Distressed dad says 'never did I think I would have a problem finding food for my baby in America'

[Anonymous]

The Abbott plant is supposed to reopen in a few weeks. Baffling how supposedly professional private sector industry screwed the pooch so badly where it comes to sanitation after gaining a monopoly on the market. I bet you some Abbott execs got very rich somewhere along the line cutting corners.

And once again it goes to show that "small government" Republicans have none of the answers. Leave it up to them and the monopoly problem, the dead-babies-from-contaminated-formula problem only gets worse.

[Anonymous]

This administration has known for some time that there was an issue, but took no action.

‘Timeline of Failure:’ The Biden Administration and U.S. Food and Drug Administration Failed Response to the Infant Formula Crisis

2019

September 16-24: U.S. Food and Drug Administration (FDA) officials conduct an inspection of the Abbott Sturgis, Michigan infant formula plant, which produces the majority of amino acid infant formula in the United States. As an outcome, the plant receives a Voluntary Action Indicated (VAI) and a Form 483. The FDA does not issue any restrictions or obligations on manufacturing at the plant.
2020-2021

2020: During the COVID-19 pandemic, the FDA transitions to conducting “mission critical” inspections. It does not re-inspect the Abbott Sturgis facility to follow up on the previously issued Form 483 and ensure appropriate actions have been taken. The FDA will not inspect the Abbott Sturgis facility again for another two years.
2021

January 20: Joe Biden inaugurated as 46th President of the United States.
July: Nationwide out of stock rate for infant formula is 8 percent.
September 20-24: FDA conducts first inspection of the Abbott Sturgis plant in two years. Inspectors find the issues uncovered in the 2019 surveillance inspection have been resolved, but issue a Voluntary Action Indicated (VAI) for different items and a Form 483 for formula inspection.
September 20: FDA receives the first complaint that a child was hospitalized with cronobacter sakazakii on September 6th in Minnesota. The complaint is received at the same time an FDA investigator is conducting the Abbott Sturgis plant’s routine surveillance inspection.
November: Nationwide out of stock rate for infant formula rises to 11 percent.
November 12: Dr. Robert Califf nominated to serve as Commissioner of Food and Drugs, 10 months after President Biden assumed office.
December 1: FDA receives a second complaint, related to the death of a child in Ohio. The Centers for Disease Control determines cronobacter “could have been a contributing factor” in the death.
2022

January 11: FDA receives a third complaint, related to a child hospitalized with cronobacter on January 4, 2022 in Texas.
January 13: Dr. Califf’s nomination to serve as Commissioner of Food and Drugs is reported favorably out of the Senate Health, Education, Labor and Pensions Committee.
January 28: The New York Times reports baby formula shortages are “worsening throughout the United States, causing parents to be increasingly concerned about how they will feed their infants.”
January 31: FDA begins a delayed follow-up inspection of the Abbott Sturgis plant.
February 13: Nationwide out of stock rate for infant formula rises to 26 percent.
February 15: Dr. Robert Califf is confirmed by U.S. Senate as new Commissioner of Food and Drugs.
February 17: Abbott announces a voluntary recall and hold of certain powdered infant formulas produced at the Abbott Sturgis plant. The same day, the FDA receives a fourth complaint, related to the death of a child, also in Ohio, with cronobacter.
February 28: After learning of the latest complaint received by the FDA, Abbott expands their recall to include a specialty product from a specific lot linked to that complaint. The FDA fully agreed with the firm’s decision to initiate, and then expand, the recall. FDA issues a recall notice.
February: As Abbott takes voluntary actions that limit production, Biden Administration officials are aware of the growing infant formula problem. When questioned by CNN, White House National Economic Council Director Brian Deese said, “As a parent, and with friends and colleagues, we were aware that people were starting to have trouble in stores, but we were aware of this from when the FDA had to take its action back in February, with Abbott and with the steps in the Michigan facility. And we have had a team on this from the FDA and in the interagency process since then.”
March 18: FDA concludes its delayed follow-up inspection of the Abbott Sturgis plant.
March 20: Nationwide out of stock rate for infant formula rises to 30 percent.
March 22: Abbott begins flying FDA-approved baby formula daily from Europe.
March 24: President Biden states there will be “real” food shortages related to Russia’s war on Ukraine.
April 1: FDA establishes an Incident Management Group (IMG) to work on supply chain and food safety issues.
April 8: Abbott submits response and corrective action plan following FDA’s 2022 inspection. Abbott immediately begins implementing protocol corrective actions and plant upgrades.
April 28: Politico reports a former Abbott employee filed a whistleblower complaint with the FDA about the Sturgis plant in October 2021, yet the FDA took no follow up action.
April 29: FDA announces it informed Abbott Nutrition that the Agency has no objection to the company immediately releasing recalled product to individuals needing urgent, life-sustaining supplies of specific specialty and metabolic formulas on a case-by-case basis.
Late-April: In 26 states, out of stock rate for infant formula rises to 40-50 percent.
May 1: Nationwide out of stock rate for infant formula rises to 43 percent.
May 10: FDA announces steps to improve supply of infant and specialty formula products. FDA downplayed the shortage, reporting that despite less available variety, 13% more total volume of infant formula was sold in April than was sold in March.
May 13: USDA announces flexibilities, including implementing a number of waivers, urging states to permit alternative formulas for beneficiaries, and ease customer purchasing requirements.
May 14: The Centers for Disease Control and Prevention (CDC) announces it has closed its investigation into the Abbott Sturgis facility, as no additional cases have been reported. The agency concluded there were no strains of cronobacter in sealed infant formula containers. The strains collected from the affected children did not match any strains present at Abbott facilities; they did match strains found in the childrens’ home environments.
May 16: FDA and Abbott announce they have entered into a proposed consent decree, subject to court approval and entry, with a plan for reopening the Sturgis plant. FDA also announces increased flexibilities to encourage importation of safe infant formulas into the United States.
May 18: The Biden administration initiates “Operation Fly Formula,” modeled on the Trump administration’s successful COVID response framework known as “Project Air Bridge.” President Biden invokes the Defense Production Act to require manufacturers of ingredients used in formula to prioritize orders placed by formula producers over others.
May 19: Dr. Califf testifies the Abbott Sturgis plant will take another one to two weeks to reopen, after the plant has been closed for nearly four months. Once the plant is reopened, officials estimate it will take another eight weeks to restock shelves with infant formula.

https://www.burr.senate.gov/2022/5/burr-releases-timeline-detailing-fda-biden-admin-failures-in-infant-formula-crisis

[Anonymous]

Anonymous wrote:The Abbott plant is supposed to reopen in a few weeks. Baffling how supposedly professional private sector industry screwed the pooch so badly where it comes to sanitation after gaining a monopoly on the market. I bet you some Abbott execs got very rich somewhere along the line cutting corners.

