News
Dec 31, 2025 - Foods
Distinction between food and pharmaceuticals remains a challenge for vitamin and mineral products
Products containing vitamins and minerals are hardly dispensable in today’s market. Nutritional supplements, in particular, are very popular among consumers. At the same time, their legal classification continues to pose significant challenges for manufacturers, authorities, and testing institutions. A recent professional article in the Federal Health Gazette (Issue 11/2025, pages 1219-1225) highlights the fact that the distinction between foodstuffs and medicinal products remains complex and depends on many factors.
The composition, dosage of the micronutrients contained, intended purpose, as well as the presentation and advertising of a product are among the key elements of legal assessment. Even small changes, such as in the recommended daily intake or health-related statements, can lead to a product being classified not as food but as a medicinal product.
Particularly relevant is the so-called principle of doubt: if a product can fall under both food law and drug law, the stricter drug law is applied in case of doubt. This has far-reaching consequences for market authorization, as medicinal products must meet significantly higher requirements for approval, effectiveness evidence, and safety evaluations.
Compounding the issue is that identical or very similar products within the European Union can be assessed differently. National authorities sometimes arrive at differing classifications, which complicates the Europe-wide distribution of micronutrient-containing products and is fraught with legal risks.
The BAV Institute supports manufacturers in this challenging environment with robust analytics, scientific evaluation, and regulatory consulting. The goal is to ensure legally compliant classification and correct labeling of vitamin and mineral products. In close cooperation with the Tentamus laboratories, the institute offers comprehensive solutions along the entire value chain — from product development to market introduction.
With technical expertise and regulatory know-how, the BAV Institute and Tentamus laboratories make an important contribution to consumer safety, legal compliance, and regulated market access for micronutrient-containing products.
Source: Federal Health Gazette - Issue 11/2025 pages 1219-1225