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Behavioral Disturbances: An Innovative Approach to Monitor the Modulatory Effects of a Nutraceutical Diet
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Nutraceuticals: opening the debate for a regulatory framework.

Antonello Santini1, Silvia Miriam Cammarata2, Giacomo Capone2

  • 1Department of Pharmacy, University of Napoli Federico II, Via D. Montesano, 49 -, 80131, Naples, Italy.

British Journal of Clinical Pharmacology
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Summary

Nutraceuticals lack a clear definition and regulatory framework, leading to unsubstantiated health claims. Establishing a precise definition and requiring clinical data are crucial for safety and efficacy in this growing pharma-food sector.

Keywords:
claimshealthlabelsnutraceuticalsregulationregulatory

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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.