Infant Formula Supplemental Appropriations Act, 2022

Floor Speech

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Ms. DeLAURO. Madam Speaker, pursuant to House Resolution 1124, I call up the bill (H.R. 7790) making emergency supplemental appropriations to address the shortage of infant formula in the United States for the fiscal year ending September 30, 2022, and for other purposes, and ask for its immediate consideration in the House.

The Clerk read the title of the bill.
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Ms. DeLAURO. Madam Speaker, I yield myself such time as I may consume.

Madam Speaker, this funding legislation will work in tandem with President Biden's launch of Operation Fly Formula and the invocation of the Defense Production Act to help quickly and safely address the infant formula shortage in this country and help prevent this from happening again.

I am shocked by the infant formula crisis. The shortage we are seeing today is in large part caused by some who chose not to prioritize the health and the safety of our babies.

In September 2021, Food and Drug Administration, FDA inspectors conducted a routine inspection of the Abbott Nutrition facility in Sturgis, Michigan, where suspicions of wrongdoing were already present, as noted in a Bloomberg article published on May 12 from a reporter who obtained the FDA report through a Freedom of Information Act request.

On October 20, 2021, a whistleblower who worked at that Abbott facility submitted a report to the FDA unveiling a damning list of allegations of wrongdoing at the hands of Abbott. Recalls happen, but if the allegations are true, this company has lied, cut corners, falsified records to cover up their misdoings at the sake of infant health. This is plain wrong.

But this was in October. The FDA knew about what Abbott was doing in October and, yes, they dragged their feet. It was not until late December that the FDA interviewed the whistleblower. And then not until a month after that, in late January, was the plant inspected in person. Abbott then issued a recall in February, 4 months later.

In March, I requested an HHS Office of Inspector General report to look into this tragedy, so that we can hold the bad actors accountable. And then I got ahold of and submitted for the record a whistleblower report with truly awful allegations against Abbott.

Their wrongdoings included the falsification of records, testing seals on empty cans, releasing untested infant formula, just to name a few. In essence, they put a product on the market, a contaminated product, which they knew was contaminated. We have lost--at least two infants died. Several were hospitalized.

Let's look back for a moment. Now, we are learning that in 2014, Abbott deliberately and successfully tried to weaken bacteria testing safety standards. At that time, the FDA issued a proposed rule that would have increased the regular safety inspections of infant formula manufacturing facilities to prevent the contamination of infant formula; the very crisis that we have today.

The Federal Government has an important role to play in addressing this painful issue. As I said, at least two babies died, and four more were hospitalized that we know of because of corporate greed, consolidation, and a disgraceful lack of proper oversight by the FDA.

This is infant formula we are talking about. Parents trust that this formula will be safe and healthy for their newborn babies. It should be the most regulated and protected of any product, and here, we see Abbott putting production and profits before people.

I introduced this bill this week because 43 percent of infant formula is out of stock nationwide. There is an immediate need to bring infant formula to the babies and families facing such a dire necessity. In the wealthiest Nation in the world, babies should not be at risk of going hungry. Parents should not have to play a guessing game and wonder if the food that they are giving their babies is safe.

Earlier this evening, President Biden announced that he would invoke the Defense Production Act to increase domestic production of infant formula, launching Operation Fly Formula to use Federal planes to fly formula in from abroad.

I have been calling for the swift importation of safe infant formula from FDA-approved facilities overseas since the beginning of this crisis. These steps will achieve this goal, and I applaud the Biden administration for rising to this urgent challenge.

Now that we are ramping up production, preparing to purchase formula from abroad, we must ensure that it is safe. And I would repeat, this product needs to come from FDA-approved facilities so we make no mistake that they are adhering to a standard. The FDA needs the resources to do that.

The FDA plays a critical role in ensuring formula provides the full nutritional needs of infants and that it is manufactured in the safest way possible. We must ensure that a lack of funding is not a barrier to getting safe formula to parents and babies.

The bill before us does just that. It addresses this pressing need by providing $28 million in new funding for the FDA. These funds will be used to prevent fraudulent products from entering the marketplace, to acquire better data of the situation in the marketplace, and to fund the balance of FDA activities. To prevent shortages from happening again, funds will strengthen the workforce focused on formula issues and increase the FDA's inspection staff.

The FDA needs resources to be able to get this work done quickly, and safely, and that includes building their workforce. Right now, they have only nine people on staff inspecting and reviewing the submissions that could increase the number of FDA-approved facilities developing infant formula. It is not enough.

