Product Safety for life'sDHA™ and life'sARA™
life'sDHA™ and life'sARA™ have been extensively evaluated for safety both as individual products and as blends. In vivo and in vitro testing procedures have been used to evaluate the safety of Martek’s products.
- In March of 2004, the U.S. Food and Drug Administration (FDA) completed a favorable review of the Company's generally recognized as safe (GRAS) notification regarding the use of its DHA oil (life'sDHA™) as an ingredient in foods and beverages.
- In 2003, life'sDHA™ (Martek DHA-S) received Novel Foods approval for use in supplements and a variety of foods in Europe.
- In 2002, life'sDHA™ (Martek DHA-S) received Novel Foods approval for use in foods in Australia/New Zealand.
- In 2003, Food Standards Australia New Zealand concluded that life'sDHA™ (DHASCO®) and life'sARA™ (ARASCO®) are safe for use in infant formula.
- In October of 2002, Canada’s government health agency, Health Canada, completed a favorable review of Martek’s submission supporting the use of its proprietary life'sDHA™ (DHASCO) and Martek's ARA (ARASCO) oils in infant formulas in Canada.
- In May of 2001, the U.S. Food and Drug Administration (FDA) completed a favorable review of Martek's generally recognized as safe (GRAS) notification regarding the use of its life'sDHA™ (DHASCO) and Martek's ARA (ARASCO) oil blend in infant formula.
- In 1996, the Committee on Toxicology of the United Kingdom independently evaluated and approved life'sDHA™ (DHASCO) and life'sARA™ (ARASCO) as safe for use in preterm and term infant formula. The Ministry of Health in France also approved life'sDHA™ (DHASCO) and Martek's ARA (ARASCO) for use in infant formula.
- In 1995, an independent panel of preeminent toxicologists and nutritionists in the U.S. concluded that life'sDHA™ (DHASCO) and life'sARA™ (ARASCO) are GRAS for use in preterm and term infant formula. In 1996, the same panel concluded that Neuromins® DHA is GRAS for use by adults, including pregnant and lactating women.
- Also in 1995, the Regulatory Office of the Ministry of Health in The Netherlands independently evaluated and approved life'sDHA™ (DHASCO) and life'sARA™ (ARASCO) as safe for use in preterm and term infant formula.
In addition to these evaluations, life'sDHA™ and life'sARA™ have a proven history of use in both preterm and term infants. Martek’s oils have been added to infant formula since 1994 and to date we estimate that over 11 million babies, including more than 500,000 preterm infants, have been fed infant formulas containing Martek’s DHA and ARA.
