In some ways formula has come full circle. The 1980s banishing of “animal fats” is now seen by some scientists as a mistake. Companies are likely to reintroduce processed milk fat in formulas where it presently does not exist. Of course bovine and human milk fats are not identical[ii], as calves have different needs from babies.
As they have for a century for different ingredients, industry tells us that:
“we now have promising [weasel words here] evidence that MFGM brings formula closer to mother’s milk, conferring similar cognitive benefits and other positive effects”.[i]
But research has indeed confirmed that in animals,
“Several individual components of the MFGM have been shown to be essential for brain development and are also known to be present at lower concentrations in infant formulas than in human milk, eg, sialic acid (5, 6), gangliosides (7–9), sphingomyelin (10–12), choline (10, 13, 14), and cholesterol.”[iii]
The health community needs to know what industry is saying about all this. So here I’ll cite – and annotate in square brackets – quotes from Anne Lau Heckmann of Arla Foods Ingredients, a Danish company that has created a bovine product, Lacprodan, designed to add back analogs of some of those components taken out:
“What is MFGM?Basically, the fat globules in milk are surrounded by a membrane containing many bioactive components vital for the healthy development of a baby’s brain and cognition, the immune system and the gut. [Since the 1970s and earlier in the USA and some other countries, many – not all – formula fed infants have lacked these vital ingredients] Our MFGM product is a natural whey protein concentration of these ingredients. [“Natural’ here meaning a heavily-processed base powder, bovine whey. The meaning of ‘concentration’ is unclear to me: is it just what is found in the whey protein concentrate they buy, or have they concentrated it by adding some other source? Whatever it is, it’s a long way from natural.] |
Arla’s evidence for claims of efficacy:
“A recent study…(Timby et al. 2014) has shown that feeding infants formula supplemented with MFGM (in this case our Lacprodan® MFGM-10) results in noticeably improved cognitive development at year one compared with a standard formula – performing at a similar level to a breastfed group.”[iv]
Such an outcome would be good news. But there were a few problems with this study:
- The definition of groups: as it often does, exclusively breastfed (EBF) meant only breastmilk at the time of inclusion into the study, not from birth; and “intention to breastfeed to 6 months” left the actual duration of BF unstated; in fact addition of other foods from 4 months was recommended. So probably few infants (or maybe none) were breastfed to the WHO template: exclusive from birth to around 6 months. That alters microbiomes. Which alters much else.
- This misnamed EBF group still did better on cognition than the formula-fed (who btw, might have been breastfed for two weeks, even EBF). “Similar to” is not “the same as”, especially when the poor definition of groups (problem 1) will definitely reduce outcome differences between them, ALWAYS in favour of the formula fed. The new formula may have “narrowed the gap” as the authors said, but it did not eliminate it, much less show any positive gain over breastfeeding. Yet parents will believe the marketing that clearly promises or implies superiority in cognitive performance…
- There were multiple differences between the formulas: not simply addition of more MFGM to an identical standard formula, but different formulas with reduced total bovine protein and calories – so simply giving less of both of those may have improved cognitive outcomes. It certainly could have altered brain development, which is influenced by amino acid concentrations and ratios.
So what was the effect of the added MFGM alone? No idea.
As an Institute of Medicine Report said
“..the safety (and efficacy) of any addition of an ingredient new to infant formulas will need to be judged against two control groups: one fed the previous iteration of the formula without the added ingredient, and one [truly exclusively] breastfed.”[v]
There were no such groups in this first study cited as evidence.
The second study Heckmann cites is a study in Peru, about which she says
“there was a significant reduction in the cases of diarrhea in 6 to 11-month old infants who consumed MFGM in their formula, which suggests a healthier gut and increased ability to fight infections. These results are very exciting, particularly for children at risk of gastric complications, and encourage us to continue to investigate potential uses for MFGM in the future.”
Some problems with that Peruvian study[vi],[vii]:
- It did not study infant formula at all; the MFGM product was added to the (older) children’s complementary foods. This tells us little about the safety and efficacy of an additive to the sole diet of the youn less developed infant.
- There was no discussion of breastfeeding in a population where breastfeeding at that age could well be common: Peruvian women have paid nursing breaks for 12 months. The group that got the MFGM may also have breastfed more.[viii]
- The protein source in the alternative complementary food was skim milk protein. Rather than MFGM reducing diarrhoeal incidence, the lactose in skim milk may have increased it. Without an EBF group we don’t have a baseline to judge by.
