Before I begin, I want to stress that I do not want to trivialize the harm that has been endured by the people in Hawaii recently. We’re talking about 29 cases of liver damage, 11 of which led to hospitalizations, two liver transplants, and one death. This is tragic and our thoughts are with those people and their families.
But in an article entitled ‘Liver or let die’ from the American Council on Science and Health (ACSH) the cases are used as an opportunity to bash all supplements, and spread a little misinformation.
The ACSH starts with: “In the never-ending battle between the unregulated multibillion dollar supplements industry and legitimate medicine, this shady industry is trying to recover from a pretty good licking it received today from the FDA.”
I read a lot of what the ACSH puts out, and for an organization that claims to deal in ‘Science. Not hype’, there’s a familiar factual inaccuracy about the supplement industry eight words into that first sentence.
That untruth (that supplements are unregulated) is not perpetuated, however, with Dr. Josh Bloom, ACSH’s Director of Chemical and Pharmaceutical Sciences, stating: “When companies sell unapproved drugs under the guise of ‘supplements’ (which, because of a sleazy law pushed through Congress by Utah’s Sen. Orrin Hatch in 1994, are exempt from FDA approval) and they start killing people, the real mystery is how companies are allowed to sell this garbage, and why more people haven’t been killed.”
Dr Bloom, who was previously an employee of Wyeth and Pfizer and is described as “a long-time critic of the supplement industry”, at least notes that there are regulations pertaining to dietary supplements.
Unanswered questions
There’s also an error at the end of the first sentence – the FDA has not given the industry a ‘good licking’. The Agency is investigating liver damage cases potentially linked to one product, which is labeled as OxyElite Pro. USPLabs, the company behind OxyElite Pro, has not had an easy ride from us in the past relating to use of the controversial ingredient DMAA, but, in response to the reports from Hawaii, the company has reacted responsibly: It has removed the products in question from distribution, and said it is cooperating with FDA. Let’s be clear, nothing has been established yet in Hawaii and we need to give the investigators time to investigate.
With the products no longer available, there is time to address several unanswered questions:
Are the products used by the unfortunate victims, which are labeled as OxyElite Pro, the cause of the liver damage? With 24 out of 29 cases of liver damage allegedly sharing the product labeled as OxyElite Pro as a common link you have to say it's highly suggestive but not definitive.
Another question is if the product labeled as OxyElite Pro is actually OxyElite Pro, considering that counterfeit products are claimed to be on the market? Counterfeiting is a problem for many industries, from foods to pharmaceuticals.
Finally, this product is sold nationwide and has been on the market for a while, so why now and why only Hawaii? The CDC is reportedly investigating other cases of liver injury nationwide that may be related... may be related but nothing is confirmed at this stage.
Let’s wait for all the evidence before we pass judgment.
‘A splendid job’
Leaving that as it is, let’s go back to the ACSH article and the beating up on supplements in general. Here’s Dr Bloom’s closing gambit: “These supplement companies have done an absolutely splendid job of portraying themselves as the little guys — knights in shining armor that provide an alternative to those deadly drugs from the pharmaceutical industry. The problem is that this is utterly false. The supplement industry is enormous and takes advantage of America’s scientific naivety in an insidious, but highly effective way.”
Allow me to flip this and argue that members of the traditional pill-for-every-ill medical community have done an absolutely splendid job of portraying supplements as unregulated, ineffective, and perhaps even dangerous.
I do agree that the supplement industry is enormous – the numbers speak for themselves. It’s also growing, and there are reasons for that. Another truth: Several pharmaceutical companies have significant interests in the dietary supplements, including Dr Bloom’s former employer.
Utopia
There are categories in supplements that have bad reputations, like weight management, sexual health, and bodybuilding products, and that is why the FDA has highlighted these areas for increased scrutiny. On the other hand, the mainstream supplements industry can make, in my opinion, a valuable contribution to public health. (Check out the CRN’s recent report on the potential of supplements to reduce healthcare costs)
If everyone ate well and exercised regularly, then you could imagine a health utopia where supplements are not needed (Let food be thy medicine). Continue that train of thought, and you could also imagine that pharmaceuticals would probably be in much lower demand. But while the medical community is focused on treating people (let our medicine be thy medicine!) and not about working harder to educate the public on the benefits of good diet and lifestyle then we won’t get there. People do have nutrient gaps, and supplements are there to supplement the diet.
The issue is not the regulations. The issue is enforcement, and this publication supports the increase in enforcement from FDA over recent years.
It’s all about safety & efficacy. Unsafe or bogus products have no place in the dietary supplements industry, but there is most definitely a place for the dietary supplements industry.
Stephen Daniells is the Senior Editor of NutraIngredients-USA & FoodNavigator-USA. He has a PhD in chemistry from the Queen's University of Belfast in Northern Ireland. He has been writing about the food and dietary supplement industries in the US and Europe for eight years.