At a time when consumers are increasingly aware and demanding, proving that the quality of a food supplement is certified is not only a guarantee of transparency, but also a true competitive advantage.

Clinical testing of food supplements

Conducting clinical studies is essential for providing scientific evidence for relating cause-and-effect with expected benefits. The “trial” process for food supplements is very different compared to medicine trials.

Supplements are food products and, as such, have no therapeutic, prevention or treatment properties, so it is not necessary for each product to be scientifically tested. The purpose of food supplements is to correct nutritional deficiencies, maintain an adequate intake of certain nutrients or support specific physiological functions.

Is clinical testing necessary for food supplements?

Clinical studies proving true efficacy are not legally required for marketing a food supplement. This is because these products contain ingredients that have already been approved by the Regulatory Bodies as listed, for example, in Regulation (EU) 2015/2283.

So why carry out a clinical validation study for a food supplement and not market it directly? Assessing the true effectiveness of a supplement is very important to guarantee real benefits for the consumer. Even if the ingredients used in the formulation are known to perform specific biological actions, it is not obvious that their combined use leads to the desired effects. This is particularly true if the aim is to achieve synergistic and harmonious effects. Therefore, conducting a clinical study is necessary to prove that the rationally designed formula is actually effective and it can truly benefit the consumer. This is especially important if we bear in mind that, as mentioned above, consumers are becoming more and more informed and demanding.

How a clinical trial works: phases and procedure

As previously said, clinical trials are not required when a new supplement is produced.

Unlike medicinal products, food supplements are tested in a clinical study directly in humans, after approval by ethics committees and regulatory authorities, using formulas containing already approved ingredients. The goal is to test the product and ensure its real effectiveness, either taken alone or in combination with other drugs.

Supplements that can be placed on the market must be produced with substances permitted by law: the vitamins and minerals listed in Regulation (EC) No 1170/2009, the botanicals listed in Annex 1 to the Ministerial Decree of 10 August 2018, the probiotics as per Ministry of Health guidelines and other nutrients and substances with a nutritional or physiological effect1.

Trials are an essential component in proving the health claims on food labels, including the labels of food supplements. If conducted in the right way, these studies provide a high level of scientific evidence in cause-and-effect relations.

How can consumers understand the quality of a supplement?

How to understand if a supplement is a quality product

Most companies in the sector offer supplements without assessing the effectiveness of the final formula and without obtaining certification. This means that there are many marketed products that contain authorised ingredients but whose real effectiveness is unknown.

Cor.Con. International stands out from other companies because it tests its products for effectiveness before marketing and only makes them available for purchase if the trial results are positive. Clinical efficacy studies on our food supplements can be found in industry-leading scientific publications, making the product claims even more reliable.