DHA Safety Concerns

What Scientists Have to Say about Safety Concerns and Questionable Benefits of Martek’s DHA

Table of Contents:

SAFETY CONCERNS: Inadequate Safety Testing of Martek’s DHA and ARA

Scientists have raised serious concerns regarding the inadequacy of pre-market safety tests performed by Martek, to determine whether its oils, algal DHA-rich oil and fungal ARA-rich oil, are safe, especially for infants and pregnant/lactating women.

Food and Drug Administration. Scientists at the FDA expressed concerns regarding the safety of adding Martek’s DHA and ARA to infant formula.

“[The Food and Drug Administration] described specific scientific concerns related to the use of infant formulas containing long chain polyunsaturated fatty acids (LCPUFAs) such as the fatty acids ARA and DHA.”
- Alan Rulis, Ph.D. and Christine Lewis, Ph.D., R.D. FDA Center for Food Safety and Applied Nutrition, Response Letter 000041 (2001)

Institute of Medicine: A panel of scientists convened by The Institute of Medicine’s Food and Nutrition Board criticized pre-market safety tests of DHA additives:

“It is not clear whether assessments of body composition, immune response, auditory function, and temperament were conducted. Several of these tests are especially important to determine the safety of long-chain polyunsaturated fatty acids because theoretical concerns exist.”
- Institute of Medicine. Infant Formula: Evaluating the Safety of New Ingredients. National Academies Press (2004)

Failure to Perform Post-Market Surveillance. Concerned with the safety of Martek’s additives, FDA scientists requested rigorous post-market surveillance of infants consuming formula with DHA and ARA. Neither Martek nor infant formula makers using Martek’s oils have submitted such reports to the FDA.

2001: “The agency has not, however, made its own determination regarding the GRAS [Generally Recognized as Safe] status of the subject use of ARASCO and DHASCO. As always, it is the continuing responsibility of Martek to ensure that food ingredients that the firm markets are safe…FDA would expect any infant formula manufacturer who lawfully markets infant formula containing ARASCO and DHASCO to monitor, through scientific studies and rigorous post-market surveillance, infants who consume such a formula. We also would expect regular reports of such studies and post-market surveillance.”
- Alan Rulis, Ph.D. and Christine Lewis, Ph.D., R.D., FDA Center for Food Safety and Applied Nutrition, Response Letter 000041 (2001)

2009: “FDA has never received any reports or studies regarding post-market surveillance or scientific studies monitoring or evaluating the safety of DHASCO and ARASCO (Martek’s proprietary name for synthetic DHA and ARA oils) in infant formula.”
- FDA response to FOIA request 2009-3310 by The Cornucopia Institute. Signed by Hilario R. Duncan, sent June 5, 2009.

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SAFETY CONCERNS: Gastrointestinal reactions to DHA supplementation

Infants, children and adults appear to react with diarrhea and other gastrointestinal symptoms to formula or food with DHA supplementation.

Food and Drug Administration. When reviewing the safety of Martek’s algal DHA oil and fungal ARA oil, FDA scientists voiced concerns:

“Some studies have reported adverse events and other morbidities including diarrhea, flatulence, jaundice, and apnea in infants fed long-chain polyunsaturated fatty acids.”
- Alan Rulis, Ph.D. and Christine Lewis, Ph.D., R.D. FDA Center for Food Safety and Applied Nutrition, Response Letter 000041 (2001)

Agency for Healthcare Research and Quality, Department of Health and Human Services. The AHRQ commissioned a review of available data in 2005 to determine the effects of long-chain polyunsaturated fatty acids, including DHA, on public health. In their report, the scientists wrote that adverse events have been reported in studies of omega-3 supplementation:

“In pregnant women, the adverse events related to the omega-3 fatty acids intake were mild and transient, with nausea and gastrointestinal discomfort being the most commonly reported.”

“A variety of adverse events were reported in 71 studies.”

