by Marion Nestle
Nov 4 2009

Europe rejects droves of health claims

In what the functional food industry refers to as a “bad day at the office,” the European Food Standards Agency (EFSA) rejected hundreds of health claims, particularly those for probiotics.  More recently, it rejected a claim that glucosamine prevents cartilege degeneration.  Hard as it may be for the food and supplement industries to believe, EFSA just can’t find scientific evidence to support those claims.

A representative of the company that applied for the glucosamine claims says his company now anticipates a loss in product sales, and complains that it had “invested quite heavily in this submission, in terms of effort and financial outlay.”

Too bad.

Why can’t they come up with the science to support those claims? For one thing, who would want to do the research?  Danone and Yakult have just announced two $50,000 grants to study probiotics.  This won’t go far and the sponsorship is an almost certain guarantee that the results will be just what the companies paid for.

Independent research is much more complicated.  Consider folic acid, for example.  The latest clinical trial of folic acid and colon cancer went to a lot of trouble to prove that folic acid supplements are harmless.  In most people, they have no effect on colon cancer, neither benefit nor risk.  Among the few people who had unusually low levels of the vitamin in their blood, the supplements appeared to have some protective effect.  You can interpret results like this either as evidence for no benefit or as evidence that folic acid supplements might benefit some people under some circumstances.

And that brings us to supplements again.  A trade association for supplement manufacturers says:

While it cannot be denied the food and supplement industry has entertained its fair share of cowboys, our concern is that the [EFSA] regulation goes so far as to throw the baby out with the bathwater. At the very point in time when consumers need most information to help them make the right food and supplement choices to help them offset largely preventable chronic diseases, we see the industry being gagged.

“Cowboys” are indeed a problem, and one well known to the American supplement industry. Says the head of the Council for Responsible Nutrition, the euphemistically named supplement trade association:

Fifteen years ago, our biggest threat was an over-reaching FDA….More recently, the problem has been an FDA that’s under funded and lacks the political will to do what it needs to do. And as a result today, many of the problems that burden the dietary supplement industry are ones that come from within the industry itself from that lack of oversight….Companies… intentionally – or inadvertently – put prescription drugs or anabolic steroids into their products and call them dietary supplements; products that just don’t do what they claim.  Also some companies practice economically motivated adulteration, passing off shoddy products as something more than they are … and ignore the new GMP requirements in hopes that they will fall under the radar screen.

Perhaps in response, the Boston Globe says we should repeal the 1994 law that deregulated dietary supplements and give the FDA some regulatory teeth.  Good idea.

Please forgive my endless repetition of this mantra: health claims are about marketing, not health.

  • Anthro

    Thanks for this. The same is true of most any advertising. The only reason people use any number of products, such as dryer sheets, is advertising. I avoid a lot of this by not having a television, but as you point out in What To Eat, the supermarket itself is a marketing machine. I figured this out years ago when all the crappy cereal was at kids’ eye level and the candy was placed at the checkout!

    It’s all to ubiquitous now, though, that I despair that we can undo it. I am encouraged by some recent events as reported here, but the repeal of the supplement (DSHEA?) deregulation would go a long way in furthering real public health efforts.

  • K.

    Out of curiousity, does anyone know if the scientific study of supplements in Europe suffers from the same “drawback” that it does in the States – that there is little financial incentive for anyone (companies, academics, and anyone in between) to run expensive and scientifically rigorous academic studies?

  • Jeff

    Just because the EFSA rejects a health claim doesn’t mean the evidence doesn’t exist. The EFSA has a strong anti-supplement bias.

    It’s true that studies using Glucosamine HCL, like the NCCAM study have found it to be no better than placebo.

    However most glucosamine supplements contain the sulfate form. Many studies using glucosamine sulfate, like the GUIDE study have shown it to have clear benefit for treatment of joint pain:

    http://www.guidetrial.co.uk/

    OsteoArthritis Research Society International recommends Glucosamine Sulfate as a useful treatment for arthritis.

    I urge anyone interested in an accurate account of DSHEA enforcement (or lack of it) to read the following article:

    The History & Future of the Dietary Supplement Health & Education Act:

    http://www.naturalproductsinsider.com/articles/2009/09/the-history-future-of-the-dietary-supplement-health-education-act.aspx#

  • Mark Douglas

    Maybe Dannon might offer the $100k to the NIH to do research on the subject — I would hope they would be willing to give it to a group that is very unlikely to have any reason to do anything but get at the facts and science.

    Or even better, maybe the supplement industry could offer to pay a voluntary “fee” (tax) to someone like the NIH to fund general research on benefits. Do you think they are that confident on the results?