And once again it goes to show that "small government" Republicans have none of the answers. Leave it up to them and the monopoly problem, the dead-babies-from-contaminated-formula problem only gets worse.

Part of the reason they have a monopoly right or wrong is because of strict FDA regulations. Once companies become large they tend to welcome lots of regulation requirements to keep smaller companies from growing and discourage other companies from opening. See Amazon who for years fought against having to collect sales tax in all states which collect it and then did a 180 on the position once they were large enough to try to keep out other platforms. The creation of the FDA was actually inspired in part by the Heinz company who pushed for its creation claiming to be a concerned company and that all new food companies should follow their clean factory specs. Heinz knew full well it would keep out other competitors because they couldn’t afford to open a new factory like theirs without significant capital.

[Anonymous]

Anonymous wrote:This administration has known for some time that there was an issue, but took no action.

‘Timeline of Failure:’ The Biden Administration and U.S. Food and Drug Administration Failed Response to the Infant Formula Crisis

2019

September 16-24: U.S. Food and Drug Administration (FDA) officials conduct an inspection of the Abbott Sturgis, Michigan infant formula plant, which produces the majority of amino acid infant formula in the United States. As an outcome, the plant receives a Voluntary Action Indicated (VAI) and a Form 483. The FDA does not issue any restrictions or obligations on manufacturing at the plant.
2020-2021

2020: During the COVID-19 pandemic, the FDA transitions to conducting “mission critical” inspections. It does not re-inspect the Abbott Sturgis facility to follow up on the previously issued Form 483 and ensure appropriate actions have been taken. The FDA will not inspect the Abbott Sturgis facility again for another two years.

[…]

Tell me, hon. Who was president these years?

[Anonymous]

[Anonymous]

You act like CEOs never lie. Of course Abbott didn't want to shut down and said whatever htey could to stay open.

[Anonymous]

Anonymous wrote:This administration has known for some time that there was an issue, but took no action.

‘Timeline of Failure:’ The Biden Administration and U.S. Food and Drug Administration Failed Response to the Infant Formula Crisis

2019

September 16-24: U.S. Food and Drug Administration (FDA) officials conduct an inspection of the Abbott Sturgis, Michigan infant formula plant, which produces the majority of amino acid infant formula in the United States. As an outcome, the plant receives a Voluntary Action Indicated (VAI) and a Form 483. The FDA does not issue any restrictions or obligations on manufacturing at the plant.
2020-2021

2020: During the COVID-19 pandemic, the FDA transitions to conducting “mission critical” inspections. It does not re-inspect the Abbott Sturgis facility to follow up on the previously issued Form 483 and ensure appropriate actions have been taken. The FDA will not inspect the Abbott Sturgis facility again for another two years.
2021

January 20: Joe Biden inaugurated as 46th President of the United States.
July: Nationwide out of stock rate for infant formula is 8 percent.
September 20-24: FDA conducts first inspection of the Abbott Sturgis plant in two years. Inspectors find the issues uncovered in the 2019 surveillance inspection have been resolved, but issue a Voluntary Action Indicated (VAI) for different items and a Form 483 for formula inspection.
September 20: FDA receives the first complaint that a child was hospitalized with cronobacter sakazakii on September 6th in Minnesota. The complaint is received at the same time an FDA investigator is conducting the Abbott Sturgis plant’s routine surveillance inspection.
November: Nationwide out of stock rate for infant formula rises to 11 percent.
November 12: Dr. Robert Califf nominated to serve as Commissioner of Food and Drugs, 10 months after President Biden assumed office.
December 1: FDA receives a second complaint, related to the death of a child in Ohio. The Centers for Disease Control determines cronobacter “could have been a contributing factor” in the death.
2022

