The supplement industry is huge and unregulated. Worldwide annual supplement sales exceed US$151 billion, yet contaminated supplements are part of the industry’s method to make their mostly useless products appear to have some clinical effect.
There is growing evidence that these contaminated supplements contain unlabeled ingredients that are found in regulated pharmaceuticals – all without telling the consumer about them. Or testing them. Or listing warnings for their use.
Let’s take a look at Big Supplement, and what’s going on with contaminated supplements.
Supplements are mostly useless
As I’ve written many times, supplements are basically worthless, unless you have specific chronic medical conditions or suffer from chronic malnutrition that prevents you from receiving enough micronutrients, like vitamins and minerals. In addition, those on highly restrictive diets, like vegans or those who have had weight-loss surgery, may require supplementation, although both could be considered “chronic medical conditions.”
For example, in modern prenatal care, the pregnant mother is urged to take folic acid supplements to reduce the risk of neural tube defects in the developing fetus. But after the pregnancy is over, folic acid is no longer needed – in fact, continued use of folic acid may increase the risk of some forms of cancer, in individuals who have no medical need for the supplement.
Because a lot of people favor confirmation bias as their go-to argument, I constantly hear, “Hey Skeptical Raptor, vitamin C prevents scurvy, ergo all supplements are the greatest thing we can consume.” Scurvy is fairly rare these days in developed countries, but it can happen especially to smokers since cigarette smoke inhibits the uptake of vitamin C (and another reason not to smoke).
So unless your diet only includes steak, ice cream, and junk food, an average American or European will get more than adequate amounts of vitamin C from their diet. Anyone deficient in vitamin C could be considered to be malnourished, and, of course, they will benefit from a vitamin C supplement. But vitamin C does not prevent colds, flu, or cancer. It is not a miracle vitamin, despite the oft-debunked claims of the pseudoscience-based supplement proponents.
Despite the utter lack of or weak evidence of the usefulness of supplements, unsurprisingly, over 80% of Americans take dietary supplements. I guess chronic malnutrition and medical conditions afflict over 80% of Americans. The facts are that human needs for nutrients, like vitamins, are more than adequately met by a broad, healthy diet that includes a lot of fruits and vegetables.
But there’s more bad news, and it’s more than just overpriced, mostly useless products. It’s that contaminated supplements are widespread in this industry, some of which are very dangerous.
A growing body of evidence is supporting the concern that popular supplements may not contain what they claim they contain. Moreover, some of the contaminants can be potentially dangerous.
A recent paper by Jenna Tucker et al. at the California Department of Public Health, published in JAMA Network Open, revealed that more than 700 supplements on the market included unlabeled ingredients that are generally only found in pharmaceutical drunks. And less than half of those were forced to be recalled by the FDA or other regulatory agencies.
The researchers reviewed a database of contaminated supplements maintained by the FDA and found pharmaceuticals, like steroids, anti-depressants, and Viagra, in 746 dietary supplements between 2007 and 2016. More than half the products were not removed from store shelves.
In other words, regulated pharmaceuticals that can only be prescribed by a physician are finding their way into contaminated supplements. Some of the drugs that are in these supplements have significant effects that need to be monitored by a physician. For example, a man could be told that he has a condition that contraindicates Viagra but buys a supplement that has it. That could be very dangerous.
Moreover, these contaminants may have significant adverse effects (many anti-depressants, for example, can raise blood sugar significantly) or have dangerous interactions with other medications. A recent study showed that over 23,000 emergency room visits yearly result from supplements.
Unfortunately, although dietary supplements are regulated by the FDA, the manufacturers are not required to test the products for safety or effectiveness before going to market. If Big Pharma sold a drug that was contaminated with another drug (either intentionally or unintentionally), they would face significant fines and would recall those products. Big Supplement, on the other hand, faces little regulatory oversight and a non-existent approval process.