  • Jeff

    @Mark Douglas: There has been quite a lot of research showing positive results using probiotics.

    Here’s one study:
    http://www.bmj.com/cgi/content/abstract/335/7610/80

    “The July 14, 2007 issue of the British Medical Journal reported the conclusion of researchers at Imperial College and Hammersmith Hospital in London that consuming probiotic bacteria, such as are found in yogurt, kefir, and probiotic supplements, helps prevent diarrhea associated with antibiotic use.”

    Probiotics assist immune function by inhibiting harmful bacterial growth, promoting good digestion, and maintaining proper pH.

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  • Mark Douglas

    @Jeff, I did not say it is not done, but why not have all claims investigated and made public rather than just the one’s that support a particular point of view.

    As probiotics, I have seen as many research results that have claimed an opposite conclusion. But, in general, I ask my doctor on most of these subjects as they come up and he simply says , with a few unique exceptions, eat less and focus on better balanced foods and diet.

    To quote Marion “health claims are about marketing, not health”. It seems that we would be better off trusting the medical professionals to our health and should expect the advice from them, not from a multi-million dollar “for-profit” ad campaign, eh?

  • Jeff

    Mark, health claims are also a freedom of speech issue:

    http://www.nutraingredients-usa.com/Regulation/Court-rules-against-FTC-in-supplement-ad-case

    “A US District Court has ruled against the Federal Trade Commission (FTC) and in favor of a supplements firm, in a landmark case that found FTC’s criticism of the company’s advertising was simply a “difference of opinion”.”

    What I like about DSHEA is that it protects the individual consumer’s freedom of choice. I can research a company’s claim, and consult a healthcare professional, but in the end it’s my decision whether or not to take a supplement.

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  • http://www.drhusbands.com Dr. Douglas Husbands

    Health claims should always be supported by good scientific data. There are numerous food and nutrient research studies, and those on particular nutrient factors that are very exciting and well supported.

    For instance, some of the most exciting research is coming out on curcumin and vitamin D. Curcumin has been recently found to be beneficial to prevent and reverse the plaques of Alzheimer’s Disease:

    According to researchers from UCLA School of Medicine, UC Riverside, and the Human BioMolecular Research Institute, a combination of vitamin D3 and curcumin may help clean-up the amyloid plaques of those with Alzheimer’s. In a newly published study in the Journal of Alzheimer’s Disease, researchers found that a combination of Vitamin D3 and curcumin stimulates some of the white blood cells, called macrophages, to engulf and digest the amyloid plaques in patients with Alzheimer’s.

    Though this study presents a preliminary finding, it shows promise for an effective treatment for AD. It is estimated that by 2030 close to half the population in this country over 85 years of age will have AD. Therefore, any potentially effective treatment that is devoid of the side effects, typically in current treatments, must be vigorously studied further.

    The cost savings for caring for the elderly, and the prevention of pain, suffering, and inconvenience for the patients and their families could be monumental.

    So, for prevention of Alzheimer’s rather than waiting for more studies, most people should be using curcumin and vitamin D3 now! Curcumin is an antioxidant that has been determined to be safe, even with many medications, and has demonstrated anti-inflammatory activity. Vitamin D3 has been found to have a multitude of health benefits for every cell and system of the body. Thus, from a healthy-aging perspective, these two are beneficial anyway. Also, if anyone suffers from arthritis or other inflammation, curcumin is a safe and effective option.

    Dr. Douglas Husbands, DC, CCN, ABAAHP
    http://www.drhusbands.com

  • Frank

    Until recently, health claims in Europa were approved by the MARKETING UNITS in Europa, but not by independent regulators.

    More and more food companies jumped on this trend of “functional” food. (Un)fortunately their marketing was much mor successful then the science backing up their health claims.

    Now, after so many negative EFSA rulings, the “non-functional” food industry is blaming EFSA for being too strict, for requiring clinical studies and for applying a “pharmaceutical approach”.

    Ups, we all thought that there actually was scientific evidence for industry claims. What kind of evidence ? Animal studies, cell cultures? Monographs on composition, health magazines ?

    EFSA does not apply a pharma approach, but a scientific approach to check the efficacy of “functional food”. A scientific approach is also applied in the assessment of drugs, that is correct. Maybe this is rhe reason why industry blames EFSA for applying a ” pharma approach”, because both (drugs and fiunctional foods) require a scientific approach to find out of they work as claimed (?)

    What’s wrong wwith that ?

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  • Elizabeth Jones

    OMG its a very shameful thing to see conflict for food and health.