January 11: FDA receives a third complaint, related to a child hospitalized with cronobacter on January 4, 2022 in Texas.
January 13: Dr. Califf’s nomination to serve as Commissioner of Food and Drugs is reported favorably out of the Senate Health, Education, Labor and Pensions Committee.
January 28: The New York Times reports baby formula shortages are “worsening throughout the United States, causing parents to be increasingly concerned about how they will feed their infants.”
January 31: FDA begins a delayed follow-up inspection of the Abbott Sturgis plant.
February 13: Nationwide out of stock rate for infant formula rises to 26 percent.
February 15: Dr. Robert Califf is confirmed by U.S. Senate as new Commissioner of Food and Drugs.
February 17: Abbott announces a voluntary recall and hold of certain powdered infant formulas produced at the Abbott Sturgis plant. The same day, the FDA receives a fourth complaint, related to the death of a child, also in Ohio, with cronobacter.
February 28: After learning of the latest complaint received by the FDA, Abbott expands their recall to include a specialty product from a specific lot linked to that complaint. The FDA fully agreed with the firm’s decision to initiate, and then expand, the recall. FDA issues a recall notice.
February: As Abbott takes voluntary actions that limit production, Biden Administration officials are aware of the growing infant formula problem. When questioned by CNN, White House National Economic Council Director Brian Deese said, “As a parent, and with friends and colleagues, we were aware that people were starting to have trouble in stores, but we were aware of this from when the FDA had to take its action back in February, with Abbott and with the steps in the Michigan facility. And we have had a team on this from the FDA and in the interagency process since then.”
March 18: FDA concludes its delayed follow-up inspection of the Abbott Sturgis plant.
March 20: Nationwide out of stock rate for infant formula rises to 30 percent.
March 22: Abbott begins flying FDA-approved baby formula daily from Europe.
March 24: President Biden states there will be “real” food shortages related to Russia’s war on Ukraine.
April 1: FDA establishes an Incident Management Group (IMG) to work on supply chain and food safety issues.
April 8: Abbott submits response and corrective action plan following FDA’s 2022 inspection. Abbott immediately begins implementing protocol corrective actions and plant upgrades.
April 28: Politico reports a former Abbott employee filed a whistleblower complaint with the FDA about the Sturgis plant in October 2021, yet the FDA took no follow up action.
April 29: FDA announces it informed Abbott Nutrition that the Agency has no objection to the company immediately releasing recalled product to individuals needing urgent, life-sustaining supplies of specific specialty and metabolic formulas on a case-by-case basis.
Late-April: In 26 states, out of stock rate for infant formula rises to 40-50 percent.
May 1: Nationwide out of stock rate for infant formula rises to 43 percent.
May 10: FDA announces steps to improve supply of infant and specialty formula products. FDA downplayed the shortage, reporting that despite less available variety, 13% more total volume of infant formula was sold in April than was sold in March.
May 13: USDA announces flexibilities, including implementing a number of waivers, urging states to permit alternative formulas for beneficiaries, and ease customer purchasing requirements.
May 14: The Centers for Disease Control and Prevention (CDC) announces it has closed its investigation into the Abbott Sturgis facility, as no additional cases have been reported. The agency concluded there were no strains of cronobacter in sealed infant formula containers. The strains collected from the affected children did not match any strains present at Abbott facilities; they did match strains found in the childrens’ home environments.
May 16: FDA and Abbott announce they have entered into a proposed consent decree, subject to court approval and entry, with a plan for reopening the Sturgis plant. FDA also announces increased flexibilities to encourage importation of safe infant formulas into the United States.
May 18: The Biden administration initiates “Operation Fly Formula,” modeled on the Trump administration’s successful COVID response framework known as “Project Air Bridge.” President Biden invokes the Defense Production Act to require manufacturers of ingredients used in formula to prioritize orders placed by formula producers over others.
May 19: Dr. Califf testifies the Abbott Sturgis plant will take another one to two weeks to reopen, after the plant has been closed for nearly four months. Once the plant is reopened, officials estimate it will take another eight weeks to restock shelves with infant formula.

https://www.burr.senate.gov/2022/5/burr-releases-timeline-detailing-fda-biden-admin-failures-in-infant-formula-crisis

The FDA is no longer an independent agency funded by taxpayers. It is, if I am not mistaken, an almost majority (40-50%) funded by user fees from the very companies they inspect. There is too much crossover. Yet again corporations have too much power. They approve the mechanisms that would keep competition high and forego the mechanisms that keep their products safe.

[Anonymous]

Anonymous wrote:

Anonymous wrote:This administration has known for some time that there was an issue, but took no action.

‘Timeline of Failure:’ The Biden Administration and U.S. Food and Drug Administration Failed Response to the Infant Formula Crisis

2019

September 16-24: U.S. Food and Drug Administration (FDA) officials conduct an inspection of the Abbott Sturgis, Michigan infant formula plant, which produces the majority of amino acid infant formula in the United States. As an outcome, the plant receives a Voluntary Action Indicated (VAI) and a Form 483. The FDA does not issue any restrictions or obligations on manufacturing at the plant.
2020-2021

2020: During the COVID-19 pandemic, the FDA transitions to conducting “mission critical” inspections. It does not re-inspect the Abbott Sturgis facility to follow up on the previously issued Form 483 and ensure appropriate actions have been taken. The FDA will not inspect the Abbott Sturgis facility again for another two years.
2021

January 20: Joe Biden inaugurated as 46th President of the United States.
July: Nationwide out of stock rate for infant formula is 8 percent.
September 20-24: FDA conducts first inspection of the Abbott Sturgis plant in two years. Inspectors find the issues uncovered in the 2019 surveillance inspection have been resolved, but issue a Voluntary Action Indicated (VAI) for different items and a Form 483 for formula inspection.
September 20: FDA receives the first complaint that a child was hospitalized with cronobacter sakazakii on September 6th in Minnesota. The complaint is received at the same time an FDA investigator is conducting the Abbott Sturgis plant’s routine surveillance inspection.
November: Nationwide out of stock rate for infant formula rises to 11 percent.
November 12: Dr. Robert Califf nominated to serve as Commissioner of Food and Drugs, 10 months after President Biden assumed office.
December 1: FDA receives a second complaint, related to the death of a child in Ohio. The Centers for Disease Control determines cronobacter “could have been a contributing factor” in the death.
2022

