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THE ABBOTT POWDERED FORMULA SCANDAL

After the global recall of potentially contaminated Abbott powdered formulas and breastmilk fortifiers, many questions remained unanswered. Abbott used the media to deny responsibility, deceive the public and denigrate critics.

It is important to place the facts on record before they are buried. Each question is answered by a summary of the facts, provides further evidence backed up by references from media reports, United Nations agencies and US government documents.

Questions are grouped together under three main headings: Formula Recalls, Reducing Health Risks and Contaminated factories.

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  1. FORMULA RECALLS

DID YOU KNOW WHY THERE IS AN INFANT FORMULA SHORTAGE IN THE UNITED STATES – AND WORLDWIDE?

In February 2022, the largest US infant formula manufacturer Abbott recalled three brands of its powdered formula and one breastmilk fortifier. The company shut down its main manufacturing facility in Sturgis, Michigan following reports of Cronobacter infections in infants who had consumed formula manufactured at the Sturgis plant.  Evidence points to contamination of the Abbott Nutrition formula factory by strains of this dangerous bacteria. A massive worldwide recall of powdered formula produced in this factory emptied stores and left shelves bare. The subsequent scramble to import more formula into the USA led to further shortages in other countries: https://www.ibfan.org/wp-content/uploads/2022/05/2022-Action-Alert-2-REVISED-IBFAN-Calls-for-Action-Cronobacter-Salmonella-infections.pdf

“From September 2021 to February 2022, the US Centers for Disease Control and Prevention (CDC) received reports of cases of Cronobacter infection in infants in Minnesota, Ohio, and Texas …These illnesses were ultimately linked by the CDC and US Food and Drug Administration (FDA) to the consumption of powdered formula produced by Abbott in its Sturgis, Michigan, factory.”

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DID YOU KNOW HOW MANY BABIES DIED OR SUFFERED SEVERE INFECTIONS IN THE USA BETWEEN DECEMBER 2021 AND MARCH 2022?

Freedom of Information requests and whistleblower action revealed that not only two, but nine US infants were reported to have died after consuming powdered infant formula manufactured at the Abbott factory. These products were contaminated by Cronobacter sakazakii as well as by other pathogens: Salmonella, Clostridioides difficile and Shigella.

During the same period,25 severe infections categorized as ‘Life Threatening Illness/Injury’ and 80 instances of ‘Non-Life Threatening Illness/Injury were reported among infants who were fed these formulas: “Every one of the sick babies was fed an Abbott powdered formula.”

Until Cronobacter infections require mandatory notification, the number of cases of illness or deaths will never be known. Neither will their extent in the 37 countries which imported the potentially contaminated Abbott formula.

https://efoodalert.files.wordpress.com/2022/06/abbott-complaints-spreadsheet-redacted.pdf

https://en.wikipedia.org/wiki/Notifiable_diseases_in_the_United_States

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DID YOU KNOW THAT POWDERED INFANT FORMULA IS NOT A STERILE PRODUCT?

Powdered infant formula is not a sterile product, unlike ‘ready-to-feed’ liquid infant formula which is packed in feeding bottles that are sterile until opened. The manufacturing process for powdered formulas does not include end-point sterilization and the powder may become infected with harmful bacteria present in the factory. This ‘intrinsic contamination’ means that microorganisms are present in unopened packages of powdered formulas, including pathogenic bacteria which can cause severe infections in vulnerable babies.

 “Powdered infant formula (PIF) has been associated with serious illness and death in infants due to infections with Cronobacter/Enterobacter sakazakii. During production, PIF can become contaminated with harmful bacteria, such as Cronobacter/Enterobacter sakazakii and Salmonella enterica. This is because, using current manufacturing technology, it is not feasible to produce sterile PIF. “

https://apps.who.int/iris/handle/10665/43659

https://apps.who.int/iris/bitstream/handle/10665/43659/9789241595414_eng.pdf?sequence=1&isAllowed=y

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DID YOU KNOW WHY ENTEROBACTER/CRONOBACTER IS SUCH A DANGEROUS RESISTANT SUPER-BUG?

Cronobacter sakazakii was formerly called Enterobacter sakazakii but has been moved into a new genus Cronobacter, a name “derived from the Greek term ‘Cronos’, a Titan of ancient mythology who swallowed his infants when they were born, in fear of being replaced by them”:

https://pubmed.ncbi.nlm.nih.gov/23538645/

The severity of invasive infections in infants caused by Cronobacter justifies its new name. These infections include meningitis, sepsis and necrotizing enterocolitis: “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.https://www.foodsafetynews.com/2022/05/publishers-platform-abbott-and-public-health-officials-have-failed-in-their-duty-to-protect-the-most-vulnerable/

Cronobacter and Salmonella infections are now increasingly resistant to antibiotics: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6463179/

These infections can be fatal and can also cause lasting neurological damage and developmental delays. Over the past 20 years there are many reports of life-changing disability in infants who do survive infections.  This mother relates how her infant daughter sustained brain damage after drinking formula that had been given by the hospital as a free sample and was tainted with Cronobacter:  https://www.washingtonpost.com/business/2022/09/06/cronobacter-sakazakii-bacteria-baby-formula/

 

DID YOU KNOW WHY CRONOBACTER INFECTIONS AND CONTAMINATION OF POWDERED INFANT FORMULAS ARE UNDER-REPORTED? 

