Sinetrol, a proprietary nutraceutical ingredient targeting improvement of body composition, developed by Fytexia (France) has been granted with an individual approval associated to an authorized health claim by the South Korean Ministry of Food & Drug Safety (MFDS), formerly known as KFDA.
Fytexia associated with Korean pharmaceutical leader RP Bio and local agency from Japanese distributor Asahi Godo to submit to the MFDS a dossier supporting the application of Sinetrol on improvement of body composition. Independent mechanistic and clinical study on Korean population have been financed and piloted by RP Bio in Seoul to complete the scientific dossier developed by Fytexia.
RP Bio has been receiving Individual authorization registration (IAR) on the 11th of September 2019 and will be the only company in Korea able to commercialize Sinetrol in food supplements in Korea. The South Korea MDFD’s health claim approval recognizes the ability of Sinetrol to “help reduce body fat” in overweight population, as proven in a total of 4 clinical trials run on a total of above 250 subjects.
The released of the approval granted by MFDS already generated many enquiries that shall drive growth in sales of Sinetrol in Asia-Pacific.
“This is a positive conclusion to several years of clinical research and it proves the efficacy of Sinetrol on management of body composition” says Matthieu Arguillere, CEO of Fytexia. “We are confident that this positive scientific opinion will allow wider applications of our extract in supplements and functional food as we believe weight management is and will remain a major concern worldwide”.