A healthy debate?

“Now the question is, if a food product states that it has a benefit and the safety is proven, how critical is it that that product has the full extent of benefit that it's stated to have on the label? In other words, where a yogurt claims to contribute to a healthy heart, how important is it to prove that this is the case in a clinical trial?”
-Ivan Baines

The food industry may be at risk of suffering the same fate as the pharmaceutical industry when it comes to the effect that regulation can have on innovation, says Ivan Baines.

Working for the Max Planck Society as part of the Institute of Molecular Cell Biology and Genetics, Ivan Baines has had plenty of experience working in partnership with both pharmaceutical and food companies on biomedical research. It is this experience that has enabled him to draw certain conclusions about the current regulatory landscape within the food industry, which, he says, has some strong parallels with the situation in the pharmaceutical industry.

"The pharmaceutical sector is subject to very stringent regulatory controls. The reasons are very well justified, because at the end of the day patient safety is a critical element of health care practice," says Baines. "However, it is also well recognised as having restricted innovation to some extent. The reason is because it now costs somewhere between $800 million and $1.2 billion to bring a drug to market, and getting there takes about 17 years."

To clear the regulatory hurdles, many pharmaceutical companies tend to play it safe in terms of the properties of the drugs that they develop. As the investment is generally so high, many companies avoid taking a higher risk approach as this increases the risk of falling foul of the regulatory hurdles. "So it is now well appreciated that it is quite hard to bring innovative new drugs to market," says Baines.

This is the parallel that Baines draws with the evolution of the regulatory environment in the European food industry. The regulation that was adopted by EU decision makers in December 2006 lays down harmonised EU-wide rules for the use of health or nutritional claims on foodstuffs based on nutrient profiles. This regulation was implemented in 2009 and contains two particular articles that are proving problematic for many in the food and nutrition industry - Articles 13 and 14.

"What these two articles mean is that in order to make a generic health claim about a food based on an ingredient, one has to prove the same benefit of the complete food with all of its ingredients as compared to the single ingredient," says Baines pointing out that the extensive and costly preclinical trials are why it takes so long for the pharmaceutical industry to bring new drugs to market.

However, one thing that Baines does not dispute is the importance of regulation in ensuring food safety. "There is consensus in the consumer sector and in the food industry that safety should not be compromised and in Europe there are very high standards for proving the safety of food products brought to market," he says.

"Now the question is, if a food product states that it has a benefit and the safety is proven, how critical is it that that product has the full extent of benefit that it's stated to have on the label? In other words, where a yogurt claims to contribute to a healthy heart, how important is it to prove that this is the case in a clinical trial?"

For Baines, as long as there are no safety issues concerned with food product, he doesn't see the problem with making specific health claims. Whilst many opponents claim that these health benefits, if unproven, become mere marketing tools for food companies, Baines does not consider this a bad thing.

"I don't see a huge harm in being able to use it as a marketing tool, as long as the foods are absolutely safe," says Baines as he outlines that people who seek out food products that claim to have added health benefits are often in pursuit of a healthier lifestyle. "The conviction of having a healthy diet leads to a lifestyle change that actually has a benefit well beyond the food product itself. In other words, the impact of having so-called nutraceuticals or health promoting food products goes beyond the ingredients in the foods themselves," he explains.

The pharmaceutical model that is being used as the basis for these regulations is simply not the right model according to Baines, and he believes that the legislation has, to some extent, taken on a life of its own. "Everyone is a little confused as to why there's suddenly this stringent requirement for proving the benefits in regard to health claims, when safety has already been proven and overall it's well recognised that healthy food products promote healthy living."

Where Baines does see a problem and a risk is in what he refers to as negative marketing, a phenomenon he says is quite prevalent in the US where food products are marketed through the absence of an ingredient. Products that are sodium free or cholesterol free for example often have higher levels of other ingredients added to them in order to compensate for the lack of that ingredient and to ensure that the product remains tasty, says Baines. This, he says, creates an imbalance in food ingredients, which can be harmful.

"What's not good is to start prejudicing the profile of foods to have very high amounts of one ingredient, where it's not known whether it has benefits. Like pharmaceuticals, it's all about dosing," says Baines. "This may now happen in foods if they're having to include single ingredients in much higher doses to be able to make the health claim, which in fact will end up being unhealthy because it's disrupting the balance of ingredients," he explains.

The regulation on health claims requires EFSA to assess all available scientific data submitted to substantiate the claims and then submit its opinion, before the European Commission and Member States decide whether to authorise the claims for use on food, taking into account EFSA's opinions.

EFSA has already released two batches of Article 13 opinions, the first in October 2009 and the second in February this year. The results have been a huge blow to the food and nutraceuticals industry, as two-thirds of the initial batch of claims were rejected by EFSA.

