CONTAMINATED DRINKING WATER, POWDERED INFANT FORMULA, & CRONOBACTER

“Today, waterborne illnesses due to pathogens in drinking water are endemic in the U.S., numbering 19.5 million cases annually, according to Kelly Reynolds at the University of Arizona.  EPA epidemiologist Stephanie DeFlorio-Barker reported that 90 million illnesses were caused by recreational waters, many of which are also drinking water sources.” Dated December 29, 2021 https://www.msn.com/en-us/news/us/congress-must-reform-the-safe-drinking-water-act-to-guarantee-the-public-right-to-know/ar-AASfNAC

"Among drinking water samples the presence of pathogenic bacteria (88%) is alarming for public health authorities.  The emergence of resistance and decreasing level of susceptibility of pathogens to a wide spectrum of antimicrobials is a matter of great concern, because it may limit the availability of antimicrobials for clinical management of water born outbreaks in future.”  “Pathogens from Drinking Water,” Quetta, Pakistan 2014 https://applications.emro.who.int/imemrf/Professional_Med_J_Q/Professional_Med_J_Q_2014_21_4_760_765.pdf

 

Back in the 1970’s friends of mine moved to New Orleans.  After living there for a few months they wondered why everyone they met drank bottled water.  At some point they asked someone why they didn’t drink the tap water in New Orleans.  They explained that the tap water was from the surface water of the Mississippi River.  New Orleans sits at the mouth of the River.  Up and down the River are many chemical plants, agriculture and pesticide industries. Barges and boats carry many consumer goods, and they have at times had oil spills on the River.  The main concern was about the cancer causing chemicals in the River contaminating the drinking water. But they also explained that the tap water tasted awful. [According to the records regarding the tap water in New Orleans, there have been no violations of the Safe Drinking Water Act for the last few years. [Safe Drinking Water Act https://www.epa.gov/laws-regulations/summary-safe-drinking-water-act

I suppose that situation described by my friends to me in the seventies made me more aware of some of the contamination issues of municipal water systems.  In the 1980’s I bought 5-gallon water bottles rather than drink tap water.  Back then the 5-gallon water bottles were glass, and too heavy for me to carry.  I don’t remember when those 5-gallon glass water bottles became plastic.  But I do remember the change in taste.  The water tasted like plastic, particularly if they sat out too long in the Florida heat. 

I never thought about possible pathogens in water, my concern at that time was about cancer-causing chemicals.  But after doing a search for articles on safe drinking water for this post, I now find myself concerned about the varied media statements regarding the safety of US drinking water, particularly in relationship to the safe preparation of powdered infant formula and the pathogen Cronobacter sakazakii.  One article I read quoted Professor Andrew J. Whelton, PhD of Purdue University that water from the tapwater delivered to buildings is not sterile.  https://www.insider.com/the-difference-between-purified-distilled-and-tap-water

 

We know that powdered infant formula is not sterile.  Is the pathogen, Cronobacter sakazakii found in water?  Yes, “Cronobacter sakazakii also known as Enterobacter sakazakii exists widely in our natural environment;  such as water, soil, plant roots, animal intestines, and even processed foods. The vitality of Enterobacter sakazakii is very tenacious.  It is resistant to cold, heat drying, acid and alkali, osmotic pressure, and ultraviolet rays.  It also has strong resistance to some disinfectants.  And if it is under adverse conditions, it will secrete adhesive polysaccharide [biofilms] to protect itself.”  And, “It can still survive when the milk powder is brewed with water below 70°C.” https://www.tellerreport.com/news/2022-03-03-cronobacter-was-found-in-milk-powder--can-i-still-drink-it-.Sy-fTPoTeq.html

Do we test for Cronobacter sakazakii in municipal water systems?  Not specifically.  Cronobacter sakazakii is considered “a yellow pigmented coliform.”  United States municipal water systems test for “total coliform.”  Total coliform is used as an indicator of bacterial contamination in the drinking water.  If the total coliform is too high, communities will get a boil water advisory alert.  In my small city in the last couple of months, we have had 3 boil water advisories for different parts of the city.  According to some papers I read, it is suppose to be rare to get a boil water advisory.  Not too rare this year in my city. 