Minnesota is the only state in the USA that mandates reporting of Cronobacter infections. If the CDC had not received notifications of cases of Cronobacter infections in this state, other cases in Ohio or Texas would have been missed. https://foodpoisoningbulletin.com/2022/minnesota-cronobacter-case-spurred-federal-investigation/

According to Abbott, the company exported batches of potentially contaminated formula to 37 countries all over the world. There is no testing of the content of packages of powdered formula in most of these countries because few of them have the highly technical laboratory facilities to identify and investigate the origin of bacterial infections. Tests are needed of the blood and cerebrospinal fluid of patients with meningitis or sepsis caused by these bacteria.

Even worse, even in high-income countries, cases of neonatal meningitis and sepsis are often attributed to common germs, without any microbiological testing because the signs and symptoms are the same.  At the same time, there must be testing of household surfaces and the content of unopened formula packages, many of which have been discarded or are not readily available. Testing of packaged powdered formula is challenging because Cronobacter can survive in dry products “for long stretches of time and can be unevenly distributed in formula powder, meaning that one scoop of formula could contain the organism and the next may not.” https://www.washingtonpost.com/business/2022/09/06/cronobacter-sakazakii-bacteria-baby-formula/

https://www.ibfan.org/wp-content/uploads/2022/05/2022-Action-Alert-2-REVISED-IBFAN-Calls-for-Action-Cronobacter-Salmonella-infections.pdf

These reviews of outbreak history, infections and fatalities show the extent of under-reporting: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6463179/

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4662064/

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DID YOU KNOW HOW TO REDUCE THE RISK TO YOUR BABY’S HEALTH?

Your baby’s immune system has not yet fully matured to fight off infections, thus increasing the risk of illness after exposure to harmful bacteria. If your baby is not breastfeeding, learning about relactation and milk banks are safer options.  When preparing powdered formula you need to include a ‘kill step’ to inactivate any dangerous bacteria introduced at factory level and thus present even in sealed packages.

Cronobacter and Salmonella bacteria are resistant to heat and drought.  Since there is no final sterilization step for powdered formula, even small colonies of bacteria can survive in a vegetative state for long periods in the dry powder. When this formula is mixed with lukewarm water to feed the baby, any bacteria in the dried powder can multiply at a rapid rate – exponentially – because Cronobacter and Salmonella thrive in warm milk. Preparation of a powdered formula feed must include the ‘validated kill step’ of mixing the powdered formula with very hot water to inactivate these bacteria. This means first boiling the water and then letting it cool to no less than 70°C before mixing the formula powder: https://www.ennonline.net/attachments/542/safe-prep-bottle-feeding-leaflet.pdf

https://www.who.int/publications/i/item/9789241595414

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DID YOU KNOW HOW BREASTFEEDING PROTECTS YOUR BABY’S HEALTH?

The infant’s immune system is not fully developed at birth. It is only after several months that the immune system matures and is robust enough to fight off infections. Powdered formulas contain no antibodies or anti-infective agents to protect against these infections.

Breastmilk and colostrum contain many substances with antibiotic properties.Breastmilk is a dynamic, living fluid with anti-infective agents as well as bioactive components. Breastfeeding is an interactive process between a mother and her baby that has been called ‘personalised medicine’ as well as the perfect food.

“There is a wealth of evidence that breastfeeding reduces the risk of babies developing infectious diseases. There are numerous live constituents in breastmilk, including immunoglobulins, antiviral factors, cytokines and leucocytes, that help to destroy harmful pathogens and boost the baby’s immune system.”

https://www.unicef.org.uk/babyfriendly/wp-content/uploads/sites/2/2020/04/Unicef-UK-Baby-Friendly-Initiative-guide-for-local-authorities-on-infant-feeding-during-the-coronavirus-crisis.pdf

in https://www.unicef.org.uk/babyfriendly/local-authorities-guide/

https://news.un.org/en/story/2015/08/505612-un-marks-world-breastfeeding-week-call-stronger-workplace-policies-nursing

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3. CONTAMINATED FACTORIES

DID YOU KNOW WHY POWDERED INFANT FORMULA CAN BE CONTAMINATED AT FACTORY LEVEL?

