So many things have been going on in Formula feeding world! Let's take a look at some of these newer updates and debunk a few myths along the way! & I know this is a long one - but one you definitely want to read through!
Kabrita Infant Formula is here!!
January 2024 means that our newest formula friend, Kabrita is officially available in the U.S.A.! This goat’s milk-based formula is made in the Netherlands and has been a long time friend overseas. In fact, they have been working for nearly 10 years to come to the U.S! Kabrita is the first official and long-term Goat’s Milk Formula to be FDA approved, so you can rest assured that Kabrita will be here for many years to come! Let's take a bit of a closer look at Kabrita!
Type Of Formula / Uses: Standard Formula; Goat's Milk Based; Best for term infants aged 0-12 months without concern for tolerance
Key Features: Goat's milk contains 'easier to digest' casein proteins (A2 primarily) versus the A1/A2 casein mixture found in cow's milk. Higher levels of oligosaccharide (a prebiotic)
Where Can I Get It?: Amazon or directly via Kabrita USA! As the year rolls on and moving forward, you can expect to see Kabrita in more and more of our favorite grocery retailers nationwide!
Check out Kabrita and learn more here!
Baby's Only Formula Glow Up!
Baby’s Only formula is starting 2024 with a GLOW UP! Check out the new labels and image and get acquainted with our friend’s new looks! The recipes remain the same, so rest assured - if this formula has been a hit for your little one, it will continue to be a hit! Baby's Only formula is considered to be USDA Certified Organic and they offer options from standard and gentle infant formula to toddler formula and junior formulas! Check out a few more fun facts below!
A few key things to know:
Baby's Only Premium becomes Baby's Only Complete Nutrition (darker Blue)
Baby's Only Gentle becomes Baby's Only A2 (Purple)
Baby's Only formula also provides these options:
Organic Pea Protein Toddler
Organic Gentle Toddler
Organic Sensitive Toddler
Goat Milk Toddler
Who is this formula best intended for?:
Considered to be a 'standard' formula
Term infants, age 0-12 months who can tolerate cow's milk protein / standard formula
Both Baby's Only Complete Nutrition and Baby's Only a2 formula contain cow's milk. This formula is NOT intended for infants with CMPA.
Toddler formulas are NOT intended for those under 12 months of age. Toddler formulas should also be used on a necessary basis - please speak with your pediatrician to see if this is a right fit for your child!
Where can I find Baby's Only?!
Check their website directly! (listed below!)
Target
Walmart
Whole Foods Market
Meijer
Albertson's
H-E-B
Sam's Club
Sprout's Farmers Market
2 quick takeaways when it comes to infant formula = Premium becomes Complete Nutrition ; Gentle becomes A2
Check out their website here! - https://babysonly.com/
Myth Debunk Time:
Formula Feeding / Breastfeeding and IQ:
One benefit* of breastfeeding I hear about time & time again🧐
“Breastfed babies have a higher IQ than formula fed”
🛑 Whoa. Stop right there. That’s a BIG deal!!
Isn’t it?? 🤨
This long debated topic is one that I'm not sure we will ever truly KNOW the answer to.
➡️The reality is… research & studies regarding this aren’t so clear cut. For one thing, ethics plays a big role. But some of the other limitations to these studies:
Genetics - this factor has shown to be between 40-80% of the IQ puzzle itself!🧬
Environment - socioeconomic status plays a role! Where does baby live and grow up? What opportunities are available? Is baby able to learn and grow in a safe space with adequate support?? *THIS has also been shown to play a huge role! Even if the genes are present, they won’t be expressed if under the wrong circumstances! 🤷🏼♀️ Kinda like trying to grow tulips in the desert.. there’s probably nothing wrong with the bulbs, just the wrong environment to grow 👀🌷☀️🥵
Maternal Intelligence- yes it falls under genetics, but this has also been identified as a specific factor in child’s IQ!🤰
Exposure to other hazards or pollutants such as lead, mercury, alcohol, certain bacteria’s, etc.🦠🚬
So what do the studies and facts say anyways?🧐
Observational studies have shown ~2.5-3.8 point increase in IQ in breastfed babies. Observational studies are just that though.. observations⚠️⚠️A formal definition of Observational Study: study draws inferences from a sample to a population where the independent variable is not under the control of the researcher because of ethical concerns or logistical constraints.
Wanna know an ABSOLUTE predictor of your child’s IQ?🤔
Malnutrition. Not getting adequate nutrition. Especially during those first 2 years of life. & whether that nutrition is achieved through breastfeeding, formula feeding, BLW, purées, or all the above.. baby must get ADEQUATE nutrition for brain development🗣️🧠
Now, go READ to that babe! 🗣️📖
What's Going On With Nutramigen??
Per the FDA website, the voluntary recall of Nutramigen by Reckitt / Mead Johnson has totally jet-setted and gone worldwide.
