Classification and Regulatory Justification of a Medical Food Product

Scientific and regulatory justification of a FSMP

Food for Special Medical Purposes (FSMP) are strictly regulated by Regulation (EU) No 609/2013 and its supplement Regulation (EU) 2016/128. 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.

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

• Its regulatory context and applicable classification

• Its composition and nutritional analysis

• The scientific studies validating its positioning

• The requirements regarding technological data and labeling

This study aims to provide substantial evidence for the evaluation by ANSES, the competent French authority, thereby ensuring the product’s compliance on the market.

Presentation and Regulatory Classification of the Product

The dossier is based on several fundamental elements that classify the product as a FSMP:

Regulatory Framework

• Regulation (EU) No 609/2013: Defines foods intended for special medical purposes and their conditions of use.

• Regulation (EU) 2016/128: Imposes specific requirements regarding composition and information.

Product Description

• Product in powder form to be reconstituted in a liquid or incorporated into foods (yogurt, applesauce).

• Contains dietary fibers with a high fiber content (79 g/100 g).

• Designed for individuals suffering from transit disorders requiring specific fiber intake.

Target Population

• Indicated for individuals suffering from chronic or transient constipation

• Cannot constitute an exclusive source of nutrition, but a specific dietary supplement

Composition and Nutritional Analysis of the Product

The product’s nutritional analysis demonstrates its regulatory compliance and adequacy to the specific needs of patients:

Product Composition (Regulatory Format)

Focus on Key Ingredients:

• Inositol, in its forms Myo-inositol and D-chiro-inositol, is used in certain digestive pathologies.
• Zinc bisglycinate is an essential nutrient whose intake is regulated.
• Vitamins B6 and B9 contribute to reducing fatigue and proper metabolic function.

Scientificvalidation and clinical studies

The product’s acceptability and effectiveness have been evaluated through several scientific studies:

Acceptability Studies

• Measurement of the product’s digestive tolerance.
• Verification of the absence of adverse effects during consumption.

Clinical Efficacy Studies

• Evaluation of benefits on the improvement of intestinal transit.
• Comparison of results with a control group.

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

Technological Criteria and Labeling Project

To ensure the product’s compliance with European regulations, several technological requirements have been validated:

• Stability Data: Preservation and product durability.
• Manufacturing Process: Adherence to food safety standards.
• Quality System: Quality control and traceability of raw materials.

A labeling project compliant with current legislation has also been developed, notably mentioning:

• The product’s identity and its ingredients
• Conditions of use
• Detailed nutritional information

Conclusion

A Solid Justification for Successful Market Placement

🔎 Key Elements Validated: 
✅ Regulatory classification compliant with Regulation (EU) No 609/2013 
✅ Nutritional composition adapted to the needs of targeted patients 
✅ Substantial scientific studies confirming its effectiveness 
✅ Technological data and labeling project compliant with European requirements

Thus, this scientific dossier provides a solid foundation for evaluation by health authorities, ensuring a compliant market placement.