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Nutrivigilance: the road less traveled

Summary

This paper discusses nutrivigilance, which is the monitoring of side effects from dietary supplements and health products. Unlike medicines, dietary supplements in the US don’t need approval before being sold to consumers. The paper explains what nutraceuticals are, how they’re classified, and the different ways the US and Europe try to keep track of harmful effects. The authors argue that better systems are needed, including more reporting from consumers and better communication between companies, regulators, and healthcare providers.

Background

Nutrivigilance is a system for monitoring adverse effects related to dietary supplements, functional foods, and nutraceuticals. Unlike pharmaceuticals which require pre-market approval, dietary supplements in the US and many in Europe can be marketed without prior safety evaluation. There is growing interest in establishing comprehensive nutrivigilance systems in both the US and Europe.

Objective

This review examines the current state of nutrivigilance in the United States and Europe, discusses the regulatory differences between regions, and analyzes the challenges and opportunities for improving nutrivigilance systems to better protect consumers from adverse effects of nutraceutical products.

Results

The FDA in the US relies on post-market enforcement without pre-market approval authority for dietary supplements. In Europe, only seven countries have established national nutrivigilance systems. Both regions lack comprehensive harmonized approaches, with manufacturers bearing primary reporting responsibility despite inherent conflicts of interest.

Conclusion

Effective nutrivigilance requires fully committed national surveillance systems, consumer awareness of reporting mechanisms, and collaboration between regulatory authorities, healthcare providers, patients, and manufacturers. Education and public health campaigns are essential to increase awareness of adverse event reporting and rational use of nutraceuticals.
  • Published in:Frontiers in Pharmacology,
  • Study Type:Review,
  • Source: PMID: 37886131
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