The third paper after these two described a small study in France and Italy.[ix] This was what is quaintly called a “non-inferiority study”. In these formula-only studies, the control group is not – as it should be – exclusively breastfed babies. It is infants being fed an accepted formula seen as the norm, with experimental groups being fed that same formula, or another, with varying amounts of the proposed new additive, in this case MFGM products. The primary outcome being assessed was simply weight gain. (Not even head circumference or length.) As the authors said, “limitations of the study for investigating other outcomes [like cognitive development and IQ, say] include its short duration and relatively small sample size, as well as the unequal allocation of subjects among groups, which may have introduced some degree of bias between the control and the experimental groups.”
Despite that, more the infants fed the higher dose of more protein-enriched MFGM formula developed eczema, more than three times as many. Small sample size, but wow!
In my experience, that sizeable difference should be a red flag for possible negative immune effects. Because not all formula-fed babies are “healthy full-term infants…whose mothers had chosen not to breastfeed beyond 14 days of the child’s life”. The list of exclusions from all such formula studies are always substantial, and raise questions about their value for a general population of infants who may subsequently be fed the formula from birth. (A bit like assuming that the results of studies on adult males apply to women.)
So this third study doesn’t reassure me about the safety of bovine-whey-protein-based-MFGM-additives – especially in populations where food sensitivity has exploded over generations of early-life exposure to bovine protein, with intergenerational transmission of immune disorder.
Where does that leave us?
The Arla Foods scientist went on to summarise the situation.
“There is still so much to figure out with MFGM. We are currently researching which components of this ingredient are responsible for which positive effects: Is it the same component that does everything, or the interplay of several components? And, while we can [perhaps, I say] see some of the [‘possible’, I would add here] overall effects, we are still trying to establish what the actual underlying mechanisms are.” [True]
Let’s translate that to plain English. According to the people who make MFGMs for use in infant formula, scientists don’t know:
- what components work, or
- how they work, or
- if they all need to be present to work (as of course they are in real milk)
Or – never mentioned – they don’t really know if there might be adverse effects of the wrong combinations, or amounts, of these heavily processed ingredients being added to the complex soup that is infant formula.
So it seems reasonable to say that until science knows HOW these things work, adding them, in guesstimate quantities of varying amounts of each, or only some, is simply another experiment whose outcome should be monitored lifelong. Especially looking for neurological issues and cognitive development, using MRIs to track early brain development…(As if that has ever happened!)
But – and this is the really big problem with infant formula research – in one sense, no one can know if or how MFGMs work, or if there are adverse effects of the various mixtures that will be patented and used, until enough babies have been volunteered as real-life guinea pigs by their loving parents. Effects across populations can be different from those in the carefully selected, strongest, healthiest, babies in other countries, perhaps born of healthier bodies. Outcomes may differ by gender, and that is only rarely an analytical variable. They can differ according to genetic factors not being measured. And, as the author noted, we still don’t know what, how much, etc.
Worrying about possibilities of negative effects is definitely not what the Arla Foods commentary raises. Rather, they ask the question –
“ one of the toughest tasks may be how formula manufacturers should communicate its benefits [suddenly it’s a proven benefit with no risks]. Because when you have a new addition to formula that [possibly] has such a range of effects, which one should you focus on? How do you get parents to understand the value of this discovery?”
The answer to Arla’s questions? Marketing. It’s not hard, and it has been happening. Arla Foods is aware that, surprise surprise..
“it seems the new ingredient has already grabbed some attention with parents, who are far more proactive and informed these days when it comes to understanding infant nutrition and choosing the best food products for their offspring. So MFGM looks set for a bright future in infant formula recipes.”
Remember, once again, industry, and we, and formula-buying parents, don’t know
- what does what,
- what quantities make any difference,
- what potential adverse effects might exist.
But suddenly for Arla there is no uncertainty? Benefit is proven because parents are looking for the product because it is being talked about? I don’t think so, not before we know more about eczema outcomes in predisposed children. Alas, such facts have never stopped marketing! Convincing trusting but ignorant parents is not hard.
And so now the marketing begins.
By now Mead Johnson has decided that this evidence is sufficient to start marketing a formula containing MFGMs in the United States, where a formula company simply has to notify the USFDA 90 days in advance of sales about any change to formulation[x]. Its “Enspire” formula contains both lactoferrin (which they say is “found in colostrum” – only in colostrum falsely implied, when lactoferrin is in ALL breastmilk) and MFGMs. And 6g/L of MFGMs.
