Motion to Discharge

Floor Speech

By: Mike Lee
By: Mike Lee
Date: June 22, 2022
Location: Washington, DC


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Mr. LEE. Madam President, I return to the floor of the Senate again today to ask that this body take immediate action--action needed--to address our Nation's massive baby formula shortage.

For months, American moms and dads have been scouring supermarkets and drugstores looking for baby formula. Anxiety-ridden parents are frantically checking online stores and pleading with family and friends, trying to figure out how to ship, purchase, and otherwise procure baby formula.

Still, some families must hospitalize their babies because they can't find formula. Yes, they are hospitalizing them for that reason alone.

Inexcusably, the crisis has only gotten worse. In May alone, reports show that the out-of-stock rate jumped from 43 percent to a staggering 73 percent nationally.

In Utah, my State--the State with the largest families, the most children per capita, and the highest birthrate in the Nation--reports show that out-of-stock rate to be as high as 88.9 percent.

Desperate parents are now resorting to places like Facebook Marketplace, buying from unknown sellers at exorbitant markups. The failure of the Biden administration's photo-op policy has not so much as put a dent--even a tiny dent--in this problem.

Now, initially, the White House said that parents should ``ask your pediatrician, who may have formula samples or possible alternatives,'' as if that were somehow a solution.

This hollow nonresponse was embarrassing enough, but, tragically, the administration's response has not improved with time, in the time that has passed since that statement was made. When the question came up again, the White House press secretary spent nearly 20 seconds flipping through a binder, only to respond with: ``I don't have anything new.''

That response is simply unacceptable. It is unacceptable for the American people generally and especially for those families dealing with this inexplicably, needlessly prolonged crisis.

By failing to act, we are leaving parents in an unimaginable situation during one of the most stressful and impactful times of life. Worse, they have received no discernible answers from their elected officials. The White House's website lays the blame solely on Abbott's plant closure in Michigan ``due to safety concerns from the FDA.''

Now, this is a very limited, narrow line of thinking. The FDA regularly recalls other food products, but none of those recalls happens to result in shortages of this magnitude or this significance with such weighty consequences on the youngest of Americans.

Look, it doesn't have to be this way. There are a lot of weighty problems that we address in the U.S. Senate that are seemingly unsolvable, intractable, or, at least, very, very difficult to solve because they involve things that very often are beyond our ability to control.

This is not one of those problems. This is within our grasp. It is within our control. In fact, the government is the problem. Government caused it, and by turning certain levers, government can relieve this problem and do so in a very short period of time. This suffering is unnecessarily being prolonged by the government itself.

So the Senate can help these families, these American families struggling with this crisis, by immediately passing my bill called the FORMULA Act.

This bill responds to the crisis in three simple ways to help solve the crisis at hand and feed American babies.

First, my bill would suspend tariff collection on currently allowed formula imports. We tax imported formula at a rate of at least 17.5 percent upon entering the United States. It can roughly double to about 35 percent, depending on the circumstances of the shipment. We can help ease the skyrocketing prices and encourage companies to import as much baby formula as possible or as much as demand within the market requires by simply suspending for a period of 6 months this tariff collection.

Look, the administration has acknowledged there are appropriate times to suspend the collection of certain taxes. For example, it is currently proposing suspending the gasoline tax for a period of 3 months. Surely, it is not the Biden White House's position that gasoline is more important than feeding infants.

Second, my bill would temporarily allow formula imports from several safe countries like those in Europe. This would enable us to access plentiful formula supplies from abroad and meet our current needs with that.

Now, allowing these imports is not going to endanger American babies. The manufacturing plants in question are already approved and are already regulated by their home countries. And the only plants that operate in countries and subject to authorities that are comparable to those imposed by our own Food and Drug Administration, these are countries from which we already import pharmaceutical products.

The fact is that parents have already begun taking matters into their own hands, often with dire consequences. We are hearing reports of parents resorting to online homemade recipes for formula that they then feed to their infants. Infant hospitalizations due to malnutrition are correspondingly increasing as a direct result of these activities and the shortages from which they stem.

Doctors have voiced their concerns that homemade formulas can lead to liver and kidney issues and, in some cases, even heart failure. Some families have tried diluting the formula that they are able to access with more water, a tactic that health experts warn can lead to brain swelling and organ failure.

Some doctors refer to this shortage as ``the worst crisis they have experienced in their careers.'' They have to place dehydrated children on IV fluids, which isn't, of course, a long-term solution; it is an acute and dire response to a life-threatening emergency brought about through an artificial government constraint on the market. These short- term consequences are scary enough. They are scary enough for the moms and dads, to say nothing of the horrors the children, the infants, experience in the process. We still don't know what the long-term effects of these might be to the babies.

Those worried about the formula quality may find solace in the fact that my bill retains the FDA's authority to recall foreign formulas in the very unlikely event that these safety issues arise. Remember, these are formulas produced in facilities in countries from which we already import pharmaceutical products based on our country's trust and confidence that their safety and quality standards are as secure as, if not more stringent than, our own.

