Organic advocacy group reports on ill effects of “omega-fortified” infant formulas, and their potential to reduce breastfeeding
by Craig Weatherby
At first glance, we were puzzled by the headline on a press release critical of “omega-fortified” infant formulas, which contain added omega-3 DHA and omega-6 ARA.
The headline reads: “Infant Formula Manufacturers Again under Ethical Cloud: ‘Marketing Gimmick’ Linked to Serious Illnesses.”
- Natural omega-3s from fish and fish oil are safe and beneficial for mothers, fetuses, and infants.
- Advertising for “omega-fortified” infant formulas, which contain omega-3 DHA and omega-6 ARA, may lead women to forgo breast feeding.
- Formulas fortified with specific omega-3/omega-6 supplements may induce diarrhea and other ailments in some infants, according to FDA files.
- Critics blame omega-fortified formulas that contain ingredients not found in breast milk.
DHA is the dominant fatty acid in human brain and retina cells, and one of the two key omega-3s in fish and fish oil.
Omega-6 ARA is also essential to brain cells, and to child development. But, unlike DHA and its plant-derived precursors, ARA and its precursors are abundant in the American diet.
(DHA stands for docosahexaenoic acid and ARA is the acronym for arachidonic acid.)
Six years ago this month, Mead Johnson® Nutritionals launched the first infant formula (Enfamil LIPIL™) fortified with omega-3 DHA and omega-6 ARA.
At the time, omega-fortified formulas were already available in more than 60 countries, including the United Kingdom, and the UN’s World Health Organization recommended the addition of these nutrients to infant formula.
Animal studies show the importance of DHA in eye and brain development, and DHA and ARA accumulate rapidly in children’s brains during their first postnatal year.
In addition, the results of epidemiologic studies suggest that breastfed children enjoy enhanced intellectual development in comparison with infants fed traditional formulas lacking DHA and ARA.
Finally, the hypothesis that omega-3-fortified diets could enhance child development has received strong support from studies involving children given fish oil: especially children with developmental difficulties.
Mothers can and do make omega-3 DHA and omega-6 ARA from other omega-3 and omega-6 fats in their diets, and pass them on to their fetuses and nursing infants.
But the average American diet is very low in omega-3s, so many pediatric researchers have advocated for adding omega-3 DHA to formulas.
Together, these facts have led researchers to conduct clinical trials designed to see whether omega-fortified infant formulas would enhance visual and cognitive development.Evidence favors omega-3-rich infant diets
The results of research testing the effects of omega-fortified infant formulas have been mixed, but generally favor addition of DHA and ARA to infant formula, to ensure adequate intake of these nutrients, and optimal child development (Auestad N et al. 2003).
Most studies in pre-term (premature) infants fed omega-fortified formulas show improved visual development in these children.
Omega-3s for mothers,
infants, and children
Here is what widely respected pediatrician William Sears, M.D., told us in response to our question about the proper intake of omega-3s by mothers and children.
“...experts attending a 2005 workshop recommended at least 300 mg [of omega-3s] a day for pregnant and nursing mothers (most mothers get only 20-25% of this amount, unless they take omega-3 fish oil supplements). In our medical practice we have mothers take at least 500 mg of DHA per day during pregnancy and lactation.”
“The recommendation for infants is at least 200mg of DHA per day, which is the dosage added to infant formulas."
“Practically speaking, infants under one year old receive their omega-3s through mother's milk or fortified formula, but it is perfectly safe and perhaps even beneficial for infants to be given extra Vital Choice fish oil at a dose of around 300 mg a day* of DHA. I stress DHA rather than EPA because DHA is the main brain growth omega 3.”
*NOTE: There are as yet no official omega-3 intake recommendations for children over two years of age, so please consult your pediatrician.
A dose of 300 mg of DHA would be provided by 8 of our 500 mg Salmon Oil capsules, 4 of our 1000 mg capsules, or 1 teaspoon of our Liquid Salmon Oil.
But only about half of all studies in full-term infants fed omega-fortified formulas show improved visual and cognitive development, versus infants fed regular formula.
However, the clinical studies that did not show any developmental benefits generally used omega-fortified formulas that contained less DHA and ARA than Enfamil LIPIL™ and competing omega-fortified formulas provide, which approximate the worldwide average DHA/ARA content of human breast milk.
Last year, researchers from the Retina Foundation of the Southwest published the results of a study—funded by a grant from the National Institutes of Health— designed to compare the visual acuity and IQs of children who had been fed only omega-fortified infant formula (Enfamil LIPIL™) for the first 17 weeks of life, versus breast-fed peers.
At age four, the children fed only on the omega-fortified formula had visual and IQ outcomes equal to their breastfed-peers (Birch EE et al. 2007).
These positive results fit with what’s known about infants’ need for ample amounts of DHA and ARA… but they may overshadow concerns about the form in which infants receive these essential developmental nutrients.
Noting that research results have been inconsistent, the Canadian authors of a 2005 review of the clinical evidence still came to a conclusion that favors supplemental DHA and ARA for pregnant mothers and for premature and full-term infants alike:
- “Collectively, the body of literature suggests that… [DHA and ARA are] important to the growth and development of infants.