And this apparently justifies a huge cost increase, “a suggested retail price of $39.99, which is approximately 50% more than Enfamil Infant and Gentlease.” Why? “The expense of the ingredients (due to their scarcity and the expertise needed to extract them from dairy sources) is driving the cost.” [xi]
Yet are they necessary, safe, and cost effective? As the IOM said,
“From a regulatory standpoint, the effect of an ingredient new to infant formulas is usually driven by a manufacturer’s desire to produce products that mimic the advantages of breastfeeding. This motivation implies that formula in its current state is inferior (e.g., relatively neurologically or immunologically less beneficial, although not necessarily unsafe) when compared with human milk.”
Parents never get that message of the ongoing inferiority of what they were fed themselves. For IOM “unsafe” means obviously damaging, toxic, clearly harmful. Most parents I know would assume that causing deviations in normal brain development is very likely to be harmful. To parents, unsafe means risky, needing to be proven completely safe. By those pushing the product. To the standard that is expected when breastfeeding is claimed to be better. (Even though it’s a no-brainer that millions of years of evolution does a better job feeding babies than a century of errors and corrections.)
Why don’t parents get the message of inferiority of all previous blends? Well, for a time most of the previous ones go on being sold when the new ones are introduced. And then look at the language. Groups like IOM talk about “the advantages of breastfeeding” rather than the risks and harms of formula feeding. (And “relatively.. less beneficial”, not “worse”!) Those risks and harms are both negative and positive: arising from
- what is not in formula (and can never be, in many cases);
- what is in it, which is more than the listed ingredients; and
- how it is prepared and fed.
So presumably MJ are indeed adding new ingredients, novel foods, which would require notification and independent assessment in some countries. I could not find references to studies testing these particular MJ mixtures. On their website MJ refers only to the three studies above, none of which used Enspire. If MJ did the research, why not publish it for independent assessment? Perhaps their research using their products showed no effect at all that would justify such a price increase? Will regulators check that?
In 2017 Asian supermarkets have a vast array of infant formula products mixed with their precursor and successor milk-based products. Aisle-end displays of Similac (Abbott) and local products are routine. In Vietnam I laughed at the unsubtle images on Similac Toddler formula of a lean active boy wearing a gold medal, clearly joyously winning a race, while a dancing giraffe (tall, lean, strong) smiled on. Subtle, that is not. Truthful? Ditto. Given formula’s links with obesity, it occurred to me that a more accurate depiction might be an inactive fat boy sitting glued to a digital device while a wallowing hippo looked on. What fun professional marketers could have with breastfeeding promotion messages that used the tricks industry does for formula marketing!
But then my eye was drawn down from the large giveaway boxes of brightly coloured packages of toys – inducements to buy two or more cans of particular milk products – to small bright gold tins adorned with an image of a pearl (attached to the tin by a gold thread.) Both gold and pearls convey strongly positive subliminal messages in Asia, a fact not lost on marketers.
This was Mead Johnson’s formula with milk fat globule membranes. And now I’ve had translated from Vietnamese, the claims and inferences on those expensive gold tins. They tout the importance of MFGMs directly, emphasizing (of course) cognition and growth, but going way beyond that to love and affection… translated, the four images used on their tin refer to speech, writing, physical skills and emotional connection.
The translation of accompanying material reads as follows:
“Support the development of the brain (beside image of child head with MFGM inside the brain); Join Enfa A+ SMART CLUB with lots of special benefits for mothers; Develop the cognitive power better from the start; and an image clearly referencing intellectual, physical, communication and emotional aspects.”
How do they say this industrial powder will achieve all that? On the second line in Ingredients, the bold text said: “mixture of refined whey protein – source of MFGM”. Was this a new ingredient that they have added, despite its scarcity and the small quantities available? (see above) Or was it simply MFGMs which happily could be found because of the less-refined whey mixture used? This is unclear, despite the accurate translator I had on hand. We concluded that possibly Mead Johnson products are using whey protein concentrate that is not fat free, and so MFGMs do exist in their formula. (For if they were adding back a product made from milk fats via a new process, regulatory approval for a “novel food” would need to be sought in countries like Australia which have defined Infant Formula Standards, and unlike the US Food and Drug Administration, don’t classify products as GRAS – generally recognised as safe- meaning they can be added to foods.)
