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Report: FDA is Not Protecting Consumers from Bad Supplements

The FDA only recalled supplements with unlisted or unapproved ingredients 46 percent of the time.

According to a new report by JAMA Network Open, an international, open access, peer-reviewed medical journal, the FDA is failing to keep potentially dangerous supplements out of the hands of consumers.

The regulatory process that applies to supplements permits the FDA to test them and also, to issue recalls in the event they contain some type of unapproved substance. It’s not uncommon for these supplements – many of which are sold for weight loss – to contain hidden ingredients like laxatives or ephedrine.

According to the report, it doesn’t seem that identifying these substances is the problem. The agency  singled out more than 700 supplement brands over a ten year period ending in 2016, but only took subsequent action sometimes, an approach Harvard Medical School professor an supplement expert Pieter Cohen called “inexplicable.”

Cohen adds that many of these problems stem from the way the FDA is legally allowed to regulate supplements. Instead of reviewing products after they’ve hit the shelves, Cohen says these supplement companies should first be required to register with the FDA, that way they could lose their license to sell if they were busted with adulterated products.

Because the way it stands now, when the FDA does issue a recall – which occurred only 46 percent of the time over the ten-year period studied – a lot of consumers aren’t aware. And in 44 percent of cases, a recall wasn’t even pursued, rather, a public notification was issued. So, unless they’re camping out on the FDA’s website or signed up their email alerts, it’s unlikely this information is actually reaching most consumers.

And while some of the errant ingredients are legal or prescription drugs, there’s no way of knowing the levels at which they might be found within these supplements. And many are manufactured overseas and have been discovered to contain ingredients that have been banned in the U.S over safety concerns, or are still in experimental stages.

Cohen says he advises patients who want to use supplements is “to only use single-ingredient supplements, and to not buy supplements that are riding a fad.”

The FDA submitted a statement to Gizmodo after the website ran a report on the study, and the agency says that “Distribution of these products can be lucrative for unscrupulous companies, and the agency faces several challenges in deterring fraudulent marketing of these types of products.” Despite this, the FDA says it “recognizes the seriousness of this problem and continues to act within its resources and authorities to address this problem as best it can.”

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