Synthetic Oils in Infant Formula Could Be Making Babies Sick
Cornucopia, WI – For years, the USDA’S National Organic Program has failed to enforce federal organic standards that prohibit the use of certain unapproved synthetic substances in organic infant formula and other organic foods. The Cornucopia Institute, a Wisconsin-based food and farm policy research group, is taking action to rein in the practice with the re-filing of a formal legal complaint with the USDA calling for the removal of the additives from organic infant formula.
The additives, DHA and ARA, are nutritional oils grown from fermented algae and soil fungus, and are being added to most conventional as well as organic formula brands. They have been linked to serious illness in some infants.
“Consumers rightfully expect organic foods to be purer and safer than conventional foods — in part because federal regulations require that they be free from potentially harmful synthetic additives,” says Charlotte Vallaeys, Farm and Food Policy Analyst with The Cornucopia Institute, a non-profit farm and food research group. “But in the case of the synthetic, chemically extracted additives DHA and ARA, the system of federal regulations ensuring organic integrity was undermined by corporate lobbying and backroom deals during the Bush Administration.”
Cornucopia’s initial research, and a related investigation by the Washington Post, revealed that career regulatory staff at the National Organic Program (NOP) initially determined the addition of DHA and ARA to organic infant formula was illegal, but were overruled by the former Director of the program, Dr. Barbara Robinson, who has since been replaced as head of the NOP.
And, a recently completed investigation and report by the Office of Inspector General at the USDA was harshly critical of Dr. Robinson during her tenure overseeing the organic program.
Freedom of Information Act documents obtained by Cornucopia revealed that Robinson ordered her staff to misinterpret the organic standards — substituting an informal recommendation for an official rule — after she had been in contact with a prominent lobbyist working for the infant formula industry.
“I called [Robinson] up,” William J. Friedman, a lawyer and lobbyist with the powerful Washington firm of Covington and Burling told the Washington Post. “I wrote an e-mail. It was a simple matter.” The back-and-forth, he said, was nothing more than part of the routine process that sets policy in Washington.
The nutritional additives, produced by Martek Bioscience Corporation, are chemically extracted from fermented algae and soil fungus, using hexane, a petroleum-based solvent explicitly banned in organic production, before being added to infant formula. Parents have linked their infant’s suffering — severe diarrhea, vomiting, and other reactions that sometimes required hospitalization — to these synthetic additives. When switching their babies to organic formula without these additives, these parents noticed the chronic symptoms would vanish, sometimes literally overnight.
“Within 24 hours of switching to formula without DHA and ARA, we had a brand new, entirely different baby. She had no abdominal distress, she smiled and played … and for the first time ever we heard her laugh,” says Karen Jensen, whose baby suffered severe gastrointestinal symptoms from formula with these synthetic additives.
Infant formula makers claim that adding DHA and ARA to formula improves brain and eye development. However, two recently published comprehensive scientific review studies on the topic both substantiate Cornucopia’s findings that challenge these claims. These two meta-analysis studies collectively consider the results of 18 clinical trials, and conclude there are no proven benefits to DHA/ARA supplementation in infant formula.
Given reports of infants getting sick from these additives, and comprehensive scientific data showing there are no proven benefits to adding DHA and ARA to infant formula, The Cornucopia Institute has re-filed a formal legal complaint with the USDA’s National Organic Program to enforce the organic standards, which currently do not allow synthetic oils such as Martek’s DHA and ARA.
“With new management in place at the USDA and the National Organic Program, which has proclaimed we have entered the ‘age of enforcement,’ we are hopeful that the organic standards will finally be earnestly enforced,” says Mark Kastel, Cornucopia’s co-director.
In addition to organic brands of infant formula, such as Earth’s Best, Similac and Wal-Mart’s Parent’s Choice, some brands of organic baby food and Horizon milk are also being supplemented with the novel oils, that have never been part of the human diet.
Besides for the prohibition of hexane as a processing agent in organic food, non-agricultural synthetic additives of this nature are required to be reviewed by the National Organic Standards Board prior to inclusion in organic products. According to Cornucopia, a formal review of Martek’s additives has never taken place.
A lawyer for The Cornucopia Institute, Gary Cox, was also quoted in the Washington Post, in response to Robinson’s actions, “This is illegal rulemaking—a complete violation of the process that is supposed to protect the public.”
Concerned parents can find at least one brand of organic formula, Baby’s Only, that is made without Martek’s synthetic DHA/ARA oils. It is available at most of the nation’s consumer-owned food cooperatives, many specialty stores like Whole Foods, and online. In addition, some conventional prescription formulas are available without the supplements.
Parents who think their babies have suffered adverse reactions to DHA and ARA in infant formula are encouraged to contact The Cornucopia Institute or the FDA directly.
“Mothers and fathers who pick a can of organic infant formula from a store shelf should be able to trust the “USDA Organic” label. They should not have to check ingredients lists to ensure the product is truly free from unapproved additives,” says Vallaeys.
The Cornucopia Institute’s research paper, Replacing Mother, an investigation into DHA/ARA, can also be viewed here.
The manufacturing process for Martek’s oils likely includes genetically engineered organisms and neurotoxic synthetic solvents, which are both explicitly banned in organic production. According documents submitted by Martek to the FDA, the process to make their oils includes growing algae and fungus in a medium that is made primarily of dextrose derived from corn, yeast extract or a hydrolyzed vegetable protein, which is usually derived from soybeans. Given that the vast majority of corn and soybean products in the food supply are produced through genetic engineering, the likelihood that Martek’s DHA and ARA oils are grown in a medium of genetically engineered organisms is almost certain. The use of genetic engineering is, of course, strictly prohibited in organics.
In a document submitted to the Food and Drug Administration, Martek also specifies that they use a neurotoxic chemical solvent, hexane, to extract the oil. Martek writes: “The oil is first extracted by blending the dried biomass with hexane in a continuous extraction process.” Synthetic solvents such as hexane, which carry serious environmental and occupational safety concerns, are also prohibited in organic food processing.