Dietary Supplement Labeling Project: Ensuring Regulatory Complianc
Le 13 January 2025
Dietary Supplement Labeling Project: Ensuring Regulatory Compliance
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 European regulations to ensure information clarity, claims accuracy, and legal compliance.
The attached case study outlines a labeling project for a probiotic dietary supplement, highlighting essential compliance points to validate before commercialization.
Objective of the labeling audit
The audit aims to:
- Ensure compliance with regulation (EU) No 1169/2011, particularly regarding readability and mandatory information.
- Verify that the product is clearly identified with a non-misleading name.
- Confirm that health claims comply with the framework defined by regulation (EC) No 1924/2006.
Key elements analyzed in the labeling projec
Readability and font size
According to regulation INCO 1169/2011, mandatory information must be printed with a minimum font size of 1.2 mm for clear readability. For smaller packaging (less than 80 cm²), a size of 0.9 mm is permitted.
Language and Accessibility of Information
The labeling must be written in a language understandable by consumers in the country of commercialization. In France, the use of French is mandatory.
Product name and denomination
- The commercial name must be explicit and not misleading.
- If the product has a fanciful name suggesting a health benefit, it must be accompanied by an authorized claim for one of the active ingredients in the formula.
Category and sales description
The dietary supplement must be clearly identified by its regulatory category. For example:
- “Dietary supplement based on lactic acid bacteria” if the product contains probiotics.
- This mention must appear in the same visual field as the product’s net weight.
Conclusion
The labeling of dietary supplements is a key element for regulatory compliance and commercialization. A well-prepared labeling project ensures:
✅ Avoidance of regulatory errors that could lead to market withdrawal.
✅ Clear and transparent communication with consumers.
✅ Compliance with control authority requirements to avoid sanctions.
Frequently asked questions about dietary supplement Labeling
What are the mandatory elements on a dietary supplement label?
The labeling must include the product name, ingredient list, usage precautions, recommended daily dose, manufacturer or distributor name, and traceability information (batch number, minimum durability date, or expiration date).
Can a brand name suggesting a health benefit be used?
Yes, but only if it is accompanied by an authorized claim under Regulation (EC) No 1924/2006 for an ingredient in the formula. Without such justification, a name suggesting a health benefit could be deemed misleading and lead to sanctions by authorities.
Why is it important to check the language used on the label?
Each country mandates the use of a language understandable to its consumers. In France, labeling must be in French to ensure information accessibility and avoid non-compliance during regulatory inspections.