“In the US there are 12-18m [million] cases of human water-borne diseases a year.  In developing countries it is possible that one in three hospital cases may be due to contamination of water.” –Professor Joan Rose, microbiologist quoted in the Guardian  https://www.theguardian.com/environment/2016/aug/31/cleaning-the-worlds-water-we-are-now-more-polluted-than-we-have-ever-been

 

Meanwhile, the CDC states, “The United States has one of the safest public drinking water supplies in the world.”—The CDC  https://www.cdc.gov/healthywater/drinking/public/water_diseases.html  The Environmental Protection Agency (EPA) regulates public drinking water. The US FDA regulates bottled water.  (Bottled water has its contamination issues, too.  Yahoo News had an article entitled, “The FDA Knew the Bottled Water Was Contaminated.  The Public Didn’t.”  https://news.yahoo.com/fda-knew-bottled-water-contaminated-150410025.html  Well water that serves less than 25 people is not regulated.

In my previous post I wrote about 6 different instructions on the safe preparation of powdered infant formula.  The Mayo Clinic on their website gives us another different instruction on safe preparation.  https://vwmcclain.blogspot.com/2022/03/the-scandal-of-cronobacter.html

The instructions are longer than what I am quoting.  I am focusing on the water preparation.

‘You can use any type of clean water—tap or bottled—to prepare liquid-concentrate or powdered formula.  If you’re concerned about the purity of your water supply, talk to your baby’s doctor or your water provider.  Many public water systems will test drinking water upon request.  If you use well water, boil it for about one minute and cool it to body temperature, 98.6°F (37°C) Measure the water after boiling it.” https://www.mayoclinic.org/healthy-lifestyle/infant-and-toddler-health/in-depth/infant-formula/art-20045791  

The instructions base their information on the belief that public water systems in the United States are the best in the world.  Therefore there appears to be little concern about the possibility of pathogens in the water.  The quality of municipal drinking water is dependent on where you live in your community, your plumbing, the season, and even what room your tap is located.  Here in Florida in the summer months the cold water tap is not cold but lukewarm due to the pipes being very warm in the ground.

Contamination of drinking water has other concerns besides pathogens in the water.  There is concerns about lead levels in water, particularly for people who live in older homes or apartment buildings.  We know that boiling for longer than a minute (longer for higher elevations) concentrates lead in the water.  PFAS chemicals, will also concentrate in water when boiled too long.  Nitrates are another contamination issue in areas that reside near agricultural areas.  A antimicrobial testing company lists the pathogens of concern in drinking water:  E. coli, Campylobacter, Jejune, Hepatitis A, Giardia lamblia, Salmonella, Legionella pneumophilia, Cryptosporidum (a protozoa that chlorine cannot kill).  Other concerns are pharmaceutical contamination and uranium in drinking water. 

Filtration of tap water is often suggested as a back-up plan for concerns about the safety of drinking water from the tap.  But good filters can be costly and must be replaced at certain intervals.  It is low income communities who are disproportionally impacted by contamination of their drinking water. There is a need to lower the risk of infant formula.  Exclusive breastfeeding should be the answer.  But as long as governmental agencies are unwilling to require all states to report Cronobacter sakazakii infections, and not test for Cronobacter sakazakii in water systems, babies will continue to get sick and some will die.

Copyright 2022. Valerie W. McClain

THE SCANDAL OF CRONOBACTER CONTAMINATION OF INFANT FORMULA

“Whose responsibility is it to control the advertising, marketing and promotional activities which may create a market in spite of health considerations?” Senator Edward Kennedy’s opening speech at the 1978 Senate Hearing—The Politics of Breastfeeding by Gabrielle Palmer pg.253

BACKGROUND

The scandal of contaminated powdered infant formula is that it maims and kills infants. What other product on the market can get away with a periodic wave of hospitalizations and deaths of infants, and still be in business? The intrinsic contamination of powdered infant formula is understood by most scientists, some attorneys, and ignored by governmental regulators; but parents of infants that are maimed or dead are blindsided by the revelation that formula is risky.  Parents believe that a product manufactured for infants must be safe, particularly since one can buy it in the grocery store. 

John J. Farmer III, who was employed by the CDC for many years, and in 1980 proposed the name, Enterobacter sakazakii (now named Cronobacter) stated in his 2015 paper, “My 40 year history with Cronobacter//Enterobacter sakazakii-Lessons Learned, Myths Debunked and Recommendations,”

“The powdered infant formula industry still cannot produce powdered formula that is free of bacterial contamination with Cronobacter, other Enterobacteriaceae [Salmonella is in this same Family], other pathogenic bacteria, and other microorganisms.  Until this happens, infants and others will be at risk of becoming infected when they ingest contaminated formula.” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4662064/

One of Farmer’s listed recommendations  to the US Government was that Cronobacter infection should be a reportable disease, and that the only state in the US that has made it a reportable disease is Minnesota.  Seven years later the situation in the US is that Minnesota is still the only state in the US that reports Cronobacter infections. 