January 11: FDA receives a third complaint, related to a child hospitalized with cronobacter on January 4, 2022 in Texas.
January 13: Dr. Califf’s nomination to serve as Commissioner of Food and Drugs is reported favorably out of the Senate Health, Education, Labor and Pensions Committee.
January 28: The New York Times reports baby formula shortages are “worsening throughout the United States, causing parents to be increasingly concerned about how they will feed their infants.”
January 31: FDA begins a delayed follow-up inspection of the Abbott Sturgis plant.
February 13: Nationwide out of stock rate for infant formula rises to 26 percent.
February 15: Dr. Robert Califf is confirmed by U.S. Senate as new Commissioner of Food and Drugs.
February 17: Abbott announces a voluntary recall and hold of certain powdered infant formulas produced at the Abbott Sturgis plant. The same day, the FDA receives a fourth complaint, related to the death of a child, also in Ohio, with cronobacter.
February 28: After learning of the latest complaint received by the FDA, Abbott expands their recall to include a specialty product from a specific lot linked to that complaint. The FDA fully agreed with the firm’s decision to initiate, and then expand, the recall. FDA issues a recall notice.
February: As Abbott takes voluntary actions that limit production, Biden Administration officials are aware of the growing infant formula problem. When questioned by CNN, White House National Economic Council Director Brian Deese said, “As a parent, and with friends and colleagues, we were aware that people were starting to have trouble in stores, but we were aware of this from when the FDA had to take its action back in February, with Abbott and with the steps in the Michigan facility. And we have had a team on this from the FDA and in the interagency process since then.”
March 18: FDA concludes its delayed follow-up inspection of the Abbott Sturgis plant.
March 20: Nationwide out of stock rate for infant formula rises to 30 percent.
March 22: Abbott begins flying FDA-approved baby formula daily from Europe.
March 24: President Biden states there will be “real” food shortages related to Russia’s war on Ukraine.
April 1: FDA establishes an Incident Management Group (IMG) to work on supply chain and food safety issues.
April 8: Abbott submits response and corrective action plan following FDA’s 2022 inspection. Abbott immediately begins implementing protocol corrective actions and plant upgrades.
April 28: Politico reports a former Abbott employee filed a whistleblower complaint with the FDA about the Sturgis plant in October 2021, yet the FDA took no follow up action.
April 29: FDA announces it informed Abbott Nutrition that the Agency has no objection to the company immediately releasing recalled product to individuals needing urgent, life-sustaining supplies of specific specialty and metabolic formulas on a case-by-case basis.
Late-April: In 26 states, out of stock rate for infant formula rises to 40-50 percent.
May 1: Nationwide out of stock rate for infant formula rises to 43 percent.
May 10: FDA announces steps to improve supply of infant and specialty formula products. FDA downplayed the shortage, reporting that despite less available variety, 13% more total volume of infant formula was sold in April than was sold in March.
May 13: USDA announces flexibilities, including implementing a number of waivers, urging states to permit alternative formulas for beneficiaries, and ease customer purchasing requirements.
May 14: The Centers for Disease Control and Prevention (CDC) announces it has closed its investigation into the Abbott Sturgis facility, as no additional cases have been reported. The agency concluded there were no strains of cronobacter in sealed infant formula containers. The strains collected from the affected children did not match any strains present at Abbott facilities; they did match strains found in the childrens’ home environments.
May 16: FDA and Abbott announce they have entered into a proposed consent decree, subject to court approval and entry, with a plan for reopening the Sturgis plant. FDA also announces increased flexibilities to encourage importation of safe infant formulas into the United States.
May 18: The Biden administration initiates “Operation Fly Formula,” modeled on the Trump administration’s successful COVID response framework known as “Project Air Bridge.” President Biden invokes the Defense Production Act to require manufacturers of ingredients used in formula to prioritize orders placed by formula producers over others.
May 19: Dr. Califf testifies the Abbott Sturgis plant will take another one to two weeks to reopen, after the plant has been closed for nearly four months. Once the plant is reopened, officials estimate it will take another eight weeks to restock shelves with infant formula.

https://www.burr.senate.gov/2022/5/burr-releases-timeline-detailing-fda-biden-admin-failures-in-infant-formula-crisis

The FDA is no longer an independent agency funded by taxpayers. It is, if I am not mistaken, an almost majority (40-50%) funded by user fees from the very companies they inspect. There is too much crossover. Yet again corporations have too much power. They approve the mechanisms that would keep competition high and forego the mechanisms that keep their products safe.

And the GOP wants to scrap every regulation in existence. Vote Democratic if you love your infants. Actually vote Democratic if you’re just a baseline decent person.

[Anonymous]

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:This administration has known for some time that there was an issue, but took no action.

‘Timeline of Failure:’ The Biden Administration and U.S. Food and Drug Administration Failed Response to the Infant Formula Crisis

2019

September 16-24: U.S. Food and Drug Administration (FDA) officials conduct an inspection of the Abbott Sturgis, Michigan infant formula plant, which produces the majority of amino acid infant formula in the United States. As an outcome, the plant receives a Voluntary Action Indicated (VAI) and a Form 483. The FDA does not issue any restrictions or obligations on manufacturing at the plant.
2020-2021

2020: During the COVID-19 pandemic, the FDA transitions to conducting “mission critical” inspections. It does not re-inspect the Abbott Sturgis facility to follow up on the previously issued Form 483 and ensure appropriate actions have been taken. The FDA will not inspect the Abbott Sturgis facility again for another two years.
2021

January 20: Joe Biden inaugurated as 46th President of the United States.
July: Nationwide out of stock rate for infant formula is 8 percent.
September 20-24: FDA conducts first inspection of the Abbott Sturgis plant in two years. Inspectors find the issues uncovered in the 2019 surveillance inspection have been resolved, but issue a Voluntary Action Indicated (VAI) for different items and a Form 483 for formula inspection.
September 20: FDA receives the first complaint that a child was hospitalized with cronobacter sakazakii on September 6th in Minnesota. The complaint is received at the same time an FDA investigator is conducting the Abbott Sturgis plant’s routine surveillance inspection.
November: Nationwide out of stock rate for infant formula rises to 11 percent.
November 12: Dr. Robert Califf nominated to serve as Commissioner of Food and Drugs, 10 months after President Biden assumed office.
December 1: FDA receives a second complaint, related to the death of a child in Ohio. The Centers for Disease Control determines cronobacter “could have been a contributing factor” in the death.
2022

