Raising hopes

While scientists on EFSA's NDA panel on dietetic products, nutrition and allergies have rejected a raft of health claims submissions under the Nutrition and Health Claims Regulation EC 1924/2006 for which preauthorisation is required (including every one of over 300 probiotic submissions under Article 13.1 general health claims) it would appear that there is some hope on the horizon.

Thanks to increasing dialogue between the industry and the NDA panel, a better understanding is beginning to emerge about the position of those on different sides of the health claims argument. There is growing understanding that there needs to be adequate consumer protection while allowing the industry to make a return on its investment in new types of food designed to improve consumer health.

After all, no reputable food and drink company would want to see 'snake oil salesmen' free to market their dubious products as is too common in many other parts of the world, including the US and the Far East. Most people in the business in Europe support the need for a rigorous scientific basis for any claims.

However, many people are frustrated by EFSA's rejection of what they see as well-established scientific evidence to support claims for products such as probiotics.

But what many companies submitting health claims dossiers for approval don't seem to have understood is that they were meant to provide evidence in a format required by the NDA, which is operating to very strict rules to ensure that its deliberations are consistent for the huge number of submissions it has had to assess. Those that have failed in their submissions would do well to look at what the successful ones are like to see what is required.

At a nutrition day organised by Leatherhead Food Research (LFR) on the theme of health claims last month, NDA panellist Professor Ambroise Martin, from the Claude Bernard University in Lyon, speaking in a personal capacity, explained what exactly he and his colleagues were looking for in submissions and why so many had fallen at the first hurdle.

Flaws in dossier formats​

To date, explained Martin, too many rejected dossiers contained evidence in a form that was primarily aimed at being accepted for publication in peer-reviewed scientific journals rather than to achieve health claims approval. He outlined the steps necessary for a positive ruling.

"It is more important to understand the rationale [for dossiers that are acceptable], rather than look for magic recipes,"​ he remarked. He stressed that studies should be designed to prove a claim. "I am sure there will be a positive opinion [on probiotics] once the industry understands this new rule,"​ he added.

Dossiers needed to provide better characterisation of the food itself and in relation to the claimed beneficial effect some of the main reasons for many submissions being rejected, according to Martin. Only then would the NDA panel examine evidence about the substantiation of the claimed effect (where human intervention studies in the target population become critical); assess whether the wording in dossiers reflected the scientific evidence; and establish the conditions of use for the products.

"If the first two are done well, the third one [substantiation] is easy,"​ said Martin. "It is characterisation that should be really carefully scrutinised in relation to the claim."​ However, if they are not, dossiers will be rejected without any further consideration, he remarked.

As well as failing to characterise the foods and beneficial effects for which claims are made to the NDA's satisfaction, other common failings of many dossiers were in not targeting (apparently) healthy target populations specifically enough and not including rigorous human intervention studies of these target groups to substantiate claims, said Martin. He went on to describe the advantages and disadvantages of using biomarkers as indicators of beneficial effects and stressed that the quality of studies and biomarkers were carefully scrutinised by NDA.

Better dialogue​

At the same meeting, Dr Julian Stowell, responsible for scientific affairs at the Danisco Health & Nutrition division of Du Pont, reported an improved dialogue between stakeholders in the sector and with the EFSA through the Global Alliance for Probiotics (GAP). GAP was established at the end of 2011 to promote understanding and awareness of probiotics and the recognition of their health benefits.

However, Stowell accepted that it remained a challenge to demonstrate the health benefits of foods including probiotics even if they were widely recognised. But the prize made it all worthwhile, he added, given that as a business probiotics in Europe were worth around euro 5.5bn, with over 100M regular consumers of probiotics, such as yogurts.

"We [GAP] believe the viable solution involves dialogue with all stakeholders and we would like to see more interaction with EFSA colleagues on a case-by-case approach before EFSA has to waste a lot of time evaluating dossiers that are going absolutely nowhere,"​ said Stowell.