So should we be surprised that it took the FDA 5 months from early September 2021 until mid February 2022 to have Abbott recall certain infant formulas manufactured in Sturgis, Michigan? Or that some time before the recall, Cronobacter contamination caused the Sturgis, Michigan manufacturing plant to destroy product without alerting authorities. A Politico article stated, “Inspectors found Cronobacter sakazakii in several environmental samples taken at the plant, FDA said.  They also found records suggesting the company had been finding the bacteria in the plant and had destroyed product because of the issue, according to the agency.”  https://www.fda.gov/consumers/powdered-infant-formula-recall-what-know

https://www.politico.com/news/2022/03/05/formula-recall-fda-abbott-nutrition-00014413

Powdered infant formula is not sterile. 

According to a 2015 research paper, “Cronobacter sakazakii grows rapidly in reconstituted PIF [Powdered Infant Formula], especially at 35°C [95°F].” https://www.frontiersin.org/articles/10.3389/fped.2015.00072/full

The conclusion of a paper in 2009 in the Journal of Applied Microbiology states, “The heat resistance of Cronobacter should not allow the survival of the pathogen during normal pasteurization treatment.  The use of hot water (≥70°C) [≥158°F] during reconstitution appears to be an effective means to reduce the risk of Cronobacter in these products.” https://sfamjournals.onlinelibrary.wiley.com/doi/epdf/10.1111/j.1365-2672.2009.04271.x

A more recent paper in 2019 in Microorganisma titled, “Outbreak History, Biofilm Formation, and Preventative Measures for Control of Cronobacter sakazakii in Infant Formula and Infant Care Settings,” states, “The study concluded that to fully inactivate a heat-resistant strain of C. sakazakii, temperatures of 70°C [158°F] or greater are needed.”  This is an important point and is omitted in the FDA website regarding safe preparation of infant formula.

IF ALL ELSE FAILS, READ THE DIRECTIONS, UNLESS THE DIRECTIONS ARE CONFUSING OR WRONG!

My personal motto has been the, “if all else fails, read the directions.”  Sometimes that works, and I never have to read the directions.  But sometimes I read the directions after what I am putting together doesn’t work.  The end result is that I have wasted a lot of time, and maybe the object I am putting together doesn’t look so good after redoing and redoing it.  Sometimes I throw out the directions, because they are so incomprehensible. I have replaced and put together ceiling fans, replaced shut-off valves to my toilet—and I didn’t read the directions and only had a minor flood on my bathroom floor!  I have seen directions put in a number of languages, and the English was as incomprehensible as the languages I did not know.  But the consequences of preparing powdered infant formula incorrectly may result in sickness and death for a infant.  For the parent it can mean heartache, depression, time taken away from employment, and massive hospitalization and medical bills.

I decided since the preparation of powdered infant formula is so critical, that I would look at instructions given by three infant formula companies, the FDA, CDC, and WHO.  I chose Abbott infant formula company, and Nestle Canada  and in US Nestle is called Gerber and their instructions are slightly different than Nestle Canada- with Canada recommending 2 minute boil time of water versus US 1 minute boil time)  

ABBOTT

“Ask your baby’s doctor if you need to use cooled, boiled water for mixing and if you need to boil (sterilize bottles, nipples, and rings before use.  If you choose to boil, follow these steps: 1.Bring water to a rolling boil for 1 minute then turn off the heat.  Overboiling can increase the concentration of impurities.” [lead is one of those impurities and does concentrate with boiling]  2. Let the water cool to room temperatures before adding formula.  Making formula with boiling water can cause clumping and decrease the nutrient value.”  https://www.similac.com/baby-feeding/formula-guide/how-to-make-a-bottle.html

NESTLE CANADA

First of all the Nestle Canada website states the need to consult the directions on the can/package of powdered infant formula.  Then water to mix with powdered must be boiled for 2 minutes and then cooled to room or body temperature 37°C. [98.6°F]

GERBER USA

Ask your health care provider if you should use tap, sterilized, or bottled water that’s designed for mixing with infant formula. Before using tap water, run cold water for at least 30 seconds.

