A24 EZ RE THE WASHINGTON POST.THURSDAY, MAY 26 , 2022
micro organisms. After the prob-
lem was found, the report alleged,
management decided to remove
some of formula from distribu-
tion but released the rest without
additional testing. The whistle-
blower said that Abbott manage-
ment was worried that the FDA
would find out about the problem
during the 2019 FDA inspection
and that after the fact, one mem-
ber of management said she was
“amazed” that the FDA was un-
able to discover what had oc-
curred with the tainted batch.
The former plant worker also
described repeatedly bringing up
concerns about regulatory viola-
tions with management, which
he claims ultimately led to his
being fired.
An Abbott spokesperson said
the company is reviewing the
claims in the whistleblower re-
port.
“This former employee was
dismissed due to serious viola-
tions of Abbott’s food safety pol-
icies. After dismissal, the former
employee, through their attorney,
has made evolving, new and esca-
lating allegations to multiple au-
thorities,” Abbott spokeswoman
Vicky Assardo said in a state-
ment. “Abbott is reviewing this
new document and will thor-
oughly investigate any new alle-
gations.”
The whistleblower report ar-
rived at the FDA weeks after a
report that a second infant in
Minnesota had been hospitalized
after allegedly consuming tainted
Abbott formula.
FDA officials did not meet with
the whistleblower until sometime
in December, according to several
people familiar with the case —
weeks after receiving the report.
According to FDA testimony
released Tuesday night in ad-
vance of the Wednesday’s hear-
ing, Califf said the agency
planned to inspect the facility
early in December, but a covid-19
outbreak at Abbott caused a de-
lay, and that a “failure in FDA’s
mailroom” delayed the receipt of
the whistleblower’s report by a
week.
As a result, the FDA didn’t
begin its inspection until Jan. 31.
The following day, FDA inspec-
tors collected samples that con-
firmed the presence of
cronobacter at the plant.
By then, one infant had died
and two had been hospitalized
after drinking formula made at
the plant.
“The ignoring of the whistle-
blower complaint is just stunning
to me and underscores the prob-
lems with how FDA is structured,”
said Marler, the food poisoning
attorney. “Everyone got that
whistle blower report but Frank
Yiannas — that makes no sense.”
On Feb. 17, the FDA issued a
warning to consumers to not use
certain powered infant formulas
produced at the Abbott plant. The
same day, the company initiated
its first in a series of recalls. And
the FDA received its fourth com-
plaint, involving an infant who
died in Ohio after drinking for-
mula made at the plant. The
cause of death was cronobacter
poisoning.
It was also the new commis-
sioner’s first day on the job —
eight days since Yiannas first
learned of the crisis.with another bacterial infection
from cronobacter sakazakii after
drinking formula from the plant.
None of this prompted the FDA
to conduct its own testing of the
formulas produced at the facility,
records show. The complaints
that the company received were
also not mentioned in the final
notice — called a 483 — which
would have been reviewed by
FDA officials with Abbott man-
agement at the close of the in-
spection. The pitting found in the
plant’s dryers was also not men-
tioned, records show.
“This really hit me between the
eyes,” said Phyllis Entis, a food
safety microbiologist of 50 years
who reviewed the inspection re-
ports. “Here was this great big
flashing red warning light in Sep-
tember. They didn’t mention it in
the 483. They didn’t do any addi-
tional swabbing or testing. They
did nothing about it.”
Taylor, the former FDA deputy
foods commissioner, said one of
the likely reasons the agency did
not take more aggressive action
when it found problems at the
plant is the agency is still operat-
ing under an old set of principles.
That was supposed to change
when Congress passed the Food
Safety Modernization Act in 2011,
which aimed to radically shift the
FDA to a model that prevents
food poisoning outbreaks.
Inspectors were supposed to
identify potential food safety
problems — and demand correc-
tions — to keep bacterial contam-
ination from spreading in food
plants. Instead, Taylor said in-
spectors continue to take aggres-
sive action mostly in cases in
which the company’s conduct has
already led to serious food-borne
illnesses.
“They still need to shift from
this historic reaction to a culture
of prevention,” Taylor said. “What
happened with the infant formu-
la illustrates that.”
Structural changes made un-
der the Trump administration
further hampered communica-
tion in the agency, Taylor said.
While Taylor was at the FDA, the
two divisions for human and ani-
mal food products — the Center
for Food Safety and Applied Nu-
trition and the Center for Veteri-
nary Medicine — reported direct-
ly to him. This changed during
the Trump administration when
then-FDA Commissioner Scott
Gottlieb, who did not return calls
seeking comment, had the two
units report directly to him. This
structure has not changed under
the Biden administration.
When FDA inspectors failed to
return to the Abbott plant, a
former quality assurance worker
turned whistleblower on Oct. 19
and 20 mailed to several agency
officials hard copies of his report,
which DeLauro released at a
hearing last month.
