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Infant Formula Supply Chain Lawsuit

Posted on: December 25, 2023

PN Editor
December 25, 2023

Infant Formula Supply Chain Lawsuit


Infant Formula Supply Chain Crisis

Parents in various regions nationwide are experiencing difficulties obtaining essential infant formulas, such as Similac and Enfamil, during June 2022. The persistent supply chain issues that plague the U.S. economy have given rise to a significant shortfall in infant formula availability, causing bare shelves and great concern among parents.

Recent Developments and Regulatory Actions

December 12, 2023: 
A resurgence of the bacterium cronobacter sakazakii has been seen in 2023, connected to two severe infantile infections. One incident in Kentucky was linked to a death, and another in Missouri resulted in neurological damage to a 6-week-old. Despite these cases involving formula from Abbott Nutrition, the FDA has detected no association with Abbott’s manufacturing sites and does not believe there is a need for additional recalls. However, this does emphasize the importance of careful handling of powdered infant formula, especially for at-risk infants such as preterm babies.

November 7, 2023: 
A bipartisan coalition of legislators, including Senators Tammy Duckworth and Marco Rubio and Representatives Chrissy Houlahan, Stephanie Bice, and Maria Salazar, introduced the “Access to Donor Milk Act of 2023”. This proposed bill intends to enhance the federal support and expand accessibility to nonprofit milk bank donations for parents and medically fragile infants. Through this act, WIC funds can be utilized for promoting donor milk significance and related activities throughout the states.

November 1, 2023: 
The FDA has released a warning letter to Abbott Laboratories regarding the safety of the Similac Probiotic Tri-Blend infant formula, pointing out at least two ingredients that might pose health risks. It further noted that Abbott’s promotional materials for this product could potentially breach FDA guidelines.

July 1, 2023: 
The FDA has announced an independent review of the U.S. infant formula sector by NASEM. This examination will address the scope of market conditions, diversity of production, product types, capacities, and the breakdown of domestic versus imported formula supplies. The comprehensive study will dissect pandemic-induced market shifts, as well as contributing factors like the Abbott recall in February 2022. Furthermore, it will assess competitive and regulatory differences between the U.S. and places like the EU. The final report from NASEM will be presented to the FDA and Congress.

May 28, 2023: 
The FTC initiated an inquiry in 2022 following allegations of bid-rigging by infant formula producers, including Abbott Laboratories, within government contracts. The investigation focuses on bids for the WIC program and analyses whether Abbott’s commercial sales benefit from these contracts. The review is concurrent with FTC’s ongoing dispute with Abbott surrounding data disclosure amid a nationwide formula shortage due to the shutdown of Abbott’s plant in February 2022.

March 29, 2023: 
Ex-FDA official Frank Yiannas voiced concerns to Congress about the adequacy of measures to avert future baby formula shortages.

Contact Pusch & Nguyen for Legal Assistance

If you require legal counsel or support regarding the infant formula shortage, please do not hesitate to contact Pusch & Nguyen at 833-787-4946.

Infant Formula Crisis and Regulatory Response

Last year, Abbott Laboratories, the largest producer of infant formula in the market, issued a recall for Similac amidst reports of illnesses and fatalities. This action caused a nationwide scramble among parents attempting to secure necessary supplies for their infants. In response, Yiannas provided legislators with a series of proposals aimed at enforcing stricter quality standards upon formula producers, highlighting the severity with which Congress is addressing the matter and actively seeking resolutions.

Recent Updates on Formula Shortage and Regulatory Measures

February 18, 2023: The scarcity of infant formula has mostly subsided; however, the scrutiny into Abbott’s practices has barely begun.

December 1, 2022: Anticipations indicate that formula shortages are likely to persist until the spring of 2023.

October 1, 2022: U.S. regulators recently announced a fresh strategy to avert future shortages in baby formula supply. The approach, albeit somewhat alarming, includes allowing foreign producers of baby formula to continue their sales within the U.S. market, thereby increasing the number of available formula sellers.

July 15, 2022: As of the week concluding on July 10, 2022, the availability of baby formula in stores, a significant metric that many have started to rely on, was recorded at 72%. This figure represents a marginal 2% improvement from the prior week but remains distressingly low.

July 1, 2022: The Sturgis facility of Abbott has recommenced operations for a second time.

June 9, 2022: Danone SA has announced its commitment to mitigating the baby formula shortage in the United States. The French conglomerate has intensified its production efforts and is currently dispatching its specialty infant formulas to the American market.

June 7, 2022: The baby formula deficit is showing no signs of improvement. Reports from Datasembly reveal that the out-of-stock rates in the U.S. surged to 74% for the week ending May 28, a hike from 70% the preceding week. Expectations are that this crisis will abate in due course, yet the end is not as near as hoped.

June 6, 2022: The White House divulged the fifth installment of Operation Fly Formula. Despite the optimistic title, many affected families continue to grapple with the shortfall and have yet to experience the perceived benefits of this initiative.

June 4, 2022: 

Abbott has announced the recommencement of production at the Michigan facility, which was implicated in a food poisoning outbreak precipitating the baby formula shortage. Nevertheless, the formula is not expected to be available to consumers until June 20th at the earliest.