Being able to have more staff who are doing this job will ensure FDA can increase the quality of submissions being reviewed without risking the quality of the review process. We also have their funds that will buttress their inspection teams so that we can get more FDA-approved facilities online.

I am proud that this bill meets this urgent need. People are looking for some relief, and I am proud that we are on the floor tonight to ensure that families get this help as soon as possible.

But we should not, and we will not be made to choose between the health and the safety of our babies and the supply that keeps them fed. I reject this dangerous and false dichotomy.

Let me be clear: The funding in this bill seeks to address the shortage now, but we must simultaneously find solutions that prevent this contamination and the shortage from happening again. Our work here is not done. We will introduce legislation in the next several days to address the root cause of the issue so that it does not happen again.

Madam Speaker, we all are heartbroken, both at the stories of the babies who died and their mourning families, and the millions of moms and dads today who are frantic and scrambling to find formula, and who, within their hearts, are scared that the product they may be giving their infant can potentially cause them grave harm.

That is not who we are. That is not who we are. Our babies are our most vulnerable, and we must work quickly and decisively to make safe formula available for every single baby in this country who needs it.

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Ms. DeLAURO. Madam Speaker, I yield myself such time as I may consume.

I might just add, just a quick moment, to indicate to my colleague, who is my friend, that, in fact, we did check with other departments and agencies, and particularly with FEMA, to find out what they might have in stock. FEMA currently has on hand formula for 550 infants for one week. So, in fact, we don't have other Federal agencies that do have a stock of infant formula. What we have said in the legislation is that the FDA must report to House and Senate Appropriations Committees on a weekly basis of where the money is being used, how it is being used, so that we have accountability.

I am really honored to yield to my colleague who chairs the Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies. This is coming through his subcommittee. He has been a tireless fighter on this issue, making sure that our kids are safe. To that end, he will be talking with the director of the Food and Drug Administration tomorrow morning. So he has been really at the center of this effort.

Madam Speaker, I yield 3\1/2\ minutes to the gentleman from Georgia (Mr. Bishop).

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Ms. DeLAURO. Madam Speaker, I yield myself such time as I may consume.

Madam Speaker, I just say to my colleague that, in fact, one would suspect from listening to our colleague that Abbott Nutrition was ready to really move forward and to deal with reopening. The fact of the matter is, I have said that the Food and Drug Administration dragged their feet by not looking at what they were doing in October, et cetera.

But the FDA had to go to court to get an agreement with Abbott about how to open. This wasn't a company that was taking on their culpability in knowingly selling a contaminated product that puts our babies at risk. Going to court, that is just a part of the delay with moving, is having to have to go to court to do this.

Congressman Pallone has spent so much of his professional career focused on food safety issues and, in fact, as the Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies is doing hearings, the Energy and Commerce Committee will be doing hearings on this issue as well.

Madam Speaker, I yield 3 minutes to the gentleman from New Jersey (Mr. Pallone), the chairman of the Committee on Energy and Commerce.

Mr. Speaker, I will say to my colleague who just spoke that, in fact, I just talked about what FEMA has in terms of stocks, which would take care of infants for about 1 week, but I would call her attention to the article that appeared on May 10, ``Military stores scrambling to get baby formula: What new parents need to know.''

Military families are dealing with the same shortage of baby formula. Now, they would have a supply. I take it from what my colleague said that we should take the product from military families, who are serving in the service of this country, take their formula and move it around.

We know where the product is, and we know we do not have enough. We know that we need to move. As to what we are doing and suggesting that we move to import from FDA facilities that are overseas, there are seven of them where we can get product on the shelves as quickly as possible.

Maloney), the chairwoman of the Committee on Oversight and Reform. Oversight and reform is Congresswoman Maloney's stock-in-trade, and she is all over this issue as well.

Mrs. CAROLYN B. MALONEY of New York. Mr. Speaker, I thank the gentlewoman for yielding and for her extraordinary leadership in responding to this crisis so comprehensively and quickly and also for her leadership as the chair of the Appropriations Committee.

Mr. Speaker, I rise in support of the emergency spending that builds on the Biden administration's progress in addressing the nationwide infant formula shortage by providing the FDA with resources to increase supply and prevent future shortages.

The national formula shortage threatens the health and economic security of America's infants and families, especially those who experience health inequities, including food insecurity.

