Abbott Baby Formula Production Likely To Restart Amid Shortage

STURGIS, MICHIGAN — Illinois-based Abbott, which has a facility in Temecula, has reached a deal with the U.S. Food and Drug Administration to restart production of powdered infant formula at the company's Sturgis, Mich., plant following a shutdown at the facility earlier this year due to alleged contamination issues.

The agreement announced Monday aims to get more formula onto retailer shelves in the coming weeks amid a national shortage.

According to the F.D.A., it has provided detailed steps Abbott must take to restart production at the Sturgis plant, which ceased manufacturing in February after several babies became ill from formula allegedly produced at the facility; two children died, according to recent reports.

In a news release, Abbott said "there is no conclusive evidence to link Abbott’s formulas to these infant illnesses."

In a complaint filed earlier this year by the U.S. Department of Justice on behalf of the F.D.A., the government alleges that powdered infant formula products manufactured at Abbott Nutrition’s Sturgis facility were tainted because they were made under insanitary conditions and in violation of current good manufacturing practice requirements.

Additionally, during F.D.A. inspections at the plant, the deadly bacteria Cronobacter sakazakii was detected, prompting a recall and halt on formula production at the facility.

In the deal announced Monday, Abbott will "ensure safe powdered infant formula is produced at the facility," according to the F.D.A. "If contamination is identified, the company must notify the F.D.A., identify the source of the problem and conduct a root-cause investigation before resuming production."

It's expected that the Sturgis plant will be up and running in about two weeks, and Abbott formula will begin hitting retail shelves in six to eight weeks. In the meantime, the F.D.A said it has been in discussions with infant formula manufacturers to encourage increased production. Gerber increased the amount of its infant formula available to consumers by approximately 50 percent in March and April, and Reckitt is supplying 30 percent more product year to date, according to the F.D.A.

On Monday, the federal agency also announced "increased" flexibility regarding some imported infant formula products.

"Today’s action paves the way for companies who don’t normally distribute their infant formula products in the U.S. to do so efficiently and safely," said F.D.A. Commissioner Robert M. Califf, M.D. "We are hopeful this call to the global market will be answered and that international businesses will rise to the occasion to assist in bolstering the supply of products that serve as the sole source of nutrition for many infants. With these flexibilities in place, we anticipate that those products that can quickly meet safety and nutrition standards could hit U.S. stores in a matter of weeks."

According to the F.D.A., it will "prioritize submissions" of international products that can "demonstrate the safety and nutritional adequacy and have the largest volume of product available and/or those who can get product onto U.S. shelves the quickest."

The U.S. normally produces 98 percent of the infant formula it consumes, with the primary source of imports coming from trading partners in Mexico, Ireland and the Netherlands, according to the F.D.A.

The Abbott plant closure compounded a supply crisis that can be traced back to the early months of the pandemic when parents rushed to stock up on formula. Frustration over shortages has been political fodder for Republicans against President Joe Biden's administration. On Thursday, Southwest Riverside County's Rep. Ken Calvert (R) blasted the leadership.

“Once again, our nation is facing shortages at the grocery store on President Biden’s watch, but this time it is a baby formula shortage,” Calvert said in a released statement. “As any parent knows, for the first year a baby must have formula or breastmilk, there is no substitute. When the recall happened months ago, the FDA and the Biden Administration should have quickly identified the potential for a shortage and worked with industry to ensure a ramp up of production. Now we are in situation that is simply untenable for parents who are desperate to feed and care for their babies and I cannot imagine the anxiety of not being able to access food for your infant."