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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

Categories
Blog Posts

Nutrition International Launches the “Cost of Not Breastfeeding” Tool

The Cost of Not Breastfeeding Tool aims to provide policymakers and advocates with a user-friendly tool to generate estimates of the potential health, human capital and economic benefits of scaling up breastfeeding promotion and support strategies. Evidence generated from the tool will be integral to raising awareness with government, industry and donors for scaling breastfeeding in accordance with the Global Breastfeeding Collective’s seven recommended policy actions.

The Cost of Not Breastfeeding Tool was first developed between 2017 and 2019 by Dr. Dylan Walters and Alive & Thrive, with funding from the Bill & Melinda Gates Foundation. This tool was instrumental in advocacy at the global level, being used for the Global Breastfeeding Collective’s Investment Case, and at the country level directly supporting efforts to advocate for policy changes and increase investments in maternal and child nutrition in numerous countries. In 2022, Nutrition International updated and developed the second version of the tool in partnership with Alive & Thrive and Limestone Analytics, with funding from the Government of Canada. This new version of the tool contains updated datasets, new indicators, a new function to calculate results for different breastfeeding rate scenarios or targets, and online access to the results for more than 100 countries.

You may access the new tool here: https://www.nutritionintl.org/learning-resource/the-cost-of-not-breastfeeding-tool/

Categories
Blog Posts

Repost: IBFAN welcomes the WHO UNICEF report – How marketing of formula milk influences our decisions on infant feeding

Original Source: 4 new WHO reports expose marketing by the $55 billion formula milk industry | Baby Milk Action

On 23rd February, WHO and UNICEF launched a hard-hitting multi-country report –How the marketing of formula milk influences our decisions on infant feeding. The report exposes the extent of marketing tactics that influence infant and young child feeding decisions. It finds that exposure to formula milk marketing reaches 84 per cent of all women surveyed in the United Kingdom; 92 per cent of women surveyed in Viet Nam and 97 per cent of women surveyed in China, increasing their likelihood of choosing formula feeding.”

The report clearly recommends that governments everywhere adopt, monitor and enforce laws to prevent the promotion of formula milk, in line with the International Code and subsequent WHA Resolutions,  prohibit promotional claims, adopt parental leave and other policies to support breastfeeding.  It also recommends that health workers are banned from accepting sponsorship from companies that market foods for infants and young children for scholarships, awards, grants, meetings, or events.


The Code does not need reform.  At the launch and in media reports some have suggested that the Code needs to be reformed.  We believe this to be a really bad idea that would be used by companies and industry-friendly governments to argue for more delay.  But there is no need.  The Code covers all forms of promotion – including e-commerce and cross promotion. Provided WHO provides its Member States with opportunities to adopt strengthening Resolutions and provided governments put these into law,  the Code can keep pace with marketing.  The Code is a global document and doesn’t address how governments legislate, prosecute and hold corporations to account. This is best done at national or regional level.


IBFAN has been monitoring company practices and alongside WHO and UNICEF has been helping governments bring in strong effective legislation on the Code for the last 40 years.  After many failed attempts  to persuade baby food companies to voluntarily stop predatory marketing, it’s clear that there is no point chasing these companies for watered down here-today, gone-tomorrow promises or considering them to be  ‘partners’ in health.   This new report should leave no-one in any doubt: strong legislation is the best and only way forward.  Policy setting processes, including global trading standards (2)(3), must be safeguarded from commercial influence through effective transparency and Conflict of Interest safeguards.  

Categories
Blog Posts

Repost: The National Baby Formula Shortage and the Inequitable U.S. Food System

Repost from source: https://www.americanprogress.org/article/the-national-baby-formula-shortage-and-the-inequitable-u-s-food-system/

It is past time for policymakers to develop a long-term vision that addresses the infant formula crisis and focuses on building a more responsive, resilient food system and safety net for all.

Introduction and summary

Food and nutrition are literally life-giving and life-sustaining, yet parents and caretakers in the United States who rely on infant and specialty formulas for their loved ones’ health and nutritional needs face high prices and severe shortages. As of May 2022, 43 percent of formula products were out of stock nationwide—a massive increase from the average out-of-stock rate of between 2 percent and 8 percent at the start of the year.1 Some states, including Iowa, the Dakotas, Missouri, and Texas, are grappling with out-of-stock rates of more than 50 percent.2 The cost of infant and specialized formula was already untenably high for many, but recent safety concerns, supply chain issues, and challenges related to the COVID-19 pandemic have raised the price of baby formula to alarming highs and driven stock frighteningly low.

