Qualitas Health announces FDA New Dietary Ingredient Notification for Almega PL

Published: 10-Jun-2014

First NDIN for high bioavailability EPA-rich omega-3 from sustainably farmed Nannochloropsis Oculata

Qualitas Health, a developer of food supplements and pharmaceutical ingredients based on microalgae, has received a New Dietary Ingredient Notification (NDIN) for its Almega PL omega-3 oil, which allows the ingredient to be used in dietary supplements in the US.

As the first NDIN for an omega-3 from the microalgae Nannochloropsis oculata, the company says the notification serves as a landmark in the development of next-generation omega-3 from farm-grown algae.

The NDIN, which confirms that Almega PL is reasonably expected to be safe, is valid only for Almega PL’s specific composition and manufacturing process. Other aspects of Qualitas Health’s intellectual property – including algae growth and extraction techniques and Almega PL’s composition – are patent-protected.

Almega PL is rich in EPA, and contains omega-3s in a polar lipid structure with phospholipids and glycolipids, delivering high-bioavailability. Almega PL’s molecular polarity enhances its incorporation into tissues and membranes, as demonstrated by results of a published clinical study comparing omega-3 uptake of Almega PL with krill oil.

'Achieving this important regulatory filing is one of the major milestones in bringing Almega PL to the US market,' said Yuri Shoshan, CEO of Qualitas Health. 'This is the first filing for Almega PL, and we are working to attain regulatory approvals in additional countries and regions for this and other products.'

You may also like