If the U.S. Food and Drug Administration recalls a product that might be harmful, you wouldn’t expect to find that product on store shelves anymore, right?
Not necessarily, according to an eye-opening new study on recalled dietary supplements published in the Journal of the American Medical Association.
In the JAMA study, researchers examined 27 dietary supplements that were still being sold in the U.S. despite being recalled by the FDA between 2009 and 2012 for containing pharmaceutical ingredients or banned substances. What they found was that two-thirds of those supplements still contained the ingredients. Most of the supplements examined were for sports enhancement, weight loss, and sexual enhancement.
The New York Times reports that the products examined in the study were initially recalled by the FDA after they were found to contain powerful prescription drugs like Viagra and Prozac and banned substances like anabolic steroids and Sibutramine, a weight-loss medication that has been linked to increased risk of heart attack and stroke.
Medscape Medical News writes that the study found that the majority of the supplements analyzed contained the same adulterant listed in the FDA recall, while just over 20 percent contained additional banned ingredients.
One of the products purchased for the study, according to an NPR report, is a weight-loss supplement known as Zi Xiu Tang Bee Pollen Capsule. The product was recalled by the FDA in 2012 for containing Sibutramine, NPR says, but researchers were able to purchase the supplement in 2013. USA Today reports that other recalled products purchased by the researchers included the recalled body-building supplements Novedex XT and Massdrol, both of which were found to contain anabolic steroids.
According to the study, the FDA issues a Class I drug recall when “products have the reasonable possibility of causing serious adverse health consequences or death.” When the FDA issues a recall on a product that it deems dangerous, it will then suggest or request that the manufacturer pull the product off the shelves. If the manufacturer refuses, the FDA can go to court to force the recall of the product.
The JAMA study notes that approximately half of all FDA Class I drug recalls since 2004 have involved dietary supplements contaminated with banned pharmaceutical ingredients. But while the study authors write that prior studies have shown that dietary supplements often remain available for purchase after being recalled by the FDA, this is the first study to look at whether the supplements remain adulterated.
One of the study’s authors, Dr. Pieter Cohen of Harvard Medical School, tells NPR that he’s disheartened to see that manufacturers would be selling the same products even after they had been recalled.
Different types of regulation
How did these products even make it to store shelves in the first place?
It may come as a surprise, but the FDA considers dietary supplements to be a special category of food, and not a drug. So unlike prescription and non-prescription drug makers, dietary supplement manufacturers and distributors do not have to obtain approval from the FDA before marketing and selling their products. They simply have to ensure that their products are safe, and that any claims made about the products are not false or misleading. The FDA only investigates a dietary supplement only after it is suspected to have caused illness or death.
A spokeswoman for the FDA tells the New York Times that because the companies do not need advance agency approval to sell their product, the agency doesn't identify tainted supplements before they reach consumers.
The study authors are urging the FDA to make more of an effort to stem the problem. “Action by the FDA has not been completely effective in eliminating all potentially dangerous adulterated supplements from the US marketplace,” they write in the report. “More aggressive enforcement of the law, changes to the law to increase the FDA’s enforcement powers, or both will be required if sales of these products are to be prevented in the future.”
What is a dietary supplement?
The FDA defines dietary supplements as a product containing a dietary ingredient intended to add nutritional value to the diet. According to the Centers for Disease Control and Prevention (CDC), multivitamins and multiminerals are the most commonly used dietary supplements. But the category also includes a wide variety of herbal supplements and products that claim to help with physical enhancement, weight loss and sexual function.
Why is this important? Dietary supplements are easily available, and you don’t need a prescription to purchase them. According to a Dallas Morning News article written by former CDC detective Dr. Seema Yasmin, 53 percent of Americans take some kind of over-the-counter dietary supplement. And dietary supplements are big business, Yasmin writes, bringing in $30 billion a year.