“From now on, these are the only health claims that can be used by any manufacturer whose product fulfills the prerequisites defined by EFSA.” says Dr. Iris Hardewig, nutrition specialist and Head of Medical Writing / Regulatory & Scientific Consulting at ICRC-Weyer GmbH. “Most acknowledged claims refer to vitamins and minerals and their beneficial health effects on the human body. However, thousands of health claims have been rejected by the European Food Safety Authority (EFSA) in the process.”
Experts have been speculating as to what impact this will have on the industry, since all these claims will have to disappear from product labels after a transition period of 6 months. While products with ingredients that are well-known to the consumer may survive without health claims (such as probiotic yoghurts), innovative products with less known ingredients may vanish from the European market as it will become impossible for many manufacturers to prove health benefits through costly research and development.
“The outcome of this process will most likely mean the market for dietary supplements and functional foods in Europe being shaken to its core.” says Dr. Hardewig. “Only a few products will prevail and the big challenge for manufacturing companies will be to demonstrate the health effects of their products by conducting clinical trials.”
Since EFSA has published several guidelines on clinical data for many indications, such as weight management, healthy blood glucose levels and immune health, the requirements are now more clearly defined. This creates opportunities for European contract research organizations (CRO), but only few have the relevant expertise and actually provide services for both pharmaceutical and health claim studies.
Being one of these CROs, ICRC-Weyer GmbH is able to conduct trials which are tailor-made for dietary supplements and the intended claims. The delivery of clinically proven data by ICRC-Weyer GmbH on these claims will drastically improve chances for a product to obtain approval by EFSA and will enable dietary supplements providers to offer products in Europe, which will legally carry truthful and non-misleading health claims.
The global market for dietary supplements and functional foods has been showing steady growth and is expected to double in size over the next five years. As a result, a significant number of large pharmaceutical companies have acquired providers of dietary food supplements or have even developed their own brands. The global players of the pharmaceutical industry hold large portfolios of dietary supplement products, ranging from vitamins and fiber to minerals and fatty acids. Most of the products in the market claim to support the structure or function of the human body in different ways – but there is limited clinical proof as to whether these claims are accurate and reliable. With the Health Claim Regulation (EC 1924/2006) of the European Parliament coming into full effect now, it will be uncertain as to what will happen to products with untruthful or misleading health claims.
# # #
ICRC-Weyer GmbH is a German contract research organization providing data management, biometrics and medical writing for phase I-IV clinical trials and expert scientific consulting.