“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). “
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
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
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