January 11: FDA receives a third complaint, related to a child hospitalized with cronobacter on January 4, 2022 in Texas.
January 13: Dr. Califf’s nomination to serve as Commissioner of Food and Drugs is reported favorably out of the Senate Health, Education, Labor and Pensions Committee.
January 28: The New York Times reports baby formula shortages are “worsening throughout the United States, causing parents to be increasingly concerned about how they will feed their infants.”
January 31: FDA begins a delayed follow-up inspection of the Abbott Sturgis plant.
February 13: Nationwide out of stock rate for infant formula rises to 26 percent.
February 15: Dr. Robert Califf is confirmed by U.S. Senate as new Commissioner of Food and Drugs.
February 17: Abbott announces a voluntary recall and hold of certain powdered infant formulas produced at the Abbott Sturgis plant. The same day, the FDA receives a fourth complaint, related to the death of a child, also in Ohio, with cronobacter.
February 28: After learning of the latest complaint received by the FDA, Abbott expands their recall to include a specialty product from a specific lot linked to that complaint. The FDA fully agreed with the firm’s decision to initiate, and then expand, the recall. FDA issues a recall notice.
February: As Abbott takes voluntary actions that limit production, Biden Administration officials are aware of the growing infant formula problem. When questioned by CNN, White House National Economic Council Director Brian Deese said, “As a parent, and with friends and colleagues, we were aware that people were starting to have trouble in stores, but we were aware of this from when the FDA had to take its action back in February, with Abbott and with the steps in the Michigan facility. And we have had a team on this from the FDA and in the interagency process since then.”
March 18: FDA concludes its delayed follow-up inspection of the Abbott Sturgis plant.
March 20: Nationwide out of stock rate for infant formula rises to 30 percent.
March 22: Abbott begins flying FDA-approved baby formula daily from Europe.
March 24: President Biden states there will be “real” food shortages related to Russia’s war on Ukraine.
April 1: FDA establishes an Incident Management Group (IMG) to work on supply chain and food safety issues.
April 8: Abbott submits response and corrective action plan following FDA’s 2022 inspection. Abbott immediately begins implementing protocol corrective actions and plant upgrades.
April 28: Politico reports a former Abbott employee filed a whistleblower complaint with the FDA about the Sturgis plant in October 2021, yet the FDA took no follow up action.
April 29: FDA announces it informed Abbott Nutrition that the Agency has no objection to the company immediately releasing recalled product to individuals needing urgent, life-sustaining supplies of specific specialty and metabolic formulas on a case-by-case basis.
Late-April: In 26 states, out of stock rate for infant formula rises to 40-50 percent.
May 1: Nationwide out of stock rate for infant formula rises to 43 percent.
May 10: FDA announces steps to improve supply of infant and specialty formula products. FDA downplayed the shortage, reporting that despite less available variety, 13% more total volume of infant formula was sold in April than was sold in March.
May 13: USDA announces flexibilities, including implementing a number of waivers, urging states to permit alternative formulas for beneficiaries, and ease customer purchasing requirements.
May 14: The Centers for Disease Control and Prevention (CDC) announces it has closed its investigation into the Abbott Sturgis facility, as no additional cases have been reported. The agency concluded there were no strains of cronobacter in sealed infant formula containers. The strains collected from the affected children did not match any strains present at Abbott facilities; they did match strains found in the childrens’ home environments.
May 16: FDA and Abbott announce they have entered into a proposed consent decree, subject to court approval and entry, with a plan for reopening the Sturgis plant. FDA also announces increased flexibilities to encourage importation of safe infant formulas into the United States.
May 18: The Biden administration initiates “Operation Fly Formula,” modeled on the Trump administration’s successful COVID response framework known as “Project Air Bridge.” President Biden invokes the Defense Production Act to require manufacturers of ingredients used in formula to prioritize orders placed by formula producers over others.
May 19: Dr. Califf testifies the Abbott Sturgis plant will take another one to two weeks to reopen, after the plant has been closed for nearly four months. Once the plant is reopened, officials estimate it will take another eight weeks to restock shelves with infant formula.

https://www.burr.senate.gov/2022/5/burr-releases-timeline-detailing-fda-biden-admin-failures-in-infant-formula-crisis

The FDA is no longer an independent agency funded by taxpayers. It is, if I am not mistaken, an almost majority (40-50%) funded by user fees from the very companies they inspect. There is too much crossover. Yet again corporations have too much power. They approve the mechanisms that would keep competition high and forego the mechanisms that keep their products safe.

And the GOP wants to scrap every regulation in existence. Vote Democratic if you love your infants. Actually vote Democratic if you’re just a baseline decent person.

Vote independent if you care about this country and your children at all. Continuing to vote Democrat is being okay with the Blue v Red crap that is literally killing our kids.

[Anonymous]

Anonymous wrote:This administration has known for some time that there was an issue, but took no action.

‘Timeline of Failure:’ The Biden Administration and U.S. Food and Drug Administration Failed Response to the Infant Formula Crisis

2019

September 16-24: U.S. Food and Drug Administration (FDA) officials conduct an inspection of the Abbott Sturgis, Michigan infant formula plant, which produces the majority of amino acid infant formula in the United States. As an outcome, the plant receives a Voluntary Action Indicated (VAI) and a Form 483. The FDA does not issue any restrictions or obligations on manufacturing at the plant.
2020-2021

2020: During the COVID-19 pandemic, the FDA transitions to conducting “mission critical” inspections. It does not re-inspect the Abbott Sturgis facility to follow up on the previously issued Form 483 and ensure appropriate actions have been taken. The FDA will not inspect the Abbott Sturgis facility again for another two years.
2021

January 20: Joe Biden inaugurated as 46th President of the United States.
July: Nationwide out of stock rate for infant formula is 8 percent.
September 20-24: FDA conducts first inspection of the Abbott Sturgis plant in two years. Inspectors find the issues uncovered in the 2019 surveillance inspection have been resolved, but issue a Voluntary Action Indicated (VAI) for different items and a Form 483 for formula inspection.
September 20: FDA receives the first complaint that a child was hospitalized with cronobacter sakazakii on September 6th in Minnesota. The complaint is received at the same time an FDA investigator is conducting the Abbott Sturgis plant’s routine surveillance inspection.
November: Nationwide out of stock rate for infant formula rises to 11 percent.
November 12: Dr. Robert Califf nominated to serve as Commissioner of Food and Drugs, 10 months after President Biden assumed office.
December 1: FDA receives a second complaint, related to the death of a child in Ohio. The Centers for Disease Control determines cronobacter “could have been a contributing factor” in the death.
2022

