Although nutraceuticals has been a recognized and studied discipline for nearly forty years, a significant regulatory gap persists. Current legislation does not clearly distinguish between food supplements and nutraceuticals. This lack of distinction compromises the recognition of the quality and specificity of nutraceuticals as functional products.

It is urgent to define clear guidelines and specific requirements for these products. This includes, for example, the need to establish the type of preclinical and clinical studies required to demonstrate mechanism of action and efficacy.

A robust regulatory framework and the introduction of the concept of "evidence-based nutraceuticals" would not only enhance the industry's reputation and credibility, but would also create barriers to entry, favoring companies that strongly believe in and invest in research and development, research, and quality.

Europe is characterized by regulatory inconsistency that limits the market and requires EU-wide harmonization. The growing scientific and commercial maturity of the sector, combined with the absence of a specific regulatory framework, create a unique opportunity for Italy to assume a European leadership position in a sector with high growth potential.

It is essential to act promptly. The implementation of dedicated regulations for nutraceuticals is not only a technical necessity, but a strategic choice that can generate significant benefits for the national economy, public health, and Italy's competitive positioning in international markets.

This is the statement made by Dr. Valeria Curti, R&D, Quality, Medical, and Regulatory Manager at Kolinpharma S.p.A., at the conference "Patient Access from Journey to System," organized by Bhave on July 17th  in Rome at Palazzo Giustiniani – Senate of the Republic.