In recent weeks, parents across the country have been forced to ration food or travel for hours to obtain formula. For parents of infants with special health needs, the nationwide formula shortage has been especially dire. Some parents have considered going to the emergency room just so that they can feed their babies. This is unacceptable.

We cannot sit by while families struggle to feed their babies. That is why the Committee on Oversight and Reform has started an investigation to support the work of the legislative committees--the Energy and Commerce and Appropriations Committees--that are putting forward legislation to address this.

We sent letters to the CEOs of the four largest baby formula manufacturers, pressing them on their plans to boost supply. When are they going to have the formula back on the shelves in the stores? What caused this? What are they doing to prevent future shortages?

I am proud to support, with my Democratic and, hopefully, Republican colleagues, today's bill, which will appropriate $28 million for FDA to safely increase our supply of infant formula and prevent future shortages so that this will never happen again.

I thank Chair DeLauro for her leadership.

Mrs. CAROLYN B. MALONEY of New York. Mr. Speaker, I thank the Biden administration for invoking the Defense Production Act to act on this. They are also moving to import safe products from other countries. I applaud the President's leadership, but I especially applaud the leadership in this Congress, Speaker Pelosi, Leader Hoyer, Chair DeLauro, Chair Pallone, all the people who have been involved in helping America's infants.

I urge a ``yes'' vote on this important bill. We should be unified for our children in this country.

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Ms. DeLAURO. Mr. Speaker, we all share the view that the infant formula shortage is a crisis. The stories that we have all heard-- mothers and fathers struggling to find formula, the images of empty store shelves--are heartbreaking. We have all heard from constituents all over this country that parents are scared. They can't find the product, and they are scared that they are going to have a product that may put their child in danger.

Mr. Speaker, we need to address two areas. We need to address the immediate crisis to get product on the shelves as soon as we can, which is what this bill does tonight, along with other measures that the administration is taking.

There are some very serious underlying issues that we face. The question arises, how did we get here? How did this happen?

One of the biggest issues and concerns is the whole issue of the consolidation of the industry. There are only four manufacturers of infant formula in the United States, and when one of the four has produced a contaminated product, knowingly putting our babies at risk, yes, and they fought the FDA on really calling for a recall. The FDA, again, had to go to district court to be able to move to a consent decree to talk about cleaning up the mess in Sturgis, Michigan.

When that product came off the shelf, 43 percent of the product was gone because that is the piece that Abbott has. They have cornered the market. We need to address that root problem of sole-source contracting. This is prevalent in the meatpacking industry as well.

We cannot just rely on four producers of infant formula. We have to take a look at that, and that will be investigated.

There is an inspector general investigation going on that will take a look at the issues of the contamination and that underlying cause. We will investigate why it took so long for the FDA--4 months--to look at addressing this issue when they had knowledge that this company was selling a contaminated product, with some very courageous whistleblower coming forward to tell the story.

Those pieces are going to be investigated. In my view, we will follow the investigation to where the difficulties are, and we will hold people accountable for that.

In the meantime, we have a responsibility. That responsibility is to make sure that there is infant formula on the shelves that parents can get access to, and that is what this bill is about. That is what our efforts are all about, giving the Food and Drug Administration resources to deal with the supply chain, to be able to go to the seven producers overseas. There are seven countries that are FDA approved: France, Germany, the Netherlands, Switzerland, Denmark, and Ireland are FDA approved.

Again, I will state my view. We only need to go to FDA-approved facilities, not open the door to facilities where we cannot deal with what their standards are in short order.

That is what the resources here can help the FDA do. It would increase their inspection force. It would increase their ability to look at infant formula submissions so they can move quickly to approve facilities and give that approval and, in the meantime, move to get the product back here.

As the President announced today, we will be able to use our airplanes. We can get product here rapidly.

Again, it should come from FDA-approved facilities. That is what we are about tonight. That is what it is. It is not about politics. We are going to investigate what happened here.

Let's come together. Let's move together to address a nationwide challenge and a problem that we face. Let's not continue to put mothers and fathers and babies at risk. We have the responsibility to do something tonight, to make it happen, and I urge my colleagues, we cannot let any baby be at risk of going to sleep hungry in this country. We must act quickly. There is no room for error.

I urge my colleagues to support this bill, and I yield back the balance of my time.

Ms. JACKSON LEE. Mr. Speaker, I rise in strong support of H.R. 7790, the Infant Formula Supplemental Appropriations Act which would provide $28 million in emergency supplemental appropriations to address the shortage of infant formula in the United States.