Over the past year, the average cost of the most popular baby formula products went up by as much as 18 percent3 at a time when millions are still struggling to recover from the pandemic and resulting economic recession. Making things even worse are the actions of a few—those who purchase formula at retail stores and resell it online at a severe markup, both increasing costs for vulnerable families and driving up scarcity.4

But the formula crisis reveals major flaws in the U.S. food production and distribution system, especially in times of emergencies, as well as weaknesses in the country’s social safety net resulting in inequitable access to food and nutrition. This report looks at how the crisis emerged and considers the longer-term opportunities to make U.S. food production, supply, and distribution systems more responsive, resilient, and equitable to ensure that all individuals and families have access to life-saving food and nourishment. The Center for American Progress recommends interventions and reforms that prioritize access and affordability to key food and nutrition; ideas to reduce market concentration, thus increasing supply; workplace policies to support parents and caregivers; increased oversight on consumer health and safety; and the reauthorization of key legislation that gives Americans the opportunity to create a truly inclusive and equitable food system.

The baby formula crisis and the conditions that created it

The formula shortage stemmed from a product recall by an Abbott Nutrition facility in Michigan, where unsanitary conditions and contaminated products led the U.S. Food and Drug Administration (FDA) to temporarily shut down the facility. Abbott re-opened the facility in early June, under strict FDA oversight, but was forced to close the plant again on June 15 due to torrential rain and flooding in the area.5 The Abbott closure was the catalyst to a crisis that has been years in the making: Policies and legislation that have permitted market consolidation of formula production by just a few companies, ongoing supply chain issues due to the pandemic, and corporate profiteering made this national shortage possible.6

The formula crisis has resulted in huge inequities, leaving millions of the most vulnerable—such as infants and children, women, grandparents who provide care, people of color, people with disabilities and/or chronic illnesses, LGBTQI+ people, and the elderly—without access to affordable and sometimes life-sustaining food and nutrition in their communities.7 Furthermore, the crisis sheds light on just how reliant the U.S. food system is on a small number of big corporations that control the majority market share of everyday grocery items and links throughout the food chain—from seeds and fertilizers to agribusinesses and slaughterhouses to grocery stores and supermarkets.8

The Biden administration and Congress are taking steps to address the current crisis and ensure that infant and specialty formula are fully stocked on grocery store shelves.9 However, once the immediate crisis abates, many of the challenges that created it in the first place will remain—including market consolidation, supply chain issues, and a lack of policies that prioritize the needs of infants, working parents, and people with disabilities or other illnesses. What has been made abundantly clear during the national formula shortage is that there is a dearth of long-term solutions to create a more equitable, sustainable food system so that everyone across the nation has access to safe nutritious foods in their community.

Market concentration has made the formula market vulnerable to large supply shocks

The supply of baby formula in the United States is highly concentrated. Three brand-name domestic producers—Abbott, Mead-Johnson, and Nestlé—supply about 98 percent of all formula domestically.10 The remainder is supplied by Perrigo—a domestic producer of store brands11 for several retailers such as Walmart, CVS, and Target—and a small amount is imported. The shutdown of the Abbott factory in Michigan, which accounted for approximately 43 percent of total consumption of formula according to the most recently available data,12 has had devastating consequences.

The baby formula market has some important idiosyncrasies that appear to contribute to market concentration. About half of all infant formula is purchased by state agencies and distributed through the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). Federal law requires state WIC agencies to purchase formula via sole-source competitive contracts. Awards are based on the net price the agency must pay, which is the wholesale price charged to all buyers minus a rebate to the state agencies. These rebates are a large source of revenue for the WIC program—in the range of $1 billion to $2 billion annually—amounting to about one-quarter of all funding.13

A sole-source contract generates large spillover effects for the winning firm that compensate for the rebates paid to WIC. The guaranteed volume of WIC sales causes retailers to give the contract winner prominent shelf space and product placement, and widespread WIC usage may increase physician referrals for contract brands. A new contract winner in a state typically sees its market share rise by 74 percent, and the market share of the other suppliers declines by an equivalent amount.18 The privileged retail treatment given to contract winners appears to make it difficult for new entrants to generate much in the way of sales. Perrigo, for example, currently supplies store-branded, FDA-approved formula to several national retailers. This shows that profitable production for the sizable non-WIC market is possible. However, Perrigo does not sell its own branded products nationally and thus has a smaller market share than its larger brand name competitors.19

