1.071
people aged 16 or older participated in a representative online survey.
Topics included health, nutrition, and knowledge about and intake of food supplements.
According to the recent BfRshort forGerman Federal Institute for Risk Assessment study, a quarter of respondents believe this statement to be true, while another 33 percent find it probable (“somewhat agree”). However, this assumption is false. Legally, food supplements are foodstuffs. More than two thirds of the respondents think this true statement is false or somewhat false.
The EU’s Directive on food supplements as well as the German Ordinance on Food Supplements (NemV) clarify what exactly is meant by the term food supplements and which vitamins and minerals may be added to them. Accordingly, only those vitamins and minerals listed in the forms provided in the Directive’s annex may be used to manufacture food supplements. Food supplements also often contain what are known as “other substances with a nutritional or physiological effect.”
These include amino acids, fatty acids, dietary fibre, and plant-based substances such as plant extracts or secondary plant constituents. So far, the question as to which “other substances” may be used and at which dosages has only been determined in a few individual cases. Why is it important to distinguish between food supplements and medical drugs? This question brings us to the second common misunderstanding.

Unlike medical drugs, which must go through an official approval process, food supplements, which are classified as foodstuffs, are not subject to mandatory approval. Official bodies do not test their safety or tolerability before they are placed on the market. The food entrepreneurs (manufacturers, importers, sellers, and distributors) are solely responsible for compliance with food regulations and for the safety of their products. Entrepreneurs wishing to place a new product on the market must simply report this to the relevant authority, namely the German Federal Office of Consumer Protection and Food Safety (BVLshort forGerman Federal Office of Consumer Protection and Food Safety). More specifically, they only have to fill out an online form.
The monitoring authorities of the German federal states ("Laender") are responsible for monitoring the products available on the market and assess whether they comply with the legal provisions, i.e. whether the ingredients and their dosages are harmless to health as well as if the products are properly labelled. However, monitoring is only conducted via sampling, meaning merely a fraction of the available and constantly newly released products are examined.
Many people are unaware of the lack of official assessment, monitoring, and approval. In the BfR’s survey, 47 percent of respondents were absolutely certain or at least somewhat certain that food supplements are monitored for health effects before they are placed on the German market.
The common misconception that food supplements are medical drugs sold without restriction is likely the cause of the third common misunderstanding.
When asked about their reasons for taking food supplements, almost half of respondents said they wished to treat illness or other health conditions (16 percent “fully agree” and 30 percent “somewhat agree”). However, unlike medical drugs, food supplements are NOT meant to be used as treatment for diseases. Promoting food supplements using “disease-related” statements is not permitted, meaning it cannot be claimed that they have properties able to prevent, treat, or cure human disease. Health claims are only permitted if they have been scientifically assessed by the European Food Safety Authority (EFSAshort forEuropean Food Safety Authority) and explicitly authorised by the European Commission. Two examples of authorised claims are: “calcium is necessary to maintain healthy bones” or “vitamin C helps alleviate tiredness and fatigue.”
That vitamins and minerals serve important functions in the body, and that deficiencies can lead to physical disorders or illness, is not disputed. For this reason, it is recommended that persons following a vegan diet take vitamin B12 via food supplements, as this vitamin is exclusively found in foods of animal origin and would otherwise be lacking in the diets of vegans, even if they consume an otherwise balanced and varied diet. Another example of a sensible case of food supplement intake is folic acid for women planning to become pregnant. Following recommendations regarding consistent intake of this vitamin (400 micrograms per day) before and during the first trimester of a pregnancy can reduce the risk of severe birth defects such as spina bifida, a condition in which the spine is incompletely formed. Studies have shown that most women of child-bearing age fail to meet the concentration of folate recommended by the World Health Organisation to reduce the risk of neural tube defects.
These are examples of the handful of cases in which experts recommend targeted consumption of food supplements. Anybody who is worried they might have a micronutrient deficiency, for instance because their diet is less balanced and varied than is recommended, should first consult with a doctor instead of immediately consuming food supplements. It may be prudent to take food supplements in cases where insufficient levels of micronutrients have been determined. However, people already consuming enough of a certain nutrient do not benefit from additional nutrient intake. This leads us to misunderstanding number 4.
There is currently no scientific evidence to support this claim. However, 37 percent of respondents still believe it to be true or somewhat true. According to experts, additional intake of vitamins and minerals beyond necessary levels is, in the bestcase scenario, a waste of money. Studies show that the intake reference values for healthy people derived by the German Nutrition Society (DGE) are generally achieved through a varied diet. But erring on the side of caution by consuming food supplements is not harmful...right? This question brings us to the fifth misunderstanding.

As foodstuffs, food supplements must be harmless to health. However, unnecessary additional intake of vitamins or minerals can lead to undesired health effects, particularly when it comes to products with high dosages. For instance, long-term self-directed consumption of high doses of vitamin D can severely increase the concentration of calcium in the blood serum. This can lead to acute symptoms such as fatigue, nausea or cardiac arrhythmia. Particularly high dosages can also damage the kidneys in the long term. In studies, it has also been observed that high doses of beta-carotene in the form of food supplements can increase the risk of lung cancer in smokers. Additional intake of biotin can falsify laboratory diagnostic studies and an extra dose of vitamin K can reduce the effectiveness of certain anti-clotting medications.
In order to prevent health impairments from food supplements with vitamins or minerals, the BfRshort forGerman Federal Institute for Risk Assessment has elaborated recommendations for maximum levels for the use of these substances in food supplements and fortified foods. Recommendations for specific labelling of certain products were also developed. These should indicate potential health risks linked to food supplements or discourage certain at-risk groups from consumption. At the moment, however, there are no legally binding maximum levels at the national or European level. Food supplements which contain “other substances” with nutrition-specific or physiological effects, such as amino acids, essential fatty acids or plant constituents, may lead to undesired effects, especially because the use of these substances is only regulated in a handful of cases. For instance, in persons with heart disease, products with omega 3 fatty acids may increase the risk of atrial fibrillation.
In the past, there have been repeated cases in which substances with pharmacological effects were found in products labelled as food supplements which were advertised for weight loss or for increasing sexual potency. However, for many of the “other substances”, the data on toxicity is insufficient. Therefore, when in doubt, these products should not be consumed

Food supplements are, legally speaking, foodstuffs, not medical drugs. They do not require official approval and do not cure diseases. They are generally not necessary for people eating a healthy and varied diet und can pose health risks, particularly at high doses.

Micronutrients and more
Which foods contain vitamins and essential minerals? Will I get sick if I consume too much or too little of them? Should I take food supplements to meet my body’s requirements, just in case? These types of questions are answered on www.microco.info/ en/vitamine-homepage.html, the information portal of the German Federal Institute for Risk Assessment (BfRshort forGerman Federal Institute for Risk Assessment). It provides information about micronutrients – vitamins and minerals – and explains their purpose in our bodies. There are also introductions to countless other substances which can be found in food supplements and enriched foods.
Check it out at: External Link:microco.info