{"id":2438,"date":"2025-01-10T09:00:18","date_gmt":"2025-01-10T08:00:18","guid":{"rendered":"https:\/\/www.pharmanager-development.com\/?p=2438"},"modified":"2025-02-26T11:01:49","modified_gmt":"2025-02-26T10:01:49","slug":"audit-labeling-dietary-supplements","status":"publish","type":"post","link":"https:\/\/www.pharmanager-development.com\/en\/audit-labeling-dietary-supplements\/","title":{"rendered":"Labeling Audit of Dietary Supplements: Compliance and Regulation"},"content":{"rendered":"\n
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Labeling Audit of Dietary Supplements: A Key Regulatory Challenge<\/strong><\/strong><\/h2>\n\n\n\n

The labeling of\u00a0dietary supplements\u00a0is a crucial element to ensure the compliance of products sold in Europe. It must adhere to strict standards established by\u00a0Regulation (EU) No 1169\/2011, particularly regarding\u00a0readability, mandatory information, and translation\u00a0for consumers.<\/p>\n\n\n\n

The image below illustrates a\u00a0labeling audit\u00a0conducted on a\u00a0probiotic dietary supplement, highlighting several essential control points:<\/p>\n\n\n\n

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  • Readability of mandatory information\u00a0(minimum font size, compliance with Articles 13 and 15 of the INCO regulation).<\/li>\n\n\n\n
  • Translation and accessibility\u00a0of information in the language of the country of commercialization.<\/li>\n\n\n\n
  • Compliance of health claims\u00a0with European regulations.<\/li>\n<\/ul>\n\n\n\n

    Non-compliant labeling can lead to\u00a0sanctions, product withdrawal, or\u00a0mandatory adjustments\u00a0to meet current requirements.<\/p>\n\n\n\n

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

    Key points analyzed during the audit<\/strong><\/strong><\/h2>\n\n\n\n

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

    European regulations require a\u00a0minimum font size of 1.2 mm\u00a0to ensure the essential information is easily readable. For packaging smaller than 80 cm\u00b2, a font size of\u00a00.9 mm\u00a0is permitted.<\/p>\n\n\n\n

    Mandatory Information<\/strong><\/p>\n\n\n\n

    The label must include the following mandatory mentions:<\/p>\n\n\n\n

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    • Detailed composition, including ingredients and additives.<\/li>\n\n\n\n
    • Conditions of use\u00a0(recommended daily dose, usage precautions).<\/li>\n\n\n\n
    • Identification of the manufacturer\u00a0and the\u00a0batch number\u00a0for traceability.<\/li>\n<\/ul>\n\n\n\n

      Verification of nutritional and health claims<\/strong><\/p>\n\n\n\n

      The claims highlighted on the packaging must comply with\u00a0Regulation (EC) No 1924\/2006<\/strong>, which prohibits misleading or scientifically unjustified statements.<\/p>\n\n\n\n

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

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

      Ensuring Labeling Compliance to Avoid Sanctions<\/strong><\/strong><\/p>\n\n\n\n

      The labeling of\u00a0dietary supplements<\/strong>\u00a0must be\u00a0accurate, legible, and compliant with European regulations<\/strong>. A thorough audit helps prevent errors, ensure\u00a0transparency for consumers<\/strong>, and anticipate inspections by authorities.<\/p>\n\n\n\n

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      • Verify readability and font size<\/strong>\u00a0to ensure the accessibility of information.<\/li>\n\n\n\n
      • Ensure all mandatory mentions<\/strong>\u00a0are present and understandable.<\/li>\n\n\n\n
      • Analyze health claims<\/strong>\u00a0to avoid any reclassification of the product as a medicine.<\/li>\n<\/ul>\n\n\n\n

        A compliant label is a\u00a0guarantee of safety and quality<\/strong>, essential for the commercial success of a dietary supplement on the European market.<\/strong><\/p>\n\n\n\n

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