Research shows that contamination by Cronobacter and Salmonella is not rare in dairy farms, the facilities are where milk is produced for dried milk powders. “The FDA conducted a sampling assignment in 2014 to understand the prevalence of Cronobacter spp. and Salmonella in 55 US dry dairy facilities. ”Cronobacter was detected in 69 percent of the facilities…”  https://www.food-safety.com/articles/7073-cronobacter-pathogen-considerations-beyond-salmonella-in-dairy-powders

The milk is then processed into powdered formula in manufacturing facilities. These are factories and not laboratories. They are exposed to bacteria like any other commercial premises, and cleaning equipment, even vacuum cleaners may harbour bacteria.

Cronobacter, like Salmonella, is found everywhere in the environment and may be introduced at factory level even after the liquid milk coming from the farm is pasteurized. These factory premises are not sterile and sources of contamination are numerous. Contamination may occur during the drying process in huge towers or when heat-sensitive probiotics vitamin premixes are added to the powder in large blenders. The WHO/FAO meeting report on Enterobacter sakazakii (now called Cronobacter) and Salmonella in Powdered Infant Formula describes how such contamination can occur in factories.  Microbiological Risk Assessment Series (MRA) 10 (who.int) pages 23-24:https://www.who.int/publications/i/item/9241563311

In 2018, Lactalis powdered formula manufactured in France was contaminated by Salmonella and exported to over 80 countries:  http://www.babymilkaction.org/archives/15630 More recently, Cronobacter contamination was found in Numil infant formula manufactured in the Czech Republic and exported to Moldova and in KetoCal formula manufactured in Europe and exported to Australia: https://www.foodsafetynews.com/2022/06/cronobacter-found-in-numil-infant-formula/

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DID YOU KNOW ABOUT THE UNSANITARY STATE OF THE ABBOTT FACTORY?

For these reasons, strict internal sanitary measures and routine mandatory product testing are necessary, in addition to stringent external controls.  In the case of the Abbott factory, ”FDA inspectors uncovered a host of violations, including bacterial contamination, a leaky roof, and lax safety controls”:  https://www.crainsdetroit.com/manufacturing/abbott-again-shuts-down-formula-production-michigan

E. At the US Congressional Hearings held on May 25, 2022 FDA Commissioner Dr. Robert Califf stated “the Abbott manufacturing plant was egregiously unsanitary …Frankly, the inspection results were shocking.” The conditions included “bacteria growing from multiple sites in the facility, cracks in key equipment, leaks from the roof, standing water and a previous citation for inadequate handwashing.” https://www.cnbc.com/2022/05/25/watch-live-house-grills-fda-commissioner-abbott-executive-on-baby-formula-shortage.html

The FDA had earlier released its inspection report on March 18, 2022, after the closure of the Abbott factory on February 15. “It found Cronobacter bacteria on multiple surfaces in the plant, and other conditions that increase the risk of contaminated products, including cracks in processing equipment, multiple water leaks and moisture, and puddles of water on the floor.” https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)01049-2/fulltext

These faults had previously been reported by the whistle-blower, an employee of Abbott who suffered retaliation by the company. This report contains 6 serious violations needing to be investigated:  https://www.marlerblog.com/files/2022/04/Redacted-Confidential-Disclosure-re-Abbott-Laboratories-10-19-2021_Redacted-1-1.pdf

The UK Guardian reports “the federal whistle-blower complaint alleged some of the Sturgis plant’s equipment that caused the bacteria to get in the product “was failing and in need of repair”, and company management was aware of the issue for up to seven years ahead of the outbreak. When in June, 2022 flooding caused the closure of the Michigan Abbott factory after it had briefly reopened, the faults previously reported by the whistle-blower show how flood waters could easily spread the bacterial contamination noted in his report. : https://www.marlerblog.com/files/2022/04/Redacted-Confidential-Disclosure-re-Abbott-Laboratories-10-19-2021_Redacted-1-1.pdf

 “A number of product flow pipes were pitting and leaving pinholes. This allowed bacteria to enter the system and, at times, led to bacteria not being adequately cleaned out in clean-in-place washes,” the report reads. “This, in turn, caused product flowing through the pipes to pick up the bacteria that was trapped in the defective areas of the pipe.” The problems are not only limited to ageing equipment, according to the whistle-blower’s report. “Management at the plant also falsified records, improperly trained employees, and successfully hid health and safety risks from the Food and Drug Administration auditors in 2019.”

https://www.theguardian.com/environment/2022/may/20/abbott-baby-formula-shareholder-profits

https://www.crainsdetroit.com/manufacturing/abbott-again-shuts-down-formula-production-michigan

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DID YOU KNOW THAT ABBOTT NUTRITION REPEATEDLY FAILED TO CLEAN UP THEIR ACT?

