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Figure 1. Food Supplements Market Trends in Europe
There are many irregularities with the European Food Safety Authority (EFSA) directives, e.g., the Food Supplements Directive 2002/46/EC, which demonstrates that the regulations in place can cause a number of challenges and questions.
General claims, labeling and classification rules for Food Supplements and Foods for Special Medical Purposes
In the EU, food supplements and FSMPs are regulated as foods. Therefore, according to the EU directives, food supplements must comply with general food labelling rules and need to have the following information:
- Portion of the product recommended for daily consumption;
- Warning not to exceed the recommended daily dose;
- Statement that food supplements should not be used as a substitute for a balanced diet;
- Statement that the product should be stored out of the reach of young children.
Unlike OTC and Rx drugs, food supplements should not be advertised for any disease-related claims. However, upon the confirmation by the EFSA, they can carry claims to reduce the risk of disease.
Slow EU Harmonization process on Food supplements

Figure 2. VMS allowed for Food Supplements in Europe

Figure 3. Food Supplements Registration Process in Europe
- Food supplement ingredient and composition check according to the European regulations;
- Label compliance with regulations according to the marketing needs;
- Possible food supplement claims review according to the European EFSA regulations;
- Registration of food, food supplements and foods for special medical purposes (FSMPs), as well as regulatory strategy;
- Understanding vitamins, minerals and supplements as well as herbal and botanical food supplements
- Distinction between food supplements and OTC drugs.