FDA, Abbott reach a deal to resume baby formula production

WHAT YOU NEED TO KNOW:

• The FDA and Abbott Nutrition reached a deal to restart the production of its baby formula in its Michigan plant.
• The plant was closed in February after several formulas were recalled over safety concerns.
• Abbott said it could take eight to ten more weeks for products to hit the shelves.

The U.S. Food and Drug Administration reached an agreement with Abbott Nutrition to reopen its Michigan plant to restart the production of baby formula.

The formula shortage came after Abbott shut down the Sturgis, Michigan plant in February due to safety concerns. The FDA started an investigation after complaints of bacterial infections related to Abbott powdered formula manufactured at the Sturgis plant.

According to the FDA, it received reports of two infant deaths and that a Cronobacteria infection may have been the culprit.

Abbott, the largest infant formula manufacturer in the US, made a voluntary recall of several of its infant formulas and halted production at the Sturgis plant. This led to a shortage in supply and prompted retailers to limit how much formula consumers could buy in stores.

Datasembly reported that as of May 8, about 43% of retailers across the US reported running out of baby formula, 

On Monday, Abbott agreed to a consent decree, filed by the Department of Justice on behalf of the FDA. This involves a regular FDA inspection at the Sturgis plant and Abbott getting outside help to be able to reopen it safely.

In a statement released Monday, Abbott said the consent decree still needs approval by a federal court in Western Michigan. Abbott could reopen the plant two weeks after the approval. It would take another six to eight weeks for the products to hit the stores.

Retailers have warned in recent days that it could take months for any infant formula to return to stores again.

Abbott noted that a CDC investigation found “no conclusive evidence” to link its baby formulas to infant illnesses.

“We know millions of parents and caregivers depend on us, and we’re deeply sorry that our voluntary recall worsened the nationwide formula shortage,” Robert B. Ford, Abbott’s chairman and CEO, said.

“We will work hard to re-earn the trust that moms, dads, and caregivers have placed in our formulas for more than 50 years.”

Source: Business Insider