WASHINGTON,
D.C. – Following multiple reports of illness and two tragic deaths linked to recalled infant formula manufactured by Abbott
Nutrition, U.S. Senators Sherrod Brown (D-OH) and Bob Casey (D-PA)
sent a letter to Food and
Drug Administration (FDA) Commissioner Robert Califf to demand information on the FDA’s actions and plans to investigate these reports
and to prevent other infants from falling ill. Because of this recall, parents
are now facing shortages of baby formula. The senators requested information
on the current status of the FDA’s investigation into the contaminated infant
formula, steps the agency is taking to make sure there is enough infant formula
on the shelves despite the shortage, and work the FDA is doing to provide
information to families and caregivers affected by the recall and contaminated
products. They are also seeking information about the FDA’s interactions with
Abbott Nutrition prior to the recall and pressing the FDA to explain the
apparent delay in their response following initial reports of infant illness.
“As you are aware, the FDA is responsible for overseeing
manufacturers of infant formulas. Parents, caregivers, and the greater public
rely upon the FDA to ensure infant formula on the shelves in our grocery stores
and food pantries is safe to consume and supports healthy growth. It is
unacceptable that FDA was made aware of complaints and positive cases related
to the Abbott Nutrition facility months before Abbott finally issued its
voluntary recall of potentially contaminated infant formula, yet failed to
alert the public, immediately initiate an inspection, or demand Abbott issue an
immediate recall of these infant formula products,” wrote the
senators.
Powdered infant formula manufactured at Abbott Nutrition’s
facility in Sturgis, Michigan was recalled in February due to reports of
possible bacterial contamination affecting Similac, Alimentum and EleCare
powdered formulas. Parents and caregivers who want to check if their powdered
formula is part of the recall can do so at the company’s website
here, and can learn
more about the recall at the FDA’s website
here.
To read the full letter to Commissioner Califf, click here or below.
April 8, 2022
The Honorable Robert Califf, M.D. Commissioner
Food and Drug Administration
U.S. Department of Health and Human Services 10903 New Hampshire
Ave
Silver Spring, MD 20993
Dear Commissioner Califf:
We write today to express our concern about the recent recall of
powdered infant formula manufactured at Abbott Nutrition’s facility in Sturgis,
Michigan due to reports of bacterial contamination affecting Similac, Alimentum
and EleCare powdered formulas, and to request information on the Food and Drug
Administration’s (FDA) plans to investigate these illnesses and deaths and
prevent other infants from falling ill. A parent should never have to worry
about whether the food they feed their child is safe, let alone deadly, and we
are heartbroken by news that infections linked to these products may have
contributed to at least four infant hospitalizations and the tragic deaths of
two of these babies.
We were alarmed to learn that reports of adverse events linked to
the recalled infant formula were reported as early as September 2021, nearly
five months prior to Abbott Nutrition’s decision to initiate a recall. This
delay was unacceptable; for nearly half a year, potentially contaminated
product remained on store shelves and in baby bottles, subjecting unsuspecting
families to unacceptable risk. Earlier actions to issue a recall and provide
information to consumers could have prevented the subsequent three known cases,
including two deaths in Ohio, reported in connection with the recalled products
or limited the quantity of recalled product and resulting shortages. The deaths
of these two infants is tragic and unacceptable, and should never have
happened.
In addition to our deep concerns over the health risks to infants
that the potential contamination and delayed action have caused, we are alarmed
by the challenges families now face in securing safe infant formula with which
to feed children reliant on this important source of nutrition.
Reports over shortages at grocery stores and food pantries due to
supply chain issues preceded the current recall, which has exacerbated the
already-dire situation and left parents and caregivers scrambling to secure
infant formula or quickly identify alternative products.
While many infant formulas are interchangeable from a health or
regulatory perspective, parents of infants who rely on formula to supplement
breastmilk or as a sole source of nutrition find that in practice, infants
often prefer certain formulations. Additionally, some infants develop allergies
or sensitivities that require the use of specific formulas to ensure the
infant’s continued health and growth; at least one of the products associated
with the Sturgis facility was a specialized formula for babies with low iron
deficiencies. Furthermore, infant formula is expensive, and the sudden drop in
supply caused by the recall is likely to drive up prices even further. The
prospect of finding a new formula as a result of the recall has posed a
logistical, financial and emotional burden for families across the U.S.
As you are aware, the FDA is responsible for overseeing
manufacturers of infant formulas. Parents, caregivers, and the greater public
rely upon the FDA to ensure infant formula on the shelves in our grocery stores
and food pantries is safe to consume and supports healthy growth.
6 It is
unacceptable that FDA was made aware of complaints and positive cases related
to the Abbott Nutrition facility months before Abbott finally issued its
voluntary recall of potentially contaminated infant formula, yet failed to
alert the public, immediately initiate an inspection, or demand Abbott issue an
immediate recall of these infant formula products.
Better understanding the actions of and authorities utilized by
the FDA in this troubling situation will help us to more quickly address and resolve
the current challenge and prevent future detrimental threats to infant health.
We respectfully request the FDA’s response to the following questions:
- What is the current status of the FDA’s investigation
into the contaminated infant formula?
- What steps is the FDA taking to ensure enough infant
formula remains on the shelves for infants and their families to rely on
despite the shortage caused by the ongoing Abbott Nutrition recall? How is
the FDA working with parents, health care providers, WIC programs, other
HHS programs and other stakeholders to help notify parents and caregivers
about the recalled products, and assist parents and caregivers in
identifying and locating suitable alternatives to the affected formulas?
How can parents be sure that the formula remaining on store shelves is
safe?
- When can parents expect the situation to be resolved,
and when will there again be adequate supply and access availability to
the products they and their children rely on?
- When was the FDA first notified about potential
illnesses linked to infant formula, and what actions were taken in
response to this report?
- What steps has the FDA taken to provide information to
other families and caregivers in impacted states, including Pennsylvania
and Ohio, to prevent further use of potentially contaminated product?
- Did Abbott Nutrition fulfill all reporting requirements
in connection to the complaints of adverse events? Is there information
that the company could have voluntarily reported that would have allowed
the FDA to respond in a more timely or effective manner?
- How did the FDA work with Abbott Nutrition to initiate
their voluntary recall? Given the serious threat of Cronobacter
sakazakii infections, and the report of deaths linked to use of the
recalled products, why was the recall voluntary, rather than mandatory?
- Although the FDA typically inspects infant formula
manufacturing sites annually, we understand that no such inspection of
Abbott Nutrition’s Sturgis facility was conducted in 2020.7 How has the COVID-19 pandemic and public health
emergency impacted the FDA’s ability to oversee and ensure the safety of
infant formula? Did you make a remote records request? Would any
authorities have enabled more effective FDA oversight and facilitated the
FDA’s ability to meet its obligations?
- We are concerned about the shortages of infant formula
resulting from the recall. What types of information does the FDA collect
from infant formula manufacturers regarding disruptions in manufacturing
or other supply chain issues that could lead to shortages? Does the FDA
have the necessary authority it needs to proactively take steps to prevent
or mitigate potential shortages of infant formula?
We stand ready to assist the FDA to help protect our most
vulnerable population—infants and newborns—from illness or death as a result of
ingesting contaminated formula.
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