F&S: The danger of overstepping health claim boundaries

With an increased focus on preventative healthcare and consumers more actively managing their personal health, products carrying health claims assume a greater level of interest. Recent food industry changes and the introduction of nutrition and health Claims legislation have together prompted the need for greater clarification of the food/drug borderline.

The review of legislation on European medicinal products has compounded the confusion, as both disease risk reduction claims (article 14), and actual disease reduction can be obtained in medicinal claims with a marketing authorisation in the EU market.

Current Issues in Functional foods​

Although the sector has enjoyed massive growth in the last five years, many European consumers are still sceptical of functional foods, and specific marketing initiatives are required to address this. It is therefore essential to ensure that consumers do not misunderstand what they consume and why.

The main selling point of functional foods is that they can help prevent future clinical health conditions, which is particularly relevant to younger consumers looking for a better quality of life.

Medicine by function​

Functional foods are distinguished from drugs as they cannot claim to treat or prevent a disease, but are designed to benefit a particular area of health. Crossing the boundaries can prove costly and damaging.

A recent landmark case concerning a red rice product may help in future classification.

In Germany, Hecht Pharma’s fermented red rice food supplement was made with monacolin, a statin-like ingredient with similar properties to the prescription-only drug lovastatin.

In January 2009, the Court of Justice determined this product was a potential cholesterol-reducing ‘medicine by function’, as it acts to “restore, correct or modify physiological functions in human beings”​, in this case inhibiting cholesterol synthesis.

Communication failure​

In Europe, claims can be either health- or nutrition-related, or can provide information on nutrition composition. Barreiro et al. (Journal of Agricultural Research​, 2009, 7(2), 257-268) demonstrated in a preference trial on pork sausages that all three claim types are valued by consumers. These authors found that health claims are preferred to nutritional ones, and consumers will pay extra for these products.

In the ongoing recession, consumers may prefer to consume functional foods or dietary supplements over more expensive medical help or over-the-counter (OTC) products if they are not clinically diagnosed. Self-diagnosis relies on being in command of the facts, so the onus for responsible marketing is squarely placed on companies.

As market launches increase, a much greater potential for failure is present in communications surrounding functional food products.

Product marketing must reflect the increased focus on science and the benefits of consumption, as well as reassure sceptical consumers.

Restricting innovation​

The new European nutrition and health claims regulation aims to protect consumers and also industry innovation. However, the process has had a troubled implementation.

Industry innovation has been somewhat restricted by the legislation so far.

The majority of claim submissions examined so far have been rejected for their primary failure to demonstrate a cause/effect relationship under a very strict evaluation of the science.

In addition, several major manufacturers have withdrawn claim submissions due to a lack of clarity from EFSA as to what is required in the dossier, pending further information.

Heavy penalties​

Erroneous marketing claims can carry heavy penalties in fines, appeals and loss of revenue – particularly if they classify products as unapproved drugs.

Companies must err towards caution in preparing their dossier submissions, as well as when considering their product marketing and positioning. Particularly, much time will be saved if a clear cause/effect of can be associated. The classification as to what products can or cannot state should become easier when the final list of approved claims becomes available in 2010.

To read the Frost & Sullivan article on the US industry, click here​.​
For more articles in this series, click ​here​​ .​