EFSA, the Obesity Epidemic and Nutritional Deficiency

During the recent Vitafoods Europe conference in Geneva, Switzerland, Paul Clayton, Ph.D., former chairman of the Food Group at the Royal Society of Medicine, chaired the opening session, a presentation by Ambroise Martin, Ph.D., M.D., chairman of EFSA's NDA Health Claims panel. Dr. Clayton queried Dr. Martin several times regarding EFSA's position around the health claims approval process, which has yielded surprisingly few positive decisions.

After the session, Dr. Clayton took time to chat regarding the situation around EFSA and the health claims approval process, as well as the failings of the current health care system and what should be done to help consumers find better health. He came into the discussion with not only a background in academia, but in regulatory affairs as well, as a former senior scientific advisor to the UK government's Committee on the Safety of Medicines.

INSIDER: What is driving the animosity between the regulators and industry around EFSA's health claims mandate, and what dangers does this situation pose to consumers?

Paul Clayton, Ph.D.: Well, regulators and commercial personnel have different perspectives. As a former regulator and someone who consults with companies and whose heart is in academia, I can understand the validity of everyones different perspective. By necessity, regulators have to be granular in their perspective, and its entirely appropriate that they should be so. From the food industrys perspective, however, it is legitimate to ask whether we are asking food companies to become quasi-pharmaceutical companies and whether thats the right thing to do. Food companies would say that it isnt. On the other hand, the regulators are required to work to appropriate standards of proof. And the consumer deserves to be protected.

The problem is that we have built this regulatory edifice, brick by brick, and it has become a wall against progress. This system was initially designed to protect consumers, but the way it has evolved has resulted in a situation where public health is undoubtedly being damaged. It has reached a point where industry is saying it's too much trouble, and why bother, when at the end of the day we wont get a claim accepted, we cant use it in our advertising, we cant give meaningful information to consumers that they can legitimately use to improve their health?

Remarkably few health claims are approvedthe refusal of EFSA to concede that water hydrates, for example, was a low pointbut this is partly due to the way in which EFSA was constructed. The right of single member state veto, for example, is patently inappropriate, and guaranteed to block progress. And this is a tragedy because while EFSA are winning every skirmishthey are judge, jury and executioner, after allif you look outside the Brussels cabal, at whats happening to public health, were losing the war.

There is not just one tidal wave, but a series of tidal waves of ill health that are overwhelming our ability to cope. The enormous and projected increases that were seeing for cardiovascular disease, diabetes, dementias, allergy, sarcopenia, auto-immune disease, infertility, neuro-developmental disorders, cancers, were already beyond the point at which we can cope. As all these conditions are strongly related to lifestyle and particularly nutritional factors, these damaging and appalling trends are clear evidence of wide-spread dysnutrition and it is hard not to conclude that EFSA and the food industry are jointly guilty of public health malpractice and criminal negligence.

We need to find a way to develop and deliver health care more effectively, more cost effectively, and more humanely. The pharmaceutical model has failed catastrophically to prevent the tsunami of degenerative diseases. We need to move toward a food-based, preventive model of health care. The regulations and the commercial interests in their current form and their current dialogue are not allowing this to happen. That is a terrible intellectual and a moral failure; we must move past it.

INSIDER: What should be done?

Clayton: Both EFSA and the food industry must start to look at the big picture, and move on from poor food design and regulatory nit-picking. I mean, a claim has recently been approved that if you eat 10 or 20 grams of beet fiber a day, it increases the weight of your stool. Big deal. In the meantime, we have these pandemics of  degenerative disease, which, the historical data tell us, are entirely preventable. So the current system is failing, and needlessly so, because the evidence base to make a better system and to create better public health already exists. You could say given the science base we have, the health issues and hurdles are no longer scientific; theyre political. Health is political, it always has been. But what could we do with the current system to make it better? I think that there are two things we could do and we should do.

