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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. 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
  2. Glutarex-1
  3. Hominex-1
  4. I-Valex-1
  5. Ketonex-1
  6. Phenex-1
  7. Propimex-1
  8. Tyrex-1

Premature Formulas---

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

Extensively Hydrolyzed Protein Formula---

  1. Similac Alimentum

Amino Acid-Based Formula---

  1. EleCare with DHA and ARA

Fortifiers---

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

Miscellaneous---

  1. Calcilo XD
  2. Pro-Phree
  3. ProViMin
  4. RCF No Added Carbohydrate Soy Infant Formula Base
  5. Similac for Diarrhea
  6. Similac PM 60/40

Mead Johnson Nutritionals, Bristol-Myers Squibb Company

Metabolic Formulas---

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

Premature Formulas---

  1. Enfamil Premature w/Iron 20 Calorie
  2. Enfamil Premature w/Iron 24 Calorie
  3. Enfamil NeuroPro EnfaCare
  4. Enfamil Premature High Protein 24 Calorie
  5. Enfamil Premature 30 Calorie

Protein Hydrolysate Formulas---

  1. Enfamil Nutramigen
  2. Pregestimil 20 Calorie
  3. Pregestimil 24 Calorie
  4. Nutramigen with Enflora LGG
  5. Nutramigen Toddler with Enflora LGG

Amino Acid-Based Formula---

  1. PurAmino

Miscellaneous---

  1. 3232A
  2. Enfamil Human Milk Fortifier Acidified Liquid
  3. Enfamil Human Milk Fortifier Powder
  4. Enfaport

Nestlé Infant Nutrition

Extensively Hydrolyzed Protein Formula---

  1. Gerber Extensive HA

Amino Acid-Based Formula---

  1. Alfamino

PBM Nutritionals

Premature Formula---

  1. 22 cal/oz milk-based infant formula with DHA and ARA for Conditions such as Prematurity & Low Birth Weight (sold under private labels)

Extensively Hydrolyzed Protein Formula---

  1. Extensively Hydrolyzed Casein-Based infant formula with ARA, DHA, and Probiotic (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 Plus Human Milk Fortifiers (+4, +6, +8, and +10)
  2. Prolact CR Human Milk Caloric Fortifier

SHS International Limited*

Metabolic Formulas---

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

Amino Acid-Based Formulas---

  1. Neocate Infant w/DHA and ARA
  2. Neocate Syneo Infant w/DHA and ARA

*Nutricia North America is listed on the product labels. Nutricia North America is the distribution company and "brand" name for the products manufactured by SHS International in the United Kingdom.

11/19