“In September 2019 the US Food and Drug Administration, FDA, inspected the facility and cited Abbott for failing to test an adequate amount of formula to assure that it met “the required microbiological quality standards.” In September 2021, the FDA returned to Abbott and found the company had “failed to maintain a building used in the manufacture, processing, packing or holding of infant formula in a clean and sanitary condition.”

https://www.cnbc.com/2022/05/25/watch-live-house-grills-fda-commissioner-abbott-executive-on-baby-formula-shortage.html

Why had Abbott failed to take action? The answer is that financial considerations – the company’s bottom line – take precedence over public health. The aim is ‘Business as Usual’ to protect the company’s reputation and avoid loss in sales: https://www.theguardian.com/environment/2022/may/20/abbott-baby-formula-shareholder-profits

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DID YOU KNOW WHY IT TOOK THE US FOOD AND DRUG ADMINISTRATION (FDA) SO LONG TO TAKE ACTION?

The FDA had already been warned that Abbott Nutrition ignored the findings of the whistle-blower who exposed the dirty conditions in the Sturgis factory, and then discredited and fired this employee. During the US Congressional Hearings, Representative Rosa de Lauro explained that the whistle-blower report was submitted to the FDA on October 20, 2021. 

The FDA had then interviewed the whistle-blower in late December of 2021.  The FDA inspected the Abbott manufacturing facility on January 31, 2022. The FDA recalled the products on February 17, 2022.  It took the FDA 4 months to shut down the Abbott plant.  https://delauro.house.gov/media-center/press-releases/icymi-delauro-shares-whistleblower-report-contaminated-infant-formula

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DID YOU KNOW THAT THE FDA HAD TO LEGALLY REQUIRE ABBOTT TO STOP FORMULA PRODUCTION?

In May 2022, the US Food and Drug Administration entered into a legally binding consent agreement that enjoins Abbott from manufacturing infant formula at its Sturgis plant and lays out steps required before resuming productions. This is the Justice Department Files Complaint and Proposed Consent Decree to Ensure Safety of Abbott Laboratories’ Infant Formula: https://www.justice.gov/opa/pr/justice-department-files-complaint-and-proposed-consent-decree-ensure-safety-abbott

This Complaint for Permanent Injunction to “permanently enjoin Abbott Nutrition from violating US law” legally orders Abbott to stop producing powdered formula in the Sturgis, Michigan plant. The Plaintiff is the UNITED STATES OF AMERICA versus the Defendants ABBOTT LABORATORIES, a corporation doing business as ABBOTT NUTRITION: https://www.docketalarm.com/cases/Michigan_Western_District_Court/1–22-cv-00441/United_States_of_America_v._Abbott_Laboratories_et_al/1/

Under the consent agreement the company is required to take specific measures designed to increase safety and ensure compliance with federal laws. “The company will – among other things – permit unannounced FDA inspections and hire an independent expert to ensure that formula is free of contaminants.” In June, 2022 the FDA allowed operations to restart at the Michigan plant after meeting initial requirements of the consent decree. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)01049-2/fulltext

“The U.S. Attorney sued Abbott and several employees. In the complaint, filed by the U.S. Department of Justice on behalf of the FDA, the government alleges that powdered infant formula products manufactured at Abbott Nutrition’s Sturgis facility were adulterated because they were made under unsanitary conditions and in violation of current good manufacturing practice requirements…. Abbott essentially confessed to the violations in the consent decree. Under the consent decree, Abbott Nutrition will be required to retain an independent expert to review the Sturgis facility’s operations to ensure compliance with the law. “ 

Abbott confessed to these violations to be allowed to reopen its Sturgis factory. This is an admission of guilt, despite repeated denials of responsibility by the company’s executives.

This article is annexed with links to the key documents related to the complaint lawsuit and consent decree.

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DID YOU KNOW HOW MANY COURT CASES ARE PENDING AGAINST ABBOTT?

There are now over 30 court cases throughout the USA: “After its recall of formula this year, Abbott has been sued at least 30 times in federal courts. The amount of evidence that has recently entered the public domain includes a lawsuit that the Justice Department filed against Abbott and the whistle-blower complaint submitted to the FDA by a former employee”. Will the lawyers who represent parents of infants who fell sick or died be more successful than in previous cases?

We do not know the outcome for these families who need long-term care for their severely disabled children, but we know that these key documents exist as evidence and that they must remain accessible in the public domain.

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ANNEX

This article contains links to the key documents related to the lawsuit and consent decree. The links are repeated below in case the original article is subsequently made inaccessible. https://www.foodsafetynews.com/2022/06/the-death-of-another-baby-linked-to-abbott-infant-formula-apparently-under-investigation/

Here is the 2021 inspection report at the plant – APPLIED – FOI II – BR Abbott Nutritions- FEI# 1815692 9-2021 EIR.

