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Across the nation, parents of newborns have faced significant challenges in securing essential infant formulas like Similac and Enfamil. Current disruptions in the U.S. supply chain have intensified the scarcity of these vital products, leaving store shelves bare and parents understandably anxious. In 2024, concerns persist regarding the infant formula supply chain and the limited number of companies that dominate the market. Nguyen Injury Lawyer is closely monitoring these developments.
Formula Shortage Updates
April 18, 2025:
Despite Health and Human Services Secretary Robert F. Kennedy Jr.’s highly publicized pledge to enhance infant formula safety through the “Operation Stork Speed” initiative, the FDA has reportedly dismantled a crucial research team dedicated to this very objective. Approximately 15 out of 20 scientists within the FDA’s Division of Food Processing Science and Technology—including those specifically focused on minimizing contamination in powdered formula—were recently informed that their positions were being eliminated.
This action occurred shortly after Kennedy vowed to increase testing for heavy metals and improve formula safety. Instead of bolstering these efforts, the government has seemingly chosen to weaken the very research team responsible for investigating bacterial threats such as Cronobacter sakazakii, the same bacteria implicated in the 2022 infant formula crisis and multiple infant deaths.
Furthermore, these researchers played a vital role in nationwide food safety, ensuring that labs across the country could test for toxins and pathogens in various products, from baby cereal to milk. They were also exploring improved methods for eliminating harmful bacteria during manufacturing and providing guidance on safe formula preparation at home.
Currently, these efforts are uncertain. The scientists, many of whom believed their work would be protected under Kennedy’s leadership, have been placed on administrative leave until June 2, after which their employment with the FDA will end.
March 25, 2025:
The central question is whether the FDA is adequately prepared as RFK Jr. advances Operation Stork Speed, an initiative aimed at increasing heavy metal testing in infant formula. While the plan appears beneficial for parents concerned about contamination, it arrives at a time when the FDA is already under considerable strain. Facing workforce reductions, internal instability, and a history of struggling to address food safety issues, the agency now faces a significant challenge.
The FDA’s oversight of food safety has been subject to criticism for years. The 2022 infant formula recall exposed critical deficiencies in the system, leading to nationwide shortages and eroding public confidence. Now, Kennedy seeks to expand the agency’s responsibilities by mandating more extensive testing of formula products. However, this occurs as the FDA’s Human Foods Program has reportedly lost nearly 100 staff members in recent months due to layoffs, buyouts, and reorganizations. Some employees reportedly worry that there are simply not enough personnel to fulfill the mission.
Consumer groups are urging the administration to ensure the FDA receives the necessary funding and staffing to follow through. Meanwhile, industry experts suggest that formula manufacturers should conduct more testing themselves, rather than relying on the FDA to identify problems after products are already on the market. Currently, the agency is testing 340 formula samples, but with thousands of products available, questions remain about whether this is sufficient.
The FDA has faced similar situations in the past. The Closer to Zero initiative was intended to limit toxic metals in baby food, yet years later, enforceable limits for heavy metals in formula do not exist. This time, Kennedy is promising a more assertive approach, even extending the personal importation ban to European formulas. However, the effectiveness of any plan depends on the resources supporting it. Without adequate staffing and funding, Operation Stork Speed may not progress as rapidly as intended.
January 11, 2025:
The FDA has unveiled a new strategy to strengthen the U.S. infant formula market following a 2022 recall and shortage crisis.
Building upon a 2023 initiative, this plan encompasses annual inspections of formula manufacturers, specialized training for investigators, and enhanced oversight of the supply chain, particularly for specialty formulas crucial for medically vulnerable infants. The agency also aims to prevent contamination, facilitate the entry of new companies into the market, and leverage its regulatory authority to mitigate supply chain risks and shortages.
The strategy follows a 2022 investigation into Abbott’s powdered infant formula, linked to Cronobacter sakazakii and salmonella infections that caused illnesses and two infant deaths. Lawmakers criticized the FDA for its slow response after a whistleblower exposed conditions at Abbott’s Sturgis, Michigan plant. The FDA, in what could be described as a belated attempt at redemption, now asserts it has improved visibility into the formula supply chain. In December, it introduced draft guidance requiring manufacturers to report production interruptions, with the goal of preventing future crises that leave shelves empty and parents desperate.
October 6, 2024: The shortage is over; the concern is not.
July 31, 2024: An NEC baby formula lawsuit led to a $495 million verdict.
May 15, 2024: Republicans are blaming the Biden administration for not acting more quickly on the baby formula shortage crisis.
April 15, 2024: Three parents filed a proposed class action representing consumers nationwide who bought Similac, Alimentum, and EleCare products from April 2021 onward. They claimed that Abbott’s failure to adhere to essential safety standards caused the shortage and that it was unjust for the company to benefit from the resulting price increases.
