DHA/ARA in Infant Formula: Safe Food or Tricky Marketing Gimmick?

Since 2002, infant formula manufacturers in the United States have produced and sold products fortified with docosahexaenoic acid and arachidonic acid (DHA/ARA). These polyunsaturated omega-3 and omega-6 fatty acids are important components of the human brain and eyes and are naturally present in human breast milk. Since breast milk is the gold standard for infant nutrition, the addition of DHA and ARA in infant formula might very well be beneficial.

What is troublesome, however, is that some infant formulas contain DHA- and ARA-containing oils that are novel foods—extracted from laboratory-grown fermented algae and fungus and processed utilizing a toxic chemical, hexane. These algal and fungal oils provide DHA and ARA in forms that are structurally different from those naturally found in human milk. These manufactured oils are known as DHASCO and ARASCO, which stand for docosahexaenoic acid single cell oil and arachidonic acid single cell oil. Scientists have conducted numerous studies that show little or no benefit to an infant’s development from adding DHASCO and ARASCO to infant formula. Overall, research results are inconsistent and inconclusive. Meanwhile, the formula companies have advertised aggressively in an attempt to convince parents that their DHA/ARA formula provides the same nutrients, and therefore the same benefits, as breast milk.

The problems with DHASCO/ARASCO in infant formula go well beyond the way in which advertisements and labeling claims may contribute to the low rates of breastfeeding in the United States. FDA scientists who reviewed the novel oils have never affirmed their safety. Included among FDA’s reasons for not affirming the safety of these novel oils are the following issues: Some studies have reported unexpected deaths among infants who consumed formula supplemented with long-chain polyunsaturated fatty acids. 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 long-chain polyunsaturated fatty acids.

But the FDA has no legal power to stop the addition of ingredients such as DHASCO and ARASCO. The agency does not give approval for a novel ingredient in infant formula, it can only raise questions regarding a company’s petition for an ingredient’s generally recognized as safe (GRAS) status. At the request of the FDA and Health Canada, a panel of independent scientists was convened by the Institute of Medicine’s Food and Nutrition Board to take a critical look at tests performed for new ingredients in infant formula. They point to problems with Martek’s premarket safety tests for DHASCO and ARASCO.

Sam Heather Doak, a nurse in Ohio, says that the nursing staff at her local hospital’s neonatal unit refers to DHASCO/ARASCO-supplemented formula as “the diarrhea formula.” The FDA has received 98 reports from parents, caregivers, and health professionals who have witnessed or treated adverse effects that they linked to DHASCO/ARASCO formula, ranging in severity from vomiting and diarrhea, which disappeared as soon as the infant was given a non-DHA/ARA-supplemented formula, to babies treated in intensive care for severe dehydration and seizures.

Here is one example: My son began taking Enfamil Next Step Prosobee Lipil [with DHA/ARA] formula. He began having severe, explosive diarrhea. His stool was watery, loose, frequent, and smelled horrible. He was obviously uncomfortable and gassy and his bottom became quite irritated from all the diarrhea. He had to drink Pedialyte to rehydrate and he lost a considerable amount of weight. The diarrhea has lasted almost three months! He has had three stool samples done since December, all showing no sign of infection, bacteria or parasite. I read about the adverse effects that infants were experiencing from the Lipil formula and took him off the Next Step immediately. Today was the first day in three months that he actually had a firm stool with no sign of diarrhea. … My baby is not an experiment. Mead Johnson should be ashamed of itself for allowing this to happen and the FDA should take responsibility for our health and the health of our children.

Report extracted from The Cornucopia Institute. The full report can be found at http://cornucopia.org/index.php/replacing-mother-infant-formula-report/