The recent research letter published in the Journal of the American Medical Association titled “Presence of Banned Drugs in Dietary Supplements Following FDA Recalls,” found 18 products that had been previously recalled were still on the market as of August 2013 with the same (in sometimes new) adulterants in them for which they were recalled. The paper’s principal author, Dr Pieter Cohen, who is associated with the Harvard Medical School, is a longtime critic of the dietary supplement industry. In the paper’s conclusion Cohen said that new regulations may be necessary to prevent similar situations in the future.
But that takes a narrow view of the reality of a recall situation, experts contacted by NutraIngredients-USA said. It’s not a one-and-done scenario; the issuance of a recall by a manufacturer or retailer is the start of a process which might have an uncertain end, they said.
Bodybuilding.com recall
Ten of the supplements mentioned in Cohen’s paper were subject to a massive recall by bodybuilding.com on Nov. 3, 2009, a case that resulted in criminal convictions and more than $7 million in fines for the online retailer and its executives. In that recall, the comapny recalled 65 products for including steroids or substances that FDA believed should be classified as steroids that went under names such as Superdrol, Madol, Tren, Androstenedione, and/or Turinabol. Of the 10 products that Cohen’s team bought in July and August 2013 and tested that were part of this huge recall, nine still had steroids in them (the research letter didn’t specifiy which steroids they contained). Only one product appeared to have been reformulated and tested clean.
FDA said acute liver injury is known to be a possible harmful effect of using steroid-containing products. In addition, steroids may cause other serious long-term adverse health consequences in men, women, and children.
Marc Ullman, an attorney in the firm Ullman, Shapiro & Ullman who counts a number of dietary supplement firms among his clients, is not surprised that Cohen’s team found tainted supplements for sale after a recall. Eight of the 10 muscle building supplements Cohen’s team purchased were either clearly past their due date or were listed as having a due that was “unavailable” (removed from the label, perhaps?). This makes it plausible that these products lingered on the market after the nationwide recall and were not being manufactured in defiance of FDA. When contacted by NutraIngredients-USA, officials with two of the manufacturers of these products, Gaspari Nutrition and Competitive Edge Labs, said their companies stopped manufacturing the products in question at the time of the recall.
“That is the nature of these recalls, when you are talking about big national chains,” Ullman told NutraIngredients-USA. “How many different websites sell bodybuilding products? Not every manufacturer or retailer is going to read FDA’s recall list every week. No recall is 100% effective.”
Steve Woods, owner of Competitive Edge Labs, said that counterfeiting may be a problem in these cases as well. Woods said after a recall, "Retailers can then comply and return the items or they could choose to keep the inventory or some of the inventory and continue to sell it then or may hold onto the inventory and sell it at a later date when the price would be very inflated due to scarcity of the product and increased demand. Also, due to the inflated prices, product demand, and scarcity, sometimes people may counterfeit these discontinued or recalled products."
Range of companies and sophistication
Rick Kingston is the president of regulatory and scientific affairs at consulting firm Safety Call Intenational and is a professor at the University of Minnesota School of Pharmacy. Safety Call helps companes manage recalls and set up adverse events reporting systems. Kingston said the nature of the companies involved in a recall has a lot to do with the recall’s effectiveness.
“If you have a company that’s a big player and has a reputation to protect they are going to be much more aggresssive in tracking down that product. A lot of these companies were fly by night organizations and might not even be in business at this point,” Kingston said.
“There are different levels of companies involved and they may have different levels of sophistication in tracking the supply chain and tracking the product down after it leaves the warehouse,” he said.
Weak deterrents
Cohen ended his paper with a call for added regulation of dietary supplements.
“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,” Cohen wrote.
Kingston seemed to agree with Cohen on the subject of the need for increased enforcement, a plea that is often heard in the responsible halls of the dietary supplement industry.
“There are laws on the books but they don’t seem to be much a deterrent to these companies. The reality is that there are companies out there that adulterate products and sell them and when they get caught they keep selling them. I have a feeling that many of these companies are not only just selling adulterated products but they are probably not complying with a lot of the other aspects of GMPs. We certainly don’t hear from them on the subject of adverse events reporting,” Kingston said.