FDA Files New Ingredient Notification for Omega-3 Oil

JERUSALEM—Qualitas Health announced the U.S. Food and Drug Administration (FDA) filed the New Dietary Ingredient Notification (NDIN) for Almega PL omega-3 oil, permitting the ingredient for sale in dietary supplements within the United States.

As the first NDIN for an omega-3 from the microalgae Nannochloropsis oculata, the notification serves as a landmark in the development of next generation omega-3s 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, extraction techniques and Almega PL’s composition – are patent-protected.

Almega PL is rich in Eicosapentaenoic Acid (EPA), and it contains omega-3s in a polar lipid structure with phospholipids and glycolipids, delivering high-bioavailability. The ingredient’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 to krill oil.

The NDI notification is a vital step toward Almega PL’s U.S. market entry—allowing Almega PL to be used in dietary supplements—and reaffirms Qualitas Health’s commitment to quality and safety, which were demonstrated previously through several clinical studies.