Additionally, my bill only calls for importing formula that is lawfully marketed and approved in select foreign countries. Again, private citizens are already doing this. The law already allows the personal importation of baby formula, meaning somebody can jump online and order it on their own, and parents are voluntarily choosing to do so because they have done the research and they trust that it is safe for their baby.

They understand, as we do, that babies in France and Switzerland and of the United Kingdom are not different than babies in the United States of America. Formula that works for them, that is safe and healthy for them, is proven safe and healthy and effective for them for many, many decades is also going to work with respect to an American baby. My bill would just make this easier and more affordable for parents, you see, because to be one of those parents, you have got to have a degree of sophistication to know what you are looking for. Most people aren't really aware of the fact that they could jump online and order this.

Secondly, it is really expensive to do it. They can't buy in bulk, and it requires extra shipping and handling costs that makes this prohibitively expensive for many people, even the lucky ones who become aware that it is even an option.

So my bill isn't making something legal that is currently illegal in that respect; it is simply making it more affordable. It is making it so that we no longer limit access to these foreign formulas--foreign top-quality formulas from places like France and Switzerland and the United Kingdom. They will be available to poor and middle-class families, and not just the wealthy.

Finally, my bill would allow WIC program recipients to buy whatever brand of formula is available with WIC vouchers. My bill will allow these parents to buy from available stock and feed their children and guarantees greater flexibility.

You see, the existing formula crisis has been exacerbated by virtue of the fact that the WIC formula--the WIC beneficiaries are given a voucher. Very often, that voucher limits them to procuring only that brand of formula specified on the voucher itself, which, in many instances, might be out of stock. This would eliminate that problem.

Keeping American infants fed should be one of the least controversial proposals imaginable, especially because this is something that can be done easily. We can bring about almost immediate relief to these American parents and especially to their babies, just by not causing the problem anymore or, at least, waiting for a few months before causing this problem again.

In the meantime, the hope and the expectation is that the American formula industry can retool, revamp, and get back in the practice of producing in sufficient quantities that they will be able to meet the demand, but we need 6 months in order to do that.

American babies are going hungry and the Federal Government is the problem. The Federal Government is causing these babies to starve and otherwise suffer.

My FORMULA Act will help solve the formula crisis and ensure that American babies do not go unfed.

Look, there is a reason why we see this crisis here, but not in any of our neighbor countries, not in any of our peer countries. No, the crisis exists here because this is a feature of U.S. law. We can fix this problem. We can help solve this crisis today. We can make sure Americans babies' cries do not go unanswered. We can and must pass my FORMULA Act.

372, S. 4261; that the bill be considered read a third time and passed; and that the motion to reconsider be considered made and laid upon the table.

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Mr. LEE. Mr. President, I appreciate the insight and the always thoughtful counsel of my distinguished friend and colleague, the Senator from Pennsylvania. I always enjoy working with him. He is a voice of reason and is a delight to work with.

I do feel compelled to respond to a few of his points. Now, yes, it is true, there are ambitious plans to fly formula over. They used the Defense Production Act to do that, to have the government to act. And the ambitious plans that he describes have yet to materialize. What we have to look at is the bottles that are available now, that have been flown over now, that are here now as a result of that program, is about 13 million bottles. Do you know what the average daily consumption of formula is in America? Nine million. So this buys us a day and a half of formula--a day and a half--and it is still not solving the problem. So that is not a solution.

As to the objection related to the FDA's regs, he points to the safety concerns and highlights a few adverse incident reports not necessarily linked to the formula itself but things that people experienced as they were switching formulas. A lot of the symptoms that he described--all of them, in fact, as I understand it--including lethargy, diarrhea, and some of those have been linked to babies switching formula. So, yes, when a baby switches formula, whether it is from one American brand to another or an American brand to a European brand, it is not uncommon during this transition period for babies to react that way.

Now, I wish--we wish--that it wasn't necessary for them to switch to begin with. This was unnecessary to make them switch. In fact, another point that I need to refute that he made at the outset about formula being responsible for the contamination, for the food-borne illness, it was, in fact, not the formula itself that caused it. In fact, an FDA investigation revealed that it wasn't the formula. It was a source of bottled water that had itself been contaminated, and it was that bottled water that the parents were mixing with the formula that turned out to be contaminated, by no fault of their own but also by no fault of the manufacturer. So we have got to keep straight exactly what happened here and what didn't happen.

Finally, with regard to the safety risks, I understand this, and it is important that we be safe in doing this. We have to remember these are countries from which we currently import pharmaceutical products because we trust that their equivalent of the FDA is safe and is effective. So if we don't trust them with respect to baby formula, I would submit that we shouldn't trust them elsewhere. But in fact, we can trust them in these areas. None of those adverse incident reports that were reported, to my knowledge, have been linked to a defect or a contamination in the formula itself.

Finally, it is important to remember that we have a massive health crisis faced by these babies who are unable to get formula. Children are being hospitalized because they are dehydrated. These can have lasting consequences. They are occurring at a time when the baby's brain development is on a very critical timeline. You don't want to interrupt that. You don't want a supply chain disruption to lead to a disruption in the baby's developmental growth.

