On February 17, 2022, FDA issued a warning to consumers that a variety of powdered infant formulas produced at Abbott Nutrition’s Sturgis, Mich., facility, may not be safe for consumption. The FDA notice came following reports of illness in four infants, which may have resulted in at least two deaths. Abbott initiated a voluntary recall of products and lot numbers identified on the same day, but denies culpability.
An FDA investigation discovered that multiple lots of formula produced at the facility were adulterated due to the unsanitary conditions found in the facility. Testing of environmental swabs and product samples linked the facility to a Cronobacter sakazakii outbreak. The agency also determined that the plant was in violation of current good manufacturing practice requirements, so Abbott temporarily closed the facility to address the corrective actions needed.
The plant closure has reportedly resulted in more than 40% of the U.S. supply of baby formula being sold out nationwide, with retailers rationing existing inventory. It’s been almost four months, and the shortage remains, with desperate parents waiting for a solution. It’s been estimated that millions of babies are currently not receiving the formula they need due to the shortage.
What’s Been Done?
During this time, FDA has leveraged its authority to bolster the supply of products that serve as the sole source of nutrition for many infants, while ensuring that the infant formula can be used safely and that it provides adequate nutrition.
In mid-May, the President Biden invoked the Defense Production Act, which looked to streamline the production and shipping of formula components and ingredients to factories to ensure production increases back to safe levels as quickly as possible. One measure taken to alleviate the growing shortage was to launch Operation Fly Formula, a plan designed to speed up the import of infant formula. FDA has also issued a Draft Guidance Document allowing temporary enforcement discretion on certain formulas and has engaged with global producers on the new expedited importation approval procedures to further bolster supply.
Kendamil, a British baby formula company that has yet to gain approval for sale in the United States, was one of the first to respond to the agency’s request to participate, reaching out to FDA director Robert Calliff offering to help. A few days later, FDA released its guidance and Kendamil pulled together a 100-page report that was submitted to FDA in three days. “The FDA worked long hours with us … to process the approval as quickly as possible,” Will McMahon, co-founder of Kendamil, tells Food Quality & Safety. “Given our formula is already nutritionally compliant with FDA standards and the agency was familiar with our quality control processes, both parties were able to work effectively together.”
Kendamil has pledged two million cans of infant formula—the equivalent of at least 54 million 8-ounce bottles, to the United States over the next six months.
The first shipments as part of Operation Fly Formula will began arriving June 9 on flights donated by United Airlines. These flights over a 10-day period will contain more than 300,000 pounds—or approximately 3.7 million 8-ounce bottle equivalents—of Kendamil infant formula. “Everyone from the FDA to HHS to Customs and Border Patrol have all been extremely responsive and treating this with the urgency it requires, working long hours, through the weekends, to get this over the line,” McMahon adds.
Other actions taken by FDA include expedited review of notifications of manufacturing changes that will help increase supply; exercising enforcement discretion on minor labeling issues to help increase volume as quickly as possible; and allowing Abbott Nutrition to produce formula for individuals needing urgent, life-sustaining supplies of certain specialty and metabolic formulas that have been on hold at its Sturgis facility.
FDA expects that the measures it’s taken, along with the June 4 reopening of the Sturgis facility will alleviate the shortage. “We will ramp up production as quickly as we can while meeting all [FDA] requirements,” an Abbott spokesperson tells Food Quality & Safety. “We understand the urgent need for formula and our top priority is getting high-quality, safe formula into the hands of families across America.”
Additionally, USDA has announced that, under the Access to Baby Formula Act signed in late May, it is offering waivers to ensure that families can use benefits from the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) to purchase formula outside what is typically designated for the program.
The U.S. Department of Health and Human Services’ Office of Inspector General has launched an audit into FDA’s overall response to the crisis, examining whether it upheld its duty to safeguard the nation’s food supply and ensure that all ingredients are safe. FDA has stated it will cooperate fully with the watchdog’s review.