• If you choose to sterilize water, bring it to a rolling boil for one minute and let it cool fully before preparing the bottle.
• Well water should be tested regularly, and often bottled water is the best alternative.
• If using bottled water, we recommend mixing formula with infant water that is fluoride-free. GERBER® Pure® purified water* is a fluoride-free choice specially designed for mixing with infant formula.

John J Farmer stated, “Always boil the water used in preparing formula, even if it is distilled or bottled water.” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4662064/

Some parents are under the mistaken impression that using bottled water, means that they do not have to boil it.  Pathogens have been found in bottled water.  Gerber has a purified water to be used with mixing formula.  Is their expensive bottled water pathogen free?  I don’t know the answer to that.  Boiling water inactivates viruses, bacteria, protozoa, and other pathogens.

THE FDA’S WEBSITE ON PREPARING INFANT FORMULA

The safety precautions of preparing infant formula on the FDA website, as well as their short video, seemed very concerned about homemade formula.  Then they do state that in preparing powdered infant formula “use water from a safe source,” and, “if not safe use bottled water.” No real explanation of the need to boil water or boil bottled water. The video states that the parent should call their health department to determine whether their water is safe.  Nothing is on the video about boiling water for use with powdered infant formula.                             https://www.fda.gov/consumers/consumer-updates/infant-formula-safety-dos-and-donts

THE CDC’S WEBSITE ON PREPARING INFANT FORMULA

• Use water from a safe source to mix your infant formula. If you are not sure if your tap water is safe to use for preparing infant formula, contact your local health departmentexternal icon.
• Use the amount of water listed on the instructions of the infant formula container. Always measure the water first and then add the powder.
• Too much water may not meet the nutritional needs of your baby.
• Too little water may cause your baby’s kidneys and digestive system to work too hard and may cause your baby to become dehydrated.
• If your baby is very young (younger than 3 months old), was born prematurely, or has a weakened immune system, you may want to take extra precautions in preparing your infant’s formula to protect against Cronobacter (see box). “

 https://www.cdc.gov/nutrition/InfantandToddlerNutrition/formula-feeding/infant-formula-preparation-and-storage.html

The CDC website is similar to the FDA website, but more informative. If the parent clicks on Cronobacter, they do get better information, and the need to not let the water temperature go below 70°C/158°F.  They also include a link to the WHO pamphlet on safe preparation of infant formula.  But the parent has to click on the Cronobacter link in order to get that information.

CLEANING & SANITIZING BREAST PUMP PARTS BECAUSE OF CRONOBACTER?

The CDC website also states the need to clean, sanitize and store breast pump parts. I am supportive of cleaning and sanitizing breast pump parts, but what does this have to do with the intrinsic contamination of Cronobacter in powdered infant formula? We seem to have picked up the belief or is the CDC implying that breastmilk is contaminated with Cronobacter?  Breastmilk is a liquid, not a powdered form of milk.  The research on Cronobacter has stated that powdered infant formula is associated with various dangerous infections.  We do have Human Milk Fortifiers manufactured by Abbott, but they are cow’s milk-based additives used to add calories, vitamins, and minerals to the breastmilk of premature babies.

What is notable is that the page on cleaning, and sanitizing breast pump parts is very long and detailed unlike the information given to formula feeding mothers on cleaning and sanitizing bottle- feeding equipment.  In sanitizing breast pump parts, the CDC states boil for 5 minutes.  But we know from reading CDC instructions on a different website on use of boiling water for bottle-feeding equipment, that boiling for over a minute is not recommended due to the concentration of impurities. https://www.cdc.gov/healthywater/hygiene/healthychildcare/infantfeeding/breastpump.html

MEDELA’S HOW TO CLEAN YOUR BREAST PUMP

The Medela breast pump company states sanitize once a day after cleaning, boiling parts for 10 minutes.  https://www.medela.us/breastfeeding/articles/how-to-clean-your-breast-pump-and-accessories

The CDC on a different website states boiling water for just one minute, to eliminate the concentration of lead and nitrates. https://www.atsdr.cdc.gov/emes/training/page2419.html

 

THE WORLD HEALTH ORGANIZATION (WHO) PAMPHLET ON PREPARING POWDERED INFANT FORMULA

The best information out there right now is still the WHO pamphlet on preparing powdered infant formula.  A number of research papers recommend this pamphlet. While it is dated 2007, it is still relevant and clearly written. They do call the pathogen we now call Cronobacter, Enterobacter sakazakii. https://www.who.int/foodsafety/publications/micro/PIF_Care_en.pdf

