The Food and Drug Administration announced Tuesday that some formula products from the shuttered Abbott facility in Michigan will be distributed on a “case-by-case” basis, as parents throughout the country struggle to find baby formula due to supply problems.
After receiving four instances of newborns being hospitalized with bacterial illnesses after drinking formula made at Abbott’s Sturgis factory, the FDA issued a warning to parents not to use certain popular powdered infant formulae. Two of the children died.
Following federal safety inspectors discovered Abbott failed to maintain hygienic conditions and procedures at the facility, Abbott issued a recall of all possibly implicated goods manufactured at the facility, and the FDA later shut down the plant.
The FDA and the Centers for Disease Control and Prevention told NBC News last month that none of the bacterial strains obtained at the Abbott plant matched those recovered from the infants, and the agencies haven’t explained how the contamination happened.
According to the Associated Press, baby formula is particularly vulnerable to supply disruptions because only a few companies control nearly all of the US supply. The supply deficit was compounded by the closure of Abbott’s main U.S. formula production facility.
Food allergies, digestive difficulties, and other issues make specialist formulas necessary for infants.
“Unfortunately, many of those very specialized formulas are only made in the United States at the factory that had the recall, and that’s caused a huge problem for a relatively small number of infants,” said Dr. Steven Abrams, of the University of Texas, Austin.
The FDA has now stated that it will not object “to Abbott Nutrition delivering a product to people in need of immediate, life-sustaining supplies of certain specialty and metabolic formulae on a case-by-case basis.”
Abbott may begin releasing some specialized formulas not touched by the recalls “on a case-by-case basis,” the FDA said.
The agency said in a statement:
“The FDA is concerned that the risk of not having certain specialty and metabolic products available could significantly worsen underlying medical conditions and in some cases pose life-threatening risks for infants and individuals who rely on these products. In these circumstances, the benefit of allowing parents, in consultation with their healthcare providers, to access these products may outweigh the potential risk of bacterial infection.”
Abbott has been given discretion by the agency, which is based on product availability and the severity of the individual’s need. The following specialty and metabolic formulations may be released:
- Glutarex-1
- Glutarex-2
- Cyclinex-1
- Cyclinex-2
- Hominex-1
- Hominex-2
- I-Valex-1
- I-Valex-2
- Ketonex-1
- Ketonex-2
- Phenex-1
- Phenex-2
- Phenex-2 Vanilla
- Pro-Phree
- Propimex-1
- Propimex-2
- ProViMin
- Calcilo XD
- Tyrex-1
- Tyrex-2
- Similac PM 60/40
Last year, the COVID-19 epidemic caused interruptions in ingredients, labor, and transportation, according to industry officials. Parents hoarding during lockdowns strained supplies even further.
The Abbott recall, which swept several leading brands off shop shelves, exacerbated months of spot shortages at pharmacies and supermarkets.
The New York Times reports that the Abbott recall has been especially hard on families who rely on public benefits like the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC), because the company was the exclusive supplier for more than half of the WIC agencies nationwide. Substitutions for WIC-covered brands are now permitted.
The Datasembly states a retail data business, roughly 40% of large retail outlets nationwide are out of stock, up from 31% in mid-April. According to the business, which collects data from 11,000 places, out-of-stock percentages are between 40% and 50% in more than half of the US states.
The Biden administration, which has no regard for unborn babies, is being forced to pay attention to those already born, the western journal reports.
Asked about the formula shortage, outgoing White House Press Secretary Jen 'Pspin' Psaki launched a string of MBA-speak buzzwords “… taking a number of steps … increasing production … stock on the shelves … optimize their supply lines …. prioritizing product lines … exercising flexibility and expediting review of notifications of manufacturing changes … blah, blah, blah.”
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Sources: Westernjournal, Ktar, Dailymail
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Author: dan
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