Bonolive® – Solabia-BioActor’s innovative women’s health ingredient, receives FDA GRAS approval

Maastricht, 6th March 2024

PRESS RELEASE

The United States Food and Drug Administration approves Bonolive® as safe for inclusion in supplements, beverages and functional foods. 

Bonolive safe foods supplements

Solabia-BioActor received а no objections letter from the U.S. Food and Drug Administration (FDA) regarding their Generally Recognized as Safe (GRAS) application for its women’s health ingredient Bonolive®. The FDA approves Bonolive® for inclusion in Dietary Supplements, Beverages and Functional Foods. 

For access to the FDA “no objection letter” please follow this link.

GRAS is a designation created by the FDA under the Federal Food, Drug and Cosmetic Act. It is a testament to the safety of a food ingredient or additive based on adequate evidence. Bonolive® had already shown a clean safety profile in published tox studies and a GRAS panel had concluded that Bonolive® should be considered GRAS.

Bonolive® is an oestrogen-free, patented ingredient, standardised for high levels of oleuropein. This all-natural ingredient is clinically validated in post-menopausal women to support women’s health during post-menopause. Human intervention studies showed that Bonolive® plays a key role in:

  • stimulating bone-building cells (osteoblasts) and stabilising bone mineral density
  • improving blood lipid profile
  • reducing joint pain and improving mobility.

A recent consumer study in menopausal women also showed that Bonolive® helps alleviating menopause related symptoms related to mood and skin appearance. Interestingly, a pharmacokinetics study showed that Bonolive® has an enhanced bioavailability in post-menopausal women.

Bonolive® targets women in peri- and post menopause that are looking for a safe, natural and oestrogen-free solution to the challenges of menopause. It is a true innovation as the only clinically evaluated olive leaf extract for women’s health. This ingredient is now also available in a convenient RTD format for everyday easy intake.

Feel free to contact us via info@bioactor.com for more information on the possibilities Bonolive® has to offer.

Further information can be found on: www.bonolive.com

 

About Solabia – BioActor

BioActor, a Solabia Nutrition company, based in Maastricht, Netherlands, is a product development company that has developed a range of proprietary bioactive formulations with clinical studies. The company focuses on the development of innovative bioactives that address active living and healthy ageing. The goal is to provide the nutrition & healthcare industry with science-based innovations that confer a real health benefit to the consumer.

For further information, see www.bioactor.com