While producers in other advanced economies are capable of meeting FDA production and labeling standards, they do not have a significant presence in the U.S. infant formula market. Tariffs and quotas, along with the cost of transporting products with limited shelf life, may explain why they do not ship products from their home facilities. Tariffs can be as high as 17.5 percent, and there are quotas limiting imports from the rest of North America.20 However, if tariffs are the obstacle, and there are profits to be made, more multinationals could follow the example of the three primary producers of formula in the United States—Reckitt Benckiser Group (United Kingdom-based owner of Mead-Johnson), Perrigo (based in Ireland), or Nestle (based in Switzerland)—and set up U.S. subsidiaries to avoid tariffs.

The Biden administration has taken several steps to increase supply in the short term. Foreign products that meet FDA standards are being airlifted to the United States, and the administration has invoked the Defense Production Act to give domestic producers priority for needed input components to manufacture more formula.21 Congress quickly passed the Access to Baby Formula Act to increase flexibility for WIC participants to purchase other formula products other than the sole-source contractor,22 and the FDA prioritized the safe reopening of the Abbott plant while expediting the evaluation of imports23 to determine if foreign producers meet FDA safety, nutrition, and other requirements.24

The formula shortage heavily affects the most vulnerable

The infant and specialty formula crisis offers an alarming commentary on this country’s priorities around food and hunger, particularly when it comes to ensuring that parents and caregivers have access to the safe, affordable, and nutritious foods needed for their infants’ healthy growth and development.

Effects of the crisis on low-income and working mothers

The effects of the national shortage are being felt by millions of families across the United States, since most parents feed their children formula at some point early in their lives.25 However, it has taken a particularly significant toll on low-income working mothers.26 All people should be able to choose the feeding method that is best suited for their family—whether that be breastfeeding, formula feeding, or a combination—but lower-income women often do not have the ability to make that choice, and they are more likely to rely on infant formula than breastfeeding or start their children on formula earlier.27 There are a variety of reasons for this, including inadequate paid family and medical leave policies that prevent women from having the time and support to initiate and sustain breastfeeding; a lack of flexibility and privacy for mothers to breastfeed or pump while at work; and difficultly affording lactation consultants or breastfeeding equipment.28 Instead, many low-income mothers—around 1.6 million in FY 201829—are covered by WIC because, while breastfeeding is difficult to maintain for the reasons listed above, baby formula remains prohibitively expensive. In fact, families can spend up to $1,500 per year on formula alone,30 and prices have only continued to climb over the past year, with the average cost of formula products increasing by as much as 18 percent.31 WIC has played an important role over the years in making infant formula affordable and accessible to low-income families, but amid the current formula crisis, that access has become severely hindered.

Effects of the crisis on disabled populations and parents

The formula shortage is equally challenging for infants and individuals with disabilities or other people with certain allergies, gastrointestinal conditions, and metabolic disorders who rely on formula for their nutritional intake and survival.32 There is limited research on the breastfeeding experiences of disabled people, but barriers can include issues with milk supply that limit breastfeeding and difficulties communicating with health care providers and lactation consultants due to accessibility or accommodation needs.33 Additionally, infants with disabilities or medical conditions may be allergic to breast milk34 or have nutritional needs that require specific formula brands that cannot be substituted.35 Due to the disproportionate number of disabled people living in poverty,36 accessing formula (often in person) is a large economic and accessibility barrier. According to a 2019 report from the National Disability Institute, the poverty rate for disabled adults is more than double that of nondisabled adults, and this is further exacerbated for disabled people of color.37 In addition, people with certain medical conditions may be unable to breastfeed, including people who are being treated with chemotherapy or have other medical issues that lead to parent-child separation.38

Due to the disproportionate number of disabled people living in poverty, accessing formula is a large economic and accessibility barrier.

