[House Hearing, 118 Congress]
[From the U.S. Government Publishing Office]






                                 



 
                         FDA OVERSIGHT PART I:


                      THE INFANT FORMULA SHORTAGE

=======================================================================

                                HEARING

                               before the

                      SUBCOMMITTEE ON HEALTH CARE
                         AND FINANCIAL SERVICES

                                 of the

                         COMMITTEE ON OVERSIGHT
                           AND ACCOUNTABILITY

                        HOUSE OF REPRESENTATIVES

                    ONE HUNDRED EIGHTEENTH CONGRESS

                             FIRST SESSION

                               __________

                             MARCH 28, 2023

                               __________

                           Serial No. 118-13

                               __________

  Printed for the use of the Committee on Oversight and Accountability
  
  
  [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
  
  
  


                    Available on: govinfo.gov
                     oversight.house.gov or
                       docs.house.gov
                             
                             
                          ______

             U.S. GOVERNMENT PUBLISHING OFFICE 
 51-718          WASHINGTON : 2023
                            
                             
                             
                             
                             
                             
                             
               COMMITTEE ON OVERSIGHT AND ACCOUNTABILITY

                    JAMES COMER, Kentucky, Chairman

Jim Jordan, Ohio                     Jamie Raskin, Maryland, Ranking 
Mike Turner, Ohio                        Minority Member
Paul Gosar, Arizona                  Eleanor Holmes Norton, District of 
Virginia Foxx, North Carolina            Columbia
Glenn Grothman, Wisconsin            Stephen F. Lynch, Massachusetts
Gary Palmer, Alabama                 Gerald E. Connolly, Virginia
Clay Higgins, Louisiana              Raja Krishnamoorthi, Illinois
Pete Sessions, Texas                 Ro Khanna, California
Andy Biggs, Arizona                  Kweisi Mfume, Maryland
Nancy Mace, South Carolina           Alexandria Ocasio-Cortez, New York
Jake LaTurner, Kansas                Katie Porter, California
Pat Fallon, Texas                    Cori Bush, Missouri
Byron Donalds, Florida               Shontel Brown, Ohio
Kelly Armstrong, North Dakota        Jimmy Gomez, California
Scott Perry, Pennsylvania            Melanie Stansbury, New Mexico
William Timmons, South Carolina      Robert Garcia, California
Tim Burchett, Tennessee              Maxwell Frost, Florida
Marjorie Taylor Greene, Georgia      Becca Balint, Vermont
Lisa McClain, Michigan               Summer Lee, Pennsylvania
Lauren Boebert, Colorado             Greg Casar, Texas
Russell Fry, South Carolina          Jasmine Crockett, Texas
Anna Paulina Luna, Florida           Dan Goldman, New York
Chuck Edwards, North Carolina        Jared Moskowitz, Florida
Nick Langworthy, New York
Eric Burlison, Missouri

                       Mark Marin, Staff Director
       Jessica Donlon, Deputy Staff Director and General Counsel
                 Reagan Dye, Professional Staff Member
      Mallory Cogar, Deputy Director of Operations and Chief Clerk

                      Contact Number: 202-225-5074

                  Julie Tagen, Minority Staff Director
                      Contact Number: 202-225-5051
                                 ------                                

           Subcommittee on Health Care and Financial Services

                   Lisa McClain, Michigan, Chairwoman
Paul Gosar, Arizona                  Katie Porter, California Ranking 
Virginia Foxx, North Carolina            Minority Member
Glenn Grothman, Wisconsin            Alexandria Ocasio-Cortez, New York
Russell Fry, South Carolina          Jimmy Gomez, California
Anna Paulina Luna, Florida           Greg Casar, Texas
Nick Langworthy, New York            Becca Balint, Vermont
Eric Burlison, Missouri              Summer Lee, Pennsylvania
                                     Jasmine Crockett, Texas
                         C  O  N  T  E  N  T  S

                              ----------                              
                                                                   Page
Hearing held on March 28, 2023...................................     1

                               Witnesses

Mr. Frank Yiannas, M.P.H., Former Deputy Commissioner, Office of 
  Food Policy & Response, U.S. Food & Drug Administration
Oral Statement...................................................     4
Dr. Peter Lurie, M.D., M.P.H. (Minority Witness), President & 
  Executive Director, Center for Science in the Public Interest
Oral Statement...................................................     6

Written opening statements and statements for the witnesses are 
  available on the U.S. House of Representatives Document 
  Repository at: docs.house.gov.

                           Index of Documents

  * Statement for the Record, Consumer Brands Association; 
    submitted by Rep. McClain.

  * Statement for the Record, Consumer Reports; submitted by Rep. 
    McClain.

  * Statement for the Record, Dr. Ostroff, Dr. Acheson, Mr. 
    Taylor; submitted by Rep. McClain.

  * Statement for the Record, North American Society for 
    Pediatric Gastroenterology, Hepatology and Nutrition; 
    submitted by Rep. McClain.

  * Questions for the Record: to Mr. Yiannas; submitted by Rep. 
    McClain.

  * Questions for the Record: to Mr. Yiannas; submitted by Rep. 
    Porter.

  * Questions for the Record: to Dr. Lurie; submitted by Rep. 
    Porter.

Documents are available at: docs.house.gov.


                         FDA OVERSIGHT PART I:



                      THE INFANT FORMULA SHORTAGE

                              ----------                              


                    Tuesday, March 28, 2023

                        House of Representatives

               Committee on Oversight and Accountability

           Subcommittee on Health Care And Financial Services

                                           Washington, D.C.

