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Women, Infants and Children (WIC)

Information for Food Manufacturers regarding the WIC Food Packages

Last Modified: 09/05/2014

Federal Regulatory requirements for WIC-Eligible Foods

WIC Regulations are published by the Federal Register in the Code of Federal Regulations,
7 CFR Part 246.10. Modifications have been made under a final rule published March 4, 2014.

How do I get a food product on a State WIC Program's Approved Food List?
What information should a food manufacturer send to a WIC State Agency for consideration?
What information is needed for determining WIC-Eligible Infant Formulas and Exempt Infant Formulas?
What information is needed for determining WIC-Eligible Nutritionals?
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 product on a State WIC Program's Approved Food List?


Manufacturers may submit product information to WIC State agencies. It is each 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.

When making decisions about which types, brands, and physical forms of WIC-eligible foods to authorize, State agencies consider factors such as:

• Nutrient profile
• Price
• Product availability in a State
• Container size
• WIC participant acceptance
• Program management costs
 

The maximum monthly allowances of WIC foods (For Children and Women and For Infants in Food Packages I, II and III) 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.

 

What information should a food manufacturer send to a WIC State Agency for consideration?


  • 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).

     WIC State agencies may request additional information consistent with their State-specific WIC food criteria (i.e. processing method)

     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.

 

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.
  • Under section 412 of the Federal Food, Drug and Cosmetic Act, a manufacturer who intends to market a new infant formula in the United States must register with; must notify; and must submit written verification to FDA.

Product Description

  • Is the product a new formula or a reformulation of an existing product? Information about Food and Drug Administration’s regulation of infant formula and exempt infant formula notification process can be found at http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/InfantFormula/ucm1    69730.htm (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 need to be re-evaluated for WIC-eligibility.)
  • The product meets the definition of an exempt infant formula or infant formula in section 412 (h) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 350a(h)) or section 201(z) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 321(z)).
  • The product has been introduced into interstate commerce (via a point of sale either online and/or retail), which means that the product meets the requirements for an infant formula under section 412 of the Federal Food, Drug and Cosmetic Act, as amended (21 U.S.C. 350a) and the regulations at 21 CFR parts 106 and 107.
  • The product is intended for enteral digestion and it can be used as an oral and/or tube feeding.
  • The product is nutritionally complete, not requiring the addition of any ingredients other than water before being served in a liquid state.
  • WIC-Eligibility category (infant formula, exempt infant formula).
  • Product type (standard milk-based, soy-based, hydrolyzed milk-protein, amino acid-based, etc.).
  • Electronic product labels for each physical form which should include nutrient level and an ingredient listing.
  • Nutrient composition of each physical form including caloric content. (This should include iron content in terms of milligrams per liter or milligrams per kilocalories of formula and the calorie content in terms of kilocalories per reconstituted fluid ounce of formula, such as 20 kcal/oz.).
  • Indication for product use in WIC (e.g. prematurity, inborn errors of metabolism, malabsorption syndromes, etc.
  • Recommended age of use.
  • Physical form of product (i.e., liquid concentrate, powder, ready-to-feed).
  • If product comes in additional flavors.
  • Other product information: the product’s special characteristics; how the product should be prepared/ served.

Packaging/Yield

  • Identification of the different product container sizes, unit type (e.g., can, bottle, etc.), and packaging (e.g., single units versus multiple-packs or cases).
  • Universal Product Code (UPC).
  • Price List
  • Reconstituted yield (e.g., total fluid ounces), as consumed, per container and/or package size of product.

Availability

  • Where the product is available (e.g., from pharmacies, grocery stores, directly from the manufacturer, etc.).

 

What information is needed for determining WIC-Eligible Nutritionals?


Regulatory requirements for WIC-Eligible Nutritionals

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

  • The product is intended for enteral digestion and it can be used as both an oral and/or tube feeding.  WIC-Eligibility category (i.e., WIC-Eligible Nutritionals ); medical documentation required for issuance.
  • Product type (e.g., amino acid-based, inborn errors of metabolism, etc.).
  • The product provides a source of calories and one or more nutrients (may be nutritionally complete or incomplete).
  • Electronic product labels for each physical form which should include nutrient level and ingredient listing.
  • Nutrient composition of each physical form including caloric content (the calorie content in terms of kilocalories per reconstituted fluid ounce of formula (e.g., 20 kcal/oz)).
  • Intended uses of the product, including identification of the types of medical conditions for which the product was designed (e.g., inborn errors of metabolism, malabsorption syndromes, severe food allergies, etc.).
  • Recommended age of use.
  • Physical form (e.g., liquid concentrate, powder, ready-to-feed or ready-to-use).
  • If product comes in additional flavors.  
  • Other product information: the product’s special characteristics: how the product should be prepared/ served.

Packaging/Yield

  • Identification of the different product container sizes, unit type (e.g. can, bottle, sachet, etc.), and packaging (e.g., single units versus multiple-packs or cases).
  • Universal Product Code (UPC).
  • Price List
  • Product reconstituted yield, as consumed, per container and/or package size of product or per standard preparation guidelines/ common dosage recipe.

Availability

  • Where the product is available (e.g., from pharmacies, grocery stores, directly from manufacturers, etc.).

Not Allowed

  • Formulas used solely for the purpose of enhancing nutrient intake or managing body weight addressing picky eaters or used for a condition other than a qualifying condition (e.g., vitamin pills, weight control products).
  • Medicines or drugs.
  • Hyperalimentation feedings (nourishment administered through a vein).
  • May not be a conventional food.
  • Enzymes, herbs, or botanicals.
  • Oral rehydration fluids or electrolyte solutions.
  • Flavoring or thickening agents.
  • Feeding utensils or devices (e.g., feeding tubes, bags, pumps) designed to administer a WIC-eligible formula.
  • Sports or breakfast drinks.

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.