The New World of Claims

Science can take a product from substantiation to meaningful market application.

By Joerg Gruenwald

For drug registration, clinical trials proving safety and efficacy have long been a primary requirement. However, many botanical products such as ginkgo biloba, valerian and ginseng are also based on solid clinical data proving the effectiveness of these products in placebo-controlled, double-blind studies.

Increasingly, regulators around the world are requesting proof of efficacy, not only for drugs, but also for dietary supplements and functional foods in order to be able to make claims for these products.

In Europe a new Food Labeling Directive has passed and will be implemented in the near future. It will require scientific proof of efficacy for individual food ingredients or food products, including dietary supplements.

There are basically three different forms of claims. The well-established and scientifically proven claims will be compiled into long lists that can then be used by all producers. But there are also two options that will help companies differentiate themselves on the claims front. These include “risk-reduction” claims and “innovative” claims. To be able to use a risk-reduction claim, at least one solid, placebo-controlled, double-blind study is required in a group of healthy volunteers that have an elevated risk for a specific disease, e.g. elevated cholesterol or blood pressure values, which are not yet high enough to require drug treatment. If in such population groups a food product is able to reduce the risk factor significantly in comparison to placebo, a company can file an application to receive the rights to use a specific risk-reduction claim, or a completely new innovative claim, which must also be proven clinically. Most of the multinational food and food ingredient companies are already preparing for the new legislation by initiating appropriate clinical trials in order to comply with the future requirements in Europe.

The Market Application of
Clinical Data

Regulatory requirements aside, clinical studies are important when proving new or traditionally known but unsubstantiated effects in natural products.

For example, the carotenoid lycopene, responsible for the red color of tomatoes, pink grapefruit and watermelon, was first linked to human health in the mid-1990s, when epidemiological studies found properties useful in the prevention of cardiovascular disease and cancers of the prostate or gastrointestinal tract. At the time, lycopene’s antioxidant properties were also known, but the lack of controlled clinical studies meant that these results were merely “strongly suggestive” for these health benefits. This changed when the first clinically derived data demonstrated that lycopene might not only prevent prostate cancer, but also have therapeutic effects. Just this year, a review in the European Journal of Clinical Nutrition of all clinical trials on the health benefits of lycopene came to the conclusion that consumption of processed tomato products, containing lycopene, is of significant health benefit and can be attributed to a combination of naturally occurring nutrients in tomatoes, and that lycopene, the main tomato carotenoid, contributes to this effect. Lycopene’s specific role, however, must to be investigated further.

The results of these clinical trials were of significant importance for the food supplement industry, which gained a new story, and also for relevant players in the food industry who could now claim that tomato ket-chup is good for you, while backing this claim with solid scientific evidence.

Curcumin, one of the active components of turmeric, which, in turn, is one of the spices used in curry, has many health benefits that have been elucidated by studies over the course of 30 years. During the last few years, however, many clinical and pre-clinical studies have been conducted, resulting in the compilation of a large amount of data. Some of the health benefits include 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. These clinically proven effects support curcumin’s centuries of traditional usage.

The antioxidants contained in a cup of cocoa, among them flavanols and polyphenols, have recently been proven to be more effective than antioxidants contained in a cup of green tea or glass of red wine. These results, together with others show-ing people who eat moderate a-mounts of dark chocolate live longer than others who don’t, support traditional views of the cocoa bean as a “food of the gods” in Aztec culture and have given the chocolate industry a “healthy” story.

All of these examples demonstrate the necessity for clinical studies not only in substantiating claims, but also for finding and elucidating new activities that can shape new claims or completely new products. NW