Food supplements are in high demand in Germany. A 2021 survey commissioned by the consumer centers shows that more and more people are consuming dietary supplements on a regular basis. Just under half of those surveyed had bought one or more dietary supplements in the last six months. However, many consumers are often not really clear what NEMs actually are or what they are NOT. Therefore, I would like to briefly discuss this in my article, as well as the distinction from pharmaceuticals and medical products, in order to make the benefits that food supplements have for the consumer clearer.
Intended Purpose
First of all, the different purposes must be taken into account. Food supplements belong to the group of foodstuffs and, as the term suggests, serve to supplement the diet of healthy individuals.
In contrast, drugs are intended to cure, alleviate or prevent disease. They are administered to correct physiological functions through a pharmacological, i.e. interaction of the ingredient with cellular structures of the human body, immunological or metabolic action.
Medical devices, on the other hand, have a medical purpose just like drugs and are also intended for use in humans. However, the main effect of a medical device must always be physical, i.e. precisely not pharmacological, immunological or metabolic as in the case of the previously mentioned medicinal products.
While food supplements have a completely different purpose than medicinal products or medical devices, the latter are in an exclusive relationship to each other due to their main effect.
Relevant regulations
From a legal point of view, food supplements are "normal" foodstuffs, which is why general food law applies to them. In addition to this, a regulation has been issued by the legislator for food supplements, which lays down additional rules for them (NemV).
Pharmaceuticals potentially entail great risks for the consumer. Accordingly, pharmaceutical law (in particular the Medicines Act and the pharmacopoeias) has an extraordinarily high regulatory density in order to protect patients. The provisions relevant to medical devices are found at the EU level; the European legislator has conclusively regulated medical device law through the so-called Medical Device Regulation (MDR).
Placing on the market
Since food supplements are only intended to supplement the diet of a healthy person (cf. intended purpose above), the requirements for marketing are designed to be low-threshold. The respective products are notified to the Federal Institute for Consumer Protection and Food Safety. There is no obligation to test the products before they are placed on the market.
Medicinal products are approved by the Federal Institute for Drugs and Medical Devices after successfully passing the testing procedure. Alternatively, the testing can also be carried out by the European Central Authority.
In the case of medical devices, no government approval is required for placing them on the market. The manufacturer is responsible for quality, efficacy and safety. He ensures this by means of a so-called
Conformity assessment.
Efficacy and safetyt
There is no obligation for manufacturers of food supplements to submit proof of efficacy or safety when registering with the BVL. The manufacturer is therefore always responsible for the safety of a food supplement.
In the case of pharmaceuticals, on the other hand, the manufacturer must submit clinical studies in the approval process that prove the efficacy and safety of the drug.
For medical devices, the classification according to MDR must first be distinguished. There are three classes (Class I, Class II and Class III). Class II also has two subclasses (Class IIa & Class IIb). These classes reflect the potential hazard to the user. While products that fall into Class I are largely considered harmless by the legislator, Class III products have a significant hazard potential. Consequently, the classes are, in ascending order, potentially more dangerous or more demanding in their application for the user. This has also been reflected in the safety requirements for the individual classes.
In the case of class I, the manufacturer himself guarantees the safety of the product by issuing the declaration of conformity, since the product poses a low risk. For the other classes, the conformity assessment is carried out by a so-called notified body (e.g. TÜV SÜD). However, the risk classification always lies with the manufacturer. No clinical studies are required, as is the case with pharmaceuticals.
Closing thought
Food supplements are for the healthy consumer to supplement the diet, compensate for possible deficiencies and thus optimize, strengthen or protect themselves.