"We are working hard we have a lot of activities underway and we are making really good progress and I am really excited. And in the end a positive way forward is going to be found for probiotics."​

The criticality of human intervention studies in achieving successful health claim applications was a point reinforced by LFR's nutrition research manager Dr Roberta Re. "Claims should be based on human data primarily from intervention studies,"​ said Re, although supporting evidence could also be used to back up this work. "You have to be able to prove beyond all reasonable doubt that it is actually your compound that has an effect on the outcome."​

She added that when designing clinical trials, selection of the population, choosing appropriate controls, study power, selection of relevant endpoints and accepted biomarkers, as well as mode of use, should also be key components of the process.

There is a hierarchy of evidence required, from a nutrition claim for food, through Article 13.1 and Article 13.5 through to Article 14 claims (see panel), which are closer to those required for proving the efficacy of drugs. But, said Re: "Your challenge is much harder than for a drug. You are dealing with a disease that can be measured in a drug, but this is not so with food. The story is much more difficult."​

She said it was crucial to think about what you are trying to achieve from intervention studies in order to prove the 'cause and effect' relationship, as well as the target population it was aimed at. She cited the example of glucosamine, which is widely accepted to have a beneficial effect on bone health but did not receive health claims approval because a study submitted focused on individuals suffering from osteoarthritis, which is not representative of the general population as far as joint tissue is concerned.

In contrast, she cited the example of Provexis's successful claim for its Fruitflow product obtained from tomatoes. In the EFSA ruling, it was accepted that water-soluble tomato concentrate made a contribution to a healthy blood flow by maintaining normal platelet aggregation. She noted this dossier submission had demonstrated good characterisation. EFSA even considered there was no basis for restricting the conditions of use to the 35–70 target age range within the adult population.

Health claims are possible, provided the right approach is used to evidence collection and dossier submission, said RE. "From the mistakes of others we have learnt quite a lot."​

Approved list​

As Food Manufacture went to press, Members of the European Parliament were expected to give their full approval for the list of 222 permitted Article 13 health claims. However, many in the industry expect further wrangling to arise as arguments emerge about the precise wording allowable in different EU Member States.

While accepting that neither the list nor the approvals process were perfect, FoodDrinkEurope (FDE), which represents food and drink manufacturers in Europe, believes the adoption of the Article 13 health claims list will help to harmonise the use of scientifically substantiated claims on foods across the EU and create a level playing field on which manufacturers can compete and innovate.

FDE said agreement on 222 health claims was an important step in the process towards the adoption of a final list of approved health claims permitted throughout the EU market.

The Advertising Standards Authority (ASA) will be responsible in the UK for arbitrating on health claims advertising that appears in print, is broadcast and published online. It also believes that publication of the list will bring greater clarity to its rulings, mindful of any transitional arrangements that apply inbetween when the law is passed (probably in May 2012) until it comes into force six months later.

However, since the ASA's job is to consider how consumers are likely to understand ads, we can expect the controversy about health claims to rumble on for some time yet.

And the issue of 'implied health claims' (through imagery on ads and implied wording) is likely to prove a whole new can of worms as will the issue of nutrient profiles (yet to be determined) of foods for which claims are allowed. As the ASA pointed out, an approved health claim does not mean an advertiser has any immunity from an ASA investigation!

Status of health claims dossiers at EFSA (January 2012) (source EFSA)​

Dossier––––Submitted––––Opinions published––––Accepted––––Rejected––––Withdrawn––––Under review

Article 13.1––––4,640––––––––2,241––––––––––––c340 (15%)––c1,900––––––331––––––––––––2,103*

(General function health claims)

Article 13.5––––60––––––––––––38––––––––––––5––––––––––––30––––––––––––14––––––––––––14

(Claims based on new science)

Article 14––––274––––––––––––86––––––––––––24––––––––––––63––––––––––––110––––––––––––82

(Disease risk reduction and child development)

* The so-called 'botanical' claims'.