    The Subcommittee met, pursuant to notice, at 10:03 a.m., in 
room 2247, Rayburn House Office Building, Hon. Lisa McClain 
[Chairwoman of the Subcommittee] presiding.
    Present: Representatives McClain, Gosar, Grothman, Luna, 
Langworthy, Porter, Ocasio-Cortez, Gomez, Balint, Lee, and 
Crockett.
    Mrs. McClain. The Subcommittee on Health Care and Financial 
Services will come to order. Welcome everyone.
    And without objection, the Chair may declare a recess at 
any time.
    I recognize myself for the purpose of making an opening 
statement.
    Welcome to the Subcommittee on Health Care and Financial 
Services. To the witnesses, thank you very much for your 
attendance and participation today in today's oversight hearing 
of the FDA's response to the infant formula shortage. Today, we 
will hear from food safety experts to better understand how 
this crisis happened, how it could have been handled better, 
and determine whether the FDA is able to prevent a future 
crisis from occurring.
    As many of you know, I have been outspoken in my 
frustration with the FDA's response to the infant formula 
shortage. The infant formula crisis underscores a major problem 
with the FDA. The FDA is responsible for 78 percent of the U.S. 
food supply, but the FDA is not prioritizing food safety. 
Instead of owning its failures, the FDA has used COVID-19 as an 
excuse to neglect inspections and justify poor performance. 
While states like Michigan were shut down, preventing 
Michiganders from making a living, the Federal Government was 
100 percent open and was paying too many of its employees to 
stay home and not do their jobs adequately. How did this 
critical shortage happen? Well, let us go back to the 
beginning.
    In the summer of 2021, the FDA was aware of significant 
supply chain disruptions resulting in potential shortages of 
several types of infant formula. By September 2021, the Abbott 
nutritional infant formula plant in Sturgis, Michigan, had not 
been inspected in two years. This plant produces 20 percent of 
the Nation's supply of baby formula. Then in October, an Abbott 
whistleblower submitted a 34-page complaint to the FDA 
outlining the concerns at the Sturgis facility.
    Despite this whistleblower and several reports of babies 
becoming sick, it took until January 31 of 2022 for the FDA to 
begin inspecting the Sturgis plant. A couple weeks later, 
Abbott voluntarily recalled its product and voluntarily shut 
down its Sturgis plant. Had the FDA or the Administration done 
anything to prepare for the closure or ensure the availability 
of infant formula across the country? No, they had not. The 
health of vulnerable infants that rely on formula is a single 
food source that was not a priority.
    Today, we have more information that we didn't have before. 
We know that the FDA ignored the Abbott's employee's 34-page 
disclosure, detailing concerns about the Abbott facility in 
Sturgis. We know that the FDA's telework policy and lax 
approach to oversight left it unprepared to address the 
shortages when the Sturgis facility was shut down. Americans 
are tired of excuses, like blaming COVID-19 or claiming there 
isn't enough money in the budget while inspectors telework and 
fail to do their job. FDA regulators were paid to do a job, but 
chose not to use its remote inspection authority, which was 
specifically intended by Congress to ensure FDA could prevent 
this type of crisis. They did not do their job and collected a 
paycheck on the backs of hardworking Americans. Americans want 
accountability, especially as it pertains to their children.
    Today, we are going to conduct a long-overdue oversight of 
the FDA's response to the infant shortage formula. We are going 
to determine the extent of the internal failures within the FDA 
that led to the crisis, and we are going to discuss ways that 
the FDA can actually improve its internal controls to prevent a 
supply chain crisis of this magnitude from happening again.
    We are also going to examine whether the FDA's proposed 
restructuring will improve its ability to keep food safe. We 
owe it to parents, caregivers, and infants to get to the bottom 
of what happened and, most importantly, prevent it from 
happening again because nothing has changed. We owe it to the 
families of the babies that died as a result of this 
contaminated formula. So, thank you to our witnesses, and we 
look forward to hearing your testimony. And I now yield to 
Ranking Member, Ms. Porter, for her opening statement.
    Ms. Porter. Thank you very much, Madam Chairwoman. Today, I 
want to focus on answering this question. If a big infant 
formula company like Abbott had a bacterial contamination 
today, would the whole formula market be at risk again? And to 
answer that question, we need to know exactly how equipped the 
FDA is to be in the prevention business now that we have 
weathered the 2022 crisis. Today, if the FDA received a 
whistleblower complaint about contamination, would it take four 
months, as it did then, to get to the Deputy Commissioner's 
desk, and over the last year, have we done enough to give the 
FDA the authorities and resources it truly needs to be 
proactive about preventing supply shocks in critical food 
markets?
    I know that some of my colleagues today, probably on both 
sides of the aisle, will be chomping at the bit to bash a 
Federal agency. That is not where I am. Discrediting an agency 
without figuring out what went wrong and how to fix it is 
simply malpractice, but I am not afraid to say that the FDA has 
a lot of work to do, no matter who that offends. At the same 
time, I am also not afraid to say that Congress is part of the 
problem. We have to empower the FDA for it to succeed. That 
means that when there is a crisis, we need to give the FDA 
resources.
    Last year, 12 Republicans joined Democrats to pass the 
Infant Formula Supplemental Appropriations Act to give the FDA 
funding to address and prevent formula shortages. For the other 
192 lawmakers who voted no and are wondering why the FDA 
couldn't do more, you should put your money where your mouth 
is. But empowerment goes beyond money. A strong FDA must have 
the authority to know what is going on in production between 
inspections, and a strong FDA must be able to review present 
and past testing data to help it make decisions. Even with the 
best structure, leadership, and resources, the FDA is only as 
well equipped as its legal authorities allow it to be. An 
improved FDA is going to take some work, and it is not on any 
one person that we can fire or blame. This is a complex issue 
that is going to take real work to solve.
    Now, as much as I am dedicated to solving the FDA part of 
the puzzle, we wouldn't be doing our job if we said that that 
is the only issue in the formula crisis. Ultimately, formula 
manufacturers are responsible for producing safe products. They 
have very few incentives to self-regulate when they are so 
powerful, but that doesn't mean we can let Abbott off the hook 
for its negligent behavior. Last year, Committee Democrats 
launched an investigation into Abbott's negligence that 
Republicans, sadly for me, declined to join. This needs to 
change. This is partially an FDA problem, but it is also 
partially a Big Business problem, and Republicans and Democrats 
can't pick and choose who to hold accountable.
    What is more, we have to stop turning a blind eye to 
consolidation in our food markets. Abbott is 1 of 3 companies 
that control 90 percent of the formula market. If something 
goes wrong in one factory, there aren't many other options to 
turn to. That doesn't make for resilient markets. By 
diversifying supply, competitive markets could cure many of the 
formula shortage risks even with the other mistakes that were 
made.
    Today, let us not give anyone or anything a pass, but at 
the same time, let us not make this hearing an attack. There 
are many commonsense moves we can regulate to diversify and 
strengthen the infant formula market. Let us learn those 
lessons today, and let us be successful by setting aside 
politics, to listen and learn, and take proactive approaches. 
That is what I intend to do, and I am grateful to the 
Chairwoman for convening this important hearing. I yield back.
    Mrs. McClain. Thank you, Ms. Porter, and I am pleased to 
introduce our witnesses today who are here to discuss the FDA's 
response to the 2022 infant formula shortage. Mr. Frank Yiannas 
was the Deputy Commissioner of Food Policy Response at the Food 
and Drug Administration from December 2018 to February 2023. 
Previously, he was Vice President of Food Safety at Walmart and 
Director of Safety and Health for the Walt Disney Company. He 
received his B.S., Bachelor of Science, in microbiology from 
the University of Central Florida and his Masters of Public 
Health from the University of South Florida.
    Mr. Peter Lurie is President and Executive Director for the 
Center of Science in the Public Interest. Previously, Dr. Lurie 
was an Associate Commissioner for Public Health Strategy and 
Analysis at the Food and Drug Administration. He received his 
Bachelor of Science in chemistry from Cornell University, M.D. 
from Albert Einstein College of Medicine, and M.P.H. from the 
University of California, Berkeley.
    Pursuant to Committee Rule 9, the witnesses will please 
stand and raise their right hands.
    Do you solemnly swear or affirm that the testimony that you 
are about to give is the truth, the whole truth, and nothing 
but the truth, so help you God?
    [A chorus of ayes.]
    Mrs. McClain. Let the record show that the witnesses all 
answered in the affirmative.
    We appreciate all of you being here, and we sincerely look 
forward to your testimony, to get to the bottom of how this 
happened, and, more importantly, what do we do to make sure 
this doesn't happen again.
    So, let me remind the witnesses that we have read your 
written statements, and they will appear in full in the hearing 
record. Please limit your oral statements to five minutes. As a 
reminder, please press the button on the microphone in front of 
you so that it is on, and the Members can hear you. When you 
begin to speak, the light in front of you will turn green. 
After four minutes, the light in front of you will turn yellow. 
When the red light comes up, your five minutes has expired, and 
we would ask you to please wrap up.
    So, with that said, I recognize Mr. Yiannas to please begin 
with your opening statement.

                       STATEMENT OF FRANK YIANNAS

                       FORMER DEPUTY COMMISSIONER

                    OFFICE OF FOOD POLICY & RESPONSE

                    U.S. FOOD & DRUG ADMINISTRATION

    Mr. Yiannas. Chair McClain, Ranking Member Porter, and 
Members of the Subcommittee, thank you for inviting me here 
today to testify before you and, more importantly, for your 
interest in better understanding what happened, so we can 
prevent an infant formula of this nature from ever happening 
again. Our bosses, the American people, and especially the most 
vulnerable among them, infants, deserve that from us.
    In February of last year, already amid unprecedented supply 
chain challenges brought upon by the pandemic, our Nation's 
parents learned of several confirmed illnesses among infants of 
a rare and potentially fatal bacterium called Cronobacter 
Sakazakii. Those illnesses, linked to a single manufacturing 
plant in Sturgis, Michigan, along with the findings of very 
egregious conditions at the facility, led Abbott to execute the 
largest recall of powdered infant formula in our Nation's 
history. It has been over a year since that recall took place 
and subsequent widespread infant formula shortage is that it 
caused. There has already been a congressional hearing on this 
matter. The FDA issued its own version of an investigation 
report titled, ``Evaluation of The Infant Formula Response,'' 
and there has been, as you know, extensive media coverage.
    Yet despite these actions, a clear and transparent 
understanding of what took place and the contributing factors 
that allowed it to occur have remained elusive. While we stand 
here today, more than a year since the recall, it is my view 
that the state of the infant formula industry today is not much 
different than it was then. The public health surveillance 
system for this pathogen remains insufficient. The necessary 
safeguards have not been advanced at an inadequate pace to 
prevent future illnesses, and the infant formula supply chain 
continues to lack serious resiliency. In other words, the 
Nation remains one outbreak, one tornado, flood, or cyberattack 
away from finding itself in a similar place to that of February 
17, 2022.
    As we all now know, FDA's response to a series of reports 
of multiple infants infected with Cronobacter, along with the 
letter received from a whistleblower, spanned a period of 
several months, beginning in September 2021. It wasn't until 
January 31 of the following year, four months later, that the 
FDA began an official inspection of the Abbott Sturgis 
facility. Had the Agency responded quicker to some of the 
earlier signals, I believe this crisis could have been averted 
or at least the magnitude lessened.
    As Deputy Commissioner for Food Policy and Response at that 
time, I was not made aware of the series of illnesses nor of a 
whistleblower complaint until February 10 of 2022. From the 
time I first learned of the incident, on that date of February 
10, to the time it took Abbott to conduct a voluntary recall to 
protect infants, it was seven days, seven days contrasted to 
four months of time in which the series of events unfolded. 
Clearly, I really wish, and I should have been, notified sooner 
so I could have initiated containment steps earlier. Had that 
happened, I believe we might not be here today.
    There is no question that FDA's siloed and decentralized 
foods program structure and culture contributed to and 
exacerbated these delays. However, after the series of events 
that allowed these issues to escalate and build one upon 
another, by the time February 2022 rolled along, the 
containment of this incident became my charter. Clearly, I 
agree Abbott Nutrition bears the primary responsibility for 
this crisis. However, there are numerous other lessons learned, 
too, and there is more that the industry and regulators can and 
must do. In my written testimony, I have included a list of 11 
specific recommendations that I hope you have had a chance to 
review.
    In closing, the infant illnesses and deaths due to 
Cronobacter, the Abbott recall, and the cascading and 
devastating effects it had on infant formula availability and 
families in our country was all a preventable--let me 
emphasize--a preventable tragedy. It is my hope that we seek 
lessons learned and take the necessary actions to prevent such 
a crisis from ever happening again. I thank the Subcommittee 
for your interest, and I look forward to answering your 
questions.
    Mrs. McClain. Thank you very much, Mr. Yiannas, and I 
recognize the next witness, Mr. Lurie, to please begin with 
your opening statement.

