BSS
  17 May 2022, 10:31

Major US baby formula producer agrees with regulators on restarting production

 WASHINGTON, May 17, 2022 (BSS/AFP) - Amid a US shortage of baby formula,

officials announced Monday a previously closed manufacturer would re-open and
encouraged foreign companies to apply to import their products -- although it
will take weeks to see more stock back on store shelves.

A "consent decree" agreement between the Food and Drug Administration (FDA)
and major formula manufacturer Abbott outlines steps needed to restart
production at the company's plant in Michigan, which was shut down due to a
recall, Abbott said in a statement.

"Once the FDA confirms the initial requirements for start-up have been met,
Abbott could restart the site within two weeks," the statement said.

However, the company cautioned that "from the time Abbott restarts the site,
it will take six to eight weeks before product is available on shelves."

Abbott, which produces the popular Similac brand used by millions of American
families, announced a voluntary recall on February 17 after the death of two
babies.

In a separate move, the FDA also said Monday it plans to accept applications
from international baby formula manufacturers "who don't normally distribute
their infant formula products in the US," FDA Commissioner Robert Califf said
in a statement.

Currently, the United States produces about 98 percent of the formula it
consumes.

- Import applications -

The FDA plans to work to quickly review such applications, especially ones
that come from "countries that have health and safety inspection systems
similar" to the United States, according to a senior White House official.

The process would also prioritize applications showing "clear quality and
safety and nutritional adequacy," a different senior administration official
added.

According to Califf, foreign-made baby formula could appear on US shelves
within "weeks."

The Biden administration was also reaching out to US manufacturers to offer
help with logistical challenges, such as shipping, the officials said.

US families have grown increasingly desperate for formula amid a perfect
storm of supply chain issues and the massive recall.

The average out-of-stock rate for baby formula hit 43 percent earlier this
month, according to Datasembly, which collected information from more than
11,000 retailers.

Abbott's agreement with the FDA to restart production at the plant in
Sturgis, Michigan also needs to be reviewed by a federal court after the
Justice Department filed a complaint on Monday.

The complaint says the facility "failed to comply with regulations designed
to ensure the quality and safety of infant formula, including protection
against the risk of contamination from bacteria."

"The actions we are announcing today will help to safely increase the supply
of baby formula for families," US Attorney General Merrick Garland said in a
statement.

Robert Ford, chairman and chief executive officer of Abbott said he regretted
the situation and that the company already had begun "working to implement
improvements and take corrective action."

"We know millions of parents and caregivers depend on us and we're deeply
sorry that our voluntary recall worsened the nationwide formula shortage," he
said in the statement.

The FDA and White House officials reiterated Monday that parents who are
concerned about running out of baby formula should talk to their child's
doctor, and that it is not safe to water down existing formula or to make
your own at home.

The scarcity is the latest crisis to confound President Joe Biden's push to
get the US economy on sound footing amid the highest inflation in four
decades and the ongoing global supply chain bottlenecks.

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