The FDA provides some guidance to supplement manufacturers for safety. They cannot make claims that the supplement prevents or cures any disease. But they can make general statements that, with winks and nods, certainly imply that they do much more than they do. For example, a supplement can claim that it “boosts the immune system,” but it cannot say it fights an infection like the flu or cold.
However, we know that Big Supplement makes these claims all the time. And if they do, they are supposed to provide the data to the FDA before actually making those claims. Unfortunately, the FDA may not be able to do much, since supplements are regulated by the Dietary Supplement Health and Education Act of 1994, which essentially ended most regulations of supplements (and even then, Big Supplement whined about the law).
…let the supplement industry have free reign to market untested products with unsupported claims, and then we’ll fund reliable studies to arm the public with scientific information so they can make good decisions for themselves. This “experiment” (really just a gift to the supplement industry) has been a dismal failure. The result has been an explosion of the supplement industry flooding the marketplace with useless products and false claims.
The FDA does provide guidance documents for manufacturers on the safety requirements for supplements. For example, supplements cannot claim that they prevent or cure disease. Instead, labels and advertising can only make general statements about supplements’ ability to maintain the health and functioning of the body. A supplement can claim it boosts immune system function, but it cannot say it fights infection.
For example, the FDA has warned consumers about the potential and actual contamination of supplements. In this case, their warning was “due to potential contamination with the bacteria Burkholderia cepacia (B. cepacia) and the risk for severe patient infection.” According to the FDA Commissioner at the time, Scott Gottlieb, MD:
B. cepacia poses a serious threat to vulnerable patients, including infants and young children who still have developing immune systems. These products were distributed nationwide to retailers, health care facilities, pharmacies and sold online – making it important that parents, patients and health care providers be made aware of the potential risk and immediately stop using these products.
I know everyone likes making all kinds of claims about Big Pharma, but this probably wouldn’t happen under strict manufacturing controls. Because the FDA lacks a lot of regulatory responsibility for supplements (see here), there is less oversight of Big Supplement’s manufacturing. And that can spell trouble.
How do these ingredients get into the contaminated supplements?
There isn’t good research into how unlabeled ingredients and pharmaceuticals get into these supplements. But some people have speculated that because companies are allowed to legally advertise these supplements as though they will actually improve your health, they make these claims about their supplements’ effectiveness, even if there’s little or no robust evidence to support Big Supplement’s claims for these products.
It’s not hard to speculate that the easiest way for these companies to deliver on their promises and claims is to intentionally spike their products with pharmaceuticals. Big Pharma can’t do this. Big Supplement can.
As Pieter Cohen, MD wrote in an accompanying article published in JAMA Network Open,
More than FDA action will be required to ensure that all adulterated supplements are effectively and swiftly removed from the market. Congress would need to reform the Dietary Supplement Health and Education Act of 1994. One practical change would be to require firms to register supplements with the FDA prior to sale and Congress could provide the FDA with more effective enforcement tools such as immediately revoking a product’s registration if a supplement is found to be adulterated with pharmaceutical drugs. In the meantime, the process that the FDA is required to follow to remove supplements from the marketplace will remain cumbersome and time-consuming; nevertheless, the agency’s failure to aggressively use all available tools to remove pharmaceutically adulterated supplements from commerce leaves consumers’ health at risk.
Big Supplement gets a pass from regulatory oversight that Big Pharma could only dream about. Before a drug gets approved by the FDA, the pharmaceutical company has to invest in years of pre-clinical and clinical studies that are thoroughly reviewed by the FDA. Supplement manufacturers have to put some pills in a bottle and make claims about safety and effectiveness that are simply unsupported by scientific studies.
It has always frustrated me that groups like anti-vaxxers reject the years of research it takes for the FDA to approve a new vaccine while jumping on board with a new supplement (or even an old supplement) without a nanogram of supporting evidence. Of course, quacks like Joe Mercola have been pushing supplements for the treatment or prevention of COVID-19 — at least, the FDA came down on him.
