FDA: 'Simply Thick' Formula Risk to Infants

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Simply ThickPreemies are vulnerable to a host of problems that full-term babies aren't. One of those problems is a particular swallowing disorder, and the treatment seemed to be a naturally-occurring substance called xanthan gum that was packaged as a product called “Simply Thick,” to be added to breast milk or formula.

The FDA has now warned that this product had caused a life-threatening condition in 15 babies who used it, with two of them dying. So if you’ve been using it, stop and check with your pediatrician about next steps.

Here's what else you need to know ...

The FDA's press release says if you’ve been using this with a full-term baby (or big kid or adult), you shouldn’t have to worry about the adverse reactions. It’s only dangerous, apparently, to babies born before 37 weeks gestation.

The whole thing is so weird to me, because xanthan gum is familiar to anyone who tried to go fat-free or gluten-free at any point -- it’s the thing companies put in fat-free cream cheese and other gross, gross products that overly-diet-obsessed women (like me!) have tried over the years. But like all sorts of other things, like wheat and gluten and who knows what else, it’s not the ingredient itself that’s toxic -- it’s the timing. Premature babies’ guts can’t handle this usually-harmless and natural ingredient.

The condition caused by Simply Thick is called necrotizing enterocolitis, and the symptoms include a bloated tummy, green vomit, bloody poop, and general illness and food-fussiness.

The FDA still hasn’t figured out exactly why xanthan gum would attack babies’ intestines this way, but they wanted to get the word out to preemie parents right away.

Were you told to use Simply Thick? 


Image via Amazon

formula, recalls, safety

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kelli... kelli0585

I had never heard of this stuff for newborns.  Only for elderly people who had a hard time swallowing.


I'm noticing it says "honey" on the box.  That's not real honey, is it?

kreag... kreaganbrown

Honey is the consistency that it is thickened to, I believe. With thickener, there are different consistencies, such as honey, nectar, etc. There isn't any actual honey in it, the liquid is thickened to the same consistency as honey. Hope that helps!

kelli... kelli0585

Makes perfect sense! 


At any rate. . . .what a shame.  I can definitely see the need for something like this.  I hope they come up with a different alternative.

Xakana Xakana

All formula has a risk of necrotizing entercolitis. Introducing solids of any kind too soon can cause it, actually--rice cereal was associated with it a few years ago.


BTW, needing fat-free items isn't just for people dieting due to weight. There are medical conditions that require it, too. For a while, I had to be on a 7g of fat or less a DAY diet becuase any more was killing me, up until my surgery to get my gallbladder out :( I was very grateful for xantham gum at that point, lol! But yeah, not for little babeis!

jpfsmom jpfsmom

I used it (at doctor's recommendation) for my son after his nissin surgery, I didn't have any medical issues with hinm (he wasn't on it very long...maybe a month) but I hated dealing with it..

Kasey Comingore

i'm really glad i didn't use this for my preemie!  i had to thicken his formula bc he would aspirate it into his lungs and cause his heart rate and breathing to drop to dangerous levels.  i just had to use rice cereal though.  unfortunately sometimes you have to take the risk of feeding babies things that they wouldn't naturally need.  if my son had been born before medical technology, he would not have lived, and we wouldn't have to add thickener to his food.  you gotta do what you gotta do. 

winte... winterrose82

I'm very glad I was not told to use that with my preemie. While in the hospital we added Human Breastmilk Fortifier to my milk for his feedings, and when we got home, our doctor had us giving him 1 bottle of preemie formula a day in addition to my pumped milk. I feel awful for the families that lost their children because of this.

azpre... azpreemiemom

We used this for our preemie, but not until she was 3 months old and term. IMO, the risk is more due to the fact that it isn't sterile than the active ingredient.

GlowW... GlowWorm889

Actually, this makes perfect sense to me. Preemies also tend to have difficulty digesting breastmilk or formula because of the lactose (sugar) in it. They don't make enough of the enzyme that metabolizes it, especially those born before 35 weeks. Since the enzyme to break down this sugar is found in the intestines, it causes upset stomach, abdominal pain, failure to thrive, etc. Of course, not all preemies react this way, but it does happen. This could stem from a similiar issue?

nonmember avatar christina bain

My daughter (adopted) was born at 24 wks gestation and has been using this for 11 months now. She started in the NICU because she couldn't swallow and has been using it since we brought her home in November because of swallowing and vomitting issues. She will be having a heart surgery this fall and I was hoping after she recovers fully from this we would be able to wean her from it She will be a year and 3 months at that time. I am very worried about it but I know if it wasnt for this product my daughter would not have been able to come home from the NICU. She had been in there for over 5 months the last one just because of feeding issues. To us it was a life saver because without it she was going to have to have a G-tube. I hope she doesn't have any problems but I am still greatful for it.

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