Letter to WIC State Agencies on Infant Formula Flexibilities for Food Package III

Dear State WIC Director:

We are writing to thank you for your work in supporting WIC participants during the infant formula shortage and your partnership in transitioning back to regular program operations. We remain committed to working as partners to ensure that WIC participants have access to the formula they need.

On June 30, 2023, the United States Department of Agriculture (USDA) Food and Nutrition Service (FNS) will complete the final phase of "Unwinding Infant Formula Flexibilities in WIC" as outlined in WIC Policy Memorandum #2023-3. The following waivers will expire at the end of this month:

• Waivers for maximum monthly allowance (MMA) for Food Package III, which allow medically-fragile infants to receive alternate container sizes, including those that are larger than usually allowed.
• Waivers for imported infant formula under FDA’s Infant Formula Enforcement Discretion, which allow medically-fragile infants receiving Food Package III to receive certain imported formulas.

Companies that notified the FDA of their intent to take steps for imported specialty (exempt) formulas to remain on the United States market do meet the requirements that infant formula issued by WIC state agencies is only obtained from manufacturers registered with the FDA (42 USC 1786(f)(15)(A), 42 USC 1786 (h)(8)(ix)(II), 7 CFR 246.10(g), and 7 CFR 246.12(g)(10)). These products include:

WIC state agencies are encouraged to keep these, and all specialty infant formulas marketed in the United States, on their Authorized Products List to ensure that medically-fragile infants have access to critical nutrition needs.

In addition, WIC state agencies may utilize any of the following flexibilities related to medical documentation for Food Package III to support access to specialty formulas, including:

• Obtaining medical documentation over the phone (verbal order) instead of written medical documentation. Consistent with 7 CFR 246.10(d)(4)(iii)(B), medical documentation over the phone must be followed up with written documentation within a reasonable amount of time (i.e., 1-2 weeks). If additional time is needed, please reach out to your FNS regional office for guidance.
• Advising health care providers that they may prescribe multiple WIC formulas on the WIC medical documentation form to provide participants with maximum redemption options. Providing the WIC state agency’s current list of state authorized formulas to health care providers may be helpful.
• Streamlining the WIC medical documentation form to list product specific options (e.g., create a list of state authorized formulas, including all authorized store brand products, with check boxes) that may assist the health care provider to quickly complete and return the medical documentation form to WIC.
• Establishing a way for health care providers to submit medical documentation to WIC directly (e.g., hospital system and WIC state agency coordinate to identify point of contacts at the hospital that can offer medical documentation over the phone for WIC participants, provided that the healthcare professional is licensed by the state to write prescriptions, eliminating the need for individual calls to doctor’s offices; or other data sharing mechanism).

Again, thank you for the work you and your staff do every day to meet the needs of your participants. We appreciate your commitment and ongoing partnership.