Frequently Asked Questions on Food Supplements
BfR FAQs, 1 February 2008
The growing use of vitamins, minerals, trace elements and other substances in food supplements which are offered for sale as capsules, tablets, powders or in liquid form as foods to supplement a normal diet, constitutes a challenge for consumer protection. Consumers must be protected not only from possible health risks but also from misleading information. Given the wide and steadily growing offering and the increasing distribution of food supplements on the internet, BfR has put together answers to frequently asked questions on this subject.
Questions
- What are food supplements?
- Which substances and what amounts of these substances may be added to food supplements?
- How does one recognise food supplements?
- Do food supplements in Germany require approval?
- Under what circumstances may food supplements, which do not comply with German food law provisions, be placed on the market?
- How safe are food supplements?
- Are there any differences between food supplements and medicinal products and, if so, what are they?
- Who decides whether a product is a medicinal product or a food supplement?
- Who "controls" food supplements?
- Can one purchase food supplements on the internet without having any cause for concern?
- Is a food supplement necessary and does it make sense?
- Can food supplements be taken together with medicinal products?
- Are there any forms of food supplementation which BfR recommends?
- What is BfR doing in order to protect consumers from the possible risks arising from food supplements?
What are food supplements?
Food supplements are foods. They are intended to supplement a normal diet. Food supplements may contain a broad spectrum of nutrients or other substances with a specific nutritional or physiological effect. They may be, for instance, vitamins, minerals, trace elements, amino acids, fibre, plants or herbal extracts which are either added individually or as a combination in concentrated form. Food supplements are sold in a dosage form, for instance as tablets, capsules, coated tablets, powders or liquids for intake in small, measured amounts. In contrast to conventional foods, food supplements may come with a recommended intake along with other specific information for consumers, e.g. that they should be stored out of the reach of small children. The ingredients of food supplements may not, by definition, have any pharmacological effects. If a product of this kind has pharmacological effects, then it is a medicinal product which requires marketing authorisation.
Which substances and what amounts of these substances may be added to food supplements?
The Food Supplements Ordinance (NemV) specifies which vitamins and minerals and their compounds may be added to foods. Furthermore, other nutrients and substances with a specific nutritional or physiological effect may also be added to food supplements. At the present time, there are no provisions regulating which individual substances (e.g. amino acids, fibre, plants, herb extracts etc.) may be added. All the same, certain substances are equated with additives in Germany which means they are governed by the principle of prohibition with a reservation regarding the granting of permission. They may only be added to foods including food supplements when they have been expressly approved through legal provisions for the respective purpose.
There are no binding maximum levels for the ingredients of food supplements either on the national or European levels. There are, however, plans to set valid maximum levels for vitamins and essential minerals throughout Europe. From the angle of risk assessment uniform European maximum levels are urgently needed. BfR has drawn up proposals for maximum levels for vitamins and essential minerals which also take into account intakes via other nutrient sources like, for instance, fortified foods.
How does one recognise food supplements?
One main identifying characteristic of supplements is that they are labelled as such, i.e. as a "food supplement". In addition to the details stipulated in the Food Labelling Ordinance, they must also carry information about recommended daily intake as well as a warning that this amount must not be exceeded. Furthermore, the packaging must bear the information that food supplements should not be used as a substitute for a balanced, diverse diet and that they should be stored out of the reach of small children.
Claims to cure, alleviate or prevent disease are currently banned in Germany both in product advertising and on packaging. However, claims to reduce a risk of disease are possible but they are subject to official examination and approval.
Do food supplements in Germany require approval?
As food supplements are foods, they are covered by the provisions of the Food and Feed Code (LFGB). Amongst other things, this Code stipulates that foods must be safe. Consumers may not be misled by the information on the package and health claims are prohibited. However, claims to reduce a risk of disease are possible after they have undergone official examination and been approved.
Food supplements do not require approval. Pursuant to the Food Supplements Ordinance (NemV), food supplements must be registered with the Federal Office of Consumer Protection and Food Safety (BVL). Responsibility for the safety of products and compliance with food law provisions lies with manufacturers and distributors. Monitoring of food supplements placed on the market and of manufacturing plants is the task of the food control authorities of the federal states.
Under what circumstances may food supplements, which do not comply with German food law provisions, be placed on the market?
Food supplements or other foods, which do not comply with German food law provisions, may only be placed on the market in Germany if they fulfil one precondition: they must have been granted an exemption pursuant to Article 68 of the Food and Feed Code (LFGB) or a general decree pursuant to Article 54 LFGB.
An application for a general decree can be submitted to the Federal Office of Consumer Protection and Food Safety (BVL) for food supplements which have been legally placed on the market in another Member State of the European Union. The application may only be rejected on compelling grounds of health protection or if the German authorities consider the supplement to be a medicinal product.
Domestic manufacturers or manufacturers from non-EU Member States also have the option of submitting an application for an exemption pursuant to Article 68 of the Food and Feed Code (LFGB) to BVL. In this case facts must justify the assumption that no risk to human health is to be expected. Here too, of course, the precondition applies that the product in question is indeed to be classified as a food.
How safe are food supplements?
Food supplements are foods. They must be safe. Manufacturers and distributors are responsible for ensuring that food supplements do not harm health and do not mislead the consumer through their appearance or claims. However, in contrast to medicinal products food supplements do not go through any official marketing authorisation procedure during which actual health safety must be proven. The product offering on the German market is monitored by random checks of the official food control bodies.
Are there any differences between food supplements and medicinal products and, if so, what are they?
