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IN.F.ACT. USA presents at the World Public Health Nutrition Congress 2024

Ellie Mulpeter, Program Coordinator for IN.F.ACT. USA, presented at the WPHN 2024 Congress in June alongside several members of the international research team working on a project that uses a novel approach to monitoring violations of the World Health Organization’s (WHO) International Code of Marketing of Breastmilk Substitutes (“The Code”).

From left to right: Ellie Mulpeter (IN.F.ACT. USA); Dr. Anna Blair (Healthy Children Project, Inc.); Betty Sterken (IBFAN Canada); Barbara O’Connor (Healthy Children Project, Inc.)

The presentation was included in a panel discussion on the evidence supporting food marketing regulations. The WPHN Congress’s focus was: “Questioning the Solutions: Has the Decade of Nutrition delivered?” Researchers presented their projects on topics ranging from food insecurity, to infant feeding, to corporate capture and conflicts of interest in the private sector – all of which are, of course, related.

The research of IN.F.ACT. USA and team members in Australia, Canada and the UK continues in its enrollment currently. Interested parties can learn more at: https://surveyswesternsydney.au1.qualtrics.com/jfe/form/SV_cN14ryUEZriqHL8

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ProPublica releases records and interviews revealing U.S. government favoring formula industry marketing

On March 21, 2024, ProPublica published a scathing story about the U.S. interference of the protection, support and promotion of breastfeeding and of the WHO Code of Marketing of Breastmilk Substitutes.

Government documents obtained by ProPublica show a stark rift between trade and health officials over international efforts to regulate toddler milk. The records provide a rare, candid glimpse into U.S. policymaking around children’s health.

The full story can be read here.

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Baby Food Manufacturer Held Accountable in $60M Lawsuit

The jury found formula manufacturing giant Mead Johnson liable and awarded the plaintiffs $60 million — $35 million more than plaintiff’s attorneys were asking. 

The company was accused of not doing enough to warn parents about the increased risk of a deadly disease in premature babies given their formula called Necrotizing Enterocolotis, or NEC for short.

The trial involving a Fairview Heights mother who lost one of her twin premature babies is the first of hundreds of similar case cases that are part of multidistrict litigation. The I-Team found more than 330 lawsuits filed nationally on the topic.

Source article can be found here: https://www.ksdk.com/article/news/investigations/formula-lawsuit/baby-formula-deadly-disease-lawsuit-closing-arguments-preemies/63-c8007dc1-b8db-44b1-9d75-3d26dce01ea4#:~:text=Baby%20formula%20manufacturer%20ordered%20to,are%20fed%20in%20NICUs%20nationwide.

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WHO 154th Executive Board Meeting, Geneva, 22 January – 27 January 2024

Ellie Mulpeter of INFACT USA will be heading to Geneva later this month alongside her global colleagues of IBFAN to advocate for a resolution to protect families and babies from predatory digital marketing practices of breastmilk substitute (BMS) companies.

As summarized by colleague Patti Rundall of IBFAN on her blog, https://www.babymilkaction.org/archives/40393:

“2024 is a reporting year for  Maternal, Infant and Young Child Nutrition so Digital Marketing will be discussed under the “Healthier Populations” agenda item.   

Digital marketing is fast becoming the predominant source of exposure to promotion of baby feeding products globally. In 2022, WHO’s report on digital marketing of breast-milk substitutes  described its cross border extent and power. It is now totally out of control and parents and carers everywhere are targeted by paid  ‘influencers’ and other deceptive schemes with information that undermines WHO and national health recommendations and disempowers parents.

A WHA Resolution supporting the  WHO Guidance on digital marketing of breast-milk substitutes  would  send a  clear message to all WHO Member States that there is a political expectation to implement it.  Implementation of this Guidance will have zero cost to governments, yet the lowering of healthcare costs and stronger, more able workforces will benefit national and family economies.”


A proposed WHA Resolution would read as follows:

CONCEPT NOTE:

It is estimated that over 800,000 child deaths occur each year due to inadequate breastfeeding. Breastfeeding is considered to be one of the most important interventions that exists to protect the health of infants and young children. Unfortunately, the active promotion of breast-milk substitutes worldwide leads to unnecessary and improper use of these products and dissuade families from breastfeeding.