                        STATEMENT OF PETER LURIE

                     PRESIDENT & EXECUTIVE DIRECTOR

               CENTER FOR SCIENCE IN THE PUBLIC INTEREST

    Dr. Lurie. Good morning. I want to thank Chairman McClain, 
Ranking Member Porter, other Committee Members for inviting me 
as a witness on behalf of the Center for Science in the Public 
Interest. I am its President and Executive Director and a 
former Associate Commissioner at the FDA.
    If we are to apportion blame for the now resolved powdered 
infant formula crisis, the best place to start is at the Abbott 
nutrition plant in Sturgis, Michigan, that produced the formula 
associated with the outbreak because it was there that infant 
formula, contaminated with Cronobacter, was destroyed years 
before the outbreak, without FDA being notified. It was there, 
according to a whistleblower, that there were lax cleaning 
practices, falsified records, and relevant information hidden 
from FDA inspectors. And it was there, that repeated FDA 
inspections revealed standing water, decaying dryers, failure 
to follow sanitary practices, and eventually multiple 
environmental samples testing positive for Cronobacter.
    My testimony touches on the consolidation in the industry, 
but I am not going to address that further. You can read that 
in my written testimony, but we want to focus here on what the 
FDA did. Much of the FDA's response was entirely appropriate. 
The Agency convened an Agency-wide incident management group, 
sought to identify alternative suppliers, exercised enforcement 
discretion on a case-by-case basis to allow product to reach 
market, facilitated the importation of products from abroad, 
and used a risk benefit approach to release the most critical 
products.
    In other respects, however, FDA's performance failed to 
live up to the high standards that American consumers expect 
and deserve. The whistleblower report went undelivered to 
senior Agency staff for months, and the Agency took too long to 
schedule a repeat inspection of the Sturgis facility, thus 
delaying the ultimate recall, the Agency audit, and internal 
review of its own response. But that report, while offering 
many strong recommendations, failed to provide a clear account 
of the events surrounding the recall or the mistakes made by 
Agency officials.
    Better prevention and management of future crises requires 
at least three elements: authority, funding, and an effective 
organizational structure. On funding, the Food and Drug Omnibus 
Reform Act of 2022 required formula and medical food 
manufacturers to develop a supply redundancy risk management 
plan, mandated the creation of an office of critical foods at 
FDA, and it also required critical food manufacturers to notify 
FDA of interruptions in manufacturing likely to lead to 
meaningful disruptions in supply. But the Agency needs 
additional authorities and should have the authority to require 
manufacturers to notify the Agency of all positive test results 
and to require more frequent environmental testing in 
production facilities. It should also be able to compel 
manufacturers to submit supply chain data, and although not an 
FDA issue, Cronobacter should be made a notifiable illness.
    Second, the food program requires more funding. Rising 
costs have left the program with a number of FTEs, similar to 
what it had in 1978. But since then, FDA has been given 
increasing responsibilities, including broad new mandates over 
infant formula, dietary supplements, food labeling, and food 
safety. The President's FY 2024 budget calls for $152 million 
in necessary new funding for the foods program, and this 
includes $64 million for health and safe food for all, which 
includes support for improved oversight of infant formula. 
There is also $12 million to establish a Center for Nutrition 
that will house its Office of Critical Foods.
    We at CSPI believe that number should be closer to $24 
million because of the importance of nutrition programs. But 
together, these programs would support increased review 
capacity for infant formula premarket notifications, improved 
surveillance of formula related adverse events, and the 
development of better laboratory methods for Cronobacter, as 
well as a more rapid review of inspection findings.
    Finally, Americans deserve a food program with a structure 
that is transparent, effective, and accountable. The formula 
crisis laid bare the high level of dysfunction, breakdowns in 
communication, and lack of clear lines of authority that 
characterized the FDA's response. The reorganization announced 
by FDA Commissioner Califf in January is an important step on a 
path toward addressing these issues. It captures the spirit of 
the Reagan-Udall Foundation report that the Agency had 
requested, and it does so in a manner that minimizes internal 
disruption.
    First, it elevates the food program to the Deputy 
Commissioner level, which is higher than any other FDA food 
product center. Second, it dissolves a dysfunctional structure 
whereby three senior officials, with authority over the human 
foods program, all reported to the Commissioner, and none had 
clear authority over the program. Third, it clarifies the 
relationship between the Human Foods Program and the Office of 
Regulatory Affairs which inspects facilities, and, as noted, it 
establishes a new Center for Excellence in Nutrition and an 
Office of Critical Foods. While more detail is still necessary 
on this proposal, it is a significant step forward and lays the 
groundwork for a foods program led by a leader who is more 
empowered and accountable than any FDA food program leader in 
recent history.
    No mother, no father should ever again face a desperate 
store-by-store search for a product simply to nourish their 
infants. Thank you.
    Mrs. McClain. Thank you, Dr. Lurie. I recognize Ranking 
Member Porter for five minutes.
    Ms. Porter. Thank you, Madam Chairwoman, for your patience 
with my schedule today. The goal of this hearing is to stop the 
entire baby formula market from being at risk when there is 
bacterial contamination in a factory. So, I want to figure out 
how much progress we have made toward that goal by looking at 
what would happen if the Abbott contamination were to repeat 
itself.
    So, Mr. Yiannas, let's say that a major formula 
manufacturer, and there are only a handful as you know, finds 
bacteria in their supply today. Does the law say the factory 
has to tell the FDA?
    Mr. Yiannas. The answer to that is no, other than the 
Abbott Sturgis facility, which, as you know, is under consent 
decree.
    Ms. Porter. So, I think this is really important that 
everyone hear this. So, I am going to ask you one more time. 
Let's say that a major formula manufacturer or factory found 
bacteria in their supply today. Does the law require them to 
tell the FDA?
    Mr. Yiannas. The answer is no. They should, but they are 
not required by law.
    Ms. Porter. But surely the FDA is now keeping a close eye 
on supply, so that they are ready for any disruption. What 
resources and authorities are now in place for the FDA, even 
though they have no requirement that anyone tell them, but 
should the FDA learn, what are the resources available for the 
FDA to do supply monitoring?
    Mr. Yiannas. That is an area of the program that needs 
further development. Historically, the FDA has been focused on 
food safety and nutrition, not supply chain availability. But 
after the pandemic, which I describe as the biggest test on the 
U.S. food system in a 100 years, we all realized that as an 
Agency, we needed more intelligence and data on how companies 
and supply chains actually worked. There were attempts to try 
to build those capabilities internally. They were met with a 
lot of resistance because it wasn't part of the core mission. 
But I am grateful that Congress, through the omnibus, has asked 
FDA to set up an Office of Critical Foods and to develop those 
type of capabilities.
    Ms. Porter. Do you think the Office of Critical Foods, as 
structured in the omnibus, will go far enough in supply chain 
monitoring, and are we making fast enough progress in getting 
it going?
    Mr. Yiannas. We started making progress before the infant 
formula crisis. Early during the pandemic, we knew that while 
the virus didn't cause transmission or illnesses through food, 
we knew it would wreak havoc to the food supply chain because 
ill workers, if not available, would affect supply chain 
continuity. And, so, we started to build those capabilities on 
what I describe as a shoestring budget without authorities, but 
it hasn't gone far enough. Although requests for additional 
fundings have been made to the commissioners and acting 
commissioners, like I said, it has been met with resistance. I 
think after the recall of 2022, now there is a greater 
appetite. Progress is being made, but it is not being made fast 
enough.
    Ms. Porter. Mr. Yiannas, since the law doesn't require, as 
we just learned, factories to report contamination, what 
incentives do monopolistic or a small number of suppliers, 
monopolistic companies have to self-regulate when the market 
isn't forcing the level of competition on quality and the FDA 
is still building out its monitoring apparatus?
    Mr. Yiannas. I think there is one critical component that 
was mentioned in the opening comments, is public health 
surveillance. Our ability to detect illnesses in society and 
learn about why they occur, what are the food vehicles that 
cause them, what are the contributing factors is critical to 
informing future prevention.
    Today, Cronobacter Sakazakii is not a reportable disease 
other than in two states. And so, that is a real disincentive 
for the industry to know what is really happening and for them 
to take corrective action. So, I would say the time is now for 
us as a Nation to make Cronobacter Sakazakii a nationally 
notifiable disease and reportable in all 50 states.
    Ms. Porter. And I really appreciate it, in your testimony, 
that you came to us with concrete actions that we can take to 
actually address and better prevent this. So, I noticed that 
was your No. 1 recommendation in your list of 11. Dr. Lurie, 
with my remaining time, can I ask for your thoughts on how far 
you think reorganizing the Human Foods Program will go toward 
creating the proactive FDA that we all need to be safe?
    Dr. Lurie. Yes. Well, I don't think one should overstate 
what can be accomplished through a reorganization. But I do 
think that what Commissioner Califf has come up with is a very 
reasonable attempt to, on the one hand, strengthen the food 
program, giving it the kind of prominence within the Agency 
that it has for a long time lacked, and yet at the same time to 
do so in a way that acknowledges the way that the Agency is 
currently structured such that any new situation is not unduly 
disruptive, and I think that they have done a pretty good 
balance of that. We have never had a Deputy Commissioner over 
the entire foods program before. Even when Mr. Yiannis was 
there, I am sure he will be the first to say that he never had 
that kind of authority. But the vision, currently, is to do 
exactly that and to elevate foods within the program in a way 
that has never been the case before.
    Ms. Porter. Thank you very much. I yield back.
    Mrs. McClain. Thank you, Ms. Porter. The Chair now 
recognizes Mr. Grothman.
    Mr. Grothman. Yes, I will ask Mr. Yiannas a few questions 
again. Currently, what is the structure of the FDA and its food 
programs?
    Mr. Yiannas. Currently, the foods program is what I call a 
very distributed in a decentralized organization. You have the 
Office of Food Policy and Response within the Commissioner's 
office, an office that I lead, of about 40 people. You have the 
largest office involving food, the Center for Food Safety and 
Nutrition, which to this day is led by Dr. Susan Mayne, who has 