They recommend that water used to prepare powdered infant formula be no less than 70°C (no less than 158°F) The other websites on powdered infant formula preparation have a lot of flaws, particularly the Abbott website which makes it a choice for mothers to boil the water or not. The FDA website is poor and it is surprising that a governmental organization seems more concerned about homemade infant formula (it is concerning but not as much as infant formula contamination which impacts a lot of babies here in the US as well as world-wide).  The CDC is a better website but I have a lot of questions regarding Cronobacter contamination of breast pumps. Sanitizing plastic pump parts daily (boiling for 10 minutes recommended by Medela) seems relevant to anyone with a hospitalized infant.  But it would seem that the boiling for lengthy times would degrade the plastic over time and parts would have to be replaced more often.  Degradation of plastic might result in an infant ingesting microplastic pieces as well as other issues such as lead contamination.

The 2017 LACTALIS INFANT FORMULA CONTAMINATED WITH SALMONELLA

The Cronobacter/Enterobacter sakazakii contamination of powdered infant formula has been evident for decades. But powdered infant formula has been contaminated with other organisms such as Salmonella.  Like Cronobacter, Salmonella is associated with a variety of illness in babies, particularly affecting premature and newborn infants. Some babies do die and some are brain damaged, and some survive.  In 2017 there was a Salmonella contamination of infant formula manufactured by a French company, Lactalis. Twelve million boxes of powdered infant formula were recalled. I am sure that few people in the US have read about it.  I don’t remember it being in the news. That was 4-5 years ago, and we continue to have world-wide  contamination issues of powdered infant formula. It adds up to a lot of babies all over the world made sick by pathogens in their baby formulas.   And some of those babies do not survive. http://www.babymilkaction.org/archives/15630

https://www.theguardian.com/world/2018/jan/14/lactalis-baby-milk-salmonella-scandal-affects-83-countries-ceo-says

EXTRINSIC CONTAMINATION OF BREAST PUMP EQUIPMENT WITH CRONOBACTER

I did find some research papers that appeared to show that breast pump equipment has been contaminated with Cronobacter. Most of the babies were premature, and Cronobacter was found on personal pump equipment not hospital pump equipment, and since the pumps were contaminated the breastmilk became contaminated.  Some of those babies died and some were very sick.  They called it extrinsic contamination, because the contamination came from outside the product rather than from the product itself. Hospitals are notorious reservoirs of many pathogens, medical personnel can carry pathogens from one patient to another, if they don’t follow prevention of infection protocols.  Patients and parents can pick up pathogens from being in the hospital environment. Mothers who pump to provide breastmilk for their very vulnerable premature infants appear in these studies to transfer Cronobacter from their breast pumps.  Yet there was no discussion on how the bacteria got from the mother to the pump without the mother being infected. In these studies it was the mother’s failure to sanitize her pump, that caused her baby to be infected.  But is it the mother’s failure or is it a failure of the hospital to train their personnel on teaching patients about sanitizing any pump they use?  If a person picks up a pathogen in the hospital, might that person sue the hospital? Is there more motivation to perceive the situation as the mother’s fault? 

I only read 4 research papers (there are more than 4 papers) on this issue of pump equipment transferring Cronobacter to babies.  All the babies were preterm babies, and 3 of the 4 research papers blamed the contamination on the mother’s personal pump not being sanitized. Each research paper that I read was on one baby.  The CDC had this paper up on their website. https://www.cdc.gov/mmwr/volumes/66/wr/mm6628a5.htm#contribAff

The above CDC paper stated that “…microorganisms can multiply rapidly in expressed human milk,” cited (footnote 4) to a study done by the Ross (Abbott Nutrition now) Preterm Lipid Study.  My understanding, when I was an active IBCLC (now retired) has been that expressed human milk had components that inactivate many microorganisms.  Citing to a study done by a infant formula company (particularly now since it is Abbott infant formulas this year that have been contaminated with Cronobacter) seems to bring a level of bias into the CDC study.   The LLLI Breastfeeding Answer Book 1997 (pg 188) revised edition states, “Recent research indicates that human milk has previously unrecognized properties that protect it from bacterial contamination.” Has this understanding changed? With all the US patenting of human milk components by the infant formula industry and using human milk bacteria (genetically engineered) for probiotics owned by supplement companies, it seems highly unlikely that research has changed regarding the inactivation properties of human milk against bacteria, viruses, fungi, and parasites. Is it the hospitals fault?  Or is it the mother’s fault?  Who do we believe when push comes to shove?  Are we seeing evidence in these research papers?

