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Clarification on Medical Documentation for Infant Formula Issued in Food Packages I and II

EO Guidance Document #
FNS-GD-2014-0004
FNS Document #
2014-1A
Resource type
Policy Memos
Guidance Documents
Resource Materials
PDF Icon Policy Memo (36.55 KB)
DATE:January 7, 2014
POLICY MEMO:WIC Policy Memorandum #2014-1A
SUBJECT:Clarification on Medical Documentation for Infant Formula Issued in Food Packages I and II
TO:Regional Directors
Special Nutrition Programs
All Regions
WIC State Agency Directors
All Regions

This policy memorandum is an addendum to WIC Policy Memorandum #2014-1, Changes to Abbott Infant Formula Product Line, issued on Dec. 4, 2013. Several WIC state agencies have requested clarification on the medical documentation requirements for infant formula issued in Food Package I and II. Therefore, this policy memorandum provides the request clarification.

Medical Documentation Requirements

Federal WIC regulations at 7 CFR 246.10(d)(2)(ii) provide a WIC state agency the discretion to require medical documentation for any contract brand infant formula, other than the primary brand, that it chooses to authorize for issuance, and to decide whether some contract brand infant formula is issued under any circumstances. Additionally, medical documentation is required for the issuance of any noncontract brand infant formula and for any contract brand infant formula that does not meet the requirements of Table 4 of 7 CFR. 246.10(e)(12).

Qualifying Conditions for Issuance of Infant Formula

WIC Food Packages I and II are intended for infant participants who do not have a condition qualifying them to receive Food Package III.

Both Food Packages I and II provide primary contract brand milk and soy-based infant formulas that meet the minimum nutrient requirements of Table 4 of 7 CFR 246.10(e)(12). At state agency option, the issuance of alternative infant formulas may be authorized to accommodate a variety of infant conditions that do not require the use of exempt infant formulas, consistent with federal WIC regulations, state agency policies, and infant formula rebate contract agreements with manufacturers. Such infant conditions include, but are not limited to: documented infant formula intolerances, food allergies or inappropriate growth patterns. WIC regulations will be revised to reflect this technical clarification.

In contrast, the WIC formulas (i.e., infant formula, exempt infant formula and WIC-eligible medical foods) prescribed to Food Package III participants provide nutritional support for specific conditions that are clinically serious or life-threatening, and are generally required for long periods of time. Examples of authorized and non-authorized qualifying conditions authorized in the program for the issuance of Food Package III are stated in 7 CFR 246.10(e)(3)(i-ii) of WIC regulations.

WIC state agencies must determine the qualifying conditions authorized in their program for the issuance of infant formula requiring medical documentation, in accordance with federal WIC regulations.

Please contact your respective regional office with any questions about the authorization, issuance and rebate of infant formula.

DEBRA A. WHITFORD
Director
Supplemental Food Programs Division

Page updated: November 21, 2023

The contents of this guidance document do not have the force and effect of law and are not meant to bind the public in any way. This document is intended only to provide clarity to the public regarding existing requirements under the law or agency policies.