recently announced her retirement. You have the field force----
    Mr. Grothman. OK. I hate to cut you out, but they only give 
us five minutes. Would you, therefore, describe the current 
structure as decentralized?
    Mr. Yiannas. Absolutely.
    Mr. Grothman. OK. Do you think that is a problem where it 
is also decentralized if you have a crisis like we had last 
year?
    Mr. Yiannas. I do. I think the decentralized and 
distributed nature of the organization caused information 
silos, not allowing critical data and information to flow to 
those that needed it quickly and that needed it most.
    Mr. Grothman. Did you elevate your concern before this 
crisis?
    Mr. Yiannas. Yes, sir.
    Mr. Grothman. OK. But nothing was done about your concern 
or----
    Mr. Yiannas. In the time that I was at FDA, which was a 
little bit over four years, I have had six different bosses, 
whether permanent or acting commissioners. It has been a 
rotating seat, and every single person that I have reported to 
has known my concerns.
    Mr. Grothman. OK. FDA Commissioner Califf released a 
restructuring plan for the program. In your opinion, does the 
Commissioner's restructuring plan do enough to resolve the 
Human Foods Program's organizational issues?
    Mr. Yiannas. Well, I believe Dr. Califf's plan is well 
intentioned. I do not think it will completely solve the issues 
at hand. No. 1, and I know we are limited in time, quickly is 
it has been referred to as a new foods program vision. A vision 
and strategy are very different than an organizational 
structure. It is a reorg. You need a strategy first, and you 
need a structure to support that strategy. That is No. 1.
    No. 2, I will disagree with my colleague here. The proposal 
does not even go as far as previous deputy commissioners once 
had. At one time, previous deputy commissioners had oversight 
over CFSAN, over their offices in the Commissioner's office, 
over CVM, but not ORA. This new reorg does not even go as far 
as to what previous deputy commissioners had.
    Mr. Grothman. That is kind of shocking. In your opinion, 
because I think when I think of the FDA, I think of drugs and 
medical devices. Do you think the current culture at the FDA is 
such that by focusing on drugs and medical devices, they do 
that to the detriment of the food and food safety programs?
    Mr. Yiannas. I think the drug program being as big as it 
is, the fact that it is supported by user fees does hinder the 
foods program, and the overall Agency's focus on the foods 
program. As I mentioned, it is a very decentralized 
organization, something I had not experienced in the private 
sector. And as such, there are many multiple or microcultures 
within the broader organization, and it hinders our ability to 
create a one FDA culture.
    Mr. Grothman. OK. And do you feel, therefore, just as far 
as the head of the FDA, they kind of, again, because they are 
focusing on the drugs and all the money that flows there, do 
they kind of consider food--maybe it is an exaggeration to call 
it an afterthought--but a little bit of an afterthought.
    Mr. Yiannas. My experience and decisions that have been 
made, including financial ones on supply chain monitoring, food 
has taken a backseat to drugs.
    Mr. Grothman. OK. Is it appropriate for the FDA to inspect 
foods in the same way the FDA inspects drugs and medical 
devices, do you think?
    Mr. Yiannas. The approach would be slightly different. It 
is a different food with different risk factors, but we should 
be inspecting food facilities for sure.
    Mr. Grothman. OK. In December, the Reagan-Udall Foundation 
for the FDA conducted an operational evaluation of the FDA's 
Human Foods Program. Are you familiar with that report?
    Mr. Yiannas. I am.
    Mr. Grothman. OK. Could you go into it a little bit?
    Mr. Yiannas. Sure. The Commissioner and the Principal 
Deputy Commissioner selected Reagan-Udall because of the close 
associations with them. I do think they attempted to create a 
fairly independent report. They provided a series of options 
for restructuring with the Commissioner having the latitude to 
choose those different options. One of the things I really 
liked in their report is that they emphasized culture. You 
cannot fix FDA or strengthen FDA by just doing a reorg. You 
also have to address cultural issues.
    Mr. Grothman. OK. And do you think to a certain extent that 
it would be addressed if we separated the human foods and drugs 
division that forces maybe a stronger culture?
    Mr. Yiannas. I think that could be a factor that could 
contribute to a stronger one food program structure. There are 
other ways to do it as well.
    Mr. Grothman. OK. Thank you.
    Mr. Gosar. [Presiding]. I thank the gentleman. The 
gentlelady from New York, Ms. Ocasio-Cortez, is recognized.
    Ms. Ocasio-Cortez. Thank you, Mr. Chair. Mr. Yiannas, 
Abbott Nutrition, Mead, and Perrigo control 90 percent of the 
infant formula market, correct?
    Mr. Yiannas. Yes.
    Ms. Ocasio-Cortez. And at the time of the infant formula 
recall last year, Abbott manufactured 43 percent of the 
powdered infant formula produced in the U.S. Is that correct?
    Mr. Yiannas. That sounds approximately correct.
    Ms. Ocasio-Cortez. And so, I think it is fair to say that 
any impact in supply from any one of these companies would 
profoundly impact the supply of formula for all Americans. And 
I wanted to dig into a little bit more of what happened at 
Abbott last year. Now, you, of course, were at the FDA during 
the Abbott recall last year, correct?
    Mr. Yiannas. I was.
    Ms. Ocasio-Cortez. And at that time, in October 2021, the 
FDA received a whistleblower complaint regarding the sanitation 
conditions of Abbott facilities in Sturgis, Michigan. Could you 
recall some of the details of what that whistleblower complaint 
alleged?
    Mr. Yiannas. I can. It was a lengthy letter, 34 pages, I 
believe. There were allegations of falsification of records, of 
trying to keep information away from Federal inspectors. There 
were very serious allegations, I thought, in that whistleblower 
complaint.
    Ms. Ocasio-Cortez. And after that complaint, the FDA did 
launch an investigation in January 2022, correct?
    Mr. Yiannas. Prior to that, they interviewed the informant, 
but they did go and inspect that facility in January 2022.
    Ms. Ocasio-Cortez. And, in fact, it seems that the 
conditions were so horrible in this facility that the DOJ 
initiated a criminal investigation into the unsanitary 
workplace conditions in the Sturgis facility. Is that correct?
    Mr. Yiannas. That has been documented in the public 
literature, but I would say that is a conversation you should 
have with the DOJ.
    Ms. Ocasio-Cortez. We also know that Abbott faced a number 
of lawsuits alleging tainted baby formula long before the 
recall happened. Following a seven-year legal battle for one 
family whose infant suffered debilitating brain damage, Abbott 
successfully sought a court order sealing trial testimony and 
evidence regarding Abbott's testing and food safety protocols 
in that same plant. And that was seven years before the 
consumption of unsafe formulas resulted in the deaths of 
several more infants that led to the shortage.
    We also see a pattern here that the Abbott company, which 
produces Similac and other major formulas, used ruthless 
tactics during their legal team to bury a lot of this 
information that its baby formula was causing brain damage or 
death in children for years before the recall happened. But I 
wanted to look a little bit and dig into the FDA's authorities 
that you were speaking into and what we need to do to prevent 
something like this from happening again?
    Mr. Yiannas, to kind of repeat the point earlier, does the 
FDA currently have the authority to require firms to notify the 
FDA of positive results even when it does not leave the 
facility?
    Mr. Yiannas. It does not.
    Ms. Ocasio-Cortez. It does not. And is the FDA, in your 
view, adequately funded and resourced to launch more aggressive 
inspections in these types of facilities?
    Mr. Yiannas. I believe we can do more with the existing 
resources. Clearly, with more resources, there is even more you 
can do, but I think with the current, existing resources, we 
can do a good job within baby formula.
    Ms. Ocasio-Cortez. And does the FDA currently have a clear 
congressional authority to issue a mandatory recall, instead of 
just relying on these corporations to voluntarily issue a 
recall?
    Mr. Yiannas. We do through something called the Food Safety 
Modernization Act for foods under FSMA. Infant formula has its 
own rule. My experience has been if you present a firm with the 
evidence, you can execute a recall much faster than relying on 
a mandatory recall. If needed, the Agency won't hesitate to use 
it, but that takes longer, and usually the quickest path to 
action is to present the evidence so that the company will do 
so, and they usually do.
    Ms. Ocasio-Cortez. And so, going back through this timeline 
here, Abbott did issue that voluntary recall after the FDA 
presented its evidence, correct?
    Mr. Yiannas. They did.
    Ms. Ocasio-Cortez. And so, in your assessment, kind of 
looking through these things, it would be helpful, and one of 
the things that we should probably move on this Committee is to 
empower the FDA to require those firms to notify you. And, I 
know you had mentioned earlier about perhaps some additional 
measures, but for the purpose of the Committee and the 
proceedings, are there any other additional provisions that you 
would emphasize as well for us to consider?
    Mr. Yiannas. I would. Thank you for that very good question 
because I think we are all trying to prevent things like this 
from happening in the first place. And I agree 100 percent, the 
primary responsibility resides on Abbott. Abbott bears this 
because they ran an operation that was under a lack of control, 
insanitary, and producing products that were prone to 
contamination. We need to make Cronobacter a nationally 
notifiable disease, we need to strengthen infant formula 
manufacturing standards, and we need to use state-of-the-art 
modern manufacturing approaches.
    Some of these plants, as you know, are very old. I refer to 
them as legacy facilities, built in the 1940's. In the Abbott 
Sturgis facility alone, there was a spray dryer that had 
multiple cracks that was purchased and installed in 1960's. 
That piece of equipment is older than I am. There is a lot that 
has changed. We know a lot more now. We should require that 
they strengthen their preventative controls.
    Another thing we should do, is we should ask them to do 
more robust verification that their procedures are working. One 
of the Achilles' heel that has allowed the Agency to become 
complacent is that our rule currently says infant formula must 
be tested at a N equals 30 sampling plan. That means that 30 
samples are taken, 10 grams of sample per each, 300 grams are 
tested for Cronobacter Sakazakii. Some of these manufacturing 
runs can be huge, 50,000, 60,000 pounds. Three hundred grams is 
insignificant, and the probability of them finding 
contamination is virtually zero. It has been a free pass for 
them to say it is tested negative, we can sell this product.
    Mrs. McClain. [Presiding.] Thank you, Mr. Yiannas. Thank 
you. The Chair now recognizes, Mrs. Luna.
    Mrs. Luna. Thank you guys for being here today. The 
bacteria outbreak in Abbott's nutrition manufacturing facility 
in Michigan is, in my opinion, just one of the many examples of 
the FDA's lack of oversight regarding not just food standards, 
but I would also argue, too, sometimes in the pharmaceutical 
industries. The FDA, as I am sure you all know, is intended to 
be the people's last line of defense, and although Abbott was 
responsible for not reporting this earlier, I do believe that 