So it is unfortunate that my friend and distinguished colleague, the Senator from Pennsylvania, has objected to this very reasonable, rational, sensible response that lists the government's impediments. I wish this were not the case because this would deliver meaningful reform, unlike the 13 million bottles--the day and a half's worth of formula that has been brought over to date through the Defense Production Act efforts that he described--this would actually solve the problem. And it would solve it for at least 6 months, long enough for our domestic production capabilities to resume.

So it is unfortunate. I wish that were not the case. But in the spirit of comity and compromise, I will modify my request.

Again, the FORMULA Act would have included these three legs, a regulatory component lifting the regulatory restrictions, an import tariff restriction, and also lifting some restrictions in the WIC Program.

So I am going to counteroffer with another amendment that would remove the waiver of the FDA regulations for the imported formula. That, after all, is the concern he expressed, and so that should allow us to deal with it. It would keep the tariff and the WIC waivers from the FORMULA Act intact and therefore shouldn't raise any concerns not addressed by my friend and distinguished colleague.

And so, Mr. President, as if in legislative session, I ask unanimous consent that the Senate proceed to the immediate consideration of Calendar No. 372, S. 4261; further, I ask that the Lee substitute amendment at the desk be considered and agreed to; that the bill, as amended, be considered read a third time and passed, and that the motions to reconsider be considered made and laid upon the table.

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Mr. LEE. Mr. President, I find this, too, unfortunate. I wish we could adopt all three of these reforms; again, we have a regulatory reform, an import tax reform, and a WIC reform. He has now expressed objections to the regulatory reform and the WIC reform.

So, in the spirit of comity and cooperation and compromise, I would like to modify again, and I will take out the WIC restrictions--the WIC component of the bill--and leave only the tariff waiver. That, at least, would remove some of the protectionist problems that we have got in place that is currently prohibiting people from being able to import this stuff, leaving it available really only to wealthy, well-connected parents who know how to find this stuff and can pay the higher price for it. This would at least allow people to buy it in stores if we could lift that restriction and do so in larger quantities while adhering to the labeling and other regulatory requirements.

So, Mr. President, as if in legislative session, I ask unanimous consent that the Senate proceed to the immediate consideration of Calendar No. 372, S. 4261; further, I ask that the Lee substitute amendment at the desk be considered and agreed to; that the bill, as amended, be considered read a third time and passed; and that the motion to reconsider be considered made and laid upon the table.

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Mr. LEE. Mr. President, I find it most unfortunate that, as American babies are starving and are literally being admitted to hospitals for dehydration and malnutrition because of a government-created problem, we can't get to a solution here.

I am determined to find one, and I am determined not to take no for an answer. We have to get to yes on that. To that end, I would like to modify my last request and shorten it down from 180 days--a 6-month suspension--to a 90-day suspension. This is the exact timeframe that mirrors the Biden administration's proposed time window for gas tax alleviation. The President has raised this and has asked us to act on that immediately. Look, I happen to think baby formula is a whole lot more important and urgent than gasoline. We can at least do this. So I am going to modify my request to move it down to just 90 days. We should be able to do that for 90 days. I am certain that we can.

372, S. 4261; further, that the Lee substitute amendment at the desk be considered and agreed to; that the bill, as amended, be considered read a third time and passed; and that the motion to reconsider be considered made and laid upon the table.

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Mr. LEE. Mr. President, I appreciate the thoughts expressed by my friend and distinguished colleague, the Senator from Pennsylvania. I share this concern and this desire to see this worked out and worked out on a bipartisan basis. I think it is important.

It is true that people have been working on it. They have been working on it now for the better part of a month and a half. Yet nothing has happened. Now, I understand that Rome wasn't built in a day. Significant legislative reforms are not usually enacted very quickly. Well, they are in some places, and we are experiencing some of that this week, but that is a different issue altogether. I understand that it takes time, on many occasions, to develop a legislative solution. This is not one of those issues. This is just not that complicated.

I appreciate the fact that people are considering it. I appreciate the fact that my friend and colleague, the Senator from Pennsylvania, is willing to try to clear this on the Democratic side. I hope and expect that one of the four alternatives that I have proposed today-- each in the spirit of comity and compromise and as something that should be acceptable to both political parties--has got to get there.

There are issues on which we are always going to struggle to find solutions. This one isn't hard. We can do this. We can fix this. American babies are going hungry because of the mismanagement within our country.

Yes, I share the Senator's belief that we have got to hold the FDA accountable, but I feel like we are in the same position as the unarmed English bobby--but with the FDA lately. The unarmed English bobby, being unarmed and upon seeing the commission of a crime, shouts, in a charming British accent, ``Stop or I will yell `stop' again.'' We need to actually do something to force this issue because people are going hungry--babies are going hungry--and there are dire, long-lasting consequences.

I hope and expect that we will solve this before the end of the week. This issue is not going away, and neither am I.

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