May 11, 2022: 

The scarcity of baby formula continues to escalate, with inventories reaching critically low levels. Top retailers like Costco, CVS, Walgreens, and Target have instituted purchase limits on formula to manage the constrained supply. The shortage was exacerbated in March due to a mandatory recall of Similac and EleCare by Abbott Laboratories after the detection of hazardous bacterial contamination.

The shortage has drawn the attention of the House Oversight Committee, which started an inquiry into the matter on May 13, 2022. Moreover, earlier in the week, the Infant Nutrition Council of America acknowledged the crisis and assured the public that both governmental bodies and formula manufacturers are diligently working to mitigate the situation. However, this provides scant consolation to parents desperately seeking baby formula.

Media Spotlight on Formula Shortage

The infant formula shortage garnered national attention after a report by CBS News highlighted the severe depletion of formula supplies. This report detailed a 20% reduction in infant formula inventory compared to pre-COVID-19 levels and the challenges in finding powdered formula in urban locations. The news of a Similac shortage quickly resonated with media outlets nationwide.

The grim reality was depicted through personal stories, including the plight of a San Francisco couple who after visiting an array of stores were compelled to switch to an alternative product for their child due to the unavailability of Similac or Similac Pro Advance. Similarly, an Orlando couple reported daunting challenges in obtaining Enfamil for their prematurely born infant.

Exploration into the 2022 Formula Shortage

An in-depth understanding of the catalysts behind this year’s formula shortage is underway, as it poses a critical question affecting families across the nation.

Understanding the Infant Formula Shortage

Notable formula manufacturers, including Mead Johnson and Abbott Laboratories, have recognized the ongoing shortage in the market. Their commitment to mitigating the issue is evident as they assure the public that their efforts to replenish stock levels at retail outlets are being expedited. However, industry pundits attribute the depletion of infant formula inventory to a maze of interconnected external factors.

A primary culprit contributing to the 2022 formula shortage is the severe scarcity of essential raw materials, predominantly sourced from cow’s milk, necessary for the production of infant formulas. The COVID-19 pandemic has been a pivotal disruptor, instigating systemic supply chain complications and rendering the procurement of these ingredients challenging. Consequently, production paces have diminished significantly due to these constraints.

The situation is exacerbated by logistical issues. Even the limited quantities of products such as Similac and Enfamil that are being produced are encountering delays before reaching retail environments like Walgreens, CVS, and Target. Supply chain inefficiencies, compounded by prevalent labor shortages, mean that the replenishment of stock is not keeping pace with demand. Additionally, online giants like Amazon are grappling with similar insufficiencies.

Consumer Response to the Crisis

In the wake of this dire shortage, there is growing concern for infants reliant on formula, particularly those who are not breastfed. The alarming scarcity has prompted behavior reminiscent of the early pandemic days, leading to panic purchases and stockpiling. A representative from INCA has indicated that there are preliminary reports of such behavior, warning that this could further strain the limited in-store formula supplies.

Further Reading and Legal Context

  • Similac NEC Lawsuits
  • Enfamil NEC Lawsuits
  • NEC Formula Product Liability Cases
  • Example of Recent Enfamil NEC Lawsuit
Implications of the Shortage

The aftermath of the formula shortage may potentially lead to increased stockpiling and price surges, intensifying the plight of families in need of these critical nutritional products for their infants.


Infant Formula Supply and Health Concerns

INCA is strongly urging parents to maintain only a two-week inventory of infant formula in order to avoid unnecessary stockpiling. This recommendation is made with the intention of ensuring equitable access to infant formula for all parents. However, this advice may not significantly influence the purchasing decisions of parents who are anxious about fulfilling the nutritional requirements of their infants, especially given that emergency sources of infant formula are currently of questionable efficacy.

The spotlight on the baby formula shortage is expected to exacerbate the existing high demand. Considering the reduced availability, this situation is likely to result in price surges, further complicating the issue for many families.

Health Risks Associated with Enfamil and Similac

The scarcity of key cow-milk-based infant formulas, such as Enfamil and Similac, coincides with emerging concerns regarding their safety for premature infants. Recent studies suggest that such formulas can significantly elevate the risk of a severe gastrointestinal disease in premature infants known as necrotizing enterocolitis (NEC), which can rapidly deteriorate intestinal tissue and become life-threatening if not promptly addressed. Despite growing scientific evidence of the association between cow-milk formula and NEC, manufacturers have reportedly failed to provide adequate warnings and continued to endorse these products as safe for premature infants.

This issue has led to a surge in legal actions, with numerous Similac NEC lawsuits and Enfamil NEC lawsuits filed by the parents of preemies who, after being fed these formulas, suffered from NEC.

FAQs: Similac Shortages

When will formula shortages end? As of April, formula shortages reached 31%, showing an increase from 23% in January. Major producers such as Abbott and Mead Johnson are implementing strategies to alleviate the shortages, including the redirection of supplies from other regions.

Is there a shortage of Similac Pro Total Comfort? Most liquid baby formula products are experiencing shortages, including Similac Pro Total Comfort. While supplies are tight, this does not imply that the product is completely unavailable, as the extent of the shortages varies regionally.

Current Status of Enfamil Puramino Availability

The absence of Enfamil Puramino from store shelves can be attributed to a widespread scarcity of baby formula products across the nation. This shortage is impacting numerous locations, resulting in challenges for consumers seeking to purchase this specific brand.


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