EU - Legal regulation of the circulation of dietary food and dietary supplements in eu countries: the experience of Germany
Germany
Feb 10, 2025
Despite the EU legislation regulating the circulation of dietary and food supplements within the internal market, the system of state control requires improvement. For instance, due to existing regulatory gaps, certain pharmaceutical entities commit violations of regulatory requirements, such as failing to register medicinal products and selling them under the guise of dietary and/or food supplements. Conversely, physicians may recommend ordinary dietary and food supplements to patients as if they were medicinal products. Additionally, violations posing health risks may include the presence of active pharmaceutical ingredients, including prescription-only substances that should be used exclusively for production of medical product ; the absence of declared nutrients (proteins, fats, carbohydrates, vitamins, minerals) or other substances with nutritional or physiological effects; and labeling that fails to meet established requirements, such as claims of therapeutic effects. In other words, there is a lack of clear mechanisms in legislation for introducing dietary and/or food supplements to the market and defining requirements for substances used in their production, such as vitamins, minerals, and other substances with nutritional or physiological effects.
Author(s): Pashkov, V.М, Soloviov, O.S & Khmelnytska, O.A.
Published in: Wiad Lek.
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