January 11: FDA receives a third complaint, related to a child hospitalized with cronobacter on January 4, 2022 in Texas.
January 13: Dr. Califf’s nomination to serve as Commissioner of Food and Drugs is reported favorably out of the Senate Health, Education, Labor and Pensions Committee.
January 28: The New York Times reports baby formula shortages are “worsening throughout the United States, causing parents to be increasingly concerned about how they will feed their infants.”
January 31: FDA begins a delayed follow-up inspection of the Abbott Sturgis plant.
February 13: Nationwide out of stock rate for infant formula rises to 26 percent.
February 15: Dr. Robert Califf is confirmed by U.S. Senate as new Commissioner of Food and Drugs.
February 17: Abbott announces a voluntary recall and hold of certain powdered infant formulas produced at the Abbott Sturgis plant. The same day, the FDA receives a fourth complaint, related to the death of a child, also in Ohio, with cronobacter.
February 28: After learning of the latest complaint received by the FDA, Abbott expands their recall to include a specialty product from a specific lot linked to that complaint. The FDA fully agreed with the firm’s decision to initiate, and then expand, the recall. FDA issues a recall notice.
February: As Abbott takes voluntary actions that limit production, Biden Administration officials are aware of the growing infant formula problem. When questioned by CNN, White House National Economic Council Director Brian Deese said, “As a parent, and with friends and colleagues, we were aware that people were starting to have trouble in stores, but we were aware of this from when the FDA had to take its action back in February, with Abbott and with the steps in the Michigan facility. And we have had a team on this from the FDA and in the interagency process since then.”
March 18: FDA concludes its delayed follow-up inspection of the Abbott Sturgis plant.
March 20: Nationwide out of stock rate for infant formula rises to 30 percent.
March 22: Abbott begins flying FDA-approved baby formula daily from Europe.
March 24: President Biden states there will be “real” food shortages related to Russia’s war on Ukraine.
April 1: FDA establishes an Incident Management Group (IMG) to work on supply chain and food safety issues.
April 8: Abbott submits response and corrective action plan following FDA’s 2022 inspection. Abbott immediately begins implementing protocol corrective actions and plant upgrades.
April 28: Politico reports a former Abbott employee filed a whistleblower complaint with the FDA about the Sturgis plant in October 2021, yet the FDA took no follow up action.
April 29: FDA announces it informed Abbott Nutrition that the Agency has no objection to the company immediately releasing recalled product to individuals needing urgent, life-sustaining supplies of specific specialty and metabolic formulas on a case-by-case basis.
Late-April: In 26 states, out of stock rate for infant formula rises to 40-50 percent.
May 1: Nationwide out of stock rate for infant formula rises to 43 percent.
May 10: FDA announces steps to improve supply of infant and specialty formula products. FDA downplayed the shortage, reporting that despite less available variety, 13% more total volume of infant formula was sold in April than was sold in March.
May 13: USDA announces flexibilities, including implementing a number of waivers, urging states to permit alternative formulas for beneficiaries, and ease customer purchasing requirements.
May 14: The Centers for Disease Control and Prevention (CDC) announces it has closed its investigation into the Abbott Sturgis facility, as no additional cases have been reported. The agency concluded there were no strains of cronobacter in sealed infant formula containers. The strains collected from the affected children did not match any strains present at Abbott facilities; they did match strains found in the childrens’ home environments.
May 16: FDA and Abbott announce they have entered into a proposed consent decree, subject to court approval and entry, with a plan for reopening the Sturgis plant. FDA also announces increased flexibilities to encourage importation of safe infant formulas into the United States.
May 18: The Biden administration initiates “Operation Fly Formula,” modeled on the Trump administration’s successful COVID response framework known as “Project Air Bridge.” President Biden invokes the Defense Production Act to require manufacturers of ingredients used in formula to prioritize orders placed by formula producers over others.
May 19: Dr. Califf testifies the Abbott Sturgis plant will take another one to two weeks to reopen, after the plant has been closed for nearly four months. Once the plant is reopened, officials estimate it will take another eight weeks to restock shelves with infant formula.

https://www.burr.senate.gov/2022/5/burr-releases-timeline-detailing-fda-biden-admin-failures-in-infant-formula-crisis

So the Trump administration swept the plant's issues under the carpet only to have them pop up on Biden's watch. Typical.

[Anonymous]

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:This administration has known for some time that there was an issue, but took no action.

‘Timeline of Failure:’ The Biden Administration and U.S. Food and Drug Administration Failed Response to the Infant Formula Crisis

2019

September 16-24: U.S. Food and Drug Administration (FDA) officials conduct an inspection of the Abbott Sturgis, Michigan infant formula plant, which produces the majority of amino acid infant formula in the United States. As an outcome, the plant receives a Voluntary Action Indicated (VAI) and a Form 483. The FDA does not issue any restrictions or obligations on manufacturing at the plant.
2020-2021

2020: During the COVID-19 pandemic, the FDA transitions to conducting “mission critical” inspections. It does not re-inspect the Abbott Sturgis facility to follow up on the previously issued Form 483 and ensure appropriate actions have been taken. The FDA will not inspect the Abbott Sturgis facility again for another two years.
2021

January 20: Joe Biden inaugurated as 46th President of the United States.
July: Nationwide out of stock rate for infant formula is 8 percent.
September 20-24: FDA conducts first inspection of the Abbott Sturgis plant in two years. Inspectors find the issues uncovered in the 2019 surveillance inspection have been resolved, but issue a Voluntary Action Indicated (VAI) for different items and a Form 483 for formula inspection.
September 20: FDA receives the first complaint that a child was hospitalized with cronobacter sakazakii on September 6th in Minnesota. The complaint is received at the same time an FDA investigator is conducting the Abbott Sturgis plant’s routine surveillance inspection.
November: Nationwide out of stock rate for infant formula rises to 11 percent.
November 12: Dr. Robert Califf nominated to serve as Commissioner of Food and Drugs, 10 months after President Biden assumed office.
December 1: FDA receives a second complaint, related to the death of a child in Ohio. The Centers for Disease Control determines cronobacter “could have been a contributing factor” in the death.
2022

