Sunday, June 26, 2022

US allows more baby formula imports to fight shortage

WASHINGTON ( Associated Press) – Under criticism from parents and politicians, President Joe Biden’s administration on Monday called for steps to ease a nationwide shortage of baby formula, including reopening the largest domestic manufacturing plant and increasing imports from overseas. declare.

The Food and Drug Administration said it is streamlining its review process to make it easier for foreign manufacturers to begin shipping formula to the US.

“The FDA expects that the measures and steps being taken with infant formula manufacturers and others will mean that more and more supplies are on the way or are headed to store shelves,” FDA Commissioner Robert Calif told reporters.

Calif said the US will prioritize companies that can provide the largest shipments and can quickly show documentation that their formulas are safe and meet US nutritional standards.

The import announcement came shortly after regulators said they had reached an agreement to allow Abbott Nutrition to restart its Sturgis plant in Michigan, which closed since February due to contamination issues. Is. The company should make changes to its safety protocols and procedures before resuming production.

Any move will not have an immediate effect on tight supplies, which have left many parents looking for formula online or in food banks.

After getting the OK from the FDA, Abbott said it would take eight to ten weeks for the new products to arrive in stores. The company did not set any deadline for the resumption of manufacturing.

According to administration officials, it may take several months for the imports to enter the US supply chain. Even before the latest change, FDA officials said baby formula imports are already up more than 300% from last year.

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Monday’s announcement was previewed last week by the White House, which is leaning on the FDA and formula makers to quickly find ways to reduce shortages. Outrage over the issue quickly snowballed and gave Republicans a new talking point to use against President Biden ahead of November’s elections.

The shortfall stems from a February recall by Abbott that exacerbated ongoing supply chain disruptions among formula makers, leaving fewer options on store shelves in much of the country. The shortage has prompted retailers such as CVS and Walgreens to limit how many containers customers can purchase per visit.

Abbott’s voluntary recall was triggered by four illnesses in infants who consumed powdered formula from a Michigan plant. All four infants were hospitalized with a rare type of bacterial infection and two died.

After six weeks of oversight, FDA investigators published a list of problems in March, including lax safety and hygiene standards and a history of bacterial contamination in several parts of the plant.

Chicago-based Abbott stresses that its products have not been directly linked to bacterial infections in children. Samples of bacteria found in its plant did not match strains collected from infants by federal investigators. The company has repeatedly stated that it is ready to resume manufacturing pending the FDA’s decision.

Former FDA officials say the problems detected at Abbott’s plant take time to fix, and that infant formula facilities receive more scrutiny than other food facilities. Companies are required to thoroughly sanitize the facility and equipment, re-train employees, repeatedly test and document that there is no contamination.

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As part of the FDA’s new import policy, regulators said companies would be required to provide documentation of their factory inspections.

Pediatricians say that baby formulas produced in Canada and Europe are roughly on par with the US but that traditionally, 98% of the infant formula supply in the US is made domestically. Companies wishing to enter the US face several major hurdles, including rigorous research and manufacturing standards imposed by the FDA.

Steven Hyde, a San Diego father, faced heartbreaking challenges finding formula for his fragile daughter, who was on Abbott Formulas, but had to switch to other brands with recalls and subsequent shortages.

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

Hyde said he used an organic brand from overseas until cost and customs constraints made it too difficult. Davis said friends and strangers from out-of-state have sent her other brands, but each time she switches it requires more blood tests and monitoring.

Despite her challenges, Zoey is walking, talking and “doing great” on other developmental milestones, Davis said.

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

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Associated Press Medical Writer Lindsay Tanner from Three Oaks, Michigan contributed to this story.

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