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- "That same day that I gave her the first bottle [of formula], she had terrible diarrhea, she had horrible spit-up, she had gas, she was crying with pain. . . . Our pharmacy accidentally ordered [formula] without DHA/ARA. She had it for four days and her symptoms improved almost overnight."
Isabel Salas reported to the non-profit Cornucopia Institute (Cornucopia) the difficulties she faced when her infant daughter reacted badly to a set of additives present in most baby formulas: DHA and ARA oils. Containers of formula containing these additives say things like, "Our formula is proven in clinical studies to enhance mental development" and "as close as ever to breast milk."
But Salas isn't the only mother who has faced these problems. The U.S. Food and Drug Administration (FDA) has recorded at least 98 self-reported incidents (PDF) of adverse reactions in infants that could be confidently linked to intolerance to these additives, according to records obtained through a Freedom of Information Act (FOIA) request by Cornucopia in 2008. The majority of these reactions involve severe gastrointestinal distress, prolonged periods of vomiting and painful bloating. Many of these parents only found out that there was a problem with their infant's formula when they accidentally tried a brand without DHA and ARA additives. Cornucopia has called the many reports to the FDA of infants' adverse reactions to these controversial additives "only the tip of the iceberg" because "most parents remain unaware that Martek’s DHA and ARA oils may be the cause of their infant’s problems."
Yet not only have these additives been approved by the FDA as "Generally Recognized as Safe" (GRAS), but they have even been approved as additives to certified organic products. They are often listed in product ingredients under the trademarked names "life'sDHA™" and "life'sARA™."
Martek Biosciences' Supplements
Martek Biosciences petitioned the FDA for GRAS status for its "arachidonic acid-rich single cell oil" (ARASCO™, or ARA oil) and "docosahexaenoic acid-rich single cell oil" (DHASCO™, or DHA oil) in 1999.
Both DHA and ARA are long chain polyunsaturated fatty acids (LCPUFAs), which when naturally present in human breast milk and in human diets, have been shown to be critical to brain and vision development (PDF). Martek owns several patents related to the process of extracting these naturally-occuring fatty acids from non-food organisms. Martek's DHA oil is an Omega-3 additive produced from algae, and its ARA oil is an Omega-6 additive produced from a fungus. These oils are extracted using petrochemical solvents (PDF, p. 2), including the potential neurotoxin hexane.
FDA Expresses Concern
When the FDA granted Martek's DHA and ARA oils conditional GRAS status in May 2001, its accompanying letter expressed the following concerns:
- "[S]ome studies have reported unexpected deaths among infants who consumed formula supplemented with LCPUFAs. These unexpected deaths were attributed to Sudden Infant Death Syndrome (SIDS), sepsis or necrotizing enterocolitis. Also, some studies have reported adverse events and other morbidities including diarrhea, flatulence, jaundice, and apnea in infants fed LCPUFAs."
The decision notes that the approval of the ingredient does not negate the responsibility of infant formula manufacturers that include the additives to monitor and submit reports on adverse infant reactions to the FDA.
However, none of the companies selling formula and other products containing the DHA and ARA oils have monitored reactions to these products and reported back to the FDA, according to the 2009 results of a FOIA request (PDF) made by Cornucopia. The 98 adverse reactions noted above were self-reported.
Martek's additives are now added to more than 99 percent of American infant formulas, according to the company, as well as baby foods, supplements, milk and other food products. This includes 90 percent (in 2009) of formulas certified as organic by the U.S. Department of Agriculture (USDA).
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