Here are the whistleblower documents – Redacted Confidential Disclosure re Abbott Laboratories – 10-19-2021_Redacted (1)

Here is the 2022 inspection report at the plant – Updated Final Applied_Unapplied Redactions Abbott Nutrition Sturgis FEI 1815692 FDA 483 1-31022 to 3-16-22 – ISSUED_Redacted

Here is the complaint – abbott_complaint_0

Here is the consent decree – abbott_proposed_consent_decree_0

Categories
Events

Protecting and Promoting Breastfeeding at the 75th World Health Assembly

“I have had the pleasure of attending the 75th World Health Assembly in Geneva, Switzerland this week, along with other members of the global Infant Baby Food Action Network (IBFAN) team. I have learned so much from other Member States and delegates from all over the world. While there are many public health issues being addressed before the Assembly, our team is here to protect and promote breastfeeding, to strengthen the WHO Code on the Marketing of Breastmilk Substitutes by keeping policy setting free of commercial influence, and to prohibit the cross-promotion of products that function as breastmilk substitutes. Throughout our time here at the WHA, I have also had the opportunity to write a briefing on the contamination and infant formula product shortage occurring in the U.S., which we are now circulating among international delegates. I look forward to returning home and working hard on the establishment of INFACT USA and Code monitoring in the states.”

– Ellie MacGregor,
Director of the Academy of Lactation Policy and Practice
Program Coordinator of INFACT USA (Infant Feeding Action Coalition USA)


Report on IBFAN / INFACT Activities at the 27th World Health Assembly

also available at http://www.babymilkaction.org/archives/32904

WATCH WHA RECORDINGS Agenda 18, Committee B  6th and 7th session Friday 27th May HERE and HERE

Fast forward to 00.59 –  Strategic Round Table on WHO Sustainable financing Monday, 23rd May.

Baby Milk Action’s Patti Rundall welcomes the increase in Assessed Contributions then asks WHO about its Conflict of Interest policy that only excludes arms and tobacco rather than all health harming industries. Dr Tedros Adhanom Ghebreyesus responds by saying ‘What she said is true by the way …”

MIYCN SUGGESTIONS EB150-7 Agenda Item 18.1

75th World Health Assembly May 22-28th 

 The IBFAN team this year is small: Elisabeth Sterken (IBFAN Canada) Ellie MacGregor (IBFAN USA/ALPP)  and Magdalena Whoolery (IBFAN Pakistan).  Maryse Arendt will also join from ILCA.  We are promoting the four new WHO reports and briefings (1) that all show that marketing in many countries is out of control and that  strong  safeguards are needed.

We will be making several statements including on Maternal, Infant and Young Child Nutrition (MIYCN) and Food Safety (Agenda item 18,  FRIDAY 27th May), Non Communicable Diseases (Agenda Item 14.1)  and Emergencies (Agenda Item 16.3)


Maternal, Infant and Young Child Nutrition (MIYCN) and Food Safety (Agenda item 18,  FRIDAY 27th May)

MIYCN SUGGESTIONS EB150-7 Agenda Item 18.1

The International Code, and its 20 Resolutions, is a landmark document that protects breastfeeding’s crucial role in child survival as a safe, renewable natural food resource that contributes to food and water security.  All Member States have an obligation to implement it and commercial companies must comply with it.

While 144 countries have implemented the Code to some degree, WHO’s recent reports expose many loopholes that allow digital and other forms of predatory marketing to flourish (1).

The Decision EB150 (7) at present, only requests the DG to provide Guidance to MSs on digital marketing and to report back in 2024.  This year WHO has published four new reports and briefings that all show the importance of strong marketing safeguards. (1)

The Director General can be asked to:

(1) Assist MS in ensuring that trading and export standards, guidelines and regulations support full implementation of the International Code of Marketing of Breast-milk Substitutes (i.e. “the Code) and subsequent WHA Resolutions. (2) Rationale:  This would help MS hold companies’ accountable for marketing practices in importing countries.

(2) Assist MS to prohibit the promotion of cross branded products that function as breastmilk substitutes within The Codex Alimentarius revision of the draft standard for Follow-up Formula. (2) Rationale: these products are unnecessary, ultra-processed, sweet-tasting and flavoured.

(3) Assist MS in adopting legal frameworks that cover all foods for infants and young children and related products, including commercial milk formulas for pregnant and lactating mothers. (A useful example is the WHO Model Law for Europe)

(4) Assist MS in keeping policy setting free from commercial influence by consistently adopting and applying conflict of interest and transparency safeguards. RationaleWith the pressure to work in Multi-Stakeholder environments WHO must consistently warn and encourage  Member States to adopt and apply such safeguards.

(5) Assist MS in ensuring effective independent food safety regulations and standardized monitoring and enforcement for all feeding products for infants and young children.

(6) Assist MS in ensuring compliance with the WHO UNICEF Ten Steps to Successful Breastfeeding.


On Emergencies we will call for increased protection and support for breastfeeding, skin-to-skin contact and relactation; ensure that micronutrient and other interventions during emergencies are culturally appropriate and not commercially promoted, to support sustainable food production, food security and biodiversity. We will also promote the UNICEF led Ukraine statement that is now  endorsed by WHO, UNHCR and  many others.


