In 2022, the United States experienced a severe shortage of infant formula as a result of the 2021–2022 global supply chain crisis compounded by a large scale product recall after two babies died after consuming Abbott infant formula, import restrictions, and market concentration. Unlike other food products, infant formula often does not have an available and acceptable substitute as a source of nutrition for those who rely on it. In addition to infants, the formula recalls affected non-infant medical patients who require nasogastric feeding or have certain other conditions.
On May 14, nationwide out-of-stock rates were reported to be 43%, up from 31% two weeks prior; by May 22, they had surged to 70%, where they remained through the start of July. This is drastically above normal out-of-stock rates of 10%, or reported in the first half of 2021, 2% to 8%. In many places, store shelves were bare. Delaware, Kansas, and Tennessee were reported to be the hardest-hit states. On May 27, FDA Commissioner Robert Califf reported to the Senate Health Committee that shortages would continue into July. Effects of the shortage were also felt in Canada.
Causes Supply chain issues The initial cause of the formula shortage was COVID-19-related supply chain issues, with some sources, including The Atlantic and Popular Mechanics, identifying these as still being (as of mid-May 2022) the leading cause. The shortage began in the early days of the pandemic, and worsened with subsequent labor shortages. By November 2021, 11% of popular brands were out of stock.
Recall and plant shutdown
The problem was exacerbated when Abbott Labs, one of three major formula producers in the United States, shut down production at its Sturgis, Michigan plant in February 2022, following a Food and Drug Administration recall of several brands of formula due to possible bacterial contamination that may have caused at least two infant deaths. Abbott produces 40% of the formula sold in the US, mostly under the Similac brand, and the Sturgis facility is its largest. The bacterium which sickened the infants, Cronobacter sakazakii, was found at the Sturgis plant. The CDC performed whole genome sequencing on Cronobacter bacteria from two patient samples, and found that the samples were not closely related to strains collected in the Sturgis plant, or to each other. In a press release, Abbott cited the CDC report and stated, "there is no evidence to link our formulas to these infant illnesses". FDA officials disputed this claim, citing the shortage of genetic data on C. sakazakii in the CDC database, making identification and comparison of strains difficult, and the high likelihood of missed detection of all strains at the plant using the procedures currently in place. The CEO of Abbott apologized for the voluntary recall on May 22, stating that their voluntary recall had exacerbated the infant formula shortage in the US, while also stating that the voluntary recall was the "right thing to do."
On June 10, the FDA stated that it was investigating reports that nine children died after consuming infant formula produced in the Sturgis plant, seven more than were previously acknowledged by the agency. In all nine reported fatalities, the agency was unable to identify the source of the infection. Abbott Nutrition maintained that no causal relationship had been established between its products and any of the reported infant deaths. The report was brought to the light by a FOIA request by eFoodAlert, a website for food safety information.
Alleged problems at Sturgis plant In October 2021, four months before the recall, a former employee of Abbott Nutrition in its Sturgis plant raised concerns about safety violations in the plant to senior FDA officials. The whistleblower outlined allegations of lax cleaning practices, improper training of employees, falsified records, and efforts by officials at the plant in 2019 to keep FDA inspectors from learning about serious issues related to the plant's system for checking for bacterial contaminants in the formula. The report alleged that some of the equipment in the Sturgis plant was "failing and in need of repair", as some product flow pipes were pitting and had pinholes, and that Abbott management had been aware of the issues seven years ahead of the outbreak. The allegations were sent to senior food safety officials in the FDA. The FDA did not inspect the plant until January 31, 2022.
Import restrictions A trade analyst for the libertarian Cato Institute noted that infant formula is subjected to high tariffs as well as tariff-rate quotas (TRQs). An item subject to TRQs has some imports subject to a tariff, and over-quota excess subject to a tariff and additional duties, making it expensive to import. A provision of the 2020 United States–Mexico–Canada Agreement imposed new restrictions on imports of formula from Canada; the United States imported no baby formula from Canada in 2021. The FDA also prohibits the import (for commercial purposes) and sale of formula from Europe in the US, even though many European formulas meet or exceed FDA nutritional guidelines, because their nutritional labeling does not conform to US requirements.
