On August 11, the US Food and Drug Administration recalled a batch of supplements manufactured by a company called PharmaTech because of possible contamination with bacteria that can cause serious respiratory infection.
Supplement recalls – instances when the FDA posts a public notice asking the companies who make these allegedly healthy powders and pills – are not rare occurrences. Most of the time they are not the result of bacteria, however. Instead, the vast majority of recalled supplements contain pharmaceutical drugs. The drugs are almost never listed on the product labels, and they have often been banned by the FDA.
A study of product recalls published in 2013 in the Journal of the American Medical Association found that of the 274 supplements recalled by the FDA between 2009 and 2012, all contained banned drugs. A 2014 report found that more than two-thirds of the supplements purchased six months after being recalled still contained banned drugs.
Ask Steven Tave, the director of the office of dietary supplement programs at the FDA, why the agency isn’t stopping more similar situations, and he’ll give a simple answer: “We’re doing the best we can.”
In 1994, Congress passed a controversial law called the Dietary Supplement Health and Education Act. Tave said that before DSHEA passed, the FDA was starting to regulate supplements more stringently, the way it does pharmaceutical drugs, but getting “pushback from the industry.” The law forced the agency to be more lenient.
Before a new drug can be sold, the company making it has to apply for FDA approval, and the agency has to conclude that the drug is safe and does what it claims to do.
“So if the drug says, you know, ‘used to treat cancer,’ then the agency’s reviewers are going to look at it and make a determination that there’s evidence that it does treat cancer,” Tave told Business Insider.
New supplements, however, don’t face any burden of proof.
The agency can review products that add new dietary ingredients when it gets a notification, Tave said, but it doesn’t “have the authority to stop anything from going to market.”
When DSHEA was passed, Tave said, the bill still made sense. In 1994, about 600 supplement companies were producing about 4,000 products for a total revenue of about $4 billion. But that market has since ballooned – today, close to 6,000 companies pump out about 75,000 products.
“We’re regulating that with 26 people and a budget of $5 million,” Tave said.
“The products we see today have gone way beyond that sort of core group that they were in 1994,” said Tave. “Now they’re promoted for all sorts of things – some are long term, some are short term, some are chemicals no one’s ever seen before. It’s a much different universe than it was at the time.”
S. Bryn Austin, a professor of behavioral sciences at the Harvard T.H. Chan School of Public Health, told Business Insider that there are three categories of supplements that consumers should be particularly wary of. Those include formulas marketed for physical enhancement, weight loss, and sexual performance.
“Some of these companies won’t identify ingredients that they purposefully put in the products,” said Austin. “Some weight-loss drugs, for example, that have been pulled from the market – we can still find these in the bottle even though they don’t put it on the label.”
Tave’s 26-person team, the only government employees looking into these issues, didn’t even have a dedicated office until about a year and a half ago.
“We’re pretty sure were not aware of everything that’s out there, but we do what we can,” he said. “All we can do is enforce the law.”
Removing a supplement from store shelves comes down to documented emergency-room visits and calls to poison-control centers. Only when a supplement is reported to be unsafe as a result of one of these “adverse events,” as the FDA calls them, is the agency compelled to act.
“Most of the time, we don’t know a product is on the market until we see something bad about it from an adverse-event report. It’s a very different regime from when we know everything is out there and we know what’s in it,” Tave said, adding: “We don’t want to be reactive. We want to be proactive. But we can’t be.”