saftey_data

Safety data & regulatory

Safety data & regulatory

As this was a novel lignan source, the researchers conducted extensive safety testing in accordance with the rules of pharmaceutical GCP (Good Clinical Practice).

In a 13-week toxicity study, high systemic exposure to HMRlignan™ was tested by dose-related increases in the total (conjugated and unconjugated) plasma concentration of 7-HMR and the metabolites enterolactone, 7-hydroxyenterolactone and matairesinol. Enterolactone appeared to be the main metabolite. HMRlignan™ exposure did not significantly affect clinical signs, ophthalmoscopic findings, neurobehavioural observations or motor activity. The observed adverse effects of HMRlignan™ were set at 0.25 % in food, corresponding to 160 mg/kg body weight/day.

In May 2004, New Dietary Ingredient (NDI) clearance from the FDA was obtained for the ingredient.