there was a combination of issues that led to unfortunately 
this happening.
    In fact, the FDA's failure to adequately inspect Abbott and 
listening to whistleblower's concern contributed greatly to the 
formula shortage as a whole, and it took months for the FDA to 
respond. Had they responded, infants could have been saved. And 
I would like to note that it stated in the briefing that we got 
that 40 percent of infants infected will die if they have this 
bacteria, which means that of the 15 Members who sit on this 
Committee, if 40 percent were infected as infants, six of these 
Members would not be here, so that is incredibly alarming.
    But it is clear that FDA is not doing their job and does 
not prioritize food safety as well as many of the food 
additives, including hazardous food dyes like Red 40, Yellow 
Number 5 and Number 6, are banned in other countries around the 
world because of their harmful side effects, yet permissible in 
the United States.
    The FDA continued to launch an ad campaign, lecturing 
parents about how alternative infant food formulas may lack 
nutrients vital to an infant's growth, yet has also, at the 
same time, approved drugs such as mifepristone for pregnant 
women that starves an unborn child of nutrients until they die, 
or what about the 1960's debacle with FDA approving thalidomide 
and actually covering up some of the investigations, according 
to an article by The New York Times, in an effort to keep this 
knowingly dangerous pharmaceutical on the market to the 
American people. So, needless to say, as a Member of Congress, 
I do not really trust the FDA.
    It seems though that the FDA is for sale and will work with 
corporations to keep harmful products on the market, knowing 
the outcomes. We need to remove food additives that are 
detrimental to our health, and pharmaceuticals, and improve our 
inspections for foods across the board. Consumers buying food 
should be able to buy food and be able to trust it, not 
chemicals and additives that are toxic and known to carry 
risks. I guess my main concern, because I have heard your 
opening statement, and I appreciate your solutions to this, but 
why is it that Abbott is still an FDA-approved manufacturing 
facility for infant formula if they have knowingly covered this 
up because that is what it seems like.
    Mr. Yiannas. The facility did voluntarily shut down. Abbott 
has several manufacturing facilities. This occurred at the 
Sturgis facility. The facility did voluntarily shut down and, 
through the consent decree, there were a series of processes 
that they had to undergo to give us confidence that they could 
produce safe product. And they met those requirements per the 
consent decree, and so, now they are back in operation.
    Mrs. Luna. Has the FDA made any changes because I 
anticipate that due to COVID, you guys were not able to get 
into some of these facilities, but to only go to three of the, 
I believe, it was 23 facilities? It seems like, God forbid, 
something like this happens in the future, that needs to be 
changed. Frankly, if I was one of these parents, I would be 
completely ticked off at the FDA for not listening to those 
whistleblower complaints earlier.
    Mr. Yiannas. I think that is a fair criticism. Thank you. 
The FDA developed an internal policy that it would monitor 
COVID transmission around the country, and if it was above a 
certain level, they would not do inspections, even though they 
were deemed critical. If you look at other segments of the food 
safety profession, USDA inspectors continue to show up. They 
were considered critical infrastructure. If you look at many of 
the states, state inspectors considered to show up, so I think 
that is a fair conversation to have. Heaven forbid there is a 
future pandemic? If our FDA inspectors, critical 
infrastructure, critical personnel in critical structure, and 
is there a role for them to play?
    Mrs. Luna. But also, to something outside of COVID because 
it is very possible. I mean, I hate to say it, but I do not 
trust China, and biochemical is a very real threat in this 
country. So, obviously something outside of COVID would be 
important to keep you guys able to do your jobs.
    Mr. Yiannas. We also need to fully explore other means to 
gather intelligence, whether it is remote access of data and 
records.
    Mrs. Luna. OK. Thank you very much. Chairwoman, I yield my 
time.
    Mrs. McClain. Thank you, Mrs. Luna. The Chair now 
recognizes Ms. Balint.
    Ms. Balint. Thank you, Madam Chair. Before I begin, I just 
want to say a colleague earlier mentioned mifepristone. I just 
want to say it is a safe and effective medication. We have to 
focus on infant formula today and not get distracted by 
essential medications that we know are safe and women should 
have access to them. I want to get that on the record.
    Next thing, you know, I can really empathize with parents 
who had to deal with the shortage. Breastfeeding was very 
challenging for me and my son, and I can certainly understand 
the intense fear and stress that comes when you are a parent 
and you do not know how you are going to take care of your kid. 
I mean, there is nothing more stressful as a parent than that. 
And one Vermont mom described bone-deep anxiety during the 
crisis--bone-deep anxiety, wondering whether she would be able 
to find formula for her child, and that really resonates with 
me.
    We absolutely owe it to parents and, of course, children to 
make sure that we do not face another crisis, and I want to 
thank you for being here today so that we can ensure that this 
does not happen again. I represent Vermont, which is a rural 
state, and I am very concerned about how the crisis impacted 
low-income folks and rural Americans in particular. According 
to the Kaiser Family Foundation, infants born into lower-income 
and rural households are much more likely to rely on infant 
formula than other babies. Formula shortages hit these 
communities harder. More than 50 percent of infant formula 
across the country is purchased through the WIC Program, an 
excellent program which helps us to take care of children in 
this country. Far too many parents were forced to drive and 
drive and drive to try to find formula, to try to find food for 
their kids, and this is especially challenging in rural 
communities.
    So, Dr. Lurie, how can we help ensure that going forward, 
low-income and rural families are a focus of our national 
strategy and response for preventing future shortages?
    Mr. Lurie. Well, I think, as you probably know, the 
government has an enormous role to play when it comes to the 
provision of infant formula in this country since more than 
half of all infant formula is actually paid for by the WIC 
Program.
    Ms. Balint. Yes.
    Mr. Lurie. So, that is absolutely critical. I think that, 
from what I can tell from the outside, the FDA did a pretty 
good job once the rubber really hit the road in this problem, 
to communicate with USDA, which runs the WIC Program, and to 
try to communicate with them in ways that kept the supply going 
best they could. But in the end, with the concentration in the 
market, there was just no way to keep up. And parents, 
understandably, began to hang on to product for fear that they 
would not be able to find it in the future, and that ended up 
with the kinds of empty shelves that we wound up seeing.
    Ms. Balint. And the other thing that I think we are all 
still reeling from, is there was the crisis of needing to drive 
from store to store trying to get ahead of the run on infant 
formula. But there is also a deep concern that I have about 
price gouging, and I have talked about that in this Committee 
before. And, so, you know, as you saw desperate parents 
realizing they could not find it in their local area and 
driving to the next town and the next town and the next town, 
they would then turn to the internet to find the formula that 
they could not find in the stores. And we began to hear stories 
of price gougers, getting up to 300 percent more for a can of 
infant formula. And I know that the Biden-Harris Administration 
worked to crack down on the price gougers, but I do think 
Congress can do more to ensure that these scammers, individual 
scammers, and also greedy companies do not prey on the 
vulnerable families in these situations when all they are 
really thinking about is how do I feed my kid, right? How do I 
feed my kids?
    So, Dr. Yiannas, why is a whole-of-government approach to 
this, a better response to this crisis? How do we need to look 
across government to have a response that really is meeting all 
of these individual issues?
    Mr. Yiannas. Thank you. That is an excellent question, 
especially as it relates to infant formula supply and 
resiliency because FDA is limited in what it can do. Clearly, 
FDA sets safety and nutrition standards, and we have spent an 
amount of time talking about that. FDA plays a role in market 
availability by accelerating approvals, and there is more that 
we can do, but there is only so much the FDA can do.
    And a lot of the factors that drive the structure of the 
infant formula supply chain, its availability and resiliency, 
rely on other parts of government, for example, USDA and the 
WIC Program, as you mentioned. American taxpayers through the 
WIC Program buy over 50 percent of that infant formula, and 
there is something called sole-source state contracts, really 
creating an artificial market incentive for certain players to 
dominate in particular states.
    If you have a crisis, with certain players dominating 
market share in a state, it is hard to be nimble and recover, 
and so, we have to look at the WIC contract process. The 
executive office of the Biden Administration was very helpful 
with the DPA and allowing us to make priority purchases to make 
sure critical ingredients that were in short supply went to 
these infant formula manufacturers. So, I found that this 
response requires an all-of-government effort, and we should 
continue to look at ways to strengthen how an all-of-government 
response occurs for shortages of critical foods.
    Ms. Balint. Thank you.
    Mrs. McClain. Thank you. The Chair now recognizes Mr. 
Langworthy.
    Mr. Langworthy. Thank you so much, Madam Chairwoman, and 
thank you to the witnesses that have joined us here today. I 
mean, this is a topic, as my colleague from Vermont just 
outlined, I mean, that has really tackled families. I have 
staff members that have newborns that are still struggling with 
supply. I am a parent of a young son, five months old, myself. 
I mean, while this has not affected our family, it has affected 
so many of our constituents, and that helpless feeling of a 
parent that does not know how they are going to be able to feed 
their child is one that I think it is incumbent on this body to 
make sure it never happens again in this great country that we 
live in.
    Mr. Yiannas, when was the FDA made aware of the Cronobacter 
outbreak at Abbott Sturgis plant?
    Mr. Yiannas. Well, the very first report of a Cronobacter 
illness linked to that plant was September 20.
    Mr. Langworthy. OK. Of 2021?
    Mr. Yiannas. 2021.
    Mr. Langworthy. And, Mr. Yiannas, is it true that soon 
after, in October 2021, the FDA received a whistleblower 
disclosure message regarding Abbott Nutrition's plant?
    Mr. Yiannas. That is true.
    Mr. Langworthy. OK. Now, to your knowledge, when was the 
earliest date that you received the notice of the whistleblower 
disclosure?
    Mr. Yiannas. I personally was not made aware of it until 
February 10 of the following year.
    Mr. Langworthy. OK. Now, Mr. Yiannas, that is four months 
after it was initially reported. What did the FDA blame this 
delay on?
    Mr. Yiannas. Several things. Initially, as you heard in the 
original congressional hearing, there was a lot of focus and 
discussion about mail rooms and that the mail rooms lost it. 