While implementation of the Code of marketing of breast-milk substitutes has limited certain types of promotions, new digital marketing strategies, including targeted ads appearing on pregnant mothers’ cell phones, clandestine participation in online baby clubs, or coaxing mothers to market formula to one another, were not possible when the Code was written. WHO highlighted the widespread exposure and power of these digital tools in 2022 (https://www.who.int/publications/i/item/9789240046085), noting that digital marketing is the dominant form of marketing in many countries and that new approaches to regulate and enforce the Code are needed.


The Seventy-fifth World Health Assembly, in decision WHA75(21) on maternal, infant and young child nutrition, requested that WHO develop guidance for Member States on regulatory measures aimed at restricting the digital marketing of breast-milk substitutes. WHO published draft guidance on 30 August and will be publishing the final guidance in early November.

It is important that the World Health Assembly takes action on this guidance and calls upon all Member States to take immediate action to address this growing challenge to breastfeeding. The collective weight of the Assembly is needed to ensure that the guidance not become just another set of recommendations from the secretariat. The nature
of digital marketing is inherently transnational and requires urgent collective action.


Xxxxx proposes to lead a Member States in developing a resolution to be adopted at the Seventy-seventh WHA in May 2024. Such a resolution would endorse the WHO guidance and call for various implementation steps to give immediate effect to the recommendations made. An initial draft of the resolution is below.

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New AAP Report on Misleading Marketing of Toddler Milks

According to the American Academy of Pediatrics (AAP), toddler “formulas” that are promoted as nutritious drinks for the older infant or preschooler are generally unnecessary and nutritionally incomplete, and the marketing practices that promote them are questionable.

The AAP has published a new clinical report, “Older Infant-Young Child ‘Formulas,'” that reviews the growing array of drinks aimed at children ages 6-36 months and observes that they lack standardization or regulatory oversight.

It is not new information that marketing efforts of breastmilk substitutes are consistently predatory and create a lot of confusion for the general public, along with undermining breastfeeding efforts of parents. However, this report, coming from an organization such as the AAP, highlights a corner of the market that is not often in the limelight – that of toddler milks and ‘follow-up’ formula.

The new report from the AAP concludes by recommending the following:

  • For infants younger than 12 months, the liquid portion of the diet should be provided by human milk or standard infant formula that has been reviewed by the FDA based on the Infant Formula Act.
  • For toddlers (children 12 months and older), caregivers should provide a varied diet with fortified foods to optimize nutritional intake. OIYCFs can safely be used as part of a varied diet for children but do not provide a nutritional advantage in most children over a well-balanced diet that includes human milk (preferred) and/or cow milk, and these products should not be promoted as such. OIYCFs have no specific role in routine care of healthy children and are more expensive than cow milk.
  • Marketing of OIYCFs should make the clear and unambiguous distinction from standard infant formula in promotional materials, logos, product names, and packaging. OIYCF product name should not be linked in any way to infant formula (numerical, steps, sequential name) and should be labeled as something other than formula—for example, follow-on or toddler “drink” or “beverage” rather than follow-on or toddler “formula.” Product placement in store shelves of OIYCFs should not be alongside standard infant formulas.
  • Education of families about OIYCFs by health care teams as part of well-child visits is encouraged.
  • Medical providers and care teams should complete a focused nutritional assessment, with consideration of mineral- and iron-rich solid food consumption and offer adjustment of solid food intake and/or vitamin supplementation as needed.

The full report can be found here: https://publications.aap.org/pediatrics/article/doi/10.1542/peds.2023-064050/194469/Older-Infant-Young-Child-Formulas?autologincheck=redirected

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Global Congress on Implementation of the International Code of Marketing of Breast-milk Substitutes – WHO/UNICEF

Geneva, Switzerland; June 20-22, 2023

Large group of IBFAN representatives from around the world

Last month, INFACT USA joined the many other global representatives of the Infant Baby Food Action Network (IBFAN) and participated in the WHO/UNICEF first ever Code Congress.

More than 400 people came together at the WHO headquarters with a shared goal – to protect every mother and pregnant woman against predatory marketing practices of infant and young child feeding products, including infant formula. Throughout the three day congress, the same message was emphasized again and again: “The best way to support these women is to enact, monitor and enforce the International Code of Marketing of Breast-milk Substitutes.”