January 11: FDA receives a third complaint, related to a child hospitalized with cronobacter on January 4, 2022 in Texas.
January 13: Dr. Califf’s nomination to serve as Commissioner of Food and Drugs is reported favorably out of the Senate Health, Education, Labor and Pensions Committee.
January 28: The New York Times reports baby formula shortages are “worsening throughout the United States, causing parents to be increasingly concerned about how they will feed their infants.”
January 31: FDA begins a delayed follow-up inspection of the Abbott Sturgis plant.
February 13: Nationwide out of stock rate for infant formula rises to 26 percent.
February 15: Dr. Robert Califf is confirmed by U.S. Senate as new Commissioner of Food and Drugs.
February 17: Abbott announces a voluntary recall and hold of certain powdered infant formulas produced at the Abbott Sturgis plant. The same day, the FDA receives a fourth complaint, related to the death of a child, also in Ohio, with cronobacter.
February 28: After learning of the latest complaint received by the FDA, Abbott expands their recall to include a specialty product from a specific lot linked to that complaint. The FDA fully agreed with the firm’s decision to initiate, and then expand, the recall. FDA issues a recall notice.
February: As Abbott takes voluntary actions that limit production, Biden Administration officials are aware of the growing infant formula problem. When questioned by CNN, White House National Economic Council Director Brian Deese said, “As a parent, and with friends and colleagues, we were aware that people were starting to have trouble in stores, but we were aware of this from when the FDA had to take its action back in February, with Abbott and with the steps in the Michigan facility. And we have had a team on this from the FDA and in the interagency process since then.”
March 18: FDA concludes its delayed follow-up inspection of the Abbott Sturgis plant.
March 20: Nationwide out of stock rate for infant formula rises to 30 percent.
March 22: Abbott begins flying FDA-approved baby formula daily from Europe.
March 24: President Biden states there will be “real” food shortages related to Russia’s war on Ukraine.
April 1: FDA establishes an Incident Management Group (IMG) to work on supply chain and food safety issues.
April 8: Abbott submits response and corrective action plan following FDA’s 2022 inspection. Abbott immediately begins implementing protocol corrective actions and plant upgrades.
April 28: Politico reports a former Abbott employee filed a whistleblower complaint with the FDA about the Sturgis plant in October 2021, yet the FDA took no follow up action.
April 29: FDA announces it informed Abbott Nutrition that the Agency has no objection to the company immediately releasing recalled product to individuals needing urgent, life-sustaining supplies of specific specialty and metabolic formulas on a case-by-case basis.
Late-April: In 26 states, out of stock rate for infant formula rises to 40-50 percent.
May 1: Nationwide out of stock rate for infant formula rises to 43 percent.
May 10: FDA announces steps to improve supply of infant and specialty formula products. FDA downplayed the shortage, reporting that despite less available variety, 13% more total volume of infant formula was sold in April than was sold in March.
May 13: USDA announces flexibilities, including implementing a number of waivers, urging states to permit alternative formulas for beneficiaries, and ease customer purchasing requirements.
May 14: The Centers for Disease Control and Prevention (CDC) announces it has closed its investigation into the Abbott Sturgis facility, as no additional cases have been reported. The agency concluded there were no strains of cronobacter in sealed infant formula containers. The strains collected from the affected children did not match any strains present at Abbott facilities; they did match strains found in the childrens’ home environments.
May 16: FDA and Abbott announce they have entered into a proposed consent decree, subject to court approval and entry, with a plan for reopening the Sturgis plant. FDA also announces increased flexibilities to encourage importation of safe infant formulas into the United States.
May 18: The Biden administration initiates “Operation Fly Formula,” modeled on the Trump administration’s successful COVID response framework known as “Project Air Bridge.” President Biden invokes the Defense Production Act to require manufacturers of ingredients used in formula to prioritize orders placed by formula producers over others.
May 19: Dr. Califf testifies the Abbott Sturgis plant will take another one to two weeks to reopen, after the plant has been closed for nearly four months. Once the plant is reopened, officials estimate it will take another eight weeks to restock shelves with infant formula.

https://www.burr.senate.gov/2022/5/burr-releases-timeline-detailing-fda-biden-admin-failures-in-infant-formula-crisis

The FDA is no longer an independent agency funded by taxpayers. It is, if I am not mistaken, an almost majority (40-50%) funded by user fees from the very companies they inspect. There is too much crossover. Yet again corporations have too much power. They approve the mechanisms that would keep competition high and forego the mechanisms that keep their products safe.

And the GOP wants to scrap every regulation in existence. Vote Democratic if you love your infants. Actually vote Democratic if you’re just a baseline decent person.

Vote independent if you care about this country and your children at all. Continuing to vote Democrat is being okay with the Blue v Red crap that is literally killing our kids.

You’re a Republican being a good little soldier and trying to siphon off every Democratic vote you can. Do you think no one is on to you?

[Anonymous]

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:This administration has known for some time that there was an issue, but took no action.

‘Timeline of Failure:’ The Biden Administration and U.S. Food and Drug Administration Failed Response to the Infant Formula Crisis

2019

September 16-24: U.S. Food and Drug Administration (FDA) officials conduct an inspection of the Abbott Sturgis, Michigan infant formula plant, which produces the majority of amino acid infant formula in the United States. As an outcome, the plant receives a Voluntary Action Indicated (VAI) and a Form 483. The FDA does not issue any restrictions or obligations on manufacturing at the plant.
2020-2021

2020: During the COVID-19 pandemic, the FDA transitions to conducting “mission critical” inspections. It does not re-inspect the Abbott Sturgis facility to follow up on the previously issued Form 483 and ensure appropriate actions have been taken. The FDA will not inspect the Abbott Sturgis facility again for another two years.
2021

January 20: Joe Biden inaugurated as 46th President of the United States.
July: Nationwide out of stock rate for infant formula is 8 percent.
September 20-24: FDA conducts first inspection of the Abbott Sturgis plant in two years. Inspectors find the issues uncovered in the 2019 surveillance inspection have been resolved, but issue a Voluntary Action Indicated (VAI) for different items and a Form 483 for formula inspection.
September 20: FDA receives the first complaint that a child was hospitalized with cronobacter sakazakii on September 6th in Minnesota. The complaint is received at the same time an FDA investigator is conducting the Abbott Sturgis plant’s routine surveillance inspection.
November: Nationwide out of stock rate for infant formula rises to 11 percent.
November 12: Dr. Robert Califf nominated to serve as Commissioner of Food and Drugs, 10 months after President Biden assumed office.
December 1: FDA receives a second complaint, related to the death of a child in Ohio. The Centers for Disease Control determines cronobacter “could have been a contributing factor” in the death.
2022

