[Congressional Record Volume 168, Number 107 (Thursday, June 23, 2022)]
[Senate]
[Pages S3108-S3110]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




      FIXING OUR REGULATORY MAYHEM UPSETTING LITTLE AMERICANS ACT

  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

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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.
  And so, to that end, I ask unanimous consent that the Senate proceed 
to the immediate consideration of Calendar No. 372, S. 4261.
  The PRESIDING OFFICER. The clerk will report the bill by title.
  The bill clerk read as follows:

       A bill (S. 4261) to suspend duties and other restrictions 
     on the importation of infant formula to address the shortage 
     of infant formula in the United States, and for other 
     purposes.

  There being no objection, the Senate proceeded to consider the bill.
  Mr. LEE. I ask unanimous consent 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.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The amendment (No. 5130), in the nature of a substitute, was agreed 
to, as follows:

                (Purpose: In the nature of a substitute)

        Strike all after the enacting clause and insert the 
     following:

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Fixing Our Regulatory Mayhem 
     Upsetting Little Americans Act'' or the ``FORMULA Act''.

     SEC. 2. DUTY-FREE TREATMENT OF IMPORTS OF INFANT FORMULA.

       (a) In General.--During the 90-day period beginning on the 
     date of the enactment of this Act, infant formula shall enter 
     the United States free of duty and free of quantitative 
     limitation.
       (b) Infant Formula Defined.--In this section, the term 
     ``infant formula'' has the meaning given that term in section 
     201(z) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     321(z)).


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  The bill (S. 4261), as amended, was ordered to be engrossed for a 
third reading, was read the third time, and passed.
  I yield the floor.
  I suggest the absence of a quorum.
  The PRESIDING OFFICER. The clerk will call the roll.
  The bill clerk proceeded to call the roll.

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