FDA greenlights Abbott Nutrition to resume baby formula production
06 Jun 2022 --- Abbott Nutrition has restarted the production of baby formula at its Sturgis, Michigan, US, operation. This comes a week after meeting initial requirements agreed to with the US Food and Drug Administration (FDA) as part of the consent decree entered into on May 16.
Production at Sturgis is now underway in a bid to ease the nationwide shortage of baby formula, which has caused havoc across the country over the last few weeks.
Abbott Nutrition says it will restart the production of a formula for children with digestive issues. The aim is to release the EleCare product later this month, on or around June 20.
The company has been at the center of the infant formula challenges since the Michigan plant closed down in February amid contamination concerns.
FDA investigations began after four infants were hospitalized with bacterial infections from drinking Abbott’s powdered formula. Two of the babies died.
FDA investigations began after four infants were hospitalized with bacterial infections from drinking Abbott’s powdered formula.Meeting guidelines
Now, Abbott stresses that it’s focused on earning trust and meeting guidelines to produce other formulas.
It’s also “working hard to fulfill the steps necessary to restart production of Similac and other formulas and will do so as soon as we can.”
“We understand the urgent need for formula, and our top priority is getting high-quality, safe formula into the hands of families across America,” says a company statement.
“We will ramp production as quickly as we can while meeting all requirements. We’re committed to safety and quality and will do everything we can to re-earn the trust parents, caregivers and health care providers have placed in us for 130 years.”
Increased formula availability
Also, over this last weekend, the FDA released an update on additional steps it has taken that will lead to more infant formula available in the US under the agency’s recent increased flexibilities.
About 1.3 million cans (about 2.2 million pounds or nearly 33 million full-size, 8-ounce bottles) of Nestlé (Mexico) Gerber Good Start Gentle are coming into the US. It could be available through retailers as early as July.
“The FDA is exercising enforcement discretion for the importation of the infant formula products listed following the review of information provided pertaining to nutritional adequacy and safety, including microbiological testing, labeling and additional information about facility production and inspection history,” says an FDA statement.
“The agency is leveraging a number of flexibilities to bolster the supply of products that serve as the sole source of nutrition for many infants while ensuring the infant formula can be used safely and provides adequate nutrition,” it says.
The FDA remains in further discussions with manufacturers and suppliers regarding additional supply to ensure there’s adequate infant formula available.
Edited by Gaynor Selby
