Solabia-BioActor received a no objections letter from the US Food and Drug Administration (FDA) regarding their Generally Recognised as Safe (“GRAS”)application for its women’s health ingredient Bonolive.
GRAS is a designation created by the FDA under the Federal Food, Drug and Cosmetic Act, being a testament to the safety of a food ingredient based on adequate evidence.
Bonolive had already shown a clean safety profile in published toxicology studies, and a GRAS panel had concluded that Bonolive should be considered safe.
Bonolive is an oestrogen-free, patented ingredient, standardised for high levels of oleuropein.
This natural ingredient is clinically validated in post-menopausal women to support health during post-menopause.
Human intervention studies showed that Bonolive plays a key role in:
- Stimulating bone producing cells (osteoblasts) and stabilising bone mineral density
- Improving blood lipid profiles
- Reducing joint pain and improving mobility
A recent consumer study in menopausal women also showed that Bonolive helps alleviating menopause symptoms related to mood and skin appearance.
Interestingly, a pharmacokinetics study showed that Bonolive has an enhanced bioavailability in post-menopausal women.
Bonolive is the only clinically evaluated olive extract for women’s health.
