Analysis: Concern mounts over infant formula additives*
|• Additives serve as marketing ploy?|
|• Formula getting more expensive|
|• Additives associated with diarrhoea?|
|• Limited progress on implementing WHO marketing code|
NEW YORK, 25 January 2013 (IRIN) - Yi Lee fell for the hype.
“After I saw TV ads claiming infant formula with DHA [docosahexaenoic acid] and ARA [arachidonic acid] can help with eye and brain development, I gave my baby formula,” said the 30-year-old mother in the southern Chinese city of Shenzhen. “Then I learned from books and doctors that breast milk is actually best.”
Lee is now nursing her nine-month-old daughter - a practice rare in China, where only 28 percent of mothers breastfeed, according to the UN Children’s Fund (UNICEF). Experts say that here and in other developing countries, nursing rates would be higher - and infants and mothers healthier - if it was not for the popularity of these formulas boosted with DHA and ARA.
Featuring doe-eyed infants and laughing mothers in newspapers, magazines, and on billboards, these ads are becoming a fixture in developing nations’ maternity wards (where nurses sometimes give free formula to new mothers) and in grocery stores (where saleswomen approach them in the nappy/diaper aisles).
Health experts have responded with alarm.
“Scientific evidence doesn’t support the industry’s statements about ARA and DHA,” said James Akre, a former member of the International Board of Lactation Consultant Examiners (IBLCE), which sets global standards for lactation and breastfeeding care. “The additives serve primarily, even uniquely, as a marketing ploy. China, the second-largest infant formula market after the USA, is the country that manufacturers are gearing up to saturate. But opportunities are also ripe in the rest of the developing world.”
Heath campaigners say that for decades, formula has consistently proven to be less healthy than breastfeeding - boosting the risk of diabetes, infections and other medical problems, and, when used exclusively, contributes to 21 percent higher infant mortality. They say that due to the addition of ARA and DHA, formula is now growing more expensive. And they warn that in developing nations, formula with additives is often being sold in a way that violates the recommendations of World Health Organization (WHO).
ARA (promoted as enhancing "visual acuity") and DHA (touted for advancing "neurological development") have been added to infant formula since 1997.
Both these long-chain polyunsaturated fatty acids are found in human breast milk and, in this form, contribute to eye and neurological development. But over the past five years, WHO and the Cochrane Collaboration, a London-based research organization, have published policy statements and studies concluding that ARA and DHA, when used as additives, do not improve infants’ development.
According to the US Food and Drug Administration, the scientific evidence is "mixed" over the benefits of adding ARA and DHA to baby formula, with no currently available published studies on the long-term impact.
“Scientists can’t make the same form of ARA and DHA that human breast milk contains,” said Elizabeth Myler, a spokeswoman for the US-based NGO that promotes breastfeeding, La Leche League International. “Instead, they extract it from fermented algae and fungus using a toxic chemical called hexane.”
Mike Brady, a spokesman for the UK-based NGO Baby Milk Action, said some infants have adverse reactions to plant-derived ARA and DHA, though it is “currently unclear if this is due to the components themselves, or to the chemicals used in processing.”
Health advocates charge that studies supporting ARA and DHA supplementation are conducted primarily by companies profiting from this practice.
Asked by IRIN to provide independent studies proving ARA and DHA benefits to infants’ health, a spokeswoman from additive-maker Martek Biosciences responded: “There is no reason to believe that the funding source would have any undue influence on the outcomes.”
Nestlé declined to comment, and Mead Johnson provided general data about ARA and DHA consumption, some of it 20 years old. While one 2010 report from the European Food Safety Authority did hint “small amounts” of DHA supplementation may help neurological development, that same authority rejected in 2009 Mead Johnson’s claim of infant health benefits from supplemented formula.
An independently funded 2010 report from the US-based research NGO Cornucopia Institute, which supports sustainable agriculture, warned ARA and DHA additives have been associated with jaundice, sepsis, colitis, and diarrhoea. The latter is one of the leading causes of infant death in the developing world.
And then there is the cost. According to the US Food and Drug Administration, DHA and ARA boost the cost of formula by 6-31 percent in the US. Though studies have yet to identify how much these ingredients are spiking prices elsewhere, ARA and DHA are now added to most brands sold globally.
Mario Tavera, UNICEF’s health officer in Peru, estimated exclusive formula feeding now costs an average US$575 for the first six months of life, prompting needy mothers to “over-dilute the formula or use other milks… thus leading to malnutrition, allergies, and even death,” he warned.
Breast is best
Experts recommend mothers nurse because it lowers their risk of anaemia (mostly caused by iron deficiency), breast cancer, diabetes, osteoporosis, and postpartum haemorrhaging. Breastfeeding also offers 98 percent protection from pregnancy during the first six months of an infant’s life, which, as Myler noted, “helps women in the developing world control the size of their families”.
For infants, breastfeeding is linked to a lowered risk of diabetes, obesity, respiratory problems, and sudden infant death syndrome, as well as a bolstered immune system.
