Republicans and the right wing media falsely blame Biden for baby formula shortage and are not telling you the truth about the real reason for the shortage.
Abbott, the company that manufacturers and produces the main brands of baby formula, were operating under unsanitary conditions and did not update their old equipment. And as a result, bacteria contaminated the formula where babies who drank the formula ended up getting sick and some even died because of the deadly bacteria.
So, all the brands of baby formula were recalled due to bacteria contamination, and since Abbott is the main company that produces the formula supplies have been scarce.
Donald Trump's disastrous rewrite of NAFTA limited Canada's exports of formula to the United States so there is no way that supply can keep up with the demand since only a limited amount of formula can be exported to the United States.
So, with Trump's USMCA restricted imports of baby formula from Canada, we imported no formula from Canada in 2021, leaving us vulnerable to domestic shock. The shock hit when Abbott plant was contaminated and the supply could not be replenished.
President Biden now has to deal with another Trump disaster by having to import baby formula from other sources since Canada can't provide us with more formula due to Trump's restrictions on dairy and baby formula which was written in the USMCA trade agreement.
We also can't forget about Trump's deregulation which allowed companies like Abbott to cut corners by not operating under a safe environment and updating old equipment which allowed the bacteria outbreak to occur. This company twice in 2019 had bacteria problems and they never cleaned up their act as it happened once again in 2022, but this time it was even worse.
Trade deal concessions threaten jobs at Kingston, Ont., baby formula plantChinese invested $225M to make formula in Canada - before the U.S. demanded pricing change, limits on exportsOctober 12, 2018The revised North American trade agreement restricts shipments of a product Canada isn't even exporting at the moment: infant formula.
Why on earth would the U.S. demand that?
As with so many of the strategic priorities of the Trump administration, it's all about China.
https://www.cbc.ca/news/politics/feihe-future-usmca-1.4858338FDA Failed to Act on Critical Safety Information Before Infant Formula RecallInspection records of Abbott Nutrition’s manufacturing plant suggest that problems with the company’s now-recalled products, linked to at least two deaths, could’ve been uncovered soonerInfant formula made by Abbott Nutrition tested positive for a deadly bacteria at least twice dating back to 2019, according to newly released records, an issue the Food and Drug Administration cited last month when announcing a recall of products made by the company.
Abbott issued the sweeping recall over concerns of bacterial contamination in multiple products—including certain Similac, Alimentum, and EleCare brands—that are now linked to at least two infant deaths and multiple illnesses. The risk stems from a particularly rare and deadly bacteria, Cronobacter sakazakii.
But Abbott tells Consumer Reports that it shared those test results with the FDA during prior inspections.
The revelations may reignite concerns among lawmakers and consumer advocates that the FDA could have acted sooner to remove infant formula from the market.
For weeks, lawmakers and advocates have questioned whether the FDA had a chance to catch the problem earlier. The agency first learned in September 2021 about a potential link between powdered infant formula made by Abbott and cronobacter, a rare and deadly infection, yet the recall wasn’t issued until four months later, after reports that at least two infants died and others were hospitalized after consuming the products. The FDA, along with the Centers for Disease Control and Prevention, says the reports of death and illnesses are being investigated.
The new records—released Tuesday in response to Freedom of Information Act requests by CR and other news organizations—include agency inspection reports in 2019, 2021, and 2022. The reports show that the FDA had documented serious and ongoing safety concerns at Abbott’s plant just as the outbreak emerged through this month.
But the FDA seemingly failed to make the company’s testing records a concern until additional reports of death and illness emerged.
An Abbott spokesperson says the company is taking the situation “very seriously and are working closely with the FDA to implement corrective actions.”
“We have already begun implementing corrective actions and enhancements at the facility,” the spokesperson says, “leveraging new technology and strengthening our processes, to give parents and customers renewed confidence in the quality of manufacturing at our Sturgis plant when we restart operations there.”
The spokesperson also says that no infant formula comes into direct contact with areas in the factory where Cronobacter was found, and that its testing did not detect that bacteria or salmonella in any of the products it distributed to consumers. In addition, they say, “Importantly, the unique genetic makeup of the Cronobacter sakazakii microbes found in nonproduct areas at the Sturgis facility did not match the Cronobacter sakazakii microbes from the reported cases.”
James E. Rogers, PhD, director of food safety and research at CR, points out that cronobacter may still have been present in other untested samples of product distributed to consumers. And he says that Abbott’s statement on the genetic makeup of cronobacter strains found at the company’s facility and in sick infants is puzzling.
“I am not sure why Abbott would emphasize this fact because plants can contain multiple strains of a pathogen,” he says. “Just because the patient strains and those isolated so far don’t match does not mean that the patients were not, or could not be, sickened by cronobacter from infant formula.”
Unanswered QuestionsWhen the FDA announced the recall, the agency said that multiple samples taken at Abbott’s lab last month revealed cronobacter in several locations, and it said the company’s own records showed that infant formula was previously destroyed because of bacterial contamination.
But questions have swirled about what the FDA knew as the first reports of bacterial infections emerged.
The FDA had sent an inspector to Abbott’s plant in September 2021, the same week it first learned about an infant in Minnesota who was hospitalized with cronobacter after consuming formula made by the company, CR reported last month. The report of that inspection, released Tuesday, documented serious sanitation concerns.
For example, the report cites an employee who failed to wash his hands and change his gloves after touching nonfood contact surfaces.
“In addition,” the report says, “the Operator’s exposed wrists, between the glove and smock cuff, were observed entering the inside of the potassium chloride ingredient bag when scooping ingredients.”
