Nutraceutical is a market in which companies must constantly innovate, and this is this innovation that drives the market and creates the dynamic for growth. The upstream of the value chain in dietary supplement development is conscious that cost is an important criterion for formulators, and in the past, this parameter probably led to poor ingredient development, to the detriment of science-based and thoughtful bioactive dosage. More than considering the dosage by itself as a parameter of formulation, the cornerstone of successful development is the understanding of an ingredient, from its mechanism of action to the demonstration of the causal relationship between a dose and an effect. The dosage of botanical extracts in food supplements must be considered in the context of nutrition and in line with the health benefits expected. The nutritional approach in food supplements must ensure a level of safety that relies on the level of bioactive ingestion and the cross-exposure more than on the business model besides the ingredient.

Clinical trials have become the standard to justify the health benefits of botanical ingredients. The characterization of the extracts is crucial, and so is the understanding of the metabolization of the bioactive within the organism, which is necessary to properly design further clinical interventions. The number of volunteers and the duration of the trials mainly depend on the type of outcomes and health benefits expected. Moreover, the length of clinical interventions may rely on the biological/physiological functions and their up/down regulation potentials. The latest must be considered as identified risk factors for health conditions and, accordingly, mainly concern people at risk but otherwise healthy.

The nutraceutical application should require a deep characterization of the ingredient including the pharmacokinetics and the bioavailability evaluations for its bioactive. It also should require determining a strong rationale strengthened with an understanding of the mechanism of action and a demonstration of efficacy during clinical interventions that are properly designed and appropriately controlled for confounding factors.

For medical nutrition, it is strongly important to demonstrate the nutritional value of botanical bioactive to justify their role in rebalancing the dyshomeostasis occurring in disease development. Unfortunately, so far, most of the bioactive from botanical extracts are still not considered by health/regulatory authorities as nutrients; there is room to bring some of them to a nutritional level in the coming decades and it is a challenge our company is aiming at on polyphenols.

The main role of botanicals is to recover biological and physiological homeostasis which can be implicated in obesity, cardiovascular health, general wellbeing etc. as many examples from the scientific literature highlight applications in these fields. The real question when formulating should focus on given health benefits and the understanding of the most efficient mechanisms to reach them. Most mechanisms will rely on inflammatory homeostasis, oxidative stress, endothelial function, immune modulation, and microbiota metabolism, all directly or indirectly linked to the above categories.