Health Claim Substantiation – 'An Apple a Day' is Being Challenged

Nutrafoods 01/2009

With the EU Regulation on nutrition and health claims of December 2006 (1924/2006), the European Parliament and the Council established harmonised rules for the authorisation of claims relating to health and nutrition used in the labelling or advertising of foods including dietetic products and food supplements. Unsubstantiated or misleading claims shall remain prohibited and consumers’ confidence in products that have been shown to promote health shall be increased.

Incorrect and misleading claims had already been outlawed before the health claims regulation came into force. Although the former rule implied that anything which had not been banned was allowed, competitors could for example issue a preliminary injunction about inaccurate claims used for competing products and so get them banned from the market. New about the health claims regulation is the introduction of an examination and authorisation of advertising claims before they can be used. This means that in the future anything which is not allowed will be banned. The scientific assessment of submitted claims is the current task of the European Food Safety Authority (EFSA). A positive or negative assessment is not however synonymous with authorisation or non-authorisation of the advertising claim: the final decision rests with the European Commission, which decides in consideration of the authority’s opinions. This may be an advantage in cases where the scientific assessment of EFSA is not conclusive.

The health claims regulation basically identifies two groups of claims: the first group consists of health claims based on generally accepted scientific evidence (Article 13). These claims will be included in a Community list, often also called the 'positive list', which is currently being prepared by the European Commission. Use of the generic claims appearing in this list will be possible for all market participants, provided the composition of the product in question meets the necessary requirements. Claims which “include a request for the protection of proprietary data" (Article 13(5)) are a special case. If the applicant cites his own studies and these prove crucial to the authorisation of the claim, the applicant is granted the exclusive right to its use for up to five years.

In January 2009 the EFSA published a list of the applications for inclusion in the Community list: it contains 4185 claims. However, the EFSA aims to evaluate just 1024 of them by summer, with a further 468 to follow by the end of November. Assessment of the other requests will be delayed, for example because these have been submitted very late, i.e. in December 2008, or because amendments have been submitted.

The second group contains “reduction of disease risk claims and claims referring to children's development and health” (Article 14). They are not part of the Community list, and individual applications for authorisation must be made to the European Commission through the competent authorities. Applications for the authorisation of such advertising claims must, in accordance with Article 15 of the Health Claims Regulation, be accompanied by e.g.: “studies, including, where available, independent, peer-reviewed studies, which have been carried out with regard to the health claim”. This requirement has in practice turned out to be the weak point in many applications.

Whereas the EFSA has not yet published any assessments of claims from the planned Community list, opinions have already been published on the 'disease risk reduction claims' and 'children's development and health claims'. To date (as of 30 March 2009), the authority has published a total of 48 opinions. 12 individual claims, dealing with a total of 7 functional relationships, have received positive assessments. The first opinions have also been published on applications with proprietary data: final assessments have so far been made of 6 applications and all have been refused.

It emerges clearly from the opinions that the EFSA makes very stringent demands of the scientific data to be submitted. The authority expects that intervention studies to be presented, designed to evaluate the particular end product, which use the same active substance, target groups and dose as the end product and which provide evidence for the claim in the form of a statistically reliable, cause-effect relation.

Thus, one of the criticisms voiced by the EFSA and resulting in negative assessments was that study populations did not correspond to the target group mentioned in the claim, for example that studies in adults were submitted for children's development and health claims. Or that results from animal studies were used which were irrelevant for the claim’s target population. In the case of negatively assessed disease risk reduction claims, the EFSA focused its attention on, for example, the inadequate characterization and/or relevance of the observed risk factors, inadequate verifiability, dosages within the study that were not comparable with the claim, small numbers of participants and on the inadequate statistical significance of results. These and miscellaneous other points led the EFSA to doubt the validity and reliability of a number of studies presented to the authority.

Only where there is sufficiently reliable evidence of a cause-effect relationship between the measured, relevant factor and the food in question does the EFSA panel support the applicant’s claim. Even then, however, it can advise restrictions in the choice of wording. For example instead of the claim originally applied for “calcium is needed for healthy bone growth of children", the authority voted for the much more neutral and less effective “normal growth and development of bone in children”.

Even though the EFSA scientific opinions described here have not yet been used in any decision on the authorisation or non-authorisation of actual claims, for the companies and brands involved, their image has already been tarnished. This is of course no fault of the authority, which makes its assessment reports public. Publication of the reports is stipulated in the Health Claims Regulation. Thus companies are well-advised to submit applications via a representative or a service provider as a neutral third party to avoid having to read the name of the company or brand in connection with a negative EFSA statement.

The level of scientific evidence demanded by the EFSA is, however, very high. It is for example well above the evidence required for traditional herbal medicinal products under Directive 2004/24/EC. For these, studies are not necessary and plausibility on the basis of long-standing use replaces scientific evidence for the active substance’s efficacy.

Since EFSA requires a 'gold standard' for the substantiation of a health claim it is likely that time-consuming and costly scientific intervention studies will become essential for a successful claim application. Innovative products with new health claims could then become restricted to the big players with the financial resources to fund such studies.

On the basis of the authority’s opinions on Article 14 claims to date, about 80% of which have been negative, it must be expected that not so many of the 4185 generic health claims submitted will get the EFSA’s blessing. It even seems extremely doubtful that the EFSA will make a positive assessment of classic dietary recommendations and proverbial sayings such as “an apple a day keeps the doctor away” unless it can be proven in a double blind placebo-controlled human study with sound statistics.

That is why the industry is eagerly awaiting 31 January 2010, the day on which, according to the health claims regulation, the European Commission will publish the 'Community list of permitted claims'. However, in view of the delays in assessments explained above, it already seems certain that not even a non-exhaustive list will be available that day. It is also completely unclear at present to what extent the Commission will follow the rigorous assessment standards of the EFSA – and thus whether fruit and veg campaigns such as the UK Department of Health’s '5 a day' will in future be permitted if no preceding intervention studies have been performed.