Healthy flak

While hope reigns eternal, even the most optimistic observers are now predicting Armageddon for large tranches of the functional foods and dietary supplements sector when the final list of health claims permitted in the EU is published. And Nigel Baldwin is no exception. "There's a very good chance that the article 13.1 list [of health claims submitted under article 13.1 of the Nutrition and Health Claims Regulation] will be completely decimated. Beyond claims about vitamins and minerals and a handful of other major ingredients, I think EFSA [the European Food Safety Authority] will simply write the whole lot off."

Now this is not altogether bad news, he says. After all, businesses should not be making claims they cannot substantiate.

But while the Regulation will weed out the cowboys and their snake oil, it could also have devastating effects on innovation in the food industry and thwart the progress of firms producing products that might offer genuine health benefits, predicts Baldwin, who handled regulatory affairs for several leading food ingredients companies before setting up the European arm of Cantox Health Sciences in 2003.

Health claims Armageddon​

So what's all the fuss about? For a start, says Baldwin, there was a "woeful lack of guidance" for applicants on what was required from the authorities for making article 13.1 health claims initially. Confidence was further damaged by the manner in which applications were sourced and filtered by the European Commission and the unrealistic amount of time given to EFSA to process them.

But the biggest worry is the criteria being used to assess applications, says Baldwin, who helps firms navigate through the minefield of EU food legislation for a living. While no opinions have yet been published on article 13.1 claims (the first tranche is expected this month), those published to date on articles 13.5 and 14 do not bode well for applicants.

Of 20 article 13.5 applications submitted thus far, three are still in progress, six have been withdrawn (including three from Danone about Actimel and Activia) and most have been rejected. Of 252 article 14 applications submitted, the vast majority have been rejected, including one from Ocean Spray proposing that cranberry proanthocyanidins can help reduce the risk of urinary tract infection in women - a claim many experts believed was a shoe in.

To be fair, says Baldwin, many of the applications were not up to scratch, and were rejected due to the applicant's failure properly to characterise the ingredients in question, a mismatch between the age/nature of the volunteers used in the cited scientific studies and the target groups for the proposed health claims, or just a lack of decent clinical studies to support the claim.

However, several other applications from credible firms with reams of well respected research under their belts have also been rejected because of a failure to demonstrate a 'causal relationship' between the ingredient and the claimed health benefit.

On the face of it, this might seem fair enough, admits Baldwin, but in reality, nutrition research rarely offers such black and white 'proof'. To make a generic claim on a product suitable for the mass of the population (as opposed to sick people - because this would stray into pharmaceuticals), EFSA is prioritising the 'gold standard' of scientific evidence, which is deemed to be double blinded, randomised, placebo-controlled clinical studies on healthy, 'normal' subjects.

However, foods are not drugs, points out Baldwin, and short-term clinical studies feeding small amounts of nutrients to healthy volunteers cannot realistically be expected to generate the kind of measurable 'improvements' seen in pharmaceutical trials, which test powerful drugs on sick people. Foods that might help maintain health over eight decades won't necessarily 'improve' already healthy people in an eight-week trial.

Indeed, most government-issued health advice would almost certainly struggle to gain approval under the Regulation because it is based on epidemiological evidence, and not short-term clinical studies, notes Baldwin. "We're told to eat more fruit and veg because people that do typically have healthier outcomes. But that does not prove a 'causal relationship' between fruit and veg and improved health.

"If you ate your 'five-a-day' and I didn't for the next two months, would anything significant show up in a clinical trial? No. But does that mean that fruit and veg isn't good for you?"

The problem with such a black and white approach is that it does not permit any kind of qualified claim - whereby firms could still communicate where the science stands without misleading the public, he argues.