Yet that inspection report does not mention Abbott’s test records showing that formula was previously destroyed in 2019 and 2020 after tests revealed it was contaminated with cronobacter. Those tests weren’t documented by the FDA until the agency conducted a follow-up inspection last month.
The Abbott spokesperson says the company provided the FDA the test results during earlier inspections.
“Our quality system and testing are set up to detect the presence of microbes prior to distribution,” the spokesperson says. “As a result of that system, once in 2019 and once in 2020, our regular testing found the presence of Cronobacter sakazakii in finished product. This product was never distributed to consumers.”
CR has repeatedly asked the FDA over several weeks about why it sent an inspector to Abbott’s facility in September 2021, and whether that inspector knew of the cronobacter report. (Infant formula makers are typically inspected by the agency once per year.) Beyond what was uncovered at that inspection, the FDA already had documented reasons of concern, suggesting that it could have acted more urgently: An earlier inspection by the agency had also cited the company for failing to test a representative sample of formula for salmonella. The FDA also has authority to mandate a recall of infant formula if problems are found.
On Wednesday, an FDA spokesperson told CR that the September 2021 visit was “a regularly scheduled surveillance inspection” but declined to explain whether that inspector was made aware of the cronobacter report.
“This remains an open investigation with many moving parts,” the spokesperson said. “Accordingly, the agency is not in a position to comment further.”
The more recent inspection, completed this month, offers other examples of contamination concerns in Abbott’s own records that seemingly could’ve been detected at the earlier inspection, including that Abbott identified cronobacter in production areas on at least eight occasions between September 2019 and February 2022.
Sanitation issues persisted after the September 2021 inspection, as well, the records show. In the most recent inspection, the FDA cited Abbott again for personnel failing to wear protective gear while handling ingredients. The FDA also said that Abbott failed to adequately investigate complaints of bacterial illness.
Brian Ronholm, director of food policy at CR, says the reports of conditions at Abbott’s plant are alarming.
“The FDA knew back in 2019 that microbiological testing going on at Abbott’s plant was insufficient and later found that there was surface contamination from a dangerous bacteria at the facility,” says Brian Ronholm, director of food policy at CRs. “It seems evident that the agency should have acted sooner. There will be plenty for the FDA to review about their enforcement process when this investigation concludes.”
https://www.consumerreports.org/baby-formula/fda-failed-to-act-before-infant-formula-recall-a1963857913/Plant behind Abbott baby formula recall was unsanitary, FDA findsBaby formula maker Abbott failed to maintain sanitary conditions and procedures at the Michigan manufacturing plant recently linked to a cluster of infant illnesses, according to findings released Tuesday by federal safety inspectors.
The Food and Drug Administration posted its initial inspection findings from the Abbott plant that's been tied to several infant hospitalizations, including two deaths, due to a rare bacterial infection. Abbott recalled various lots of three popular powdered infant formulas in mid-February after four babies reportedly became sick and were hospitalized. The recall was expanded in March to include some lots of Similac PM 60/40 Powdered Instant Formula. FDA inspectors have been on site inspecting the Sturgis, Michigan, facility since late January.
Abbott didn't maintain clean surfaces used in producing and handling the powdered formula, according to the FDA inspection, which concluded last week. Additionally, inspectors found a history of contamination with the bacteria, known as cronobacter, including eight instances between fall 2019 and February of this year.
The report gives the agency's preliminary findings and is likely to be followed by a formal report and a warning to the company.
Food safety advocates who have followed the recall noted that neither the FDA nor the company has been able to explain what caused the contamination.
"This sheds a little more light on what went wrong, but we still don't have all the answers," said Sarah Sorscher of the Center for Science in the Public Interest. "Abbott and the FDA really need to do more work to get to the bottom of what happened so we can prevent the next outbreak."
Abbott said in a statement it is "taking this very seriously and working closely with the FDA to implement corrective actions."
Abbott has not confirmed how many units have been recalled, but the company's brands include some of the best-selling baby formulas in the world, including Similac, Alimentum and EleCare. The company says it continues to produce baby formula at its other plants in the U.S. and overseas.
Infections with the cronobacter bacteria are rare but can be fatal in babies. The FDA in March said five infants had to be hospitalized due to reported bacterial infections which it said "may have contributed to death in two patients."
Powdered baby formula mostlyAlmost all outbreaks reported in the U.S. have been linked to powdered baby formulas, which don't undergo the same high temperatures used to kill germs in many other foods. Manufacturers have long said that it's impossible to eliminate all bacteria from the formulas.
There had been little new information about the recall since last month, despite requests from Senate lawmakers for Abbott to turn over documents on conditions at the Michigan plant.
In a letter last month, members of the Senate health committee specifically asked Abbott about the amount of time it took to start the recall. According to the letter, Abbott first received a report of an illness tied to its formula from Minnesota health officials in September, with additional reports in coming months from Ohio and Texas.
Failure to take action after first visitIt's also unclear why the FDA didn't take action at the plant earlier. FDA inspectors visited the plant in late September and cited several problems, including unsanitary conditions, a lack of temperature controls, and employees who failed to sanitize their hands. But none of the problems resulted in a formal FDA warning or requirement that Abbott halt production.
The FDA released the September inspection report Tuesday evening along with another from 2019.
In addition to its plant inspectors, the FDA has scientists at its Washington headquarters who specialize in food outbreaks linked to baby food and formulas. A high-ranking FDA deputy commissioner is also assigned to oversee food safety issues.
The recalled Abbott products can be identified by examining the coding on the bottom of each container. The affected formulas all have an expiration date of April 1, 2022, or later. The company has set up a website where parents can check if products have been recalled.
https://www.cbsnews.com/news/abbott-baby-formula-recall-fda-details/
