 FDA Provides New Updates on Activities to Mitigate Infant Formula Supply Challenges, Abbott Nutrition Agrees to Take Corrective Actions at Facility to Produce Safe Infant Formula
The U.S. Food and Drug Administration is announcing important updates on its ongoing work to increase the supply and availability of infant formula in the U.S. On Feb. 17, the agency warned consumers not to use certain powdered infant formula products from Abbott Nutrition’s Sturgis, Michigan infant formula production facility, and Abbott voluntarily ceased production at this facility as well as initiated a voluntary recall of certain products.
Today, a proposed consent decree of permanent injunction between the FDA and Abbott Nutrition, as well as three Abbott principals, was filed in the U.S. District Court for the Western District of Michigan. Under the proposed consent decree, which is subject to court approval and entry, Abbott has agreed to take corrective actions following an FDA inspection of its Sturgis, Michigan facility. The proposed consent decree obliges Abbott to take actions that are expected to ultimately result in an increase of infant formula products, while ensuring that the company undertakes certain actions that would ensure safe powdered infant formula is produced at the facility. When the company decides to restart production at this facility, it must conform with the provisions of the proposed consent decree and meet FDA food safety standards. If contamination is identified, the company must notify the FDA, identify the source of the problem and conduct a root-cause investigation before resuming production.
“Today’s action means that Abbott Nutrition has agreed to address certain issues that the agency identified at their infant formula production facility in Michigan. The public should rest assured that the agency will do everything possible to continue ensuring that infant and other specialty formulas produced by the company meet the FDA’s safety and quality standards, which American consumers have come to expect and deserve,” said FDA Commissioner Robert M. Califf, M.D. “We recognize the hardships that parents and caregivers have faced in obtaining infant formula and the FDA is focused on boosting the availability of the country’s supply of these products, including new steps regarding importation. We are also taking a look at the supply of infant formulas developed by manufacturers across the country and around the world to determine if a reallocation of their distribution can be made to help get the right product to the right place, at the right time.”
Additional Information:
 Please join the FDA’s Center for Food Safety and Applied Nutrition (CFSAN) for a stakeholder call about actions to increase infant formula supply. The call will feature Frank Yiannas, Deputy Commissioner for Food Policy and Response and Susan Mayne, Ph.D., CFSAN Director.
CLICK HERE TO JOIN ZOOM MEETING
Meeting URL:
https://fda.zoomgov.com/j/1608615915
Join by Telephone:
Dial: 1 669 254 5252
Meeting ID: 161 223 8612
One tap mobile:
+16468287666,,1612238612#,,,,*874020#
About Us
The Stakeholder Engagement Staff resides within the Office of the Commissioner and falls under the Office of External Affairs. We aim to build stronger relationships with health professional organizations, consumer groups, trade associations, patient advocacy organizations, think tanks/academia, and other stakeholders, in order to better inform our policy making process, identify policy hurdles or stakeholder misconceptions, and create strategic collaborations.
Contact the Stakeholder Engagement Staff at: FDAStakeholderEngagementTeam@fda.hhs.gov
|
