Authors from the California Department of Public Health just published an article revealing that hundreds of dietary supplements have been contaminated with pharmaceutical ingredients. Between 2007 and 2016, the FDA identified 776 products containing active, unapproved pharmaceutical chemicals.
“These products were commonly marketed for sexual enhancement, weight loss, or muscle building,” the authors write. “The most common adulterants were sildenafil for sexual enhancement supplements, sibutramine for weight loss supplements, and synthetic steroids or steroid-like ingredients for muscle building supplements.”
Dietary supplements are a booming industry: reportedly, over 50% of US adults take supplements, and the industry brings in billions of dollars of revenue a year. Unfortunately, supplements are not tested by the FDA before being put on the market. Legally, they are considered “food,” so they do not fall under the stricter regulations for pharmaceutical drugs, which must demonstrate studies of efficacy and side effects before marketing to the public. Supplements may market to the public without any such testing, although the FDA tests them after sale, just as it does for foodstuffs.
Presumably, most people taking dietary supplements are taking them as an alternative to pharmaceuticals, believing that they are an “all-natural” remedy. However, without their knowledge, they may be ingesting dangerous drugs—in some cases, drugs that have been recalled due to serious side effects.
For instance, people who are under the impression they are building muscle with natural ingredients may be ingesting synthetic steroids, known to cause heart attacks, kidney damage, and liver damage, in addition to acne and hormonal changes.
Likewise, people taking herbal remedies for weight loss may be ingesting sibutramine—which, under the brand name Meridia, was taken off the EU and US markets in 2010 due to its known risks of stroke and heart attack (Meridia was also found to be barely more effective than placebo for weight-loss). The selective serotonin reuptake inhibitor (SSRI) fluoxetine (marketed as the antidepressant Prozac) was also detected in weight-loss supplements, and the authors note that this could lead to suicidal thinking, abnormal bleeding, and seizures.
In addition, men who believe they are taking an herbal remedy for erectile dysfunction may actually be ingesting sildenafil (brand name Viagra), which is a vasodilator known to cause heart attacks, stroke, vision loss, and hearing loss. Additionally, an unapproved SSRI called dapoxetine was also detected in these types of supplements.
According to the authors, other supplements “were marketed to assist with various conditions including joint pain, muscle pain, osteoporosis, bone cancer, sleep issues, gout, and prostate health.” These types of supplements contained a variety of pharmaceuticals, but most commonly included diclofenac, which is a non-steroidal anti-inflammatory drug, and dexamethasone, an anti-inflammatory steroid.
The current study found that, between 2007 and 2016, the FDA identified 146 different companies selling herbal supplements with active pharmaceutical ingredients, so this is not just an isolated incident with a few companies responsible. Instead, this appears to be a widespread problem—and the researchers found that it is actually becoming worse: more products were identified in recent years. In addition, many of the companies were warned repeatedly by the FDA for these violations—after which they sometimes changed the ingredients to a different unapproved pharmaceutical.
“These products continue to be sold and are potentially dangerous even after FDA warnings,” the authors write.
The researchers also found that 157 of the supplements contained more than one pharmaceutical ingredient, and some contained up to 6 different pharmaceuticals. As these ingredients may interact with one another, this is a particularly dangerous problem.
But just how dangerous is the addition of small amounts of pharmaceutical ingredients?
According to the researchers from the California Department of Public Health, “Dietary supplement use was associated with 23,000 emergency department visits and 2,000 hospitalizations in the United States each year. Serious adverse events reported with the use of dietary supplements include stroke, acute liver injury, kidney failure, pulmonary embolisms, and death.”
In an invited commentary in JAMA Network Open, Pieter A. Cohen, MD, writes that this problem is “dereliction of duty” on the part of the FDA. Official warning letters were sent to only seven of the 156 companies. Less than half of the supplements identified by the FDA were actually subject to a recall, and even this was considered a “voluntary recall”—meaning the FDA did not make it mandatory. The majority of the supplements remain for sale with no clear marker identifying them as potentially dangerous.
Cohen’s research team has separately identified two “experimental stimulants” in weight-loss supplements, and he writes that although they informed the FDA, that organization has yet to issue warnings or even notify the public.
Cohen urges that the FDA more aggressively use its warnings and public advisories to inform the public and regulate offending companies. He also suggests that Congress could reform the Dietary Supplement Health and Education Act of 1994 so that companies would be required to register their ingredients with the FDA before selling supplements to consumers.
Tucker, J., Fischer, T., Upjohn, L., Mazzera, D., & Kumar, M. (2018). Unapproved pharmaceutical ingredients included in dietary supplements associated with US Food and Drug Administration warnings. JAMA Network Open, 1(6), e183337. doi:10.1001/jamanetworkopen.2018.3337 (Link)
Cohen, P. A. (2018). The FDA and adulterated supplements—Dereliction of duty. JAMA Network Open, 1(6), e183329. doi:10.1001/jamanetworkopen.2018.3329 (Link)