DeLauro Seeks $28M In Emergency Funding To Tackle Infant Formula Shortage

U.S. Rep. Rosa DeLauro Tuesday continued taking a lead on addressing the nationwide infant formula shortage, introducing a bill to allot $28 million in emergency federal funds to tackle the current crisis as well as prevent future ones.

The money would be available through Sept. 30, 2023. It would help the Food and Drug Administration ​“acquire better data on the infant formula marketplace,” boost inspection staff, and focus more on ​“formula issues,” according to a DeLauro release. The shortage developed in the wake of a voluntary recall of infant formula by Abbott Nutrition, which controls 43 percent of the domestic market.

“The stories of mothers and fathers struggling to find formula and the images of empty store shelves are heartbreaking,” DeLauro stated. ​“Parents and caretakers across the country cannot wait — they need our support now. This bill takes important steps to restore supply in a safe and secure manner. Additionally, with these funds, FDA will be able to help to prevent this issue from occurring again. While we know we have more work to do to get to the bottom of serious safety concerns at an Abbott facility and the FDA’s failure to address them with any sense of urgency, this bill is the first step to help restock shelves and end this shortage.”

The money would help the FDA ​“acquire better data on the infant formula marketplace,” boost inspection staff, and focus more on ​“formula issues,” according toa DeLauro’s office.

In a separate release, DeLauro criticized an FDA plan to purchase emergency supplies of formula as needing more stringent standards.: ​“While I welcome action from the FDA to address the infant formula shortage, I continue to echo my concerns about safety. As I have said before, we cannot make a false choice between safety and supply. I am disappointed that these actions do not do enough to ensure the formula FDA imports is safe for consumers. Instead of purchasing formula from FDA-regulated facilities, the administration is opening the door to any company that self-identifies its formula as ​‘safe’. That is unacceptable. Several babies have been hospitalized and at least two have died. We cannot put another child at risk.” Click here to read the guidance FDA issued for manufacturers seeking ​“enforcement discretion” for formula that ​“is safe and nutritionally adequate but may not comply with all FDA statutory and regulatory requirements.”

An earlier version of this article follows.

DeLauro Vows Swift Action On Infant Formula

U.S. Rep. Rosa DeLauro, who first called attention in Congress to a problem with infant baby formula, started the week with a vow to get safe product into the country to address a shortage that has parents nationwide worried about feeding their babies.

The New Haven Democrat made that promise Monday morning during a virtual press conference (which you can watch above, streamed on WNHH FM).

DeLauro, who chairs the House Appropriations Committee, said she expects this week to advance legislation to speed the flow of infant formula from European countries and/or Mexico to make up for the suspension of domestic sales of formula made by Abbott Nutrition. Abbott formula was recalled after discovery of contaminated batches and lack of safeguards linked to the deaths of at least two infants; Abbot controls 43 percent of the infant formula market in the U.S.

The two immediate challenges involve safety and availability of formula, DeLauro said.

“You have a newborn. You go out and purchase formula. You want to feed your baby. Product is not available. In addition to that, it could be harmful and so dangerous to your child.

“What are we doing? The federal government needs to step in and do something about it immediately,” DeLauro declared.

She stressed that infant formula should be allowed in from only those foreign suppliers whose product is approved by the U.S. Food and Drug Administration. She noted that at least seven European and Mexican manufacturers’ product is FDA-approved — and that European standards tend to be higher than those of the FDA.

At the press conference, DeLauro also said she will hold hearings in Congress to investigate how the crisis developed, and how to ​“hold people accountable.” She cited three sources of concern:

• Abbott’s actions. ​“An October whistleblower’s report sent to FDA laid out what Abbott did or did not do. In essence they were selling a contaminated product. They falsified records related to testing. They released untested infant formula. The allegations went on and on … Lack of cleanliness in the workplace, traceability.

• The Food and Drug Administration’s inaction. DeLauro held up a copy of a whistleblower’s report she made public last October. She questioned why it took months for FDA to respond to the allegations and take action. 

