Beyond Labels: Nutrivigilance, an Emerging Frontier and a New Activity in Drug Safety

Adverse drug reactions are unintended and harmful effects that occur at normal therapeutic doses. While pharmacovigilance systems are well established for conventional medicines, the increasing global use of nutraceuticals, including dietary supplements, herbal products, and functional foods, has raised significant safety concerns. These products are often perceived as inherently safe due to their natural origin and are frequently consumed without medical supervision. This review highlights the emerging concept of nutrivigilance as a critical extension of pharmacovigilance aimed at monitoring adverse effects associated with nutraceuticals. The analysis of available literature indicates substantial gaps in consumer awareness, widespread self-medication practices, and significant underreporting of adverse events related to nutraceutical use. Common adverse effects identified range from gastrointestinal disturbances and dermatological reactions to neurological and metabolic complications. Furthermore, the review identifies limitations in existing regulatory frameworks, particularly in post-marketing surveillance and standardization of nutraceutical products across different countries. The findings emphasize the urgent need for improved regulatory policies, enhanced awareness among healthcare professionals and consumers, and the establishment of robust reporting systems to ensure the safe and rational use of nutraceuticals. Nutrivigilance thus plays a vital role in bridging the gap between consumer practices and regulatory oversight, ultimately contributing to improved public health safety.