(1)The 8 Country  Marketing reportReport on Digital Marketing  and  The 2022 State of the Code report – Effective regulatory Frameworks for ending inappropriate marketing of BMS and baby foods in the WHO European Region

[2] The 1992 Export Directive (92/52/EEC) and Council Resolution called for Code compliance by EU Based companies when marketing in ‘third countries’ along with monitoring and reporting and accountability proposals.  The Codex CODE OF ETHICS FOR INTERNATIONAL TRADE IN FOOD requires Member States to “…make sure that the international code of marketing of breast milk substitutes and relevant resolutions of the World Health Assembly (WHA) setting forth principles for the protection and promotion of breastfeeding be observed.”


CLICK HERE for IBFAN  interventions made at the 150th Executive Board Meeting. Click here for the IBFAN Blog on the run up to the EB.


IBFAN STATEMENTS FOR WHA 75

Maternal Infant and Young Child Nutrition and Food Safety   Agenda Item 18.1  read by Elisabeth Sterken

Over 800,000 babies die every year because of unsafe feeding, and many more do not reach their full potential because they are not breastfed.  This year four WHO reports show that too many of the 144 countries with Code legislation have serious loopholes allowing predatory marketing to flourish.

It’s time that exporting nations take responsibility for the marketing activities of their companies. WHO, the parent of Codex, must defend Assembly decisions, as amended by Bangladesh,  against challenges by those pushing unnecessary, sweetened, flavoured ultra-processed products.  The forthcoming decisions at Codex will fundamentally affect child health and survival

The undermining of breastfeeding using digital marketing, deceptive claims and cross promotion must be eliminated. Mandatory paid maternity leave, effective and independent food safety systems and baby-friendly birthing practices are essential to reduce illness and death associated with formula feeding

NCDs and Humanitarian emergencies.  Agenda item 14.1. A75/10 Add 2, Annex 4 read by Patti Rundall

Recommendations on how to strengthen the design and implementation of policies, including those for resilient health systems and health services and infrastructure, to treat people living with noncommunicable diseases and to prevent and control their risk factors in humanitarian emergencies

The recommendations on NCD risk factors in humanitarian emergencies rightly calls for strengthened policies and services but also calls for partnerships with the private sector – with  NO mention of the need for conflicts of interest safeguards – nor any mention of the protection of breastfeeding – a resilient practice that protects children from the worst of emergency conditions.

Safeguards must be consistently integrated into ALL policies to ensure that partnerships are appropriate and that policy setting is not commercially influenced.

When talking about health harming industries terms such as ‘partnership’ ’trust’ ‘shared aims’ and ‘values’ is naive.  It blurs identities and responsibilities. Corporations have no democratic accountability and public health policy decisions should be free of their influence.

In times of crisis, companies mislead and exploit public fears, donating inappropriate products that claim to build immunity –  good that WHO supports the statement warning of the risks of formula donations in Ukraine.

Public Health Emergencies.  Agenda Item 16.3  Read by Dr Magdalena Whoolery

Breastfeeding is a resilient practice that provides food, care, immune support and protection from the worst of emergency conditions while protecting against malnutrition in all its forms. Breastfeeding and conflict of interest safeguards must be consistently integrated into all Emergency Prevention & Management policies.

As poverty rates, economic disparity, conflicts and hunger are rising, short term treatment models that rely on market-led approaches and fail to recognise how companies undermine health and the environment pose serious risks to child health.  Ready to Use Therapeutic Foods should not be on retail sale and should be used only in programmes that promote skin-to-skin,  re-lactation and continuation of breastfeeding with appropriate transition to nutritious family food and psycho-social support. Micronutrient interventions should be culturally appropriate and not undermine sustainable food production, food security and biodiversity.

We are pleased that WHO  endorsed the joint statement on Ukraine led by UNICEF and UNHC  warning of the risks of donations of baby feeding products.


Informal list of intergovernmental meetings  streamed on the following website: – https://www.who.int/news-room/events/detail/2022/04/11/default-calendar/informal-wha75-pre-meeting-for-member-states–non-state-actors-in-official-relations-and-the-secretariat-during-11-april-to-6-may-2022

Non State Actors in Official Relations (such as IBFAN) can listen and intervene on some of these meetings.   On the  Working Group on Emergency Preparedness (WGPR Intersessional Informal Meeting (Systems and Tools / Finance) on 24th March,  I made the following intervention:

IBFAN – like all  public interest civil society –  supports the call from Germany for a long overdue increase in Member States contributions to WHO.   This is important for so many reasons, but essential if WHO is to continue to lead in emergency preparedness and response. Without such secure income and in the absence of strong safeguards on COI there are huge risks. IBFAN is especially concerned about  the need to protect infant and young child feeding and of course breastfeeding – a lifeline in emergencies.  We see now that appeals and funds are being attracted to the WHO Foundation and we’re very, very concerned about this and feel that its policy must be strengthened and donors carefully screened. The Foundation has recently dropped an exclusion criteria from its initial guidance guidelines that would have forced it to reject funding from companies that do not contribute to “a healthy diet.”  And its messages have failed to follow WHO policy and alert the public to the risks of donations of feeding products.