• Oligopoly: Four companies control close to the entire infant formula market in the U.S., with Abbott accounting for a full 43 percent. That made it more difficult to respond to its products being pulled form the shelves. ​“They have cornered the market,” DeLauro said, noting as well that the company has a $1.7 billion federal contract to provide infant formula for low-income families, through the WIC (Women, Infant and Children) program.

Last week, U.S. Sen. Richard Blumenthal of Connecticut co-signed a letter with colleagues urging the U.S. Department of Agriculture, which oversees WIC, to address the ​“high levels of corporate concentration in the infant formula marketplace.”

“The infant formula industry has reached an alarming level of corporate concentration with four companies – Abbott Nutrition, Mead Johnson, Gerber, and Perrigo – controlling nearly 90% of the infant formula market,” they wrote. ​“Abbott Nutrition, the manufacturer of products currently under recall, alone controls around 40% of the infant formula market. This level of concentration has created a fragile system unable to adequately respond to shocks in the supply chain. Unfortunately, this puts our most vulnerable populations at risk, and disproportionately impacts low-income families who rely on programs such as” WIC.

Abbott's Response

Abbott responded to the allegations against it in the following public statement:

Since the recall, one of our priorities has been to mitigate the supply issues. In particular we’ve been focusing on production in our Cootehill, Ireland, facility to serve state Special Supplemental Nutrition Program for Women, Infants and Children (WIC) consumers. Abbott has been working with the USDA and WIC agencies and paying rebates on competitive products in states where Abbott holds the WIC contract, when Similac is not available. Abbott will continue to pay rebates for competitive products through August 31. This means program participants will continue to be able to obtain formula, free of charge whether it is Similac or formula from another manufacturer.

We know that the recall has worsened the industry-wide infant formula shortage, and we have been working to get as much product into the hands of parents as we can. Since February:

• We’ve air shipped millions of cans of infant formula powder into the U.S. from our FDA-registered facility in Cootehill, Ireland.
• We have prioritized infant formula production at our Columbus, Ohio, facility, converting other liquid manufacturing lines into manufacturing Similac liquid ready-to-feed. 
• We are offering an increased number and value of coupons available for all our infant formula products, including Similac ready-to-feed, to enable customers to purchase formula, either free or deeply discounted.
• And our other manufacturing facilities are running at full capacity as we continue to prioritize production of infant formula to help replenish the supply in the market.

At the same time, we have been working to address the FDA’s 483 observations so we can restart operations at the Sturgis, Mich., facility. We immediately began implementing corrective actions and subject to FDA approval, we could restart our Sturgis, Mich., site within two weeks.

We are confident that we can continue to produce safe, high-quality infant formula at all of our facilities as we have been doing for millions of babies around the world for decades.

May 11, 2022

The following provides current information on the findings from the investigation, our Sturgis, Mich., facility and supply.

The February voluntary recall involved four complaints of Cronobacter sakazakii — a common environmental bacteria — in infants who consumed infant formulas produced in this plant. Two infants became sick; two tragically passed away.

The facts about what was learned about the cases of Cronobacter have not been widely communicated. After a thorough review of all available data, there is no evidence to link our formulas to these infant illnesses.

It’s important to know:

• Abbott conducts microbiological testing on products prior to distribution and no Abbott formula distributed to consumers tested positive for Cronobacter sakazakii or Salmonella.
• All finished product testing by Abbott and the FDA during the inspection of the facility came back negative for Cronobacter and/or Salmonella. No Salmonella was found at the Sturgis facility.
• The Cronobacter sakazakii that was found in environmental testing during the investigation was in non-product contact areas of the facility and has not been linked to any known infant illness. Specifically:
  • Genetic sequencing on the two available samples from ill infants did not match strains of Cronobacter in our plant. Samples from ill infants did not match each other, meaning there was no connection between the two cases.
  • In all four cases, the state, FDA, and/or CDC tested samples of the Abbott formula that was used by the child. In all four cases, all unopened containers tested negative.
  • Open containers from the homes of the infants were also tested in three of the four cases; two of the three tested negative. The one positive was from an open container from the home of the infant, and it tested positive for two different strains of Cronobacter sakazakii, one of which matched the strain that caused the infant’s infection, and the other matched a strain found on a bottle of distilled water in the home used to mix the formula. Again, neither strain matched strains found in our plant.
  • The infants consumed four different types of our formula made over the course of nearly a year and the illnesses took place over several months in three different states.

