The United States is allowing more baby formula to be introduced to combat the shortage


Criticized by parents and politicians, the administration of President Joe Biden on Monday announced steps to alleviate the nationwide shortage of infant formula, including the reopening of a major domestic factory and an increase in imports from abroad.

The Food and Drug Administration says it is simplifying its review process to make it easier for foreign manufacturers to send more formulas to the United States.

“The FDA expects that the steps it is taking with baby formula manufacturers and others will mean that more and more supplies are being bought along the way or on store shelves,” FDA Commissioner Robert Calif told reporters. :

Infant formula is put on the table during infant formula to help Houston lose weight on Saturday, May 14, 2022. (AP Photo / David J. Phillip)

Calif said the United States would prioritize companies that could deliver the most shipments, show evidence quickly that their formulas were safe, and compliant with US food standards. The policy is constructed as a six-month interim measure.

The import announcement came shortly after regulators said they had agreed to allow Abbott Nutrition to reopen its Sturgis plant in Michigan, which has been closed since February due to pollution problems. The company must review its safety protocols and procedures before resuming production.

No move will immediately affect the limited supplies that have forced many parents to search for dairy products online or in food banks.

After receiving the FDA OK, Abbott said it would take eight to ten weeks for new products to reach stores. The company has not set a timetable for resuming production.

According to administration officials, the import will take a few weeks for the US supply chain. Goods from Australia, New Zealand and the United Kingdom are expected to meet import standards.

But regulators say national industry data show that most US stores, on average, still have 80% of their formula inventory in stock. They speculated that some of the empty shelves seen in recent days may be due to parental panic attacks.

Monday’s announcement was pre-empted last week by the White House, which relied on FDA’s formula makers to quickly find ways to mitigate the shortfall. The outrage over the issue quickly turned into a snowball վեց gave the Republicans new talk to use against President Biden ahead of the November election.

The shortfall stems from Abbott’s February recall, which has exacerbated ongoing supply chain disruptions among formula makers, leaving fewer options on store shelves in much of the country. The shortage has forced retailers like CVS և Walgreens to limit how many containers customers can buy per visit.

Abbott’s voluntary recall was due to four illnesses reported in children who used a mixture of its plant powder. All four newborns were hospitalized with a rare bacterial infection, and two died.

After a six-week inspection, FDA investigators released a list of problems in March, including a history of bacterial contamination in several parts of the plant, including unsafe safety և sanitary standards:. According to Monday’s agreement, Abbott will have to consult with an external security expert on a regular basis to resume or maintain production.

Abbott, based in Chicago, said his product was not directly linked to bacterial infections in children. Bacterial specimens found at the plant do not match strains collected from two newborns by federal investigators.

But FDA officials backtracked on that reasoning during a press conference Monday, the first time they had publicly addressed the company’s argument. FDA officials said they were unable to collect bacterial strains from two of the four patients, limiting their chances of finding a match.

“From the beginning, we limited ourselves to determining the causal link to whether the product was involved in these four cases, as we only had sequences on two,” said FDA Food Director Susan Maine.

It takes time to fix the abuses found at the Abbott plant, according to former FDA officials. Companies must thoroughly clean the facility և equipment, train staff, test repeatedly և prove that there is no pollution.

President Joe Biden addresses the White House Rose Garden in Washington on Friday, May 13, 2022. (AP Photo / Andrew Harnik)

As part of the FDA’s new import policy, regulators have said companies must submit their plant inspection documents.

Pediatricians say that baby formulas made in Canada and Europe are roughly equivalent to US formulas, but traditionally in the United States, 98% of baby formulas are made domestically. Companies seeking to enter the United States face several major hurdles, including FDA-required rigorous research and production standards.

San Diego’s father, Steven Hyde, faced heartbreaking challenges in finding a formula for his fragile medical daughter who used Abbott’s formula but had to change it with the recall’s lack of other brands.

Zoe Hyde was born 19 months ago without a kidney, a rare life-threatening condition that requires dialysis and a feeding tube until she is overweight for a kidney transplant.

Hyde said he used a foreign organic brand as long as costs and customs barriers made it extremely difficult. Friends and strangers outside the state have sent her other brands, but each time she changes, she requires more blood tests and monitoring, DG said.

Despite her difficulties, Zoe walks, talks, and “does quite well” on other development guidelines, DG said.

“She is a shining light in my life,” he said.

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