Abbott Strikes Deal With FDA To Reopen Baby Formula Plant At Center Of National Shortage

Topline

Abbott Laboratories has reached an agreement with the Food and Drug Administration to reopen its baby formula plant in Sturgis, Michigan, the company announced Monday, raising hopes that a national formula shortage—fueled partly by the Sturgis plant’s closure due to safety concerns—will be over in a matter of weeks.

Key Facts

Once the FDA confirms that the plant is ready to reopen, it could resume production of baby formula within two weeks, after which it would take an additional six to eight weeks for products to hit store shelves, the company said in a statement.

Abbott said it will first resume production of the hypoallergenic formulas Alimentum and EleCare and formulas for babies with metabolic disorders, followed by other products.

The Sturgis plant closed in February after regulators launched an investigation into possible links between formula produced there and a series of infant bacterial infections and two deaths.

However, a Centers for Disease Control and Prevention investigation into the issue concluded last week without identifying any additional infections.

Additionally, the company said its own screening measures found no contamination with bacteria from the outbreak in formula distributed to consumers.

Key Background

The FDA in February cautioned consumers not to use certain powdered baby formulas manufactured at Abbott’s Sturgis plant, as it investigated a string of bacterial infections among infants that had consumed formula from the plant. Abbott voluntarily recalled some lots of Similac, Alimentum, EleCare and other formulas produced at the plant. The infections included two Cronobacter sakazakii cases in Ohio—one in Minnesota and one in Texas—as well as one Salmonella infection. The two Cronobacter-infected infants in Ohio died, with the bacterium a possible contributor to their deaths, the FDA concluded. As the amount of baby formula on store shelves plummeted by 43% earlier this month, speculators began to buy up some of the remaining stock, selling it online for up to $120 per can, the New York Times reported. Last week, White House officials announced the administration would coordinate with manufacturers like Gerber and retailers like Walmart and Target to surge baby formula production and make formula available more quickly. Additionally, the White House asked regulators to crack down on price gouging by baby formula resellers.

Surprising Fact

Some GOP legislators misleadingly suggested that the Biden Administration had intensified the national baby formula shortage by choosing to send formula to migrants at the U.S.-Mexico border rather than to U.S. families. However, the administration is legally obliged to provide baby formula, along with drinking water and medical assistance, to children detained at the border, according to the terms of a lawsuit settled in 1997. Additionally, it’s unlikely that the quantities of baby formula used at detention facilities would do much to curtail the national shortage, the New York Times reported.

Tangent

Cronobacter is a rare bacterial infection that can cause life-threatening meningitis in infants. Cronobacter bacteria can infest dry foods like powdered baby formula. Salmonella is a usually foodborne bacterial infection that can cause diarrhea and fever. Salmonella causes 1.35 million infections, 26,500 hospitalizations and 420 deaths in the U.S. annually, according to the CDC.

Further Reading

“Baby Formula Shortage Worsened By Shopping Bots Buying Up Inventory” (Forbes)

Source: https://www.forbes.com/sites/zacharysmith/2022/05/16/abbott-strikes-deal-with-fda-to-reopen-baby-formula-plant-at-center-of-national-shortage/