Food Supplements are de jure foodstuffs the purpose of which is to supplement the normal diet. According to Directive 2002/46/EC, food supplements are concentrated sources of nutrients or other substances with a nutritional or physiological effect, alone or in combination, marketed in dose form, designed to be taken in measured small unit quantities. The labelling, presentation, and advertising of food supplements shall not include any mention stating or implying that a balanced and varied diet cannot provide appropriate quantities of nutrients in general. Accordingly, the labelling, presentation, and advertising must not attribute to food supplements the property of preventing, treating, or curing a human disease or refer to such properties. Preventing, treating, or curing human disease is subject to medicinal products.
As they are usually marketed in dose forms as well and in several cases contain low-dosed drugs, delimitation questions occur frequently.
Hence the issue, whether some of these products are to be classified as medicinal products and how they are to be differentiated.
Subsequently, we would like to introduce the basic requirements to put those food supplements legally on the market.