That whistleblower complaint was sent by FedEx, hard copies to 
multiple individuals and multiple offices, so that means it 
would have been lost at multiple office: at the White Oak 
Campus, at the CFSAN Campus in College Park, also a field 
office located in the north. So, allegedly, it was lost in the 
mailroom.
    We do know that some individuals received copies by emails, 
and in hindsight, those should have been escalated to my office 
very rapidly, but those are some of the reasons that were 
reported. And then finally, in the report that the FDA put out, 
they said that we lacked the systems to actually detect these 
signals and escalate them.
    Mr. Langworthy. So again, it is the decentralization of the 
FDA that may be an issue here. I mean, it is 2023. The White 
House has declared the pandemic is over. It is almost two years 
since the first infant formula shortage, and our country is on 
the verge of perhaps another. In your opinion, how can this 
still be happening?
    Mr. Yiannas. I think that we have not taken enough urgent 
action. I think there are some things that we need to do. The 
long-term resiliency of the infant formula market is not 
something that can be solved overnight, so we are going to have 
to be intentional, and I hope Congress will request it. I am 
grateful that through the omnibus, you have asked that there be 
a resiliency report conducted, analysis of the infant formula 
supply chain resilience, and reported back to Congress. That is 
a good step, and we have to look at what are the market 
incentives and what are the contracts that WIC uses. For 
example, I think WIC contracts actually contributed to this 
crisis. But WIC might very well be part of the solution to the 
crisis, and so, but there is more we can do on the prevention 
that we can do faster. The resiliency and market consolidation 
is going to take a little bit longer to resolve.
    Mr. Langworthy. Now, I am aware that our infant formula 
supply is not even back at full capacity yet. Now, why is that 
taking so long? Is there not enough urgency delivered through 
the court of public opinion to these companies to wake up and 
ramp this up?
    Mr. Yiannas. One of the things we did--it is a great 
question--very rapidly building on this data analytic platform 
that I have described that we call 21 FORWARD to monitor food 
supply chains. We started adding additional functionality very 
quickly to deal with the current crisis. And one of the things 
the FDA has today is really impressive, that they did not have 
before, we have manufacturers in this country of infant formula 
reporting production volumes to the FDA on a weekly basis, not 
required by law, but they are doing it.
    FDA knows how much infant formula is being produced. We 
have good quantitative data and what is the national need to 
feed all infants in this country. So, we know production and 
consumption. We are tracking sales data. We are tracking how 
much infant formula is on shelves and where it is located 
through in stock improvement rates. And I can tell you that the 
call to action has been met. All the private sector companies 
that I have talked to have ramped up production. There has been 
what we call SKU consolidation. They limited the types of 
products they produce, so they can get more product out, so 
store shelves still will look scarce because there are less 
SKUs, stock keeping units, available, there is less variety. 
But I think in short order, we should find ourselves in a very 
much better situation.
    Mr. Langworthy. Thank you, Mr. Yiannas. I yield back.
    Mrs. McClain. Thank you. The Chair now recognizes, Ms. 
Crockett.
    Ms. Crockett. Thank you, Madam Chair, and thank you so much 
for being here today. Mr. Yiannas, I want to give you a little 
bit of an opportunity to flesh out some of the things that you 
have been talking about. But obviously, we have these 
constraints, because I think that you are offering us a really 
good glimpse into solutions, which sometimes in this building, 
as a freshman, I feel like we don't really get to solutions. 
And I think, I know at least in my district, they do not want 
us just kind of jumping on the bandwagon of rhetoric. They 
actually want us to solve problems.
    And so, one of the things that you have mentioned that I 
think is interesting, as someone who also serves on the Ag 
Committee, and it is technically in Ag right now, is you talk 
about WIC, and you say that WIC was part of the problem as well 
as it could be part of the solution. Now, the way that my ears 
interpret that is that we have an opportunity in WIC because 
these are Federal contracts, right? And so, with that, we can 
then put certain constraints, regulations, things like that on 
our baby formula, and honestly, kind of like what we saw in the 
last session.
    There was a vote that said that we would not be charging 
over $35 for insulin. And next thing you know, guess what? The 
private sector, Eli Lilly followed suit because there are so 
many government contracts that, honestly, where are you going 
to compete, right? And so, if we have got 50 percent--I think 
that was the number that you gave us--of the folk that are 
actually getting this formula, they are getting it through WIC. 
So, can you just expand a little bit or expound a little bit 
upon how you think we can also be a solution?
    Mr. Yiannas. Sure. I think USDA is very open to this, and I 
would encourage you to have this conversation with them. They 
are reimagining the WIC Program, but if you think of the infant 
formula supply chain, the fact that it is very in-elastic, and 
very fragile and consolidated, generally supply chains form 
this way through market incentives, its resources, its dollars. 
The WIC contract of sole-source contracting, picking winners 
for certain states, there have been studies that show, if you 
get a contract, if a manufacturer gets a contract in a state, 
they dominate in that state. Even for the infant formulas that 
are purchased outside of WIC, they just dominate.
    So, we have created an artificial intelligence on picking 
winners and losers for who is going to have the majority of 
infant formula share in a particular state. But we can use this 
artificial market incentive, the fact that the government buys 
about half of all infant formula, to create a more diversified 
contract system, so you don't have sole ownership or sole 
dominance in particular states. When a crisis like this 
happens, if you are in, let us say, an Abbott-run state, all 
the grocery stores had SKUs and supply chains that were 
dependent on Abbott. And that is not very easy to change very 
quickly, and so, I think diversifying the contract process is a 
key to the solution.
    The other thing I was very sensitive was to parents that 
could not get WIC products online. And many of you know this, 
WIC availability wasn't available online, and people had to 
travel many miles to find products. It would have been nice 
that even if you were a WIC customer, you could have gone 
online and searched for the infant formula that you needed.
    And so, I would encourage this Subcommittee, Congress, and 
all relevant regulatory agencies to really work hard on how do 
we create the types of flexibilities and market incentives to 
create a more resilient infant formula supply chain in this 
country. It can be done. I don't think it is going to be that 
difficult, but we need to make sure that the groups are working 
together, that they are held accountable, and they are given 
timelines to make it happen because in my sense, the past year, 
things have moved along too slow.
    Ms. Crockett. Thank you so much for that. And finally, I 
just want to talk for a second, you mentioned that the FDA 
can't, essentially,--I am paraphrasing--that the FDA can't just 
do whatever they want to do. I mean, they have to have the 
authority to do various things. And so, you know, the FDA gets 
its guidance from our Administration as well as from the 
Congress, and it seems like you are suggesting fixes that would 
implicate more regulations. What I hear you talking about is, 
maybe, listing this particular bacteria as one of those things 
that has to be reported because we can't rely on those that 
have a financial incentive to always do what is right. That is 
what regulations are for. So, it sounds like you are suggesting 
that we implement a few more regulations. Am I understanding 
you correctly?
    Mr. Yiannas. There are additional regulations needed to 
strengthen protections, no doubt. I would also say the entire 
infant formula industry needs to wake up and say what they are 
doing is not adequate enough. I am a strong believer for 
regulations, but I am also a strong believer for the free 
market to set the right type of conditions and standards 
because they are responsible and not being held accountable.
    Ms. Crockett. Thank you so much.
    Mrs. McClain. Thank you, and, Mr. Yiannas, I do agree with 
you, accountability is a wonderful tool, and I appreciate when 
the accountability is there for all parties, so thank you for 
that. The Chair now recognizes Mr. Gosar for five minutes.
    Mr. Gosar. Thank you. Today's testimony only highlights the 
FDA's negligence in the response to the compromised baby 
formula. A lag time of four months from the time the FDA first 
received the news of food safety violations in the Michigan 
plant to inspection, is obviously unacceptable. Instead of 
ensuring safe food consumption, the FDA focused on approving 
COVID-19 vaccines that have led to devastating consequences for 
Americans.
    As of January of this year, over 22,000 deaths and over 1 
million adverse events caused by COVID-19 vaccines have been 
voluntarily reported to the CDC and the FDA. These numbers make 
COVID-19 vaccine 226 times as deadly as the flu vaccine, but 
these scary numbers may be on a low estimate. A 2010 study from 
the Agency of Health Research and Quality, found that the CDC 
Vaccine Adverse Event Reporting System undercounted vaccine 
deaths by a factor of 100. It is high time the FDA returned to 
its focus on protecting people's health rather than pushing 
experimental dangerous vaccines.
    Mr. Yiannas, when did you first learn of the food safety 
violations occurring in the Michigan plant?
    Mr. Yiannas. February 10.
    Mr. Gosar. Now, the whistleblower relayed violations in FDA 
in October 2021. If you had known about these violations, what 
immediate actions would you have taken?
    Mr. Yiannas. Yes, I would have demanded that an inspection 
be done sooner. As you know, the inspection didn't occur until 
late January 2022. I would have demanded that the informant be 
interviewed sooner. As you know, there was a two-month gap 
between which the informant was interviewed. I would have 
questioned the termination or outcome of that interview, which 
concluded by the investigators that conducted it, that it was 
too vague for follow up or action. If you read that 34-page 
report and the allegations in there, I don't think you would 
say it is too vague. So, there would have been, I believe, with 
certainty quicker action, quicker inspection, follow up, 
additional testing. And, I believe that had we responded 
sooner, we could have curtailed or minimized this from reaching 
such a catastrophic level.
    Mr. Gosar. So, why do you believe the FDA officials ignored 
the emails containing these allegations of food safety 
violations from the whistleblower?
    Mr. Yiannas. I can't speak for the individuals that saw and 
why they didn't act on it more seriously, but I----
    Mr. Gosar. I mean, in other details where we have 
whistleblowers, I mean, we respond very quickly to them, so, I 
mean----
    Mr. Yiannas. We should have.
    Mr. Gosar [continuing]. it seems very odd.
    Mr. Yiannas. We should have.
    Mr. Gosar. Could you please explain the extent of the food 
safety violations occurring in the Michigan plant and what 