Effects of the crisis on LGBTQI+, foster, and adoptive parents

The formula shortage also affects grandparents who provide care and LGBTQI+, foster, and adoptive parents who rely on formula for their infants’ healthy growth and development. LGBTQI+ families face unique concerns in the wake of this formula shortage.39 An estimated 292,000 children40 live in households with same-sex parents, and same-sex couples are seven times more likely to foster or adopt than opposite-sex couples.41 Parents who adopt or who have babies through surrogates, including many LGBTQI+ parents, may be more likely to rely on formula for feeding their children, significantly raising the stakes42 for these households if formula is not available.

In addition, due to employment discrimination, workforce exclusion, and other determinants of health, LGBTQI+ people collectively report higher rates43 of economic insecurity than non-LGBTQI+ people, heightening financial barriers to accessing formula when there are supply shortages and price fluctuations. Compared with non-LGBTQI+ populations, LGBTQI+ communities also report higher participation rates in public benefit programs, including nutrition assistance programs.44 For example, according to 2019 data from the Federal Reserve Board, LGBTQI+ households with children were almost twice as likely to receive assistance through the WIC nutrition program than non-LGBTQI+ households (14.8 percent compared with 8 percent) and through Supplemental Nutrition Assistance Program (SNAP) benefits, formerly known as food stamps (14.6 percent compared with 7.8 percent).45

Health consequences of the formula crisis

Infant and specialty formula itself is often exceedingly expensive.46 The high cost of baby formula, even when not amid a national shortage, forces some parents to modify or substitute formula, but this can lead to malnutrition and other serious health risks. The FDA has specific requirements for nutrient compounds in infant formula vital to children’s early development.47 At-home fixes, such as watering down baby formula to stretch it longer, homemade alternatives, and the use of other milk types for infants less than one year old, such as cow’s milk or plant-based milk, do not contain the nutritional composition that babies need.48 Additionally, if prepared in unsanitary conditions, these homemade alternatives can also contain foodborne illnesses, which can be fatal for young children.

Malnutrition takes a particularly high toll in infants, leading to slowed physical, cognitive, and neurodevelopment growth, including difficulties with language and speech, motor skills, behavior, memory, learning, or other neurological functions.49 Several children with medical conditions that require specific formulas were recently hospitalized in Tennessee when their families were unable to access needed formulas.50

Malnutrition in infants takes a particularly high toll, leading to slowed physical, cognitive, and neurodevelopment growth, including difficulties with language and speech, motor skills, behavior, memory, learning, or other neurological functions.

These alternatives are even riskier for infants with allergies or metabolic disorders who need specialized formulas to ensure they still get the nutrients they need. The Abbott plant in Michigan held a near monopoly on the production of specialized formulas that thousands of people rely on. The FDA recently announced new permissions for Abbott’s Michigan plant to release some specialty formulas on a “case-by-case basis” while the investigation into the safety concerns reported last year continued.51 The plant reopened on June 4, 2022, with a requirement to comply with regular external health and safety audits,52 but was forced to close again on June 15 due to flooding from torrential rains in the area.53 It remains to be seen how this latest closure will affect the ongoing formula shortage.

WIC also contributes to young children’s healthy growth development. For every dollar spent on WIC services, the United States saves $2.48 in health care costs.54 WIC clinics actively collaborate with other federal programs, health care providers, the food industry, and retail partners to strengthen community health infrastructure. Increased linkages—particularly with health care providers—can help address existing health disparities, including persistently high rates of maternal and infant mortality and morbidity. Proposed federal legislation focused on social determinants of health would create an interagency council to promote collaboration and coordination across federal programs.55 It would also provide grants to support community-based, cross-sector collaborations to coordinate care and services in communities with significant unmet health and social needs with the aim of improved and equitable outcomes.

Finally, it is important to keep in mind the toll that being unable to feed one’s child takes on parents and caregivers, regardless of circumstance. As this crisis has shown, many are quick to judge parents—particularly women—for using formula in the first place as opposed to focusing on needed policy interventions that ensure all parents can keep their babies healthy. The backlash from some, asserting that parents should simply breastfeed, reveals the enduring stigma around formula feeding and a lack of understanding of the needs of disparate populations who rely on formula.56

Recommended legislative and policy action

Access and affordability remain key challenges to all kinds of families, as well as for infants and babies who rely on specialty formula for their survival. In the long term, the United States needs to increase the number of suppliers of domestic infant formula to reduce the risk of supply shocks. Perrigo, one of the few companies supplying baby formula to U.S. grocery stores, expects shortages and increased demand for formula to last to the end of the year.57 To mitigate enduring shortages, WIC contracting should be reconfigured to increase entry of more domestic producers. Financial incentives may also be needed to assure swift entry. To the extent possible, supply of foreign formula production that meets FDA standards should be encouraged. Policymakers might reconsider tariffs applied to reliable producers, or the FDA could be empowered to suspend tariffs on these companies in the event of a significant supply shortage.

