Recalled Dietary Supplements Return to the Shelves

Unlike pharmaceutical drugs, dietary supplements do not have to be proven safe and effective before they can be sold. All the FDA can do is to force specific products to be pulled from store shelves (recalled) after it receives complaints about the product's safety.

A study published in JAMA shows how ineffective the FDA's recall power really is. The authors of the study examined 27 dietary supplement products that had been recalled by the FDA. Some of the products were recalled for containing anabolic steroids or prescription drugs such as Viagra and Prozac. Several weight-loss products contained an amphetamine-like drug not approved in the U.S. The authors found that within an average of three years after recall, approximately 2/3 of the products were being sold again - under the same name and with the same ingredients. Even the manufacturers and distributors were the same! Most of the manufacturers are U.S.-based.

Why can't the FDA put a stop to this? In part, their hands are tied because dietary supplement manufacturers have the right to sell their products without any proof that they are safe and effective. Tainted products are only identified after they have hit store shelves and after complaints are received. And even then, recall can be difficult because many of these products are sold over the internet from unknown physical addresses.

Until the dietary supplements regulatory environment changes and the FDA is given more power to punish unscrupulous companies, it remains "buyer beware" when it comes to dietary supplements. Unfortunately for us, the authors did not name the manufacturers, distributors, or products in their study. That's a shame.