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  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. The 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. The products on this list are also provided as part of a comprehensive list of all infant formulas marketed in the U.S.

Abbott Nutrition

Metabolic Formulas---

  1. Cyclinex-1 with Iron, Nonessential Amino Acid-Free
  2. Glutarex-1 with Iron, Lysine- and Tryptophan-Free
  3. Hominex-1 with Iron, Methionine-Free
  4. I-Valex-1 with Iron, Leucine-Free
  5. Ketonex-1 with Iron, Isoleucine-, Leucine- and Valine-Free
  6. Phenex-1 with Iron, Phenylalanine-Free
  7. Propimex-1 with Iron, Methionine- and Valine-Free, Low in Isoleucine and Threonine
  8. Tyrex-1 with Iron, Phenylalanine- and Tyrosine-Free

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 22 Cal with Iron

Extensively Hydrolyzed Protein Formula---

  1. Similac Alimentum Hypoallergenic with Iron

Amino Acid-Based Formula---

  1. EleCare Hypoallergenic with Iron

Fortifiers---

  1. Abbott Liquid Protein Fortifier, Extensively Hydrolyzed Protein
  2. Similac Human Milk Fortifier Extensively Hydrolyzed Protein Liquid
  3. Similac Human Milk Fortifier 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 PM 60/40 Low-Iron

Mead Johnson Nutrition, A Reckitt Benckiser Group

Metabolic Formulas---

  1. BCAD 1 with Iron, Isoleucine-, Leucine- and Valine-Free
  2. GA with Iron, Lysine- and Tryptophan-Free
  3. HCY 1 with Iron, Methionine-Free
  4. LMD with Iron, Leucine-Free
  5. OA 1 with Iron, Isoleucine-, Methionine-, Threonine- & Valine-Free
  6. Phenyl-Free 1 with Iron, Phenylalanine-Free
  7. TYROS 1 with Iron, Phenylalanine- and Tyrosine-Free
  8. WND 1 with Iron, Non-essential Amino-Acid Free

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. Nutramigen Hypoallergenic with Iron
  2. Nutramigen with Probiotic LGG Hypoallergenic with Iron
  3. Pregestimil 20 Cal Hypoallergenic with Iron
  4. Pregestimil 24 Cal Hypoallergenic with Iron

Amino Acid-Based Formula---

  1. PurAmino DHA & ARA Hypoallergenic with Iron

Fortifiers---

  1. Enfamil Human Milk Fortifier Liquid - High Protein (4 g protein)
  2. Enfamil Human Milk Fortifier Liquid - Standard Protein (3.4 g protein)
  3. Enfamil Liquid Protein Fortifier, Extensively Hydrolyzed Protein

Miscellaneous---

  1. 3232A Protein Hydrolysate Base with Iron
  2. Enfaport Infant Formula with Iron

Nestle Health Science

Extensively Hydrolyzed Protein Formula---

  1. Extensive HA with Iron

Amino Acid-Based Formula---

  1. Alfamino Infant with Iron

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

Extensively Hydrolyzed Protein Formula---

  1. Parent’s Choice Hypoallergenic with Iron (Walmart)
  2. Up&Up Hypoallergenic with Iron (Target)

Prolacta Biosciences, Inc.

Premature Formulas---

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

Fortifiers---

  1. Prolact+4 H2MF Human Milk Fortifier Liquid
  2. Prolact +6 H2MF Human Milk Fortifier Liquid
  3. Prolact +8 H2MF Human Milk Fortifier Liquid
  4. Prolact +10 H2MF Human Milk Fortifier Liquid
  5. Prolact CR Human Milk Caloric Fortifier Liquid
  6. Surgifort Human Milk Fortifier Liquid

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

Metabolic Formulas---

  1. GA1 Anamix Early Years with Iron, Lysine-Free and Tryptophan-Low
  2. HCU Anamix Early Years with Iron, Methionine-Free
  3. IVA Anamix Early Years with Iron, Leucine-Free
  4. MMA/PA Anamix Early Years with Iron, Methionine-, Threonine- and Valine-Free, Isoleucine-Low
  5. MSUD Anamix Early Years with Iron, Valine-, Leucine- and Isoleucine-Free
  6. PKU Periflex Early Years with Iron, Phenylalanine-Free
  7. SOD Anamix Early Years with Iron, Methionine- and Cystine-Free
  8. TYR Anamix Early Years with Iron, Tyrosine- and Phenylalanine-Free

Amino Acid-Based Formulas---

  1. Neocate Infant Hypoallergenic with Iron
  2. Neocate Syneo Infant Hypoallergenic with Iron
  3. Pepticate Infant Hypoallergenic with Iron

Miscellaneous---

  1. Fortini Infant Formula with Iron

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

Vitaflo (A Nestle Health Science Company)

Metabolic Formula---

  1. PKU start with Iron, Phenylalanine-Free
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