UNITED STATES NEWS

US allows more baby formula imports to fight shortage

May 16, 2022, 2:33 PM | Updated: May 17, 2022, 8:55 am

WASHINGTON (AP) — Under fire from parents and politicians, President Joe Biden’s administration announced steps Monday to ease a nationwide shortage of baby formula, including reopening the largest domestic manufacturing plant and increasing imports from overseas.

The Food and Drug Administration said it was streamlining its review process to make it easier for foreign manufacturers to begin shipping more formula into the U.S.

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

Califf said the U.S. will prioritize companies that can provide the largest shipments and quickly show documentation that their formulas are safe and compatible with U.S. nutrition standards. The policy is structured as a temporary measure lasting six months.

The imports announcement came shortly after regulators said they’d reached a deal to allow Abbott Nutrition to restart its Sturgis, Michigan-based plant, which has been closed since February due to contamination issues. The company must overhaul its safety protocols and procedures before resuming production.

Neither step will have an immediate effect on tight supplies that have left many parents searching for formula online or in food banks.

After getting the FDA’s OK, Abbott said it will take eight to ten weeks before new products begin arriving in stores. The company didn’t set a timeline to restart manufacturing.

Getting imports into the U.S. supply chain will also take several weeks, according to administration officials. Products from Australia, New Zealand and the U.K. are expected to meet the standards needed for importation.

But regulators said national industry data shows most U.S. stores, on average, still have 80% of their formula inventory in stock. They suggested 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 leaning on the FDA and formula makers to quickly find ways to alleviate the shortage. Outrage over the issue has quickly snowballed and handed Republicans a fresh talking point to use against President Biden ahead of November elections.

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

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

After a six-week inspection, FDA investigators published a list of problems in March, including lax safety and sanitary standards and a history of bacterial contamination in several parts of the plant. Under Monday’s agreement, Abbott must regularly consult with an outside safety expert to restart and maintain production.

Chicago-based Abbott has emphasized that its products have not been directly linked to the bacterial infections in children. Samples of the bacteria found at its plant did not match the strains collected from two babies by federal investigators.

But FDA officials pushed back on that reasoning Monday on a call with reporters– their first time publicly addressing the company’s argument. FDA staffers noted they were unable to collect bacterial strains from two of the four patients, limiting their chances of finding a match

“Right from the get-go we were limited in our ability to determine with a causal link whether the product was linked to these four cases because we only had sequences on two,” FDA’s food director Susan Mayne said.

Fixing the violations uncovered at Abbott’s plant takes time, according to former FDA officials. Companies need to exhaustively clean the facility and equipment, retrain staff, repeatedly test and document there is no contamination.

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

Pediatricians say baby formulas produced in Canada and Europe are roughly equivalent to those in the U.S. But traditionally, 98% of the infant formula supply in the U.S. is made domestically. Companies seeking to enter the U.S. face several major hurdles, including rigorous research and manufacturing standards imposed by the FDA.

San Diego father Steven Hyde has faced heart-wrenching challenges finding formula for his medical fragile daughter, who was on an Abbott formula but has had to switch with the recall and subsequent shortages in other brands.

Zoie Hyde was born 19 months ago with no kidneys, 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 costs and customs hurdles made that too difficult. Friends and strangers from out of state have sent him other brands, but each time she switches requires more blood tests and monitoring, Davis said.

Despite her challenges, Zoie is walking, talking and “doing pretty good” on other developmental milestones, Davis said.

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

___

AP Medical Writer Lindsey Tanner contributed to this story from Three Oaks, Michigan.

Copyright © The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

United States News

Wall Street Journal reporter Evan Gershkovich stands in a glass cage in a courtroom in Yekaterinbur...

Associated Press

U.S. reporter Evan Gershkovich appear in court in Russia for hearing on espionage charges

Wall Street Journal reporter Evan Gershkovich appeared in court in Russia on Thursday for the second hearing in his trial on espionage charges, the court said. Gershkovich, his employer and the U.S. government vehemently deny the charges against him. Gershkovich was accused by the Russian Prosecutor General’s office of “gathering secret information” on orders from […]

1 hour ago

FILE - A pedestrian traverses the rotunda inside the New Mexico Capitol, March 16, 2023, in Santa F...

Associated Press

New Mexico governor cites ‘dangerous intersection’ of crime and homelessness, wants lawmakers to act

SANTA FE, N.M. (AP) — Citing what she calls the “dangerous intersection” of crime and homelessness, New Mexico’s governor is calling on lawmakers to address stubbornly high crime rates as they convene Thursday for a special legislative session. In issuing her proclamation, Gov. Michelle Lujan Grisham talked about a vulnerable segment of society that falls […]

3 hours ago

Republican presidential candidate former President Donald Trump arrives on third day of the Republi...

Associated Press

FACT FOCUS: Trump, in Republican convention video, alludes to false claim 2020 election was stolen

DONALD TRUMP, alluding that the 2020 vote was stolen: “Whether you vote early, absentee, by mail or in person, we are going to protect the vote. That’s the most important thing we have to do is protect the vote. Keep your eyes open because these people want to cheat and they do cheat. And frankly, […]

4 hours ago

Supporters cheer as Republican presidential candidate former President Donald Trump arrives for a c...

Associated Press

‘One screen, two movies’: Conflicting conspiracy theories emerge from Trump shooting

WASHINGTON (AP) — A former president is shot, the gunman quickly neutralized, and all of it is caught on camera. But for those who don’t believe their eyes, that’s just the start of the story. For some supporters of former President Donald Trump, the failure of the Secret Service to prevent the attempted assassination point […]

4 hours ago

Associated Press

Hundreds attend vigil for man killed at Trump rally in Pennsylvania before visitation Thursday

SARVER, Pa. (AP) — Hundreds of people who gathered to remember the former fire chief fatally shot at a weekend rally for former President Donald Trump were urged to find “unity” as the area in rural Pennsylvania sought to recover from the assassination attempt. Wednesday’s public event was the first of two organized to memorialize […]

4 hours ago

Follow @ktar923...

Sponsored Content by Sanderson Ford

3 storylines to get you revved up for the 2024 Arizona Cardinals

Arizona Cardinals training camp is just a couple weeks away starting on July 25, and Sanderson Ford is revved up and ready to go.

Sponsored Articles

...

Sanderson Ford

3 storylines to get you revved up for the 2024 Arizona Cardinals

Arizona Cardinals training camp is just a couple weeks away starting on July 25, and Sanderson Ford is revved up and ready to go.

...

Collins Comfort Masters

Here’s how to be worry-free when your A/C goes out in the middle of summer

PHOENIX -- As Arizona approaches another hot summer, Phoenix residents are likely to spend more time indoors.

...

DISC Desert Institute for Spine Care

Sciatica pain is treatable but surgery may be required

Sciatica pain is one of the most common ailments a person can face, and if not taken seriously, it could become one of the most harmful.

US allows more baby formula imports to fight shortage