- Thus, for preterm infants we recommend… [DHA and ARA] intakes in the range provided by feeding of human milk typical of mothers in Western countries.”
- “The addition of… [DHA and ARA] in infant formulas for term infants, with appropriate regard for quantitative and qualitative qualities, is safe and will enable the formula-fed infant to achieve the same blood LCPUFA status as that of the breast-fed infant” (Fleith M, Clandinin MT 2005).
One part of the last statement—“…with appropriate regard for quantitative and qualitative qualities …”—underscores the wisdom of ensuring that infants receive DHA and ARA in forms identical to those in mothers’ milk.
Group critiques ill effects of unnatural elements in omega-fortified formulas
Last week’s critical press release came from The Cornucopia Institute, an organic foods and family farm advocacy group, which in their words, is “…dedicated to the fight for economic justice for the family-scale farming community …through research, advocacy, and economic development….”
The Institute’s release was titled “Infant Formula Manufacturers Again under Ethical Cloud: ‘Marketing Gimmick’ Linked to Serious Illnesses”, and its subject was a thorough new report by the Institute, titled “Replacing Mother: Imitating Human Breast Milk in the Laboratory”.
The Cornucopia report acknowledges that omega-3 DHA and omega-6 ARA are natural components of mothers’ milk, and could be beneficial additions to infant formula: “It’s true that DHA and ARA are important nutrients for developing infants —hat’s why they’re found in human breast milk” (TCI: Replacing Mother 2008).
In fact, the report includes this recommendation: “Fish such as [wild] Salmon are a good source of DHA and are typically low in mercury.”
But as Dr. Francis says in the Cornucopia report, “…we have also seen that some infants are experiencing side effects like diarrhea from consuming the manufactured DHA and ARA oils in formula” (TCI: Infant Formula Manufacturers 2008).
Report sees two problems with omega-fortified formula
The Cornucopia Institute outlines two major concerns about omega-fortified formula:
Problem #1: The misperception that omega-fortified formulas are equivalent to breast milk.
Mead-Johnson’s response to criticism of omega-fortified Enfamil LIPIL™
Here is the company response posted at the web site of the Marketplace public radio show, which aired a report on this controversy last week:
“Mead Johnson is confident in the safety and efficacy of our infant and toddler nutrition products. Our claims about Mead Johnson products which contain DHA and ARA are accurate, scientifically and clinically supported, and do not mislead consumers.”
“It is unfortunate that some individuals with specific agendas are unnecessarily frightening mothers by making these scientifically unsubstantiated allegations. Breast milk and infant formula are recognized by leading health organizations and health care professionals around the world as safe and effective methods of infant feeding.”
Concerning the first problem, the Institute’s press release included this quote from Kathy Eng, a former employee of the WIC (Women, Infants, and Children Nutrition) program in Houston, Texas:
“Since they added [DHA and ARA] to formula, many new mothers seem to believe that [this omega-fortified] formula is just as good for their babies as breast milk. It became much harder for us to convince mothers to breastfeed when formula ads claim that formula is as close as ever to breast milk.”
And as the Institute’s report reveals, surveys by the Office of Women’s Health of the Department of Health and Human Services show a spike in the proportion of women who believe that infant formula and breast milk are equally good.
In 2003, shortly after the launch of the first omega-fortified formula, only 12 percent of respondents agreed that infant formula and breast milk provide equally good ways of feeding infants.
But just one year later—following heavy advertising and publicity about omega-fortified formulas—the proportion of women who perceived formula and breast milk as equally healthful doubled to 24 percent.
And in August 2007, the Washington Post reported that the infant formula industry succeeded in pressuring government agencies to change the content of advertisements that were aimed at increasing the rates of breastfeeding in the United States.
Cornucopia’s critique of omega-fortified formula enjoys support from the National Alliance for Breastfeeding Advocacy, which joined the Institute in petitioning the FDA for a label alerting parents to the possible complications from omega-fortified formulas, at least as these products are currently made.
Problem #2: Adverse reactions tied to the DHA and ARA products used in most omega-fortified formula.
According to the Cornucopia Institute report, their Freedom of Information Act request produced 98 “adverse event” reports filed by parents, caretakers, and health professionals who witnessed and/or treated infants reacting badly to omega-fortified formulas.
And this record probably understates the problem greatly. An Institute of Medicine expert panel estimated huge underreporting of adverse infant-formula effects, in part because physicians, nurses or parents would not necessarily associate infant illnesses with formula. And the panel noted the lack of regulatory guidelines for health professionals, or requirements on manufacturers, in terms of safety surveillance of infant formulas (IOM 2004).
The adverse reactions reported to the FDA ranged in severity from vomiting and diarrhea that disappeared as soon as the infant was given a non-omega formula, to babies treated in intensive care for severe dehydration and seizures.
