TECHNICAL ASSISTANCE NOTE
No. 2005-30
Contact:
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Irene Wimbush
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School Business Services
FOOD AND NUTRITION MANAGEMENT
(850) 245-9334
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John L. Winn, Commissioner
(800) 504-6609
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DATE: March 25, 2005
TO: Sponsors the National School Lunch and School Breakfast Programs
FROM: Diane Santoro, Administrator
Food and Nutrition Management (FNM)
SUBJECT: Clarification on Acceptable Infant Formulas
The Florida Department of Education’s goal of “Highest Student Achievement” is one of the top
priorities of Food and Nutrition Management. The following are questions and answers issued by the
United States Department of Agriculture (USDA), Child Nutrition Division (CND), in response to
questions from a State agency regarding infant formula.
1.
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Must a formula served in the National School Lunch Program (NSLP) and the School Breakfast
Program (SBP) be from the current approved list of the
Iron-Fortified Infant Formulas That Do
Not Require a Medical Statement?
No. The current list of
Iron-Fortified Infant Formulas That Do Not Require a Medical Statement
is
NOT an all-inclusive list, because new infant formula products are continually being developed.
According to the NSLP regulations, 7 CFR 210.10-41, and SBP regulations, 7 CFR 220.08-08,
“either breast milk or iron-fortified infant formula, or portions of both, must be served for the entire
first year.” Any product labeled as an iron-fortified infant formula, legally must meet the Food and
Drug Administration (FDA) definition, 21 CFR 107.10(b)(4)(i), as a product “which contains 1
milligram or more of iron in a quantity of product that supplies 100 kilocalories when prepared in
accordance with label directions for infant consumption.” The number of milligrams of iron per
100 kilocalories of formula can be found on the nutrition label.
2.
Must a Program sponsor have a medical statement on file for an infant formula to be part of a
reimbursable meal?
TAN 2005-30
March 25, 2005
Page 2
If a formula is not on the current list of
Iron-Fortified Infant Formulas That Do Not Require a
Medical Statement
, a Program sponsor may use the following criteria to determine whether or not a
formula is reimbursable under the NSLP/SBP without a medical statement:
a)
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Ensure that the formula is not listed as an FDA Exempt Infant Formula. An exempt infant
formula is an infant formula labeled for use by infants who have inborn errors of metabolism
or low birth weight, or who otherwise have unusual medical or dietary problems (21 CFR
107.3). Formulas classified as Exempt Infant Formulas by FDA require a medical statement
in order to be served to infants under the NSLP/SBP as part of a reimbursable meal. A
medical statement must be signed by a licensed physician if an infant is considered disabled
according to USDA’s regulation, or a recognized medical authority specified by the State
agency if an infant has medical or other special dietary needs. To check whether or not an
infant formula is an FDA Exempt Infant formula, visit FDA’s website at
.
b)
c)
specifications listed in FDA Regulation, 21 CFR 107
and in Section 412 of the Food, Drug, and
.
http://www.cfsan.fda.gov/~dms/inf-exmp.html
Examine the nutrition label to make sure that the formula is iron-fortified. The statement
“Infant Formula with Iron” or a similar statement must be on the label.
Be aware of the fact that all infant formulas marketed in the United States must meet the nutrient
http://www.cfsan.fda.gov/~lrd/cfr107.html#spD
Cosmetic Act http://www.fda.gov/opacom/laws/fdcact/fdcact4.htm#sec412
If a formula is
purchased outside of the United States, it is likely that the formula is not regulated by FDA;
therefore, it may not be creditable under the NSLP/SBP.
The nutritive values of each formula are listed on the product’s nutrition label. Infant
formula manufacturers may have their own proprietary formulations, but they must contain
at least the minimum levels of all nutrients specified in FDA regulations without exceeding
maximum levels, when maximum levels are specified.
d)
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Also be aware that manufacturers of infant formula are required by FDA regulation to follow
current Good Manufacturing Practices, including quality control procedures to assure that
the infant formula provides nutrients in accordance with Section 412 of the Food, Drug, and
Cosmetic Act, and to assure that the infant formula is manufactured in a manner designed to
prevent adulteration.
A child care provider can serve a formula if the exact product is on the current list of the
Iron
Fortified Infant Formulas
without obtaining a medical statement.
A State agency has asked for guidance regarding two specific brands of infant formulas and
their creditability. Similac Advance is an iron-fortified infant formula that is currently
TAN 2005-30
March 25, 2005
Page 3
included on the list of
Iron-Fortified Infant Formulas That Do Not Require a Medical
Statement.
Similac Alimentum Advanced is an infant formula that is on the FDA Exempt
Infant Formula list; therefore, it is not creditable unless supported by a statement from a
licensed physician or a recognized medical authority specified by the State agency as
appropriate that indicates the need for this special formula.
If a Program sponsor is not sure whether or not an infant formula is creditable under the
NSLP/SBP, Food and Nutrition Management (FNM) should be contacted for assistance.
3.
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Can you provide guidance about a formula supplied by a parent that is not iron-fortified? Would
service of this product require a medical statement in order to be creditable for a reimbursable meal
for an infant?
As stated above, according to 7 CFR 210.10-41 and 220.08-08, “either breast milk or iron-fortified
formula, or portions of both, must be served for the entire first year.” In addition, Page 24 of
Feeding Infants: A Guide for Use in the Child Nutrition Programs,
Paragraph 2, states that low-
iron formulas do not meet the meal pattern and may be served as a dietary substitution only if an
infant is unable to consume iron-fortified infant formula because of medical or other special dietary
needs. The substitution can only be made when supported by a statement from a licensed physician
or a recognized medical authority that indicates the recommended infant formula. These rules
apply to formula provided by the NSLP/SBP facility and to formula provided by the parent.
If you have questions, please contact Irene Wimbush at 1-800-504-6609 or irene.wimbush@fldoe.org.
DS/IW/set