"What’s New
January 10, 2024
Products produced during the same finished product campaign as the U.S.-recalled product were distributed in at least the following countries: Argentina, Belgium, Belize, Canada, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Ireland, Israel, Jamaica, Mexico, Nicaragua, Peru, Poland, Spain, United Kingdom, and Venezuela. Reckitt/Mead Johnson Nutrition has indicated to FDA that the company has already contacted the regulatory authorities in each of the countries to determine the proper disposition of these products."
Um.... okay...
On December 31, 2023, Reckitt / Mead Johnson closed out our year by initiating a voluntary recall of Nutramigen infant formula due to concern for Cronobacter sakazakii contamination. Ya know, that same bacteria that has been associated with the Abbott / Similac infant formula recall that lead to the nationwide formula shortage..
At this time, there have been no confirmed illnesses associated with this batch of formula. But, I think it is important the we remember the culprit we are speaking of. Just as we saw with the Abbott / Similac formula, finding exact matches in the genome sequences of these bacteria has proven difficult. This could be for many reasons, including:
Minimal sample size in comparison to production size - perhaps this area of contamination was simply missed?! When we were uncovering the facts in 2022, we learned that the sample sizes of the tested product was often like a drop of water in a lake compared to actual production size. Meaning, this sample probably accounted for 1/80th of the formula present and produced at that specific time. It is known that contamination may not be evenly distributed is the product.
Various areas of contamination - perhaps one batch was contaminated when running through the drying process due to a crack in machinery while another part of the batch was contaminated through the water or packaging or what have you..
The craziest part though..?
Reckitt / Mead Johnson didn't exactly 'voluntarily' recall that product..
On December 14, 2023, the Israeli Ministry of Health notified the FDA that Nutramigen Powdered Infant Formula that had been produced and exported by Mead Johnson Nutrition in Zeeland, Michigan has tested positive for Cronobacter species per routine border testing. Israel initiated whole genome sequencing (WGS) on the sample. The results of this sequencing found Cronobacter sakazakii was present. This information was communicated to the FDA on December 28, 2023.
During this gap in time from December 14-28, the FDA did perform a 'for-cause' inspection at the Reckitt / Mead Johnson Nutrition facility in Zeeland, Michigan. This inspection took place on December 18, 2023. The FDA took environmental samples as well as samples of finished product from the same batch of Nutramigen formula. At this time, all testing conducted by FDA and Reckitt/Mead Johnson Nutrition has been negative for Cronobacter, however the investigation is still ongoing.
When the FDA received word from Israeli health officials on December 28, 2023 of the positive testing for Cronobacter sakazakii, the FDA immediately contacted Mead Johnson Nutrition, recommending a recall of the product. On December 29, Reckitt/Mead Johnson agreed to initate the voluntary recall of 675,030 cans of Nutramigen powdered infant formula. This initial recall focused on those cans distributed to the United States, however Reckitt/Mead Johnson also did acknowledge manufactured and completed product from this same time frame had also been distributed elsewhere, outside of the United States. Over the next days, Reckitt/Mead Johnson Nutrition began contacted the regulatory authorities in each country impacted to determine the next appropriate steps. As you see above, January 10, 2024, the list was updated to include many countries around the world.
One scary part to me? This seems to be a pattern here...
If you remember, last year, ProSobee Infant Formula was recalled due to concern for Cronobacter sakazakii contamination. During this review and inspection, many key things were pointed out regarding the Zeeland, Michigan facility.. (Sound familiar, aka Sturgis?). You can read the full report from August 2023 at the button below. Here are some major findings that stick out to me though...
*All quotes and findings below directly pulled from FDA report:
WARNING LETTER
Reckitt/Mead Johnson Nutrition
MARCS-CMS 654775 — AUGUST 30, 2023
"Your corrective actions submitted in response to the Form FDA-483 provided additional information about the contamination event and your rationale behind your product release. However, your corrective action responses did not indicate that you will evaluate your sanitation and hygienic control activities in making product disposition decisions if future product testing detects a pathogen."
"FDA’s previous inspection conducted from May 23, 2022, through July 7, 2022, documented observations pertaining to deficiencies in conducting a root cause analysis in response to Cronobacter positive findings within your environment."
"FDA’s review of your firm’s OOS Reports found that three (3) Cronobacter positive environmental samples, located in “critical” hygiene zones, did not contain the information as required by your procedures. These critical swabs were collected from the (b)(4) Room on September 6, 2022, the (b)(4) Bag Room on October 4, 2022, and the (b)(4) Bed Room on October 4, 2022."
"c. FDA investigators observed multiple water events in your facility during the inspection. Specifically, on February 7, 2023, the following water events were observed in the (b)(4) Tower:
In Room 57-401 (60’ elevation, high hygiene zone), a hose station located on the (b)(4) corner wall was dripping water onto the floor.
In Room 57-206 (level 2, medium hygiene zone), the steam vent on the air handling unit for (b)(4) of the (b)(4) bed was leaking water onto the equipment below.