Link from the Home page of WHO 1st March 2022

Articles about WHO Funding

Report issued by a team around Jonathan Glennie  based on research funded by the BMGF, adapting Glennie’s “global public investment” proposal (The Future of Aid: Global Public Investment) narrative to  the field of financing pandemic preparedness and response

South Centre Research Paper No. 147 (28 February 2022): Can Negotiations at the World Health Organization Lead to a Just Framework for the Prevention, Preparedness and Response to Pandemics as Global Public Goods?

By Viviana Muñoz Tellez  This paper advances that WHO Member States, having agreed to the objectives of advancing equity and solidarity for future pandemic prevention, preparedness and response, now must operationalize these. The paper offers suggestions for the ongoing WHO processes of: 1) review of recommendations under examination by the Working Group on Strengthening WHO Preparedness and Response to Health Emergencies, 2) consideration of potential amendments to the International Health Regulations (IHR) 2005, and 3) elaboration of a draft text for an international instrument on pandemic preparedness and response.

Other articles:

Elaine Ruth Fletcher, Health Policy Watch: “United States Fast Tracks Proposal to Change WHO Rules on International Health Emergency Response” https://healthpolicy-watch.news/united-states-fast-tracks-world-health-assembly-proposal-to-change-global-emergency-response-rules/

Human Rights Principles for a Pandemic Treaty
Ongoing publication project and informal working group convened by OSF
A final/full version of the “10 principles” is expected to be published by the end of March
Main messages: https://www.icj.org/wp-content/uploads/2021/12/Pandemic-Treaty-Principles.pdf

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The politics of a WHO pandemic treaty in a disenchanted world
G2H2 research and advocacy project 2021.
Members of the Geneva Global Health Hub are currently exploring a follow-up action
Report: https://g2h2.org/posts/whypandemictreaty/

Von: HMP <HMP@who.int>
Gesendet: Mittwoch, 23. März 2022 10:28
An: HMP <HMP@who.int>
Betreff: Informal WHA75 pre-meetings during 11 April to 6 May

Dear non-State actors in official relations,

Please find attached the draft concept note for the” Informal WHA75 pre-meetings for Member States, non-State actors in official relations and the Secretariat” to take place over 4 days during the period from 11 April to 6 May 2022.  The informal meeting is organized as per the decision of the Executive Board at its 150th meeting. In developing the concept note, the comments and input from non-State actors who attended the planning meeting on 28 February on the concept and content for the meeting , have been considered.

The proposed dates and the agenda for the informal WHA75 premeeting are:

Monday 11 April 2022 at 10:00-13:00 CEST

Pillar 1: One billion more people benefitting from universal health coverage 

13.1 Follow-up to the political declaration of the third high-level meeting of the General Assembly on the prevention and control of non-communicable diseases:

(a) Draft implementation road map 2023–2030 for the global action plan for the prevention and control of noncommunicable diseases 2013–2030

(d) Draft recommendations on how to strengthen the design and implementation of policies, including those for resilient health systems and health services and infrastructure, to treat people living with noncommunicable diseases and to prevent and control their risk factors in humanitarian emergencies

(h) Draft action plan (2022–2030) to effectively implement the global strategy to reduce the harmful use of alcohol as a public health priority

21 April 2022 at 15:30-18:30 CEST

Pillar 1: One billion more people benefitting from  universal health coverage 
Human resources for health

Pillar 3: One billion more people enjoying better health and well-being
17.1 Maternal, infant and young child nutrition

3rd item TBD

28 April 2022 at 15:00-18:00 CEST

Pillar 2:   Public health emergencies: preparedness and response
15.2 Strengthening WHO preparedness for and response to health emergencies

15.4 WHO’s work in health emergencies

Pillar 4: More effective and efficient WHO providing better support to countries

Sustainable Financing

Thursday 6.5.  at 10.00-11:00 CEST

Engagement modalities

Feedback on the meeting

Constituency statements

The duration of each session is 3 hours, with 3 agenda items for discussion, and with expected participation as panel members from Member States, WHO Secretariat including regional offices and non-State actors in official relations. We would propose that non-State actor representative will moderate the sessions like last time. It is expected that panel members will be respond to questions from the audience and discuss with other panel members on the agenda item. The fourth session on 6 May is dedicated for a discussion on engagement modalities for non-State actors, and to a dialogue between non-State actors and the Director-General as well as giving a space for non-State actors to prepare for the Seventy-fifth World Health Assembly (22 – 28 May 2022). Should you have any suggestions for the format or agenda items of the meeting or comments, especially for the 3rd agenda item on 21 April, please contact hmp@who.int.

