It’s well known that dietary supplements can be risky because there’s no requirement that they be tested before they’re sold. But what happens when the federal government tries to remove a product from the market because of dangerous or illegal ingredients?
Not much, according to a recent study that analyzed more than two dozen recalled supplements, including one distributed by an Atlanta-area company.
The study, published in the Journal of the American Medical Association, found that most of those supplements remained available to consumers — and contained the very ingredients that caused them to be recalled.
That is stirring renewed debate about the effectiveness of the U.S. Food and Drug Administration’s ability to police the flow of products in an industry where deaths and other adverse events are regular occurrences.
“It sort of makes your jaw drop,” said David Schardt, senior nutritionist at the Center for Science in the Public Interest, a health and nutrition advocacy group. “You think, `Well, this stuff has been recalled. The FDA wanted it off the market, so the consumer is protected.’ Then you have this research saying, `Not so fast.’”
Researchers led by Dr. Pieter Cohen, an assistant professor at the Harvard Medical School, purchased and tested 27 of the 274 dietary supplements recalled by the FDA between 2009 and 2012. They found that 18 were still available for purchase in 2013 and contained dangerous pharmaceuticals.
All but one of the products had the same adulterants identified by the FDA when they were recalled, including 10 with anabolic steroids, the study found.
In the U.S., anabolic steroids are Schedule III controlled substances, making it illegal to possess them without a prescription. Acute liver disease and infertility are among the serious health issues that can arise from regular use.
“The bottom line here is, after the recalls, these products with steroids were still available for U.S. consumers to purchase,” Cohen said in a recent interview.
The 27 products were selected because they had the same names and distributors as those that were recalled, and all were purchased online from supplement retailers, not from websites where products are resold, Cohen said.
“The FDA had drawn attention not only to a particular company, but to a particular product,” he said. “All (the companies) would have to do is go back and print a different label, but they didn’t. They feel they can get away with it, and the FDA isn’t going to do anything.”
In looking closer at the list of tainted supplements purported to be available even after recall, the Atlanta Journal-Constitution found that one, Finaflex 550-XD, was a muscle-building product developed and distributed by an Alpharetta company, Redefine Nutrition LLC.
According to the study, a sample of Finaflex 550-XD purchased in August 2013 contained two anabolic steroids. That was nearly four years after a product with the same name was recalled because it contained a “steroid or steroid-like compound or analog,” the study said.
In a series of interviews, the company’s officers vigorously disputed that finding, saying they believe the study tested a counterfeit product.
They said they discontinued Finaflex XD-550 in 2009 after learning that it contained illegal ingredients. They acknowledged that they created a new product under the same name, but said it had a different color bottle and did not contain anything illegal. That product also has been discontinued for lack of sales, they said.
“The market is replete with fake and counterfeit versions of products purporting to be genuine Finaflex,” said Kyung Kim, CEO of the six-year-old company headquartered in an office park near State Highway 400.
Cohen said supplement companies often cite counterfeiting as the reason when their products are found to include illicit ingredients. Those claims should be investigated, he said.
“I strongly encourage the FDA to inspect every company producing supplements that we found to be spiked with drugs,” he said.
Mike Perko, an associate professor of public health at the University North Carolina at Greensboro who studies sports performance products, said the number of supplements containing steroids in Cohen’s study is particularly disturbing. Those products are widely used by younger athletes who likely wouldn’t know about the recalls, he said.
“They would have no idea,” Perko said. “The worst marketing agent in the world is the federal government. Unless you go to the FDA website, you’re not going to hear about this, and it’s a huge threat to public health.”
In a statement, the FDA acknowledged the challenges of dealing with millions of products after they enter the marketplace. The supply chain is “extremely fragmented,” the statement noted, and businesses are difficult to locate, in some cases operating out of the owners’ homes.
“Even after recall and enforcement action against one major distributor, the product may continue to be widely sold,” the FDA said.
Dan Fabricant, who left his position as the director of the FDA’s supplement division in April, said that while the agency has weeded out hundreds of tainted products, it could do better.
He said the FDA and the Department of Justice need to be more willing to seek criminal prosecutions of those who continue to manufacture or distribute tainted supplements.
“With those recalls, how many have actually been brought to felony or misdemeanor prosecution? I think you would see it’s a very small percentage, “ said Fabricant, now CEO of the Natural Products Association, an industry lobbying group.
Cohen believes the FDA lacks the resources to do its job. He also said the agency is hampered by regular changes in leadership, Fabricant’s departure being only one.
“I used to say they are a deer in the headlights,” he said. “Now I say they are a deer that’s been run over and lying by the side of the road.”
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