Dr Alex Schauss, chief executive of contract research organization AIBMR Life Sciences, was speaking to NutraIngredients-USA following an investigation conducted by the Dr Oz show into spiking.
Tests conducted by James Neal-Kababick, director of Oregon-based Flora Research Laboratories as part of the Dr Oz show investigation, revealed the presence of unauthorized active pharmaceutical ingredients (APIs), including some banned and potentially dangerous APIs, in supplements sold via multiple channels across the US.
One supplement tested contained six times the levels of a drug banned by the FDA because of deaths associated with its use, while analysis of others revealed the presence of multiple banned APIs.
Shocking and disturbing
The findings were “shocking and very disturbing and if continued will undermine consumer confidence unless effectively addressed”, claimed Schauss, who has chaired the safety subcommittee of ComPLI (the Compliance and Label Integrity Committee of the Natural Products Association) since 1991.
“The levels of some of the APIs in these products was off the chart. But I think it also showed that this problem is not just limited to renegade supplement makers selling products on the internet, but to products sold all over the US in every kind of channel.”
Unfortunate lack of context
However, it was unfortunate that a comment made by Neal-Kababick that nine out of 10 of his samples tested positive for APIs or their analogs was not clarified by Dr Oz, who left viewers with the erroneous impression that nine out of 10 supplements on the market were spiked with drugs, said Schauss.
“It was not made clear that the figures referred specifically to samples sent to Neal-Kababick’s lab because there were suspicions about them in the first place. It is unfortunate that a second segment of the show could not have been dedicated to providing balance and discussed the steps ethical stake holders take to ensure that the public is receiving truthful and not-misleading information about the dietary supplements they buy."
It was also disappointing that comments made by another guest on the show - associate professor of medicine at Harvard University, Dr. Pieter Cohen – suggesting the solution was more regulation, were not challenged, said Schauss.
“He basically proposed a system where everything is tested before it is allowed to be put on the market. But that is not going to solve this problem. Anyone can send off a clean sample for testing – but is it the same product that you actually put on the market?”
Laboratories with the expertise and experience to carry out forensic investigations
Part of the problem was that rogue elements in the trade were getting ever more sophisticated at fooling those conducting analytical tests, said Schauss. “There needs to be more help for people to know what methodologies they should be using to test for these substances and any analogs.”
He added: “The information on what to test for and how is available and should be made available to stakeholders. It should be available to all QA/QC managers and directors. Manufacturers and distributors should be utilizing contract analytical laboratories that have the expertise and experience to carry out forensic investigations such as was performed for Dr Oz, if they don’t have the same quality of forensic capabilities.”
Meanwhile, retailers could also do “more to demand from manufacturers and distributors selling them products to make sure this [appropriate testing] is done for any category of supplements where there is an economic incentive to mislead the public about a product’s content”, he said.
Neal-Kababick: I am seeing a rise in this problem
Neal-Kababick, who recently alerted the trade to the threat of dangerous stimulants in so-called ‘bath salts’ making their way into the supplements trade, said: “I must say that I am seeing a rise in this problem not an abatement. Is that because more people are forwarding samples for us to test or is it because unethical midnight manufacturers are catching on to the opportunity?
“Regardless, we must remain vigilant, applying proper sampling plans and state of the art technology combined with strong phytoforensic techniques to assure that spiked raw materials do not make it into consumer products.”
Deliberate spiking or inadvertent contamination?
Asked whether the APIs detected in samples passing through his labs were the result of deliberate spiking or inadvertent contamination due to poor supply chain controls, Neal-Kababick said: “It’s both. We’re seeing more deliberate spiking with high levels of APIs but also more samples with low level contamination.”
In the latter case, this might be due to manufacturers producing supplements in facilities that are also licensed to produce drugs, or where manufacturers are making counterfeit drugs and then producing ingredients or dietary supplements out of the same facility, he said.
“Some of these companies use compressed air to clean up kit between batches – which can leave residues - instead of properly washing down the facility and then validating the cleaning as per pharmaceutical standards.
“I’d say that this low level contamination is a more recent phenomenon and it concerns me, because it is sloppy manufacturing.”
He added: “What is also worrying is that while most of the spiking is in weight loss, sports and male virility products, we’re also seeing more in anti-diabetic blood sugar support products – where we have detected anti-psychotic and blood pressure meds.”
Click here to read about Neal-Kababick’s warning on ‘bath salt’ stimulants.