{"id":2432,"date":"2025-01-13T16:21:56","date_gmt":"2025-01-13T15:21:56","guid":{"rendered":"https:\/\/www.pharmanager-development.com\/?p=2432"},"modified":"2025-02-26T11:01:33","modified_gmt":"2025-02-26T10:01:33","slug":"dietary-supplement-labeling-project","status":"publish","type":"post","link":"https:\/\/www.pharmanager-development.com\/en\/dietary-supplement-labeling-project\/","title":{"rendered":"Dietary Supplement Labeling Project: Ensuring Regulatory Complianc"},"content":{"rendered":"\n
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Dietary Supplement Labeling Project: Ensuring Regulatory Compliance<\/strong><\/strong><\/strong><\/strong><\/strong><\/h2>\n\n\n\n

The labeling of dietary supplements plays a key role in their market launch in Europe and worldwide. Every element on the packaging must comply with\u00a0European regulations<\/strong>\u00a0to ensure\u00a0information clarity<\/strong>,\u00a0claims accuracy<\/strong>, and\u00a0legal compliance<\/strong>.<\/p>\n\n\n\n

The attached case study outlines a\u00a0labeling project for a probiotic dietary supplement<\/strong>, highlighting essential compliance points to validate before commercialization.<\/p>\n\n\n\n

Objective of the labeling audit<\/strong><\/p>\n\n\n\n

The audit aims to:<\/p>\n\n\n\n

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  • Ensure compliance with regulation (EU) No 1169\/2011, particularly regarding readability and mandatory information.<\/li>\n\n\n\n
  • Verify that the product is clearly identified with a\u00a0non-misleading name.<\/li>\n\n\n\n
  • Confirm that health claims comply with the\u00a0framework defined by regulation (EC) No 1924\/2006.<\/li>\n<\/ul>\n\n\n\n
    <\/div>\n\n\n\n

    Key elements analyzed in the labeling projec<\/strong><\/strong><\/strong><\/strong><\/h2>\n\n\n\n

    Readability and font size<\/strong><\/strong><\/strong><\/strong><\/strong><\/p>\n\n\n\n

    According to\u00a0regulation INCO 1169\/2011<\/strong>, mandatory information must be printed with a\u00a0minimum font size of 1.2 mm<\/strong>\u00a0for clear readability. For smaller packaging (less than 80 cm\u00b2), a size of\u00a00.9 mm<\/strong>\u00a0is permitted.<\/p>\n\n\n\n

    Language and Accessibility of Information<\/strong><\/strong><\/strong><\/strong><\/p>\n\n\n\n

    The labeling must be written in a\u00a0language understandable<\/strong>\u00a0by consumers in the country of commercialization. In France, the use of French is mandatory.<\/p>\n\n\n\n

    Product name and denomination<\/strong><\/strong><\/strong><\/p>\n\n\n\n

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    • The\u00a0commercial name<\/strong>\u00a0must be explicit and not misleading.<\/li>\n\n\n\n
    • If the product has a\u00a0fanciful name suggesting a health benefit<\/strong>, it must be accompanied by an\u00a0authorized claim<\/strong>\u00a0for one of the active ingredients in the formula.<\/li>\n<\/ul>\n\n\n\n

      Category and sales description<\/strong><\/strong><\/p>\n\n\n\n

      The dietary supplement must be clearly identified by its\u00a0regulatory category. For example:<\/p>\n\n\n\n

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      • “Dietary supplement based on lactic acid bacteria” if the product contains probiotics.<\/li>\n<\/ul>\n\n\n\n
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        • This mention must appear\u00a0in the same visual field as the product\u2019s net weight<\/strong>.<\/li>\n<\/ul>\n\n\n\n
          <\/div>\n\n\n\n

          Conclusion<\/strong><\/h2>\n\n\n\n

          The labeling of dietary supplements is a\u00a0key element<\/strong>\u00a0for regulatory compliance and commercialization. A well-prepared labeling project ensures:<\/p>\n\n\n\n

          \u2705\u00a0Avoidance of regulatory errors<\/strong>\u00a0that could lead to market withdrawal.
          \u2705\u00a0Clear and transparent communication<\/strong>\u00a0with consumers.
          \u2705\u00a0Compliance with control authority requirements<\/strong>\u00a0to avoid sanctions.<\/p>\n\n\n\n

          <\/div>\n\n\n\n
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