United States (US) President Joe Biden on Wednesday, 18 May, invoked the Defense Production Act to boost the supply of baby formula. The country is facing a major shortage due to the closure of a key manufacturing plant in Michigan.
"I know parents across the country are worried about finding enough formula to feed their babies," Biden said in a video statement. "As a parent and as a grandparent, I know just how stressful that is."
"I've directed my team to do everything possible to ensure there's enough safe baby formula and that it is quickly reaching families that need it the most," Biden added, calling it "one of my top priorities".
But what caused this shortage, and what is the 'Defense Production Act'? We explain.
Explained: Baby Formula Shortage in US and How the Country Is Tackling It
1. Why Is There a Shortage of Baby Formula in US?
Four manufacturers of baby formula, namely Abbott, Mead Johnson Nutrition, Nestle USA, and Perrigo, dominate the US market. And ever since Abbott Nutrition shut its plant in Sturgis, Michigan, (which happens to be the country's largest manufacturing plant) due to bacterial contamination, parents in the US have struggled to find formula for their infants. It has also left fewer options on store shelves for parents to choose from.
In February, Abbott Nutrition, based in Sturgis, Michigan, announced a recall of powdered formula brands made at the plant after four infants who consumed the products fell ill with bacterial infections. Two of the infants later died.
Food and Drug Administration (FDA) investigators then conducted a six-week inspection and later published a list of problems in March. These included lax safety and sanitary standards and a history of bacterial contamination in several parts of the plant.
In a complaint filed on Monday, the Justice Department said that Abbott Nutrition introduced adulterated baby formula into the consumer market.
Abbott maintains that there is no conclusive evidence that its formula caused the infants to fall ill and die. The Chicago-based company maintains that its products have not been directly linked to bacterial infections in children. Bacteria samples found at the plant reportedly did not match the strains collected from the two babies.
However, FDA officials said they were unable to collect bacterial strains from two of the four patients.
"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," the FDA's food director, Susan Mayne, said according to The Guardian.
FDA officials further said that fixing the violations found at the Abbott plant would take time. Companies need to clean the facility and equipment, retrain their staff, and repeatedly test and document that there is no contamination.
Expand2. How Is It Affecting Families and How Are They Coping With It?
According to Google Trends, Google searches on how to make formula at home have increased by 2400 percent in the last 30 days.
The BBC reported that many parents are circulating a 1950s recipe for baby formula to cope with the shortage.
However, the former chair of the American Academy of Paediatrics Committee on Nutrition, Dr Steven Adams, has also seen the same recipe online and advised parents not to use it, dilute formula, or attempt to develop other homemade substitutes.
The shortage is also "disproportionately" impacting low-income women and children, who rely on state-subsidised nutritional programmes for groceries, reported the BBC. Around half of all infant formula sold nationwide is reportedly bought through government subsidised schemes.
According to TIME, families with babies with allergies, gastrointestinal issues, or metabolic disorders who require a certain type of formula for their nutrition have also been severely impacted.
Meanwhile, major retailers like CVS, Walgreens, and Target have started limiting the number of formula products that customers can buy.
Expand3. What Is the Defense Production Act?
The Defense Production Act was passed in 1950 during the Korean War. It gives the president broad authority to require companies to prioritise the manufacture and allocations of goods in times of a crisis.
Suppliers will now have to direct ingredients to baby formula manufacturers before any other companies who may have placed orders for those same goods. However, it remains unclear which major suppliers will be subjected to the order.
Expand4. What Other Measures Are Being Taken by the US Government?
The country produces 98 percent of the baby formula that American parents buy.
To help ease the shortage, the FDA said on Monday it was streamlining its review process, which would make it easier for foreign manufacturers to ship more formula into the country.
Biden also wrote a letter to the Department of Health and Human Services and the Department of Agriculture on Wednesday, directing them to work with the Pentagon to identify overseas suppliers of formula that meet US standards over the next week.
"Imports of baby formula will serve as a bridge to this ramped-up production," Biden wrote.
Biden also asked the Health and Human Services Department and Department of Agriculture to use aircraft from the Defense Department to procure infant formula from overseas that meet US' health and safety standards.
The White House has termed it 'Operation Fly Formula'.
To sell formula in the US, companies are required to submit an application to the FDA. The agency would then review the application to ensure the products' safety for consumption and check if it provides adequate nutrition.
Regulators also said companies would have to provide documentation of their factories' inspections as part of the FDA's new import policy.
Last week, Democratic lawmakers said the FDA has a shortage of inspectors to ensure the safety of imported formula. The FDA has only nine inspectors to watch infant formula manufacturers, the agency informed the chair of the House Appropriations Committee, Rosa DeLauro.
DeLauro introduced a legislation this week which would provide the agency with $28 million in emergency funding to increase inspections, check the supply chain and get rid of fraudulent products from getting on to store shelves.
White House to Approve Two Bills to Address Shortage
The White House is also expected to approve two bills which would help address the shortage.
One bill would enable the agriculture secretary to issue a narrow set of waivers in case of a supply disruption.
The aim is to give participants in an assistance program known as 'Women, Infants, and Children' (WIC) the ability to use vouchers to purchase formula from any producer rather than buying it from just one brand that may be unavailable.
The WIC program accounts for about half of infant formula sales in the country.
The other measure, the above-mentioned $28 million emergency funding, is likely to have less bipartisan support. There is no clarity if the Senate would take it up.
Expand5. What Are the Conditions for Abbott Nutrition To Reopen?
Meanwhile, Abbott Nutrition reached an agreement with the FDA on Monday to reopen the plant, but under conditions subject to a federal court's enforcement. The conditions include hiring independent experts to ensure that the plant meets US food safety standards.
