(ORDO NEWS) — Many over-the-counter dietary supplements – especially those used for sexual enhancement and weight loss – are tainted with undisclosed pharmaceutical ingredients. This is the main conclusion of my recently published review in the Journal of Clinical Pharmacology.
An analysis of the Food and Drug Administration’s database of health fraud revealed 1,068 unique dietary supplements sold from 2007 to 2021 that contained active ingredients found in prescription drugs or deemed too dangerous for use in the human body. .
Of the tainted dietary supplements identified in my research, 54 percent were for sexual dysfunction and 35 percent were for weight loss.
Although many such products are withdrawn from the market after FDA discovery, other tainted dietary supplements may appear on the market instead.
Why is it important
Dietary supplements are used by 58 percent of US adults. According to recent research from the Council for Responsible Nutrition, American consumers have a moderate level of confidence in the quality and safety of dietary supplements.
However, my research shows that this reliance is misplaced as many dietary supplement products contain unlabeled synthetic active ingredients.
What are these hidden substances, and why do they matter?
Many tainted weight loss supplements hide the active ingredient sibutramine, which the FDA recommended withdrawing from the US market in 2010 after research showed it increased the risk of heart attacks and strokes.
And phenolphthalein, which is also commonly found in dietary supplements in the FDA’s database, was removed from over-the-counter laxatives in 1999 when the FDA reclassified it as “not generally recognized as safe or effective.”
The FDA warning came after studies showed that the ingredient can damage human DNA and increase the risk of cancer.
My research also revealed the presence of ingredients that are only approved for use in prescription drugs. These include sildenafil and tadalafil, which are used in FDA-approved erectile dysfunction drugs such as Viagra and Cialis.
Such unintended use can be dangerous because the active ingredients in these drugs carry risks such as loss of vision or priapism, or prolonged penile erection.
My study also documented frequent cases where more than one active ingredient found in erectile dysfunction medications was combined in a way that had never been studied for safety.
Another reason hidden active ingredients are problematic is that they pose a risk of serious drug interactions. When the active ingredients in erectile dysfunction medications are used along with high blood pressure or prostatitis medications such as nitrates and alpha-1 blockers, a life-threatening drop in blood pressure can occur.
Similarly, two of the dietary supplements identified in my study contained flibanserin, the active ingredient in the prescription drug Addyi, which is used to treat female sexual dysfunction. Flibanserin is generally safe, but can greatly lower blood pressure when taken with alcohol.
Pharmacists test for these types of drug interactions before dispensing prescription drugs. However, if undisclosed ingredients are hidden in dietary supplements, it is impossible to prevent unwanted drug interactions.
What is still unknown
Dietary supplement manufacturers do not provide evidence of good manufacturing practice to the FDA before selling them in the US, and these manufacturers may change their products without notice.
The FDA must prove that a dietary supplement product is unsafe before taking action, but this is difficult to ensure when more than 29,000 dietary supplement products are sold in the US.
The FDA evaluation is time-consuming and costly because it also looks for other problems with dietary supplements, such as the presence of heavy metals, bacteria, or mold.
The evaluation process for these supplements is also heavily underfunded. The FDA is alerting consumers to newly identified tainted dietary supplements through its Health Fraud Database in an effort to take these products off the market.
If the product you intend to use is on this list, refrain from using it. However, if your product is not included in the database, it may mean that it has not been reviewed yet.
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