03.13.15
The International Journal of Toxicology has published a study showing Qualitas Health’s Almega PL is safe, marking a key step towards Generally Recognized as Safe (GRAS) status for use in the U.S. food and beverage market.
Almega PL is an omega-3 oil sourced from Nannochloropsis oculata, a non-GMO strain of microalgae. The safety of Almega PL was evaluated in a battery of tests, including: an in vivo, 14 day Maximum Tolerated Dose (MTD) study; in vivo 90 day subchronic oral toxicity; and in vitro genotoxicity studies. This is the first study that examines the safety of an omega-3 oil extracted from N. oculata.
The in vivo studies used dosages ranging from 250mg/kg to 2500mg/kg. At all dose levels, no mortalities occurred and no signs of toxicity were observed during the studies. There were no signs of genotoxicity in multiple in vitro models, and no presence of organophosphate or organochlorine pesticide residues. The researchers concluded that Almega PL is safe for human consumption at up to 1250mg/day.
“This study reaffirms Qualitas Health’s commitment to quality and safety, which were demonstrated previously through several scientific studies and the New Dietary Ingredient Notification (NDIN) filing by the U.S. Food and Drug Administration,” said Yuri Shosan, CEO, Qualitas Health. “Almega PL is moving steadily and deliberately toward GRAS status, which will open additional U.S. markets for functional foods and beverages containing Almega PL, and will address the large and growing consumer demand for vegetarian, kosher and sustainable sources of omega-3.”
Manufactured by Qualitas Health, Almega PL is selected for its high level of EPA and unique polar-lipid structure. It contains omega-3 fatty acids with phospholipids and glycolipids that provide superior digestibility and incorporation into tissues and membranes. This has been demonstrated by results of published clinical studies comparing omega-3 uptake of Almega PL to krill oil. Sustainably produced, using natural sunlight, brackish water, non-arable land and low-energy processes, Almega PL originates from a farmed microalgae source of omega-3 that does not exploit the fragile marine ecosystem.
For more information: www.qualitas-health.com
Almega PL is an omega-3 oil sourced from Nannochloropsis oculata, a non-GMO strain of microalgae. The safety of Almega PL was evaluated in a battery of tests, including: an in vivo, 14 day Maximum Tolerated Dose (MTD) study; in vivo 90 day subchronic oral toxicity; and in vitro genotoxicity studies. This is the first study that examines the safety of an omega-3 oil extracted from N. oculata.
The in vivo studies used dosages ranging from 250mg/kg to 2500mg/kg. At all dose levels, no mortalities occurred and no signs of toxicity were observed during the studies. There were no signs of genotoxicity in multiple in vitro models, and no presence of organophosphate or organochlorine pesticide residues. The researchers concluded that Almega PL is safe for human consumption at up to 1250mg/day.
“This study reaffirms Qualitas Health’s commitment to quality and safety, which were demonstrated previously through several scientific studies and the New Dietary Ingredient Notification (NDIN) filing by the U.S. Food and Drug Administration,” said Yuri Shosan, CEO, Qualitas Health. “Almega PL is moving steadily and deliberately toward GRAS status, which will open additional U.S. markets for functional foods and beverages containing Almega PL, and will address the large and growing consumer demand for vegetarian, kosher and sustainable sources of omega-3.”
Manufactured by Qualitas Health, Almega PL is selected for its high level of EPA and unique polar-lipid structure. It contains omega-3 fatty acids with phospholipids and glycolipids that provide superior digestibility and incorporation into tissues and membranes. This has been demonstrated by results of published clinical studies comparing omega-3 uptake of Almega PL to krill oil. Sustainably produced, using natural sunlight, brackish water, non-arable land and low-energy processes, Almega PL originates from a farmed microalgae source of omega-3 that does not exploit the fragile marine ecosystem.
For more information: www.qualitas-health.com
