Feb 13 2008
The core principle of science-based medicine is that health care decisions should be based upon our best current scientific evidence and understanding. When applied to the regulation of health products this means that health claims should first be required to meet some reasonable threshold of scientific evidence before they are allowed. Admittedly this is not a purely scientific question but the application of scientific knowledge to an essentially political question – the balance of protection vs freedom.
Regardless of where one thinks this balance should be, I think most would agree that is it a problem if the public generally wants more protection than it is getting, or believes it is currently getting more protection than it is. A Harris poll from 2002 indicates that the majority of Americans believe that companies cannot make health claims about supplements unless they have been proven scientifically and approved by the FDA, when in fact this is not the case. The Dietary Supplement Health and Education Act of 1994 (DSHEA), largely through the efforts of Senator Orin Hatch from Utah, removed supplements from the control of the FDA and specifically allowed for so-called structure function claims to be made about products without any burden of proof. Most Americans are not aware of this fact.
Since DSHEA there has been an explosion in the supplement industry with products making the exact kind of claims that the law now allows without prior approval. In many ways we have returned to the time of the patent medicine craze, prior to the creation of the FDA, when dubious remedies of all kinds (so-called snake oil) were sold out of the back of traveling carriages. Now the internet is the favorite venue, and snake-oil salesmen have learned how to thrive within the current system – but their claims and marketing ploys are otherwise not very different from the purveyors of patent medicine from last century.
Fad medicines tend to come and go with the fashions of the marketplace. In recent years super juices have been particularly popular. Companies selling exotic fruit juice, usually from a tropical island, for exorbitant prices make a host of health claims for their magic elixir. Over the last decade Tahitian Noni has been popular. More recently XanGo juice has scored billions of dollars in sales.
Here are some of the claims made for XanGo on the company website:
XanGo® Juice boasts a proprietary whole–fruit formula, harnessing a concentrated rush of xanthones—a vigorous family of next–generation phytonutrients. Sounds complex. But here’s the straight scoop. Research shows xanthones possess potent antioxidant properties that may help maintain intestinal health, strengthen the immune system, neutralize free radicals, help support cartilage and joint function, and promote a healthy seasonal respiratory system.*
The asterix links to the following small-print disclaimer:
*These statements have not been evaluated by the FDA. This product is not intended to diagnose, treat, cure or prevent any disease.
You will notice that the company makes those claims that are specifically allowed for by DSHEA without the need for any evidence – that their product “maintains intestinal health,” “strengthen the immune system,” and “support cartilage and joint function.” The disclaimer is also required by DSHEA, so the company is completely within the law, at least as far as their website goes.
But is the public served by allowing this type of marketing? Despite the disclaimer, most people think these claims have been proven scientifically and approved by the FDA, and the distinction between “structure function” claims and actual health claims is deliberately blurred. Does “maintain intestinal health” mean that this juice will help with irritable bowel syndrome or crohn’s disease? The company is not allowed to make such claims – ones that refer to specific diseases, but they can infer it all they want.
The other component to the marketing strategy is to simply refer to basic science claims (as opposed to clinical claims) – just list some of the ingredients in the juice as if they have been proven to be healthful. Antioxidants are among the most popular recently, but as I have discussed recently there is no evidence that routine supplementation with antioxidants has any measurable health benefit.
Are these claims of superior content (regardless of their health implications) even true? Recently the Associated Press did an independent analysis, just to find out about the antioxidant content of XanGo. This is what they report:
For the lab test, The Associated Press shipped a 750-milliliter bottle of XanGo to Oregon State University’s Linus Pauling Institute at Corvallis. The institute measured its antioxidant strength against store-bought juices that sell for a few dollars a bottle.
On a scale of molecular weight, XanGo’s antioxidants measured 14,884 “micromoles” per liter — slightly higher than cranberry juice, but lower than black cherry and less than half the power of blueberry juice. Apple juice finished last in this test.
“In terms of its antioxidant capacity, XanGo is in the middle of the pack,” said Balz Frei, the institute’s director and chairman.
So XanGo is likely just ordinary fruit juice. It contains calories and nutrients, and is probably reasonably good nutrition, but no more so than many other more common fruit juices. The difference, however, is that XanGo costs $40 per bottle and is sold with a host of pseudo-health claims, while cranberry juice is not.
XanGo maintains, however, that it’s product is “a rich cocktail of other beneficial chemicals barely known to science” If they are barely known to science, then how does this company know about it? There is no evidence that they have conducted any research, published papers, or otherwise established that their product has any special “beneficial chemicals.” I would also point out that “beneficial chemicals” sounds an awful lot like drugs. Yet they are not studied or regulated as such.
It is also interesting to note that both Noni juice and XanGo are sold through multi-level marketing. Critics of MLM companies point out that only the top 1% of distributors actually make any money. The rest are really consumers who are forced to stockpile product they may never sell, and who at best sell enough product to support their own use. In essence, and by their own admission, XanGo has “700,000 unsalaried sales associates in 17 countries.” That is a huge free sales force, that doubles as a customer base, making money for the top 1%. I will also note that both Tahitian Noni and Xango (like much of the supplement industry) are based out of Utah, the home state of Orin Hatch (the man behind DSHEA).
The MLM strategy also allows the company to make one-on-one sales pitches. There is no way to track what individual sales people say to their potential customers – if the claims are not on the company website or in official sales publications. This gives the company of layer of protection from the FDA and FTC. To see this in practice, the AP reports:
XanGo has been warned by the FDA for claiming that mangosteen could ward off disease or cancer. The company insists those claims were printed by a third party on a brochure at a recruitment seminar and it’s not responsible.
The current experience with the “super juice” nutritional supplements highlights many weaknesses of our current system. The public believes that it is getting more protection, and more assurance of honesty and safety, than it is currently getting. Claims are allowed that are virtually designed to be deceptive. Marketing claims go far beyond the evidence. Also, the supplement industry has no incentive to perform meaningful research. Research is a lose-lose proposition: it will cost them money, it may turn out negative, and in any case they already have access to their market without the need to provide scientific evidence.
Unless and until the current regulations change, consumers need to be very aware of DSHEA and exactly what it means. The current system relies heavily on the principle of let the buyer beware – which means consumers need to have sharp criticism toward any supplement claims.
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