The FDA is stymied
The FDA can issue warnings and public notifications if they deem contaminated supplements as unsafe. The problem is that there’s no system to detect them. For real pharmaceuticals, the company has to continually monitor and report the purity of their ingredients, and there are powerful regulatory and criminal procedures that enforce these regulations. That’s completely lacking in the US supplement industry.
Furthermore, because about anyone can develop and market any supplement they want, the FDA cannot track what is on the market. But it’s worse than that. According to the study, the FDA is aware of these contaminated supplements, but they didn’t act. In addition, the FDA may not have the authority to force a mandatory recall of these supplements.
The FDA can’t even keep a list of supplements on the market. I can go to the FDA and find all kinds of information about every single prescription or over-the-counter drug marketed in the USA. But according to an article in MedPage Today:
The database is critical — even the more responsible members of the industry support it, which ought to tell you something — but it should offer more extensive information. The listings should provide consumers with access to recent FDA enforcement actions where food safety and labeling laws have been violated. It should also be linked to product labels so that consumers can look up those they are considering buying and doctors can thoroughly research those they are considering recommending to patients. There is also a need to address an existing provision whereby companies can simply self-certify new ingredients as safe, without even telling FDA, much less providing any evidence. The FDA also needs to be alerted to any new ingredients, and they should be added to the database before the products can be altered and sold.
As someone who is intimately aware of the regulatory process of pharmaceuticals, I find it just amazing that supplements, contaminated or otherwise, are not under the same level of scrutiny by the FDA as the pharmaceutical industry.
Part of the problem is that the FDA’s Office of Dietary Supplement Programs is severely underfunded so they can’t even use the limited powers they have to regulate Big Supplement. That’s why the supplement industry is so profitable — they can sell whatever they want, make whatever claims they want, and contaminate their supplements with whatever they want. And laugh at the FDA while essentially printing money.
The most important piece of advice is that one should speak with a physician about whether you need a supplement. If you are presenting symptoms that may be related to a nutrient deficiency, a physician can order tests to determine levels of the nutrients.
But supplements are not going to boost your immune system, prevent any of the 200 or more different cancers, or suddenly make you a genius. Most of the information on the internet about supplements is not based on scientifically reputable evidence.
But if you insist on taking supplements, because you believe in magic, then don’t trust any supplement that makes outrageous claims. Weight loss, sexual enhancement, and muscle-building claims are generally found to be adulterated and contaminated supplements. Single-ingredient supplements, like vitamin A or D, are generally less prone to being “enhanced” with unlabeled contaminants.
But the most important conclusion to make, irrespective of this scandal of contaminated supplements, is that most of us do not need or require any supplements, adulterated or otherwise. The bulk of these supplements ends up in the urine, creating very expensive urine flushed down the toilet.
- Cohen PA. The FDA and Adulterated Supplements—Dereliction of Duty. JAMA Netw Open.2018;1(6):e183329. doi:10.1001/jamanetworkopen.2018.3329
- Garcia-Cazarin ML, Wambogo EA, Regan KS, Davis CD. Dietary supplement research portfolio at the NIH, 2009-2011. J Nutr. 2014 Apr;144(4):414-8. doi: 10.3945/jn.113.189803. Epub 2014 Feb 12. PubMed PMID: 24523489; PubMed Central PMCID: PMC3952619.
- Geller AI, Shehab N, Weidle NJ, Lovegrove MC, Wolpert BJ, Timbo BB, Mozersky RP, Budnitz DS. Emergency Department Visits for Adverse Events Related to Dietary Supplements. N Engl J Med. 2015 Oct 15;373(16):1531-40. doi: 10.1056/NEJMsa1504267. PubMed PMID: 26465986; PubMed Central PMCID: PMC6196363.
- 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 Network Open.2018;1(6):e183337. doi:10.1001/jamanetworkopen.2018.3337