“The investigation of this most recent consumer complaint is in its preliminary stages and the agency will provide an update as it learns more,” the FDA said.
“With the limited product and clinical information Abbott was provided to evaluate the case, there are no conclusions that can be drawn and no evidence to suggest a causal relationship between Abbott’s formulas and this reported case,” Abbott said in a statement.
Earlier this year, Abbott recalled baby formula after complaints about Cronobacter sakazakii were made. At the time, the FDA warned consumers against using certain powdered infant formula products that were manufactured at Abbott Nutrition’s Sturgis, Michigan, infant formula production facility.
FDA and White House move to address baby formula shortage
Federal officials are currently taking steps to increase the availability of infant formula. On Wednesday, the FDA said it had approved the importation of more than 4.8 million cans of British-produced Kendamil First Infant Formula with Iron (Kosher formula). An initial distribution of 150,000 cans will kickstart the supply-bolstering effort, with an additional 1.2 million more cans to be distributed each month.
“The FDA is leaving no stone unturned to further increase the availability of infant formula. We are doing everything in our power as part of the all-of-government efforts to ensure there’s adequate product available wherever and whenever parents and caregivers need it,” said FDA Commissioner Robert M. Califf, M.D.
“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. 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.”
The White House made a similar move on Wednesday when President Biden announced that his administration is sourcing trucking for Operation Fly Formula to transport Gerber infant formula from Mexico to Fort Worth, Texas. The deliveries are scheduled to begin on June 24 and will include approximately 1 million pounds of Gerber Good Start Gentle infant formula, the equivalent of approximately 16 million 8-ounce bottles. The product will be available through retail channels.