exactly were the violations?
    Mr. Yiannas. Well, I will tell you the conditions. I don't 
have a copy of the inspection report in front of me, but a lot 
of people have questioned how egregious were the conditions at 
Sturgis? And I would say they were very egregious. First of 
all, we had four reported cases of Cronobacter Sakazakii, all 
linked to products produced in Sturgis. Sturgis is one of 21 
plants servicing the U.S. market. While they had a large market 
share, the fact that all four illnesses consumed products 
produced in Sturgis was significant.
    Upon our inspection, we found very egregious conditions. We 
found critical equipment, such as spray dryers, that had major 
cracks and disrepair. I mentioned this and I wrote them in my 
testimony. We found water leaks and water. Standing water in a 
dried infant formula plant is not a good mix. Our own 
inspectors found abundant samples positive for Cronobacter 
Sakazakii itself. We found up to five different genetic strains 
of Cronobacter Sakazakii, and we found evidence that Abbott 
itself had found Cronobacter in finished product, not just the 
environment, in finished product and never reported to it to 
us.
    I have already explained that it is unlikely to test it in 
finished product. So, I think the abundance of evidence 
suggests that Abbott was operating under very unsanitary 
conditions and likely was sporadically contaminating infant 
formula. And it evaded final product testing because of 
probabilities and served to infants across the----
    Mr. Gosar. So, I'm going to fast track these. You made 
mention of monopolistic contracts, and I would like to explore 
that a little bit with you in regards to maybe how we could do 
this, maybe a fast track mechanism where you have more upfront 
dictations and then predicated follow-throughs. But, you know, 
I have a substantial ag community, and their response is very, 
very quick. With E. coli on lettuce, it is very, very timely. 
So, could you explain that? Because these contracts are very 
similar to what DOD has as their problem in sole sourcing.
    Mr. Yiannas. Yes, those contracts are run through USDA. So, 
I am not an expert on it and I won't be able to articulate it 
fully, so I highly recommend you talk to them, but I do think 
where there is a will there is a way, and we can accelerate 
action on WIC contracts.
    Mr. Gosar. Thank you, Mr. Yiannas.
    Mrs. McClain. Thank you, Mr. Gosar. The Chair now 
recognizes Ms. Lee.
    Ms. Lee. Thank you, Madam Chair. So, we spent the morning 
listening to people attack a formula supply chain they 
described as premature and inefficient recalls that worsen the 
issue, but when we are talking about sick babies, can we be too 
cautious? The reporting mechanisms did not work. We must do 
more to make sure this doesn't happen again. It is beyond 
regulation. This is a need to protect our most vulnerable 
population--infants--so we cannot allow weak regulations to 
allow children to die. Dr. Lurie, how should infant formula 
manufacturers have notified us of suspected contamination?
    Mr. Lurie. Well, as you know, there is no requirement at 
present for them to do so. And so, you know, if I were an 
infant formula manufacturer, at the moment I have a sample that 
tests positive, my response is not to destroy product and tell 
nobody. My response is to test more widely. My response is to 
tell the regulatory agency involved, but that is not what they 
did.
    Ms. Lee. Thank you. So, changing gears, as has been 
mentioned, infant formula manufacturers played a critical role 
in keeping babies fed and safe from foodborne illnesses. But 
when 90 percent of our supply is provided by three 
manufacturers like Abbott, American consumers lose. It took 
just one Abbott factory closure to throw this market into 
disarray. This industry is lacking the competition to maintain 
a robust market and protect our most vulnerable populations, 
infants who are being put at risk.
    Dr. Lurie, how can Congress foster competition within the 
infant formula market to promote safety and accessibility?
    Mr. Lurie. Well, I will just say first that, you know, I 
worked on drug shortages when I was at FDA, and it was quite 
the same problem when it came to generic injectables. It was a 
concentrated market, and you had a supply chain that was very 
friable that could break at any moment and there would be very 
few people who could step in, and that is very much what we saw 
on infant formula.
    I do want to say one thing, though, about the WIC Program, 
which I think, you know, it is not a sole-source program. It is 
a single contractor in each state program. That is different. 
But, as important as it is to look at the WIC Program and 
whatever role it might have played in the concentration of the 
market, it is also important to remember that the way the 
contracts are currently constructed is saving this government 
about $1.6 billion a year. And if we have to pay, somehow, you 
know, either this Congress is going to have to come up with 
$1.6 billion or there is going to be a $1.6 billion smaller 
amount of infant formula produced.
    So, we need a solution. I think the Federal Trade 
Commission should be taking a close look at this, but we should 
be careful, you know, when we talk about reform at WIC, that we 
make sure that access to the infant formula is part of the 
formulation as well.
    Ms. Lee. Thank you. You know, if our Congress is serious 
about this, we also want to investigate Abbott to get at the 
heart of what prompted the recalls and shortages, so we must 
continue to work to diversify our domestic suppliers and 
increase the resiliency of the infant formula market. Americans 
can't afford to keep relying on three manufacturers to prop up 
such a vital industry. I yield back.
    Mrs. McClain. Thank you. The Chair now recognizes Mr. Gomez 
for five minutes.
    Mr. Gomez. Thank you, Chair. First, let me just thank the 
Chair for having this important hearing and focusing on the 
issue, although she can't control all her Members. You know, 
bringing in COVID and vaccines, I think is not an appropriate 
place here, especially when it comes to this issue, because the 
American people have a profound interest in this.
    And I have a profound interest in this. I became a new dad 
for the first time last August, and as we were approaching the 
due date, I was watching the issue with a very, very interested 
eye, because it was like, OK, of course, we can try to 
breastfeed, but sometimes you got to make up the difference. 
And that was something that scared me, and something that 
concerned me, so I was watching it very, very, very carefully.
    One thing I want to kind of really focus on is even if we 
had the ideal--your FDA with appropriate staffing, reporting--
can that make up for the fact that there is market 
concentration? And I am also on the Ways and Means Committee 
that deals with trade issues. Can we really make up for the 
market concentration of 90 percent of the formula with these 
three companies even if we had an ideal, perfect, pristine FDA 
working in an exquisite form, Mr. Yiannas? And then I will ask 
Mr. Lurie.
    Mr. Yiannas. And the answer to that question is no. As I 
stated earlier, there are limited authorities and limited 
levers that FDA can pull to affect the market concentration and 
diversity. Again, the FDA approves these products. They set the 
safety standards and the nutrition standards, and the only way 
they can accelerate this is by making approvals go a little bit 
faster. The true levers on how you affect market resilience and 
market diversification reside outside of FDA.
    Mr. Gomez. Mr. Lurie, you mentioned you had some comments 
in your written testimony.
    Mr. Lurie. No, I think I have had the opportunity to make 
them, but I agree with what Mr. Yiannas is saying. This is not, 
in that sense, primarily an FDA problem. It is a trade problem. 
It is a market problem. And, FDA has very few levers when it 
comes to that. But, you know, the President's budget does have 
some funding that would allow faster approval of new infant 
formula entrants, and the Agency has done a lot in the current 
crisis to permit the entry of foreign products into the market. 
And so, that has diversified, at least for a short while, the 
available products, but it won't sustain us in the long term.
    Mr. Gomez. And is that temporary, or is that a permanent--
--
    Mr. Lurie. That is temporary.
    Mr. Gomez. What needs to occur in order to make it 
permanent? Would you tell----
    Mr. Lurie. Yes. My understanding is that it is an authority 
that has elapsed. Isn't that correct?
    Mr. Yiannas. Yes, they are looking at trying to create 
permanent pathways. Anybody right now could apply for a new 
infant formula product to hit the U.S. market. Having stated 
that, despite the heroic efforts, and they were heroic by the 
Administration, Operation Fly Formula and the enforcement 
discretion. And, if you looked at the total quantity of infant 
formula that was brought into the country in that manner, it 
was just like icing on the cake. It didn't make a significant 
material difference, and so, domestic manufacturing is 
something that we really need to focus on.
    Mr. Gomez. So, after my son was born, I actually did face a 
situation where I had to go store to store, and the shelves 
were empty. You know, I can't remember--those first few months 
are kind of blurry--I can't remember if it was September, 
October. And even today, they still seem bare, the shelves. Are 
we still facing a supply problem, or are we facing a 
psychological shortage problem, like people are stocking up 
because they think that there could be another disruption?
    Mr. Yiannas. I will take a shot at that because I was so 
involved in actually creating the systems to track this. And 
this is an excellent question, and it provides us an 
opportunity to explain to the American public what was 
happening.
    There is something called an in-stock rate. The different 
infant formulas that you might have, what percentage of them 
are in-stock at your favorite grocery store or drug chain. 
Before the pandemic, in-stock rates were in the mid-90's. That 
is good. That is considered good. 95 percent of the types of 
infant formulas you desired would be present when you went to 
the grocery store. The pandemic caused supply chain 
disruptions, and those in-stock rates started to drop to the 
low 90's, maybe even 89, even before the recall. That massive 
recall, with Abbott's Sturgis facility being so big, caused 
that to drop even further, and it dropped well into the 60's at 
one point.
    The worst it probably got was in the month of May, when a 
lot of news reports started being published, and we had a run 
with people buying more than their normal amount. Instead of 
buying 1 unit for the week, you were worried there wouldn't be 
enough, and you do what we call pantry loading. We do not 
criticize parents for doing that. It is a totally rational 
behavior, but thereafter, we started to improve, and before I 
left the Agency about a month ago, we were at those 90 percent 
in-stock rates.
    Now having stated that, I told you that the shelves will 
not look the same because the assortment has been reduced. 
Manufacturers are producing less high volume in certain types. 
As a Nation, we are producing more infant formula than ever 
before, but variety has been reduced. I hope that explains it.
    Mr. Gomez. Thank you so much.
    Mrs. McClain. Thank you, and I now recognize myself for 
five minutes.
    I think you made a very excellent point on the domestic 
manufacturing of this, not only for mothers, and fathers, and 
babies themselves. To be able to control the domestic 
manufacturing, I think, is critical for obvious reasons as well 
as, you know, national security as well. It is good to invest 
in business, and it is good to invest in business domestically. 
