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  3. Guidance & Regulation (Food and Dietary Supplements)
  4. Guidance Documents & Regulatory Information by Topic (Food and Dietary Supplements)
  5. Infant Formula Guidance Documents & Regulatory Information
  6. Exempt Infant Formulas Marketed in the United States By Manufacturer and Category
  1. Infant Formula Guidance Documents & Regulatory Information

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).

This list is provided as a service to anyone using FDA's website and does not represent FDA endorsement of these companies or their products. The directions for use of these products provided on the product label/labeling or by the health care provider should be followed. FDA cannot ensure that the information on this list is the most current. As the agency becomes aware of newer information, the list will be periodically updated.

Abbott Nutrition

Metabolic Formulas---

  1. Cyclinex-1 Amino Acid-Modified with Iron
  2. Glutarex-1 Amino Acid-Modified with Iron
  3. Hominex-1 Amino Acid-Modified with Iron
  4. I-Valex-1 Amino Acid-Modified with Iron
  5. Ketonex-1 Amino Acid-Modified with Iron
  6. Phenex-1 Amino Acid-Modified with Iron
  7. Propimex-1 Amino Acid-Modified with Iron
  8. Tyrex-1 Amino Acid-Modified with Iron

Premature Formulas---

  1. Similac Special Care Premature 20 Cal with Iron
  2. Similac Special Care Premature 24 Cal with Iron
  3. Similac Special Care Premature 24 Cal High Protein with Iron
  4. Similac Special Care Premature 30 Cal with Iron
  5. Similac NeoSure with Iron

Extensively Hydrolyzed Protein Formula---

  1. Similac Alimentum with Iron

Amino Acid-Based Formula---

  1. EleCare with Iron

Fortifiers---

  1. Liquid Protein Fortifier
  2. Similac Human Milk Fortifier Powder
  3. Similac Extensively Hydrolyzed Protein Human Milk Fortifier Concentrated Liquid
  4. Similac Human Milk Fortifier Concentrated Liquid

Miscellaneous---

  1. Calcilo XD Low Calcium, Vitamin D-Free Infant Formula with Iron
  2. Pro-Phree Protein-Free Energy Module with Iron, Vitamins & Minerals
  3. ProViMin Protein-Vitamin-Mineral Module with Iron
  4. RCF No Added Carbohydrate Soy Infant Formula Base with Iron
  5. Similac for Diarrhea with Iron
  6. Similac PM 60/40 Low Iron

Mead Johnson Nutrition, A Reckitt Benckiser Group

Metabolic Formulas---

  1. Phenyl Free 1 Iron Fortified
  2. BCAD 1 Iron Fortified
  3. GA Iron Fortified
  4. HCY 1 Iron Fortified
  5. LMD Iron Fortified
  6. OA 1 Iron Fortified
  7. TYROS 1 Iron Fortified
  8. WND 1 Iron Fortified

Premature Formulas---

  1. Enfamil Premature 20 Cal with Iron
  2. Enfamil Premature 24 Cal with Iron
  3. Enfamil Premature High Protein 24 Cal with Iron
  4. Enfamil Premature 30 Cal with Iron
  5. Enfamil NeuroPro EnfaCare with Iron

Extensively Hydrolyzed Protein Formulas---

  1. Enfamil Nutramigen with Iron
  2. Enfamil Nutramigen with Probiotic LGG with Iron
  3. Enfamil Nutramigen with Probiotic LGG Toddler with Iron
  4. Pregestimil 20 Cal, Iron Fortified
  5. Pregestimil 24 Cal, Iron Fortified

Amino Acid-Based Formula---

  1. PurAmino with Iron

Miscellaneous---

  1. 3232A Protein Hydrolysate Base with Iron
  2. Enfamil Human Milk Fortifier Acidified Liquid
  3. Enfamil Human Milk Fortifier Powder
  4. Enfamil Human Milk Fortifier Liquid High Protein
  5. Enfamil Human Milk Fortifier Liquid Standard Protein
  6. Enfaport with Iron

Nestle Health Science

Extensively Hydrolyzed Protein Formula---

  1. Extensive HA with Iron

Amino Acid-Based Formula---

  1. Alfamino Infant with Iron

Vitaflo (A Nestle Health Science Company)

Metabolic Formula---

  1. PKU start with Iron

PBM Nutritionals, LLC (A wholly owned subsidiary of Perrigo Company)

Extensively Hydrolyzed Protein Formula---

  1. Hypoallergenic Infant Formula with Iron (sold under private labels)

Prolacta Biosciences, Inc.

Premature Formulas---

  1. Prolact RTF 24 Human Milk-Based Premature Infant Formula
  2. Prolact RTF 26 Human Milk-Based Premature Infant Formula
  3. Prolact RTF 28 Human Milk-Based Premature Infant Formula

Fortifiers---

  1. Prolact+ H2MF Human Milk Fortifiers (+4, +6, +8, and +10)
  2. Prolact CR Human Milk Caloric Fortifier

SHS International, Ltd. / Nutricia North America, Inc.*

Metabolic Formulas---

  1. MSUD Anamix Early Years with Iron
  2. IVA Anamix Early Years with Iron
  3. GA1 Anamix Early Years with Iron
  4. HCU Anamix Early Years with Iron
  5. MMA/PA Anamix Early Years with Iron
  6. PKU Periflex Early Years with Iron
  7. TYR Anamix Early Years with Iron
  8. SOD Anamix Early Years with Iron

Amino Acid-Based Formulas---

  1. Neocate Infant DHA and ARA with Iron
  2. Neocate Syneo Infant with Iron

Miscellaneous---

  1. Fortini with Iron

*Nutricia North America, Inc. is the distributor and “brand” name for the products manufactured by SHS International, Ltd. in the United Kingdom.

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