Suboptimal breastfeeding accounts for one million infant deaths annually, and 10 percent of the disease burden in children, reported the UK publication, Archives of Disease in Childhood, in 2012.
For these reasons, UNICEF, WHO and other authorities advocate exclusive breastfeeding - no other liquids or foods - during the first six months of life, followed by continued breastfeeding until age two.
In the past, authorities recommended infant formula for the children of women infected by HIV. But in the last five years, researchers discovered that in the developing world, where HIV rates are highest, infants are more likely to die of diarrhoea if they are not breastfed than they are to contract the virus from an infected mother’s breast milk.
Studies also show the risk of transmission from breast milk is just 2 percent if the mother receives antiretroviral (ARV) drugs. As result of these findings, WHO is now recommending HIV-positive mothers breastfeed for six months, and the UN is urging developing countries to offer ARV drugs to all HIV-infected mothers. In 2009, about 53 percent of women diagnosed with HIV receive ARVs worldwide.
Though well-meaning donors often give formula in camps for refugees and displaced persons, health campaigners are working to change this practice, too, noting that even if women are malnourished, their breast milk is probably healthier than formula, and that breastfeeding promotes bonding and a sense of security vital for women and children facing upheaval.
Heath experts warn that in unsanitary conditions, formula can kill infants if mothers prepare it with contaminated water, or if they fail to sterilize equipment properly.
After commercial infant formula was introduced in the developing world in the early 1900s, cases of lethal diarrhoea spiked (and anti-formula sentiment mounted) leading to the penning by WHO in 1981 of its International Code of Marketing of Breast-Milk Substitutes.
Endorsed by UNICEF and quickly adopted by 150 of 194 WHO member nations (with the US, home to two leading infant-formula makers, voting against it), the code stipulated manufacturers should not distribute free samples to promote their products, that advertising should not “idealize the use of breastmilk substitutes”, and that packaging should include information on the benefits of breastfeeding.
Despite the code’s longstanding existence, Yi Lee still sees images of babies (initially Caucasian and now mostly Asian) in TV ads for formulas with ARA and DHA in Shenzhen.
Infant-formula-division sales at Martek Biosciences (based in Maryland in the US and owned by the Dutch company Royal DSM, the leading maker of plant-derived DHA and ARA) have spiked to $317 million annually. And the Penang-based International Baby Food Action Network (IBFAN) reports 23 percent of countries that have adopted the WHO code have not implemented it.
“The code is a recommendation, and not a treaty,” said George Kent, a professor at the University of Hawaii who has researched food, nutrition and ethics and is author of Regulating Infant Formula. “It isn’t legally binding, and it isn’t being enforced as companies work to market products containing ARA and DHA.”
Limited progress is being made to implement the WHO code. In 2011, the Pan American Health Organization released a report showing Latin America had made “significant progress” in constraining infant-formula marketing.
In May 2012, the World Health Assembly (a WHO decision-making body) passed a resolution to establish “adequate mechanisms” to deal with conflicts of interest in this realm. And in June 2012, the Archives of Disease in Childhood reported that India, which restricts advertising via its Infant Milk Substitute Act, had boosted its breastfeeding rate to three times the rate in the Philippines, where there are looser controls.
“Developments like these offer hope,” said Akre, former IBLCE member and author of the book The Problem with Breastfeeding. “But progress is difficult because this is a case of shoestring-budget NGOs battling large, deep-pocket commercial interests and their unfettered merchandising.”
Leading manufacturers (Nestlé, in Vevey, Switzerland; followed by Mead Johnson and Abbott Laboratories, both in Illinois in the US; and Danone, in Paris) are among the most successful corporations worldwide.
Fuelled by profits from the baby-foods market (which includes but is not limited to infant formula and generates $30 billion in global sales annually, with growth projected to reach $35 billion in 2016), these companies have funnelled money to projects like the Singapore-based Asia Pacific Infant and Young Child Nutrition Association (APIYCNA). Presented as an NGO, its membership actually includes seven infant-formula industry companies, including the four manufacturers listed above.
According to IBFAN, APIYCNA’s main aim is to foster sales in Asia, where infant formula sales are projected to grow the most by 2016, from the current $6 billion to an estimated $10 billion annually.
Health experts told IRIN they are concerned that in the developing world, formula makers’ marketing push may succeed just as well as it has in developed countries.
In 2004, just two years after DHA and ARA were introduced in the US, government surveys there showed the percentage of people who believed formula and breast milk were “equally healthy” had suddenly doubled. And in 2011, in the wake of heavy lobbying by infant-formula makers, the European Parliament fell short of the vote needed to prevent a disputed DHA claim from being made on formula labels.
“Formula makers have a powerful, pervasive influence,” said Myler from La Leche League. “But it doesn’t bode well for the world’s neediest mothers and infants, whose health is literally on the line.”
*This article was amended on 25 January to add a comment by the US Food and Drug Administration