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Approved Infant Formulas

We recommend that the school, center, or day care home offer the type of formula that the infant's health care provider has suggested to the infant's parent (or guardian). If the school or child care facility offers a different type of formula, the infant's parent may decline the offered formula, and supply another type.

Iron-fortified Infant Formulas That DO NOT Require Medical Statements for Food Substitutions

Formulas approved by ODE CNP (Revised February 2013)

Although the list is not meant to be all-inclusive, it does include most of the brands of iron-fortified infant formula that are currently available to consumers. It does not represent our (FNS or ODE CNP) endorsement of these companies or their products.

  • 365 Everyday Value Organic Soy-Based Infant Formula with Iron (Whole Foods)
  • Baby’s Only Organic Dairy Iron Fortified-Toddler Formula
  • Baby's Only Organic Soy Iron Fortified Toddler Formula
  • Bright Beginnings Infant Formula with Iron-Organic
  • Comforts for Baby Gentle Milk-Based Infant Formula with Iron
  • Earth's Best Organic Infant Formula with Iron
  • Earth’s Best Organic Sensitivity Infant Formula with Iron - Low Lactose Formula for Fussiness and Gas
  • Earth's Best Organic Soy Formula with DHA & ARA
  • Enfagrow Gentlease Next Step Lipil
  • Enfamil Gentlease for Fussiness & Gas Infant Formula Milk-Based with Iron
  • Gerber Good Start Gentle Infant Formula with Iron
  • Gerber Good Start Protect Advanced Immune Support Infant Formula with Iron
  • Gerber® Good Start® Protect PLUS® Formula
  • Gerber Good Start Soothe Infant Formula with Iron for Excessive Crying, Colic and Fussiness
  • Kirkland Infant Formula with Iron
  • Mead Johnson Enfamil Premium Lipil (previous name for Enfamil Premium Infant, per Mead Johnson 2/14/11)
  • Mead Johnson Enfamil Premium Infant (the new name for Enfamil Premium Lipil per Mead Johnson 2/14/11)
  • mom to mom Milk-Based Infant Formula with Iron, Lucerne North America
  • mom to mom Sensitivity Infant Formula with Iron
  • mom to mom Soy—Soy-based Infant Formula with Iron
  • Nature’s One Baby’s Only Organic Toddler Formula—Lactorelief Iron Fortified
  • Nestle Good Start Gentle Formula Gentle PLUS
  • Nestle Mild Havrevalling, berikad med jarn
  • O for Baby Organics, Organic Milk-Based Infant Formula with Iron
  • Parent's Choice Infant Formula with Iron Gentle
  • Parent's Choice Lactose-Free Formula
  • Parent's Choice Organic Infant Formula with Lipids (DHA &ARA) with Iron
  • Private Selection Organic Milk-Based Infant Formula with Iron
  • Safeway Select Soy Infant Formula with Iron with a blend of Lipids (DHA &ARA)
  • Similac Alimentum Advance Protein Hydrolysate Formula with Iron
  • Similac Alimentum Hypoallergenic Formula with Iron
  • Similac For Spit-Up in Healthy Infants
  • Similac Go & Grow Complete Toddler Nutrition Infant Formula with Iron
  • Similac Go & Grow Soy-Based Formula with Iron
  • Similac NeoSure Infant Formula with Iron
  • Similac Organic Infant Formula with DHA and ARA, with Iron
  • Similac Sensitive Infant Formula with Iron
  • Similac Soy Isomil for Fussiness & Gas Infant Formula with Iron
  • Similac Total Comfort (for Discomfort Due to Persistent Feeding Issues) Infant Formula with Iron
  • up&up infant formula with iron—advantage
  • up&up Infant Formula with Iron-partially broken down whey protein (Target Corporation)
  • up&up Infant Formula with Iron-Sensitivity (Target Corporation)

Formulas that DO Require a Medical Statement for Food Substitution

Exempt Infant Formulas Marketed in the United States By Manufacturer and Category

An exempt infant formula is an infant formula intended for commercial or charitable distribution that is represented and 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). Prior to any company or person manufacturing and marketing a new exempt infant formula or any infant formula, certain practices, procedures and processes must be followed (Section 412 of the Federal Food, Drug, and Cosmetic Act). For exempt infant formulas, there are specific terms and conditions that must also be met (21 CFR 107.50). The following list provides all of the products classified as exempt infant formulas that FDA believes are currently available (to date) on the U.S. retail market. The products are grouped by the company that manufactures and/or distributes them as well as grouped by type of product (if applicable).
◦FDA Exempt Formula List