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U.S. Department of Health and Human Services

Food

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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 w/Iron
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 (to be discontinued in the US)
2. EleCare with DHA and ARA

Miscellaneous---

1. Calcilo XD
2. Similac Expert Care for Diarrhea
3. Pro-Phree
4. ProViMin
5. Ross No Added Carbohydrate Soy Formula w/Iron
6. Similac Human Milk Fortifier
7. Similac PM 60/40

Mead Johnson Nutrition

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 LIPIL 20
2. Enfamil Premature LIPIL 20 w/Iron
3. Enfamil Premature LIPIL 24
4. Enfamil Premature LIPIL 24 w/Iron
5. Enfamil EnfaCare LIPIL
6. Enfamil Premature LIPIL 24 Cal High Protein

Protein Hydrolysate Formulas---

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

Amino Acid-Based Formula---

1. Nutramigen AA LIPIL

Miscellaneous---

1. Product 3232A
2. PFD 1
3. Enfamil Acidified Liquid Human Milk Fortifier
4. Enfaport LIPIL with MCT Oil

Nestle Infant Nutrition

Formulas for Premature Infants---

1. Gerber Good Start Premature

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)

SHS International Limited*

Metabolic Formulas---

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

Amino Acid-Based Formula---

  1. Neocate Infant
  2. 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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