The World Health Assembly (WHA) in 1981 adopted the International Code of Marketing of Breast-milk Substitutes. Forty-two years later, formula milk manufacturing companies continue to violate these established principles and place commercial interests before children’s and families’ health. Subsequent WHA resolutions have repeatedly called upon national governments to enact, monitor and enforce the provisions of the Code.

“Over 70% of Member States have enacted legislation that puts in place at least some of the provisions of the Code,” said Dr Francesco Branca, Director of Nutrition and Food Safety at WHO. “But industries are still expanding to push an ever-increasing range of formula milk products on families, using insidious tactics to access their networks and influence their choices. Parents have the right to impartial information on infant feeding, which is actively undermined by exploitative industry marketing.”

WHO and UNICEF notably excluded commercial companies from participation at the Code Congress, much to the annoyance of the International Special Dietary Foods Industries (ISDI), who issued this Statement just one day after the start of the Congress in Geneva.

Here in the United States, there is an incredible amount of work to be done to advance the WHO Code and its subsequent resolutions. To date, the U.S. is one of three countries in the world that did not sign onto the Code back in 1981. While that step may never come for the U.S., there are other options and avenues to implement protections against predatory marketing practices of these commercial baby-food product companies.

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After 10 years of struggle, Codex puts child health before trade at last.

REPOST: Baby Milk Action Policy Blog – P.Rundall

Source: https://www.babymilkaction.org/archives/37316

7th March, 2023,  Dusseldorf

IBFAN, WHO, UNICEF and partners breathed a sigh of relief today at the Codex Nutrition Committee in Dusseldorf.  After 10 years of tortured discussions in a Committee dominated by food corporations and powerful exporting countries, the main text of the revision of the 1987 Codex Standard for Follow-Up Formula was finalised with the addition of some important safeguards at the last minute. (1) The fact that the meeting was  webcast for the first time (private recording was banned previously) might have contributed to the good outcome.

Despite 8 countries saying that a preamble was not necessary and reservations from the USA about trade, the new standard  (2) will be sent to the Codex Alimentarius Commission for adoption in July and WILL refer to the International Code of Marketing of Breastmilk Substitutes and subsequent WHA Resolutions (the International Code).

While the standard has also improved its requirements for ingredients (the 1987 standard set no upper limits for sugar!),  banned health and nutrition claims and included many other labelling restrictions,  there are still unresolved problems. (3)

IBFAN urges governments to waste no time before bringing in strong marketing controls for all products up to 36 months in line with the International Code and Resolutions. If not, the ‘improved’ new Standard will lead to renewed commercial promotion and a slew of new ultra-processed products for young children with all their attendant risks.(4)  IBFAN, WHO and UNICEF are ready to help governments achieve this, ideally before these products are allowed on markets.

Governments have the sovereign right to adopt any legislation they consider necessary to protect child health as long as it does not violate international trade principles. The newly added references to the International Code and Resolutions in the Preamble will make it less likely that Code-aligned laws trigger costly, time-consuming WTO discussions or other challenges that have a chilling effect on policy-making. (5)

What happened this week

In a skilfully managed debate, the Chair, Dr Anja Brönstrup,  allowed plenty of time – two days – for debate on the final crucial aspects that had been left to the very end of the revision. In the 2019 meeting, the debate was curtailed, resulting in a bad decision on whether Cross Promotion should be forbidden.(6)

The industry notion that there should be two separate standards was quickly rejected, as many countries called for ONE standard with two parts.  Many also called for a Preamble that would protect breastfeeding and help governments position the products correctly in their regulatory frameworks. With such strong arguments and a clear majority, Canada, Switzerland, Australia and the EU changed their positions and indicated that they could support or at least ‘live with’ the compromise Preamble proposed by the New Zealand.  (7). The 9 reservations will be specified in the report but will not stop the Standard going forward for adoption by the Commission in July.

Some of the statements and written comments from country delegates:

John Oppong-Ottoo, for the African Union:

Gry Hay,  for Norway“Norway appreciates the proposed preamble text provided by the New Zealand chairs. Although we would have preferred a more comprehensive wording  [its] referral to key WHO and WHA documents, as well as a reference to subsequent WHA resolutions concerning infant and young child feeding ….provides context for understanding and implementing the standard. This will be of great importance for many countries in order to facilitate coherence with global policies to protect breastfeeding … WHO and UNICEF have documented how parents and pregnant women globally are exposed to aggressive marketing for baby formula milk and how marketing of formula milk influences decisions on infant feeding and undermines breastfeeding… The evidence is strong. Formula milk marketing, not the product itself, disrupts informed decision-making and undermines breastfeeding and child health.”