In addition to policies that dilute market concentration and incentivize new market entrants to produce a range of formula products, as discussed above, Congress has an important legislative opportunity to address some of the limitations and inflexibilities of the WIC program, making it stronger and more responsive to future spikes in need. Federal child nutrition programs—which include WIC—have not been reauthorized since 2010.58 These programs have continued operating through the annual appropriations process but have not been improved or strengthened in more than a decade. In 2021, congressional leaders in the U.S. House of Representatives and the U.S. Senate expressed interest in advancing the reauthorization but have yet to address the issue in 2022. Congress should reauthorize child nutrition programs and WIC this year with an eye to preserving the rebate program while incentivizing other entrants into the market to offer a wider range of products and lower costs.

It should not take a national emergency for policy change to support parents and WIC participants. State flexibilities, such as allowing parents and caregivers the options of buying alternate formula products, alternate sizes, and brands of formula using WIC benefits, should be made widely available to better meet the needs of caregivers and to be more responsive, especially during times of emergencies or shortages. Furthermore, America needs family friendly policies that support mothers, in particular low-income mothers, in their decision to either breastfeed or use formula. These policies can include:

  • Pursue permanent national paid leave legislation that covers all employees—including part-time and self-employed workers—and is inclusive of “chosen family”;59 includes short- and long-term caregiving leave; and ensures adequate wage replacement for caregiving leave.
  • Enforce existing workplace breastfeeding protections for covered employees—as stipulated under the Break Time for Nursing Mothers provision of the Fair Labor Standards Act—and expanding the types of workers not currently protected by the Break Time law.60
  • Enact regulations to ensure people enrolled in traditional Medicaid plans are not forced to pay out of pocket for breastfeeding counseling and equipment—a practice that is prohibited for most Medicaid expansion and private plans—and require federal and state Medicaid plans to cover at least one breast pump per pump type (electric, manual, or battery-operated).61

And finally, there needs to be increased oversight and accountability to become more responsive to future supply shortages and to address health and safety concerns, ensuring a food system that is equitable and resilient. Compounding supply shortages, regulators are also confronting enduring health and safety issues in powdered infant formula manufacturing. As such, the pandemic has pointed to the need to build the government’s capabilities to detect and prevent threats early, to respond quickly to health emergencies, and to ensure coordination across federal agencies to leverage communication and resources more effectively to address disruptions.

There is no comprehensive mechanism for detecting or investigating deadly bacteria, such as Cronobacter sakazakii, which has been linked to powdered formula and can cause serious brain damage, developmental disabilities, and even death in babies.62 While the U.S. Centers for Disease Control and Prevention (CDC) and FDA are working with state and local health officials to investigate a recent outbreak of the Cronobacter bacteria that resulted in several babies being sick and two passing away, the lack of regular testing and reporting makes it challenging to determine just how many people were affected. Currently, there is only one state that requires doctors and labs to report Cronobacter sakazakii cases to authorities.63 And although the FDA established regulations in 2014 requiring formula makers to test samples from every product lot for Cronobacter, lots tend to vary significantly in size, making testing inadequate. As a result, the FDA is now seeking authority to require additional testing and reporting by formula makers to ensure greater health and safety standards.64

These actions are critical, as chronic underinvestment in the nation’s public health system, including in the data systems and workforce needed to ensure that key functions such as food safety operate smoothly, has left the nation vulnerable. It highlights the need for timely information to assess risk and inform critical decisions and reveals the need for—and limitations of—the nation’s public health data for tracking and monitoring disease. President Joe Biden’s FY 2023 budget includes funding to strengthen the nation’s public health infrastructure and early warning capabilities, including funding for the CDC to develop workforce, laboratory capacity, and data collection, as well as for the FDA to expand and modernize its regulatory capacity and laboratory infrastructure.65 Congress should pass these funding increases, among other necessary reforms.