We are calling for expressions of interest from non-State actors to be members of the panels as well as moderators of the panels in this meeting. Kindly indicate your interest to Taina Nakari at hmp@who.int by 27 March 2022. Please also let us know which session you are interested in to moderate or to be a panel member. Once all the proposals have been received, we will contact the panel members and moderators to finalize arrangements. Looking forward to working with you to shape the sessions.

Connection details and other practical arrangements will be sent ahead of the meeting.

Thanking in advance for your participation.

Best regards,
Dr Gaudenz Silberschmidt
Director
Health and Multilateral Partnerships
External Relations

Categories
Events

Virtual Webinar

Protecting Breastfeeding in the United States: Time for Action on The Code

Thursday, April 28 & Friday, April 29, 2022
9:00AM – 3:30PM Eastern (GMT-4)

5 E-CERPS plus 4.5 L-CERPs for IBCLCs, 9.5 hours for CLCs and 9.5 professional development continuing education hours for nurses will be available.

Please note that this conference will not be recorded and participants must attend the conference in its entirety to obtain contact hours.


Full Schedule

Thursday, April 28

9:00-9:30Introduction/Welcome
Speakers: Linda Smith, Betty Sterken, Karin Cadwell
9:30-10:00History of Infant Feeding
Speaker: Karin Cadwell
10:00-10:15BREAK
10:15-11:15Medical and Social Origins of Breastfeeding Myths
Speaker: Jackie Wolf
11:15-12:00Focus on the Black Family
Speaker: Kimarie Bugg
12:00-1:00LUNCH BREAK
1:00-1:30US Policies and the CODE
Speaker: Linda Smith
1:30-2:15Regulatory Systems to Protect Breastfeeding – CODEX
Speaker: Betty Sterken
2:15-2:30BREAK
2:30-3:15History of the International Code
Speaker: Leah Margulies
3:15-3:30Discussion/Wrap up
Speakers: Linda Smith, Betty Sterken, Karin Cadwell

Friday, April 29

9:00-9:15Introduction/Welcome
Speakers: Linda Smith, Betty Sterken, Karin Cadwell
9:15-10:30What You Need to Know About the Code:
Scope and Main Provisions
Speaker: David Clark
10:30-10:45BREAK
10:45-11:00Code Responsibilities of Professionals
Speaker: Linda Smith
11:00-12:00WHO Presentation
Livestream
12:00-1:00LUNCH BREAK
1:00-2:00Where There is No Code?
Challenges/Monitoring/Enforcement
Speaker: Betty Sterken and Constance Ching
2:00-2:30The New WHO Marketing Findings
Speaker: Linda Smith
2:30-2:45BREAK
2:45-3:15IBFAN Working Around the World to
Protect Infant and Young Child Feeding
Speaker: Betty Sterken
3:15-3:30INFACT Canada/USA & IBFAN North America
Discussion/Wrap Up
Speakers: Linda Smith, Karin Cadwell, Betty Sterken

Speakers include:

  • Kimarie Bugg
  • Karin Cadwell
  • David Clark
  • Constance Ching
  • Leah Margulies
  • Linda Smith
  • Betty Sterken
  • Jackie Wolf

Sponsored by:
INFACT Canada and USA
IBFAN North America


Webinar Speaker Bios:

Elisabeth Sterken is Director of INFACT (Infant Feeding Action Coalition) Canada/IBFAN (International Baby Food Action Network) North America, past chair of the IBFAN Global Council, coordinates the IBFAN Codex Alimentarius Program, and represents IBFAN on the UNICEF/WHO the Global Breastfeeding Collective.

Linda J. Smith is the owner and director of Bright Future Lactation Resource Centre, author of 4 breastfeeding textbooks, and created the International Code Committees of ILCA and La Leche League International. She is a consultant to INFACT Canada/IBFAN North America.

Karin Cadwell is a faculty member of the Healthy Children Project and is serving as convenor of the new organization, Infant Feeding Action Coalition USA.

Kimarie Bugg is President and CEO of Reaching Our Sisters Everywhere (ROSE), adjunct faculty for Morehouse School of Medicine/Pediatrics, and faculty at Union Institute and University.

David Clark is an international public health and human rights lawyer who spent 25 years as the Legal Specialist with the Nutrition Section, UNICEF, New York.

Constance Ching currently provides technical support in Code advocacy and implementation for Alive & Thrive in the ASEAN region. Prior to that, she worked for IBFAN-ICDC, was involved in capacity building with governments, UN agencies and NGOs on Code implementation and monitoring.

Leah Margulies is a lawyer, founder of Corporate Accountability International (formerly Infact), and the International Nestle Boycott.  She set up the legal office of the Baby-Friendly Hospital Initiative, UNICEF and was legal staff at the Environment Unit of the UN Centre on Transnational Corporations.

Jacqueline H. Wolf is professor of the history of medicine in the Department of Social Medicine at Ohio University. She specializes in the history of birth and breastfeeding practices in the United States.