Qualitas Health announced that its new dietary ingredient notification (NDIN) for Almega PL omega-3 oil has been filed by the U.S. Food and Drug Administration, permitting the ingredient for sale in dietary supplements in 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 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 to krill oil.
The NDI notification is a vital step toward Almega PL’s US 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.
“Achieving this important regulatory filing is one of the major milestones in bringing Almega PL to the U.S. 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. We are excited to offer our customers high-quality omega-3 from algae in time for 2014 consumer product launches.”