Notes:

(1) The 1987 Follow Up Formula Standard legitimised these problematic products, that were deliberately invented to get round the marketing recommendations of the World Health Assembly in 1981. The standard’s poor composition requirements and total lack of marketing safeguards (based on the claim that follow-up formulas are not breastmilk substitutes) boosted the growth of a $ multi-billion market for these unnecessary products. Its existence undermined laws to protect breastfeeding, fuelled the obesity epidemic and added to the environmental burden.  One third of the world’s countries breastfeeding is a lifeline and the majority of children are breastfed in the 2nd year of life.  When this new work was started in 2012/13,  IBFAN proposed that the standard should be ‘sunsetted’ rather than updated.

(2) Reservations came from: Argentina Cuba, Vietnam, Panama, Guatemala, USA, Colombia, Costa Rica and Morocco. The Name of the Standard will be: Codex Standard for Follow-Up Formula for Older Infants and Product for Young Children**Other equivalent names for this product are drink for young children with added nutrients or product for young children with added nutrients or drink for young children.  

(3) While the standard has improved its requirements for ingredients (the 1987 standard set no upper limits for sugar!) banned health and nutrition claims and included many other labelling restrictions,  there are still unresolved problems including:  the sodium levels; the sweetness; that the drinks can contain flavourings; the inadequate safeguards to stop misleading Cross Promotion; the nutrient claim in one of the proposed names ‘drink/product with added nutrients’ and the lack of reference to the fact that the products are not necessary.

(4)  Risks of Ultra-Processed Foods (UPFs): UPFs form 50% of Britons’ calorie intake; Nelson et al Premature Deaths Attributable to the Consumption of Ultraprocessed Foods in Brazil  American Journal of Preventive Medicine  10.1016/j.amepre.2022.08.013 2022) https://www.eurekalert.org/news-releases/970082Review article; Angel et al.  Ultraprocessed Foods and Public Health: A Need for Education. Mayo Clinic Proceedings, Volume 94, Issue 11, November 2019, Pages 2156-2157; Wang et al. Trends in Consumption of Ultraprocessed Foods Among US Youths Aged 2-19 Years, 1999-2018.JAMA. 2021;326(6):519-530. doi:10.1001/jama.2021.10238; Neri et al. Ultraprocessed food consumption and dietary nutrient profiles associated with obesity: A multicountry study of children and adolescents. Obes Rev 2022 Jan;23 Suppl 1:e13387.do10.1111/obr.13387. Epub 2021 Dec 9; Nelson et al. Premature Deaths Attributable to the Consumption of Ultraprocessed Foods in Brazilhttps://doi.org/10.1016/j.amepre.2022.08.013FAO. Ultra-processed foods, diet quality, and health using the NOVA classification system Monteiro et al.

(5)  Weak Codex standards have regularly been used in  attempts to stop governments bringing in strong marketing controls. The wrong assumption is made that  Codex standards are a ‘regulatory ceiling’ for trade purposes. These threats have been highlighted in the 2023 Lancet Series on Breastfeeding.

(6) In the 2019 CCFSNDU meeting the critically important sentence: ‘Cross promotion between product categories is not permitted on the [label/labelling] of the product’, that was supported by many developing countries, was replaced by much weaker text that was falsely presented as having the same ‘intent’.  Cross Promotion’ or ‘brand stretching’ is a deceptive marketing technique used to expand the sale of tobacco and other products with public health concerns. Cross Promotion of milks is especially harmful and increases the risk of infants not being breastfed or being fed with entirely inappropriate products.

(7) Text of new Preamble proposed by New Zealand and agreed: “This Standard is divided into two sections. Section A refers to Follow-up Formula for Older Infants, and Section B deals with Drink for Young Children with Added Nutrients, or Product for Young Children with Added, or Drink for Young Children, or Product for Young Children. The application of this Standard should be consistent with national/regional health and nutrition policies and relevant national/regional legislation and take into account the recommendations made in the International Code of Marketing of Breast-milk Substitutes, as per the national context. Relevant World Health Organization (WHO) guidelines and policies and World Health Assembly (WHA) resolutions were considered in the development of this Standard and may provide further guidance to countries.”

