The resounding answer for a number of producers, particularly the beleaguered probiotics industry, is no. The vast majority of claims are rejected by the EFSA, with some reports of up to 80% of all claims rejected.
A number of commentators have praised the EFSA for this position as defender of consumers. They have cited cunning marketing ploys and false, misleading, unsubstantiated claims. This sounds very good – no one likes to think of cynical industry ripping off the concerned shopper. The health and nutrition area is big business – consumers hope to add health to their shopping list, and it was an area that did require some further regulation.
However, there’s an argument that the authorities have not only lost sight of the intention of the legislation, but also of common sense.
It should be remembered that any marketing concerns food (and not a medicine). Therefore, there’s already a blanket ban on any substance or combination of substances presented as having properties for treating or preventing disease in human beings Or, with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.
The amount and type of substantiation for claims required by the EFSA may be argued to be disproportionate. Also, it’s unknown. The EFSA itself states that there is no pre-established formula as to how many or what type of studies are needed to substantiate a claim. There seems to be a focus on formal human intervention studies to the detriment of evidence based on epidemiological/observational studies.
The difficulty of imposing scientific rigour on such a generic area means that requiring proof of a definitive proof of a cause-and-effect relationship cuts out a massive amount of common sense, generations of traditional use and knowledge.
Finally, vague claims are actually more likely to be rejected. The EFSA has emphasised that claims needed to be ‘sufficiently defined’, which may result in several claims being submitted for one nutrient or product.
‘The claimed effect needs to be specific enough to be stable and measurable by generally accepted methods. For example, ‘gut health’ is too general (unclear what measure can be used), but ‘transit time’ is specific (measurable by generally accepted methods).’
This may also put at risk generic disease risk reduction claims, certain foods may be deemed to be insufficiently characterised, with no cause-effect relationship demonstrated despite perhaps being included in national dietary advice.
The EFSA will be organising a series of consultations on specific topics to provide additional guidance to applicants. The first consultation on gut and immune function claims is due to be held on 2 December 2010. The EFSA is aiming to finalise the evaluations of all ‘general function’ health claims by late 2011 or early 2012 (and has even referred to as early as June 2011.) Decisions on botanicals will follow.
The likelihood for the future is a generation of restricted health claims that ultimately reduces consumer information and choice. Time for a side order of common sense?
Jessica Burt is a consultant solicitor for CMS Cameron McKenna LLP, specialising in food product regulatory and product liability issues.
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