Regarding the status of our work to reopen Sturgis:

The FDA concluded its inspection with a 483 letter to Abbott on March 18. This is a list of observations that point out where Abbott did not follow our processes and where we can improve our systems and protocols.

We take this very seriously and we responded to the 483 on April 8. Even before our formal response, we had begun working to address these issues, implement improvements and take corrective action. Some of these actions have included reviewing and updating education, training and safety procedures for both employees and visitors, as well as updating our protocols regarding water and cleaning and maintenance procedures at the facility. We immediately implemented corrections to address the items the FDA raised in the 483. We’ve also been making upgrades to the plant, including installing nonporous, easily cleanable and sanitary floors.

We know the recall has worsened an already existing industry-wide infant formula shortage in the U.S. and we’ve been seeing and hearing the stress and despair of parents who are facing empty shelves. We deeply regret the situation and since the recall, we’ve been working to increase supply at our other FDA-registered facilities, including bringing in Similac from our site in Cootehill, Ireland, by air and producing more liquid Similac and Alimentum. We also began releasing metabolic formulas that were on hold earlier this month at FDA’s request to those who need these unique formulas.

We understand the situation is urgent – getting Sturgis up and running will help alleviate this shortage. Subject to FDA approval, we could restart the site within two weeks. We would begin production of EleCare, Alimentum and metabolic formulas first and then begin production of Similac and other formulas. From the time we restart the site, it will take six to eight weeks before product is available on shelves.

Apr.15, 2022

Our Efforts to Address Infant Formula Supply

Millions of parents rely on our formula to feed their babies. And we know that our recent recall caused additional stress and anxiety in an already challenging situation of a global supply shortage. We are working hard to help moms, dads and caregivers get the high-quality nutrition they need for their babies.

Abbott is working closely with the U.S. Food and Drug Administration (FDA) to restart operations at the Sturgis, Mich., facility. We continue to make progress on corrective actions and will be implementing additional actions as we work toward addressing items related to the recent recall. In the meantime, we are working to increase the supply of infant formula by prioritizing infant formula production at our facilities that provide product to the U.S. market.

Shipping Formula From Cootehill, Ireland

We have an FDA-registered plant in Cootehill, Ireland, where we’ve increased the volume of Similac Advance powder formula produced for the U.S. We’re air-shipping product from this facility into the U.S. daily and the product is being restocked regularly.

Our Cootehill team sources ingredients from approximately 1,000 dairy farms in the local area. Following stringent quality and safety processes, each batch of infant formula undergoes extensive quality checks before it reaches stores.

Prioritizing Infant Formula Production in Columbus, Ohio

Columbus, Ohio, is the headquarters for Abbott’s U.S. nutrition business and is home to one of our five manufacturing facilities that produce infant formula for the U.S. market. At this facility we’ve made significant changes to ensure we can prioritize production of Similac Ready-to-Feed liquid formula, a product that can be used directly from the bottle. In the second quarter of the year, we expect to produce nearly three times more Similac Ready-to-Feed liquid formula than we did during the same period of time last year. And this product will be available on retail shelves and online soon.

Across the U.S., we’re prioritizing production of infant formula products to help replenish the supply in the market. And, this year, we will more than double the amount of Similac Advance powder formula we’re bringing in from our manufacturing facility in Cootehill, Ireland.

We are dedicated to doing everything possible to ensure parents and caregivers have what they need to feed their babies. And we’re always focused on what we can do to continue to serve our customers. We will continue to work closely with the FDA to implement corrective actions at the Michigan facility.

We know getting your baby high-quality infant formula is your priority — it is ours too.