IOM report: One step forward, two steps back

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Related tags: Dietary supplements, Nutrition

IOM report: One step forward, two steps back
The call for better biomarkers to substantiate health claims is a bold and timely move, but we need to move away from trying to judge foods as pharmaceuticals.

Last week the United States’ Institute of Medicine’s (IOM) report, commissioned by the Food and Drug Administration, made the much-needed call for the use of biomarkers for evaluating the claims associated with dietary supplements and functional food ingredients, as well as pharmaceuticals.

For those not familiar with the term, biomarkers are “characteristics that indicate a biological process”​, like immunoglobulin levels in allergy response and immune health, or cholesterol levels for cardiovascular health.

Most nutrition science studies already report on biomarkers, but what we don’t have is a complete list of acceptable biomarkers. Scientists select specific biomarkers based on their own judgement of what is best, but does everyone agree?

The good…

So, the IOM’s recommendation that FDA convenes “expert panels to evaluate biomarkers and biomarker tests”​ is welcome. We need this, and industry should be happy that we are moving towards a biomarker-based system. After all, regulators around the world are increasingly looking for data in healthy populations to substantiate claims, so biomarkers are the way to go​.

The process needs to be transparent, with the list published and explanations provided as to why a certain biomarker is chosen over another: No doubt some will be clear cut, others will be contentious.

The bad…

But this was as far as the good news went in the report​. The rest of it had me shaking my head at the apparent lack of understanding of the differences between food and drugs.

One theme of the report is that the system for evaluating pharmaceuticals is best, and that foods and dietary supplements are getting by on a less rigorous system. They think that that needs to change and that if a food or dietary supplement wants to make a health claim (the realm of pharma) then they should undergo the same system of testing.

“The committee concludes that there is neither rationale nor scientific grounds for basing regulatory decisions on different levels of scientific evidence for different substances—science is science,”​ says the report. Don’t give me that. As a scientist and I know ‘science is science’, but I also know I wouldn’t use the same techniques to measure the composition of jet fuel and the safety of a new genetically modified crop.

Likewise, dietary supplements and functional food ingredients are not drugs. I’m not taking two pills a day until the rash goes away. I’m taking a nutritional supplement to my diet. I’m making sure I’m crossing all the t’s and dotting all the i’s. Drugs are short-term fixes, dietary supplements and functional foods are long-term investments.

Diets are complicated things and parts overlap. I may be getting vitamin E from my multivitamin, and I may also be getting it from the olive oil on my salad. I’m pretty sure that the penicillin I get from the pill is not being repeated elsewhere. How can we apply the same criteria to such fundamentally different substances?

Adverse events are another area of conflict. It’s rare that pharmaceuticals do not have adverse effects. Indeed they are tolerated so long as the benefits outweigh the risks. Food or dietary supplement ingredients are not allowed such ‘luxuries’. There can be little room for error if a substance is to be consumed as a food.

And the ugly

This then leads me on to wondering why the report blurs the argument. We are talking about health claims but the report then adds in questions on safety.

Aren’t there already safety frameworks for new food and dietary supplements ingredients in the US – GRAS and NDIs? Europe also has its own with novel foods approval.

We can evaluate the safety of an ingredient or product. We can also evaluate the accuracy of a health claim. Are we now to start evaluating the safety of a health claim? Isn’t a health claim, by definition, a positive thing?

I recently spoke with a member of the EFSA panel who judges on health claims in Europe. This is an authority that has come under significant attack from various quarters, including on occasion this publication, for its over-reliance on evidence-based medicine, but the panel member was clear that to judge health claims you judge the strength of the science. It is not the job of the panel, he said, to judge safety – that is someone else’s job.

Science to inform policy

We need to move away from the drug model of testing substances, of pulling nutrients out of context. Biomarkers are one way forward and the IOM’s report should have stopped there. I would then have written a glowing editorial.

The regulation of food and drugs may come under the auspice of one agency in the US – FDA – but foods and drugs are different. Just because Hippocrates said food should be our medicine, doesn’t mean we should regulate them as the same thing.

Stephen Daniells is the science editor for NutraIngredients, NutraIngredients-USA, FoodNavigator, and FoodNavigator-USA. He has a PhD in chemistry from the Queen’s University of Belfast and has worked in research in The Netherlands and France. He has been writing about nutrition and food science for almost five years.

Related topics: Research, Product claims

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Are we abandoning DSHEA?

Posted by Steve Baugh,

I thought DSHEA created a division between dietary supplements and drugs. Dietary supplements were not required to demonstrate efficacy? The Antioxidant rule changed all that and opened up the slippery slope of drug requirements for dietary supplements. After all the mouthpiece of our competitors (drug companies) is our regulator. But we are also to blame. 10 years ago there were botanical extracts that were 5%, 10% or 24% potency. Now we have a rash of 98% pure "ingredients". Our movement away from synergistic natural products towards synthetic or purified forms should draw interest from the drug folks at FDA. Hmmmmm, it seems we need to decide who we are and then ask the FDA to regulate accordingly. Right now things are too muddy to even make good points.

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Good Points

Posted by Jonathan W. Emord,

As this excellent article reveals, the IOM Report is predicated on a basic misunderstanding of the difference between foods and drugs. While a drug is ordinarily a xenobiotic substance pre-approved for a precise disease intervention, a food (including a supplement) undergoes no such pre-approval because the safety of foods is known from a history of safe ingestion and because foods must be ingested habitually to sustain life. Having no choice but to eat if we are to live, we have an essential need to know not only of demonstrably proven nutrient-disease associations but also of the potential of nutrients to affect health and disease, even in the absence of proof of an effect on a biomarker. In short, we, as consumers, have a right to know the state of science associating elements in foods with health and disease, even if those associations are potential (neither proved nor disproved). We base virtually all decisions on such potentials but base few on information of greater import to life than that affecting our choice of what to eat. Thus, it is sophomoric to treat the foods we eat daily in the same manner as the synthetic drugs we ingest only upon prescription. The former are demonstrably safe and known to our bodies. The latter are not. The consumer must choose from among foods based on the information available in the market. The patient depends on a professional proscription for receipt of drug treatments. IOM missed the basic distinctions and thus has disserved the government and the public.

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Couldn't agree more!

Posted by Herbie Thyme,

Even if the biomarkers do get developed for the number of different nutraceuticals currently in circulation (which in itself may take years), the individual context of each intervention must be estimated! Future studies need to take into account a host of measurable factors for proper stratification of subject groups. A classification of "healthy" needs to be introduced, perhaps not unlike the Ayurvedic body types. Naturally inclined doctors, including NDs, need to be more active in getting their voices heard in developing these procedures for the evaluation of effectiveness of natural medicines!

Also, it is still unclear how structure-function claims will be affected by this new approach.

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