2010 Update The safety of the ingredients - the US experience:
DHA enriched formulas (which use the LCPUFAs made by Martek) have been on the market for longest in the US. In such a large bottle feeding population this is where problems are most likely to show up. From the evidence available there does seem to be a subset of babies who cannot tolerate these formulas.
Senior scientists from the US Food and Drug Administration reviewed the safety of Martek's DHA and ARA and had serious concerns. They stated in their letter to Martek: "some studies have reported adverse events and other morbidities including diarrhea, flatulence, jaundice and apnea in infants fed long-chain polyunsaturated fatty acids." They recommended convening a panel of independent scientists to review the safety of these additives. Martek sent a lobbyist to Washington DC and a month later, the FDA issued their letter of "non-objection" for DHA and ARA. The Cornucopia Institute requested, through a Freedom of Information Act request, information regarding what happened during this meeting, but no records of the meeting were kept by the FDA.
The FDA clearly stated that they expected regular reports of post-market surveillance or scientific studies monitoring the safety of DHA/ARA. Cornucopia requested access to these reports, both from Mead Johnson and the FDA. MJ responded they had none because their formula is completely safe, and FDA responded they have never received a report regarding post-market surveillance of formula with DHA and ARA.
The Institute of Medicine's Food and Nutrition Board also pointed to problems with Martek's safety tests.
Blog from 2008
A Freedom of Information action in the United States has revealed that regulatory authorities permitted LCPs (Long-Chain Polyunsaturated Fatty Acids) to be added to infant formula despite evidence that these cause illness in some babies.
If you are using formula and you have noticed problems with diarrhoea, fusiness or breathing problems when using formula with LCPs please contact us and the other organisations mentioned at the end of this blog.
The findings come in a report from the Cornucopia Institute, which presents itself as "Promoting Economic Justice for Family-Scale Farming", and has worked to defend the organic classification for food from being weakened. It presented its report in partnership with the National Alliance for Breastfeeding Advocacy (NABA), which, like Baby Milk Action, is a member of the International Baby Food Action Network (IBFAN).
Most of the LCPs added to formula are produced by the company Martek. Specific types produced have the names DHA (docosahexaenoic acid) and ARA (arachidonic acid).
These are the products which formula companies promote as 'for brain and eye development' or as 'brain-building blocks' despite the fact that independent reviews of research by the Cochrane Library has found the claims are not supported by the evidence. See:
Now the Cornucopia Institute has uncovered scores of cases of illness attributed to the additives registered by the US Food and Drug Administration.
Its press release and report is available at:
It states in part:
---press release extracts
Martek’s products are extracted from fermented algae and fungus, with the use of the synthetic solvent hexane, a neurotoxic chemical. They contain only 40 to 50% DHA and ARA, with the balance being sunflower oil, diglycerides, and nonsaponifiable materials. Some of these components are not found in human breast milk, and the triglycerides carrying DHA and ARA are not identical to those found in human breast milk—and have never been part of the diet for human infants.
“This report presents a disturbing look at the addition of novel ingredients into infant formula,” says Marsha Walker, Executive Director of the National Alliance for Breastfeeding Advocacy. “The FDA has received scores of reports on the adverse effects of these ingredients, but, to date, the public’s only access to these is through Cornucopia’s Freedom of Information Act request. This report will help alert the health care community and federal agencies to some of the adverse effects of added DHA and ARA in infant formulas.”
While FDA officials had previously noted studies that reported diarrhea, flatulence, jaundice, and apnea in infants fed DHA/ARA-supplemented formula, they nevertheless did not block the use of the oils. That action gave the green light for infant formula manufacturers to add the oils to formula. Today, Martek boasts that 90% of formula in the U.S. contains its patented DHA- and ARA-containing oils.
NHS Direct describes apnea as follows : "Apnoea is when the airway collapses and is blocked completely, cutting off the flow of air."
The European Union has also cleared the way for LCPs to be added to formula. Its Scientific Committee found no benefit from doing so and did not make it a requirement, stating: "Having reviewed the available literature the Committee sees the evidence insufficient to set an obligatory minimum level of LCPUFA." It did suggest that there is no risk from the additives.
Evidence obtained from the US Food and Drug Administration and cited in the Cornucopia Institute report suggests, however, that there may be risks of illness and even death. It quotes an Food and Drug Administration response to a Martek application for its additives to be declared GRAS (Generally Recognised as Safe) available at:
---FDA response to Martek - extract
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.
The FDA also stated:
"In addition, CFSAN [Center for Food Safety and Applied Nutrition] noted that your notice had not accounted for the fact that the bioactive fatty acids ARA and DHA when consumed in mature human milk are part of a complex matrix that includes, for example, linoleic acid, alpha-linolenic acid, and other polyunsaturated fatty acids and that important physiologic considerations relative to the matrix are not accounted for by the simple addition of LCPUFAs to infant formula."
The documents obtained using the Freedom of Information Act application found 98 cases had been registered with the FDA by concerned parents. Some are quoted in the report. Here is an example:
“My son cannot tolerate the infant formulae with the DHA/ARA additives. Similac Advance, Enfamil Lipil, Good Start with DHA/ARA—every time he has tried a DHA/ARA formula he gets extremely gassy, fussy and has terrible gas pains. He does do better on the Similac Advance, which has less DHA/ARA than the other products. I can’t find plain Similac in my local grocery store, as they only carry the DHA/ARA formulae.
Why did the FDA allow the formula companies to produce these formulae without long-term testing???”
LCPs are already in formula in many countries and provide Martek with exclusive contracts and growing revenues. See:
The Cornucopia Institute also questions the use of Martek's additives in organic formulas. While conceivably it may be possible to argue that algae and soil fungus from which the LCPs are now obtained are organic, the cocktail of other chemicals from the extraction process are another matter.
In the US: "The Cornucopia Institute is urging parents of infants who have reacted negatively to formula with DHA and ARA to report these adverse reactions to the FDA’s Safety Information and Adverse Event Reporting Program."
And it is calling for warnings to parents. From its press release:
Cornucopia and the National Alliance for Breastfeeding Advocacy also announced that they are calling for a warning label on all formula containing DHA/ARA. The groups are petitioning the FDA for a label alerting parents of the range of possible complications from DHA/ARA-supplemented formula.
“Although many infants seem to be able to tolerate these materials, regardless of their efficacy, we know that some children face serious and even life-threatening impacts,” said Vallaeys [the report author]. “At a minimum parents need to be informed of the risks so they can immediately pull children off these designer formulas if health complications occur.”
As part of Baby Milk Action's safer formula campaign we would like to receive reports from parents in the UK who may have concerns that their child has experienced diarrhoea, fussiness or breathing difficulties specifically when fed with a formula containing LCPs. Click here to contact us. This is to help track the problem. We cannot provide medical advice in these cases and health workers should be consulted.
Concerns can also be reported to the Food Standards Agency office for your country (England, Ireland, Scotland or Wales). Find contact details for the officer working on baby foods at:
|DHA UPDATE 2010.pdf||220.12 KB|
|CALWIC UC Davies LCPF .pdf||441.02 KB|
|Cornucopia to Martek.doc||26.5 KB|