Finger pointed at specific omega supplement in infant formulas
Virtually all omega-fortified formulas feature DHA and ARA in the form of DHASCO and ARASCO: the proprietary omega-3 and omega-6 supplements made by Martek Biosciences Corporation.
Martek says its DHA and ARA are already in 80 percent of US infant formulas, including products from Mead Johnson, Wyeth, Abbott Laboratories, and Nestle.
Until February 2006, Martek was the only source of DHA and ARA the FDA had approved for use in infant formula: a list that now includes fish oils.
However, as the company said at the time, “Martek is not aware of any customer with plans to switch to DHA derived from tuna oil or any other fish oil sources for use in infant formula to be sold in the US” (Decision News Media SAS 2008).
Cornucopia’s critique makes these criticisms of omega-fortified infant formulas that contain DHASCO and ARASCO:
- Some infants develop diarrhea, flatulence, jaundice, or sleep apnea after being fed omega-fortified formulas. The Institute’s press release included this quote from Nurse Sam Heather Doak, LPN, “When I worked in the hospital’s neonatal ward, the nurses all called it ‘the diarrhea formula’. We’ve seen infants, tiny little humans, with diarrhea that just wouldn’t stop after being given this formula” (TCI: Infant Formula Manufacturers 2008).
- About five percent of the ingredients in DHASCO and ARASCO—hi-oleic sunflower oil, diglycerides, and “non-saponifiable materials”are not found in human breast milk.
- A small portion of the DHA and ARA in DHASCO and ARASCO occurs as pairs of DHA or ARA linked to triglyceride molecules. However, in human breast milk, only one DHA or ARA molecule is linked to each triglyceride molecule: a seemingly minor but possibly problematic difference.
- The DHA and ARA in DHASCO and ARASCO are extracted from fermented algae and fungus using hexane, a neurotoxic petrochemical solvent. (Martek, the maker of DHASCO and ARASCO, says that any hexane traces are distilled out of their omega fatty acid products.)
While we cannot vouch for the accuracy of the Cornucopia report’s claims concerning the risk to infants from omega-fortified formula, they seem to carry enough weight to prompt a closer regulatory look.
And it certainly is true that there is no substitute for breast milk. With its myriad irreproducible elements, only breast milk— ideally, milk containing omega-3s in abundance—can ensure optimal child development.
- American Public Media (APM). Mead Johnson response to Cornucopia report. January 25, 2008. Accessed online January 27, 2008 at http://marketplace.publicradio.org/display/web/2008/01/25/mead_johnson_response/
- Auestad N, Scott DT, Janowsky JS, Jacobsen C, Carroll RE, Montalto MB, Halter R, Qiu W, Jacobs JR, Connor WE, Connor SL, Taylor JA, Neuringer M, Fitzgerald KM, Hall RT. Visual, cognitive, and language assessments at 39 months: a follow-up study of children fed formulas containing long-chain polyunsaturated fatty acids to 1 year of age. Pediatrics. 2003 Sep;112(3 Pt 1):e177-83.
- Birch EE, Garfield S, Castañeda Y, Hughbanks-Wheaton D, Uauy R, Hoffman D. Visual acuity and cognitive outcomes at 4 years of age in a double-blind, randomized trial of long-chain polyunsaturated fatty acid-supplemented infant formula. Early Hum Dev. 2007 May;83(5):279-84. Epub 2007 Jan 18.
- Decision News Media SAS. Martek to supply Mead Johnson worldwide with exclusive deal. Accessed online January 27, 2008 at http://www.nutraingredients-usa.com/news/ng.asp?id=67869-martek-biosciences-mead-johnson-nutritionals-omega-infant-formula-dha
- Fleith M, Clandinin MT. Dietary PUFA for preterm and term infants: review of clinical studies. Crit Rev Food Sci Nutr. 2005;45(3):205-29. Review.
- IOM. Committee on the Evaluation of Addition of Ingredients New to Infant Formula (2004) infant formula: evaluating the safety of new ingredients. National Academies Press.
- Mead Johnson & Company. New Enfamil LIPIL™ the First and Only Infant Formula to Contain Additional Nutrients Important to Babies' Mental and Visual Development. Accessed online January 27, 2008 at http://www.meadjohnson.com/app/iwp/MJN/Content2.do?dm=mj&id=/MJN_Home/News/THE_FIRST_AND_ONLY_INFANT_FORMULA
- Olsen KE. Omega-3: The seafood industry’s new million-dollar business. Intrafish Meida, 2008. Accessed online January 27, 2008 at http://www.intrafish.no/global/industryreports/article159593.ece
- The Cornucopia Institute (TCI). Infant Formula Manufacturers Again under Ethical Cloud: ‘Marketing Gimmick’ Linked to Serious Illnesses. January 25, 2008. Accessed online January 27, 2008 at http://www.cornucopia.org/DHA/DHA_NewsRelease.pdf
- The Cornucopia Institute (TCI). Replacing Mother: Imitating Human Breast Milk in the Laboratory. January 25, 2008. Accessed online January 27, 2008 at http://www.cornucopia.org/DHA/DHA_FullReport.pdf