CONCLUSIONS

In a study done in 2019 in Microorganisms called, “Outbreak History, Biofilm Formation and Preventative Measures for Control of Cronobacter sakazakii in Infant Formula and Infant Care Settings,” they state,

“Despite demonstrated health benefits [breastfeeding], and although a low rate of breastfeeding adds as high as $2.2 billion a year to medical costs in the United States, according to Centers for Disease Control and Prevention, most hospitals do not fully support breastfeeding.” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6463179

In a paper written in 2008 to the journal Surgical Infections titled, “Enterobacter sakazakii:  An Emerging Pathogen in Infants and Neonates,” the author states,

“Because of the ubiquitous nature of ES [Enterobacter sakazakii now named Cronobacter] and the mystery surrounding its pathogenesis, preventative measures by parents, infant formula manufacturers, and health care providers will be important in the prevention of ES-related infections.  We recommend a focus on simple preventative strategies such as the promotion of breast milk feeding [Valerie McClain believes the correct word would be breastfeeding not breast milk feeding].  Inclusion of warnings on powdered infant formula packages that they may be contaminated with ES, and abstinence from the practice of re-warming of reconstituted formula.” https://pubmed.ncbi.nlm.nih.gov/18687047/

It seems so simple, just promote breastfeeding and/or breastmilk feeding!  Yet we have an industry that makes billions of US dollars a year, and easily hires promoters of infant formula feeding.  Remember the Similac Ad (the Mommy Wars) on the internet that many people thought was a cute movie clip? Even when at the end it showed the word, Similac (the word was derived from the words, Similar to Lactation), people still refused to believe it was an advertisement. Remember the Fearless Formula Feeder?  She eventually got hired by AbbieVie, a spin-off company of Abbott.  She told mothers to collect infant formula coupons and used Similac infant formula coupons as an example. She suggested that mothers leave those coupons at stores.  Not much of a surprise to learn that she had been hired by AbbieVie.  How does one compete against the advertising budgets of the infant formula industry? How about the researchers who get paid to do studies that benefit the infant formula industry?  Will government regulation ever happen?

There is a need to pressure our representatives in the US Senate and House of Representatives to have an investigation into this issue and to make Cronobacter infection a reportable disease in every state.  When infant feeding choice becomes a death sentence for some babies, maybe we need to revisit the need for legislation to regulate advertising and promotion of infant formula?  Maybe we ought to actually enforce the WHO Code of marketing breast milk substitutes (which was signed by President Clinton in 1994) by creating legislation that saves babies and mothers? 

Copyright 2022 Valerie W McClain

DEATH, SADNESS AND TEARS; CRONOBACTER AND INFANT FORMULA

 "As subjects of research, breastfeeding and breastmilk have attracted much attention during recent decades, yet as academic careers thrive on discoveries of how breastfeeding works and what breastmilk contains, women and their babies are still prevented from fulfilling this unique relationship.  As knowledge about breastfeeding increases, so do global sales of artificial milks and feeding bottles."  by Gabrielle Palmer, The Politics of Breastfeeding, 2009 pg1.

A second US baby died from Cronobacter infection caused by Abbott’s infant formula. So far this makes 5 babies exposed to pathogens (4 cases Cronobacter, 1 case Salmonella) from Abbott Lab’s infant formulas. The following video news clip mentions that some moms have been seeking donor milk from milk banks due to the difficulty of obtaining infant formula from stores. No one mentions that mothers might want to consider relactation (reintroducing lactation).  Having relactated with my first baby, it is an option mothers might not be aware of and might want to consider. https://www.khou.com/article/news/nation-world/abbott-recalls-more-similac-formula/507-dd8aac3e-7c7b-4c49-963e-52e290ba71f2

In 2002 the FDA notified Health Care Professionals that milk-based powdered infant formula was the source of Enterobacter sakazakii (now called Cronobacter) infections. So officially we have known for 20 years that powdered infant formula is a risk for Cronobacter infections.  Yet only one state in the US is required to report Cronobacter infections.  How many babies must die, be injured, and/or hospitalized before all states are required to report this deadly infection? Where is the support for breastfeeding not just pumping breastmilk? How about maternity and family leave so that mothers can get breastfeeding off to a good start?

