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<p>Food supplements play an important role in the everyday lives of many consumers, whose desire for a&#xa0;healthy lifestyle is supposedly fulfilled by a&#xa0;growing market of a&#xa0;variety of preparations. Although they often resemble medicinal products in their presentation, food supplements are also foodstuffs and are subject to the same legal provisions as other foodstuffs. However, the demarcation between medicinal products and foodstuffs—especially food supplements—poses a&#xa0;complex regulatory and practical challenge. Both product groups can be similar in terms of composition, dosage form, and effect, but they differ fundamentally in their regulatory requirements. Placing medicinal products on the market is preceded by a&#xa0;strict authorization procedure with proof of efficacy, safety and quality. In contrast, food supplements, which often contain identical substances in lower dosages, are subject only to a&#xa0;notification procedure without prior authorisation. In some cases, products are incorrectly marketed as food supplements even though they should be classified as medicinal products due to their effects or presentation. The classification as a&#xa0;medicinal product is always based on a&#xa0;case-by-case assessment of various factors, with the pharmacological effect usually being the key criterion. Despite the dynamic and diverse market, however, the authorities succeed in classifying such products in a&#xa0;legally compliant manner and in the interests of consumer protection.</p>

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Produkte mit Mikronährstoffen: Arzneimittel oder Lebensmittel?

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2025年9月19日

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  • Hendrik Schulze,
  • Benjamin Conrads,
  • Ulrike Saerbeck,
  • Evelyn Breitweg-Lehmann

摘要

Food supplements play an important role in the everyday lives of many consumers, whose desire for a healthy lifestyle is supposedly fulfilled by a growing market of a variety of preparations. Although they often resemble medicinal products in their presentation, food supplements are also foodstuffs and are subject to the same legal provisions as other foodstuffs. However, the demarcation between medicinal products and foodstuffs—especially food supplements—poses a complex regulatory and practical challenge. Both product groups can be similar in terms of composition, dosage form, and effect, but they differ fundamentally in their regulatory requirements. Placing medicinal products on the market is preceded by a strict authorization procedure with proof of efficacy, safety and quality. In contrast, food supplements, which often contain identical substances in lower dosages, are subject only to a notification procedure without prior authorisation. In some cases, products are incorrectly marketed as food supplements even though they should be classified as medicinal products due to their effects or presentation. The classification as a medicinal product is always based on a case-by-case assessment of various factors, with the pharmacological effect usually being the key criterion. Despite the dynamic and diverse market, however, the authorities succeed in classifying such products in a legally compliant manner and in the interests of consumer protection.