He claimed Abbott purposeful-
ly falsified records, released un-
tested formula, employed lax
cleaning practices, misled audi-
tors, failed to take corrective mea-
sures and lacked good systems for
tracing potentially contaminated
products, the report shows.
The whistleblower said that
before the 2019 FDA inspection,
management authorized the re-
lease of some of an infant formula
batch that tested positive fortion reports, you see FDA not
being there during covid, even
though they had found serious
problems before. That seems cra-
zy, especially for infant formula,”
said Bill Marler, a food poisoning
attorney who is well known for
helping shape federal food safety
laws and policies.
Although the FDA is under-
staffed in its inspection ranks,
during the height of the pandem-
ic, the absence of inspectors in
food plants was a matter of policy.
Woodcock signed off on a work-
from-home model for inspectors.
Meanwhile, food safety problems
mounted at the Abbott facility,
records show.
“The untold story is that the
FDA took all of their staff out of
the field for nearly two years
during covid except for ‘emergen-
cy for-cause inspections,’” said
Steven Mandernach, executive di-
rector of the Association of Food
and Drug Officials, the organiza-
tion responsible for the inspec-
tions at the state level. “Wood-
cock said they did all these in-
spections, but for two years many
food inspectors never left their
home — the states did them.”
However, Michigan food in-
spection records show that state
inspectors also did not visit the
Abbott plant in 2020. The last
time they visited was in October
2019, records show.
Mandernach said that during
the pandemic, the FDA hired ad-
ditional staff, but because many
of them were stuck at home,
inspectors left the agency. “The
FDA has had a huge retention
problem,” he said, adding that
food investigators or inspectors
often are paid dramatically less
than medical products investiga-
tors.
When FDA inspectors ulti-
mately returned to the plant in
2021, they documented a host of
new food safety problems at the
Abbott plant. Workers were han-
dling raw materials, packing and
equipment after failing to proper-
ly wash their hands. There was
also pitting found in the dryers —
nooks and crannies that had de-
veloped over the years where bac-
teria could lodge and grow. The
report concluded that Abbott “did
not maintain a building used in
the manufacture, processing,
packing or holding of infant for-
mula in a clean and sanitary
condition.”
These and other observations
were made by FDA inspectors
even though the agency had de-
parted from its routine of con-
ducting “surprise” or unan-
nounced inspections during the
pandemic. Records show the
agency gave the plant several
days notice before inspectors ar-
rived.
During their visit, inspectors
also learned that Abbott had re-
ceived 16 complaints from 2019 to
2021 about infants who became ill
after drinking Abbott products,
agency records indicate. Testing
showed it was from bacterial in-
fections, including from salmo-
nella and cronobacter. As with
the previous complaints found
during 2019 inspection, Abbott
said it had determined its prod-
ucts were not responsible.
In the middle of the inspection,
the FDA also received its first
complaint of a child hospitalizedtraining and firsthand experience
in the food industry.
“The FDA’s delays on inspec-
tion and acting on the whistle-
blower complaint made the recall
so much worse,” he said of the
shortage. “They didn’t under-
stand that the Sturgis facility was
such a dominant source and that
they would need to backfill for-
mula from other sources.”
The Sturgis plant has experi-
enced food safety problems in the
past. In September 2010, the com-
pany issued a recall of some of its
Similac powered infant formula
after beetles and beetle larvae
were found in the finished formu-
la, which was produced at the
plant.
The following month, the FDA
went into the plant to investigate
and cited the company for several
food safety violations and a “fail-
ure to manufacture foods under
conditions and controls neces-
sary to minimize contamination,”
public records from the agency
show.
After that, the Abbott facility
passed annual inspections for
nearly a decade without any seri-
ous food safety findings, agency
records show.
That changed in 2019. During a
routine inspection that year, FDA
inspectors learned that Abbott
had found the potentially deadly
pathogen cronobacter in its fin-
ished products. They also discov-
ered plant workers were doing
inadequate pathogen testing of
formula produced at the plant.
“You did not test a representa-
tive sample of a production ag-
gregate of a powdered infant for-
mula at the final product stage
and before distribution to ensure
that the production aggregate
meets the required microbiologi-
cal quality standards,” the report
read.
Inspectors also found the com-
pany had received at least 10
complaints from nurses and par-
ents who believed Abbott’s prod-
ucts were making infants sick.
One complaint came from a pedi-
atric nurse who said five babies
had consumed Similac Sensitive
Infant Formula and that “all ba-
bies were projectile vomiting,”
records show.
In another instance, involving
three different Abbott formulas,
records show an infant had a
seizure and was diagnosed with a
bacterial infection from a strain
of the cronobacter pathogen.
The children recovered and, in
each case, the company said it
investigated and determined
their products were not responsi-
ble, records show.
Despite these findings, the
FDA did not issue any restrictions
on the plant and closed out the
investigation. Inspectors did not
return to the plant for two years,
records show, and the agency
cited the pandemic and the risk of
spreading the coronavirus as one
of the reasons.
