FDA Issues Warning Letters to Three Infant Formula Manufacturers

@his_word_is_truth I did exactly this for my preemie twins. It took much longer, and people looked at me like I was crazy when I shared, but it’s such a simple solution for a known (but thankfully uncommon) issue. Better safe than sorry IMO. I stopped once they were a little older.
 
@seven2014 I combo fed my baby and this is how I made up her formula: boiled water, poured the boiling water into the baby bottle, added formula, secured top, shook it up vigorously, put it in the fridge, then later tested the temp on my arm before feeding to baby.
 
@his_word_is_truth We use a instant water heater. Half hot, half room temp. Kills everything. We also do not use bottles that haven't been boiled. We wash, then boil to ensure all bacteria is eliminated. I don't trust the sanitizing machines.
 
@fetorahjesuslibertarian Kind of surprised to see Perrigo on the list. They make TONS of store brand stuff for pretty much every major retailer, and they always have excellent quality products and good scores on facility inspections. I always like their stuff.

(I work for a lab that tests store brand products for safety and efficacy; I haven’t been on the testing side of things in a few years though-I’m on the facility inspections side of things now)
 
@kashanali897 That's really interesting. I don't think any of the brands are bad. Like there are definitely formulas that fall under these umbrellas like Nutrimigen which I know some parents rely on. I'm thinking that certain bacteria are becoming perhaps more and more evasive but also it is SO easy to create contamination. I also think the particular bacteria is of note here too. It's a xerotolerant microorganism and it was first discovered in dry milk. It might just be the nature of the beast that this is a very tricky bacteria to deal with. Likely something every facility has to contend with at some point. (This is me speculating- a hunch, I have no proof of this.)

According to the CDC https://www.cdc.gov/cronobacter/sources.html formula becomes contaminated two ways- either from a surface/fomite or from an ingredient...which I could see an ingredient contaminating a surface. I imagine it can be really complicated to narrow this down (chicken vs egg here). My guess is the best they can do is test each batch before release, diligent and rigorous hygienic measures, and aggressive action when it comes up.

Also super interesting about your work, lab experience etc. Do you ever inspect facilities like the formula factories?
 
@fetorahjesuslibertarian Yeah in fact Perrigo is one of the companies my company works with, which is how I’ve seen their reports. They’re pretty meticulous with the manufacturing sites they use.

But generally speaking, the manufacturing standards for a product like that are pretty stringent; every raw material is usually tested for identity, strength, micro, heavy metals (when applicable), and a handful of other quality measures, then the finished batch is tested. Plus there are requirements for equipment cleaning and validation.

As another commenter noted, the factory was a recent purchase by Perrigo so it may have been in a non-compliant state before Perrigo bought it.
 
@pelegrinus It doesn't make ya feel good, does it?

But the cover letter does provide information about how to prepare powdered formula to help protect against Cronobacter.

Ensuring the safety of powdered infant formula at home: "...caregivers can also take extra steps to prepare powdered formula for these infant groups by heating water to at least 158°F/70°C to help protect against Cronobacter, adding the powdered infant formula and mixing, and then cooling the formula to body temperature (98.6°F) before feeding."
 
@fetorahjesuslibertarian Can I ask (someone might know) how strictly formula is regulated in the USA? I was shocked to see corn syrup in formula????? Is this normal? Is australia just particularly fussy about formula or is it just couched in different terms? I don’t understand
 
@leina In Australia corn syrup is labelled as glucose syrup, but it is also found in many formulas, particularly hypoallergenic formulations. It’s a perfectly safe, easily digestible source of energy, often used as a substitute for lactose.
 
@leina Breastmilk is high in glucose, ie blood sugar. Glucose is essential for infants' metabolic needs and development.

Most formulas contain lactose, which the body breaks down into glucose and galactose. But as we all know, some babies don't tolerate lactose well. So how do we get them the glucose they need?

Corn syrup is 100% glucose. The glucose found in corn syrup is identical to the glucose found in breastmilk, and the glucose your body would break down from lactose. It's just a form of glucose that's easier to digest.

I guarantee Australian non-lactose formulas use corn syrup. They just call it something else like glucose syrup, dextrose, etc.
 
@leina It is very highly regulated. This is what regulation looks like. If it was poorly regulated no one would be inspecting and there would be no letter for us to read.
 
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