The Washington Post - USA (2022-05-17)

A12 EZ RE THE WASHINGTON POST.TUESDAY, MAY 17 , 2022

tion from formula for the first six

months of life, a limited number

of manufacturers have the ability

to produce it effectively.

About 90 percent of the infant

formula supply in the United

States is produced by four major

companies: Abbott, Gerber, Mead

Johnson and Perrigo Nutritionals.

To make up for the Sturgis facil-

ity shortfall, Abbott has priori-

tized infant formula production

at its other plant in Columbus,

Ohio, converting other liquid

manufacturing lines into making

liquid Similac, and has brought in

millions of cans of product from

its Ireland production facility.

Perrigo has stepped up produc-

tion to ship 37 percent more for-

mula in the past three months

than during the same period last

year, and Gerber is running for-

mula factories at capacity to accel-

erate product availability to re-

tailers and online.

Still, grocery store shelves have

dipped more than 40 percent be-

low full stock in recent weeks,

retailers are rationing popular

brands, and parents have traveled

miles to find formula for their

infants.

Members of Congress have ex-

pressed frustration with both Ab-

bott and the FDA, with Republi-

cans also singling out the broader

Biden administration for criti-

cism over the shortage.

“Months ago, I called for the

FDA to take action on this loom-

ing crisis, and the Biden adminis-

tration failed to provide a timely,

substantive response,” Rep. Elise

Stefanik (R-N.Y.) said in a recent

statement.

House Appropriations Com-

mittee Chair Rosa L. DeLauro (D-

Conn.) said she received a lengthy

report from a former Abbott em-

ployee who registered a litany of

complaints about conditions at

the Sturgis plant with the FDA in

October.

But the agency did not inter-

view the whistleblower until late

December, DeLauro said at a

hearing in April. The FDA began

its inspection at the plant on Jan.

31, and the recall was issued Feb.

17, according to FDA documents.

“Why did the FDA not spring

into action? Why did it take four

months to pull this formula off

store shelves?” DeLauro said at

the hearing.

needed in terms of a review of

ingredients, testing results and

inspection history.

And on Friday, the White House

announced the possibility of in-

voking the Defense Production

Act to produce baby formula amid

the shortage. But supercharging

production of formula is no easy

feat.

Most formulas are made from a

mix of protein concentrate from

cow’s milk, rice starch, corn syrup

and oils. They are sold ready to

drink and in powdered forms that

must be reconstituted with water.

Because the minimum

amounts of fat, protein, calcium

and a number of vitamins is so

stringently regulated, as many ba-

bies get 100 percent of their nutri-

would disproportionately impact

low-income families.

“The FDA is working closely

with Abbott to bring the facility

back online safely,” White House

press secretary Karine Jean-

Pierre told reporters Monday af-

ternoon. “That is the key here,

safely.” She said the administra-

tion is also “moving as quickly as

possible” to bring in more formu-

la from overseas.

On a call Monday night, Susan

Mayne, the director of the Center

for Food Safety and Applied Nu-

trition at the FDA, said the agency

would approve new types of for-

mula from foreign and domestic

sources on a case-by-case basis. It

is already in discussion with pro-

ducers, she said, to explain what is

formula production facility in
Michigan. The public should rest
assured that the agency will do
everything possible to continue
ensuring that infant and other
specialty formulas produced by
the company meet the FDA’s safe-
ty and quality standards,” Califf
said in a statement late Monday.
“This is a major step toward
re-opening our Sturgis facility so
we can ease the nationwide for-
mula shortage,” said Robert Ford,
chairman and chief executive of
Abbott, who noted that the short-
age was also exacerbated by a
voluntary recall by the company
of formula that had been possibly
tainted by a bacteria that sickened
two babies and killed two others.
The FDA has not proven that the
Sturgis plant was the source of the
contamination, the company has
said.
“We know millions of parents
and caregivers depend on us and
we’re deeply sorry that our volun-
tary recall worsened the nation-
wide formula shortage. We will
work hard to re-earn the trust that
moms, dads and caregivers have
placed in our formulas for more
than 50 years,” Ford added.
According to the FDA state-
ment, a proposed consent decree
between the FDA and Abbott Nu-
trition and three of its top execu-
tives was filed in the U.S. District
Court for the Western District of
Michigan.
The proposed consent decree
must be approved by the court.
“Abbott Nutrition will be required
to retain an independent expert to
review the Sturgis facility’s opera-
tions to ensure compliance with
the law,” the statement said.
The consent decree “allows the
company to get back in operation.
Given what has happened so far,
the FDA is going to scrutinize
everything Abbott does. There
will be inspectors there. They will
want to see batches to determine
that problems will not recur,” said
Carl Tobias, a law professor at the
University of Richmond.
A protracted shortage affects
low-income Americans the most,
since half of baby formula is pur-
chased by recipients of a food
assistance program benefiting
poor mothers and young children.
Many more months of a shortfall

FORMULA FROM A

FDA and formula maker reach agreement to fix problems

DAVID J. PHILLIP/ASSOCIATED PRESS

A woman helps distribute infant formula at a Houston formula drive. The director of the Center for Food Safety and Applied Nutrition at

the FDA said the agency would approve new types of formula from foreign and domestic sources on a case-by-case basis.

“The FDA is going to scrutinize everything

Abbott does. There will be inspectors

there. They will want to see batches to

determine that problems will not recur.”

Carl Tobias, law professor at the University of Richmond

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