IFC Guidance Regarding Unsaleable Infant Formula Products
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Infant formula is the most highly regulated food in the world and continues to be the only safe, nutritious and recommended alternative to breast milk. Because it is often a sole-source food product for newborn babies, its nutrient content is critical to support a baby’s proper growth and development. To ensure appropriate nutrient levels and delivery throughout shelf life, infant formulas are made according to Good Manufacturing Practices. Suppliers of ingredients and packaging go through a rigorous qualification process, and clinical studies are performed to validate the safety and nutritional adequacy of each formula for its intended use.
Infant formula manufacturers take their responsibility to provide safe and nutritious infant formula to millions of infants every day very seriously. These manufacturers are dedicated to selling quality goods, with sufficient shelf life remaining at the time of shipment to allow for normal flow through distribution channels. Infant formula manufacturers are committed to the long-term goal of reducing the amount of product that becomes unsaleable and continually review data to identify causes of unsaleability and eliminate those that are under their control.
Customers are asked to do the same for causes under their control. Customers are relied upon to routinely rotate and inspect product at shelf to assure that all infant formula product sold to consumers is in good condition and within use by code dating. It is generally recommended that shelf inventories be inspected / rotated on a monthly basis, and all products with less than 30 days remaining shelf life be removed.
Infant formula manufacturers understand that product will sometimes become unsaleable. Due to the sensitive nature and value of infant formula, the following recommendations regarding unsaleables processing is provided by the International Formula Council* (IFC) to ensure only the highest quality infant formula product is available for sale to consumers.
• Purchase infant formula only from the manufacturer or an approved wholesaler. Product that is purchased from other sources may have been inappropriately stored by the seller (e.g., exposed to extremely high temperatures), may be past its use by date, or may have been subjected to tampering (e.g., labels or use by dates changed). Such products could experience nutrient losses which could impact the product’s safety as well as potentially threaten an infant’s health. The U.S. Congress enacted a law requiring State Agencies administering the Supplemental Nutrition Program for Women, Infants, and Children (WIC) to maintain a list of state-licensed infant formula manufacturers, wholesalers, distributors, and retailers approved to provide infant formula. Retailers and other vendors participating in the WIC program are now required to purchase infant formula only from authorized vendors.
• Do not accept consumer returns without a sales receipt.
• Consumer returns shall not be placed back on the shelf for re-sale.
• Store personnel shall be trained in the proper handling and sensitive nature of the infant formula product being returned.
• All infant formula unsaleables shall be processed through approved reclamation centers without regard for the type of manufacturer reimbursement method to ensure all regulatory requirements for product disposition and recall management are satisfied. Reclamation centers shall use manufacturer disposition instructions for product disposal.
• Pending FDA Guidance, a Manufacturer Recall / Withdrawal may be handled using an alternate method of return.
• Bioterrorism Act Compliance – Manufacturers have the right to inspect federally mandated customer records regarding product sourcing and distribution for facilities owned or controlled by its customers, which includes reclamation centers.
• Manufacturers may request customers indemnify and hold them, their agents and representatives harmless for actions that do not comply with this recommendation and for expenses resulting from these actions.
We provide these recommendations because the primary focus of the IFC and its member companies is the health and welfare of infants and children. We support taking steps to avoid the potential for putting innocent babies at risk. We believe following these recommendations will assure the quality of infant formula sold to consumers.