If the pandemic taught us anything, it was that.
    But, I am going to shift gears a little bit. On May 25, 
2020, Commissioner Califf testified before Congress that there 
were nine staff working on infant formula at the FDA. Is that 
an accurate statement? Yes, sir, Mr. Yiannas?
    Mr. Yiannas. I think that statement deserves clarification. 
There was nine individuals at that time working in the Office 
of Nutrition and Labeling. These individuals are specifically 
involved with approving new infant formula submissions. But the 
reality--I led the IMG. There were dozens and dozens of people 
working on infant formula at FDA: the field staff that does the 
inspections, the laboratory staff that does the testing, the 
administrative staff that responds in a crisis. And so, I feel 
that that statement could have been misleading, and it deserves 
clarification. There are more than nine people working on 
infant formula at FDA.
    Mrs. McClain. Were they working on the right things?
    Mr. Yiannas. You know, in hindsight, I wish they would have 
been working on some additional things. I mean, if you are 
responsible for approving new infant formulas, one of the 
things we saw in the crisis is that that team knew very little 
about the market. They didn't have data, which is readily 
available, on who owns what share, very quickly, where is it 
produced, how is the market performing. This data is readily 
available--what is the in-stock rate? And we found ourselves, 
in the midst of a crisis, having to scramble to collect data 
and build systems that I think should have been there before 
the crisis.
    Mrs. McClain. Did they approve any new?
    Mr. Yiannas. That is a great question to ask, is how many 
new products have been approved and how long does it take them 
to do. It is a good question. I don't know the answer to that 
question.
    Mrs. McClain. OK. In your opinion, does the Solomon report 
objectively evaluate the FDA's response to the infant formula 
shortage?
    Mr. Yiannas. The way I will answer that, is that I felt it 
was a very controlled report. A couple of things that I will 
say. One, it was not independent, correct? It was created 
internally by FDA. Whenever a crisis of this magnitude happens, 
it is good to have some independence. No. 2, I think you have 
already heard comments, it was presented at a very high level 
and doesn't get to really the root issues for you understand 
what really happened. I would just ask you to compare my 
written testimony, compare it to the Solomon report, and say 
did you learn new things that were a little bit more detailed. 
So, I don't think it went far enough, deep enough, and that it 
offered the appropriate solutions.
    Mrs. McClain. Why do you think that was? I mean, we had a 
major crisis in our country that affected the most vulnerable, 
infants, and it seems like we just kind of glossed over some 
things. Why?
    Mr. Yiannas. I think because it lacked independence. It was 
conducted internally, and, you know, clearly, there was a very, 
what I would call, rose-covered lens approach to writing that 
report.
    Mrs. McClain. So, were you permitted to contribute to the 
report?
    Mr. Yiannas. You know, when the crisis first happened, 
since the fact that I wasn't notified on February 10 and my 
office was the Office of Food Policy Response, I immediately 
wanted to know how could something like this happen and what 
could we do to prevent it from ever happening again. And so, I 
asked all program components to start developing a timeline, 
but shortly thereafter, the Principal Deputy Commissioner and 
the Chief of Staff told me that they would develop the 
timeline. And shortly thereafter, we learned that the Principal 
Deputy Commissioner would write the report or create the 
report.
    I specifically recall mentioning to the Commissioner that I 
get it, since I am in the food program, if you want 
independence. But the Principal Deputy Commissioner that was 
leading the report was the Acting Commissioner on whose watch 
all of this happened, and I didn't think that was a good idea. 
So, in the May hearing, I learned for the first time that it 
would be Steve Solomon writing it. So, I wish I would have had 
the opportunity to conduct that investigation, but I was not 
offered. I was not interviewed by Steve Solomon. I was 
interviewed by direct reports to the Principal Deputy 
Commissioner. I did have a meeting with Steve Solomon after the 
report was written, but had I written it, I would have written 
it quite differently.
    Mrs. McClain. Thank you, Mr. Yiannas. We are going to 
switch gears. In closing, I want to thank our panelists once 
again for their important and insightful testimony today, and I 
really commend you both on doing something that does not really 
happen a lot here, and that is you came with some solutions on 
how to correct the problem. I mean, we all know that there is a 
problem. I mean, anybody who has had a child or known somebody 
who has a child--I mean, there is a problem.
    So, I often say we cannot fix a problem that we first do 
not admit exists. We all admit that it exists, and I applaud 
and commend your efforts on some ideas on how do we work to 
make sure that this problem does not help again. So, with that, 
I commend you both for that.
    I yield to the Ranking Member now for her closing remarks. 
Thank you.
    Ms. Porter. Thank you, Madam Chairwoman. I agree, and want 
to echo what she said about the professionalism that you both 
brought to this hearing and really helping Members focus not on 
the partisan nature of this, but on the solutions. And, anyone 
who has seen how I do hearings know that I will call out wrong 
where I see wrong, and no matter who is in charge or who it may 
offend, and the truth is, nobody gets a pass today.
    Yes, the FDA must do better. It could have been faster. It 
could have been more adept in anticipating the formula crisis. 
It could have been more thorough in its after-action review and 
learning from the mistakes. So, there is no pass for the FDA 
here. Lawmakers, though, also have to do better by providing 
the FDA with the resources and authorities that they are 
telling us they need in order to get the results the American 
people deserve, so no pass for government.
    What is more, big businesses can do better regardless of 
who is looking over their shoulder. It is their job to produce 
safe, quality products. That is the cost of doing business in 
food. Abbott engaged in negligent behavior, full stop. It 
prompted a formula recall. It put Americans at risk, and it 
undermined the stability of the formula market, so no pass for 
big businesses.
    And, finally, even with shortcomings from the government 
and from industry, we wouldn't be here today talking about 
supply shortages if baby formula were sold in the strong, 
competitive marketplace. For too long, Washington has allowed 
markets to consolidate, domestic manufacturers to offshore, and 
critical infrastructure, including regulators, to crumble. 
Luckily, the Biden Administration has done a great deal in the 
last year to respond to disruptions and invest in our supply 
chains and to enforce competition policy. They are thinking 
toward the future.
    That is what our Committee is doing here today. And I think 
that is the mindset that Washington-at-large needs to have, so 
that we never have to wonder if infant formula will be 
available for anyone or what other critical food may face a 
shortage from contamination or other health risks, so no pass 
today for Washington. No pass today for manufacturers. No pass 
here for anyone except, I think, the professional and helpful 
suggestions from both of our witnesses.
    So, I am eager to take what we have learned at the hearing 
today, strengthen the FDA, hold big business accountable, and 
focus on policy solutions. I yield back and, again, thank the 
Chairwoman for this hearing.
    Mrs. McClain. Thank you, Ms. Porter, and I thank you for 
your help as well.
    I ask unanimous consent to enter three statements into the 
record. The first one is a Statement by the former FDA 
officials; Statement by Consumer Reports; and No. 3, a 
Statement by Consumer Brands Associated.
    So, ordered.
    Mrs. McClain. I now recognize myself for closing statement.
    Republicans and Democrats agree that Abbott is responsible 
for the Cronobacter outbreak at the Sturgis facility. I don't 
think there is any getting around it. They own it. But what I 
want to make sure that we are doing, is we hold government to 
the same standards, at least the same standards, as we hold 
private businesses too. That is our job. There is no question 
about that.
    Abbott is facing SEC, FTC, and DOJ investigations. Abbott 
is also facing lawsuits, as they should, from grieving families 
who have lost a child. They are, and will be, held accountable 
for any negligence, but the FDA is just as guilty. The FDA is 
guilty of neglecting its inspection duties. The FDA is guilty 
of neglecting its duty to fully understand the fragile infants 
formula supply chain. The FDA is guilty for failing to prepare 
for the potential shutdown of the Sturgis facility, but, unlike 
Abbott, the FDA has not been held accountable. Clearly, there 
is a double standard.
    And now, the FDA wants Congress to reward its negligence 
with more money to the tune of $372 million for not doing their 
job. When Congress appropriates funding to the FDA for food 
safety and inspection efforts, it has a duty to conduct those 
efforts. We would not be here today talking about this if the 
FDA had done what it is supposed to do. Today's hearing has 
illustrated just how ineffective the FDA's food safety efforts 
are, and I want to put the emphasis on food safety, right? I 
said earlier 70 some percent of their job is food safety. Yet, 
they are not really doing a real good job of that, and I think 
you both agreed with me in your testimony on that.
    The FDA Commissioner is turning a blind eye to the reality 
that its Agency is in turmoil. American families deserve to 
trust that their baby formula is safe. Instead, Americans are 
facing the uncertainty of continued recalls of baby formula. 
Just last week, several lots of Gerber formula were recalled 
for potential Cronobacter contamination, just last week. What 
has been shared by the witnesses today has been extremely 
remarkable. The FDA needs to be held accountable for its lack 
of transparency to the Congress and the American people, just 
as we are holding Abbott accountable as well.
    FDA officials discounted and ignored the whistleblower 
report. That is concerning to me. They failed to react quickly 
to reports of the Cronobacter infections. They failed to 
conduct an objective internal review, and they failed to take 
ownership of their actions. Now, they are trying to hide behind 
a weak proposed restructuring plan to distract from their 
failing and deflect blame, of which I commend you two for 
actually coming up with some solutions that I think we actually 
can work with. We will not allow them to avoid accountability 
for their failure to do their job. We have invited FDA 
officials to appear in a follow up on April 19, and we will 
hold them accountable.
    So again, I thank you both for your time. I thank you both 
for your insight. I thank my Ranking Member, Ms. Porter, for 
her help on this Committee hearing. And I hope we can make the 
necessary changes to instill faith in the American people, and 
especially with parents out there with newborn babies.
    So, without objection, the Members will have five 
legislative days to submit materials and to submit additional 
written questions for the witnesses, which will be forwarded to 
the witnesses for their response.
    Mrs. McClain. If there is no further business, without 
objection, the Subcommittee is adjourned. Thank you again.
    [Whereupon, at 11:33 a.m., the Subcommittee was adjourned.]