Baby formula disappeared from store shelves a year ago due to a combination of a massive recall, supply chain issues, the temporary shuttering of the country’s largest formula manufacturing plant and panic buying by scared parents as store shelves started emptying.
In the year since the crisis began, the supply has not fully recovered.
But another recall of 145,000 cans of specialty formula is apt to send more families scrambling to find infant formula. Formula manufacturer Reckitt on Sunday announced the recall of two batches of Enfamil ProSobee Simply Plant-Based Infant Formula.
The recall cites potential or cross-contamination with cronobacter bacteria, though Reckitt said in a news release that the impacted product had undergone “extensive testing” and no contamination was found.
Specialty formulas have been harder to find than normal formula throughout the crisis. As The Associated Press reported, “The shortage was especially acute for children with allergies, digestive problems and metabolic disorders who rely on specialty formulas.”
The factory that was in crisis, Abbott Nutrition’s plant in Sturgis, Michigan, was also the sole manufacturer of some of those formulas.
Demographic Intelligence’s chief information officer, Lyman Stone, told the Deseret News in May that other factors identified by its survey also likely contributed, including the nation’s wildly fluctuating number of births and a decrease in the number of women who breastfeed.
Meanwhile, the Securities and Exchange Commission and the Federal Trade Commission have announced investigations of Abbott Laboratories, which had the initial recall and whose plant in Sturgis, Michigan has experienced closures — first over safety and contamination concerns and then after a storm seriously damaged the facility. The facility resumed formula production in June.
Investigating the crisis
As CBS News reported, the investigations “are the latest in a series of inquiries into the factors that precipitated the company’s Michigan factory shutdown and kickstarted a nationwide formula shortage.”
The SEC’s Enforcement Division issued a subpoena in December regarding the company’s infant formula business “and related public disclosures.”
In January, CBS said that “the FTC issued the manufacturer a civil investigative demand connected with an investigation into companies” that bid for formula contracts with federal nutrition programs, including the supplemental nutrition program for Women, Infants and Children, often referred to simply as WIC.
Also in January, Abbott said the U.S. Justice Department is investigating operations at its Sturgis plant.
The initial recall, as Deseret News reported, included Similac, EleCare and Alimentum, as well as powdered infant formulas manufactured at the Sturgis facility. Four babies who were fed Abbott’s formula contracted cronobacter infections and two died, leading to the recall over concerns about the product. The plant was closed for weeks after investigators found cronobacter sakazakii in the facility, though not in actual formula.
Abbott has said repeatedly that no link was found between their products and the cronobacter infections in the babies.
Per the Centers for Disease Control and Prevention, “Cronobacter is a bacteria that has been found in a variety of dry foods, including powdered infant formula, powdered milk, herbal teas and starches. It has also been found in water. Cronobacter illnesses are rare, but they can be deadly for infants and can be serious among people with weakened immune systems and people 65 years and older.”
Food and Drug Administration Commissioner Robert Califf told media last year that an inspection revealed “shocking” and “egregiously unsanitary” conditions at the plant. The Justice Department investigation seems focused on those concerns.
“There are accusations in federal court filings of baby formula being manufactured under conditions that did not meet regulatory standards for quality and safety,” Food Safety News reported in late January.
Breastfeeding benefits
Public health officials on a global scale have said that breastfeeding is the healthiest option for most babies — and it is free. Some believe that companies manufacturing infant formula have tried to sway parents to instead purchase their product.
The American Academy of Pediatrics recommends “exclusive breastfeeding for about six months, followed by continued breastfeeding as complementary foods are introduced, with continuation of breastfeeding for one year or longer as mutually desired by mother and infant.”
The benefits, the academy says, include lowering the risk of ear infections, asthma, respiratory infections bowel and digestive issues and atopic dermatitis, among other conditions.
But not everyone can successfully breastfeed and families turn to formula for a number of reasons. During the crisis, the federal government undertook a number of measures to boost the supply of formula, from loosening restrictions on importing formula as long as it met U.S. standards — flying in the equivalent of millions of bottles worth of formula — to prioritizing infant formula materials in the supply chain using the Defense Production Act and more.
The medical journal The Lancet this month lambasted the formula milk industry for “underhanded marketing strategies designed to prey on parents’ fears and concerns, to turn the feeding of infants and young children into a multibillion-dollar business — generating revenues of about $55 billion each year.”
The three-paper series said the “dubious marketing practices” are further compounded by “lobbying governments, often covertly via trade associations and front groups, against strengthening breastfeeding protection laws and challenging food standard regulations.”
In May, the Federal Trade Commission announced it had “launched an inquiry” into the ongoing infant formula shortage, from the business practices of manufacturers to potential price gouging by others during the shortage. It’s also looking at government agencies with oversight and regulatory barriers, among other issues.
The agency said that “the inquiry seeks information about the nature and prevalence of any deceptive, fraudulent or otherwise unfair business practices aimed at taking advantage of families during this shortage. It also aims to shed light on the factors that have led to concentration in the infant formula market and the fragility of the supply chains for these crucial products.”
Among concerns, the FTC said it would look into whether families encountered “fraud, deception or scams when attempting to purchase infant formula or been forced to purchase formula from online resellers at exorbitant prices.”
The Reckitt recall
The Reckitt recall includes the ProSobee Simply Plant-Based Infant Formula in 12.9-ounce containers made between August and September 2022 and distributed through retailers in the United States, Guam and Puerto Rico, according to a release from Reckitt.
The affected product bears this on the bottom of the can: Batch numbers L2HZF and ZL2HZZ, both with UPC Code 300871214415. The use-by date is “1 Mar 2024.”
Per the company’s announcement, “No illnesses or adverse events have been reported. If parents have any questions, they should consult with their pediatrician or contact us at 1-800-479-0551 24/7 or by email at consumer.relations@rb.com.”