The increasing use of natural products in food, cosmetics and in therapy has necessitated the regulation of this sector. The general trend is that of viewing the products of herbal origin, including so-called herbal medicines, as harmless since they are natural, and to use them as self-medication without consulting a doctor.
However, products based on plants can also present serious health risks, both for possible interactions with synthetic drugs taken concomitantly as well as for their quality (e.g. for the presence of residues of phytopharmaceuticles, herbicides and heavy metals) in addition to consumer hypersensitivity. To address the need for monitoring these products and the identification of potential risks associated with the use of natural products, since 2002 there has been a phytovigilance and natural substances surveillance system, which collects spontaneous reports of suspected adverse reactions arising after the intake and / or administration of the products used in “natural medicine” such as vitamins and minerals, dietary supplements, herbal products, homeopathic products (according to the Legislative Decree 219/2006), products of exotic origin, such as those of traditional Chinese medicine and Ayurvedic medicine, probiotics and other products, such as amino acids.
The system involves the participation of the ISS, the AIFA and the Ministry of Health and provides for the intensification of surveillance and control in order to ensure greater safety in the use of these products.
Di Renzo Regulatory Affairs offers a personalized service of post marketing phytovigilance for companies with supplements, herbal products and foods. We are also able to perform toxicological evaluations of herbal ingredients and food products.