Medicinal products are intended to heal, alleviate, prevent or identify diseases, suffering, physical defects or health disorders, to replace active substances produced by the human or animal body, or to influence the condition, state or function of the body or mental state. They are governed by the provisions of the Medicinal Products Act. Their ingredients are pharmacologically active. Medicinal products are subject to marketing authorisation by the Federal Institute for Drugs and Medical Devices (BfArM) in Bonn or approval by the competent bodies of the European Union. During both types of authorisation procedure, their quality, efficacy and safety must be proven. Besides other important information on safe use, possible side effects, which may occur during proper intake, must be listed in the package insert.
Food supplements are foods and are governed by the provisions of the Food and Feed Code (LFGB). They are intended to supplement the diet and must be safe. Unlike medicinal products, they do not require marketing authorisation. Food supplements may not be advertised with any health claims. However, claims to reduce the risk of disease are admissible but they must nonetheless be examined and approved by public authorities. It is prohibited to mislead consumers.
The mere fact that a food supplement is on the market does not mean that the purchaser can assume that this is a worthwhile or valuable food. Food supplements may also be on the market when their nutritional-physiological value is questionable. At the present time, health claims which are used in conjunction with foods including food supplements are undergoing a review in order to draw up an EU list of admissible advertising claims. The EU list is to be adopted at the latest on 31 January 2010 according to Regulation (EU) No 1924/2006.
Who decides whether a product is a medicinal product or a food supplement?
It is possible that ingredients contained in food supplements are also used in medicinal products. Furthermore, food supplements are placed on the market in the same pharmaceutical forms as medicinal products like tablets, capsules, powders or liquid preparations. This highlights the fact that food supplements and medicinal products are, in some cases, very similar.
Under the federal system of the Federal Republic of Germany it is the federal states that decide whether products have been legally placed on the market. This is also the level where official medicinal product and official food control is located. Within the framework of their competences both decide in an individual review on the classification of a product as a medicinal product requiring marketing authorisation or a food. Formal responsibility lies with the public authorities of the federal state in which the product is on the market or in which the manufacturer, importer, seller or distributor has its head office.
Because of differences in legal situations, products offered for sale on the internet from outside Germany may be marketed in the countries concerned as food supplements but are classified as medicinal products in Germany.
Who "controls" food supplements?
The manufacturer, importer, supplier or distributor is responsible for the safety of food supplements. There is no control of the products prior to their placing on the market along the lines of state authorisation. Once the product is on the market, it undergoes official monitoring by the federal states. They monitor the products which are on the market by doing random checks for their compliance with the statutory provisions.
Can one purchase food supplements on the internet without having any cause for concern?
Irrespective of the distribution channel, the relevant German food law provisions of course apply to food supplements which are sold on the Internet. However, there have been reports of individual cases in which non-marketable food supplements were sold on the Internet. One example from the past concerns muscle-enhancing products. Studies by the control authorities in Germany had shown that some products sold on the internet as food supplements contained anabolic agents which had not been listed as ingredients.
When purchasing food supplements on the Internet, consumers should bear in mind that the use of the internet as a gateway to global markets offers not only opportunities but may also be linked to risks. In the case of the direct purchase of food supplements on the internet from manufacturers/distributors abroad, it cannot simply be assumed that the products sold as food supplements comply with German food law provisions. Furthermore, there is the question whether these suppliers are reliable and whether the products on sale comply with the legal provisions which are applicable to them abroad.
Is a food supplement necessary and does it make sense?
The virtually incalculable number of food supplements on the market wrongly give the consumer the impression that sufficient nutrient intake is not possible solely from a diet with traditional foods. In principle a balanced, diverse diet supplies a healthy body with all the essential substances. In most cases supplements are, therefore, superfluous.
However, there are exceptions to this general rule. A one-sided or inadequate diet can mean that not enough essential nutrients are taken up. During pregnancy and breastfeeding there is an elevated need for specific nutrients. The intake of essential nutrients by older people may also be insufficient for instance as a consequence of chewing or swallowing disorders or a loss of appetite. The chronically sick may have an elevated need for essential nutrients, too. In these cases, dietary supplementation may be necessary or advisable. Whenever a food supplement is used as an additional measure to treat or heal diseases like a chronic gastrointestinal tract disorder, this should be done under medical supervision.
Data on nutrient intake indicate that the intake of a small number of vitamins and minerals like vitamin D, calcium, folic acid and iodine by some groups in the population is not in line with the intake recommendations of the German Nutrition Society (DGE e.V.). However this cannot generally be equated with insufficient intake or even a deficiency. In individual cases, however, dietary supplementation may make sense. For instance, the intake of additional calcium by people who do not consume any dairy products may be prudent. For several years now table salt has been fortified with iodine in order to improve the iodine intake by large echelons of the population in Germany.
Nevertheless, the best nutritional strategy is still a balanced, diverse diet with plenty of fruit and vegetables. Food supplements are not substitutes of equal value.
Can food supplements be taken together with medicinal products?
Food supplements should only be taken together with medicinal products over longer periods after consulting a doctor. Interaction with specific medicinal products cannot be ruled out and the effects of some medicinal products may be weakened or amplified. This could have a negative effect on treatment.
Are there any forms of food supplementation which BfR recommends?
For the purposes of improving or reliably ensuring the adequate intake of folic acid, women planning to have a baby or pregnant women are advised to add food supplements to their diet. The vitamin, folic acid, has a positive impact on the complete closing of the neural tube in the embryo and reduces the risk of neural tube defects like "open spinal cord" (Spina bifida) in newborn babies. The BfR FAQs on folic acid contain more detailed information.
What is BfR doing in order to protect consumers from the possible risks arising from food supplements?
In the past BfR has adopted a comprehensive stance on the possible risks from food supplements and has informed consumers about problems which could be linked to the consumption of these products. BfR opinions on food supplements or substances added to food supplements are used as a decision-making aid and basis for risk-reducing measures by management institutions on the federal level and by federal state authorities.
