Proprietary Food Claims

New regulations favor innovation.

By Joerg Gruenwald

The Nutrition and Health Claims Regulation came into force in Europe last July with mixed reactions from industry. While the advantages of the new regulation include a harmonized field throughout Europe and the prevention of misleading and unsubstantiated claims, companies still voiced concerns regarding a potential slowdown in innovation. Further, the regulation confused food and cosmeceuticals manufacturers, who never really had to deal with such tough claim substantiation before.

But recently, following sustained pressure from industry, the European Commission has decided to allow the submission of health claims based on new scientific data—starting from February 2008, not two years later as originally scheduled. This move is expected to boost innovation and thus overcome one of the main criticisms of the new regulation.

The most immediate consequence of this change is that companies will be able to accelerate the approval process for their new claims, significantly cutting down on filing time. This process will also help companies gain valuable headway in the market. Manufacturers that succeed in filing a new, proprietary claim will not only distinguish their product from others, but will also be granted exclusive use of their proprietary data for a period of five years.

Of course, a new claim that is not on the list of well-established and scientifically proven claims can only be made if that claim is substantiated by well-controlled human clinical studies, a big hurdle for the food and drink manufacturers striving to make their products stand out from the crowd using generic claims off the European Commission’s list.

Due to the change in the submission requirements of new health claims, the multinational food and food ingredient companies can now start performing the appropriate clinical trials in order to file new proprietary claims. For a company that has never performed clinical trials before, however, there is a wealth of requirements and regulations to wade through, not to mention the up-front investment necessary before the new product can even be launched bearing the new claim.

Companies are often daunted by costs and timing involved with conducting the necessary clinical studies. But even with smaller budgets, it is possible for companies to conduct meaningful studies in a reasonable timeframe.

There are some good examples of claims on food ingredients backed by solid scientific proof that subsequently grew considerably in market value once the results of these studies became more well known. For example, the recently proven health benefits of cocoa flavanols and catechins have given the functional confectionery industry a new “health story,” so much so that EGCG (epigallocatechin gallate), the main catechin contained in cocoa, is being talked about as a potential new vitamin.

Another example is curcumin, an active component in turmeric, which is one of the spices used in curry. It has many health benefits that have been elucidated by studies over the course of 30 years. During the last few years, many clinical and pre-clinical studies have been done, amassing a large array of data. Among the benefits revealed in these studies are pain relief and reduction of swelling in arthritic joints, as well as the prevention of heart disease, various forms of cancer, Alz­heimer’s, dyspepsia and ulcers. The usefulness of curcumin in the treatment of postoperative inflammations has also been demonstrated.

Cinnamon’s blood sugar lowering effect, too, has good scientific evidence behind it. In fact, several well controlled clinical trials prove the postprandial lowering of glucose response that is the spice’s main health benefit, making cinnamon-cocoa mixes an attractive combination for functional beverages. There are also indications that cinnamon could aid in the treatment of metabolic syndrome.

Also of particular interest to the food and beverages industries are the so-called superfruits whose high antioxidant activity opens the door for health benefits as diverse as the fruits themselves. The many biodiversity-rich areas of the world may still hide the next superfruit and the next proprietary claim for the manufacturer that performs the necessary studies.

Often, such clinical trials are performed in populations of diseased people, which can create a problem, especially since food is intended to be used by healthy individuals or by people at risk for a certain disease. The regulators from the European Food Safety Authority (EFSA) expect companies to perform at least one randomized, placebo-controlled trial in such a population group. But keep in mind that studies in patients with diseases can serve as additional evidence, but would not be accepted by itself for a new claim.

Clinical studies are not only important for substantiating claims, but also for finding and elucidating new activities that can then be made into claims or completely new products. And with the change of attitude on the part of the European Commission, companies can get started on these studies right away.NW