WASHINGTON — The US Food and Drug Administration has taken several steps, including those related to imports and minor labeling issues, to increase the availability of infant and specialty formula products, the agency announced May 10. A shortage of infant formula came after Abbott Nutrition suspended operations at its Sturgis, Mich., facility due to an FDA warning.
The FDA on Feb. 17 warned consumers not to use Similac, Alilmentum or EleCare powdered infant formulas from the facility. Four infants had become ill after consuming powdered infant formula produced at the Sturgis facility.
Abbott then initiated a voluntary recall of certain products. The recalled powdered infant formulas potentially could be contaminated with Cronobacter, a bacteria known to cause life-threatening infections (sepsis) or meningitis (an inflammation of the membranes that protect the brain and spine), according to the FDA.
Some steps the FDA has taken include expediting review of notifications of manufacturing changes designed to increase supply, expediting certificates to allow for flexibility in moving already permitted products from abroad into the United States, offering a streamlined import entry review process for certain products coming from foreign facilities with favorable inspection records, exercising enforcement discretion on minor labeling issues for both domestic and imported products, and not objecting to Abbott Nutrition releasing products to consumers needing “urgent, life-threatening” supplies of certain specialty and metabolic formulas on a case-by-case basis that have been on hold at the Sturgis facility.
“We recognize that many consumers have been unable to access infant formula and critical medical foods they are accustomed to using and are frustrated by their inability to do so,” said Robert M. Califf, MD, FDA commissioner. “We are doing everything in our power to ensure there is adequate product available where and when they need it.
“Ensuring the availability of safe, sole-source nutrition products like infant formula is of the utmost importance to the FDA. Our teams have been working tirelessly to address and alleviate supply issues and will continue doing everything within our authority to ensure the production of safe infant formula products.”
Abbott Nutrition in April said it was working with the FDA to restart operations at the Sturgis facility. The company also said it was increasing the volume of Similac Advance powder formula produced in a Cootehill, Ireland, plant that is registered with the FDA and was air-shipping the product into the United States daily. This year Abbott Nutrition expects to double the amount of Similac Advance powder formula that it brings into the United States from the Cootehill facility.
Abbott Nutrition has five manufacturing facilities that produce infant formula for the US market. The company is prioritizing production of Similac Ready-to-Feed liquid formula, a product that may be used directly from the bottle, at a facility in Columbus, Ohio, where Abbott Nutrition’s US nutrition business is based.