Market concentration Ninety percent of the formula in the United States is made by just four companies, including Abbott Nutrition. Abbott manufactures 43% of the US infant formula. Transportation Secretary Pete Buttigieg alleged that the industry's "enormous market concentration" may have exacerbated the problem. Senator Tammy Duckworth (D-IL) also urged the FTC to study whether market consolidation in the infant formula industry caused the shortage. According to Claire Kelloway of the Open Markets Institute, manufacturers operate a relatively small number of formula factories to increase efficiency and to reduce cost. But this creates lots of risk if a plant is closed, as happened with the Sturgis plant. FDA Commissioner Robert Califf acknowledged that the market concentration in the industry deserves more scrutiny. David Davis, a professor of economics at the South Dakota State University, has alleged that WIC (Special Supplemental Nutrition Program for Women, Infants, and Children) contracts help create monopolies that make it hard for other brands to break into the market. Davis stated that without WIC contracts, no player will be able to enter the industry. Davis stated that this kind of market concentration gives little flexibility if things go wrong, as one single plant will have a big impact on the industry.
Effects At the start of May, with shortages nationwide, the worst-hit states were Tennessee, Texas, Iowa, North Dakota, and South Dakota, all with out-of-stock rates at or greater than 50%. A further twenty-five states and Washington, DC, had out-of-stock rates between 40% and 50%, according to the market analysis firm Datasembly. As of May 16, San Antonio, Texas, was the most affected place, with out-of-stock rates reaching 57%. Shortages were reportedly particularly acute in rural areas. Black and Hispanic parents were particularly affected; these groups typically receive less support for lactation, and were historically marketed to at higher rates by formula manufacturers, resulting in lower rates of breastfeeding. In addition, Black and Hispanic families are more likely to be reliant on WIC programs that limit formula purchasing options, and to live in areas where shortages were particularly acute.
Sale and donation of breast milk Milk banks reported a surge in demand for breast milk and breast milk donations in response to the shortage. Milk banks in the US and Canada are overseen by the Human Milk Banking Association of North America, which certifies that banks employ donor screening, blood testing, and testing of donated milk to ensure dangerous drugs and communicable diseases are not transmitted, and pasteurize milk to prevent contamination. However, milk from milk banks is typically reserved for premature infants and those with certain high-risk health conditions. Where it can be purchased for healthy, full-term infants, it is often expensive, as high as $4 to $5 per ounce.
The informal sale or exchange of breastmilk in the US is both legal and unregulated. Some outlets such as Craigslist and eBay do not allow the sale of breastmilk. Informal sharing of breastmilk carries risks for contamination, disease transmission, and exposure to harmful drugs and medications, and is discouraged by the American Academy of Pediatrics and the FDA. A 2018 survey found that twelve percent of surveyed mothers had donated milk informally, and seven percent had given their babies donated milk. Outcomes of babies given informally donated milk are not well researched. The Academy of Breastfeeding Medicine encourages parents who are considering using informally donated milk to talk to their pediatrician first; to interview potential donors about the use of medications or herbs, recreational drug use, and disease status; and to pasteurize donated milk whenever possible.
Use of alternative foods Some parents watered down the formula to stretch their supply. Doctors warn that this practice can upset the sodium balance in infants' bodies and cause dangerous brain swelling and seizures. Doctors also warned that this practice can also result in too much potassium being retained, which could increase the risk of cardiac conductive abnormalities.
Other parents introduced cow's milk, almond or soy milk, juice, or solids before their children are developmentally ready. Doctors warned that giving cow's milk to babies under one year old is unhealthy, as cow's milk does not have enough iron to support brain development, and the heavier solute load in cow's milk makes the kidneys work harder. Feeding cow's milk to infants under a year old can also trigger allergies and intestinal bleeding. Doctors stated that, under extreme circumstances, babies older than six months can be given whole cow's milk for a few days.
Google searches for homemade formula recipes increased by 2400%, and a formula recipe from the 1950s circulated online, as doctors warned of the dangers of trying to make formula at home, including possibilities for dangerous contamination, and nutrient and electrolyte imbalances which may lead to severe malnutrition and death.
Hospitalizations Children in several states were hospitalized as a result of the shortage. In Tennessee, two children requiring an amino-acid-based formula due to short bowel syndrome were hospitalized. They had been eating EleCare, an Abbott product manufactured in the shut-down Sturgis plant. In South Carolina, four infants were hospitalized, three due to poor reactions to new formulas and one due to mineral imbalances in a homemade formula. A hospital in Atlanta also reported treating infants affected by the shortage.
Bot usage There were reports of people using Internet bots to continuously search the web for formulas available for online purchase. Some people used bots to resell the scarce product at a steep markup, while others set them up as a free service for parents struggling to find available products.
Shortage in Canada On May 21, Health Canada announced a shortage alert on formulas for babies that are at risk of severe allergic reactions. Health Canada stated that the shortage was related to the closing of the Abbott plant in Sturgis. The closed Sturgis plant had shipped hypoallergenic formula to Canada.
Responses
Efforts to prevent price gouging On May 12, the White House called on the Federal Trade Commission and state attorneys to crack down on price gouging and other unfair market practices affecting the sale of infant formula.