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Addressing the Baby Formula Shortage: FDA Powers Explained

May 16, 2022, 8:24 PMUpdated: May 17, 2022, 12:46 AM

The Food and Drug Administration announced new steps to ease the import of baby formula following a nationwide supply chain shortage that has the White House and Congress clamoring to provide answers.

The agency said in new guidance Monday that it’s allowing suppliers abroad to apply to import their infant formula into the US, and the FDA will determine on a case-by-case basis whether a foreign product is safe and provides adequate nutrition.

“The FDA is leaving no stone unturned to further increase the availability of infant formula,” FDA Commissioner Robert Califf said in a statement. “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.”

Here’s a look at the reasons behind the shortage and where the FDA stands in addressing it.

1. Why is there a shortage?

Abbott Laboratories recalled Similac and other top-selling baby formula brands in February following reports of four infants falling ill, including two who died, after consuming formula from a Michigan factory. Federal inspectors noted during a routine inspection in September 2021, that it was possible that formula from the factory was contaminated by cronobacter, a pathogen.

In January FDA inspectors returned to the Michigan factory. Abbott issued its recall during the inspection and shut down production. Abbott maintains that its product didn’t make the infants sick.

The halt on production worsened shortages that had arisen earlier from Covid-related supply chain issues.

2. What is the FDA doing so far?

The FDA said Monday that it’s already in discussion with manufacturers and suppliers regarding additional supply. In its review of applications for foreign importations, the FDA said it will prioritize “submissions for products that can demonstrate the safety and nutritional adequacy and have the largest volume of product available and/or those who can get product onto U.S. shelves the quickest.”

Prior to Abbott’s recall, the FDA was working on pandemic-related supply chain issues impacting the baby formula industry. The agency said in a press announcement May 10 that it’s meeting with major manufacturers to ramp up formula production and speeding up reviews of manufacturing change notifications.

The FDA also said it is expediting certificates for the import of “already permitted” products and compiling data to understand what areas are most at-need.

Abbott on Monday agreed to enter into a consent decree with US regulators outlining the steps needed for it to reopen its baby formula plant in Sturgis, Mich. The proposed agreement requires Abbott to retain an independent expert to review the facility’s operation, and implement a new employee training program, among other actions.

The company said it could restart formula production in weeks and get its products on shelves pending FDA clearance, Bloomberg reported.

3. What is the agency required to do?

Infant formulas don’t need to be approved by the FDA before they’re marketed.

However, manufacturers must meet certain nutritional requirements in the Federal Food, Drug, and Cosmetic Act and additional FDA regulations. Baby formula makers must also notify the FDA of any new product before it’s marketed, according to the FDA’s website.

The FDA can take compliance action against a manufacturer of any “adulterated” infant formulas or those for which the manufacturer doesn’t “provide the elements and assurances required in the notification for a new or reformulated infant formula.”

4. Who else is involved?

Senior administration officials said in a call with reporters Monday that the White House has alerted embassies, retailers, and manufacturers to identify potential companies that could participate in the flexible importation process. The administration also worked throughout the weekend with manufacturers and retailers to identify transportation and logistical needs to increase the availability of infant formula across the country, the officials said.

The House is expected to vote this week on two measures aimed at ameliorating the infant formula shortage. One would approve emergency funding.

The other would give emergency authority for the US Department of Agriculture’s Special Supplemental Nutrition Program for Women, Infants, and Children (WIC), which is administered by states that have contracts to purchase Abbott’s formula. That measure would allow the program to relax certain non-safety regulations around baby formula.

To Learn More:

—From Bloomberg Law:

Baby Formula Shortage Sparks Democratic Inquiry, GOP Attack

—From Bloomberg News:

Abbott in Pact With US on Steps to Reopen Baby-Formula Plant

Baby-Formula Shortage Spurs US to Prod Abbott Over Access

Tainted Baby-Formula Risk Was Seen Months Before Abbott’s Recall

Biden Under Fire for FDA’s Delay in Fixing Baby Formula Shortage

Abbott Infant Formula Plant Found Unsanitary Before Recall

Biden Seeks to Quell Baby Formula Crisis With Logistics Help

(Updates with new developments and details throughout.)

To contact the reporters on this story: Celine Castronuovo at ccastronuovo@bloombergindustry.com; Ian Lopez in Washington at ilopez@bloomberglaw.com

To contact the editors responsible for this story: Alexis Kramer at akramer@bloomberglaw.com; Fawn Johnson at fjohnson@bloombergindustry.com