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Letter to State Directors Regarding Infant Formula

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Technical Assistance & Guidance
Technical Assistance
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May 13, 2022

Dear State Health Commissioner:

On behalf of the United States Department of Agriculture (USDA), Food and Nutrition Service (FNS), I am writing to address the Abbott formula recall and its impact on the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). Over the last several months, we have worked closely with WIC state agencies to ensure that they have the information and flexibility necessary to respond to this unprecedented situation. USDA is acutely aware that the ongoing recall has left many parents and caregivers concerned about access to formula and how they will feed their babies.

Today, I am writing to reiterate the flexibilities that USDA has made available to all WIC state agencies and to urge all states to take additional action to make it easier for families to get the formula they need.

On Feb. 18, 2022, FNS issued recall-specific guidance to allow state agencies to take expedient action to ensure that WIC participants could exchange recalled product on hand, and use WIC benefits in their Electronic Benefits Transfer (EBT) balance or on paper WIC food instruments to purchase product that has not been recalled. State agencies should work with legal counsel, procurement offices, and infant formula rebate contractors to:

  1. Determine products that may be substituted for recalled products (e.g., an identical product that has not been recalled or a different physical form or container size of the same product, a different contract brand product, or a noncontract brand product).
  2. Develop processes for ensuring that all WIC participants can receive enough infant formula that has not been recalled (i.e., either by exchanging recalled product on hand, using WIC benefits to purchase product that has not been recalled, or obtaining product that has not been recalled through the state agency’s home delivery or direct distribution system).
  3. Communicate relevant information to WIC local agencies and clinics, participants, health care providers, and vendors.

The guidance also outlined the process to request waivers. To date, USDA has issued more than 200 regulatory waivers to WIC state agencies to allow maximum flexibility to respond to the recall. We have processed these waiver requests within two days, most within a workday. However, we continue to hear reports of WIC participants who are unable to purchase infant formula available on store shelves. In some situations, this is due to regulatory requirements that some state agencies have not requested to waive. Therefore, we request that you immediately review the actions your state agency has taken, including waivers requested (see WIC Infant Formula Recall Waivers), and ensure that the appropriate flexibilities are implemented in order to meet the needs of your WIC participants. The most commonly requested waivers are:

  • Maximum Monthly Allowance: A waiver to provide administrative flexibility to exceed the MMA (and to issue multiple container sizes and physical forms) for infants in food packages I and II. (Note: waivers related to food package III are also being considered, on a case-by-case basis.) We believe that this waiver is a critical source of flexibility in all states as both retailers and manufacturers work to manage nationwide changes in supply, and we request that each state agency review policies to ensure full flexibility.
  • Medical Documentation: A waiver to provide administrative flexibility to allow for the issuance of noncontract brand infant formula without medical documentation for infants in food packages I and II.
  • Vendor Exchanges: A waiver to allow WIC authorized vendors to treat WIC participants like all other customers when they exchange recalled product at the store.

Additionally, we ask that you review your WIC state agency’s policies and procedures related to minimum stocking requirements (MSR) for WIC authorized vendors (i.e., retail stores). All WIC state agencies should be working proactively and collaboratively with WIC authorized vendors during this unprecedented time, not unduly penalizing them as they work to keep up with demand in the face of shortages. Therefore, we request that your WIC state agency update its WIC MSR to remove requirements related to infant formula, if possible and in consultation with legal counsel, and/or forgo periodic assessments of vendor compliance with MSR until formula supply has normalized. Our hope is that removing this requirement in all states will facilitate improved distribution of available formula. More information about the flexibilities available to WIC state agencies related to MSR can be found in the Vendor Management & Food Delivery Handbook.

I recognize there are many uncertainties with this evolving situation and our nation’s infant formula supply. USDA is committed to continuing to meet with key stakeholders (e.g., formula manufacturers and vendor organizations) and providing technical assistance to and between WIC state agencies on issues as they arise. Next week, I’d like to invite you to a listening session with your fellow State Health Commissioners to hear about your specific challenges and promising practices to better inform potential solutions that will ensure that WIC participants receive the program’s important benefits. More details will follow on this opportunity.

I deeply appreciate your WIC staff’s work in response to the recall over the past several months and look forward to your continued efforts to ensure your WIC state agency is taking full advantage of the flexibilities USDA has made available. Please direct your WIC state agency to submit any waiver requests or additional technical assistance needs to its respective FNS regional office as soon as possible. I look forward to our continued partnership as we work together in support of the WIC Program.

Sincerely,

Stacy Dean
Deputy Under Secretary
Food, Nutrition, and Consumer Services
U.S. Department of Agriculture

Updated: 05/13/2022