The plaintiffs argued that by controlling a significant market share and being a key supplier for the Special Supplemental Nutrition Program for Women, Infants, and Children, Abbott had a responsibility to maintain production levels or stabilize prices. Plaintiffs argued that unjust enrichment, price increases were unnecessary, and the formula industry’s profit margin rose by 2.6 percentage points.
But, let’s face it, that is a slight increase. The court rejected the class, finding that overall sales revenues during the relevant timeframe most likely significantly declined, too, so isolating profit margin is not the best way to look at it.
The court’s opinion also highlighted that similar duties have not been imposed on pharmaceutical companies during drug shortages. He dismissed the argument that Abbott’s case was different because it was responsible for the production stoppage and shortage, stating that if Abbott had any duty, it was to halt the release and distribution of the contaminated formula—a measure taken by closing the facility and recalling the products.
A win here would have been nice, but most parents care more about safe formula than making a few bucks in a consumer class action lawsuit.
March 15, 2024: The Federal Trade Commission (FTC) conducted a study to investigate the long-term characteristics of the U.S. infant formula market that made it susceptible to these disruptions. The study aimed to provide insights for creating a more resilient supply chain in the future. The purpose? To ensure the debacle in 2022, when we faced significant disruptions in infant formula supply, adversely affecting millions of American families, does not repeat itself. These disruptions highlighted the critical nature of maintaining an uninterrupted supply chain for essential goods, including infant formula. Because a lot of children and families went through a lot
The FTC examined the effects of the U.S. Department of Agriculture’s Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) and the U.S. Food and Drug Administration’s (FDA) regulatory framework for infant formula. Both federal programs profoundly impact the market, balancing competition, consumer safety, and the well-being of vulnerable populations.
The FTC’s findings highlighted the role of WIC’s single-supplier contracts and FDA regulations in shaping the market dynamics. While these programs aim to support public health and safety, the study suggests that certain aspects may inadvertently contribute to market concentration and supply chain fragility. For instance, WIC’s approach of contracting with a single formula manufacturer in exchange for rebates has led to a high concentration of market power with a few manufacturers, making the supply chain vulnerable to disruptions. This, combined with regulatory barriers for new entrants, poses challenges to market competition and resiliency.
Furthermore, the FTC report underscores the importance of competition-based reforms to enhance the supply chain’s robustness. It suggests reevaluating WIC’s single-supplier contract model and considering the competitive impact of FDA regulations to ensure a more diversified and resilient infant formula market.
In response to the formula shortages, the FTC supports exploring policy adjustments that could mitigate risks of future disruptions while balancing the essential objectives of consumer safety and accessibility. This includes examining the structural factors within the infant formula market and the roles of federal programs in contributing to these challenges. The report calls for a thoughtful analysis of potential trade-offs between competition, supply chain stability, and regulatory priorities to serve American families better and ensure safe, nutritious infant formula availability.
March 14, 2024: This week, a $60 million verdict was entered in an NEC lawsuit in Illinois.
January 9, 2024: Reckitt/Mead Johnson Nutrition has voluntarily initiated a recall of select batches of Nutramigen Powder, a specialty infant formula designed for managing cow’s milk allergies. This decision comes amid concerns of potential bacterial contamination with Cronobacter sakazakii. The U.S. Food and Drug Administration (FDA) has clarified that all products in question underwent extensive testing by Reckitt/Mead Johnson and tested negative for the bacteria.
The affected products include Nutramigen Powder in 12.6 and 19.8 oz cans, manufactured in June 2023. These products were distributed primarily in June, July, and August 2023 through retail stores nationwide. The FDA has noted that it is likely most, if not all, of the recalled products in the United States have already been consumed.
December 12, 2023: In 2023, cronobacter sakazakii, the bacterium responsible for last year’s powdered formula recalls, has reportedly been linked to two severe infant infections. One case in Kentucky resulted in a fatality, and another in Missouri led to brain damage in a 6-week-old infant. Although the infants consumed formula produced by Abbott Nutrition, the FDA has found no connection to the company’s manufacturing facilities and sees no current public health concern warranting further recalls. The situation underscores the need for heightened awareness and caution when handling powdered infant formula, particularly for vulnerable groups like premature babies.
November 7, 2023:
If your child has been harmed by contaminated infant formula, Nguyen Injury Lawyer is here to help. Contact us at https://www.nguyeninjurylawyer.com/contact or call us at XXX-XXX-XXXX for a free consultation.
