Monday 16 May 2022 02:49 PM FED chief claims troubled Michigan baby formula factory could reopen in the ... trends now
The troubled Michigan factory that exacerbated the ongoing baby formula shortage could reopen in just two weeks, according to the head of the Food and Drug Administration.
Dr. Robert Califf says his agency is working closely with Abbot Laboratories to jumpstart production as frustrated parents slam the Biden administration's slow response to the crisis.
The Sturgis, Michigan plant closed down in February after two babies who drank formula produced at the facility - which includes the brands Similac, Pedialite and Ensure - died from bacterial infections.
Califf says it's 'quite likely' that the company, which voluntarily recalled its own products amid scrutiny from federal regulators, will open in two weeks.
'Of course Abbot is responsible for the timeline, but I'm very comfortable with what they said about two weeks,' he told NBC's Today show Monday morning.
The FDA commissioner says the government will soon announce plans to import product from abroad, as one baby formula executive predicts that shortages and heightened demand will last for the 'balance of the year.'
He defended the agency, noting that ordering the plant to close down earlier would have led to a supply shortage anyway but committing to a 'full investigation' of how the debacle has been handled.
Dr. Robert Califf, commissioner of the Food and Drug Administration, says the troubled Sturgis, Michigan baby formula factory is 'quite likely' to reopen in two weeks
The Abbot Laboratories factory closed down in February after the FDA found multiple violations at the facility, including a lack of handwashing and poor temperature control
The formula shortage is the result of supply chain disruptions and workforce issues, but it was amplified by a safety recall of formulas by the factory
The formula shortage is the result of supply chain disruptions and workforce issues, but it was amplified by a safety recall of formulas made by Abbott and an ongoing shutdown of its manufacturing plant in Michigan.
Califf told Today anchor Savannah Guthrie that the FDA has been working closely with the plant as it seeks to reopen while maintaining quality standards.
The factory needs FDA approval to reopen, the FDA chief said.
'Every step of the way we have an obligation to make sure that the problems have been rectified and that the formula will be safe and also contain the constituents that are needed,' he added, pointing out that there are 30 such constituents that make formula a suitable replacement for breast milk.
He defended the FDA as concerned parents blast the government for not taking action earlier regarding the troubled plant.
'There will be a full investigation of the timeline and we'll do anything possible to correct any errors in timing that we had so we don't repeat any mistakes that we've made,' Califf said.
He also revealed that the Biden administration will announce plans to import formula later in the day.
The $4 billion US baby formula market is dominated by domestic producers, with import options limited, subject to high tariffs and onerous safety rules that include labeling standards.
These longstanding rules have exacerbated the current crisis - and are central to officials' efforts to ease the shortage.
Califf cautioned that foreign products are labeled with instructions written in languages that American mothers and caretakers may not understand.
'We also have to make sure we're testing the formula,' he said.
The Sturgis plant, which is now expected to reopen in two weeks, closed down in February after the FDA uncovered multiple violations at the plant, ranging from a lack of handwashing among employees to poor temperature controls.
More than half of U.S. states are seeing out-of-stock rates between 40 percent and 50 percent
The nationwide out-of-stock percentage of formula reached 40 percent the week beginning April 24, according to Datasembly. That's an increase from 31 percent at the start of April
In February, the agency linked consumption of Abbot-produced formula to four infants who were infected with the bacteria Cronobacter sakazakii. A fifth infant developed a Salmonella Newport infection.
Cronobacter may have contributed to the death of two babies, the agency said.
Multiple reports say the FDA ordered the plant closed down, but Cardiff says the plant was closed 'voluntarily based on the findings of inspections.'
Murray Kessler, head of formula giant Perrigo, has warned shortages of baby food could last throughout 2022
On Friday, the CEO of formula giant Perrigo Murray Kessler told Reuters he expects shortages and heightened demand to last for the 'balance of the year.'
Kessler said his factories in Ohio and Vermont are running at 115 percent capacity to compensate for Chicago-based Abbott's shutdown, but added that supplies would remain erratic for the remainder of 2022.
'We have stepped up and are killing ourselves to do everything we can,' Kessler said.
At the request of the FDA, Perrigo is focusing on four items: the store-brand versions of Similac Pro Sensitive and Pro Advance, and Enfamil Gentle Ease and Infant, Kessler said.
His company and three others control 90 percent of the US market.
Perrigo is working with retailers including Walmart and Target Corp so they 'get something each week,' Kessler said.
Retailers' allocations are based on an average of what the retailers received prior to 'this crisis,' he said.
Concerned Americans slammed Biden and the FDA for the handling of the formula crisis
Concerned parents are slamming the Biden administration's perceived lack of effort on the crisis.
'We're going to be, in a matter of weeks or less, getting significantly more formula on shelves,' Biden said on Friday after the Food and Drug Administration (FDA) announced it was working to streamline a process that will get more products to consumers.
'This is unacceptable,' Chris Skates, whose three-month-old grandson requires a special formula due to stomach sensitivity, told DailyMail.com. 'FDA under Biden is beyond incompetent!'
