March 7, 2021

After Recalls, Dietary Supplements with Banned Drugs Stay on Market

About half of all FDA drug recalls in the last decade have been for dietary supplements that contain  banned ingredients. These recalls are meant to be swift enforcement actions that protect consumers from serious, sometimes life-threatening, conditions,  but in some cases these dangerous products remain on the market for longer than six months after they are recalled, according to a new report in the Journal of the American Medical Association (JAMA).

Dietary SupplementsFor the study, Harvard researchers looked at supplements recalled between January 1, 2009 and December 31, 2012 that were still on the market with the same name, maker and distributor in July or August of 2013. Of the 274 dietary supplements recalled, 27 met these criteria.

These recalled supplements, labeled as weight loss, sports enhancement or sexual enhancement products, remained on the market eight to 52 months after they were recalled, with an average of 11.5 months. Seventy four percent of them were made by American companies.

About two thirds of them still contained one or more banned substances after they were recalled. Products marketed as sports enhancers were the worst offenders. About 85 percent of them were still on the market with banned ingredients after they were recalled,  compare with 67 percent of  recalled “weight loss” supplements and 20 percent of those marketed as sexual enhancements.

The banned drugs found in these supplements included: sibutramine, sildenafil, fluoxetine, phenolphthalein, aromatase inhibitor and several anabolic steroids.  These drugs were banned for good reason and putting them into supplements without declared them on the label can create serious health problems. Phenolphthalein, which acts as a laxative was banned because of an association with an increased risk of cancer and sibutramine, a close cousin of the amphetamine family,  was banned after it was found to cause increased risk of stroke and cardiovascular events. A study by the Drug-Induced Liver Injury Network found that dietary supplements account for nearly 20 percent of drug-related liver injuries treated at hospitals.

Many consumers don’t realize that supplements don’t go through an approval process by the U.S. Food and Drug Administration (FDA) before they enter the market. In terms of the food and drugs that the agency regulates, energy drinks and supplements fall into the “food” category.


“Dietary Supplements ought to be regulated as drugs,” said Food Poisoning Bulletin Publisher Fred Pritzker, a food safety attorney who represents clients with liver damage from the dietary supplement OxyLite Pro. “Making that change would provide consumers with the assurance, rather than the assumption, that these products are safe and manufactured according to strict standards. Right now, dandruff shampoos get more scrutiny than dietary supplements.”

Dandruff shampoos fluoride toothpastes, antiperspirants and sunscreens are among the products the FDA regulates as drugs.


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