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CODEX to decide on global trade of ultra-processed baby drinks

REPOST: Baby Milk Action Policy Blog – P.Rundall

Source: https://www.babymilkaction.org/archives/36905

CCNFSDU43 March 7-10, 2023

IBFAN, alongside ENCA,  ILCA, HKI, WHO and UNICEF  are attending the Codex Nutrition Committee once again where the Review of the Standard for follow-up formula (CXS 156-1987) is expected be finalised this week. 

Background: The lack of marketing safeguards in the original 1987 Standard for Follow-up Formula (FUF) undermined breastfeeding globally and boosted the growth of a $ multi-billion market for unnecessary, denatured, ultra-processed, sweet-tasting, additive laden and flavoured products for older babies – products deliberately invented to get round the marketing recommendations applying to infant formula.

These totally unnecessary and risky products have damaged child health, fuelled the obesity epidemic and added to the environmental burden. (IBFAN Cop26)

The 2023 Lancet Series on Breastfeeding, highlighted baby food industry and powerful exporting states use weak Codex standards in their attempts to stop governments bringing in strong marketing controls, wrongly claiming that Codex standards are a ‘regulatory ceiling’ for trade purposes.  Such challenges have a chilling effect on governments.

IBFAN will be once again calling on Governments to use this opportunity to safeguard the most vulnerable members of society.

SUMMARY OF IBFAN’s CONCERNS:  There are still many unresolved issues on the standard including:   sodium levels,  sweetness; flavourings an  inadequate safeguards to prevent Cross Promotion. Most importantly, a Preamble is needed to ensure that Member States are not challenged when adopting legislation in line with WHO recommendations to halt promotion of these products – ideally before they are placed on the market.

IBFAN COMMENTS

One good thing: after complaining for many years about the lack of transparency in this Codex Committee, this meeting will be broadcast live here.

The Agenda and background papers are HERE. 

OUR PROPOSED TEXT FOR PREAMBLE:

This Standard is divided into two sections. Section A refers to Follow-up Formula for Older Infants, and Section B deals with REVERSE ORDER: Drink for Young Children, or Product for Young Children, or alternatively Drink for Young Children with Added Nutrients, or Product for Young Children with Added Nutrients.

The application of this Standard should be consistent with national health and nutrition policies and relevant national/regional legislation and take into account the recommendations made in the International Code of Marketing of Breast-milk Substitutes, DELETE: as per the national context], relevant World Health Organization (WHO) guidelines and policies and World Health Assembly (WHA) resolutions that were considered in the development of this Standard and DELETE may provide further guidance to countries in ending the inappropriate promotion of these products and misleading practice of cross-promotion.

ADD: Follow-up Formula and Drinks for Young Children are not necessary. Energy and nutrient dense family foods with continued breastfeeding for young children can provide the essential complementary feeding to meet the nutrient requirements for older infants and young children.

SWEETNESS:  At the last meeting in November 2021, New Zealand, Australia, the US and the baby food industry (ISDI) called for the deletion of this key sentence: “for products based on non milk protein, carbohydrate sources that have no contribution to sweet taste should be preferred and in no case sweeter than lactose.   Norway, Uruguay, Mexico, Brazil, EU, Chile, Switzerland, WHO, NHF, IBFAN and ENCA all supported its retention. EU and Switzerland now have a new statement calling for extra safeguards: EU/CH CRD16

FLAVOURSAt the last meeting  flavourings were banned for follow-up formulas for older infants. Many countries, WHO, UNICEF and NGOs also strongly opposed for fruit extracts and vanilla flavourings for the drinks 12-36 months. The EU (representing 27 countries) saw no technological need for flavours and questioned the safety of fruit extracts as flavouring agents in that many contain additional compounds.  The US, Canada, Australia and New Zealand and the industry friendly European Society for Paediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) argued that a prohibition of flavours would put the baby drinks at a disadvantage to ‘less good’ products that don’t meet Codex standards. A compromise sentence was added: National or regional authorities may restrict or prohibit the use of the listed flavourings.


