As the functional food concept is predicated on a direct association with health benefits, the debate over health claims is without doubt the central issue that companies operating in or entering this sector face.

Recent controversies over the health claims and advertising of probiotic brands in the UK and the US only serve to highlight the issue.

The European Union

The job of assessing the validity of health claims in the EU has fallen to the European Food Safety Authority (EFSA).

After concerted campaigning around five years ago, the EU passed regulation on nutrition and health claims on food with the aim of ensuring that such claims were scientifically proven. EFSA was given the job of assessing these claims. More than 4,637 health claims were submitted. When it published its third series of assessments last October, EFSA stated that 1,745 claims had so far been assessed and it expected to finalise the evaluations of all ‘general function’ health claims, other than botanicals, by the end of June 2011.

The ongoing EFSA review is clearly a significant regulatory intervention and is notable for the number of health claims that have not been endorsed, with probiotic ingredients in particular faring badly.

While campaigners have been concerned at the length of time it is taking the EU to address the issue, food industry representatives have criticised EFSA for taking an overly strict view towards assessing health claims.

Clearly mindful of industry concerns, EFSA held a meeting in Amsterdam last December where around 200 representatives from the food and drink industry, academia, Member States and the European Commission, had an opportunity to discuss with EFSA experts the scientific requirements for health claims related to gut and immune function. EFSA plans to hold three more such meetings addressing health claims relating to various other health issues, including weight management and blood glucose concentrations, cardiovascular health and bone and joint health.

Professor Jeya Henry, director of the Functional Food Centre at Oxford Brookes University, believes the EFSA review has rightly set some strict limits but he believes ultimately there will have to be given and take.

"I think quite rightly in a European context EFSA's decree was highly rigorous and highly proscriptive," Profesor Henry tells just-food. "That seems to be a good thing because what you don't want in the first round is all the charlatans coming through the system, so therefore you set the goalposts very high. You have to be rigorous and get rid of all the chaff and make sure you have only the wheat to actually pursue. Then have some negotiation and that is happening now."

Professor Henry sees a parallel between what is happening in the functional foods market and the discovery of vitamins in the early part of the 20th century, which was also greeted with considerable scepticism.

However, he warns that if the regulatory approach towards functional foods is too heavily influenced by the sceptics and the campaigners, an opportunity could be missed.

Notwithstanding the serious danger of deceptive or exaggerated claims misleading consumers, he believes that the growth of functional foods represents a paradigm shift in how people look after their health. "There is little doubt in my mind we are going to see people moving from the medicine cabinet to the kitchen cabinet and that's the evolution, that people are not going to take tablets and medication alone for their health outcomes but are also going to use diet and food."

He adds: "I am not saying functional foods are a panacea but I'm saying that it's a very interesting area of scientific development. Let's give it a chance, at the same time maintain very good controls."

However, Professor Henry does not feel that the controls governing functional foods need to be directly equivalent to those governing pharmaceuticals. Interestingly, a report from the Institute of Medicine in the US published last year, referred to in more detail below, calls for equivalent scrutiny.

In general, campaigners have been highly critical of the current level of control over health claims in both Europe and the US. There has been strong condemnation from NGOs regarding certain trends in the marketing of functional foods, and campaigners have welcomed recent interventions, notably by the Advertising Standards Authority (ASA) in the UK, to clamp down on probiotic advertising.

In response to the most recent EFSA evaluations, the UK consumer advocacy group, Which?, said: "Clearly many food companies are exploiting people's interest in improving their health, often over-charging them for alleged health benefits which can't be proved."

However, Which? acknowledged that there are some functional foods with scientifically proven health benefits. "On a more positive note, there are foods using proven health claims, so it's vital that industry acts responsibly when making claims," the group added."

Professor Henry advocates better communication between industry and regulators to find a "balance between legislative rigour and scientific support for the industry". He also believes regulators, notably the Food and Drug Administration (FDA) in the US and EFSA, need to communicate to "iron out" inconsistencies between their respective approaches to functional food.

The US

The debate over claimed health attributes for functional foods is at least as fierce in the US as it is in the EU, if not more so. The regulatory authority charged with policing health claims on foods is the Food and Drug Administration (FDA) but the Federal Trade Commission (FTC) will also be involved where advertising is concerned.

However, campaigners have complained for many years that the FDA's powers to regulate health claims on foods are weak. That debate was fanned last year by the publication of a report by the Institute of Medicine (IOM), sponsored by the FDA itself, which concluded that FDA should "apply the same rigour to evaluating the science behind claims of foods' and nutritional supplements' health benefits as it devotes to assessing medication and medical technology approvals".

The report added: "There are no scientific grounds for using different standards of evidence when evaluating the health benefits of food ingredients and drugs given that both can have significant impacts on people's well-being."

IOM has set out a new framework the FDA could employ to judge both "consistently and transparently" the "appropriateness and validity" of scientific evidence used by companies to support health claims they make for their products.

The IOM report made some specific observations regarding the health claims issue which are equally relevant to the debate being conducted in Europe.

As it can be time-consuming and difficult to test products against actual clinical outcomes, companies often conduct studies measuring effects on "biomarkers", which are used as biological yardsticks or substitutes for clinical outcomes, such as cholesterol level being used as a biomarker for effectiveness in reducing the risk of coronary heart disease.

However, the IOM report concluded that FDA had been hampered in its ability to assess the proliferation of health claims on foods partly because it lacks a process broadly accepted across the regulatory, food, and medical communities to evaluate such biomarkers and their effectiveness as a proxy for clinical outcomes. The report called on Congress to boost FDA's authority to require further studies of drugs and devices after they are approved if their approval is based on studies using biomarkers as surrogate clinical outcomes.

The IOM also said Congress should give FDA the authority to conduct studies of how well consumers understand food and supplement health claims and require manufacturers to make changes if needed to promote greater clarity. It also called for FDA to be given more scope to study how health-related information can be communicated more effectively to consumers and asked for FDA to have more resources and authority to act on claims when they are found to cause confusion or to exceed regulatory limits.

The IOM report was welcomed by campaigners who have been pushing for tighter controls on health claims in the US for many years.

A report from the Government Accountability Office (GAO) in January also called for FDA to be given greater powers by Congress to police functional health claims on food.

Japan

As the birthplace of the functional food category, it is no surprise to find that Japan has an established regulatory structure for examining the claims of so-called FOSHU (foods for specified health use) products.

In order to sell a product as FOSHU, companies must satisfy requirements regarding its safety and effectiveness, laid down by the Ministry of Health, Labour and Welfare (MHLW).

According to the MHLW website, these requirements include that the effectiveness of the health impact on the human body is "clearly proven", that there are no safety issues, and that nutritionally appropriate ingredients are used, for example no excessive use of salt.

The debate over the level of rigour required by lawmakers in the validation of health claims on food has to a degree already been played out in Japan, with the establishment of different types of FOSHU. In simple terms, the three classifications are qualified FOSHU, where health functions are not substantiated on scientific evidence; standardised FOSHU, where the accumulation of scientific evidence meets certain scientific specifications set out by the Ministry; and reduction of disease FOSHU. The latter is only permitted when the claim of reduction of disease risk is clinically and nutritionally established in an ingredient.

While Japan has arguably established an elaborate regulatory structure governing functional foods, some campaigners have suggested that the system does not sufficiently protect consumers from misleading claims.