FDA Issues Warning Letters to Three Infant Formula Manufacturers

[fetorahjesuslibertarian]

https://www.fda.gov/news-events/pre...ng-letters-three-infant-formula-manufacturers

Please don't shoot the messenger! I have a baby due 10/01/2023 and I'd want to know about this and I feel like other parents have a right to be informed too. I've not seen this in any of my feeds or on the news so I thought it was worth a post. I dug around and didn't see one so I hope this isn't redundant. If you formula feed or plan on it then it may be worth reading the letters to see what's going on.

Excerpt as an example:

a. On October 17, 2022, you notified (b)(4) that a batch of ByHeart Whole Nutrition Infant Formula finished product had tested positive for Cronobacter spp. and was later confirmed as Cronobacter sakazakii (“C. sakazakii”). The infant formula base, which was a component of the contaminated finished product, was manufactured during a continuous production campaign at the (b)(4) facility from July 13, 2022, through August 23, 2022. The infant formula base from this campaign was then blended and packaged as a finished product at one of your third-party contract manufacturer’s facilities from September 15, 2022 through October 7, 2022.

Despite the discrepancy between the third-party laboratory and the internal conclusion within (b)(4) root cause analysis, neither you nor your subsidiary company, (b)(4), took any additional efforts to evaluate other routes of contamination that may have contributed to this event. Our review of your records obtained during the (b)(4) inspection show that you did not work with your third-party contract manufacturer to further investigate the origin(s) or root cause(s) of the finished product positive findings. As the parent company and entity making all product disposition decisions, it is your responsibility to investigate all aspects of the production process for your products,

They also found things like leaking skylights etc. The list goes on and that's just one letter. And this is from an offense committed over 6 months ago and they are just issuing warnings now.

Edit: This isn't intended to freak anyone out. Info about how to properly prepare powdered formula or avoid it is in the cover letter (quoted in the following)

Ensuring the safety of powdered infant formula at home

Parents and caregivers should follow manufacturer instructions for preparing powdered infant formula. For babies less than 2 months old, born prematurely, or with weakened immune systems the CDC recommends, if possible, using ready-to-feed liquid infant formula. Liquid infant formula is made to be sterile (without germs) and is the safest option for infants not receiving breast milk. However, parents and 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.

 

[sophian]

@fetorahjesuslibertarian Just a little background on how FDA Warning Letters tied to Inspection findings usually work, all 3 of these manufacturers issued voluntary recalls during their FDA inspections earlier this year/late last year.

At the conclusion of their inspections, the FDA, if they have findings, issue Form 483s which are basically warning letters in and of themselves. The Manufacturers then are given time to respond and correct the findings. If the manufacturers do not respond to and correct the issues to the FDA’s satisfaction they are then issued Warning Letters on top of the existing Form 483s which are also “sanctions” and a part of public record. This seems like it is/will be an ongoing thing for formula manufacturers.

 

[asurfpro]

@sophian Can you clarify the very last sentence?

 

[sophian]

@asurfpro The formula shortage in 2021/2022 was caused by several factors, one being general supply chain issues related to the global pandemic, obviously, but another being Abbott’s recall of Similac formulas due to potential chronobacter contamination from their manufacturing facility, similar to these three recalls/warning letters.

 

[naturefanatic79]

@fetorahjesuslibertarian News article about it. "The agency said parents and caregivers do not need to discard or avoid purchasing formula at this time."

The manufacturers in question are Mead Johnson, Perrigo, and ByHeart.

 

[fetorahjesuslibertarian]

@naturefanatic79 Thanks for sharing the article! More info always welcome.

It seems like in a lot of the cases the contamination was self-reported and self-contained. It just seems like the FDA is taking issue with specifics and pushing them to do more investigations and identify problems or sources of contamination. They also occasionally point to violation of specific regulations.

It also sounds like these companies have a small window to respond and take action. SO I'm curious about what happens in the coming weeks and if there will be any follow-up on the story or on the letters as to any resolution or outcomes.

