WIC Flexibilities in Response to the Impact of a Tornado on Certain Mead Johnson Infant Formulas - MMA in Food Packages I and II

This letter is in response to the impact of a destructive tornado that hit Mount Vernon, Indiana on July 9, 2024, causing substantial damage to a Mead Johnson distribution center. As a result of this incident, Mead Johnson cited limited availability of certain sizes of the following contract brand infant formulas:

• Enfamil® Gentlease® (12.4 oz),
• Enfamil® A.R.™ (12.9 oz), and
• Enfamil® Reguline™ (12.4 oz).

Therefore, USDA has determined that affected WIC state agencies may need flexibility with regard to maximum monthly allowance requirements in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) as a result of a supply chain disruption.

To this end, USDA waives regulations at 7 CFR 246.10(e)(9) for affected state agencies contracted with Mead Johnson, pursuant to the authority granted under 7 CFR 246.29(b)(2)(ii), providing USDA with waiver authority during a supply chain disruption determined by the Secretary, as defined in 7 CFR 246.2. This approval applies to all affected state agencies that elect to use it, without further application. If the affected state agency elects to implement these flexibilities, it must notify its respective FNS regional office, which will acknowledge receipt. These waivers will remain in effect through Sept. 1, 2024. State agencies who have chosen to opt-in into these waivers may opt-out at any time prior to expiration of this waiver and must notify their respective regional office.

The waiver/modification being granted is only applicable to regulations at:

• 7 CFR 246.10(e)(9), which defines a maximum monthly allowance (MMA) for WIC formula.

Approval is granted to waive the MMA for WIC participants receiving Enfamil® Gentlease® (12.4 oz), Enfamil® A.R.™ (12.9 oz), and Enfamil® Reguline™ (12.4 oz) powder infant formulas in Food Packages I and II only. Under this waiver, WIC state agencies must authorize and issue infant formula containers in sizes that most closely provide the maximum monthly allowance, and do not create new supplemental food categories as set forth in 7 CFR 246.10(e)(12) Table 4. As applicable, the WIC Competent Professional Authority (CPA) should still perform a nutrition and breastfeeding assessment to ensure the correct formula and amounts are issued to the participant and documented. Approval is not granted to waive the maximum monthly allowance for the following supplemental foods and regulatory requirements:

• Any infant formula issued to infant participants in Food Package III (246.10(e)(9));
• Any exempt infant formula or WIC-eligible nutritional issued to infant participants in Food Package III (246.10(e)(9)); and
• Any supplemental foods (other than infant formula) issued to infant participants in Food Package I, II, and III (246.10)(e)(9)).

These waivers only apply to the affected state agencies contracted with Mead Johnson in response to a supply chain disruption as a result of the tornado impacting the availability of certain Mead Johnson contract brand infant formulas. Unless a state agency has additional active FNS waivers, all other federal WIC requirements must be met.

WIC state agencies should work with their legal counsel, procurement offices, and contract infant formula manufacturer, as appropriate.

USDA FNS appreciates WIC state agencies’ commitment to ensuring the availability of infant formula to WIC participants. State agencies may direct any questions related to this letter to their respective FNS regional office.

Sincerely,

Diane Kriviski
Associate Administrator
Supplemental Nutrition and Safety Programs