FDA Issues Warning Letters to Three Infant Formula Manufacturers

[danaross67]

@jeremyumc The CDC recommends a water temperature of 158 degrees F when preparing powdered formula. This is hot enough to kill cronobacter but is still well below the boiling point of 212 degrees F.

 

[jeremyumc]

@danaross67 That is so specific but also thank you and to everyone for explaining! I felt like I was losing my mind with the conflicting advice.

 

[danaross67]

@jeremyumc I does seem like an oddly specific temperature! However, when you realize that the Celsius equivalent is 70 degrees, it’s like “oh, okay.” So the water used to make powdered formula should be 158 F / 70 C.

 

[fetorahjesuslibertarian]

@danaross67 Also boiling point is 100C or 212F. 70 and 100 seem a lot easier to remember and less random than 158 and 212.

 

[kamga]

@jeremyumc It might denature the proteins but that wouldn't affect the nutritional composition. If anything it would just make it easier to digest. The digestive system needs to break it all apart to use anyway.

 

[peanutcm]

@jeremyumc I used kendamil (UK brand available at target) and the instructions state to boil water for each bottle.

 

[8weaponx]

@peanutcm UK midwife here. Boil the kettle for each bottle and allow to cool for 20-30 mins (gives a temp of around 70C). Then make up bottle, and cool bottle as a whole. That’s our advice.

Things such as the above is why we don’t recommend Prep Machines that add a cold shot, or making up bottles with anything other than hot water.

 

[scarlett95]

@8weaponx Please listen to Bryntripp! I know kettles aren’t as universal as they are in Ireland/England but it’s worth the investment.

Also with the multiple formula scandals from the US, I honestly don’t know why the guidance hasn’t been updated to boiling the water/letting it cool a bit at this point. It’s just not worth the risk.

 

[noldoxis]

@8weaponx I struggle with this, because my baby doesn't always use formula. She's 10 months and slowly weaning to solid foods. If you mix the powder formula with the boiled water and leave it to cool in the fridge, is there anything wrong with that?

 

[enduring_until_the_end]

@noldoxis Nothing wrong with that. As you add the powder to the boiled water, it sterilizes the powder. After that you can safely store it in the fridge for 24hrs.

 

[noldoxis]

@enduring_until_the_end Great to know, thank you!

 

[fetorahjesuslibertarian]

@jeremyumc If I'm stupid and wrong someone please correct me.

So I tried to look this up cause I imagine heat has to be involved in the process of making powdered formulas and also in sterilizing the liquid ones. On Wikipedia page for infant formula it has a section called 'current general procedure' and it explains that formula is pasteurized. So it is heated to kill off microorganisms at some point. So it's already heated.

Now I know regular milk is too but for instance when you get a latte that technically alters the physical composition of milk and you get foam. But I don't think that the same happens in this instance with boiling water and adding formula and letting it cool. So I'm honestly not sure but I don't think heating water to prevent Cronobacter would be advised if it compromised nutritional value. I would think they would just say no powder formula for you.

https://en.wikipedia.org/wiki/Infant_formula

 

[scarlett95]

@fetorahjesuslibertarian UK, Ireland and many European jurisdictions recommend using somewhat cooled boiling water precisely because of the risk of chronobacter. Not just because there may be a contamination from the factory but also once opened, the formula can is open to external contaminants from your home too.

 

[seanm112]

@fetorahjesuslibertarian Chemical engineer: I'm not familiar with the exact process in formula, but methods for shelf-stable pasteurization often involve getting the liquid very hot very fast for a very short amount of time (literally like 5 seconds) then cooling it down very fast. This brief shock of high heat will kill bacteria and whanot but won't affect the nutritional profile.

Whereas slow boiling and slow cooling would change the nutritional profile. Just for example: B and C vitamins are water soluble. When water boils, it evaporates, and some of those water-soluble nutrients go with it.

That being said, chemical/biological safety recommendations are based on risk:reward ratio.

So while boiling the formula does change the nutritional profile, it probably does so in such a minor way that it's worth mitigating the elevated risk they've identified with potential Cronobacter exposure. Whereas if there were no potential Cronobacter exposure to worry about, boiling wouldn't be worth the minor changes in nutritional profile

Hope that wasn't confusing. Just wanted to offer an explanation of why there is inconsistency in messaging around heat, pasteurization, etc.

 

[fetorahjesuslibertarian]

@seanm112 I love your ELI5 explanation and totally makes sense. Hopefully this will help someone else who stumbles on this with the same questions. Thank you!

 

[harbor]

@fetorahjesuslibertarian sorry what is this about? just warning letters on how to prep powdered formula? Is there anything wrong with these formulas? I have low reading comprehension pardon me

 

[noizyvegan]

@harbor Infant formula is treated more like a medicine than a food. Medicines have rigorous testing and investigation requirements.

In October of 2022, they notified the FDA that a batch produced over a month tested positive for a microbe that can cause illness in infants. The FDA feels the company did not do enough work to find out where it came from.

Companies are required to respond to these kind of warning letters and address the problem or they risk being shut down.

Does that help?

 

[peacetoall]

@noizyvegan Yes thanks