Here’s How the Federal Government is Responding to the Baby Formula Shortage

Federal agencies have been working to increase the availability of infant formula amid the nationwide shortage, and now face another roadblock after the facility at the center of the crisis had to pause production again due to weather disruptions. The Abbott plant in Michigan had been closed from February through early June due to safety concerns and several types of formula had been recalled; it had just reopened a few weeks ago.   

“The president has made this a priority,” said White House Press Secretary Karine Jean-Pierre during the briefing on Thursday. “He has used his authorities to make sure we can do everything we can to help get baby formula on the shelves,” such as by invoking the Defense Production Act and launching Operation Fly Formula. She didn’t have a specific timeline for how long parents and caregivers will continue to scramble, but reiterated the administration’s commitments. 

Jean-Pierre said the news that Abbott’s plant had to pause production on Wednesday due to flooding from severe storms after reopening on June 4 is “disappointing;” however, “we can’t control their timeline; what we can do is continue to focus on what we’re going to do.” 

President Biden said earlier this month he didn’t become aware how serious this situation was until April, which was well after the formula manufacturers knew. 

Actions By the Federal Agencies 

For the week of June 13, 10 Operation Fly Formula flights have been scheduled, which are expected to import nearly 5 million, 8-ounce bottle equivalents of infant formula to the United States,” said a press release from the Health and Human Services Department. By Sunday, the flights will have imported almost 13 million 8-ounce bottle equivalents of infant formula. Operation Fly Formula is a collaborative effort among the Health and Human Services, Agriculture and Defense departments, the General Services Administration and the White House. 

USDA’s Food and Nutrition Service issued a memo on June 6 laying out how the agency will implement a new law the president signed that grants USDA flexibility to waive certain requirements so families can continue using their Special Supplemental Nutrition Program for Women, Infants, and Children or “WIC” benefits amid a public health crisis or supply chain issues to purchase baby formula and better protect WIC participants during a product recall.

The Food and Drug Administration has been sharing updates on its efforts to increase flexibility to make more formula available. 

Request for a Watchdog Probe

Rep. Rosa DeLauro, D-Conn., chair of the House Appropriations Committee, asked the HHS inspector general on June 3 to look into the FDA’s use of enforcement discretion of certain requirements for formula manufacturers that might not be in compliance with statutes and regulations in order to increase availability of formula. 

“My concern here is that the approval process for enforcement discretion is moving quickly for having only nine full-time staff members, while the standard process for approval is more extensive and takes longer,” she wrote in a letter. “An additional concern I have is that there is no standardized application that the FDA is making their decisions from; if manufacturers are able to pick and choose what they submit from the guidance list, then there is no uniform application being submitted.”

Yvonne Gamble, spokesperson for the watchdog office, told Government Executive on Thursday they received the letter and “are reviewing it for appropriate action.”

Jean-Pierre was asked on Monday during the briefing if the president still has confidence in the FDA in reference to DeLauro’s request. Jean-Pierre said she hadn’t seen the letter, but “if you're asking me if the president has confidence in the FDA: he does.” 

The HHS IG already announced it would review the FDA’s actions in the lead up to the formula recall at the Abbott facility in February to determine if the agency followed its policies and procedures to inspect the facility and oversee Abbott’s management.

Update on the Michigan Plant 

Abbott Nutrition’s plant restarted production of EleCare and other specialty and metabolic formulas on June 4, with the intention of restarting production of other types of formula as soon as feasible. Then production was paused on Wednesday due to floods in part of the facility caused by severe thunderstorms and heavy rains in southwest Michigan. 

“We have informed FDA and will conduct comprehensive testing in conjunction with the independent third party to ensure the plant is safe to resume production,” said an update from Abbott on Wednesday. “This will likely delay production and distribution of new product for a few weeks.” The company has projected that it has “ample existing supply” of this formula and most specialty formulas until more of the product is available. 

Dr. Robert Califf, FDA commissioner, said during a Senate hearing on Thursday, “this is an unfortunate setback and a reminder that natural weather events can cause unforeseen disruptions in supply chains.” However, “I do want to reassure parents and caregivers that the all-of-government work to increase supply means we’ll have more than enough product to meet current demand and FDA is committed to working closely with Abbott, so that Sturgis can restart producing safe and quality formula products quickly.   

Califf also said the FDA now gets production data from all the manufacturers involved (all of whom have ramped up their production), which is in addition to what is received through Operation Fly Formula.