Nutraceuticals: opening the debate for a regulatory framework.

Area of Science:

• Food Science
• Pharmacology
• Regulatory Science

Background:

• Nutraceuticals are food-derived products with potential health benefits, often lacking distinct definitions from supplements or functional foods.
• Existing research explores active components in food for health improvement, but clear substantiation is often missing.
• Nutraceuticals are increasingly viewed as 'pharma-foods' bridging diet and pharmaceuticals for disease prevention and management.

Purpose of the Study:

• To highlight the absence of a universally accepted definition for nutraceuticals.
• To emphasize the need for clear regulatory guidelines and scientific substantiation for health claims.
• To address the challenges in safety and efficacy assessment due to the ambiguity of nutraceuticals.

Main Methods:

• Literature review on the definition and regulation of nutraceuticals.
• Analysis of the current scientific understanding of active food components.
• Examination of the gap between claimed benefits and required evidence (in vitro, in vivo, clinical data).

Main Results:

• Nutraceuticals currently lack a specific, distinct definition, causing confusion with other food categories.
• A significant gap exists between the potential health benefits of nutraceuticals and the availability of robust safety and efficacy data.
• International regulatory differences pose challenges for nutraceutical market access and health claim substantiation.

Conclusions:

• An unequivocal definition and shared regulations for nutraceuticals are urgently needed.
• Assessing the safety, mechanism of action, and efficacy of nutraceuticals through clinical data is essential.
• Clearer scientific and regulatory frameworks are required to manage the growing demand and challenges in the nutraceutical sector.