According to Abbott Nutrition, the Michigan facility would take about two weeks to reopen after receiving FDA approval. The products would also arrive in stores across the country in up to eight weeks.
(With inputs from The Guardian, BBC, TIME and CNBC.)
(At The Quint, we are answerable only to our audience. Play an active role in shaping our journalism by becoming a member. Because the truth is worth it.)
Expand
Why Is There a Shortage of Baby Formula in US?
Four manufacturers of baby formula, namely Abbott, Mead Johnson Nutrition, Nestle USA, and Perrigo, dominate the US market. And ever since Abbott Nutrition shut its plant in Sturgis, Michigan, (which happens to be the country's largest manufacturing plant) due to bacterial contamination, parents in the US have struggled to find formula for their infants. It has also left fewer options on store shelves for parents to choose from.
In February, Abbott Nutrition, based in Sturgis, Michigan, announced a recall of powdered formula brands made at the plant after four infants who consumed the products fell ill with bacterial infections. Two of the infants later died.
Food and Drug Administration (FDA) investigators then conducted a six-week inspection and later published a list of problems in March. These included lax safety and sanitary standards and a history of bacterial contamination in several parts of the plant.
In a complaint filed on Monday, the Justice Department said that Abbott Nutrition introduced adulterated baby formula into the consumer market.
Abbott maintains that there is no conclusive evidence that its formula caused the infants to fall ill and die. The Chicago-based company maintains that its products have not been directly linked to bacterial infections in children. Bacteria samples found at the plant reportedly did not match the strains collected from the two babies.
However, FDA officials said they were unable to collect bacterial strains from two of the four patients.
"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," the FDA's food director, Susan Mayne, said according to The Guardian.
FDA officials further said that fixing the violations found at the Abbott plant would take time. Companies need to clean the facility and equipment, retrain their staff, and repeatedly test and document that there is no contamination.
How Is It Affecting Families and How Are They Coping With It?
According to Google Trends, Google searches on how to make formula at home have increased by 2400 percent in the last 30 days.
The BBC reported that many parents are circulating a 1950s recipe for baby formula to cope with the shortage.
However, the former chair of the American Academy of Paediatrics Committee on Nutrition, Dr Steven Adams, has also seen the same recipe online and advised parents not to use it, dilute formula, or attempt to develop other homemade substitutes.
The shortage is also "disproportionately" impacting low-income women and children, who rely on state-subsidised nutritional programmes for groceries, reported the BBC. Around half of all infant formula sold nationwide is reportedly bought through government subsidised schemes.
According to TIME, families with babies with allergies, gastrointestinal issues, or metabolic disorders who require a certain type of formula for their nutrition have also been severely impacted.
Meanwhile, major retailers like CVS, Walgreens, and Target have started limiting the number of formula products that customers can buy.
What Is the Defense Production Act?
The Defense Production Act was passed in 1950 during the Korean War. It gives the president broad authority to require companies to prioritise the manufacture and allocations of goods in times of a crisis.
Suppliers will now have to direct ingredients to baby formula manufacturers before any other companies who may have placed orders for those same goods. However, it remains unclear which major suppliers will be subjected to the order.
What Other Measures Are Being Taken by the US Government?
The country produces 98 percent of the baby formula that American parents buy.
To help ease the shortage, the FDA said on Monday it was streamlining its review process, which would make it easier for foreign manufacturers to ship more formula into the country.
Biden also wrote a letter to the Department of Health and Human Services and the Department of Agriculture on Wednesday, directing them to work with the Pentagon to identify overseas suppliers of formula that meet US standards over the next week.
"Imports of baby formula will serve as a bridge to this ramped-up production," Biden wrote.
Biden also asked the Health and Human Services Department and Department of Agriculture to use aircraft from the Defense Department to procure infant formula from overseas that meet US' health and safety standards.
The White House has termed it 'Operation Fly Formula'.
To sell formula in the US, companies are required to submit an application to the FDA. The agency would then review the application to ensure the products' safety for consumption and check if it provides adequate nutrition.
Regulators also said companies would have to provide documentation of their factories' inspections as part of the FDA's new import policy.
Last week, Democratic lawmakers said the FDA has a shortage of inspectors to ensure the safety of imported formula. The FDA has only nine inspectors to watch infant formula manufacturers, the agency informed the chair of the House Appropriations Committee, Rosa DeLauro.
DeLauro introduced a legislation this week which would provide the agency with $28 million in emergency funding to increase inspections, check the supply chain and get rid of fraudulent products from getting on to store shelves.
White House to Approve Two Bills to Address Shortage
The White House is also expected to approve two bills which would help address the shortage.
One bill would enable the agriculture secretary to issue a narrow set of waivers in case of a supply disruption.
The aim is to give participants in an assistance program known as 'Women, Infants, and Children' (WIC) the ability to use vouchers to purchase formula from any producer rather than buying it from just one brand that may be unavailable.
The WIC program accounts for about half of infant formula sales in the country.
The other measure, the above-mentioned $28 million emergency funding, is likely to have less bipartisan support. There is no clarity if the Senate would take it up.
What Are the Conditions for Abbott Nutrition To Reopen?
Meanwhile, Abbott Nutrition reached an agreement with the FDA on Monday to reopen the plant, but under conditions subject to a federal court's enforcement. The conditions include hiring independent experts to ensure that the plant meets US food safety standards.
According to Abbott Nutrition, the Michigan facility would take about two weeks to reopen after receiving FDA approval. The products would also arrive in stores across the country in up to eight weeks.
(With inputs from The Guardian, BBC, TIME and CNBC.)
(At The Quint, we are answerable only to our audience. Play an active role in shaping our journalism by becoming a member. Because the truth is worth it.)