"What has happened is that a number of companies have actually withdrawn their products from the market, because they are afraid of a negative review from EFSA and this has had a very serious impact on both their image and their marketing of the product," says Baines.

He also highlights that the legislation on health claims is biased towards larger companies, as they are more likely to have the resources to finance the types of studies required to prove the health benefits of their products. This leaves smaller companies, who are more innovative than their larger counterparts, unable to compete.

"It's also a concern with regards to Europe's competitiveness in the health and wellness global market, which is a hugely growing market. It grew 60 percent from 2002 to 2007. It's compromising European competitiveness because those regulations do not exist in Asia or in the United States.

"So it's putting a much greater burden on European companies and the European market, and it means that R&D in this area may move overseas," says Baines once again looking to the pharmaceuticals industry to draw his parallels.

And the occurrence of this R&D exodus is worryingly imminent in Baines' opinion. He suggests that companies may even be looking to ship their R&D elsewhere before this year is out.

Research has unfortunately been profoundly affected by the health claims legislation. "What has been particularly affected is where food companies have performed very innovative empirical research, for example where they've used model organisms to see which food products actually have an impact on longevity. Now these are studies you can't perform in any kind of clinical environment. If you did they would take 15 generations and 300 years to be able to prove," explains Baines.

"That's extraordinarily useful research and it's no longer admissible because it doesn't satisfy the requirements of the review process. So it is compromising the scientific completeness of the peer review process, because in fact the types of studies that food companies have performed are quite frequently good science."

With the threat of a European R&D exodus looming, Baines is convinced that ignoring the unrest in the ranks is not something that EFSA or the European Commission can afford to ignore. "It seems like there's a fairly unanimous voice saying that this doesn't make sense and I think that they will have to sit up and take notice. My fear is that it may be too late," says Baines.

If the European authorities were to take action to alleviate some of the burden that the new regulations have placed on the shoulders of the food and nutraceuticals industry, Baines suggests that broadening the scope of permissible scientific evidence to admit the types of studies that have been the basis for making claims in the past would be a good place to start.

"They need to accept that foods are not like pharmaceuticals. They're not being taken to cure a life-threatening disease. They're helping to shift into a healthier lifestyle. And as such it's acceptable to consider the full breadth of scientific evidence, including empirical observation and model organism studies, and the full breadth of studies that are performed by food companies," he explains.

There have admittedly been some changes taking place since the overwhelming number of EFSA rejections. Many of those claims originally submitted under Article 13.1 of the regulation have been rejigged and resubmitted under article 13.5 for proprietary and emerging science.

It's not yet clear if this will prove successful, but what is clear is that something needs to be done if we are to avoid the potential brain drain of European R&D that many in the industry are starting to fear.

Industry appeal

In April a letter signed by over 350 large, medium and small companies from across Europe in the food and nutrition industry was sent to José Manuel Barroso, President of the European Commission, calling for his personal intervention to stop the adoption of the list of “positive” functional health claims in batches. The letter is printed below.

Dear Mr Barroso,

Nutrition and Health Claims Regulation: Impact on the European Food and Food Supplements Industries.

The undersigned group of concerned companies are writing to you to ask for your personal intervention in the current application of Articles 13.1 and 13.3 of the Nutrition and Health Claims Regulation.

We believe that the planned piecemeal approach to the adoption of the Community lists of Article 13.1 “permitted” and “prohibited” health claims, distorts competition in the market and will have a potentially devastating impact on industry.

The Member States submitted the claims for validation to the European Commission, which passed them on to the European Food Safety Authority (EFSA) for their evaluation and opinion.

Procedurally, it was understood that the Commission would regulate on EFSA’s opinions at one time, by 31st January 2010, as stipulated in the Regulation. However, this deadline has slipped.

EFSA will not deliver all of its opinions at the same time, despite the DG SANCO Director General’s call last July that opinions should not be published in a batch-wise fashion. Subsequently, DG SANCO has decided to proceed with the piecemeal adoption of EFSA’s opinions through until 2011.

We call upon you to intervene and stop this piecemeal approach, which:

• Distorts competition in the market, giving a competitive advantage to those companies who have received positive opinions on claims from EFSA and are free to market their claims across Europe, over those companies that await EFSA’s opinion for claims that are only authorised in some national markets.
• Creates unnecessary and disproportionate costs for manufacturers due to successive label changes as they await the opinions for each claim for the ingredients in their products, which are decided upon in batches at different times. This entails huge costs with the greatest impact on SMEs.
• Creates confusion in the market as non-harmonised claims co-exist with harmonised claims for a period of up to two years with unequal conditions of access to markets across the EU.

We call for all EFSA opinions to be delivered before any further steps are taken towards a formal decision on the final list of “permitted” Article 13.1 health claims.

Yours Sincerely,