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.

Information Needed for Determining WIC-Eligible Foods

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)
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• 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.

Information for Determining WIC-Eligible Medical Foods

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).

WIC Food Packages and Maximum Monthly Allowances

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