Food supplements currently play a crucial role for people’s health and well-being. For this reason, the quality and safety of these products remains a primary concern for pharmaceutical companies. In this article, we will explore how to assess the quality of a food supplement and what the “certification” of a supplement actually consists in.

How to assess if a food supllement is of good quality

To determine the quality of a dietary supplement, it is essential to consider several factors. The evaluation criteria include:

  • the purity of the components;
  • the absence of contaminants;
  • consistency in production.

A high-quality supplement must be produced according to strict quality control standards, thus ensuring safety and effectiveness.

Clinical trials and efficacy of supplements

Clinical trials for food supplements provide numerous new market opportunities, delivering evidence of health benefits. This allows consumers to distinguish between the many products on the shelves of pharmacies, health retailers and supermarkets.

To date, there are many general and widely used indications in the EU, because Article 13.1 of the EC Regulation on nutrition and health claims made on food of the EFSA allows manufacturers to use a large number of “health claims”, which also cover the content of vitamins and minerals.

It is important to stress that currently, in Europe, it is possible to market supplements that include, among their ingredients, the substances permitted by the law:

  • the vitamins and minerals listed in Regulation (EC) 1170/2009;
  • the botanicals included in Annex 1 of the Italian Ministerial Decree of 10 August 2018;
  • probiotics, as per the Italian Ministry of Health guidelines;
  • other nutrients and substances with a nutritional or physiological effect.

Clinical trials are an essential component in proving the health claims in food labels, including supplements. The studies are therefore useful for scientifically confirming the cause-and-effects claims and develop evidence-based dietary supplements..

National Register of Food Supplements and labelling

In many countries, there is a national register of food supplements. This register is intended to ensure product traceability and provide consumers with a reliable reference to verify that food supplements are safe and legal.

It is important to remember that “Inclusion in the register does NOT constitute consent to the marketing or a declaration of conformity or an express or implicit authorisation. The notification is, in fact, made at the same time as the notification under the responsibility of the notifying FBO.1

In addition, the supplement’s label plays a key role in communicating information to consumers. It must include details such as ingredients, recommended doses and warnings. Accurate and compliant labelling is essential to ensure that consumers are fully informed of the nature and quality of the product they are buying.

For pharmaceutical companies, ensuring that their products comply with these standards is not only a matter of regulatory compliance, but also a way to build trust and credibility in the market.


References

1.         https://www.salute.gov.it/portale/temi/p2_6.jsp?id=3668&area=Alimenti%20particolari%20e%20integratori&menu=regi