Dietary supplements are typically assumed to contain natural ingredients and, so, are safe to use. But new research has revealed that many of these actually contained unapproved, possibly dangerous compounds.
Findings from this new study that was recently published may lead to even stricter monitoring and control of dietary supplements.
The researchers analyzed 776 supplements in the database of the Food and Drug Administration (FDA) that were identified between 2007 and 2016. A shocking discovery was that a significant majority of these products had ingredients, specifically drugs, which were not approved for use. Some of them actually had at least two of such substances.
Practically all of these supplements (about 98 percent) were marketed for weight loss, muscle growth and sexual enhancement.
The study, carried out by researchers at the California Institute of Public Health, was published in JAMA Network Open on Oct. 12.
During the period from 2007 to 2016, the FDA identified 776 supplements that were observed to contain unapproved substances. These were the focus of analysis in the new study.
The researchers found that roughly 80 percent contained a drug that ought not to be present. Around 1 in 5 products had at least two unapproved medications.
Six unapproved substances were detected in two of the supplements. It was also revealed that a particular product actually contained drugs that both increase and reduce blood pressure.
The most common unapproved drug that was found in sex supplements was sildenafil. This is the popular erectile dysfunction (ED) medication many people know as Viagra. There were also other ED drugs in these products.
The most common unauthorized inclusions in weight loss supplements were sibutramine, a banned drug for weight loss, and phenolphthalein, a laxative agent. The most common for muscle enhancement supplements were synthetic steroids or their analogues.
The presence of these potentially harmful ingredients exposes users to unexpected risks. Millions of people use dietary supplements in America, with majority of such viewing these products as safer alternatives to drugs.
Need for greater control
The FDA doesn’t regulate supplements the same way it does pharmaceuticals. This is mainly because they are not expected to contain synthetic chemicals. But with evidence from this new research, it is obvious the agency needs to do more.
The researchers somewhat suggested that the regulator isn’t doing enough currently. For example, in spite of identifying the tainted supplements, it caused less than half (about 46 percent) to be recalled.
It is not clear why all the contaminated products identified were not recalled. It is possible that the manufacturers were not contacted to recall them. Another possibility is that the companies making the products failed to recall when asked to.
Earlier research by Pieter Cohen and colleagues had shown that some supplements continued to sell in stores even when they were recalled. They reported that this was the case for up to 52 months afterwards.
Indicating the need for greater monitoring, the authors of the new study noted the capability of the tainted products “to cause serious adverse health effects owing to accidental misuse, overuse and interaction with other medications, underlying health conditions or other pharmaceuticals.”
Side effects that may result from use of tainted products include rapid heart rate and elevated blood pressure in the case of some weight-loss supplements. Sex supplements containing ED drugs may reduce blood pressure to dangerously low levels.
Supplements are considered food and regulated as such under the 1994 Dietary Supplement Health and Education Act. They are therefore not subject to strict safety and efficacy testing as is the case with pharmaceuticals.
An FDA spokesman revealed that the agency was looking into the findings from the new research.
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