After a weeklong national-level crisis of baby formula shortage, Abbott Nutrition and the FDA finally announced a timeline to get baby formula stocks back on the shelves on Monday, May 16. The press release states that Abbott Nutrition has signed a consent decree with the government to reopen its closed factory in Sturgis, Michigan, which was shut down after a voluntary recall by the company in February.
The recall was issued due to four babies being hospitalized in connection to the consumption of products from the Michigan plant, which eventually led to two deaths by bacterial infection. A complaint filed by the Justice Department accused Abbott of failing to comply with quality and safety regulations. A regulatory check by the FDA also flagged the Michigan facility after finding traces of a deadly bacteria called cronobacter.
The baby formula shortage was already beginning to emerge due to supply chain issues brought on by the pandemic, but it was exacerbated multifold due to this recall since Abbott is one of the leading baby formula manufacturers.
Abbott Nutrition's timeline to restock baby formula supplies
Abbott Nutrition has stated that production at its Michigan factory could restart within two weeks once the FDA clears it for approval. A qualified third-party expert will be posted at the Michigan infant formula plant to supervise the safety standards of production. Once production resumes in full force, Abbott estimates that it will take between six and eight weeks to get the finished baby formula products on store shelves.
Meanwhile, the company will continue to import baby formula from an FDA-registered factory in Ireland to assist in easing the current supply shortage. Abbott has also increased formula manufacturing at two of its facilities in Ohio and Arizona.
Robert B. Ford, Chairman and Chief Executive Officer of Abbott, stated in a press release:
"Our number one priority is getting infants and families the high-quality formulas they need, and this is a major step toward re-opening our Sturgis facility so we can ease the nationwide formula shortage. We look forward to working with the FDA to quickly and safely re-open the facility."
Ford also issued an apology:
"We know millions of parents and caregivers depend on us and we're deeply sorry that our voluntary recall worsened the nationwide formula shortage. We will work hard to re-earn the trust that moms, dads and caregivers have placed in our formulas for more than 50 years."
What is the FDA's next course of action?
The FDA is also leading efforts to alleviate the critical baby formula shortage across the United States. Commissioner Robert Califf said in an FDA briefing:
"Our new guidance streamlines the ability for companies, including those that do not normally sell infant formula in this country, to make products available to the U.S. market. It provides other flexibilities to domestic distributors who can help increase availability [so] additional products can quickly hit U.S. stores."
Susan Mayne, Director of the FDA's Center for Food Safety and Applied Nutrition, emphasized the crucial regulatory standards for products that are permitted to be sold in the U.S. in comparison to those that are sold abroad.
Mayne said:
"We are casting a broad net. We are seeking manufacturers around the globe who may have available product that could meet our standards for both nutrition and food safety — to reach out to us let us know what they have available and we can discuss with them what that might look like to get that product into the US."
Frank Yiannas, the FDA's Deputy Commissioner for Food Policy & Response, has offered assurances that the FDA is "focused on getting as much product as possible on store shelves" and that they will not "rest until the infant formula market gets back to normal."