AGENDA ITEM 4  REVIEW OF THE STANDARD FOR FOLLOW-UP FORMULA (CXS 156-1987): PREAMBLE AND STRUCTURE.

Comments in reply to CL 2022/24/OCS-NFSDU

CRD 2.  REVIEW OF THE STANDARD FOR FOLLOW-UP FORMULA STRUCTURE AND PREAMBLE
Prepared by New Zealand. Agenda Item 4.  CRD 2. NFSDU43_CRD02e

CRD3: REVIEW OF THE STANDARD FOR FOLLOW-UP FORMULA Prepared by New Zealand. Consideration of relevant concepts and technical guidance in WHO/WHA documents for the labelling and other provisions in the draft standard for follow-up formula

u.s.-draft-position-paper-7-feb-2023

(2)  Russ K, Baker P, Byrd M, et al. What you don’t know about the Codex can hurt you: how trade policy trumps global health governance in infant and young child nutrition. International Journal of Health Policy and Management 2021; 10(12): 983-97.  Baker et al. Globalization and Health (2021) 17:58. Advocacy at Work During the Codex Committee on Food Labelling Meetinghttps://www.ijhpm.com/article_4101.html

INTERVENTIONS AT WTO AND CODEX RELATED TO NATIONAL IMPLEMENTATION OF THE WHO INTERNATIONAL CODE OF MARKETING OF BREASTMILK SUBSTITUTES.  Katheryn Russ*


Agenda Item 6

TECHNOLOGICAL JUSTIFICATION FOR SEVERAL FOOD ADDITIVES Comments in reply to CL 2022/80/OCS-NFSDU

Comments of Brazil, Canada, Chile, Colombia, Cuba, European Union, Iran, Iraq, Japan, New Zealand, Paraguay, Peru, Philippines, Republic of Korea, Saudi Arabia, South Africa, Syrian Arab Republic, United States of America and European Network of Childbirth Associations (ENCA), International Food Additives Council (IFAC), International Baby Food Action Network (IBFAN), International Special Dietary Food Industries (I

IBFAN comments on Additives

IBFAN comments in response to the requests in the circular letter CL 2022/80/OCS-NFSDU regarding the technological justification for the use of certain food additives in food complying with The Standard for Infant Formula and Formulas for Special Medical Purposes (CXS 72-1981).


Agenda Item 7.  PRIORITIZATION MECHANISM / EMERGING ISSUES OR NEW WORK PROPOSAL

FINAL REPORT OF CAC45

  1. In the discussion on the adoption of the Guidelines for Ready-to-Use Therapeutic Foods (RUTF) at Step 8:
    •   Many Members intervened in support of final adoption and commended the leadership of the working group in completing the Guidelines.
    •   One Member and an Observer noted the level of carbohydrates, specifically sugar, exceeded WHO recommendations. This issue was discussed extensively at CCNFSDU including current constrains on product formulation and it was also highlighted that RUTF were meant for short term use.
    •   Observer organizations expressed the view that the level of magnesium was too low; stressed the need to guard against inappropriate promotion of the products; underlined the need to ensure the availability of potable water; expressed the view that the preamble should further address the need for appropriately designed programmes to support continued breastfeeding and re-lactation; and that the use of RUTF should not preclude the use of culturally appropriate home-based foods.Conclusion
  2. CAC45 adopted the Guidelines for Ready-to-Use Therapeutic Foods (RUTF) at Step 8 with the editorial amendments as proposed by WHO on the definition for Severe Acute Malnutrition and by EU in CX/CAC 22/45/4 Add. 1.
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Codex Alimentarius: Upcoming CCNFSDU43 Meeting

The 43rd Session of the Committee on Nutrition and Foods for Special Dietary Uses will be held in Duesseldorf, Germany on 7 – 10 March 2023. The report adoption will be held virtually on 15 March 2023 at 11:00 – 16:00 (CET).

INFACT USA will be supporting the broader International Baby Food Action Network (IBFAN) comments submitted to the committee on relevant agenda items. Unfortunately, IBFAN’s comments are not in line with the U.S. CODEX office’s comments.

Patti Rundall, the Global Advocacy Spokesperson for IBFAN, notes: “Agenda Item 4  on the revised standard for Follow-up Formulas may well be concluded during this session.  IBFAN considers that the standard has too many unresolved areas so should not be approved at this session.” IBFAN comments can be found here. 

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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