Long-term reform of the nation’s food and nutrition system

Every child, individual, and community deserves a food system that delivers affordable, nutritious food that protects their health and well-being. But the infant formula crisis, along with the COVID-19 pandemic and resulting economic downturn, has exposed persistent and deeply damaging inequities in the U.S. food system that must be addressed as a country. In a survey conducted from April 27, 2022 to May 9, 2022, almost 34 million households reported that they sometimes or often did not have enough to eat during the week.66 More than 11 million households with children under age 18 reported that they sometimes or often did not have enough to eat during the week. And almost 4 million households with children who were getting federal food benefits through SNAP still struggled with food insecurity and hunger during this time.67 Food insecurity is felt most acutely by people of color, individuals with disabilities,68 and LGBTQI+ people.69

Despite the United States producing enough food to feed everyone within its borders,70 millions of Americans rely on federal food benefits and programs—such as WIC, SNAP, or school meal programs—and food banks for their next meal. Such programs are intended to be emergency or supplemental aid for individuals or families struggling with temporary financial precarity and hunger. But increasingly, these programs have turned into a resource of basic survival for millions. Simply put, the U.S. food system does not meet the needs of all communities, especially rural, low-income, and communities of color.

America’s hunger crisis—both the infant formula shortage and more systemic food insecurity—should be a wake-up call to policymakers, forcing their attention to longer-term solutions rooted in the goal of fostering equitable and sustainable access to food and nutrition.

Policymakers can begin with two upcoming legislative reauthorizations that give Congress the opportunity to take meaningful action in fostering a food system that better meets the needs of all Americans:

  • In 2022, Congress is due to reauthorize the Child Nutrition and Women, Infant and Children Act,71 which authorizes all federal child nutrition programs, including WIC, reaching millions of children and their families each day. While Congress is long overdue for reauthorizing the Child Nutrition Act, it must at minimum renew the programs’ funding in 2022 while using the broader reauthorization opportunity to rethink the country’s food and distribution systems, especially for the most vulnerable.
  • In 2023, Congress will turn its attention to reauthorizing the Farm Bill, which includes SNAP, the largest anti-hunger program that supplements the food budget of needy families, enabling them to purchase healthy food and move toward self-sufficiency.

Both bills offer Congress an unprecedented opportunity to strengthen and coordinate food production, distribution, and supply systems in this country, while addressing emerging challenges that are affecting the national and global food systems—such as pandemics, the impact of climate change on food production, economic recessions, and more.

Secondly, the White House is hosting a conference on hunger, nutrition, and health in the fall of 2022, which presents an opportunity to reimagine the nation’s food system, focusing on sustainable, resilient productions, strong supply chains, adequate supply, and access to quality, affordable, and culturally and nutritionally diverse food for every person.

Simply put, the U.S. food system does not meet the needs of all communities, especially rural, low-income, and communities of color.

The domestic infant formula industry would also be subject to any changes made by way of new laws affecting the country’s domestic manufacturing and supply chain resiliency. Provisions in the House-passed COMPETES Act72—currently being reconciled in a conference committee with the Senate-passed U.S. Innovation and Competition Act73—would foster market entry, with additional incentives for small- and medium-sized manufacturers. If passed in a final package, these provisions could increase supplier diversity and expand the number of producers in the domestic infant formula market. However, these proposals may only have value to potential manufacturers if WIC single-source contracting evolves to increase access to market share by new producers that would otherwise be shut out of the preferential treatment previously described.74

And thirdly, long-term efforts to rebuild the food production, distribution, and supply system in an equitable and sustainable way should be combined with intersectional policies that support and build stability for low-income and other marginalized communities. For example, instituting a livable minimum wage throughout the United States, coupled with paid family and medical leave and other worker protections—including those that allow parents the flexibility they need to breastfeed or pump—are imperative to ensuring that individuals and families have the means to care for themselves and their loved ones with dignity. Good jobs can give low-income individuals and families a step up to financial security and self-sufficiency, reducing poverty and reliance on emergency food resources. Similarly, investing in safety net programs—making them stronger, more resilient, and more responsive in times of crisis—can ensure that every person is fully supported during times of personal, national, and global financial precarity. An intersectional approach to addressing the systemic inequities in the country’s food system can be aligned with a whole-of-government approach to address food insecurity from multiple angles—from production to distribution to supply and access.

Conclusion

The infant formula crisis has made one thing clear: It is time for a wake-up call. No child or individual should go hungry in the wealthiest nation in the world. For too long, key parts of the U.S. food system have been underfunded, monopolized by a small number of key players, and dependent on systems that can easily be disrupted and/or are underregulated, resulting in food and nutritional inequities with dangerous implications.

