Food

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. 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

Formulas for Premature Infants---

  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 Expert Care NeoSure

Protein Hydrolysate Formulas---

  1. Similac Expert Care Alimentum

Amino Acid-Based Formula---

  1. EleCare with DHA and ARA

Miscellaneous---

  1. Calcilo XD
  2. Liquid Protein Fortifier
  3. Pro-Phree
  4. ProViMin
  5. RCF No Added Carbohydrate Soy Infant Formula Base
  6. Similac Expert Care for Diarrhea
  7. Similac Human Milk Fortifier
  8. Similac Extensively Hydrolyzed Protein Human Milk Fortifier Concentrated Liquid
  9. Similac Human Milk Fortifier Concentrated Liquid
  10. 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

Formulas for Premature Infants---

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

Protein Hydrolysate Formulas---

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

Amino Acid-Based Formula---

  1. Pur Amino

Miscellaneous---

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

Nestle Infant Nutrition

Formulas for Premature Infants---

  1. Gerber Good Start Nourish
  2. Gerber Good Start Premature 20
  3. Gerber Good Start Premature 24 High Protein
  4. Gerber Good Start Premature 24
  5. Gerber Good Start Premature 30

PBM Nutritionals

Formulas for Premature Infants—

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

Prolacta Biosciences, Inc.

Miscellaneous—

  1. Prolact Plus Human Milk Fortifiers (+4, +6, +8, and +10)
  2. Prolact CR Human Milk Caloric Fortifier
  3. Prolact RTF 24 Human Milk-Based Premature Infant Formula
  4. Prolact RTF 26 Human Milk-Based Premature Infant Formula
  5. Prolact RTF 28 Human Milk-Based Premature Infant Formula

SHS International Limited*

Metabolic Formulas---

  1. MSUD Analog
  2. XLeu Analog
  3. XLys, Trp Analog
  4. XMet Analog
  5. XMTVI Analog
  6. Periflex Infant
  7. X Phe, XTyr Analog
  8. XPTM Analog
  9. XMet, XCys Analog

Amino Acid-Based Formula---

  1. Neocate 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.

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