World Food Safety Day: who should be held accountable for the 9 US baby deaths?
IBFAN Statement 7th June 2022
Above: The baby formula shortage is prompting calls to increase support for breastfeeding, NPR May 30, 2022. “Parents are scrambling to find baby formula. Factories are working around the clock to make more … And military cargo planes are airlifting formula from overseas … If we did more to support breastfeeding, we wouldn’t be in this mess … ” Photo: Andrew Burton/Getty Images
IBFAN has worked since its founding in 1979 to ensure optimal feeding for infants and young children, citizens who are most vulnerable to food safety hazards. For babies who are not breastfed, the contamination of commercial baby milks and foods is particularly serious because these products are the sole source of food during the first months of life. Formulas are ultra-processed products that contain no anti-infective agents and provide no protection against disease or boost to the immune system. They are not sterile and it has been known for decades that they may be contaminated with pathogens such as Cronobacter sakazakii – that can, although rarely, cause serious illness in the first days or weeks of life with a mortality rate between fifty and eighty percent.(1)
As we join WHO in promoting World Food Safety Day, the failure of the US Food and Drug Administration (FDA) to investigate the unhygienic production conditions in the Abbott Nutrition infant formula factory in Michigan, is becoming clearer. Following Freedom of Information requests and whistleblower action, it seems that not just two, but nine US infants have died after consuming formula contaminated by the Cronobacter sakazakii and other pathogens, Salmonella, Clostridioides difficile and Shigella – a revelation made possible because Cronobacter illness is a notifiable disease only in Minnesota, the state where some of the cases were found. There were 25 reported severe infections among infants who were fed these brands, all of them leading to hospitalizations and 9 deaths. Of course, until these illnesses are notifiable in all countries the full extent will never be known. (2)
“The agency’s failure to respond quickly to health hazards at the Abbott Nutrition facility in Sturgis, MI, that released potentially contaminated formula across the country has provoked rare bipartisan outrage in Congress and equally rare apologies from the manufacturer. The shutdown and resulting shortage have also prompted calls for major changes in the FDA’s food safety division, along with questions about why one supplier dominates the market.” (2)
Just four companies – Abbott, Mead Johnson Nutrition (now owned by Reckitt Benckiser), Nestlé USA and Perrigo (makers of store brand formula) – control about 90% of its baby formula market. Because Abbott has nearly 50% of the market, the closure of its factory has led to a chaotic nationwide shortage and a crisis for many families that rely on infant formula for feeding their children (including those on the US Special Supplemental Nutrition Program for Women, Infants, and Children (WIC)). Until now, mainstream media has – perhaps understandably – focused on parents’ dilemmas and the children in the 50 states who have ‘reportedly been hospitalized as a result of the formula shortage.’ With the new revelation more attention is being paid to the intrinsic Cronobacter contamination. Scant attention is paid to the failure of Abbott and other formula companies to adequately warn parents of the risks or the global implications and the number of countries to which the products were exported. (3)
Abbott initially succeeded in rehabilitating its reputation by describing its action as a ‘voluntary recall’ and establishing ‘a $5 million fund to help families.’ While global food giants such as Nestlé who themselves have had numerous contamination problems over the years, presented themselves as rescuers – flying in humanitarian formula relief.
Underscoring the crisis is the failure of the US policy makers to consider recommendations such as the Global Strategy for Infant and Young Child Feeding as a human right for all. (4) The US is the only high income country with no statutory national paid maternity leave (5) and US parents are continually bombarded with commercial promotion that is forbidden by law in many countries.(6,7)
As noted by Elisabeth Sterken, Director of INFACT Canada and member of the IBFAN Global Council:
“The US policy has left citizens without Code regulation, trained health worker force, breastfeeding support and mandatory maternity leave for decades. This has not only benefited the U.S. formula industries but US exports also impact negatively on child health and survival globally.”
On May 18th, US President Biden invoked the Defense Production Act to ensure that U.S. baby formula producers can continue production and his launching of a new U.S. government airlift of formula from abroad. (8) During the 75th World Health Assembly the following week, the United States mentioned the critical importance of ensuring sufficient access to safe breast milk substitutes (when breastmilk is not available) and said support for breastfeeding was a priority programme area in the US Global nutrition coordination plan. But no mention was made of the formula crisis, the failure of the FDA and the important accountability questions and possibilities it raises:
- Will treating infant formula as a strategic commodity improve production standards, require regular independent scrutiny of products and protection from undue commercial influence?
- Will Salmonella and Cronobacter sakazakii infections become mandatory notifiable/reportable diseases in all USA states and other countries?
- Or, would such a decision create shortages of infant formula globally leading to manufacturers ‘cutting corners’ in food safety in order to meet demand?
- would it further institutionalize formula use on a global scale, undermining breastfeeding and boosting the power of the baby food giants?
- Or, will this, and former recent cases in France and Spain and new scientific evidence, lead to a strengthening of the Codex Alimentarius Code of Hygienic Practice and the updating of the WHO Nutrition and Food Safety 2007 Guidelines. These should be harmonised with the Codex code that applies to all powdered infant formulae and should specify reconstitution with water ‘no less than 70°C’ .
- Will formula labelling be generic, replacing idealizing claims, text and imagery with full and frank information about ingredients along with warnings that powdered formulas are not sterile and must be reconstituted with safe water at no less than 70° Celsius?
