Status: 06.07.2023 2:53 p.m
Dietary supplements are often compressed into pills or filled into capsules as a powder. This makes them look like medicines. However, there are enormous differences in terms of their approval and control.
Drugs have the purpose of curing or preventing diseases and alleviating ailments. The legal basis is the Medicines Act. This regulates, among other things, that medicinal products must be approved by an authority. Efficacy, quality and safety of the medicinal product must be proven in the long-term approval process. The quality of each batch of medicinal products produced is also checked later. The active ingredients in the product must not deviate from the information on the packaging by more than five percent. All this does not apply to vitamin preparations and other supplements.
Dietary supplements: No approval procedure planned
Dietary supplements are not covered by the Medicines Act because they are considered foods. There is no official approval procedure for them, they only have to be reported to the Federal Office for Consumer Protection and Food Safety (BVL). Once the ad is complete, they may be sold. Whether the products are harmless to health is the sole responsibility of the manufacturer. The on-site monitoring authorities only carry out spot checks.
Health claims: Only a few health claims are allowed
Dietary supplements have no healing effect. Their sole purpose is to provide nutrients to maintain normal bodily functions. In terms of advertising law, the Health Claims Ordinance has been in force since 2006, just as it is for food, in which the permitted formulations for describing their function are precisely defined. Statements such as “Vitamin C contributes to normal energy metabolism” or “Calcium is required for the maintenance of normal bones” are permissible. However, suppliers of dietary supplements must not give potential customers the impression that they are suitable for treating or preventing diseases.
Botanicals: No health claims allowed
Plant substances and parts of plants such as spirulina, turmeric or aronia berries are not listed in the Health Claims Regulation. The positive health effects of such “botanicals” should therefore not be advertised. A corresponding list has been in the process of being drawn up at EU level since 2006, but it is not foreseeable when it will be published.
The effects to be expected from the use of such ingredients can be viewed by consumers as a guide in the substance lists of the Working Group on the List of Substances of the Federal Office for Consumer Protection and Food. The working group draws up the lists taking into account scientific findings. They are not legally binding.
No maximum levels for vitamins and nutrients
The actual amount in the product may deviate by up to 50 percent from the quantities stated on the packaging of dietary supplements. Even if it is undisputed that an overdose of some vitamins and nutrients can also have serious health consequences, there are no legally prescribed maximum amounts. However, the Federal Institute for Risk Assessment has drawn up concrete proposals for maximum quantities that consumers can use as a guide. The proposals apply not only to food supplements but also to fortified foods.
Central office for the control of dietary supplements
In order to be able to control food supplements traded on the Internet, the federal states have set up a joint central office at the BVL “Control of LFGB products and tobacco products traded on the Internet”, G@ZIELT for short. The results of the risk-oriented research initiated there are forwarded to the relevant competent authority in Germany.
Further information
Dietary supplements and combination preparations can lead to an overdose of vitamins and minerals. more
A vitamin B12 deficiency can lead to nerve damage. Older people and vegans are particularly at risk. more
Tests of vitamin levels in the blood are often expensive. Specific tests for vitamin D or B12 are usually more useful. more
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The Tricks | 07/17/2023 | 8:15 p.m