Updates on the Infant Formula Shortage
A bipartisan group of legislators, including U.S. Senators Tammy Duckworth (D-IL) and Marco Rubio (R-FL), along with U.S. Representatives Chrissy Houlahan (D-PA-06), Stephanie Bice (R-OK-05), and Maria Salazar (R-FL-27), has introduced a bill in both the House and Senate. This proposed law aims to strengthen federal support and broaden access to donated breast milk via nonprofit milk banks across the nation for parents and their medically vulnerable infants. The “Access to Donor Milk Act of 2023” would allow state agencies to use funds from the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) to promote awareness of the importance and need for donor milk. Additionally, it would authorize the use of WIC funds to support donor milk initiatives in various states.
November 1, 2023:
The FDA issued a warning letter stating that Similac Probiotic Tri-Blend infant formula might be unsafe for consumption. The letter cautioned Abbott Laboratories, the manufacturer of Similac formula, that at least two ingredients in the formula product posed potential safety risks. The FDA also suggested that Abbott’s marketing materials for the product could be in violation of agency regulations.
July 1, 2023:
The FDA announced that the National Academies of Sciences, Engineering, and Medicine (NASEM) will conduct an independent inquiry into the U.S. infant formula industry. This investigation will examine current market conditions, the diversity of manufacturers, product types, production capacities, and the volumes of domestic versus imported formula.
The study intends to understand market changes both before and after COVID-19, including events like the Abbott recall in February 2022. It will also explore factors affecting market competition and regulatory differences between the U.S. and foreign markets, such as the European Union. Upon completion, NASEM will present its findings to Congress and the FDA.
Under the 2022 Food and Drug Omnibus Reform Act, the FDA was directed to create an immediate strategy for enhancing the resilience of the U.S. infant formula market, which was published in March 2023. Using insights from the NASEM study, the FDA will develop a long-term national strategy.
May 28, 2023:
In 2022, the U.S. Federal Trade Commission (FTC) initiated an investigation into potential bid-rigging among baby formula manufacturers, including Abbott Laboratories, concerning state contracts. The investigation focuses on bids submitted to supply the Department of Agriculture’s Women, Infants, and Children (WIC) program, which provides free formula to low-income families. Winning these contracts is believed to boost commercial sales. Furthermore, the FTC is scrutinizing the company’s formula sales outside the WIC program. This inquiry coincides with an ongoing dispute between the FTC and Abbott over the disclosure of information following a nationwide formula shortage resulting from the closure of Abbott’s Sturgis, Michigan, plant in February 2022.
March 29, 2023:
Frank Yiannas, a former Food and Drug Administration (FDA) official, informed House lawmakers that more action is necessary to prevent another baby formula shortage.
Last year, Abbott Laboratories, the largest manufacturer of infant formula for the market, recalled Similac following reports of illnesses and deaths. The subsequent recall left parents across the country struggling to find supplies. Yiannas presented lawmakers with recommendations, including demanding higher standards from formula manufacturers.
Congress is addressing this issue seriously and seeking solutions.
February 18, 2023:
The shortage has largely ended, but the investigation of Abbott is still in its early stages.
December 1, 2022:
Shortages are expected to continue through the spring of 2023.
October 1, 2022:
U.S. regulators unveiled a new plan to prevent future baby formula shortages. This plan involves allowing foreign baby formula manufacturers to continue selling in the U.S. to increase the number of formula sellers.
July 15, 2022:
In-stock statistics, which measure the expected demand that stores have available for sale, showed 72% availability for baby formula for the week ending July 10, 2022. This is a 2% increase from the previous week but remains significantly below normal levels.
July 1, 2022:
The Sturgis plant for Abbott reopened for the second time.
June 9, 2022:
Danone SA announced its efforts to help alleviate the baby formula shortage in the United States. The French company stated that it has doubled production and is sending its specialized baby formula to the U.S.
June 7, 2022:
The baby formula shortage is not improving. According to Datasembly, out-of-stock rates jumped to 74% in the U.S. for the week ending May 28, up from 70% the previous week. While it is hoped that this crisis will soon be over, that time has not yet arrived.
June 6, 2022:
The White House announced the 5th operation of Operation Fly Formula. While this sounds promising, families are not yet experiencing the benefits.
June 4, 2022:
Abbott announced the restart of production at its Michigan facility, where a food poisoning outbreak was a significant factor in the baby formula shortage. However, the formula will not reach consumers until at least June 20th.
May 11, 2022:
The baby formula shortage continues to worsen, with inventories reportedly at their lowest point. Several major retailers, including Costco, CVS, Walgreens, and Target, have announced strict rules limiting the amount of formula that individual customers can purchase. The infant formula shortage was exacerbated in March when Abbott Laboratories was forced to recall Similac and EleCare formula products after discovering dangerous bacteria contamination at its facility in Sturgis, MI.
The Similac recall is contributing to the formula shortage.
April 8, 2022 update on the shortage
May 13, 2022 – House oversight committee is investigating the baby formula shortage
Earlier this week, the Infant Nutrition Council of America issued a statement acknowledging the baby formula shortage. The Council claims that government agencies and formula companies are working to ensure that infants have access to formula. This provides little comfort for parents struggling to find baby formula for their children.