 

[nrg23]

@fetorahjesuslibertarian ByHeart shut everything down and is only now going to become available again in Target over this so it appears they did take it seriously and have their own manufacturing plant or whatever now. Hopefully that leads to greater quality control. Things do happen anywhere and everywhere though. It’s part of manufacturing but obviously this is why testing/QA exists-to catch things early and before they go out.

 

[fetorahjesuslibertarian]

@nrg23 That's great! Do you have an article on it by any chance? I've tried searching but everything coming up mostly has to do with the FDA letter. I'm also probably not entering the right terms in the search engine but I'd love to learn more about this.

I did find that it's available at Target, like you said: https://www.target.com/p/byheart-whole-nutrition-powder-infant-formula-24oz/-/A-87956594 And I haven't found it retailing anywhere else.

 

[nrg23]

@fetorahjesuslibertarian I don’t remember where the article was-98% sure it was forbes or wsj. They are exclusively at Target per their insta, though. Their aug 22 post gives a quick overview of what they’ve done in this year/since the recall.

 

[francoisakafran]

@fetorahjesuslibertarian I had a baby right at the end of the shortage. It scared me enough into beating myself up to breastfeed for a full year, even though at times it slowly beat me up. I don’t trust these companies at all. This happens far too often.

 

[fetorahjesuslibertarian]

@francoisakafran It's really unfair that you had to go through this. I breastfed through the shortage too but I had very close friends that experienced the extreme stress of trying to feed their babies and it's really messed up and unacceptable.

 

[loveofgod220]

@fetorahjesuslibertarian I exclusively formula fed my first and will do so with my new baby due soon. In my province the guidance is to never give powdered formula to infants 3 months or younger as powdered formula can not be truly sterilized. The recommendation is ready to feed only. We use that for the first 6 months and then use a liquid concentrate. Liquid forms of formula can be properly sterilized before sale and are safer. If you use a liquid concentrate and need to dilute, always make sure you use filtered or previously boiled and cooled water.

 

[enduring_until_the_end]

@loveofgod220 Liquid is not readily available. Where I live, you are unable to buy it or even receive it from a doctor or pharmacy unless your baby has specific health conditions, and even then it wouldn’t be offered for months.

 

[his_word_is_truth]

@fetorahjesuslibertarian FYI, cronobacter etc isn’t an issue here in the UK as we use boiled water cooled to 70 degrees to make formula. Do that and it kills any bacteria. Just, do that if you’re going to use formula. There’s no reason you can’t.

 

[seven2014]

@his_word_is_truth Do you boil and cool the water before adding it to the formula? Or boil after mixing? I don't understand how the former would kill anything in the formula.

 

[his_word_is_truth]

@seven2014 Boil, leave to cool to 70, then mix. 70 is hot enough that it kills any cronobacter/salmonella in the powder but not too hot that any of the nutrients etc are fully killed off. It’s a risk v reward balance. It honestly shocked me that American’s are risking cronobacter for their newborns!

 

[fetorahjesuslibertarian]

@his_word_is_truth It's a failure to educate or disseminate information. People aren't risking it intentionally. They just don't know better.

 

[seven2014]

@fetorahjesuslibertarian Never heard of cronobacter before. My now-2yo was combo fed, I just used filtered water.

 

[his_word_is_truth]

@seven2014 I fully breastfed, my son didn’t have formula until he was 10 months and my husband picked up a feed. I didn’t know why it said to boil and cool, we just followed instructions. It wasn’t until the whole scandal a couple of years back that killed some US babies came out that I actually read into it and realised it was that one simple step that eliminated the risk.

 

[his_word_is_truth]

@fetorahjesuslibertarian I’m not suggesting they are, but here the formula companies include boiling and cooling in their ‘making’ instructions so even if people don’t know why they’re doing it, the regulators have eliminated the risk. I cannot believe your regulatory bodies don’t think adding this simple step to a known unsterile powder being given to the most health vulnerable category of human wouldn’t be worth it. Insane.