Ministry of Health conference on food supplements: correct definition of the regulating framework for a strong growing sector
The conference “Food supplements in the current regulating framework” was held on 16 July at the Auditorium of the Ministry of Health (MoH) and attended by several companies. The day was organised by the General Direction for hygiene and safety of food and nutrition, and it was divided in two main sessions: the first on the allowed ingredients and the role of food supplements, and the second in quality, safety and efficacy of these products.
The conference was opened by an interesting speech of Dr Bruno Scarpa who addressed the current technical and regulating framework of food supplements, presenting their strong points and their critical issues. After him, professionals from the Higher Health Institute (ISS) and academics and doctors presented their speeches.
The unrestrained increase of the sales volume of food supplements, that in Italy was 3.3 billion euros in 2018 (mostly due to the increasing demand from consumers), requires a greater knowledge of the use of these products and of the norms regulating them by manufacturers as well as prescribers.
The hope is that the growing health expenditure by consumers generates positive outcomes on the sustainability of the National Health System.
Food supplements fall into the frame of a wider regulation regarding food, however it is not possible to reduce their role to the simple integration of nutrients in the ordinary diet. In order to avoid misleading effects on consumers and health professionals, it is necessary to clearly define the physiologic effect that supplements can exert. In fact, it is not allowed to attribute any therapeutic purpose to these products. This is an exclusive prerogative of medicinal products. On the other hand, food supplements are defined and should be considered as concentrated sources of nutritional substances that can favour the homeostatic balance of the body functions or reduce disease risk factors. They should therefore be intended only for healthy or conventionally subjects presenting a certain disease risk factor. In view of disease prevention and maintenance of good health, food business operators marketing food supplements should propose quality products, both in terms of safety and efficacy on the maintenance of the normal homeostatic condition. In order to assess the safety and properties of these products, clinical trials are also possible according to the Ministry of Health guidelines.
Without prejudice to the responsibility of the food business operator for the quality and safety of food supplements, the Ministry has the task of providing all tools required to comply with the regulations.
From the point of view of health protection, during the conference the Ministry of Health appeared to be well ahead of other Member States. In these years, the MoH drafted communications and guidelines on specific ingredients used in supplements, such a probiotics, botanicals, and other substances, for which the wide European food legislation is not still very clear. In particular, it was stressed again that for botanicals it is important to look for the traditional use of the plant and extract to be employed. Any change in the extraction process involving, for instance, a variation in the “natural” composition of the substance of herbal origin could move this ingredient to the category of the novel foods.
As for the control of the manufacturing, during the day it was underlined that even of Italian manufacturing site operating in the food sector are acknowledged at regional level, the MoH maintains interrelations with the Regions, monitoring and assessing any reports of non compliance. On this regard, it is possible to refer to the ministry guidelines on the good manufacturing practice of food products.
For a wider control of the safety of the Italian market, the new online system was presented for the reports of plant vigilance, “VigiErbe”, already implemented in December 2018 by the MoH, ISS and AIFA thanks to a collaboration with the University of Verona.
During the final debate, many companies asked for updates on the current situation of the reports of adverse events following the intake of food supplements containing curcuma.
The MoH explained that the assessment has not been completed yet, however a new warning should be soon implemented on the label to avoid new cases.
The conference pointed out many issues and criticalities for a market under steady growth. There is still much to do to fill in some gaps due to the wide and varied field of application of the food regulations, but with the cooperation of all stakeholders involved and of the Authorities it will be possible to reach the main goal, i.e. ensure the presence of effective and safe food supplements on the market, for the maintenance of the good health of the healthy population.
Written by: Giorgia Martini
