EFSA gut/immune health meeting

NDA details the food-drug divide and its “impossible task”

By Shane Starling in Amsterdam

- Last updated on GMT

Related tags: Nutrition

Defining the drug/food borderline is an "impossible task" says the NDA
Defining the drug/food borderline is an "impossible task" says the NDA
“It’s a critical issue to figure out how to show the health benefits with foods without crossing the borderline into medicines,” European Food Safety Authority (EFSA) NDA health claims panel working group member, Maria Saarela, told NutraIngredients at yesterday’s EFSA-hosted immunity/gut health workshop.

Nothing new there perhaps, but the issue was the primary motivation for around 220 academics, company scientists, consultants and those with a commercial interest working in pro- and prebiotics to attend EFSA’s Dietetic Products, Nutrition and Allergies (NDA) panel-hosted meeting in Amsterdam.

While frustration – even bafflement - was apparent at the NDA’s treatment thus-far of probiotic and prebiotic claims and science under the nutrition and health claims regulation [NHCR], Saarela, joined by NDA panel member, Seppo Salminen, explained why the issue of disease and its prevention had become so contentious.

“People ask for claims for ‘prevents’ which is already strictly out of the scope of [the NHCR],”​ said Salminen. “So it’s important to continue the discussion and for all parties to thoroughly understand the regulation.”

That said, the NDA panel was assessing submissions case-by-case, especially in the light of emerging science that had revealed more about the behaviour and impact of particular bacterial strains.

“At the moment it is difficult to separate these small groups of bacteria from the rest,” ​said Saarela, noting this ambiguity had prompted the NDA to focus instead on pathogens.

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1 comment

Consumer rated outcomes could be the solution

Posted by Drew Fobbester,

There are three weaknesses in the current claims evaluation model:

1. We are trying to substantiate claims based on biochemical or functional markers that may not be relevant.

2. The relevance of a functional food or functional component varies depending on the functional status of each individual - which function is most important for the person?

3. The human organism is complex and outcomes are dependent on multiple environmental and biochemical 'inputs'. Functions are also interdependent to complicate things further.

Trying to use the simplistic clinical trial or 'pill for ill' model just doesn't work with multivariate inputs and multivariate outputs.

So what's the solution?

A) To identify the functional status of subjects either using 'hard' diagnostic markers, using 'soft' qualitative markers or a combination of the two.

B) To monitor self reported outcomes based on perception of the subject as well as diagnostic markers. This can be via comprehensive symptom and quality of life questionnaires.

C) Apply relevant interventions based on the functional priorities of each individual and monitor both the hard, soft and self reported outcomes.

At interactive profiling (www.interactiveprofiling.com) for the last ten years we have been delivering nutrition advice based on qualitative functional assessments using interactive questionnaires. We are now beginning to evaluate efficacy/outcome effectiveness and identify the most important factors where successful remediation has been achieved.

Using multivariate analysis we can then identify the protocols or interventions that succeed.

Functional food health claim substantiation needs to step away from the two dimensional medical model. If we are looking to improve function then let's look to the outcomes of that improved function in terms that are relevant to consumers. So when looking at probiotics for example look at symptom based outcomes - flatulence, bloating, intestinal discomfort, nature of stools, frequency of evacuation etc. This provides rich outcome data in real time that will substantiate efficacy in terms that are relevant to consumers.

Not impossible by any means. Probably the most exciting and rewarding development in health in 100 years. Hippocrates would be proud of us all.

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