IRENE WOHLFAHRT
Analyze & realize GmbH, Berlin, Germany

Abstract

Clinical trials for natural extracts pose their own issues compared to trials for single substances. A clever trial design taking all these issues into account is required in order to measure the small effect sizes that can be expected, and to convert them into meaningful and clinically relevant health benefits. However, due to the fact that authorized health claims on natural extracts are valuable USPs for ingredient manufacturers, it is definitely worth the time and money to invest in a clinical trial.

INTRODUCTION

Extract manufacturers providing raw materials to the food industry have several ways of establishing USPs for their products. These ways involve either exceptional quality (purity, batch-to-batch consistency, high concentration of active compounds), uniqueness (special blends, rare or novel plant extracts, special extraction methods), or proven efficacy for a food-specific health effect. Other USPs are a wide range of possible applications, or superior sensory qualities.

The regulatory environment is rather prohibitive for the first two kinds of USP. A high concentration of active compounds will quickly pose Novel Food issues, at least in Europe. 

The same goes for rare extracts of plants that do not have a sufficiently long or significant history of food use. New extraction methods also have an inherent Novel Food risk. In fact, the only non-technical USP that does not pose a Novel Food risk is proven efficacy.

Since the Nutrition and Health Claims Regulation (NHCR) can also be argued to apply for B2B communication, extract manufacturers should not mak ...