“The GISSI-Prevention Trial, that had over 11,000 subjects and a follow up duration of 182 weeks, reported the largest number of adverse events. This trial contributed about one-third of the total number of gastrointestinal complaints.”
- Lewin GA, Schachter HM, Yuen D, Merchant P, Mamaladze V, Tsertsvadze A, et al. Effects of Omega-3 Fatty Acids on Child and Maternal Health. Evidence Report/Technology Assessment No. 118. (Prepared by the University of Ottawa Evidence-based Practice Center, under Contract No. 290-02-0021.) AHRQ Publication No. 05-E025-2. Rockville, MD: Agency for Healthcare Research and Quality. August 2005

FDA Medwatch reports. More than 100 adverse reaction reports (as of 2009) submitted to the FDA’s Medwatch program can confidently be linked specifically to DHA algal oil and ARA fungal oil in infant formula. One example, out of more than 100 submitted reports:

Child was given Enfamil with DHA and ARA formula at two different times. Child developed severe diarrhea and constipation for three days, every time. When switched to Enfamil with Iron [without DHA and ARA] did fine. He is now X months old and doing fine.”
- report #61311, acquired from FDA Medwatch program through a Freedom of Information Act request

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SAFETY CONCERNS—Supplementation May Be Harmful

Recent research studies, published in peer-reviewed academic journals, suggest that great care must be taken with supplementation of omega-3 fatty acids, especially for infants, young children and pregnant/lactating women. Over-supplementation may lead to an imbalance of fatty acids in the body, with potential long-term health effects.

“The Excess group had elevated ABR thresholds (hearing loss) at all tone pip frequencies in comparison to the Control and Deficient groups… Consuming diets that are excessively rich or deficient in omega-3 fatty acids during pregnancy and lactation seems inadvisable because of risks for long-lasting adverse effects on brain development and sensory function.”
- Church, et al. (2009) “Abnormal neurological responses in young adult offspring caused by excess omega-3 fatty acid consumption by the mother during pregnancy and lactation” Neurotoxicology and Teratology, 31 (1): 26-33

“The differences in blood pressure, particularly among boys, suggest that early omega-3 long-chain polyunsaturated fatty acid intake may have adverse effects, which should be investigated in future studies.”
- Asserhoj et al. (2009) Maternal Fish Oil Supplementation during Lactation May Adversely Affect Long-Term Blood Pressure, Energy Intake, and Physical Activity of 7-Year-Old Boys” Journal of Nutrition 139 (2): 298-304

Modest levels of DHA alleviate oxidative DNA damage whereas high levels of DHA accelerate lipid peroxidation. Thus, DHA supplementation during pregnancy may exert oxidative or antioxidant properties via different mechanisms and depending on dosage.
- Shoji, H, Franke C, Demmelmair H, Koletzko B. (2009) Effect of docosahexanoic acid on oxidative stress in placental trophoblast cells. Early Human Development 85(7): 433-437.

“Girls born preterm and randomized to long-chain polyunsaturated fatty acid-supplemented formula showed increased weight, adiposity and blood pressure at 9–11 years, which might have adverse consequences for later health.”
- Kennedy K, Ross S, Isaacs EB, Weaver LT, Singhal A, Lucas A, Fewtrell MS (2010) The 10-year follow-up of a randomized trial of long-chain polyunsaturated fatty acid supplementation in preterm infants: effects on growth and blood pressure. Archives of Disease in Childhood 95:588-595

The Excess [omega-3 fatty acid supplementation] offspring had a higher incidence of presbycusis than the Control and Deficient groups and a persistence of other sensory/neurological abnormalities and lower body weights in old adulthood. In conclusion, omega-3 fatty acid over-nutrition or imbalance during pregnancy and lactation had adverse effects on life span and sensory/neurological function in old adulthood. The adverse outcomes in the Excess offspring were likely due to a “nutritional toxicity” during fetal and/or neonatal development that programmed them for life-long health disorders. The health implication is that consuming or administering large amounts of omega-3 fatty acids during pregnancy and lactation seems inadvisable because of adverse effects on the offspring.
- Church MW, Jen K-LC, Anumba JI, Jackson DA, Adams BR and Hotra JW (2010) Excess omega-3 fatty acid consumption by mothers during pregnancy and lactation caused shorter life span and abnormal ABR’s in old adult offspring. Neurotoxicology and Teratology 32(2):171-81.