Infant Formula Shortage Makes National Headlines
The infant formula shortage gained national attention recently after CBS News issued a report highlighting the severe lack of formula in many parts of the country. The CBS report noted that infant formula inventories were down 20% compared to pre-pandemic levels and that powdered formula was becoming extremely hard to find in many urban areas. The report of a Similac shortage was quickly picked up by the rest of the national media.
According to the story, a couple in the San Francisco area with a 10-month-old went to nearly a dozen different stores and were not able to find Similac or Similac Pro Advance. After driving as far as an hour away to find liquid Similac, the couple was forced to switch to a different product for their son. A couple in the Orlando area reported a similar experience when searching for Enfamil for their 10-week-old son who was born prematurely.
Why Is There a Formula Shortage in 2022?
Formula manufacturers such as Mead Johnson and Abbott Laboratories have acknowledged the issue. They claim that they are shipping products to stores as quickly as possible. Industry experts say that the shortage is the result of external factors that are interrelated.
First, there is an acute shortage of many of the raw ingredients that are used to manufacture infant formulas (which are mostly derived from cow’s milk). These shortages are the result of systemic supply chain problems that have resulted from the COVID pandemic. The lack of raw ingredients has forced manufacturers to slow production.
To compound the formula shortage of 2022, the reduced volume of formula products that are being manufactured is taking longer to make its way onto store shelves. This is largely due to supply chain problems and labor shortages. The net result is that products such as Similac and Enfamil are not available at major retailers such as Walgreens, CVS, and Target. Online retailers such as Amazon are also short on supplies.
Related Posts:
- Similac NEC Lawsuits
- Enfamil NEC Lawsuits
- NEC Formula Product Liability Cases
- Example of Recent Enfamil NEC Lawsuit
Shortages May Trigger Stockpiling and Price Inflation
The Similac and Enfamil shortage, which is a grave concern for infants who cannot breastfeed, has predictably started to prompt panic buying like what we saw with toilet paper and other items at the start of the pandemic. A spokesperson for INCA noted that they were seeing “some anecdotal evidence suggesting pantry-loading behaviors, which can put increased pressure on in-store inventory.”
INCA is encouraging parents to only keep a 2-week supply on hand and “avoid unnecessary stockpiling” to ensure that all parents have access to the formula they need. But will likely have little impact on the individual choices of parents desperate to meet the nutritional needs of their new babies. There are emergency sources of infant formula. But it’s not clear how effective or efficient these are.
The increased attention now being given to the baby formula shortage will likely increase the already high level of demand for formula. The presence of intense demand in the face of lower supplies will almost invariably lead to some level of price inflation.
Health Risks of Enfamil and Similac Infant Formulas
The current supply shortages of major cow-milk infant formulas such as Enfamil and Similac come just as these formula products are coming under fire for posing serious health risks for premature babies. Recent research has determined that formulas made from cow’s milk are potentially dangerous for premature infants because they significantly increase their risk of developing a deadly intestinal infection called necrotizing enterocolitis (NEC).
NEC is a very aggressive infection that attacks the gastrointestinal systems of infants and can cause rapid tissue decay. If not immediately treated, NEC can lead to perforations in the walls of the intestines and lead to systemic infections that are frequently fatal for premature babies.
Over the years, a growing body of scientific evidence of a causal link between NEC in premature infants fed with Similac, Enfamil, and other bovine formulas. Despite being aware of this evidence, the formula manufacturers have deliberately ignored this link, failed to warn about the risk of NEC for premature infants, and falsely marketed their products as safe for preemies.
This has prompted a wave of Similac NEC lawsuits and Enfamil NEC lawsuits by parents of preemies who were fed with these formulas at the hospital and subsequently developed NEC.
FAQs: Similac Shortages
When will formula shortages end?
Formula shortages were at 31% in April, compared to 23% in January. However, major formula manufacturers like Abbott and Mead Johnson are trying to address the issue by rerouting supplies from other markets.
Is there are shortage of Similac Pro Total Comfort?
There is currently a shortage on almost all liquid baby formula products, including Similac Pro Total Comfort. This doesn’t mean this product will be unavailable. The shortages are very regional in nature.
Why is puramino out of stock everywhere?
Enfamil Puramino may be out of stock in stores in your area because there is currently a nationwide shortage in baby formula supplies.
Contact Us About NEC Formula Lawsuits
If your premature baby was fed with formula and developed NEC, you may be entitled to financial compensation. Contact Nguyen Injury Lawyer today for a free case evaluation by calling XXX-XXX-XXXX or through our website’s contact page at https://www.nguyeninjurylawyer.com/contact.