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This is the first NDI notification for an omega-3 ingredient derived from the microalgae species Nannochloropsis oculata.
Qualitas Health (Jerusalem, Israel) has filed a new dietary ingredient (NDI) notification to FDA for the company’s Almega PL algae-derived omega-3 oil. This is the first NDI notification for an omega-3 ingredient specifically derived from the microalgae species Nannochloropsis oculata. Qualitas’s NDI notification pertains to Almega PL only. NDI notification permits the ingredient’s sale in dietary supplements in the United States.
Another algae-ingredients firm, Martek Biosciences (Columbia, MD), filed an NDI notification in 2010 for its EPA and DHA algal oil obtained from the microalgae species Schizochytrium.
Qualitas describes Almega PL as a “high-bioavailability, EPA-rich omega-3 from sustainably farmed Nannochloropsis oculata.” The ingredient has a unique “polar lipid structure” containing phospholipids and glycolipids that results in high bioavailability, the firm says.
Qualitas said the NDI notification “serves as a landmark in the development of next generation omega-3s from farm-grown algae” and “is a vital step toward Almega PL’s U.S. market entry.”
With the NDI notification filed, CEO Yuri Shoshan said U.S. product launches with Almega PL could happen as soon as this year, adding that the company is also pursuing regulatory approval in other countries.
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