Microphyt issued the following announcement on Oct. 16.
- PhaeoSOL is a natural microalgae-based nutritional ingredient aiming at improving the well-being of the elderly and preventing certain metabolic disorders
- Backed by proprietary efficacy data, PhaeoSOL key benefits will be presented at the 2019 Supply Side West show in Las Vegas (USA)
- Microphyt is the first European microalgae company which has received NDI Status from the FDA
Microphyt received the FDA’s Acknowledgement Without Objection letter within its 75-day evaluation period to respond. The recommended conditions of use allow a safe and high-dose of this ingredient in the dietary supplements. Proprietary preclinical data on PhaeoSOL have demonstrated significant nutritional benefits in the prevention of age-related cognitive decline. Compared to standard natural ingredients, the superior efficacy of PhaeoSOL was demonstrated and was associated with the synergy of unique bioactive compounds.
PhaeoSOL will first be presented at the SupplySide West show in Las Vegas, the largest gathering of health & nutrition professionals that takes place October 15-19, 2019. The world market for ingredients for these markets, represents more than US$ 70 billion with a share of natural ingredients (US$ 5 billion) that shows the strongest growth (8% per year). Among the natural ingredients, microalgae best meet consumer expectations thanks to their natural diversity, offering richness of molecules that can be produced in a close-controlled and sustainable way.
PhaeoSOL is produced in Microphyt’s proprietary production technology. This patented process, developed in-house, solves the usual drawbacks of microalgae production. It is based on 5,000-litre tubular photobioreactors, which offer both high differentiation potential (access to a new diversity of species) and the ability to supply natural active ingredients in an industrial and standardized way. This technology, operated within an industrial production platform, has already made it possible to establish several commercial partnerships with key players in the sector.
Virginie Wasiolek, Regulatory Affairs Manager at Microphyt indicated "Thanks to the dedication of the whole Microphyt team, we have been able to place on the market our first flagship ingredient PhaeoSOL which is backed by a strong body of science and intellectual property. The FDA’s decision confirms PhaeoSOL’s safety”.
Vincent Usache, Microphyt’s CEO, said “This NDI notification is a significant milestone in our development and opens the door to the commercialization of PhaeoSOL in the US, which is the world-leading market for dietary supplements”.
In addition of PhaeoSOL, and following its latest funding of €28.5 million, Microphyt is pursuing the development of its portfolio of microalgae-based natural solutions for nutrition and well-being with 10 nutritional active ingredients and 20 cosmetic active and functional ingredients being developed.
About Microphyt
Microphyt is a leading company in the production and marketing of microalgae-based natural active ingredients. With more than 10 years of expertise in this field, Microphyt draws from the untapped microalgae diversity to provide unique solutions for Nutrition and Wellness. Microphyt's technologies, developed in-house and patented, allow the controlled production of a wide variety of microalgae on an industrial scale and in a sustainable way. The company has 20 employees and has filed 5 patent families.
About NDI notification
The Federal Food, Drug and Cosmetic Act (FD&C Act) requires that manufacturers and distributors who wish to market dietary supplements that contain “new dietary ingredients” notify the FDA about these ingredients. Generally, the notification must include information that is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing a new dietary ingredient will reasonably be expected to be safe under the conditions of use recommended or suggested in the labeling.
Original source can be found here.
