Dietary Supplements Recalled by FDA Are Often Still Available: Study

Federal drug regulators are calling for stricter punishments for manufacturers, after finding that many recalled supplements remain available containing dangerous pharmaceutical additives, which may pose a risk of serious and potentially life-threatening injury. 

In a study conducted by the FDA and published in the Journal for the American Medical Association (JAMA) on October 22, researchers examined 27 of the 274 supplements recalled by the FDA between 2009 and 2012, which were were marketed for sports enhancement, weight loss, and sexual enhancement. The study found that 18 of the 27 supplements still contained harmful pharmaceutical ingredients.

As part of the agency’s report, lead author Dr. Pieter Cohen and his associates purchased the recalled supplements directly from the manufacturers’ websites roughly eight months to four years following their recall by the FDA. Testing the chemical makeup of the dietary supplements found that more than half still had the ingredients that had been banned by the FDA.

Among the substances in the products were sibutramine, which is a weight loss drug that has been recalled from U.S. markets due to its link to heart attacks and strokes. Researchers also found the drug phenophthalein, a laxative being removed from many markets world-wide due to growing evidence it causes cancer.

When a supplement or drug is recalled by the FDA, it is illegal for the manufacturer to continue selling the products and also for anyone in possession of the drug to resell it. The FDA has determined that such drugs caused harm to patients, which is why the substances were banned. In many cases the FDA has concluded that use of the products will cause severe adverse health consequences, including death.

In most cases involving FDA recalls, such as those involving contaminated food products, the FDA will issue the recall and the products will be disposed of, the facility will be cleaned and then manufacturing will resume. In the case of recalled dietary supplements, due to a lack of enforcement, some companies continue to produce the products and sell them discretely online, or just change the name and launch it as a new product. The “new” version of the supplement can remain on the market for quite some time before the FDA has time to test and recall the product again.

Another underlying problem with the dietary supplement industry is that many recalled products continue to be sold in stores after the FDA determines they contain banned ingredients, because it is difficult for distributors to locate the products and retailers generally operate out of small stores and distribute through online sales.

Steve Mister, President and CEO of the Council for Responsible Nutrition in Washington, D.C. claims that the FDA should file criminal charges against companies who continue to put consumers at risk. Cohen adds in the report that the supplements he and his associates purchased online had no warnings or recall notices associated with them during the purchasing, leading consumers to believe that if the product is available online without any warnings that it is safe to take.

Dr. Cohen recommends that consumers avoid multi-ingredient supplements, known as “cocktail supplements” such as muscle builders, weight loss, and sexual enhancement drugs. The safest forms of supplements to take are single ingredient vitamins or mineral supplements, Cohen said.