Fixing Our Regulatory Mayhem Upsetting Little Americans Act

Floor Speech

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Mr. LEE. Mr. President, for months, American moms and dads have endured an unprecedented baby formula shortage.

All of us know someone that this crisis has personally affected. In May alone, reports showed that the out-of-stock rate jumped from 43 percent to 74 percent nationally. In my home State of Utah, that out- of-stock rate is much higher.

And while the Biden administration made ambitious attempts to invoke the Defense Production Act and fly in formula from other countries, these efforts ultimately provided less than 2 days' worth of formula for our country's hungry babies--less than 2 days.

So yesterday, I took to the floor asking that this body take immediate action to address our Nation's massive formula shortage by unanimously passing my FORMULA Act, something that I have come repeatedly to the Senate floor in an effort to pass and it has been met with objections so far.

My bill included three measures to accomplish this goal. The first was a regulatory component, one that would remove certain FDA requirements for imported formula, mostly dealing with labeling. And I will explain more about that one in a moment. The second removed the restrictions that limited the availability of formula brands available to WIC recipients. And, finally, the bill temporarily suspended import tariffs on formula, increasing supply and decreasing consumer costs.

These three components would provide immediate relief to anxiety- ridden parents who were forced to scour supermarkets, make dangerous homemade formula, or, even worse, hospitalize their infants.

I need not explain why a problem of this magnitude is so deserving of our immediate attention.

After addressing the Senate on each of these topics, I engaged in a lengthy and substantive debate with my friend and distinguished colleague from Pennsylvania, Senator Bob Casey. I listened intently to his objections regarding his concern for the safety and quality of formula crossing over our borders.

And while I appreciate my colleague's concerns, I still believe that this body can and must fix this problem, a problem that is, no doubt, the sole creation of the Federal Government. It is no accident, for example, that we are the only country facing this particular shortage.

No other country is dealing with this because our country and our own Federal laws in this area and the way they have been enforced and implemented have caused it.

So I am determined to provide relief to families dealing with this inexplicably, unnecessarily prolonged crisis.

For far too long, the people enduring this mess have gone without answers. And so in the spirit of comity and compromise, I have modified my request by removing the FDA regulatory component of the bill. I hoped that this would resolve any reservations that my colleague from Pennsylvania may have had regarding the safety of these products.

And I should add here, those concerns are not concerns that I agree with for the simple reason that the countries that, under my bill, we would have allowed to produce formula, to have that formula introduced into the United States, they are countries that we have already identified as having safe regulatory systems.

They are countries with regulatory systems that are strong enough, in fact, that we allow imports of their pharmaceutical products produced in those countries because their standards are as rigorous as those imposed by our own FDA.

Nonetheless, I offered to remove that and made that a request for passage by unanimous consent. Still, my friend objected to expanding the range of products available to WIC recipients. Remember, this component to the bill would have simply allowed American moms and dads who were beneficiaries under the WIC program to use their vouchers to purchase any form of formula they would prefer, or more commonly these days, any form of formula that is available. Whereas, right now, the WIC vouchers require you to stick to the brand specified on the vouchers in question.

My distinguished colleague objected also to that version of what I offered, despite the retention of FDA regulatory authority and the fact that wealthy Americans are personally importing these products already from Europe.

And while I find this unfortunate, I was still determined to make an argument and to, ultimately, formulate an agreement consistent with that argument to fix a problem that our Federal Government has made and has created and in which it has made no discernible progress in its attempts to resolve it.

So, again, in the spirit of comity and compromise and a willingness to do absolutely whatever it takes to provide whatever relief we can provide to hungry babies throughout America suffering from malnutrition, I modified my request yet again. This time to include only the provisions related to the tariff suspension.

And while I am hopeful that we will be able to come together to address the concerns of my colleagues and pass the first two provisions of my bill as well, I hope to report today to families across the country that my legislation has achieved unanimous support and passed the Senate.

This would be an incredible win for families and for hungry babies nationwide. My bill would make meaningful headway in dealing with an issue that some doctors call ``the worst crisis of their careers.''

By suspending the import tariff on formula imports or providing cheaper access to formulas to individual consumers and to retailers alike, no longer will access to these safe formulas be limited to a select group of wealthy individuals because, again, wealthy individuals have been able to pay the higher prices and suffer the inconvenience of going online or otherwise making a special order on their own of these European formulas.

Again, these European formulas from the countries that we are talking about--countries covered by the bill--are countries that produce safe, effective formula and that are regulated by regulatory bodies that are every bit as stringent as the U.S. Food and Drug Administration. And on that basis, in fact, we import pharmaceutical products from those same countries.

Currently, formula is produced in those countries, countries like France and Switzerland and the United Kingdom. Babies there do just fine on those formulas. In fact, they do great. And some American families have been able to benefit from those formulas as they have ordered it online, but they pay higher prices, and they have to deal with restrictions that make it more difficult to access those things. So this bill will open that up.

This is relief that really is long overdue, particularly for Utahns who have the largest families, the most children per capita, and, also, the highest birthrate.

Not coincidentally, those are some of the same reasons why the baby formula shortage is felt so acutely in Utah, but it is being felt acutely throughout the United States.

I hope that we can come together and pass even more meaningful reforms that will help solve the problem completely and once and for all.

I am grateful, however, that the countless hours of behind-the-scenes work and successful negotiations with my colleagues on a bipartisan basis have resulted in a win for the most vulnerable Americans. Passing my FORMULA Act is a victory for families and for babies in Utah and everywhere else in the United States.

372, S. 4261.
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