Food supplements: answers to frequently asked questions by consumers
What are food supplements? What are the differences between food supplements and medicinal products? These are just some of the many questions answered here.
- 1. What are food supplements?
- 2. What is the difference between food supplements and medicinal products?
- 3. Who controls compliance with food law provisions?
- 4. Is it safe to order food supplements over the internet?
- 5. Which substances may be added to food supplements?
- 6. Is it true that food supplements with high vitamin dosages help against specific diseases?
- 7. Is it recommended to take food supplements?
- 8. Time and again, there is talk about a decrease in vitamin content of fruit and vegetables and of mineral content in our soils. Is this true?
- 9. As a consumer, where can I find reliable information about food supplements?
1. What are food supplements?
According to § 1 of the Ordinance on Food Supplements (Verordnung über Nahrungsergänzungsmittel), food supplements are foodstuffs
- intended to supplement a normal diet,
- which are concentrated sources of nutrients or other substances with a specific nutritional or physiological effect, alone or in combination, and
- which are marketed in a dosage form, such as capsules, pastilles, tablets, pills and other similar forms, sachets of powder, ampoules of liquids, drop dispensing bottles and other similar forms of liquids and powders designated to be taken in measured small unit quantities.
2. What is the difference between food supplements and medicinal products?
Food supplements are foodstuffs. Therefore, they are subject to the relevant food law provisions. Foodstuffs means any substance or product, whether processed, partially processed or unprocessed, intended to be, or reasonably expected to be ingested by humans. The complete definition can be found under Article 2 of Regulation (EC) No. 178/2002 of the European Parliament and of the Council of 28. January 2002, laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety.
Medicinal products are not foodstuffs. Therefore, it has to be decided on a case-by-case basis whether a product is a food or a medicinal product.
Medicinal products are primarily intended to heal, alleviate, prevent or identify diseases, suffering, physical defects or health disorders, or to influence the condition, state or function of the body or the mental state. They are governed by the provisions of the Medicinal Products Act (Arzneimittelgesetz). Medicinal products are marketable only after being authorised or if a marketing authorisation has been granted by the Commission of the European Community or by the Council of the European Union in accordance with Article 3 (1) or (2) of Regulation (EC) No. 726/2004 of the European Parliament and the Council from 31. March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the evaluation of medicinal products (Official Journal of the EU No. L 136 page 1). Products authorized as medicinal products may not be marketed as foodstuffs.
Accordingly, food supplements must not be labelled as medicinal products or be advertised with claims relating to healing, alleviating or preventing diseases (Prohibition of health-related advertisement, cf. also § 12 Food and Feed Act (Lebensmittel- und Futtermittelgesetzbuch, LFGB)
3. Who controls compliance with food law provisions?
Compliance with food law provisions is monitored by the competent authorities of the Länder. If, after the purchase of a food supplement, consumers have reasonable doubt about its labelling and composition, they may turn to the local competent food supervisory authority (usually the regulatory agency) or to the supreme authority responsible for food monitoring in the respective Land. You will find an overview of the competent Ministries/Senate Departments of the Länder on the website of the Federal Office of Consumer Protection and Food Safety, Bundesamt für Verbraucherschutz und Lebensmittelsicherheit, BVL.
4. Is it safe to order food supplements over the internet?
The relevant food law provisions also apply for food supplements offered on the internet. However, there are repeatedly individual cases of non-marketable food supplements being distributed via the internet.
It is recommended that German consumers pay particular attention when ordering products directly from suppliers from other member states of the European Union or from third countries. If in doubt, consumers should seek expert advice before ordering food supplement products by turning, for example, to local consumer advice centres. Consumers may also refer to the internet portal www.was-wir-essen.de.
5. Which substances may be added to food supplements?
The permitted vitamin and mineral compounds are laid down in Directive 2002/46/EC of the European Parliament and of the Council of 10. June 2002 on the approximation of the laws of the Member States relating to food supplements, which has been transposed into German law with the Ordinance on Food Supplements (Verordnung über Nahrungsergänzungsmittel). On that basis, only the addition of vitamins and minerals in food supplements are currently regulated, the Ordinance does not, however, contains regulations on other substances such as amino acids, essential fatty acids and plant or herb extracts. Products containing such substances must be verified on a case-by-case basis to see whether they comply with the general legal provisions. In Germany, certain substances used for nutritional purposes are treated in the same way as additives. They are therefore subject to prohibition per se subject to the granting of permission, i.e. they may only be used for the production of food if they have been explicitly authorised for the respective purpose through legal provisions.
6. Is it true that food supplements with high vitamin dosages help against specific diseases?
The notion that vitamins are essential for life is uncontested from a scientific point of view. However, there is no sufficient scientific backing for the claim that high-dosage vitamin intake can prevent specific diseases such as cancer or heart attacks and no international studies have confirmed this so far. Instead, such recommendations pose the danger that known risk factors which are conducive to certain diseases and which also have a negative effect in respect of the development of other diseases are not taken into account and that patients go without medical care, believing that high-dosage vitamin intake is sufficient.
In Germany, high-dosage, therapeutical vitamin and mineral packaged products are classified by the supervisory authorities as medicinal products. Their main purpose is to heal, alleviate or prevent diseases, suffering, physical defects or health disorders. As a consequence, such products are primarily of a medicinal nature and are therefore subject to the provisions of the Medicinal Products Act and require authorisation.
7. Is it recommended to take food supplements?
According to the German Nutrition Society (Deutsche Gesellschaft für Ernährung, DGE) and the Federal Institute for Risk Assessment (Bundesinstitut für Risikobewertung, BfR), a diverse, balanced diet covers the daily vitamin and mineral requirements. An unhealthy lifestyle (lack of physical exercise, excessive energy input) cannot be compensated for with vitamins and minerals in food supplements. Only in the case of iodate (iodised salt) and folic acid (particularly for women wanting to have children), sufficient supply with certain nutrients is not always possible through food intake. Here, an additional intake of specific nutrients for a limited period of time and under medical supervision may be appropriate. As a general rule, a balanced diet which includes frequent consumption of fruit and vegetables is always preferable to food supplements.
8. Time and again, there is talk about a decrease in vitamin content of fruit and vegetables and of mineral content in our soils. Is this true?
Such claims are untenable from a scientific point of view. There is no problem of vitamin deficiency in Germany. There is no serious reason to call into question the nutrient content of food of vegetable origin on offer in Germany.
In its 2004 Nutrition Report, the German Nutrition Society (Deutsche Gesellschaft für Ernährung, DGE) concludes that a comparison of nutrient data of selected food of vegetable origin over a period of 50 years shows no decrease in mineral and vitamin concentrations.
Against this backdrop, labels and packaging of food supplements as well as their advertisement must not contain any reference claiming or pretending that a diverse, balanced diet is generally inadequate to supply an appropriate and sufficient nutrient intake. This provision of the Ordinance on Food Supplements is intended to protect consumers against deception and deceit, caused for example by wrong promises in claims for food.
9. As a consumer, where can I find reliable information about food supplements?
A wide variety of information about food and food supplements are available on the internet. For example, www.was-wir-essen.de is an internet portal supported by the Federal Ministry of Food and Agriculture (BMEL) and set up by the aid infodienst where consumers can, among other things, gather information about nutrition, food and food supplements free of charge. They can also address specific questions to independent food experts. Personal information on this topic is also available from the local consumer advice centres.