Additionally, on February 9, 2023, FDA investigators observed a water event in the (b)(4) Tower. In Room 901 (118’ elevation, high hygiene zone), water was dripping down the side of the heat exchanger to the floor below. Water was also on the floor approximately (b)(4) away under the heat exchanger. A water event in this heat exchanger was previously documented in your firm’s Deviation Overview Report dated November 19, 2022."
"Wet conditions – such as those areas of a manufacturing plant where water occasionally wets the area, either intentionally as part of wet cleaning, or inadvertently as the result of leaking pipes or valves or roofs – are especially favorable for the growth of Cronobacter. An ideal growth and survival environment is one which periodically gets wet even if only once every few months and then takes at least one day or more to fully dry. For example, when equipment is mounted to the floor of the plant, water may seep under the structure of the equipment and then remain wet for many days. Organisms may grow to high numbers during the time the area is wet; when the area dries, the organisms will remain viable and when Cronobacter becomes established in a “niche” environment, it may be difficult to locate the organisms. In the niche environment, the organisms grow to very high numbers during periods of nutrient and water availability. The organism may spread to other areas of the food processing plant from this niche environment by various means including employee movement, forklifts and totes, air flow, and water used during sanitation."
"a. Zeeland Facility
On September 4, 2022, your Enfamil Prosobee Simply Plant-Based Infant Formula (Prosobee) powder product, tested positive for C. sakazakii. The Prosobee product was manufactured in a continuous production campaign that ran from August 29, 2022, through September 1, 2022. Upon FDA’s further evaluation of your sanitation activities and batch records surrounding this production campaign during our inspection in February 2023, FDA determined that your firm released adulterated batches of Prosobee into U.S. commerce. Ultimately, on February 19, 2023, your firm conducted a voluntary recall of these batches released within this production campaign. These batches of adulterated infant formula product left control of your facility between November 1, 2022, through January 26, 2023, and you did not notify FDA of this occurrence. (Based on recall effectiveness checks, FDA believes that your recall was effective and that you successfully removed these batches from the market.)"
Okay... like... WHAT though?!
The Nutramigen recall has reignited a few in the political world to take a harder and closer look at what is going on. One example of this is Pennsylvania Senator Bob Casey, who is demanding answers from the formula manufacturer. These answers were requested a few weeks ago - I wonder if he got them?!
Per the FDA website, "The FDA has taken numerous steps to enhance the safety of powdered infant formula through the development of a Cronobacter prevention strategy, enhanced inspectional activities, increased engagement with the infant formula industry, and by pursuing regulatory action when appropriate. The agency also sent a letter to manufacturers, packers, distributors, exporters, importers, and retailers involved in the manufacturing and distribution of powdered infant formula to share current safety information and call on the industry to take prompt action to improve processes and programs for the protection of our most vulnerable population. The agency remains committed to helping ensure an adequate supply of infant formula and giving consumers the utmost confidence that infant formula available in the U.S. is safe and nutritious."
The statements above are true really. The FDA has taken numerous steps of improvement! But it is clear, there remains quite a hike ahead. And we must keep going. We must make the changes and improvements necessary so these patterns stop. We all deserve it.
Recalled product batches information:
ZL3FHG (12.6 oz cans)
ZL3FMH (12.6 oz cans)
ZL3FPE (12.6 oz cans)
ZL3FQD (12.6 oz cans)
ZL3FRW (19.8 oz cans)
ZL3FXJ (12.6 oz cans)
The products have a UPC Code of 300871239418 or 300871239456 and “Use By Date” of 1 Jan 2025.
*If you have these products - contact Reckitt/Mead Johnson and DO NOT USE THEM!
*No Liquid / Ready To Feed formula is included in this recall. Powdered formula product only.
FDA website updates:
*TLDR = Recalled Nutramigen Infant Formula made its way to multiple countries and the concern was actually caught in Israel. Over the years, Cronobacter seems to be an issue for Reckitt / Mead Johnson based on the FDA inspection reports...
Baby Food and Fun Shop Resources:
Did you know that I have some formula and breastfeeding resources available to you?! Check out our Storage Guideline Magnets (available in formula, breastmilk, combo, and baby food!) + some of our PDF downloads available directly to you! A few topics include Formula Comparable Guide, Introducing Common Food Allergens, and Starting Solids Shopping Lists. + Many more to come!
Shop now: https://www.babyfoodandfun.com/shop
Phew, if you made it through this marathon Blog post of infant formula insights, you deserve a gold star for blog-reading endurance! Thanks a bunch for hanging in there with me on this formulaic journey. I hope you find this information and the resources available to be useful and helpful in your journey! Until our next blog adventure, happy reading and may your formula knowledge and confidence be as enriched as a well-shaken bottle. Cheers!
Thank you for your support and love in this space! It means more to me than you will ever know.
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Jessica Enderle, R.D., L.D.
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