Positioning and compliance audit of DADFMS
Le 13 January 2025
A positioning audit is a key step in bringing a DADFMS to market. it allows evaluating the risk of reclassification as a medicine and ensuring that the product meets european regulatory requirements.
key points in the audit
the compliance audit examines several aspects:
- Feasibility of positioning: Verification that the product meets the criteria of an FSMP and not those of a food product or a food supplement, among others.
- Evaluation of the risk of reclassification as a medicine:
- If a product has curative or preventive properties, it risks being reclassified as a medicinal product by function.
- A product, even if marketed as an FSMP, must not claim a pharmacological effect.
- Analysis of claims used: All communication must comply with the framework of authorized nutritional and health claims.
Conclusion
The positioning audit is an essential step to ensure FSMP compliance and prevent regulatory sanctions. A thorough analysis of the composition, indication, target population, and commercial positioning helps guarantee a fully compliant market placement.
Your frequently asked questions about the DADFMS compliance audit
Why can a DADFMS be reclassified as a medicine?
If a DADFMS claims curative or preventive properties, it may be considered a medicine and subject to stricter regulations.
What are the key elements of a compliance audit for DADFMS?
The audit ensures that the product’s composition effectively meets the nutritional needs of the target population, guaranteeing compliance with regulatory positioning.