In a statement, the FDA noted
that “mission-critical inspections
when possible were made on a
case-by-case basis. ... We can con-
firm that during the pandemic,
the agency conducted a number
of inspections of powdered infant
formula manufacturers.”
But not at Abbott’s Sturgis fa-
cility.
“When you look at the inspec-seriously to stop the domino ef-
fect. That didn’t happen.”
The national fallout over the
Abbott case has exposed a frac-
tured structure at an agency that
has long prioritized drugs and
medicine over food safety, experts
say — a problem exemplified by
its handling of the whistleblower
complaint and other warning
signs of problems at the plant.
Neither of the FDA’s food policy
divisions has to report to Yiannas,
and neither do the agency’s food
safety inspectors. Instead, they
report directly to FDA Commis-
sioner Robert M. Califf, a physi-
cian who was appointed to the
top post on Feb. 17, the day Abbott
recalled many of its powdered
products. Before Califf was ap-
pointed, food safety problems
were reported directly to Princi-
pal Deputy Commissioner Janet
Woodcock, another physician
who was acting commissioner
when the whistleblower com-
plaint arrived.
“The essential thing is that
you’ve got three major operating
components that are reporting
only to the [FDA] commissioner,
who, by tradition and current
reality is a physician who is fo-
cused on medical products and
doesn’t have the bandwidth or
the inclination to spend time
providing the leadership that’s
needed for the food program to be
successful,” said Michael R. Tay-
lor, who was deputy commission-
er for foods and veterinary medi-
cine during the Obama adminis-
tration.
On Wednesday, two House
committees held separate hear-
ings to investigate the agency’s
actions in the Abbott case as well
as whether there are deeper
structural problems in the agen-
cy.
“Why didn’t we act more quick-
ly on the complaints and the
whistleblower report? Who knew
what when?” Yiannas said.
“Those are going to be some of the
tough questions that will have to
be answered.”
Yiannas spoke to The Post after
calling back a reporter who stated
their name, title and the nature of
the story in a voice mail; after
repeatedly addressing the report-
er by name, Yiannas later termi-
nated the conversation and
claimed he did not realize he was
speaking to a journalist.
In a statement on Tuesday, an
FDA spokeswoman declined to
comment on Yiannas’s claim
about a lag of months in learning
of the whistleblower’s report. She
said that Califf will testify in the
hearings about the agency’s re-
sponse to the formula crisis.
“Once the immediate public
health risk is minimized, the FDA
will conduct a programmatic re-
view to ensure the maximum
effectiveness of agency programs
and policies related to infant for-
mula and special medical food
complaints, illnesses and recalls,”
the spokeswoman wrote.
Abbott said there is not clear
evidence that the contamina-
tion affecting babies originated at
its plant. “After a review of all
available data, there is no conclu-
sive evidence to link Abbott’s
f ormulas to these infant illness-
es,” the company said in a state-
ment.
Organizations representing
consumers, the food industry and
state food regulators are pushing
to restructure the FDA. In April,
the groups sent a letter to Califf,
calling on him to unify the entire
FDA food program under Yiannas
and to maintain that structure
with his successors.
Meanwhile, Yiannas said he
continues to be cut out of the
FDA’s oversight of the Abbott
facility. He began work on a cor-
rective action plan for Abbott in
February but said he was told to
“stand down” by Woodcock.
The FDA disputed that Wood-
cock gave such an order, and also
Yiannas’s claim that he hasn’t
been given oversight of the facili-
ty’s reopening process. The agen-
cy said he is managing an agency-
wide group working to address
the formula crisis.
Lawmakers have expressed
concern at Woodcock’s role in the
FDA as it works with Abbott to
address the safety issues to re-
open its plant. Rep. Rosa L. De-
Lauro (D-Conn.) in a hearing
called Woodcock — who received
the whistleblower complaint and
was heading the agency as offi-
cials failed to act on it for months
— a “fox in the hen house” and
said it appeared she was playing a
leading position in the Abbott
plant review. (The FDA also dis-
putes that Woodcock is oversee-
ing efforts to reopen the plant.)
Tom Neltner, chemicals policy
director for the Environmental
Defense Fund, who has been
working with the agency to elimi-
nate heavy metals from baby
foods, said the national formula
shortage has been exacerbated
because the agency has given
authority to officials without
FDA FROM A1
Whistleblower report didn’t reach top FDA safety official
MATTHEW HATCHER/BLOOMBERG NEWSThe Abbott infant formula
factory i n Sturgis, Mich.
The company in a statement
said there is not clear evidence
that the contamination
originated at its plant. “After a
review of all available data,
there is no conclusive evidence
to link Abbott’s f ormulas to
these infant illnesses.”“Why didn’t we actmore quickly on thecomplaints and thewhistleblower report?Who knew whatwhen? Those are goingto be some of thetough questions thatwill have to beanswered.”
Frank Yiannas,
the FDA’s deputy commissioner for
food policy and response