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New specialised infant formulas - evidence or experiment?

Something I've been wondering recently is how the safety of new breastmilk substitutes is established, what about those that are very different such as say lactose free or amino acid based?  If anyone has any further research links, please do share. Bear with me as this may be rambly!

Human milk is particularly high in lactose and infants produce "lactase" to break it down into glucose and galactose.  In fact human milk has the highest lactose level of all mammalian milk providing 40% of baby's energy requirements, particularly important to the rapidly growing brain and the nervous system. 

"Consider what effects a lactose-free artificial infant formula could have on the infant fed on it" (health-e-learning)

So I had a Google to try and dig up research around the subject of lactose free formulas - but it seems to be really thin on the ground.  I can't find anything that compares the outcome of infants fed lactose free formula compared to those breastfed or fed a standard formula - either in the short or longer term.  In fact I can't find anything period that compares outcome when infants get their energy from something other than lactose... I'm sure before sale they would need to run trials to show infants gained weight and appeared to be developing normally? but where are these studies and what period is this considered over? has anyone studied areas other than just growth such as the nervous system, brain development or rates of illness?

So I had another Google.
I found one article that mentioned a study that compared the outcome for breastfed, standard cow's milk fed and soy fed over a twelve month period - a dig later I found it.

Growth and development during the first year of life of infants fed breast-milk, milk formula or soy formula
If you're interested in reading the abstract, you can visit the link above - I think the last sentence is the most telling:
Statistically significant differences were observed mostly between breast-fed and formula-fed infants.
So surely given this someone is going to focus on researching this and also over a longer period than twelve months? There are markers in breastmilk that suggest a much longer term impact - but who will fund it?  I'm guessing no breastmilk substitute company is going to be spending the money examining this...

I then googled to find any studies pertaining to the brain and found this 2010 study:
CONCLUSIONS: The development of brain electrical activity during infancy differs between those who are breastfed compared with those fed either milk (infant formula) or soy formula, but is generally similar for formula-fed groups. These variations in EEG activity reflect diet-related influences on the development of brain structure and function that could put infants on different neurodevelopmental trajectories along which cognitive and brain function development will proceed.

Ah well that's reassuring then.

None of the above touched on lactose free - if a standard formula can show significant differences, what about one that removes a large component?  Or what about one that is an entirely different make up such as free amino acid-based hypoallergenic versions.  I would be really interested in any research anyone has on these - the long term results of only being fed free amino acids has surely been studied before use, but I'm suspecting probably not?  Interestingly even those who promote this type of formula state it is only appropriate if extensively hydrolised formula cannot be tolerated - why if it's so good?!

I then had a news item delivered that described a new fat free formula - it was far lower in calories as skimmed milk was used, energy was derived from "protein concentrate"; but protein in breastmilk is low and a minimal contributor to energy - so again what is the impact of this sort of substitute?

During my hunt I also found studies where various other ingredients had been added to breastmilk substitutes to try and improve outcome - some appeared beneficial, others not so - but what about all the infants fed formula before the "latest must have ingredient"? what about the infants that don't fare well in the testing?

I also realised that:
Manufacturers may propose the addition of a new ingredient to infant formulas by demonstrating the safety, not the efficacy (the capacity to produce an intended effect under the realistic situation of product use), of the proposed ingredient.
So as long as a product has been shown safe for infants, it can go in the milk - at what point is the line drawn?  it appears manufacturers can change the makeup of formula as suits, providing they use substances shown to be safe (and as this article highlights they regularly do based on price).  But doesn't research covering formula study typical formulation rather than a situation where someone has removed the fat or lactose or changed composition significantly in other ways such as removing fat?

I can totally appreciate that for mums who have a seriously ill infant from food related conditions,  something like a specialised formula may feel like the only answer (and at times it may indeed be).  But what is worrying is that if a baby is refluxy/unsettled even after mum has cut dairy/soya from her diet - some specialists are suggesting a specialist formula as the next step; even for those breastfeeding.  Despite the fact we know breastmilk has factors that support normal gut development; often without even looking in baby's mouth to see if other reasons for a problem exist or contacting a lactation consultant,  ie not as a last resort.

What's even more worrying is that some sources state if we do not consume lactose, we stop producing lactase - and thus become lactose intolerant.  Making an accurate diagnosis pretty essential!

What we also need to remember is that specialist formulas are hugely profitable - and that whilst manufacturers are not allowed to market these directly to parents, they can market them to Health Professionals....

It feels as though infant feeding and babies are almost one big experiment - very profitable but at what cost?


  1. Hi Armadillo
    Are you aware of the article "Formula Milk: A review of the evidence" by Rosie Dodds of the NCT in this months' Perspective Magazine? Very interesting, and broadly similar conclusions to yours. Extensive detail, and like you, she goes through the evidence carefully.

  2. No haven't seen that - is it available online? I don't get NCT mag...

  3. Yeah the whole thing has been one big experiment since they started using evaporated milk etc. Oops this one makes loads of babies die, let's try something else. It's been a big old game of russian roulette from the outset.

  4. "Infant formula advocates now advance some curiously contradictory arguments. We should trust current formulas to be good because they have the same name as products used over generations. But current products cannot fairly be compared with the older milks once sold as perfect foods under those names, and now considered unsafe: current formulas have not been demonstrated to do any harm. And even though we condemn the older formulas as unsuitable, neither they nor current formulas are guilt of having caused any harm to babies." Maureen Minchin, 'Breastfeeding matters', p224

  5. Let me know if you want me to find the NCT article for you, I will try to do so, email me or tweet me @birthology,