“Although the natural habitat of E. sakazakii [now called Cronobacter] is unknown, milk-based, powdered infant formula has been epidemiologically identified as the source of E. sakazakii infections, as was reported in an alert issued to United States Health Care Professionals by the United States Food and Drug Administration (USFDA) in April 2002. In addition to powdered milk-based formulas, powdered human milk fortifiers may also pose a hazard.” US Patent #7749724, entitled,”Flurogenic selective and differential medium for isolation of Enterobacter sakazakii, filed in 2006, assigned to Washington State University

 “Research has shown that the sources of Cronobacter spp. Contamination are mainly from these areas.” US Patent #10743544, entitled, “Method for inactivating Cronobacter sakazakii,” assigned to the Northeast Agricultural University of Harbin China.  The three areas are “hospitals, powdered infant formula, and the natural environment (soil, sewer, plant roots, and animal excrement).”

If an infant formula factory has contamination of Cronobacter and Salmonella within its facilities, isn’t it possible that it will not be just powdered infant formula that needs to be recalled, but also liquid formulas produced in the same contaminated environment? 

“[0016]It has been unexpectedly found that stable, concentrated liquid human milk fortifiers and concentrated liquid nutritional compositions can advantageously be prepared with a low water activity and/or low pH level.  The low water activity for example, a water activity of less than 0.90 and/or low pH, for example, a pH within the range of 4.6 to 6.5, of the liquid can reduce or even inhibit bacterial growth in the liquid such as Cronobacter sakazakii, preventing food spoilage.” US Patent Application #20140370153, filed in 2012, assigned to Abbott Labs

The result of Cronobacter infections on infants can be sepsis, necrotizing entercolitis (NEC), or neonatal meningitis.  Exclusive breastfeeding lowers the risk of all 3 sometimes fatal illnesses.  While researchers continue to repeat how rare Cronobacter is; this cannot be known, when only one state in the US is required to report this infection.

“E. sakazakii [now named Cronobacter] is a rare, but life threatening cause of sepsis, necrotizing entercolitis [NEC], and neonatal meningitis.  In general, the case-fatality rate varies from 40-80% among newborns diagnosed with this type of severe infections.” US Patent #7749724, “Flurogenic selective and differential medium for isolation of Enterobacter sakazakii, filed in 2006, assigned to Washington State University

“However, despite improvements in formula compositions over the past 10-15 years, formula-fed infants are still at a 6- to 10-fold higher risk than breast-fed infants.  The data suggest that human milk contains something else that is missing in formula  and protects breast-fed infants from NEC [Necrotising Enterocolitis].  Identifying the protective component in human milk as well as its mechanisms of action would pave the way for the development of desperately needed additional options to treat and maybe even prevent this devastating disorder.” US patent #9675649, entitled, “Disialyllacto-N-tetraose (DSLNT) or varients, isomers, analogs and derivatives thereof to prevent or inhibit bowel disease,” Lars Bode-inventor, assigned to The Regents of the University of California, filed in 2012

“In a large prospective multicenter study of 926 infants 51 infants (5.5%) developed NEC.  The mortality rate was 26%.  In exclusively formula-fed infants, the incidence was 6 to 10 times more common then in those who received human milk exclusively.  In those who received human milk and formula, it was three times more common than in the exclusively breastfed group…The comparison was more dramatic at more than 30 weeks’ gestation, when formula-fed infants were 20 times more apt to develop NEC than human milk-fed infants.” Lawrence et al., Ninth Edition Breastfeeding:  A Guide for the Medical Profession, 2022 pg.531-532.

“It was concluded that human milk feeding is associated with a significantly decreased incidence of nosocomially [from the hospital] acquired sepsis…” Lawrence et al., Ninth Edition Breastfeeding:  A guide for the Medical Profession, 2022 pg.532

“Breastfed infants rarely have bacterial infections of any kind, especially bacterial meningitis (Cochi et al., 1986; Fallot, 1980; Istre et al., 1985; Leventhal, 1986).” 2^nd Edition Breastfeeding and Human Lactation, Riordan & Auerbach, 1999, pg.641 

Infant formula is a mass-produced, manufactured, artificial food.  It has its risks. Are they acceptable risks? Do parents understand the risks?                                           Copyright Valerie W McClain, 2022