Over the next year, the United States has a crucial, once-in-a-generation opportunity to improve the lives and health of millions of children and other vulnerable people by undertaking a coordinated cross-sector response across federal agencies, leveraging resources to build an equitable, sustainable food system that accounts for the needs of diverse communities. New policies can foster communities in which every person can not only survive but thrive and prosper. It is imperative for policymakers to take advantage of this opportunity, creating a society and economy that supports and works for all its residents.

Acknowledgments

The authors would like to thank Hailey Gibbs, Madeline Shepherd, Maggie Jo Buchanan, Seth Hanlon, Nicole Ndumele, and Emily Gee for their guidance. The authors also thank Justin Schweitzer, Anona Neal, and the CAP Editorial team for their valuable contributions to this report.

Endnotes

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  2. Megan Cerullo, “The nationwide baby formula shortage is getting worse,” CBS News, May 10, 2022, available at https://www.cbsnews.com/news/baby-formula-shortage-rationing-national-crisis/.
  3. Ibid.
  4. The White House, “FACT SHEET: President Biden Announces Additional Steps to Address Infant Formula Shortage,” Press release, May 12, 2022, available at https://www.whitehouse.gov/briefing-room/statements-releases/2022/05/12/fact-sheet-president-biden-announces-additional-steps-to-address-infant-formula-shortage/.
  5. Laura Reiley and Timothy Bella, “Abbott’s Troubled Baby Formula Factory Closed Again Due to Flooding,” The Washington Post, June 16, 2022, available at https://www.washingtonpost.com/business/2022/06/16/abbott-baby-formula-plant-closes-flooding-elecare/; Eduardo Medina, “Please Help: A Nationwide Baby Formula Shortage Worsens,” The New York Times, May 8, 2022, available at https://www.nytimes.com/2022/05/08/business/baby-formula-shortage-retailers.html.
  6. Richard Howells, “Baby Formula Shortage Underscores Need for Supply Chain Resilience,” Forbes, May 19, 2020, available at https://www.forbes.com/sites/sap/2022/05/19/baby-formula-shortage-underscores-need-for-supply-chain-resilience/?sh=360d78599565; Jonathan Chang and Meghna Chakrabati, “The corporate monopolies behind the baby formula shortage,” wbur, May 19, 2022, available at https://www.wbur.org/onpoint/2022/05/19/the-corporate-monopolies-behind-americas-baby-formula-crisis.
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  66. U.S. Census Bureau, “Week 45 Household Pulse Survey: April 27 – May 9, 2022,” May 18, 2022, available at https://www.census.gov/data/tables/2022/demo/hhp/hhp45.html.
  67. Ibid.
  68. Kyle Ross and others, “The ARP Grew the Economy, Reduced Poverty, and Eased Financial Hardship for Millions” (Washington: Center for American Progress, 2022), available at https://www.americanprogress.org/article/the-arp-grew-the-economy-reduced-poverty-and-eased-financial-hardship-for-millions/.
  69. Taylor N. T. Brown, Adam P. Romero, and Gary J. Gates, “Food Insecurity and SNAP Participation in the LGBT Community” (Los Angeles: The Williams Institute, 2016), available at https://williamsinstitute.law.ucla.edu/wp-content/uploads/Food-Insecurity-SNAP-July-2016.pdf; Rooney, Whittington, and Durso, “Protecting Basic Living Standards for LGBTQ People.”
  70. Zach Conrad and others, “Capacity of the US Food System to Accommodate Improved Diet Quality: A Biophysical Model Projecting to 2030,” Current Developments in Nutrition 2 (4) (2018), available at https://doi.org/10.1093/cdn/nzy007.
  71. National Center for Homeless Education, “Child Nutrition and WIC Reauthorization Act of 2004,” available at https://nche.ed.gov/legislation/child-nutrition/#:~:text=The%20Child%20Nutrition%20and%20WIC,to%20healthy%20and%20nutritious%20foods (last accessed June 2022).
  72. United States Innovation and Competition Act of 2021, H.R. 4521, 117th Cong., 2nd sess. (May 5, 2022), available at https://www.congress.gov/bill/117th-congress/house-bill/4521.
  73. Ibid.
  74. Ibid.