- Will the USA implement the International Code and Resolutions and provide essential supports for breastfeeding, re-lactation, donor milk sharing and banking, statutory maternity leave, protection from commercial promotion and overall safer infant and young child feeding? (9,10)
1 In 2000, health care professionals were alerted to mortality and morbidity caused by infections species of Salmonella and Enterobacter/Cronobacter. Two World Health Assembly Resolutions were adopted in 2005 and 2008 calling for explicit warnings about intrinsic contamination on packages. The World Health Organisation (WHO) and Food and Agriculture Organisation (FAO) convened three expert meetings and prepared Guidelines on the safe preparation, storage and handling of powdered infant formula.
It is highly likely that many infections are unidentified because there are few facilities to perform tests on body fluids of sick babies and correlate these with the content of unopened powdered formula packages. Often this packaging is discarded, and the evidence disappears. Complex testing is needed to prove a causal link with the serious infections in infants and young children to powdered formula. In 2002, it was noted that “Enterobacter sakazakii could be recovered from 20 out of 141 samples (14%).”
2 Nine baby deaths reported to FDA during Abbott Nutrition investigation, Food Safety News, 8th June 2022
Publisher’s Platform: Abbott and public health officials have failed in their duty to protect the most vulnerable“According to the CDC, Cronobacter can cause severe, life-threatening infections or meningitis. Although Cronobacter infections are rare, they can be deadly in newborns in the first days or weeks of life with a mortality rate between fifty and eighty percent. Only a handful of Cronobacter infections are reported yearly but given only the state of Minnesota requires labs to report positive tests, it is unclear how many illnesses are missed”.
Abbott, FDA were warned about formula plant a year before recall, ABCNews June 09, 2022 “Abbott and the Food and Drug Administration were alerted to a whistleblower complaint about Abbott’s Sturgis infant formula plant as far back as February 2021, ABC News has confirmed … The allegations made in that October report include “ongoing problems” with the “integrity” of seals on powdered products, that the facility had used “questionable practices” to test whether the issues had been fixed, made efforts to evade certain oversight and override quality checks, falsified records “on a regular and ongoing basis” and allowed “questionable practices” related to the cleaning of equipment to “proliferate.”
’I almost lost my baby’: Parents demand answers from FDA.” Politico, March 5, 2022. A recall of infant formula tied to two deaths came five months after the agency learned of the first hospitalized child, raising questions about the pace of the government’s investigation.
(3) Abbott, is one of three companies that dominate the US market and one of five that dominate the global market. According to Abbott Nutrition, recalled products were distributed to the following countries: Australia, Bahrain, Barbados, Bermuda, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, Egypt, Guam, Guatemala, Hong Kong, India, Indonesia, Israel, Jordan, Kuwait, Lebanon, Malaysia, Mexico, New Zealand, Oman, Peru, Puerto Rico, Qatar, Saudi Arabia, Singapore, South Africa, Sudan, Taiwan, Thailand, United Arab Emirates, United Kingdom, and Vietnam ANI South. IBFAN Global Alert
(4) WHO/UNICEF Global Strategy for Infant and Young Child Feeding (ICYF) recognizes that “breastfeeding is an unequalled way of providing ideal food for the healthy growth and development of infants; it is also an integral part of the reproductive process with important implications for the health of mothers.” World Health Organization. (2003). “For those few health situations where infants cannot, or should not, be breastfed, the choice of the best alternative – expressed breast milk from an infant’s own mother, breastmilk from a healthy wet-nurse or a human-milk bank, or a breast-milk substitute fed with a cup, which is a safer method than a feeding bottle and teat”
(5) Is the US infant formula shortage an avoidable crisis? Lancet, May 30th 2022. “The crisis has exposed the risk inherent in an infant feeding culture reliant on commercial milk formula produced and marketed by a few consolidated transnational corporations and with considerable political backing. The shortage of formula could have been avoided with a more enabling and resilient infant feeding environment…The US is the only high income country with no statutory national paid maternity leave….”
(6)The baby formula shortage is prompting calls to increase support for breastfeeding, NPR May 30, 2022. “The formula makers would just give tons and tons of free formula to the hospital to try to sell their brand and have the hospitals send the mothers home with gift bags full of formula, so if they run into any problem at home they just pop in a ready-to-feed bottle in the baby, and that starts the mother becoming dependent on formula,”
(9) Compliance with the WHO/FAO “Guidelines on for the safe preparation, storage, and handling of powdered infant formula” and the Codex Alimentarius Code of hygienic practice for powdered formula for infants and young children (2008) is essential for minimizing the risk of illness.
Further links to WHO, IBFAN and other reports and guidance.
IBFAN letter to Dr Francesco Branca September 2021 about WHO’s Global Strategy for Food Safety
IBFAN pages on intrinsic contamination https://www.ibfan.org/contaminants-in-baby-foods/
Enterobacter sakazakii and Salmonella in powdered infant formula: meeting report: Microbiological Risk Assessment series 10 https://www.who.int/publications/i/item/9241563311
- Enterobacter sakazakii (Cronobacter spp.) in powdered follow-up formula: meeting report: Microbiological Risk Assessment series 15 https://www.who.int/publications/i/item/9789241563796
- Safe preparation, storage, and handling of powdered infant formula: guidelines https://www.who.int/publications/i/item/9789241595414
- The information for parents and caregivers on preparation of infant formula is of critical importance for emergency and relief workers and thus can also be found here: https://www.ennonline.net/infantformulaguidelines.
- Infosan in action to control an outbreak of Salmonellosis linked to infant formula: https://www.who.int/news/item/23-02-2018-infosan-in-action-to-control-an-outbreak-of-salmonellosis-linked-to-infant-formula.