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Infant Formula Shortage Flexibilities

Published: 89 days ago
" November 1, 2022 - Given the recent infant formula shortages threatening the nutritional quality of meals served to infants in the care of CACFP operators, the Food and Drug Administration (FDA), is temporarily allowing the import of certain infant formula products from abroad. USDA has issued recent guidance about the allowable use of imported infant formula within the CACFP.
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November 1, 2022 - Given the recent infant formula shortages threatening the nutritional quality of meals served to infants in the care of CACFP operators, the Food and Drug Administration (FDA), is temporarily allowing the import of certain infant formula products from abroad.

Per program regulations, infant formula served in CACFP is creditable if it is iron-fortified (containing at least 1 mg of iron per 100 calories, as prepared); is mixed in the proportions recommended (not diluted); and is regulated by the FDA. On this last point, Infant formulas imported into the U.S. as a result of the 2022 FDA Infant Formula Enforcement Discretion Policy have been determined to be nutritionally adequate and safe by the FDA, and thus meet the intent of FDA regulation. Therefore, imported formulas that are iron-fortified and are mixed in the proportions recommended can be included as part of a reimbursable meal in CACFP.

The FDA is permitting the formulas approved for enforcement discretion to be imported to the U.S. until January 6, 2023, and FDA’s continued exercise of enforcement after January 6, 2023 will be made on a case-by-case basis.
  • After January 6, 2023, imported formulas are creditable as long as they are available for sale in the U.S. retail market and utilized prior to the formula expiration date.
  • TDA will continue to provide guidance and technical assistance as the January 6 deadline approaches.

It is important to note that the mixing instructions on formulas imported from abroad may use the metric system; CACFP operators should be cognizant of this measurement difference and ensure formulas are appropriately and safely mixed.

Best practices for the use of infant formula include:
  • Infant formula for the CACFP should only be purchased from reputable retailers such as local, regional or national grocers, pharmacies, or membership-based warehouses. Purchases may be made in-person or online from these retailers.
  • For those used to using a specific general brand (one that is not designed for a specialized medical need), it is safe to use different brands as available (Note that it may take some time for an infant to adjust to a new formula; parents may wish to contact their child’s pediatrician with questions about whether the infant is tolerating a particular formula.)
  • Homemade infant formulas are not regulated by the FDA and are not creditable under any circumstances in the CACFP.
  • Parents may supply the infant formula for the reimbursable meal if this practice complies with State and local health codes. However, parents or guardians cannot donate formula or food they receive through WIC to the center or day care home for general use.
  • CACFP institutions may receive donations of food items to meet any component of a reimbursable meal, including formula. However, institutions should be mindful of expiration dates, evidence of potential tampering, and other potential food safety issues when using donated foods in CACFP meals.
  • Please notify your ESC if you are unable to procure formula that meets the standards described in this FAQ.

For additional information, refer to the following resources:
 

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Program information may be made available in languages other than English. Persons with disabilities who require alternative means of communication to obtain program information (e.g., Braille, large print, audiotape, American Sign Language), should contact the responsible state or local agency that administers the program or USDA’s TARGET Center at (202) 720-2600 (voice and TTY) or contact USDA through the Federal Relay Service at (800) 877-8339.

To file a program discrimination complaint, a Complainant should complete a Form AD-3027, USDA Program Discrimination Complaint Form which can be obtained online at: https://www.usda.gov/sites/default/files/documents/USDA-OASCR%20P-Complaint-Form-0508-0002-508-11-28-17Fax2Mail.pdf, from any USDA office, by calling (866) 632-9992, or by writing a letter addressed to USDA. The letter must contain the complainant’s name, address, telephone number, and a written description of the alleged discriminatory action in sufficient detail to inform the Assistant Secretary for Civil Rights (ASCR) about the nature and date of an alleged civil rights violation. The completed AD-3027 form or letter must be submitted to USDA by:

1. Mail:
U.S. Department of Agriculture
Office of the Assistant Secretary for Civil Rights
1400 Independence Avenue, SW
Washington, D.C. 20250-9410; or
2. Fax: (833) 256-1665 or (202) 690-7442; or
 
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