US allows more infant formula imports, reopens major factory to ease shortage |  CBC News

US allows more infant formula imports, reopens major factory to ease shortage | CBC News

Under criticism from parents and politicians, the administration of US President Joe Biden announced, on Monday, steps to ease the nationwide shortage of infant formula, including reopening the largest domestic factory and increasing imports from abroad.

The U.S. Food and Drug Administration (FDA) said it is streamlining its review process to make it easier for foreign manufacturers to start shipping more formulations to the United States.

“The FDA expects that the actions and steps it is taking with manufacturers of infant formula and others will mean more and more supplies on the way or on store shelves moving forward,” FDA Commissioner Robert Califf told reporters.

Califf said the US will prioritize companies that can provide the largest shipments and quickly show documents that their formulas are safe and compliant with US nutrition standards. The policy was put in place as a temporary measure lasting six months.

The announcement came shortly after regulators said they had reached an agreement to allow Abbott Nutrition to restart its plant in Sturgis, Michigan, which has been closed since February due to pollution issues. The company must reform its safety protocols and procedures before resuming production.

A woman helps distribute infant formula while driving in Houston on Saturday. Parents looking for infant formula are turning to the supermarket and drugstore shelves, in part due to constant supply disruptions and a recent safety recall. (David J. Philip/The Associated Press)

Neither step will have an immediate impact on the limited supplies that have left many parents searching for formula online or at food banks.

After obtaining FDA approval, Abbott said it will take six to eight weeks before new products start hitting stores. The company has not set a remanufacturing timeline, which must be certified with the Food and Drug Administration.

According to administration officials, bringing imports into the US supply chain will take several weeks. Products from Australia, New Zealand and the United Kingdom are expected to meet the necessary standards for import.

But regulators said national industry data shows that most US stores, on average, still have 80 percent of formula stock in stock. They suggested that some of the empty shelves seen in recent days may be due to panic buying by parents.

Monday’s announcement was previewed last week by the White House, which has been relying on the Food and Drug Administration and formula makers to find quick ways to alleviate the shortage. Outrage over the issue quickly compounded, giving Republicans a new talking point to use against Biden ahead of the November midterm elections.

I remember the already tense show shrinking

The Abbott plant was tested earlier this year after four children developed a bacterial infection after ingesting formula milk powder from a Michigan plant. Two children died.

Abbott’s manufacturing plant is shown in Sturgis, Mich. The company has reached an agreement with US health officials to resume production at the plant. (Brandon Watson/Journal Sturgis/The Associated Press)

In February, the company halted production and pulled several brands from the formula. These steps have slashed supplies already strained by supply chain disruptions and hoarding for parents during COVID-19.

Shortages have led retailers like CVS and Target to limit the number of containers customers can buy per visit and have forced some parents to swap and sell the formula online.

Abbott is one of only four companies that produce nearly 90 percent of US formula, and their brands account for nearly half of that market.

After a six-week check, US Food and Drug Administration investigators published a list of problems in March, including lax health and safety standards and a history of bacterial contamination in several parts of the plant.

Watch | Effects of Formula Deficiency in Canada:

US infant formula shortage affects Canadian parents

The shortage of infant formula in the United States is beginning to affect Canadian stores and parents, especially those looking for special formulas.

Chicago-based Abbott has confirmed that its products have not been directly linked to bacterial infections in children. The bacteria samples found at her factory did not match the strains collected from the children by federal investigators.

But FDA officials backed away from that reasoning Monday in a call with reporters — the first time they’ve publicly addressed the company’s argument. Food and Drug Administration personnel note that they are unable to collect bacterial strains from two of the four patients, limiting their chances of finding a match.

“From the beginning, we were limited in our ability to determine whether a product was associated with these four conditions through causal association because we only had sequences in two,” said Susan Mayne, FDA food director.

It will take time to fix problems

Former Food and Drug Administration officials say it takes time to fix the kind of problems detected at the Abbott plant, and infant formula facilities receive more scrutiny than other food facilities. Companies need to thoroughly clean the facility and equipment, retrain employees, and frequently test and document the absence of contamination.

As part of the Food and Drug Administration’s new import policy, regulators said companies will need to submit documentation for inspections at their plants.

Pediatricians say baby formulas produced in Canada and Europe are roughly equivalent to those in the United States, but traditionally, 98 percent of the United States’ infant formula supply is manufactured domestically.

Companies seeking to enter the United States face several major obstacles, including stringent research and manufacturing standards imposed by the Food and Drug Administration.

2022-05-16 21:21:00

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