Laboratoire Lescuyer Achieves Article 14 Health Claim for Limicol
16 Oct 2013 --- Biofortis, a Mérieux NutriSciences company has provided its expertise to Laboratoire Lescuyer to successfully obtain the first positive opinion on a health claim under Article 14 for a food supplement (Limicol) from the European Food Safety Authority (EFSA) Nutrition, Dietetic product and Allergies (NDA) panel.
After 5 years of research and three clinical trials with strong support from Biofortis, Laboratoire Lescuyer’s product has obtained the scientific recognition from the highest European Authority on Limicol’s benefits in reducing LDL cholesterol. A high level of LDL cholesterol is a major factor in the risk of developing heart disease.
The final step to place the health claim** on Limicol is the authorisation of the health claim by the European Commission (EC). Biofortis expertise supports clients with their needs in contract research in nutrition, cardiometabolism and gut health. From the beginning of this application process, Biofortis worked closely with Laboratoire Lescuyer and key opinions leaders in designing a clinical program and performed clinical trials that were convincing for the EFSA NDA panel. The panel has underlined that “it could have not reached its conclusions without the intervention studies claimed as proprietary by the applicant”.
Until now, only sixteen Article 14 health claims received a positive opinion from EFSA for adult nutritional products in Europe. It is the first time that a food supplement dossier with data protection gets a positive assessment from EFSA with regards to a claim on a risk reduction of disease. Biofortis is proud of Laboratoire Lescuyer’s success and look forward to replicating this consolidated approach. “We are confident that this success will motivate new players in targeting EFSA claims with a new and proven methodology,” said Murielle Cazaubiel, head of Biofortis Clinical.
*Article 14 health claims refer to the reduction of the risk of disease or to children's development or health. Source: EFSA
**Health claims are used on labels, in marketing or in advertising campaigns and highlight the health benefits from consuming a given food or from a component such as vitamins, fibre and minerals.