January 11: FDA receives a third complaint, related to a child hospitalized with cronobacter on January 4, 2022 in Texas.
January 13: Dr. Califf’s nomination to serve as Commissioner of Food and Drugs is reported favorably out of the Senate Health, Education, Labor and Pensions Committee.
January 28: The New York Times reports baby formula shortages are “worsening throughout the United States, causing parents to be increasingly concerned about how they will feed their infants.”
January 31: FDA begins a delayed follow-up inspection of the Abbott Sturgis plant.
February 13: Nationwide out of stock rate for infant formula rises to 26 percent.
February 15: Dr. Robert Califf is confirmed by U.S. Senate as new Commissioner of Food and Drugs.
February 17: Abbott announces a voluntary recall and hold of certain powdered infant formulas produced at the Abbott Sturgis plant. The same day, the FDA receives a fourth complaint, related to the death of a child, also in Ohio, with cronobacter.
February 28: After learning of the latest complaint received by the FDA, Abbott expands their recall to include a specialty product from a specific lot linked to that complaint. The FDA fully agreed with the firm’s decision to initiate, and then expand, the recall. FDA issues a recall notice.
February: As Abbott takes voluntary actions that limit production, Biden Administration officials are aware of the growing infant formula problem. When questioned by CNN, White House National Economic Council Director Brian Deese said, “As a parent, and with friends and colleagues, we were aware that people were starting to have trouble in stores, but we were aware of this from when the FDA had to take its action back in February, with Abbott and with the steps in the Michigan facility. And we have had a team on this from the FDA and in the interagency process since then.”
March 18: FDA concludes its delayed follow-up inspection of the Abbott Sturgis plant.
March 20: Nationwide out of stock rate for infant formula rises to 30 percent.
March 22: Abbott begins flying FDA-approved baby formula daily from Europe.
March 24: President Biden states there will be “real” food shortages related to Russia’s war on Ukraine.
April 1: FDA establishes an Incident Management Group (IMG) to work on supply chain and food safety issues.
April 8: Abbott submits response and corrective action plan following FDA’s 2022 inspection. Abbott immediately begins implementing protocol corrective actions and plant upgrades.
April 28: Politico reports a former Abbott employee filed a whistleblower complaint with the FDA about the Sturgis plant in October 2021, yet the FDA took no follow up action.
April 29: FDA announces it informed Abbott Nutrition that the Agency has no objection to the company immediately releasing recalled product to individuals needing urgent, life-sustaining supplies of specific specialty and metabolic formulas on a case-by-case basis.
Late-April: In 26 states, out of stock rate for infant formula rises to 40-50 percent.
May 1: Nationwide out of stock rate for infant formula rises to 43 percent.
May 10: FDA announces steps to improve supply of infant and specialty formula products. FDA downplayed the shortage, reporting that despite less available variety, 13% more total volume of infant formula was sold in April than was sold in March.
May 13: USDA announces flexibilities, including implementing a number of waivers, urging states to permit alternative formulas for beneficiaries, and ease customer purchasing requirements.
May 14: The Centers for Disease Control and Prevention (CDC) announces it has closed its investigation into the Abbott Sturgis facility, as no additional cases have been reported. The agency concluded there were no strains of cronobacter in sealed infant formula containers. The strains collected from the affected children did not match any strains present at Abbott facilities; they did match strains found in the childrens’ home environments.
May 16: FDA and Abbott announce they have entered into a proposed consent decree, subject to court approval and entry, with a plan for reopening the Sturgis plant. FDA also announces increased flexibilities to encourage importation of safe infant formulas into the United States.
May 18: The Biden administration initiates “Operation Fly Formula,” modeled on the Trump administration’s successful COVID response framework known as “Project Air Bridge.” President Biden invokes the Defense Production Act to require manufacturers of ingredients used in formula to prioritize orders placed by formula producers over others.
May 19: Dr. Califf testifies the Abbott Sturgis plant will take another one to two weeks to reopen, after the plant has been closed for nearly four months. Once the plant is reopened, officials estimate it will take another eight weeks to restock shelves with infant formula.

https://www.burr.senate.gov/2022/5/burr-releases-timeline-detailing-fda-biden-admin-failures-in-infant-formula-crisis

The FDA is no longer an independent agency funded by taxpayers. It is, if I am not mistaken, an almost majority (40-50%) funded by user fees from the very companies they inspect. There is too much crossover. Yet again corporations have too much power. They approve the mechanisms that would keep competition high and forego the mechanisms that keep their products safe.

And the GOP wants to scrap every regulation in existence. Vote Democratic if you love your infants. Actually vote Democratic if you’re just a baseline decent person.

Vote independent if you care about this country and your children at all. Continuing to vote Democrat is being okay with the Blue v Red crap that is literally killing our kids.

Vote independent if you want to throw a tantrum.

Grow TF up and pick a side. That’s how it works in a two-party system. You pick the lesser of two evils. And right now that is the Ds. Period.

[Anonymous]

Anonymous wrote:The Abbott plant is supposed to reopen in a few weeks. Baffling how supposedly professional private sector industry screwed the pooch so badly where it comes to sanitation after gaining a monopoly on the market. I bet you some Abbott execs got very rich somewhere along the line cutting corners.

And once again it goes to show that "small government" Republicans have none of the answers. Leave it up to them and the monopoly problem, the dead-babies-from-contaminated-formula problem only gets worse.

That Abbott plant is opening this weekend and running three shifts. I see plenty of formula on my local shelves, even the sensitive formula. I think the GOP is trying to prolong this "scandal."

https://www.usnews.com/news/health-news/articles/2022-05-25/abbott-to-re-open-baby-formula-plant-on-june-4

[Anonymous]

Anonymous wrote:

Anonymous wrote:The Abbott plant is supposed to reopen in a few weeks. Baffling how supposedly professional private sector industry screwed the pooch so badly where it comes to sanitation after gaining a monopoly on the market. I bet you some Abbott execs got very rich somewhere along the line cutting corners.

And once again it goes to show that "small government" Republicans have none of the answers. Leave it up to them and the monopoly problem, the dead-babies-from-contaminated-formula problem only gets worse.

That Abbott plant is opening this weekend and running three shifts. I see plenty of formula on my local shelves, even the sensitive formula. I think the GOP is trying to prolong this "scandal."

https://www.usnews.com/news/health-news/articles/2022-05-25/abbott-to-re-open-baby-formula-plant-on-june-4

Scandal? It's not a scandal.
It's just yet another example of a crisis that was either caused by, or ignored by this administration until things got out of control. Same as pretty much every crisis plaguing this administration.

[Anonymous]