Herbal supplement manufacturers must do more to stop the spiking of their products with unapproved substances, experts have warned. New information unveiled on the Dr. Oz show has provided damning evidence that the supplement trade is severely under-regulated. The presence of unauthorized active pharmaceutical ingredients (APIs) has been found to be literally off the chart in many best-selling dietary supplement products.
Dietary Supplement Side Effects Update 8/14/12: An article published in next month’s issue of Consumer Reports investigates the risks involved with taking vitamins, minerals, herbs, and so-called ‘dietary supplements.’ The report states that a large number of supposedly natural products are laced with active ingredients found in prescription drugs, and that users often experience serious side effects after taking them. Click here to learn more.
Dietary Supplement Update 4/10/12: Less than a third of active soldiers discuss dietary supplement use with their doctors prior to taking them, according to a new study about drug use by military service members. Many of these individuals don’t consider the use of supplements to affect medications. However, when taken simultaneously, prescription drugs and dietary supplements can significantly increase a person’s risk of potentially life-threatening side effects. Click here to learn more.
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What’s the problem?
Recent tests conducted by Flora Research Laboratories as part of a Dr. Oz show investigation revealed the presence of APIs – including a number of banned and potentially life-threatening drugs – in so-called ‘dietary supplements’ sold nationwide via multiple channels.
One product in particular contained six times the level of a drug that was banned by the U.S. Food & Drug Administration (FDA) because it had been linked to deaths, while tests on other supplements revealed the presence of multiple banned APIs.
The results of the tests were “shocking and very disturbing and if continued will undermine consumer confidence unless effectively addressed”, claimed Dr. Alex Schauss, chief executive of contract research organization AIBMR Life Sciences.
“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.”
Schauss believes part of the problem with the dietary supplement trade is that rogue elements of the industry are getting increasingly sophisticated at duping those performing analytical tests.
“There needs to be more help for people to know what methodologies they should be using to test for these substances and any analogs,” Schauss said. “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.”
Asked whether the unapproved substances found in many herbal supplements were the result of deliberate spiking or accidental contamination due to shoddy manufacturing procedures, James Neal-Kababick, director of Oregon-based Flora Research Laboratories, 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 case of accidental contamination, the problem may be due to companies manufacturing supplements in the same plants that are also licensed to make drugs, or where entities are producing counterfeit drugs and then manufacturing supplements out of the same facility.
“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,” Neal-Kababick said. “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.”
Do You Have a Dietary Supplement Lawsuit?
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Free Dietary Supplement Lawsuit Evaluation: If you or a loved one has been injured by a dietary supplement, you should contact our law firm immediately. You may be entitled to compensation by filing a dietary supplement suit and we can help.