WEDNESDAY, Oct. 22, 2014 (HealthDay News) — Two-thirds of dietary supplements recalled by the U.S. Food and Drug Administration (FDA) because they contained banned ingredients remained on store shelves at least six months after they were recalled, a new study finds.
For example, in July 2013, researchers were able to purchase EverSlim — a weight-loss supplement that had been recalled in February 2012 by the FDA. The product was recalled for containing sibutramine, a substance that’s banned in the United States, the study reported.
What’s more, the product purchased in July 2013 still contained sibutramine. It also was found to contain fluoxetine, a prescription antidepressant, according to the researchers. The expiration date on the bottle was Jan. 2018, the researchers reported.
“What we found was alarming,” said lead researcher Dr. Pieter Cohen, an assistant professor of medicine at Harvard Medical School in Boston.
These supplements contained not only the same prescription drugs the FDA cited in the recall, but also other substances, such as banned drugs and drugs not tested on humans, he said.
“The system for getting these drugs off the market is clearly not working,” Cohen said. “The FDA has a lackluster approach,” he said.
For the study, Cohen and colleagues analyzed 27 of 274 supplements recalled by the FDA. The mean time of purchase was 34 months after recall, according to the study. That means half were purchased before 34 months and the other half after that time.
Banned substances identified in recalled supplements included the weight-loss drug sibutramine and drugs similar to sibutramine, the erectile dysfunction drug sildenafil (Viagra), the antidepressant fluoxetine (Prozac), the laxative phenolphthalein, breast cancer drugs called aromatase inhibitors used to boost testosterone and a number of anabolic steroids.
Of these supplements, 74 percent were made by U.S. manufacturers, he said.
The researchers found one or more banned drugs in nearly 67 percent of the supplements they bought.
Specifically, banned drugs remained in 85 percent of supplements used to enhance sports performance, in 67 percent of supplements used for weight loss and in 20 percent of supplements used for sexual enhancement, according to the study.
Moreover, 63 percent of the supplements contained the drug the FDA had cited in its recall, the researchers reported.
In addition, six supplements contained one or more banned ingredients not identified by the FDA, and some contained both the previously identified ingredient plus new drugs, the researchers found.
“I recommend avoiding all supplements that are sold as if they will help you lose weight, improve your workout or improve your sex life, because we just don’t know which of those contain these dangerous drugs and which ones are benign,” Cohen said.
The labels on these products list only herbal contents and not the drugs they may contain, Cohen noted. Consumers have no way of knowing what they are buying, he said.
“Stay away from these combination products that claim to have some beneficial effect,” Cohen suggested.
The report was published in the Oct. 22/29 issue of the Journal of the American Medical Association.
FDA’s ability to regulate supplements is limited, said agency spokeswoman Jennifer Dooren. Manufacturers and distributors do not need FDA approval to sell dietary supplements.
“The agency faces the challenge of providing effective deterrents to prevent unscrupulous firms from fraudulently marketing and importing these products,” she said.
“Even after recall and enforcement action against one major distributor, the product may continue to be widely sold,” Dooren said.
The FDA recognizes that enforcement is not the only means of preventing consumer exposure to these dangerous products, Dooren said. “The FDA has issued hundreds of consumer alerts and press announcements warning consumers about tainted products,” she said.
Scott Melville, CEO of the Consumer Healthcare Products Association, another industry group, said, “Unapproved or adulterated drugs masquerading as lawful supplements is a threat to public health and to consumer confidence in the supplement industry.”
Melville said his group supports FDA’s oversight. “This is the best way to ensure manufacturers are adhering to good manufacturing practices and to stop rogue supplement makers from spiking their products and putting the health of the public at risk,” he said.
More information
For more about supplements, visit the U.S. Food and Drug Administration.
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