Americans spend about $4 billion a year on weight-loss supplements. And the Food and Drug Administration spends a lot of effort policing distributors who market fraudulent products that are tainted with unsafe, banned drugs.
But a study published Tuesday finds that buyers should beware: Just because the FDA recalls a product for containing dangerous substances doesn't mean the product disappears from the market.
Researchers from the Cambridge Health Alliance, a health care network affiliated with Harvard University, got a list of 274 dietary supplements that the FDA recalled between 2009 and 2012.
Then, they analyzed 27 products (including supplements marketed for weight loss, sexual enhancement and sports performance enhancement) that were still being sold months after being recalled. They found that two-thirds of the products still contained banned ingredients.
"I was so disheartened to see that manufacturers would have the chutzpah to sell the exact same product" even after it had been recalled, says Harvard's Dr. Pieter Cohen, a Cambridge Health Alliance researcher and internist. His findings are published in the current issue of JAMA, the Journal of the American Medical Association.
Consider, for example, a weight-loss product called Zi Xiu Tang Bee Pollen Capsule.
The FDA took action to recall the product in October 2012. But when Cohen and his colleagues purchased the product in July 2013, it still contained sibutramine — the banned drug that led to its recall in 2012.
Sibutramine, once marketed as the diet drug Meridia, was pulled from the market in 2010 after research linked it to an increased risk of heart attack and stroke. (Six of the 27 recalled products analyzed in the JAMA study contained sibutramine.)
It's possible that the manufacturer has changed the formulation since the JAMA study testing was conducted, but we were unable to reach the distributor for comment. Our email was returned as undeliverable.
"People selling these products should be enforced against to the fullest extent of the law," says Daniel Fabricant, CEO of the Natural Product Association, a nonprofit trade association that represents supplement-makers and other companies.
Fabricant points out that products adulterated with drugs are not considered to be supplements, so he chafed at the use of the term "dietary supplements" to describe the products analyzed in the JAMA study.
"The products analyzed in this study aren't supplements," Fabricant told NPR. "People selling these products online don't represent the industry."
In a written statement, the FDA told NPR that the agency has pursued civil and criminal enforcement against people who illegally market these products, but it's tough to crack down.
"The supply chain for these products is extremely fragmented," an FDA spokesperson said in an email. "One product manufactured by an unknown company overseas may be sold by dozens of different distributors in the United States."
In the case of the Zi Xiu Tang Bee Pollen capsules, for example, even if one distributor is detected and shut down, many more may still be selling the product.
And it can be tough for consumers to know which products might pose dangers.
Given the uncertainty, Candy Tsourounis, a professor of clinical pharmacy at the University of California, San Francisco, says her advice is to steer clear of all weight-loss supplements.
"I think what's most striking about [the findings of the study] is that these supplements pose a significant health risk," Tsourounis says.
And even when weight loss products don't contain banned substances, she says, they're unlikely to help.
"None of these supplements," Tsourounis says, "has been adequately tested to demonstrate that it will work" to help sustain weight loss over time.
DAVID GREENE, HOST:
If you find it hard to change your diet or hit the gym more, maybe you've looked at weight loss supplements as an easier fix. Well, this morning some reasons to reconsider. NPR's Allison Aubrey has been looking at new research published in the Journal of the American Medical Association. Turns out some dietary supplements that have been recalled by the Food and Drug Administration are actually still on the market, and they might be putting consumers at risk.
ALLISON AUBREY, BYLINE: Americans spend about $4 billion a year on weight loss supplements. But physician Pieter Cohen of Cambridge Health Alliance in Massachusetts says he now warns his patients to beware. And why?
PIETER COHEN: Several years ago, I was struck that many of my patients were taking a weight loss supplement that the FDA had already recalled. And I was struck by both the side effects that they were having and the fact that they were still able to purchase them.
AUBREY: The supplements had been recalled because they contained a banned drug, or dangerous ingredient. Side effects of patients told them about included anxiety, a racing heart and trouble sleeping. Cohen wondered, was this just one rogue distributor selling a tainted product, or was the problem more pervasive? To look into it, Cohen and his colleagues got a list of 274 products that the FDA recalled between 2009 and 2012, not just weight loss products, but also sports and sexual enhancement products. They also looked to see which ones were still on the market.
COHEN: And then we went about purchasing those products to see what was really in them.
AUBREY: They analyzed 27 products, and they found in about two-thirds of them the dangerous ingredients have not been removed.
COHEN: I was so disheartened to see that so many manufacturers would have the chutzpah to continue selling the exact same product.
AUBREY: Take, for instance, a product called Zi Xiu Tang Bee Pollen Capsules. The FDA took action to recall this product back in late 2012 because it contained a banned drug called sibutramine, which can increase the risk of heart attacks. But this product can still be found on the Internet.
DANIEL FABRICANT: People selling these products should be enforced against to the fullest extent of the law.
AUBREY: That's Daniel Fabricant, the CEO of the Natural Products Association, which represents the supplement industry. He says the distributors of the illegal products are not part of the legitimate supplement industry.
FABRICANT: The products analyzed in this study aren't supplements. People selling these products online don't represent the industry.
AUBREY: In a written statement, the FDA told us that they pursue civil and criminal enforcement against fraudulent distributors. But cracking down on them is tough. For instance, a weight loss product such as the bee pollen capsules, which appears to be manufactured overseas, may be sold by dozens of different distributors in the U.S. Candy Tsourounis is a pharmacy professor at UC, San Francisco. She says her advice is to steer clear of all weight loss supplements.
CANDY TSOUROUNIS: I think what's the most striking is that these supplements pose a significant health risk.
AUBREY: And she says even weight loss products that don't contain banned substances are unlikely to help.
TSOUROUNIS: None of these supplements have adequately been tested to demonstrate that they work even marginally.
AUBREY: To sustain weight loss over time. Allison Aubrey, NPR News. Transcript provided by NPR, Copyright NPR.