{"id":2426,"date":"2025-01-13T17:11:12","date_gmt":"2025-01-13T16:11:12","guid":{"rendered":"https:\/\/www.pharmanager-development.com\/?p=2426"},"modified":"2025-02-26T11:01:33","modified_gmt":"2025-02-26T10:01:33","slug":"classification-medical-food-product","status":"publish","type":"post","link":"https:\/\/www.pharmanager-development.com\/en\/classification-medical-food-product\/","title":{"rendered":"Classification and Regulatory Justification of a Medical Food Product"},"content":{"rendered":"\n
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Scientific and regulatory justification of a FSMP<\/strong><\/strong><\/strong><\/strong><\/strong><\/h2>\n\n\n\n

Food for Special Medical Purposes (FSMP) are strictly regulated by\u00a0Regulation (EU) No 609\/2013<\/strong>\u00a0and its supplement\u00a0Regulation (EU) 2016\/128<\/strong>. Their classification is based on scientific criteria demonstrating that they are specially formulated to meet the nutritional needs of specific populations who cannot satisfy their needs through regular diet.<\/p>\n\n\n\n

The case study presented here details the regulatory and scientific justification of a product falling into this category, based on key elements:<\/p>\n\n\n\n

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  • Its regulatory context and applicable classification<\/li>\n<\/ul>\n\n\n\n
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    • Its composition and nutritional analysis<\/li>\n<\/ul>\n\n\n\n
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      • The scientific studies validating its positioning<\/li>\n<\/ul>\n\n\n\n
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        • The requirements regarding technological data and labeling<\/li>\n<\/ul>\n\n\n\n

          This study aims to provide substantial evidence for the evaluation by\u00a0ANSES<\/strong>, the competent French authority, thereby ensuring the product’s compliance on the market.<\/p>\n\n\n\n

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

          Presentation and Regulatory Classification of the Product<\/strong><\/strong><\/strong><\/strong><\/strong><\/h2>\n\n\n\n

          The dossier is based on several fundamental elements that classify the product as a FSMP:<\/p>\n\n\n\n

          Regulatory Framework<\/strong><\/p>\n\n\n\n

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          • Regulation (EU) No 609\/2013<\/strong>: Defines foods intended for special medical purposes and their conditions of use.<\/li>\n<\/ul>\n\n\n\n
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            • Regulation (EU) 2016\/128<\/strong>: Imposes specific requirements regarding composition and information.<\/li>\n<\/ul>\n\n\n\n

              Product Description<\/strong><\/p>\n\n\n\n

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              • Product in powder form to be reconstituted in a liquid or incorporated into foods (yogurt, applesauce).<\/li>\n<\/ul>\n\n\n\n
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                • Contains dietary fibers with a high fiber content (79 g\/100 g).<\/li>\n<\/ul>\n\n\n\n
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                  • Designed for individuals suffering from transit disorders requiring specific fiber intake.<\/li>\n<\/ul>\n\n\n\n

                    Target Population<\/strong><\/strong><\/strong><\/strong><\/p>\n\n\n\n

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                    • Indicated for individuals suffering from chronic or transient constipation<\/li>\n<\/ul>\n\n\n\n
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                      • Cannot constitute an exclusive source of nutrition, but a specific dietary supplement<\/li>\n<\/ul>\n\n\n\n

                        Composition and Nutritional Analysis of the Product<\/strong><\/strong><\/strong><\/strong><\/h2>\n\n\n\n

                        The product’s nutritional analysis demonstrates its regulatory compliance and adequacy to the specific needs of patients:<\/p>\n\n\n\n

                        Product Composition (Regulatory Format)<\/strong><\/p>\n\n\n\n

                        Ingredient<\/strong><\/td>Quantity (mg \/ stick)<\/strong><\/td>% Active<\/strong><\/td>% RDI (for 2 sticks)<\/strong><\/td><\/tr>
                        Myo-inositol<\/td>\/<\/td>\/<\/td>\/<\/td><\/tr>
                        D-chiro-inositol<\/td>\/<\/td>\/<\/td>\/<\/td><\/tr>
                        Zinc bisglycinate<\/td>\/<\/td>100%<\/td>\/<\/td><\/tr>
                        Vitamin B9<\/td>\/<\/td>142%<\/td>\/<\/td><\/tr>
                        Vitamin B6<\/td>\/<\/td>100%<\/td>\/<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

                        Focus on Key Ingredients:<\/strong><\/p>\n\n\n\n

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                        • Inositol<\/strong>, in its forms Myo-inositol and D-chiro-inositol, is used in certain digestive pathologies.<\/li>\n\n\n\n
                        • Zinc bisglycinate<\/strong>\u00a0is an essential nutrient whose intake is regulated.<\/li>\n\n\n\n
                        • Vitamins B6 and B9<\/strong>\u00a0contribute to reducing fatigue and proper metabolic function.<\/li>\n<\/ul>\n\n\n\n

                          Scientificvalidation and clinical studies<\/strong><\/h2>\n\n\n\n

                          The product’s acceptability and effectiveness have been evaluated through several scientific studies:<\/p>\n\n\n\n

                          Acceptability Studies<\/strong><\/p>\n\n\n\n

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                          • Measurement of the product’s digestive tolerance.<\/li>\n\n\n\n
                          • Verification of the absence of adverse effects during consumption.<\/li>\n<\/ul>\n\n\n\n

                            Clinical Efficacy Studies<\/strong><\/p>\n\n\n\n

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                            • Evaluation of benefits on the improvement of intestinal transit.<\/li>\n\n\n\n
                            • Comparison of results with a control group.<\/li>\n<\/ul>\n\n\n\n

                              The studies demonstrate that the product’s formulation meets the nutritional needs of patients suffering from constipation, in accordance with FSMP criteria.<\/p>\n\n\n\n

                              Technological Criteria and Labeling Project<\/strong><\/h2>\n\n\n\n

                              To ensure the product’s compliance with European regulations, several technological requirements have been validated:<\/p>\n\n\n\n

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                              • Stability Data<\/strong>: Preservation and product durability.<\/li>\n\n\n\n
                              • Manufacturing Process<\/strong>: Adherence to food safety standards.<\/li>\n\n\n\n
                              • Quality System<\/strong>: Quality control and traceability of raw materials.<\/li>\n<\/ul>\n\n\n\n

                                A labeling project compliant with current legislation has also been developed, notably mentioning:<\/p>\n\n\n\n

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                                • The product’s identity and its ingredients<\/strong><\/li>\n\n\n\n
                                • Conditions of use<\/strong><\/li>\n\n\n\n
                                • Detailed nutritional information<\/strong><\/li>\n<\/ul>\n\n\n\n
                                  <\/div>\n\n\n\n

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

                                  A Solid Justification for Successful Market Placement<\/strong><\/strong><\/p>\n\n\n\n

                                  \ud83d\udd0e\u00a0Key Elements Validated:<\/strong>\u00a0
                                  \u2705\u00a0Regulatory classification compliant with Regulation (EU) No 609\/2013<\/strong>\u00a0
                                  \u2705\u00a0Nutritional composition adapted to the needs of targeted patients<\/strong>\u00a0
                                  \u2705\u00a0Substantial scientific studies confirming its effectiveness<\/strong>\u00a0
                                  \u2705\u00a0Technological data and labeling project compliant with European requirements<\/strong><\/p>\n\n\n\n

                                  Thus, this scientific dossier provides a solid foundation for evaluation by health authorities, ensuring a compliant market placement.<\/strong><\/p>\n\n\n\n

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