What parents need to know
So, there’s some there. What quantity of MFGM is needed for any effect? Why were Lacprodan and other patented products created, if simply using this type of whey protein concentrate would be adequate to supply MFGMs? (Such deconstructed milk products come in multiple versions[xii]) Were the old high-solute formulas with milk fats better for brain development in this regard while worse in other ways (excessive amino acid and mineral levels, eg)? Are brains more important than kidneys? (And as an aside, why don’t renal researchers check out early feeding in kidney disease?)
Could we even now get some MRIs done on brains of artificially-fed infants in different parts of the world where a variety of infant formula products are in use? We know that brain white matter development is different in babies not breastfed.[xiii] What brand and product comes closest?
Should we ensure that all research comparing infant outcomes specifies the brand and composition of formula used, since it may be that some milk protein mixtures/processes result in more adverse outcomes that are concealed by the better outcomes of others?
Why do we assume that formula is all the same when it absolutely isn’t? Why don’t we have independent product comparison research to guide parental choice of infant formula when its use is unavoidable for whatever reason? Parents can know more about washing machine performance or soap powder than about the synthetic food that programmes a baby’s lifelong development. There are many more questions than answers….
How well I remember in the 1970s carefully comparing what was in each brand of formula and choosing the one that had some ingredient the others didn’t list. How little I understood composition and labelling in those days! How little do similar conscientious formula-feeding parents understand it these days! But unlike me, today’s parents can learn if they want to, by reading my book Milk Matters for a start, and going on to their own searches online, sifting science from industry marketing. And condemning any study that omits a control group of infants exclusively breastfed from birth. Most still do, despite the IOM’s statement that “Thus a breastfed control group should be part of experimental designs to assess the addition of ingredients new to infant formulas in order to provide a performance standard.”
As Arla Foods rightly said online:
“Of course, we [in the formula industry] all know that human milk will always be best for babies. Charlotte Vallaeys, senior policy analyst for the Food Safety and Sustainability Center at Consumer Reports puts it well when she writes: “Breast milk is an infant’s natural food, a living food that has hundreds or thousands of nutrients and components, many of which scientists haven’t even identified or understand fully.”
But most expectant parents don’t know that. And reactive ignoramuses – perhaps more politely described as formula advocates or infant feeding denialists- are telling pregnant women that the differences don’t matter, that public health advocates and legions of selfless volunteers just want to shame women like them. As if.
The bottom line for parents of all sexes and genders is this. They need to understand that every change of infant formula is a new experiment, one they may wish to participate in, or not. That is their responsibility, and their guess is as good as anyone’s about the risk/benefit ratio involved. Only they can know what pressures make formula necessary, and as Milk Matters makes clear, they are NOT responsible for being in a situation that makes formula feeding unavoidable, so guilt is simply inapplicable. (Though regret may be unavoidable.) Because comparative studies of brands don’t exist, no one can tell them what brand or product is the safest option for their unique child. So whatever decision they make, they should try to get as much information as possible, and consider all options, not simply assume the safety of an always imperfect shapeshifting product. And then they should get detailed and ongoing help and support to minimise potential harms of their feeding method. However they feed, all parents need that.
Regrettably, though not surprisingly, too many obstetricians (and doctors and midwives even) past and present, have been ignorant about infant formula risks and harms. Some still seem to feel obligated to continue their obviously poor past practice, rather than repenting about the harms done, learning what they need to, and informing and supporting parents with the most important health decision they will ever make.
Of course it takes real strength of character to admit that, with the best possible intentions, they have been responsible for harming not just one generation, but those to come as well. But as the World Health Organisation understands, there really is only one recommendation any health professional can responsibly make except in the direst of circumstances. That some parents will not wish to, or be able to, breastfeed does not relieve healthworkers of the obligation to inform them that “For the infant, formula is always the inferior choice.” And then to support whatever decision the parents deem best in their circumstances.
The science and ingenuity that goes into creating infant formulas is massive, and heavily subsidised. Yet women’s own milk is simply the best and safest option, firstly from the mother’s breasts, or by bottle, followed by wet nursing, then expressed donor milk, fresh or pasteurised, with formula as the 5th choice – not the second – in the considered opinion of the World Health Organisation.
This is not to say that there are no risks to breastfeeding or to the use of donor milk. There are, and the risks vary, some probably increasing with each layer of processing involved in feeding, just as with formula. Breastmilk is a complex biodynamic living tissue, and processing alters it. But that is a topic for another post.
