- The Biden Administration and FDA are being scrutinized for their handling of the baby formula shortage across the U.S.
- Lawmakers claim the Administration knew there was a problem with the Abbott plant in Michigan last fall but only ramped up its response after outcry from the public and lawmakers.
Months after a baby formula shortage started, 78,000 pounds of infant formula arrived from Europe Sunday night by military transport plane. It is the first of several flights planned in “Operation Fly Formula” ordered by the Biden administration, but it comes after months of shortages that have led to hoarding, empty shelves, and near panic as parents across the country try to feed their infants. Current data show that North Carolina’s formula stock rate is nearly half of the normal level. One can of powdered formula lasts about four days for an average infant feeding schedule.
“What we are hearing is that adequate supplies are flowing into North Carolina of infant formula, but as soon as it hits the shelf, even with some purchase limits, we are having a hard time keeping it on the shelf at retail locations,” Andy Ellen, president and general counsel of the North Carolina Retail Merchants Association, told CJ in a May 20 phone interview.
Last week, President Joe Biden invoked the Defense Production Act, normally used during wartime, to address the nationwide baby formula shortage and directed his administration to use Defense Department aircraft to pick up formula from overseas from countries like Switzerland that meet U.S. health and safety standards. Lawmakers across the country, including North Carolina, say the action only comes after public outcry and political attacks on the administration over the past few weeks.
“I’m glad the Biden Administration is finally taking the infant formula crisis seriously, but their response is still too little, too late,” said Sen. Richard Burr, R-North Carolina, ranking member of the Senate Health, Education, Labor and Pensions Committee, in a statement posted on his website. “There were warning signs of an impending infant formula shortage as early as last fall. By February, the Administration was aware that parents were struggling to find formula on store shelves — at the exact same time production in the United States was being severely limited with the closure of Abbott’s Sturgis, Michigan, plant.”
In his public statement, Burr gave a timeline detailing the Food and Drug Administration’s and the Biden administration’s failures in handling the situation. He said the FDA conducted its first inspection of the Abbott Sturgis plant in September 2021, two years after its last inspection. Issues uncovered in a 2019 surveillance inspection were resolved, but the plant was issued a Voluntary Action Indicated for different items and a form for formula inspection.
Last fall, the FDA received complaints about children becoming sick or even dying from Cronobacter sakazakii, a bacterial infection that could lead to meningitis and sepsis in children, that could be linked to the formula. In February, Abbott issued a recall of baby formula and shut down production. The Centers for Disease Control said in May there were no strains of Cronobacter sakazakii found in any of the sealed formula containers.
Burr’s timeline also shows the nationwide shortage for formula grew from 8% in July 2021 to 43% on May 1, 2022.
“Instead of resolving this matter quickly, however, the FDA dragged its feet, the formula out-of-stock rate skyrocketed, and parents across the country found themselves driving hours in search of a store with the formula their baby needs,” he said.
Frustration in finding formula has led to fights among parents in stores, like a Target in Massachusetts.
Also sparking frustration among parents and lawmakers are pictures taken by Rep. Kat Cammack, R-Florida, of pallets of baby formula at a migrant processing facility near the U.S./Mexico border.
The FDA began a follow-up inspection on Jan. 31 but took nearly two months to conclude it, wrapping it up on March 17.
Abbott officials said they submitted a corrective action plan to the FDA on April 8 answering problems the FDA cited in its inspection of the plant, but neither said why the plant wasn’t allowed to reopen soon after.
Democrats in Congress pointed fingers directly at Abbott for cutting safety protocols and putting tainted formula on store shelves that sickened infants.
Republican aides told The Washington Times their own investigators found the FDA had been dragging its feet and didn’t take any significant action to get the plant reopened until the Biden administration responded to lawmakers and the public’s criticism over recent weeks.
Appearing before Congress Thursday, FDA Commissioner Robert Califf testified that the agency didn’t get in the way of efforts to get the plant back up and running, but also didn’t explain what happened to cause the delay in letting the plant reopen.
The FDA announced a preliminary agreement with Abbott to restart production, pending safety upgrades and certifications, but it may take six to eight weeks to see product on the shelves once production starts. In the meantime, a new formula company based in Pennsylvania, ByHeart, which began production in March, is also ramping up its services to help out parents nationwide.
The U.S. House approved a $28 million emergency funding bill for the FDA to catch up to the shortfall. However, most of the money earmarked for salaries for new inspectors is drawing criticism from Republican senators, who said it was more of a blank check to the FDA bureaucracy, rather than increasing access to formula. Many Republicans voted against it, but it passed 231-192. Democrats have seized on the vote to criticize the GOP.
Republicans instead voted in favor of the House Access to Baby Formula Act, which provides waivers that allow parents enrolled in the Women, Infants, and Children supplemental nutrition program to buy formula from companies outside of the government-approved list. The bill passed the House 419-9, and the Senate passed the same bill Thursday evening. It was signed by Biden on Saturday.
“The current baby formula shortage is unacceptable,” said Rep. Ted Budd, R-13th District, who is running to replace Burr in the U.S. Senate. “Instead of hoarding stockpiles of baby formula at the southern border, the Biden administration should prioritize the needs of the American people first. I was proud to vote to loosen federal restrictions for families to get formula for their infants and prevent future supply chain disruptions. The infant formula shortage is an emergency and is one more consequence of the Biden administration’s mismanagement hurting North Carolina families.”
The N.C. Department of Health and Human Services produced a handout that discourages parents from attempting to make homemade baby formula or stretch it with water. It also advises that parents contact manufacturers’ customer service lines, increase breastfeeding or pumping, and call a United Way hotline for guidance on finding formula. If parents find formula prices that seem too high, NCDHHS advises calling 1-877-5-NO-SCAM to report price gouging.
“While other manufacturers have ramped up their production of formula products, they report that it is taking longer than usual to get product to retail shelves due to global supply chain issues,” Summer Tonizzo, press assistant for the NCDHHS wrote to Carolina Journal in an emailed statement. “Standard powdered formula for WIC has returned to having wide availability in the retail market throughout the state.”