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BIAS IN SCIENCE

In a letter, published in the British Medical Journal’s Archive of Disease in Childhood, scientists note their experience with bias in the field:

“We contend this field of research has been driven to an extent by enthusiasm and vested interest.”

“Our experience of publishing in this field has consistently been that publications supporting the addition of LCPUFA [DHA and ARA] to infant formula are more readily accepted and less criticized than those which do not support the intervention, or which raise potential concerns.”
- Katherine Kennedy, Alan Lucas and Mary Fewtrell , published in Archive of Disease in Childhood

The following letters in Pediatrics, are in response to a published study which found no differences in cognitive development between infants given formula with and without DHA/ARA, yet concluded: “adding both DHA and ARA when supplementing infant formulas with long-chain polyunsaturated fatty acids supports visual and cognitive development through 39 months.”

“This is not correct, or at the very least, is quite biased. A more accurate assessment would be: “The addition of DHA with or without ARA does not appear to inhibit growth in full-term infants.” There is no evidence given in this study to indicate that DHA or ARA “support” growth or development.”
- Dr. Michael Verive, Physician, Sinai Children’s Hospital

“What troubles me and what I found confusing was the authors’ concluding statement “providing both DHA and ARA when supplementing infant formulas with long-chain polyunsaturated acids supports visual and cognitive development through 39 months.” The results of their study indicate otherwise. In my opinion, this last sentence is at best misleading.
- Dr. Alvin Eden, Physician, Wyckoff Heights Medical Center

“I have read through this important article several times, and cannot find justification for the last sentence in the abstract and in the conclusion section of the paper: “In conclusion, DHA and ARA… support visual and cognitive development through 39 months of age.” It appears to me that the gist of the article is that there is no difference among the groups, and therefore it would seem there is NO support for the assertion that DHA and ARA are necessary.
- Dr. Lance A. Chilton, Pediatrician, University of New Mexico

As reported by the Canadian Broadcast Corporation in 2006, renowned scientist Dr. Ranjit Kumar Chandra was found to have fabricated results of studies that were published in peer-reviewed scientific journals. He had been hired by Nestlé to prove certain claims regarding their infant formula, and the results of his faked studies were exactly what the corporations had paid for. When fictitious results supported Nestlé and Mead Johnson’s infant formulas, but not Abbott Laboratories’ formula, the scientist explained:

“Well, [Abbott] didn’t really pay me enough to do [the study] correctly.”
- Canadian Broadcasting Corporation. “The secret life of Dr. Chandra.” Reported by Chris O’Neill-Yates and produced by Lynn Burgess.

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NO BENEFITS – Infants

Review studies and meta-analysis studies conclude that there are no proven benefits to infant development from adding DHA and ARA to infant formula.

2005 Review Article—American Journal of Clinical Nutrition

“[Randomized clinical] trials have often not shown an effect of long-chain polyunsaturated fatty acid supplementation on cognitive or behavioral performance, and some reviewers have considered that, overall, the evidence was insufficient to conclude that long-chain polyunsaturated fatty acid supplementation benefited development.”
- McCann, J.C., Ames, B.N. (2005) Is docosahexaenoic acid, an n-3 long-chain polyunsaturated fatty acid, required for development of normal brain function? An overview of evidence from cognitive and behavioral tests in humans and animals. American Journal of Clinical Nutrition 82, 2: 281–295

2006 Review Article—Journal of Specialists in Pediatric Nursing

“The majority of studies found the addition of DHA and ARA to have no significant effect on infant development. … More expensive formula with endogenous DHA and ARA is not necessary.”
- Wright, K., Coverston, C., Tiedman, M., Abegglen, J.A. (2006) Formula supplemented with docosahexaenoic acid (DHA) and arachidonic acid (ARA): a critical review of the research. Journal for Specialists in Pediatric Nursing 11: 100–112