One of those is to move away from a system where one country can veto the entire proceedings, which is ridiculous; it was baked into the cake from the outset and one wonders whose interests that protects. We should move toward a majority decision to streamline things. Second, we need to develop new risk assessment models. The risk assessment models currently used were borrowed from the pharmaceutical side. We need a bi-directional risk model, because the risk model, in the case of nutrients, should also be looking at what is the risk of not adding these nutrients to our currently very depleted food chain. The mid-Victorian data tells us that those were four or five orders of magnitude greater. We dont take that into consideration, which is a grotesque error and should be rectified. That would also help streamline the current system.

INSIDER: So in terms of a depleted food chain, are we talking about this increasingly overweight population being overfed, but malnourished?

Clayton: Its not legitimate to talk in terms of nutritional deficiency, as it has a very clear and well defined meaning. Were not talking about scurvy or beri-beri. This is a different type of malnutrition, which is characterized not so much by an absolute lack of a specific nutrient, but a depletion pattern involving multiple nutrients, which we find typically in many vitamins, a number of trace elements, the omega-3 HUFAs, phytonutrients such as the polyphenols, xanthophylls and cyanogens, prebiotic fibers and CR3 agoniststhe list goes on and on. People are compromised in multiple areas.

There are two major reasons for this. First, a low calorie lifestyle. We get by on 2,000 calories a day. Our ancestors didnt. Go back 100 years before the time saving technologies that shape todays urbanized lifestyles. People were living much more physically active lives, so in the mid-Victorian period, for example, women were consuming 3,000 to 3,500 calories a day, but were whip slimas you can see in photographs of the time. Men were consuming up to 7,000 or 8,000 calories a day, levels that can be achieved now only by Olympic athletes. But theirs was a far more physical lifestyle. Our calorific requirements are far lower, due to our physically inactive lifestyles. Because were eating so little, were depleted in lots of things. Second, that depletion pattern is made worse by the fact that the way food manufacture, distribution and pricing is organized, means so many of us make the mistake of eating nutrient-depleted foods. Put those two things together and you get type B malnutrition, AKA multiple micro- and phyto-nutrient depletion, and it is emerging as the most common and most important cause of disease. The so-called diseases of civilization, heart disease, diabetes, cancerweve never been more civilized, and thats entirely due to our poor food chain.

The idea of being over-fat and undernourished is interesting. Yes, a lot of us are eating too many calories. From an historical perspective you can see that actually were not eating very much, because were so physically inactive, were stuck at these very low levels of energy and calorific requirements. At these low levels, our multiple satiety mechanisms do not work so well. And people are overwhelmed by stress and the universality of food and the convenience of food, which you could call food over-security. So, many of us are eating 100 more calories a day than we need. A daily excess of 100 calories a day may not seem significant, but thats enough over time to make us overweight and obese. To make matters worse many of us make poor food choices, we consume foods and beverages with a remarkably low nutrient density and the wrong electrolyte ratios. So underneath that overweight surface, we are undoubtedly malnourished. This idea of being overfed and undernourished is legitimate, and it is clearly the most important cause of disease today. The regulations as they are now arent helping us to resolve this.

INSIDER: So what is a possible solution?

Clayton: I think the industry should consider working together in a more coordinated way. The problem is so large that I dont know that any one company could tackle this in an appropriate way. Id like to see a project that would convey to the general public very simply and very clearly the health benefits that would spin off from better nutrition. You will not cure our multiple health problems by giving people lycopene or cranberry extract or green tea. It doesnt work that way. But if you were to take, for the sake of argument, a population with a high risk of death, the very elderly, a couple of old folks homes, randomize them, divide them in two, give one group the nutritional equivalent of the Mediterranean or even better the mid-Victorian dietwith all the nutritional ingredients shoehorned into a modern diet, and the other group the diet they were eating before. It is very certain that you would see significant reductions in morbidity and mortality within three months. At six months youd have to abandon the project for ethical reasons, and by six months and one day youd have the worlds media beating on the door. At that point our largely scientifically illiterate politicians will get dragged into it whether they like it or not. Too many politicians are in the pocket of the pharmaceutical industry and the food oligopolies, but a real-life Cocoon project would change the debate .