The findings of a recent study on dietary supplements should give pause to anyone who buys over-the-counter products for sexual enhancement, weight loss or muscle growth. The report, published in JAMA Network Open, analyzed data from the FDA’s Tainted Dietary Supplements database and included entries from 2007 through 2016.
A whopping 80 percent of the dietary supplements were found to contain unapproved and potentially dangerous pharmaceuticals. Despite finding 776 contaminated supplements – some with active medications that raise or lower blood pressure — less than 50 percent were recalled by the manufacturer.
Analysis of tainted dietary supplements
The FDA classifies health supplements, including botanicals, vitamins, minerals and enzymes – as a food item rather than a drug. This means that supplements for erectile dysfunction, weight loss and other common concerns are not vetted for safety or efficacy by health regulators. Instead, this burden falls on the manufacturer, whose interests lie in profits.
Over half of American adults take dietary supplements, many under the assumption that product labeling and marketing claims are accurate. In reality, the presence of unapproved and unknown ingredients in supplements is commonplace. Most consumers have no idea exactly what they are purchasing since the supplement industry is not strictly regulated.
The study’s authors caution of the serious public health risk posed to unwary consumers, concluding that these unapproved ingredients may cause “serious adverse health effects owing to accidental misuse, overuse or interaction with other medications, underlying health conditions or other pharmaceuticals.”
Supplements not vetted for safety by the FDA
Dietary supplements rake in $35 billion dollars a year in the United States, but what happens when these products cause life-threatening harm? A separate study published in The New England Journal of Medicine discovered that dietary supplements were linked to more than 2,000 hospitalizations and 23,000 ER visits each year.
While the FDA does issue safety communications on supplement dangers and can ask manufacturers to perform a ‘voluntary’ recall, the agency rarely forces manufacturers to pull products off the shelves. FDA spokesman Jeremy Kahn told the Washington Post that when officials take measures against one supplement distributor, others may relabel their products to evade detection and fill the void.
Dangerous ingredients found in common supplements
Of the supplements analyzed, 45.5 percent were promoted for sexual enhancement, 40.9 percent for weight loss, and 11.9 percent for building muscle.
Sildenafil – the active compound in Viagra — was the most commonly found contaminant in tainted sexual enhancement supplements. Researchers also found dapoxetine, an antidepressant that has not been cleared for human use in some of the sexual enhancement pills.
Some of the weight loss supplements had sibutramine, a potent diet drug that has been pulled off the market due to cardiovascular and stroke risks.
Anabolic steroids or steroid-like components were found in muscle growth supplements, despite no such language on the product labels.
When it comes to dietary supplements, “it’s the Wild West,” says Dr. Lawrence Appel of the Johns Hopkins Medical Institutions in Baltimore. The FDA has stated its commitment to keeping dangerous products off the market, but under the current system, supplement recalls are infrequent and usually initiated after the fact, when serious harm or death has been reported.
Explore your legal option with Showard Law Firm
If you or a loved one suffered adverse effects or injury from a dietary supplement, Showard Law Firm can help explain your legal rights. Call today to schedule a free case review with an experienced dangerous drug lawyer.
Additional Resources on Dietary Supplement Contamination:
- Washington Post, Diet, weight loss and sex supplements are tainted with unapproved drugs https://www.washingtonpost.com/national/health-science/diet-weight-loss-and-sex-supplements-are-tainted-with-unapproved-drugs/2018/10/12/b3e93bfc-cd7c-11e8-a360-85875bac0b1f_story.html?utm_term=.f1ac4f9fd13c
- Health Day, Many Supplements Contain Dangerous, Unapproved Ingredients https://consumer.healthday.com/vitamins-and-nutrition-information-27/nutritional-supplements-health-news-504/many-supplements-contain-unapproved-dangerous-ingredients-study-738565.html
- Forbes, What Is In Your Dietary Supplements? Study Reveals Unapproved Ingredients https://www.forbes.com/sites/brucelee/2018/10/12/what-is-in-your-dietary-supplements-study-reveals-unapproved-ingredients/#4a2c666877e9