2007 Review Article—Journal of Perinatology

“Studies in both preterm and term infants have not consistently demonstrated efficacy with long-chain polyunsaturated fatty acids supplementation of infant formulas.”
- Adamkin, D.H. (2007) Controversies in neonatal nutrition: docosahexanoic acid (DHA) and nucleotides. Journal of Perinatology 27, Suppl 1: S79–82

2008 Meta-Analysis—Cochrane Database of Systematic Reviews

“The results of most of the well conducted randomized clinical trials have not shown beneficial effects of long-chain polyunsaturated fatty acid supplementation of formula milk on the physical, visual and neurodevelopmental outcomes of infants born at term.”
- Simmer, K., Patole, S. and Rao, S. (2008) Longchain polyunsaturated fatty acid supplementation in infants born at term. Cochrane Database Systems Review. Jan 23;(1):CD000376.

2009 European Health Safety Authority—Rejection of a Health Claim

“On the basis of the data presented, the Panel concludes that the data presented are insufficient to establish a cause an effect relationship between the intake of infant and follow-on formula supplemented with DHA at levels around 0.3% of the fatty acids and a ratio ARA:DHA between 1.4:1 and 2:1 and the contribution to normal brain development in infants and young children from birth to three years of age.”
- European Food Safety Authority. Scientific substantiation of a health claim related to DHA and ARA and brain development pursuant to Article 14 or Regulation (EC) No 1924/2006. EFSA Question # 2008-212

2010 Meta-Analysis—Journal of Pediatric Gastroenterology and Nutrition

“The absence of any detectable benefit or disadvantage in Neurodevelopment assessed with BSID at the age of 18 months for all of the children or in any subgroup therefore provides evidence against beneficial effects of LCPUFA [DHA and ARA] supplementation on BSID at 18 months under the conditions of the trials included here.”
- Beyerlein, A, Hadders-Algra M, Kennedy K, Fewtrell M, Singhal A, Rosenfeld E, Lucas A, Bouwstra H, Koletzko B, von Kries R (2010) Infant Formula Supplementation With Long-chain Polyunsaturated Fatty Acids Has No Effect on Bayley Developmental Scores at 18 Months of Age-IPD Meta-analysis of 4 Large Clinical Trials. Journal of Pediatric Gastroenterology and Nutrition 50(1): 79-84.

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NO BENEFITS – Pregnant and lactating women

The following reviews conclude that no benefits exist for pregnant and lactating women from taking omega-3 supplements. Pregnant and lactating women are encouraged to consume adequate amounts of naturally occurring omega-3 fatty acids from foods such as low-mercury fish, flaxseed, walnuts, etc. as part of a wholesome and varied diet.

2005 Review by the Agency for Healthcare Research and Quality, Department of Health and Human Services

Pregnancy outcomes were either unaffected by omega-3 fatty acid supplementation, or the results were inconclusive.

2009 Conclusion by the Scientific Committee, European Food Safety Authority

The Panel concludes that there is insufficient evidence to establish a cause and effect relationship between the consumption of supplementary DHA during pregnancy and lactation and visual development in unborn children or breastfed infants.
- European Food Safety Authority. Scientific substantiation of a health claim related to DHA and support of the visual development of the unborn child and breastfed infant pursuant to Article 14 or Regulation (EC) No 1924/2006. EFSA Question # 2008-675

2009 Conclusion by the Scientific Committee, European Food Safety Authority

The Panel concludes that there is insufficient evidence to establish a cause and effect relationship between the consumption of supplementary DHA during pregnancy and lactation and cognitive development in unborn children or breastfed infants.
- European Food Safety Authority. Scientific substantiation of a health claim related to DHA and support of the cognitive development of the unborn child and breastfed infant pursuant to Article 14 or Regulation (EC) No 1924/2006. EFSA Question #2008-773

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