Letter to Xavier Becerra, Secretary of Health and Human Services, and Robert Califf, Commissioner of the Food and Drug Administration - Requesting Answers, Action in Baby Formula Shortage

Letter

Dear Secretary Becerra and Commissioner Califf:

We write to you today deeply concerned about the infant formula shortage. No parent should have to worry about being able to feed their newborn. As parents, we know how scary these shortages are for families reliant on formula. We're frustrated by months of inaction that have further compounded existing supply chain challenges. We need rapid response from the Administration to alleviate this current crisis and mechanisms in place to ensure a crisis like this never happens again.

This was preventable. The Food and Drug Administration (FDA) first learned about suspected illnesses linked to formula from a plant in Sturgis, Michigan in September 2021. Abbott received additional complaints from September through January, yet it took until February 2022 for a voluntary recall and FDA investigation. Amidst broader supply chain issues in this country, it should have been anticipated that significantly reducing production capacity could lead to shortages.

Formula is essential to the majority of families with babies. According to the Centers for Disease Control and Prevention (CDC), nearly one in five newborns receive formula within their first two days of life.1 Breastfed babies use formula as they wean- by three months, more than half of the babies in the United States use some sort of formula supplement, and they require that supplement until their first birthday. Babies with severe food allergies or gastrointestinal problems are often entirely dependent on specialized formulas.

Every option to increase supply in the short-term needs to be on the table. And we need to understand what led to this current situation to prevent future shortages.

Specifically, we ask that you please respond to the following questions:

- The FDA first issued a warning in February after the voluntary recall initiated by Abbott. What steps were taken at that time to mitigate supply challenges?

- What actions are routinely taken at the FDA to monitor voluntary recalls? Who has oversight of how recalls will impact supply chains?

- In 2017 the Inspector General found that the FDA has "serious deficiencies with its food recall process" and that the "FDA does not have adequate procedures to ensure that firms take prompt and effective action."2 What steps have been taken to improve the process and which recommendations have been implemented?

- Advanced notification of potential shortages could help trigger emergency production. What mechanisms are in place to provide notifications of potential infant formula shortages? What is the current process for manufactures to alert the FDA of anticipated production challenges?

- What is the status of FDA action to allow the reopening of the Michigan facility? When did the facility request to reopen and what actions have been taken to prioritize inspections of facilities producing infant formula products?

- The Defense Production Act is a known tool for jumpstarting production if there are other facilities or manufacturers who can step in to fill the supply gap. Was there any communication between FDA and the White House regarding the use of the Defense Production Act in February when the potential for shortages first became apparent? Has there been any communication with the White House on using the Defense Production Act during this acute shortage?

- What can the Office of the Assistant Secretary for Preparedness and Response (ASPR) do now to ensure we have a backstop supply in an emergency? What, if anything, is preventing ASPR from having a stockpile of infant formula--particularly medically necessary ones--for emergencies?

- What is being done to communicate with parents about how to access formula and how to safely feed formula dependent children during this significant shortage?

When there is a voluntary recall of essential nutrition that can impact the whole nation, we need to ensure we are equipped to take quick action. We have mechanisms in place in other supply chains to trigger rapid response to shortages that we believe we should also have in place for infant formula. This was a preventable crisis. Families depend on a consistent, safe supply of infant formula and it is our responsibility to do everything we can to alleviate this crisis.

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