The Food and Drug Administration reached an agreement with Abbott Laboratories on the steps needed to reopen the company's shuttered baby formula plant, which could begin to ease the shortage of infant formula that has frightened and frustrated parents nationwide.
Once the company has taken the necessary steps, the F.D.A. must grant approval. Several babies who had eaten formula produced there fell ill and two of them died.
The agreement with the F.D.A would need federal court approval, according to Abbott. The company said production could begin within two weeks and that it could translate to more formula on shelves in six to eight weeks. The company said it will keep flying formula from Ireland.
It was not clear when the F.D.A. would approve reopening the plant.
Abbott's plant has been offline since February, when the F.D.A. discovered a deadly bacteria, called cronobacter. Abbott said thebacteria were found in areas that indicated proximity to open products, but not necessarily in or on the production lines themselves.
Four recent infant illnesses and two deaths have been linked to the same type ofbacteria. There is no conclusive evidence to link Abbott's formulas to these infant illnesses.
Parents rushed to stock up on formula after the plant shut down. With store shelves bare in some communities, some have been so desperate they have fed their infants powdered oatmeal cereals and fruit juice, even though breast milk is a crucial source of nutrition from birth to the first birthday.
In addition to the F.D.A.'s actions, RepresentativeRosa DeLauro, a Democrat from Connecticut, said in an interview on Monday that she planned to introduce a bill that would ease the process of imports of infant formula from F.D.A. She plans to hold hearings in the House to look into what went wrong in the run-up to the discovery of thebacteria and shortages.
Both the company and the F.D.A. need to be held accountable in order to move forward. She invited Abbott to testify at a hearing on May 25 after she called for an investigation by the Health and Human Services inspector general.
The first routine inspection of the Abbott Sturgis plant since the Covid-19 outbreak took place in September. According to agency documents, inspectors discovered standing water inside the plant and personnel working with formula without proper hand hygiene.
The plant leaders hid information from the F.D.A. and omitted important information from official documents, according to a complaint filed by a whistle blower.
According to agency records, the F.D.A. returned to the plant on January 31 and discovered persistent problems, including the presence of cronobacterbacteria near production lines.
The F.D.A. and Abbott issued a wide-ranging recall of Abbott's infant formula. Since then, supplies have dwindled in stores, setting parents on frantic trips to find formula to feed their babies, some of whom reject a new or unfamiliar taste.
Dr. Robert was the F.D.A. commissioner. M Califf said on CNN that the agency was working to get formula back on store shelves.
A growing problem. A nationwide shortage of baby formula has left parents confused and concerned. There are ways to manage uncertainty.
Finding a formula. If your baby's formula wasn't affected by the recall, you can call your local store and ask when it will be back in stock. You can buy it online. If your baby is on special formula, you should reach out to your doctor's office.
A new formula is being picked. If you use a name-brand formula, look for a generic version. If you want a new formula that matches your usual one, seek it. If your baby is on a special formula, make sure to check with your doctor.
A new product transition. You want to switch your child gradually. Gradually phase out the old product when you mix three quarters of your usual formula with one quarter of the new one. If you can transition gradually because you have run out of your usual formula, it's fine.
What not to do. If you can't find your baby's usual formula, don't make your own, homemade formulas are often inadequate and at risk of being contaminated. Don't try to stretch your formula by adding more water, and don't buy it from unvetted online marketplaces. Don't use toddler formula for a baby less than a year old.
We anticipate that within a few weeks we will have things back to normal, according to Dr. Califf.
The degree of the shortage was pushed back by Dr. Califf. He described the events since the production shutdown as "relatively unpredictable consequences." He also said the supply numbers quoted in some reports, which showed formula supplies at 56 percent of normal, were incorrect. The in-stock rate is closer to 80 percent according to the White House officials.
None of those figures were relevant to the woman who went to a local Target and found the shelves completely stripped of infant formula. Toddler formula was the only thing in stock. She went to the store 16 miles away to get the last two cans of formula for her son.
She said that you want to buy it whenever you see it because you don't want to run out. Limits on formula purchases are put on most retail outlets.
Dr. Califf is scheduled to appear before a House Appropriations subcommittee on Thursday. In an interview with CNN, he said that the agency has nine staff members who are focused on baby formula, and that they were given funds for four more.
Dr. Califf said that we will need more than that.
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