The study’s principal author is Dr Pieter Cohen, a longtime critic of the way dietary supplements are regulated in the United States. In the research letter titled “Presence of Banned Drugs in Dietary Supplements Following FDA Recalls,” Cohen, who is associated with the Harvard Medical School, and his team combed through the reports of 274 dietary supplements that were the subject of class I drug recalls in the 2009-2012 time frame for being adulterated with undeclared pharmaceutical ingredients. They then looked at supplements from that list that could be found for sale either from manufacturers’ websites or on retailers’ websites, and excluded general e-commerce sites such as Amazon, eBay and Alibaba. They further winnowed their sample to those products that had identical names to what was listed in the recall documents. All of the products, some of which were recalled as early as 2009, were purchased in July and August of 2013.
The sample size came down to 27 products that met the inclusion criteria, or about 10% of the total. Those products were sent to Flora Research Labs in Grants Pass, OR to be tested for adulterants. The tests found that one or more pharmaceutical adulterant was present in two thirds (18, or 66.7%) of the products.
“These were all blinded samples when I tested them (in 2013),” James Neal-Kababick, founder and director of Flora Research Labs, told NutraIngredients-USA. “The reason they were blinded was to avoid any analytical bias on our part. There were cases where we found the same adulterant that was mentioned in the recalls and there were some cases where we found different adulterants.”
The products fell into three categories. Nine products fell into the weight loss category, with the initial recalls mentioning the inclusion of sibutramine or analogs thereof. Testing revealed three of those products to be clean, while the others contained either the orginial adulterant or new ones, such as phenolphthalein or fluoxetine. Five products fell into the sexual enhancement realm, with four of those subsequently testing clean for sildenafil, tadafil or analogues, and 13 products fell into the sports performance realm with only two testing clean of adulterants that included aromatase inhibitors and anabolic steroids.
What's wrong with a 90% success rate?
Experts in the dietary supplement realm said that while the continued availability of tainted products under these circumstances is a black eye for industry, overall the study is actually good news. They take the view that getting 9 out of 10 products off the shelves isn’t a bad place to start, and that increased enforcement by FDA of existing laws is what is needed to clean up the rest.
“If you have 27 products with (274) as the denominator, that is not bad,” said Daniel Fabricant, PhD, CEO of the Natural Products Association. Until May of this year, Fabricant had been head of FDA’s Office of Dietary Supplement Programs. “I think the challenge with these recalls really is that you have people on the margin. FDA will work with one particular distributor and others may not go along. I think some of this might be an example of hoarding. It is so hard in some of the cases to get back to the actual manufacturer.”
“I have always said there needs to be a strong hand. I’m less worried about these kind of repeats and more worried about new people coming into the market. There need to be prosecutions,” he said.
Steve Mister, president and CEO of the Council for Responsible Nutrition, said his concern was the spin JAMA, and the press release announcing the study, put on the results.
“My first concern is the way the journal and the study are misrepresenting the results. I think this is egregous what is going in this study. If there were recalls for 274 products, it means FDA needs to do more and industry needs to do more. But if you look at 18 products out of 274, that’s a 93% effective enforcement rate for the agency,” he said.
“If there were 18 tainted products still available for sale, that’s 18 too many. But to call 18 a majority, that is a mispresentation of what the researchers found. We are quite concerned about this kind of press intended to incite concern that there is something wrong with the existing dietary supplement laws,” Mister said.
An overly optimistic reading
Cohen, for his part, said parsing the numbers in that was itself a misinterpretation of the study. He said that at least 20 additional products were successfully purchased but were excluded because the researchers couldn’t be reasonably sure they were the same product mentioned in the recalls. Names might have been altered slightly or there were other anomalies on the label. And he said that there could have been more products recalled than the 274 for which FDA issued formal recalls in the period in question. Some of these were handled via consumer alerts, he said, estimating that an additional 70 or so products fall into that category. Put that together with the products he bought but didn’t test, and the picture looks different.
“Looking at it that way, that over 90% of the products have been removed, is a misinterpretation of the study, I would venture to guess that somewhere between 30% to 50% of products that are tainted and recalled aren’t removed from the shelves,” Cohen said.
“I would like that to be the case, but I think 90% is overly optimistic. I think we can all agree that these are outliers that need to be removed for public safety,” he said.
A spokesman for Gaspari Nutrition, one of the companies whose products were bought and tested, said he was not sure how the product in question, Novadex XT, was still available for sale after being recalled. The product was recalled by FDA in 2010 for containing an aromatase inhibitor and a steroid-like compound, and was tested in Cohen’s study to have the same adulterants when it was purchased in July 2013. The spokesman, who indentified himself only as the company’s quality executive, said the recall was conducted with FDA supervision and that the agency was satistifed with the result and that production of the product ceased at that point.
Supplements, or illegal drugs?
One issue that is often raised by industry advocates in these cases is the fact that these products are tainted with drugs, and so are not supplements at all.
“As we have stated repeatedly in the past, these products are not legal dietary supplements but mis-branded or mislabeled drugs, and it is crucially important for Dr. Cohen and his colleagues and consumers to make this important distinction. It’s highly unfortunate for consumers that these products have remained on the market, yet it is the responsibility of the Food and Drug Administration to enforce the regulations that are the law of the land, to remove them from the market and to pursue legal action against the companies that are selling them. We fully support FDA in this effort,” said Loren Israelsen, president of the United Natural Products Alliance.
"The authors' latest effort to convince the public and policymakers to change the laws that regulate dietary supplements misses the mark because the products used in their study are not dietary supplements, they are illegal, adulterated drugs," said Michael McGuffin, president of the American Herbal Products Association.
CRN's Mister emphasized the point mentioned in the paper that these recalls were handled as class I drug recalls because of the inclusion of active pharmaceutical ingredients. That shows the agency views them as renegade drugs, too, he said.
“I have a hard time swallowing that framing of the question. FDA has also found shards of glass in many injectable drugs. Does that mean these automatically are not drugs but that it is a problem of glass manufacture? If something is being hidden in the product and it is being sold as a supplement, I think we have to address this as a supplement problem, not a drug problem,” Cohen said.
Cohen said his increasing interactions with stakeholders in the dietary supplement industry have led him to alter his stance somewhat. He said he has come to have respect for the way in which industry is trying to openly grapple with the problem.
“I used to think that it was mostly the regulatory framework, and I still think there is a problem there. But I have come around to agreeing more that there is a major enforcement problem. Even when FDA indentifies problems with recalls they are still not going back and checking to make sure this stuff comes off the market,” he said.
To read the full text of Cohen’s study, click here.