prescription medications for erectile dysfunction, antidepressants, and many other drugs have all been found in supplements. If people feel better after taking a supplement, it’s possible it’s because they are unknowingly receiving a pharmaceutical or even an untested designer drug. 

The issue here is that the regulations in the United States are not designed to protect the consumer. Truthfully, they are not designed to do anything useful for the consumer or for health care. To qualify as a dietary supplement, a product must contain only one of the following: vitamins, minerals, botanicals, amino acids, or enzymes, and the product cannot claim that it treats or prevents disease. There is no research required before the product hits the market. According to the FDA, manufacturers are supposed to ensure their products are safe, that their labeling is accurate, and that they adhere to good manufacturing practices, but it’s clear this often doesn’t happen. Look, when only 11% of products in one study are labeled correctly, or 2 out of 12 manufacturers consistently produce accurately labeled products, it raises the concern that good manufacturing practices are the exception, not the rule. Many people assume the FDA tests supplements for safety, but this only happens when a supplement is “suspected to be adulterated, fraudulent, or otherwise in violation of the law.” While there are some inspections and random testing, this seems to be largely confined to products shipped from international sources, if it even occurs at all. 

From a safety standpoint, the FDA acts after the fact, once a supplement is on the market and people have been potentially placed in harm’s way or harmed. The FDA relies on reports of adverse events, either from consumers, medical professionals, or the manufacturer. But many consumers and doctors don’t know if it’s a supplement that caused the issue, and if someone did think a supplement made them sick, they may not be thinking about reporting the product to the manufacturer or the FDA. Also, I don’t have the highest degree of confidence that a company that slips a compound never approved for human use into its supplement is keeping accurate records of product concerns and is then reporting those concerns to the FDA.   

From 2007 to 2016, the FDA sent 776 warning letters about tainted supplements, but of course, the real number of tainted products is likely to be much higher. Also, the warning letter system isn’t exactly a robust way to protect consumers because even when a warning letter is generated, the product may not even be removed.

In one review of warning letters for 31 products that contained one of three banned stimulants, only 3% (one product) was recalled, and 29% (nine products) were still available for purchase six years after the FDA warning. The researchers analyzed the products that were still on the market, and 5 out of the 9, or 56%, contained at least one substance banned by the FDA. Looking at the data that is available, it seems that supplements marketed for weight loss, sexual enhancement, and muscle building were most likely to have received warning letters. 

If no fines or other government action rarely follows warning letters, it’s no wonder there’s such a problem. For example, right now, there are products being sold that contain tianeptine, which is an antidepressant not approved for use in the United States and is most certainly not classified as a dietary ingredient. On the FDA’s own website, it says the following:

Although the FDA has warned consumers about tianeptine, vendors continue to market and sell this drug. The FDA is aware that tianeptine has been sold online, typically in tablet or powder form.

Please make note of exhibition A.

Because this is exactly the kind of place where researchers buy their non-FDA-approved compounds for study. Actually, at this “health store,” the “researchers” have three more brands to consider.

The FDA system is so useless that to get tianeptine off the shelves, many states are resorting to banning it.

Le sigh. 

The fact that supplements may not contain what they claim is also a huge concern for safety. For example, supplements are a growing cause of liver failure, but if you took Supplement A, which claims to contain a specific herb, your doctors don’t know if it’s the herb that damaged your liver or perhaps the fact that what you took contained an untested steroid. Many people also don’t disclose their supplements to their healthcare provider because they just assume they are tested, natural, and safe. 

Furthermore, the lack of uniformity in supplement manufacturing means researchers can’t study them with confidence. If I want to test supplement A on 100 people to see if it helps hot flashes, for my study to be of any value, all of the tablets with supplement A need to have the same ingredients in the same dose, but we can’t know this with many (most) supplements. And then, if my study were to show that supplement A works, people need to know that when they buy supplement A at the drug store or online, it actually contains what I studied, and with the current system, that isn’t possible.

It’s hard to give advice about supplements with all these concerns. Consumer Reports has some good information about third-party testing, which is worth a read, and you can find more here. If you need a single-ingredient supplement, for example, iron for iron deficiency or vitamin D, choose a product with third-party testing. Also, the Department of Defense has a website (here) with a lot of information and a supplement checklist. This is primarily geared towards what is banned by the military, but there is good general information, a supplement checker that might make you think a little more about the products you are using or considering using, as well as links for reporting adverse events. They recommend being wary of any product that uses the words “proprietary, blend, matrix, or complex,” which is basically a posh term for “secret recipe” because there is no requirement to list the dose of products that make up the secret recipe. This is a good general rule.

Ultimately, the bottom line with supplements is you have pretty much no idea what is in that pill you are thinking of popping into your mouth. And even if there is a quality study with a supplement (which is rare), the likelihood that what you buy in the store or online contains the product that was tested is low.

There are all kinds of issues with Pharma and pharmaceuticals, but adulterated products aren’t one of them. Given the laxity of the regulations and the sheer number of supplements, the FDA simply can’t monitor the situation or protect the public. As shocking as it seems (heavy sarcasm), billion dollar industries just aren’t frightened by warning letters, and so it is best to think of supplements as untested, unregulated pharmaceuticals.

References

Cohen PA, Avula B, Katragunta K, Travis JC, Khan I. Presence and Quantity of Botanical Ingredients With Purported Performance-Enhancing Properties in Sports Supplements. JAMA Netw Open. 2023;6(7):e2323879. doi:10.1001/jamanetworkopen.2023.23879.

Cohen  PA, Travis  JC, Keizers  PHJ, Deuster  P, Venhuis  BJ.  Four experimental stimulants found in sports and weight loss supplements: 2-amino-6-methylheptane (octodrine), 1,4-dimethylamylamine (1,4-DMAA), 1,3-dimethylamylamine (1,3-DMAA) and 1,3-dimethylbutylamine (1,3-DMBA).  Clin Toxicol (Phila). 2018;56(6):421-426. doi:10.1080/15563650.2017.1398328

Cohen PA, Avula B, Wang Y, Katragunta K, Khan I. Quantity of Melatonin and CBD in Melatonin Gummies Sold in the US. JAMA. 2023;329(16):1401–1402. doi:10.1001/jama.2023.2296

Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to advance agency’s continued evaluation of potential regulatory pathways for cannabis-containing and cannabis-derived products https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-new-steps-advance-agencys-continued-evaluation

Erland LA, Saxena PK. Melatonin natural health products and supplements: presence of serotonin and significant variability of melatonin content. J Clin Sleep Med. 2017;13(2):275–281.

Newmaster, S.G., Grguric, M., Shanmughanandhan, D. et al. DNA barcoding detects contamination and substitution in North American herbal products. BMC Med 11, 222 (2013). https://doi.org/10.1186/1741-7015-11-222.

Baker DA, Stevenson DW, Little DP: DNA barcode identification of black cohosh herbal dietary supplements. J AOAC Int 2012, 95:1023–1034.

Tucker J, Fischer T, Upjohn L, Mazzera D, Kumar M. Unapproved Pharmaceutical Ingredients Included in Dietary Supplements Associated With US Food and Drug Administration Warnings. JAMA Netw Open. 2018;1(6):e183337. doi:10.1001/jamanetworkopen.2018.3337.