Indeed, the Regulation does stipulate that regulators should look at the totality of the available data and weigh the evidence, looking at the extent to which a causal relationship between a food and health benefit has been demonstrated, rather than seeking absolute proof, he says, "as in most cases, absolute proof is just not possible"

In the case of the omega-3 fatty acid DHA, this is particularly pertinent, he says. "Healthy neuronal tissue is rich in DHA and babies cannot produce it themselves; they must get it from their mother. This is a fact. So is it prudent to suggest to mothers that it might be a good thing to get enough fish or other sources of DHA in their diet? Yes. Why else does every paediatric organisation advise mums to do this? But can we get a health claim along these lines? No."

If at first you don't succeed ...​

So what will the industry do if most article 13.1 claims are rejected? There are several possible outcomes, says Baldwin. One is that many firms simply give up and focus on other parts of their portfolios - which could have a devastating effect on innovation in the food industry.

The alternative scenario is that firms which feel they have not been given a fair assessment under article 13.1 will redouble their efforts and put together fresh applications under article 13.5. This would at least give them more control over the process, says Baldwin.

"Given the way article 13.1 claims were collated by Member States and then filtered by the Commission before they even reached EFSA, no one knows what EFSA has actually been given to assess. For example, do the lists of references it has for each claim reflect the totality of the data?

"Many companies are now realising that the only way you can control the process is to submit your own dossier directly, which means going through article 13.5 or 14." For firms like Cantox, which helps firms make submissions under all areas of food legislation, July is a critical month, says Baldwin. "Everyone's been waiting for the first article 13.1 opinions to be published. We could be absolutely inundated with work as everyone goes down the dossier route, or everything could go quiet."

The effect of a negative opinion from EFSA - and an official rejection from the Commission - will vary, predicts Baldwin. Take satiety claims. For some ingredients such as inulin, polydextrose and gum Arabic, rejection would not be the end of the world as satiety is just another string to an already full bow (high fibre, prebiotic effects, fat and sugar replacement).

By contrast, an approved health claim is arguably mission critical for ingredients such as satiety agents PinnoThin (a Korean pine nut oil from Lipid Nutrition) and Fabuless (a palm and oat oil emulsion from DSM). They do not perform any other useful function in a food or supplement, so they must stand or fall on their health claims.

For other ingredients such as cranberry juice and omega-3s, public awareness of their alleged health benefits is already so high that the absence of formal claims on pack may not actually make much difference. But for many others, this could be the end of the road, predicts Baldwin. "Botanicals are in real trouble. Half might fail because they have not been properly characterised, and the rest could fail because of a lack of clinical trials."

As to how devastating this legislation proves to be for industry, much will depend on the press, he predicts. At the moment, journalists are not paying much attention to the steady stream of opinions published on the EFSA website. However, a front page headline in the Daily Mail arguing that fish oil is 'officially' snake oil on the back of a negative opinion could set the cat amongst the pigeons, he says.

"But bad press or otherwise, if you are selling a substance you can't make any claims about, your days may well be numbered." FIHN

EU Health Claims Regulation: an idiot's guide​

Article 13.1 claims: Generic claims referring to the role of a nutrient/substance in the growth, development and the functions of the body; psychological/behavioural functions; and weight control claims - supported by 'generally accepted science'. Claims that make it on to the 'Community list' of approved claims will become available for any company to use, provided they adhere to the conditions of use. eg. 'Calcium is necessary for the normal structure of bone.'

Article 13.5 claims: Claims based on new or emerging science or proprietary data. eg. 'Fruitflow tomato extract helps maintain normal platelet aggregation.

Article 14 claims: Claims on disease risk reduction or children's health and development. eg. 'Plant sterols have been shown to lower blood cholesterol; blood cholesterol lowering may reduce the risk of coronary heart disease.'

Deadlines: EFSA originally committed to evaluating 1,024 of the 4,185 article 13.1 claims in its in-tray by July 31 and a further 468 by November, leaving a whopping 2,693 more requiring assessment before Christmas to give the Commission time to put together the final list by January 2010. This, the Commission has finally acknowledged, is a logistical impossibility. EFSA is now aiming to publish the first tranche of article 13.1 claims in September/October 2009.