Adverse effects to plant food supplements

Products containing botanical ingredients are widely accepted by consumers and are increasingly part of the daily dietary habits in Europe. Products with vegetable ingredients or their derivatives (botanicals) fall into various categories, which can be regulated differently in among countries, including those belonging to the European Community. Most European countries classify products containing botanicals as food supplements (Plant Food Supplements or PFS) that, commercialized in pharmaceutical form (capsules, tablets, drops, etc.), intend to improve the daily intake of nutritional or functional substances. They should not be considered as a substitute of healthy diet and lifestyle approach. In the last decades, Plant Food Supplements have received an increasing interest by consumers for their possible beneficial effects but, in parallel, concerns have been raised by international bodies responsible for consumers\u2019 safety. The quality of a food product is always important for consumers\u2019 safety. Supplements containing botanicals, being mainly classified as food, must comply with the legislation of the sector in terms of production and control. Since the botanicals are ingredients of plant origin, the problem of residues of environmental contaminants is of particular importance. To minimize the risks for the consumers, farmers must follow the rules of good agricultural practices (GAP) for the use of pesticides and fertilizers or adapt to the legislation for organic farming. Among other parameters, the quality of final PFS includes the content in those active compounds, which are responsible for the desired physiological effect. The quality of PFS can be regulated by national/international limits for both active molecules and/or other undesired compounds having toxicological concerns. Table 1 lists the most important problems, associated with the raw botanical material, having a possible role on consumers\u2019 safety; some of them are not intentional, other come from illicit activities. Adverse effects to PFS can be due to different problems, where quality is only one of the most important contributors. Very important is the information provided both to the general population and to group at risk: consumers must know that botanical ingredients could be responsible for adverse events. Pregnant or lactating women, as well as children, should avoid the use of products with plant derivatives apart from those products specifically formulated and, in any case, recommended by a medical doctor. Particular attention must then be given to consumers suffering from food-related diseases, such as celiac disease and allergy. \u201cSocial cofactors\u201d can also contribute to the onset of an adverse event as described in Table 2.The most critical issues, relating to adverse events, lie in the fact that the average consumer considers the \u201cnatural\u201d safe and therefore does not consider botanical products as a possible source of discomfort; furthermore, it rarely tells the doctor to use it in the case of short or long term therapy. On these bases, to reply to the EU concerns on PFS safety, an important gathering of information was carried out during and after the period of the European research project PlantLIBRA. Risk associated with PFS consumption, was analyzed collecting information from different sources: 1) critical review of the adverse effects reported in the scientific literature (case reports and human clinical studies); 2) retrospective study involving several European and a Brasilian Poison Centers; 3) assessment of adverse effects self-reported by people participating to the PlantLIBRA PFS consumer survey. 4) collection of adverse effects made available by the Pavia Poison Centre (after the end of the EU Project), ANSES and FDA. According to PlantLIBRA results and the new collected data, Valeriana officinalis and Camellia sinensis were the most frequently cited in Europe for their role in adverse effects. Data from FDA listed Silybum marianum and Serenoa repens in the corresponding first positions. Although most case reports showed minor symptomatology, some severe events occurred, including fatalities. Symptoms involved mainly liver, gastrointestinal and nervous systems. The evaluation of the whole data confirmed that some plants are more frequently involved in adverse effects than others with a certain difference between continents. These data are very important for family doctors and other health professionals to become aware about the possible consequences of the increasing use of food supplements containing botanicals. This information is also necessary to educate the public to prevent an unsuitable use of PFS and the possible associated adverse events