I thank my good friend and colleague, Chairwoman Rosa DeLauro, for introducing this important bill that addresses the ongoing national crisis in shortages of infant baby formula.

The bill provides appropriations for the Food and Drug Administration (FDA) to:

address the current shortage of FDA-regulated infant formula and certain medical foods in the United States; and

prevent future shortages by taking necessary steps to block fraudulent products from entering the U.S. market.

This is the first time in recorded memory that our Nation has had a substantial shortage of infant formula.

Babies are in need and parents and caregivers are desperate to find formula to feed their children.

As the founder and Chair of the Congressional Children's Caucus, I have worked to address the needs of women, families, and children.

On Saturday, May 14, 2022, I hosted a baby formula giveaway and was joined by the National Association of Christian Churches (NACC), a 501(c)(3) organization to provide free baby formula to eight hundred families in need of formula for the babies.

The formula provided would only last a few days, but it was important because it gave families a few more days to find more formula for their children.

I am in strong support of this bill and H.R. 7791, a bill to amend the Child Nutrition Act of 1966 to establish waiver authority to address certain emergencies, disasters, and supply chain disruptions, which includes providing relief during this baby formula crisis.

I serve on the House Committees on the Budget and Homeland Security, both of which have oversight or funding responsibilities for addressing this current crisis.

As many parents know, there has been a short supply of baby formula nationwide for months, due to pandemic-related supply chain issues.

That shortage is now a crisis after four children became sick, and two died, after suspected bacterial contamination of formula which originated from Abbott Nutrition's formula plant in Sturgis, Michigan.

The FDA's Coordinated Outbreak Response and Evaluation (CORE) Network, along with the CDC and state and local partners investigated the issue.

According to the FDA, CORE is no longer investigating the incident, but the FDA established an Incident Management Group (IMG) on April 1, to continue to work on supply chain and food safety issues.

Although the source of the contamination has been determined and the investigation has ended, the baby formula shortage problems continue to remain around the country, and the recall is still in effect.

Currently, the nationwide out-of-stock rate for baby formula has reached a high of 43 percent.

Over fifty percent of the infant formula produced in the United States goes to the Special Supplemental Nutrition Program for Women, Infants, and Children (commonly known as the WIC program).

WIC serves to safeguard the health of low-income women, infants, and children younger than 5 who are at nutritional risk.

Infants must eat every three to four hours and their formula or breast milk must have certain nutrients in order to provide them with essential nutrition for their growth and development.

Oftentimes, formula feeding exists on a continuum with breast feeding.

There is no substitute for formula feeding because only 1 in 4 infants breastfeed exclusively.

For parents who depend on baby formula either out of choice or necessity, this crisis has the potential of impacting an entire generation of infants for the rest of their lives.

Desperation is overwhelming parents, and some are turning to making their own baby formula at home.

Pediatricians caution against homemade baby formula as it runs the risk of not providing the right amount of nutrients necessary for healthy development.

Not having the correct formula can put a child's physical and mental development at risk due to malnourishment that could occur if the formula is not correct.

This is not an issue that parents can easily solve at home.

This places the onus on the manufacturers of baby formula and the Congress to handle the supply chain issues to deliver formula to parents and caregivers as quickly as possible.

This bill would give money to ensure that already existing formula brands are safe and can return to shelves as soon as possible.

According to CBS News, more than half of all baby formula products available in Texas are completely sold out, with an out-of-stock rate at 52.5 percent in Houston.

The baby formula shortage is hitting poorer communities disproportionately hard.

According to an article from CNN, about half of WIC beneficiaries lost access to baby formula when their major supplier, Abbott Nutrition, recalled their products.

The shortage has left all parents with less choices and is adding further pressure to already existing economic disparities.

Recently, I partnered with the National Association of Christian Churches to distribute baby formula at Jack Yates High School to my constituents in Houston.

Ovie and Mikayla Cade are just two of the many parents that have been struggling to feed their baby and looked to the drive for much needed support.

A drive like this provides short-term relief for an issue that requires institutional action to create long-term changes.

That is why for the time being I plan to reach out to national disaster organizations to pull together resources to provide immediate support for these families.

This shortage transcends state lines and requires a joint effort on all fronts to get these infants the nutrition they need as quickly as possible.

I urge all my colleagues to support H.R. 7790 for the Infant Formula Supplemental Appropriations Act.

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