So too is the issue of society making that live tissue safely available to all infants, just as we make other living tisues and organs available to those who need them, even at considerable expense. Infant formula is simply a stopgap in that social evolution, a wrong turn that will be righted as science reveals its costs, and the lawsuits begin. When a baby cannot be breastfed, many affluent educated parents are already accessing human milk for the first months of a child’s life.[xiv] It is a tragedy that so many women have no choice but to use an inferior product on the critical first year of life.
But to come back to the issue of formula marketing. Reckitt Benckiser (Mead Johnson’s new owner) must rein in the Vietnamese promotions of ENFA formulas that include gold, pearls, and prominent signs on the fences and walls of kindergartens, along with inducements to health professionals and parents alike.
And Reckitt Benckiser might use some of its profits to tell families everywhere that the most expensive infant formula can never be as good as the poorest mother’s breastmilk. Companies need to help correct the inanities being spread by advantaged denialists who have no idea of the consequences of their glib assertions that there are only minor differences between breastmilk and formula feeding.
Everywhere babies die, and women die young, because they didn’t breastfeed.
No one who ignores that fact is a true feminist.
And the additional collateral damage is vast and intergenerational.
No one who ignores that fact is a true environmentalist.
Feeding infants non-human foods in the first months of life
costs the planet and its families way too much.
What we feed them now does matter forever
Endnotes
[i] https://www.arlafoodsingredients.com/the-whey-and-protein-blog/health/can-mfgm-boost-babies-brain/
[ii] Bode L, Beermann C, Mank M, Kohn G, Boehm G. Human and bovine milk gangliosides differ in their fatty acid composition. J Nutr. 2004;134(11):3016–20.
[iii] Infant formula with probiotics and milk fat globule membrane components
https://www.google.com/patents/WO2011069987A1?cl=en
[iv] https://www.arlafoodsingredients.com/the-whey-and-protein-blog/health/can-mfgm-boost-babies-brain/
[v] Institute of Medicine. 2004. Infant Formula: Evaluating the Safety of New Ingredients. Washington, DC: The National Academies Press. https://doi.org/10.17226/10935.
[vi] Zavaleta N, Kvistgaard AS, Graverholt G, et al. Efficacy of an MFGM-enriched complementary food in diarrhea, anemia, and micronutrient status in infants. J Pediatr Gastroenterol Nutr. 2011;53(5):561–810.1097/MPG.0b013e318225cdaf
[viii] https://www.pri.org/stories/2015-08-06/these-are-best-places-be-breastfeeding-mother
[ix] Billeaud C Puccio G , Saliba E , Guillois B et al. Safety and tolerance evaluation of milk fat globule membrane-enriched infant formulas: a randomized controlled multicenter non-inferiority trial in healthy term infants. Clin Med Insights Pediatr 2014, 8:51-60] higher rate of eczema in the MFGM-P group (13.9% vs control [3.5%], MFGM-L [1.4%]
[x] The USFDA then acknowledges receipt, someone reviews the dossier the company supplies to justify the inclusion, and asks the company for post-market surveillance reports to be sent. None have been filed to date if a US public interest group is to be believed. The FDA does NOT approve any formula. And I have to wonder about how detailed or expert its review process has been, since its workforce and budget has been slashed by those since the 1980s by who think government regulation unnecessary.
[xi] Referenced and discussed in Milk Matters: Infant Feeding and Immune Disorder, p. 409
[xii] Outinen M , Rantamäki P , Heino A . Effect of milk pre-treatment on the whey composition and whey powder functionality. J Food Sci 2010, 75(1):E1-10; Damodaran SJ. Straightforward process for removal of milk fat globule membranes and production of fat-free whey protein concentrate from cheese whey. J Agric Food Chem. 2011; 59(18):10271-6. doi: 10.1021/jf201686v. Epub 2011 Aug 24. https://www.ncbi.nlm.nih.gov/m/pubmed/21830791/
[xiii] Referenced and discussed in Milk Matters, p. 60.
[xiv] Meanwhile, less advantaged and assertive parents have to make to do with formula based on animal and vegetable proteins that cannot replicate what women’s milk does. Women who are forced to formula feed – in societies dependent on them doing so – are given no strategies to reduce the risks to their own health and wellbeing created by not lactating after childbirth. Yet some denialisms, male and female, declare that they are feminists!