May 13 2010

IOM Report on Supplement Regulation

The Institute of Medicine (IOM) is an organization of independent scientists and experts who are tasked with providing, “independent, objective, evidence-based advice to policymakers, health professionals, the private sector, and the public.” In my experience they generally do good work – those IOM reports I have read in areas that I have some knowledge seem to be thorough and objective.

They were recently tasked by the Food and Drug Administration (FDA) to prepare a report on the science behind health claims for food and drugs. Their report is now in, and the results are in accord with my own writings on the topic. They conclude, basically, that there should be a rigorous standard of evidence for not only drugs but also health claims made for food and supplements as well.

Their key points focus on the fact that many food and supplement claims are based upon basic science research – the use of biomarkers instead of clinical outcomes. They point out that extrapolation from biomarkers to health outcomes is problematic, and they outline methods the FDA can use to standardize the use of biomarkers. This is a valid point, but I am not sure why they focused as much as they did on this one point.

I have not read the whole report, but in their summary they did not mention the use of structure/function claims for supplements, which for me is a major problem. Essentially, companies can claim that any supplement supports a structure or function of the body without the burden of providing any evidence – they just cannot claim that it treats or cures a disease. But this, in practice, is a distinction without a difference. Companies can and do say, for example, that a product “boosts the immune system” and that the immune system fights off cancer, but they cannot say the product treats cancer. They can even have a doctor saying, “I give this product to my cancer patients.” It’s all a pointless game.

Other parts of the report were dead on.

“Many people naturally assume that the claims made for foods and nutritional supplements have the same degree of scientific grounding as those for medications, and this committee thinks that should in fact be the case,” said committee chair John Ball, executive vice president, American Society for Clinical Pathology, Chicago.

They call upon the FDA to regulate health claims for food and supplements better. Of course, they really can’t under current regulation, namely the Dietary Supplement Health and Education Act of 1994 (DSHEA). And recent efforts to reform DSHEA were quashed by the supplement industry and their stooges in the Senate. The IOM report does:

…calls for Congress to enhance FDA’s abilities to study how health-related information can be communicated more effectively to consumers to help them better understand the science behind claims they see on packaging.

Congress needs to do more than that – they need to abolish DSHEA and replace it with a rational science-based regulation. It’s not just about communicating the information to the public – that seems hopeless as industry will always have vastly more resources and incentive to spread misinformation to the public. Congress needs to give the FDA more power to actually regulate health products and their claims.

The IOM report is very welcome, but it does not go far enough. The problem really rests squarely in the lap of Congress – they hamstrung the FDA in 1994 at the behest of the supplement industry, and they continue to serve the interests of this industry over the consumer. I also don’t see this issue as being very much on the public’s radar – as the report notes, most people assume health claims for food and supplements are regulated already. The public is further kept nicely distracted from this issue by the frantic propaganda of the pushers of supplements and dubious health products and services. They seem to be dominating the discussion with anti-scientific nonsense and conspiracy-mongering.

For the time being, the con artists are winning.

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