The need of nutrients to balance our physiological conditions is growing worldwide. Recently, the global market for food supplements has been quoted for 2022 around 145 billion euros with an annual growth of more than 8% and the recent pandemic situation, which has led to a greater focus on health and well-being, has contributed to the increase in market volume. Moreover, food supplements are intended to maintain an adequate intake of certain nutrients or support specific physiological functions. Particular conditions, such as nutrients deficiencies are more likely to affect specific population groups with greater requirements or inadequate intakes. In this scenario, elderlies, frail subjects and even people following particular dietary behaviors (i.e., vegetarians or vegans) are exposed to the risk of inadequate coverage of nutritional requirements and the use of food supplements may be warranted following healthcare professionals’ recommendation.

Food ingredient conferring health properties may consist of the plants themselves, extracts thereof, or more purified components. Companies are well aware that the quantitative demand on food supplements and nutrients is strictly link to a qualitative consumer’s need, who is oriented to the search for effective and safe botanical products, as well as environmental sustainability. If within the wide range of products offered in the market of food supplements we focus only on plant extracts (botanicals), this awareness takes on greater significance. Quality of botanicals ingredients comprises a continuous monitoring on all the phases involved, starting from the idea of development, through the selection of the plant source, procurement of raw material, standardization of the production process, biological effectiveness and safety characterization up to the positioning on the market. Ensuring quality in all these operations requires also teamwork and last but not least, to reconcile everything with the available budget and a sustainable consumer price.

Focusing only on the aspect of effectiveness, those involved in the early development of a product must take into account on the one hand scientific evidence, indicating the minimum effective dosages, and on the other hand the safety requirements that sometimes direct towards lower dosages. The result should always be born, therefore, from the comparison between the data obtained from pre-clinical and clinical studies and the current regulations.

The scientific literature is abundant with articles not only on the beneficial properties, but also on possible adverse health effects of plants and their components, mostly related to dosages. An accurate food supplement development finally is linked to quality assessment of the finished product and requires the determination of the safe use providing advice on the development of risk assessment strategies consistent with due diligence under existing food regulations. Product specifications, composition and characterization of standardized food supplements and authentic materials, documented history of use, description of the intended use and consequent exposure are highlighted as key background information on which a risk evaluation should be based.

In particular, for botanical products incremental innovation arises from a careful case-by-case approach, and it should follow a thorough process that involves the development of the following topics:

1. Analysis of traditional uses and human consumption through the review of epidemiological studies and bibliographical sources
2. Identification of the correct quantities and traditional use
3. Selection of the appropriate botanical source, with the control on its quality and environmental sustainability
4. Development of cost-effective production processes suitable for the health food field
5. Application of food-grade formulations that may even enhance their effectiveness also through the optimization of biological absorption with natural delivery systems such as phytosomes
6. Verification of safety and tolerability with validated toxicological tests
7. Identification of Biological Mode of Action hypothesis, with in targeted in vitro assays
8. Selection of the health fields of application
9. Exploration not of the minimum and maximum effective doses, but of the "best" dose for biological effectiveness with no safety issue in borderline subjects
10. Context plausible cost of good (COG) assessment

Focusing on “the best dose” correlated to cost restrictions and safety requirements, new botanicals products can be predicted allowing companies to find the right compromise between market demand and “product sustainability”.