Abbott makes deal with FDA, says infant formula plant could reopen within weeks

The FDA and Abbott Nutrition released details of a deal this week that could lead to the reopening of an infant formula plant that was closed earlier this year amid a recall related to bacterial contamination.

The FDA also announced other updates and guidance pertaining to the ongoing infant formula shortage in the United States.

FDA Commissioner Robert M. Califf, MD, said the agency was “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,” Califf said.

Issues with the country’s formula supply began in February after the FDA warned consumers against using powdered infant formulas produced at Abbott’s plant in Sturgis, Michigan. The company ceased production and initiated a voluntary recall of certain products after the FDA found evidence of Cronobacter sakazakii in non-product contact areas of the plant.

Researchers have identified powdered infant formula as the source of a significant increase in invasive Cronobacter infections in recent years.

On Monday, a proposed consent decree of permanent injunction between the FDA and Abbot 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 FDA said in a release. “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.”

Abbott said the agreement created a pathway to reopen the facility within 2 weeks of the FDA confirming that the requirements for a start-up have been met. The company said it would take 6 to 8 more weeks before any product is available on shelves.

In the meantime, the FDA is putting guides in place for international importation of formula products.

“[This] 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,” Califf said. “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.”

When reached for comment, the AAP directed Healio to a Q&A by Steven A. Abrams, MD, FAAP, professor of pediatrics at the University of Texas at Austin and a past chair of the AAP’s National Committee on Nutrition.

For those struggling to find formula in “urgent” situations, Abrams suggested “check[ing] smaller stores and drug stores,” as well as buying formula online. He said that “for most babies, it is OK to switch to any available formula, including store brands,” unless a child is on a “specific extensively hydrolyzed or amino acid-based formula such as EleCare.”

Abrams noted that the AAP advised against watering down baby formula, creating a homemade formula, substituting toddler formula and using plant-based milk. He also addressed whether cow’s milk was a safe alternative.

“If your child is older than 6 months of age and is usually on regular formula [not a specialty product for allergies or other special health needs], this may be an option,” Abrams wrote. “In a pinch, you could feed them whole cow's milk for a brief period of time until the shortage is better. This is not ideal and should not become routine. However, it is a better option than diluting formula or making homemade formula.”

References:

Abbott enters into consent decree with U.S. Food and Drug Administration for its Sturgis, Mich., plant; agreement creates pathway to reopen facility. https://abbott.mediaroom.com/2022-05-16-Abbott-Enters-into-Consent-Decree-with-U-S-Food-and-Drug-Administration-for-its-Sturgis,-Mich-,-Plant-Agreement-Creates-Pathway-to-Reopen-Facility. Published May 16, 2022. Accessed May 16, 2022.

Abrams, S. With the baby formula shortage, what should I do if I can't find any? https://www.healthychildren.org/English/tips-tools/ask-the-pediatrician/Pages/are-there-shortages-of-infant-formula-due-to-COVID-19.aspx. Published May 16, 2022. Accessed May 18, 2022.

FDA. FDA encourages importation of safe infant formula and other flexibilities to further increase availability. https://www.fda.gov/news-events/press-announcements/fda-encourages-importation-safe-infant-formula-and-other-flexibilities-further-increase-availability?utm_medium=email&utm_source=govdelivery. Published May 16, 2022. Accessed May 18, 2022.