Products
Dietary supplements are commercially available in dosed form, for example, as tablets, capsules, liquids and as powders, and are labeled accordingly on the packaging. They are sold not only in pharmacies and drugstores, but also without advice in supermarkets or online stores.
Definition
Dietary supplements are regulated by law in many countries by the FDHA Ordinance on Food Supplements (VNem). They are defined as follows: “Food supplements are foodstuffs intended to supplement the normal diet. They consist of single or multiple concentrates of vitamins, minerals or other substances with a nutritional or physiological effect and are marketed in dosed form.”
Ingredients (examples)
The following list shows a selection of substances that may be contained in dietary supplements:
- Vitamins, e.g. vitamin A, vitamin B complex, vitamin C, vitamin D, vitamin K.
- Minerals and trace elements, e.g. calcium, iron, magnesium, zinc, copper, silicon.
- Amino acids, e.g. lysine, methionine, cysteine; taurine.
- Alkaline salts
- Coenzyme Q10
- Carotenoids: lutein, lycopene, zeaxanthin
- Glucosamine, chondroitin sulfate
- Enyzme: lactase
- Methylxanthine: caffeine
- Omega-3 fatty acids: docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA).
- Omega-6 fatty acids: linoleic acid
- Probiotics: Lactobacilli
- Creatine, carnitine, inositol
- Methylsulfonylmethane (MSM)
- Betaine, choline
- Hesperidin, isoflavones, catechins, epigallocatechin gallate.
Which substances are allowed, is defined by the ordinance of the FDHA on food supplements.
Fields of application
Food supplements are taken for an adequate supply of nutrients, for the improvement of health, for the promotion of physical and mental performance, for the prevention of deficiencies, and additionally for the prevention and treatment of diseases.
Dosage
The maximum allowable amounts are set by the VNem. For example, products containing magnesium may contain a maximum of 375 mg of the mineral per unit. For medicinal products, the dose may be higher, such as iron tablets for the treatment of iron deficiency.
Health claims.
Health claims on food supplements are regulated in detail and strictly by the EDI Ordinance on Food Information (LIV). Example iron: “Iron contributes to the normal formation of red blood cells and hemoglobin. Iron contributes to the reduction of fatigue and tiredness.” Health claims not listed in the regulation’s annex require authorization.
Patient information
Dietary supplements do not contain patient information, and no SmPC is available. Therefore, they convey only brief and incomplete information on properties, effects, interactions, contraindications, and adverse effects. Health claims and brief warnings are printed on the packaging. For example, in the case of vitamin K, attention is drawn to a possible interaction with anticoagulants.
Differentiation from pharmaceuticals
Dietary supplements are legally classified as foods and are primarily intended to supplement the diet. Women take folic acid to ensure adequate supply in case of pregnancy. Vitamin B12 is important for vegans because it is mainly found in animal products. Dietary supplements are not drugs or medical devices, and they may not be advertised as cures. Some products are on the borderline between dietary and medicinal products and there is overlap. Cough syrups with plant extracts, vitamins and minerals are taken for a cold cough, cannabidiol as a sedative. In fact, these are therapeutic medical uses. A minority of dietary supplements are pharmacologically active. Dietary supplements are also developed and marketed specifically for medicinal purposes. Often, the packaging is modeled on pharmaceuticals. This presentation makes it impossible for customers to understand at first glance that, from a legal point of view, it is not a drug.The market launch is attractive because there is no need for time-consuming registration. There are also numerous substances that are both registered as drugs and marketed as dietary supplements, such as calcium or chondroitin sulfate.
