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.

Ross Products Division, Abbott Laboratories, Inc.

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 Advance 20 w/Low Iron
2. Similac Special Care Advance 20 w/Iron
3. Similac Special Care Advance 24 w/Low Iron
4. Similac Special Care Advance 24 w/Iron

Protein Hydrolysate Formulas---

1. Alimentum Advance

Amino Acid-Based Formula---

1. EleCare

Miscellaneous---

1. Calcilo XD
2. Isomil DF
3. Pro-Phree
4. ProViMin
5. Ross Carbohydrate Free (RCF) Soy Formula w/Iron
6. Similac Human Milk Fortifier
7. Similac Natural Care Advance Human Milk Fortifier
8. Similac NeoCare Advance
9. Similac PM 60/40

Mead Johnson Nutritionals, Bristol-Myers Squibb Company

Metabolic Formulas---

1. MSUD Diet Powder (to be discontinued 4^th quarter of 2005)
2. Phenyl Free 1
3. Product 3200AB (to be discontinued 4^th quarter of 2005)
4. BCAD 1
5. GA
6. HCY 1
7. LMD
8. OA 1
9. PFD 1
10. TYROS 1
11. 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

Protein Hydrolysate Formulas---

1. Nutramigen
2. Nutramigen LIPIL
3. Pregestimil
4. Pregestimil 24

Miscellaneous---

1. Enfamil EnfaCare LIPIL
2. Product 3232A
3. Product 80056 (to be discontinued 4^th quarter of 2005)

Milupa AG

Metabolic Formulas*---

1. HOM 1
2. MSUD 1
3. OS 1
4. PKU 1
5. TYR 1
6. UCD 1

*These products are manufactured by Milupa AG in Germany but no longer distributed by Bristol-Myers Squibb/Mead Johnson in the United States. They are currently distributed by Milupa North America.

SHS International Limited

Metabolic Formulas---

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

Amino Acid-Based Formula---

1. Neocate