Bonolive receives FDA GRAS approval

Published: 11-Mar-2024

The FDA approves Bonolive for inclusion in dietary supplements, beverages and functional foods

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.

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