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Information for Food Manufacturers
regarding the WIC Food Packages
How do I get a food
evaluated for WIC eligibility?
Information Needed for Determining WIC-Eligible Foods
Information Needed for Determining WIC-Eligible
Infant Formulas and Exempt Infant Formulas
Information for Determining WIC-Eligible Medical Foods
How do I get a food added to
the WIC food packages?
What are the WIC food
packages and maximum monthly allowances?
How do I get a food evaluated for WIC eligibility?
It is the WIC State agency’s responsibility to identify
foods that are acceptable for use in its WIC Program in accordance with
Federal WIC regulations
7 CFR Part 246.10. In addition, WIC-eligible
food products must comply with all applicable Federal, State, and local
laws and regulations governing these products. State agencies use these
requirements when determining which WIC-eligible foods to approve for
their State WIC food lists. State agencies consider factors such as
price, product availability in a State, WIC participant acceptance, and
program management costs when making decisions about which types,
brands, and physical forms of WIC-eligible foods to authorize.
The maximum monthly allowances of WIC foods affect which
container sizes and physical forms of WIC foods State agencies may
authorize for the Program. State agencies are required to authorize
container sizes that provide the full maximum monthly allowance of foods
without exceeding the maximum.
Manufacturers may submit product information to
WIC
State agencies. The following
guidelines provide the general type of information needed by the State
agency in order to determine WIC-eligibility status. WIC State agencies
may request additional information consistent with their State-specific
WIC food criteria. Manufacturers that request WIC State agencies to
include their products on State-approved WIC food lists have a
responsibility to inform those State agencies about any changes in the
products’ formulation or nutritional value. A State agency does not have to approve all
foods that meet WIC eligibility requirements. Manufacturers may
also submit product information to the
Food and
Nutrition Service for WIC-eligibility determination. The same
guidelines for submission apply.
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Regulatory
requirements for WIC-Eligible Foods
-
Electronic copies of
actual package flats or labels for the product. For those foods that must comply with
the Nutrition Labeling and Education Act of 1990 and relevant Food and
Drug Administration (FDA) labeling regulations (21 CFR Parts 100-169),
include electronic copies of the Nutrition Facts panels. Files should be
JPG or GIF formats.
- Universal Product Code (UPC)
.
-
Nutrient profiles for the product, in
the form as sold or at standard dilution (if relevant), expressed in
metric measurements in accordance with applicable Federal WIC
regulations (7 CFR Part 246.10).
-
Ingredients of the product, listed in
decreasing order of predominance by weight.
-
Include written verification that the
product meets Federal WIC requirements. For example, is the juice 100%
fruit/vegetable juice; what is the vitamin C fortification level in
milligrams per 100 milliliters?
-
Copies of product literature, if
available, providing additional details about the development and/or
intended use of the product, such as brochures or monographs.
-
Available forms of the product.
-
Types and sizes of all product
package containers.
-
Average/suggested retail prices for
the product per container size.
-
Date when the product will be
available on the market, if it is a new item.
-
Expected or current geographic and
store distribution of the product (e.g., confirmation that the product
is or will be available nationally or just in certain states or regions
of the United States and its territories and a list of the major chain
stores that will sell or currently sell the product).
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Regulatory requirements for infant formulas/exempt infant formulas
Manufacturer Information
-
Precise brand name of the product,
including the name of the manufacturer.
-
Name and phone number of the
manufacturer representative who the WIC State agency should contact to
purchase the product directly from the manufacturer.
Product Description
-
Is the product a new formula or a reformulation of an
existing product? (Please note: any reformulation that would meet the
definition of a "major change" to the formula per section 412(c)(2)(B)
of the Federal Food and Drug Cosmetic Act at 21 CFR 106.30(c)(2), such
as the addition of a new ingredient or a significant change in the
amount of protein, fat or carbohydrate, will be re-evaluated for WIC-eligibility.)
Whether the product is intended for
enteral digestion and whether if can be used as both an oral and tube
feeding.
Whether the product is nutritionally
complete, not requiring the addition of any ingredients other than water
before being served in a liquid state.
Electronic product labels for each
physical form, flavor, and variety of the product, which should include
nutrient level and an ingredient listing. Files should be JPG or GIF
formats.
Nutrient composition of each physical
form, flavor, and variety of product, including caloric content. (The
following should be confirmed in writing for the product at standard
dilution: iron content in terms of milligrams per liter of formula; and
the calorie content in terms of kilocalories per 100 milliliters of
formula.)
Yield (e.g., total fluid ounces), as
consumed, per container of product.
Product literature describing: the
product’s special characteristics; how the product should be
prepared/served; intended uses of the product, including identification
of the types of medical conditions for which the product was designed.
Copies of the correspondence FDA sent
to the manufacturer confirming: how the product is classified by FDA
(i.e., infant formula or exempt infant formula); that the product
complies with the Infant Formula Act of 1980, as amended, and that FDA
does not object to the product being marketed in the U.S.; and whether
there are any outstanding concerns FDA has about the product information
under review (e.g., product claims or label format).
Physical Form
Identification of the different
product container sizes, types, and packaging.
Whether the product is sold in single
units versus multiple-packs or cases.
Availability
Whether the product is available
nationally or only in certain geographic areas.
Where the product is available (e.g.,
from pharmacies, grocery stores, or directly from the manufacturer).
Infant formula, exempt infant formula and medical foods
that have been reviewed by the National Office and have been determined
to meet the minimum Federal regulatory requirements and therefore are
WIC-eligible will be listed on the WIC Formula database found at:
http://www.nal.usda.gov/wicworks/Databases/formula_database.html.
We will request a written description of the following five data fields
to ensure the WIC formula database accurately reflects your product(s).
The five data fields include manufacturer name, product name, brief
description, indication for use in WIC, and form (powder, liquid
concentrate, etc.). The language used in the field labeled "Use in
WIC" may be limited to reflect authorized uses in the Program.
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Regulatory
requirements for WIC-Eligible Medical Foods
Manufacturer Information
- Precise brand name of the product, including the name of the
manufacturer.
- Name and phone number of the manufacturer representative who the
WIC State Agency should contact to purchase the product directly
from the manufacturer.
Product Description
- Whether the product is intended for enteral digestion and
whether it can be used as both an oral and tube feeding.
- Whether the medical food serves the purpose of a food, meal or
diet (may be nutritionally complete or incomplete).
- Whether the product provides a source of calories and one or
more nutrients (may not be a conventional food, drug, flavoring or
enzyme).
- Electronic product labels for each physical form, flavor and
variety of the product, which should include an ingredient listing.
- Nutrient composition of each physical form, flavor, and variety
of product, including caloric content.
- Product yield, as consumed, per container of product.
- Product literature describing the identification of the types of
medical conditions for which the product was designed.
- Additional product literature describing the product’s special
characteristics: how the product should be prepared/ served and
intended uses of the product.
Physical Form
- Identification of the different product container sizes, types,
and packaging.
- Whether the product is sold in single units versus
multiple-packs or cases.
Availability
- Whether the product is available nationally or only in certain
geographic areas.
- Where the product is available (e.g., from pharmacies, grocery
stores, or directly from manufacturers).
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How do I get a food added to the WIC food packages?
Any changes or additions to the WIC-eligible foods as
identified in WIC Federal Regulations 7 CFR Part 246.10. require
regulatory or legislative action.
What are the WIC food packages
and maximum monthly allowances?
WIC Food Packages
and Maximum Monthly Allowances
Back to the Top
Back to WIC Food Package
main page
Last modified 05/09/12 |
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