Anhas found that hundreds of over-the-counter dietary supplements contain unapproved pharmaceutical ingredients that have the potential to cause serious adverse health effects.
The analysis of 10 years-worth of FDA records, showed that between 2007 to 2016, the unapproved substances were present in 746 brands of dietary supplements commonly marketed for sexual enhancement, weight loss, and muscle building.
As reported in the journal JAMA Network Open, researchers from the California Department of Food and Agriculture extracted data from the FDA’s Center for Drug Evaluation and Research, Tainted Products Marketed as Dietary Supplements_CDER database.
The data included the date, product name, company, hidden ingredients, product category and source of sample for each product.
The most commonly identified contaminants were sildenafil for sexual enhancement, sibutramine for weight loss and designer steroids for muscle building. Approximately one-fifth (157) of the products contained more than one adulterant and in two cases, up to six contaminants were identified.
The researchers say the adulterants have the potential to cause adverse health effects “owing to accidental misuse, overuse, or interaction with other medications, underlying health conditions, or other pharmaceuticals within the supplement.”
Furthermore, of the 746 products found to be contaminated, less than half (48%) were recalled as a result, leaving the majority of adulterated supplements available for sale.
In an associated commentary, general internist Pieter Cohen warns that more than FDA action will be needed to ensure that contaminated supplements are removed from the market, saying that congress would need to reform the Dietary Supplement Health and Education Act of 1994.
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.”