Iron-fortified infant formula and medical food powder for infants and toddlers with phenylketonuria (PKU).
Last Updated: Wednesday, December 27, 2017
Metabolic clinicians can contact the Mead Johnson Medical Department at email@example.com to find out about receiving a starter case of Phenyl-Free® 1 for a newly diagnosed infant.
Phenyl-Free 1 is an iron-fortified infant formula and medical food powder that is free of the essential amino acid phenylalanine for infants and toddlers with documented phenylketonuria (PKU). This product provides all other essential amino acids as well as nonessential amino acids, carbohydrate, fat, essential fatty acids, vitamins and minerals. Use under direct and continuing supervision of a doctor.
Product nutrient values and ingredients are subject to change. Please see product label for current information.
|Per 100 grams Powder|
|Protein equivalent, g*||16.2|
|Linoleic acid, mg||4000|
|Per 100 grams Powder|
|Vitamin A, IU||1520|
|Vitamin D, IU||380|
|Vitamin E, IU||10|
|Vitamin K, mcg||40|
|Thiamin (Vitamin B1), mcg||1000|
|Riboflavin (Vitamin B2), mcg||1000|
|Vitamin B6, mcg||1000|
|Vitamin B12, mcg||2|
|Folic acid (Folacin), mcg||100|
|Pantothenic acid, mcg||3800|
|Vitamin C (Ascorbic acid), mg||60|
|Per 100 grams Powder|
* WARNING: Protein is incomplete since it does not contain the essential amino acid phenylalanine.
|Protein Equivalent (% Calories)*||13|
|Fat (% Calories)||47|
|Carbohydrate (% Calories)||40|
|Potential Renal Solute Load (mOsm/100 g powder)3||144|
|Osmolality (mOsm/kg water)†||350|
|Lactose-Free||Suitable for someone with lactose intolerance|
* Protein is incomplete since it does not contain the essential amino acid phenylalanine. † Determined at 20 Cal/fl oz dilution.
CAUTION: Mead Johnson Nutrition Phenyl-Free® 1 is to be used only in the dietary management of infants and young children with documented phenylketonuria while under direct and continuing medical supervision.
WARNING: This product is nutritionally incomplete. Care must be taken to provide enough phenylalanine to support growth using other foods with this amino acid as required. Medical professionals must carefully and constantly supervise use of Phenyl-Free 1 with other foods and liquids and adjust the diet based on frequent blood tests.
WARNING: Not for parenteral (I.V.) use.
Phenyl-Free® 1 is available in powder.
Item #: 892601
Unit Size: 1 lb can
Prod. Yield / Unit (fl oz): Varies
Case: 6 cans per case
HCPCS Code: B4162
Reimbursement Code: 00087-510172
Ingredients: Corn syrup solids, vegetable oil (palm olein oil, coconut oil, soy oil, high oleic sunflower oil), amino acids (L-glutamine, L-leucine, potassium aspartate, L-lysine hydrochloride, L-tyrosine, L-proline, L-valine, L-isoleucine, L-alanine, L-arginine, L-threonine, L-serine, glycine, L-histidine, L-methionine, L-tryptophan, L-cystine), modified corn starch, sugar, calcium phosphate and less than 1%: Mortierella alpina oil‡, Crypthecodinium cohnii oil§, ethyl vanillin, sodium citrate, potassium citrate, magnesium oxide, ferrous sulfate, potassium chloride, zinc sulfate, cupric sulfate, manganese sulfate, sodium iodide, sodium selenite, choline chloride, inositol, ascorbic acid, niacinamide, calcium pantothenate, vitamin B6 hydrochloride, thiamin hydrochloride, riboflavin, vitamin D3, folic acid, biotin, vitamin K1, vitamin E acetate, vitamin A palmitate, vitamin B12, taurine, L-carnitine.
‡ A source of arachidonic acid (ARA). § A source of docosahexaenoic acid (DHA).
The baby’s health depends on carefully following the instructions below. Use only as directed by a medical professional. Proper hygiene, preparation, dilution, use and storage are important when preparing infant formula. Powdered infant formulas are not sterile and should not be fed to premature infants or infants who might have immune problems unless directed and supervised by a doctor. Discuss with parents which formula is appropriate for the baby.
Discuss with parents whether they need to use cooled, boiled water for mixing and whether they need to boil clean utensils, bottles and nipples in water before use.
WARNING: Do not use a microwave oven to warm formula. Serious burns may result.
Refer to the product label for the most accurate information.
The baby’s medical professional will provide instructions for the correct amounts of water and powder. Pour the required amount of water into the bottle. Add the correct amount of powder, cap the bottle and shake vigorously.
If instructed to use the scoop in the can, each unpacked, level scoop delivers approximately 4.5 g of powder. Store DRY scoop in can.
Fat provides 47% of total calories in Phenyl-Free® 1. The fat content is similar to the fat content of human milk¶ and consists of a four-oil vegetable blend of palm olein oil (44%), soy oil (19.5%), coconut oil (19.5%) and high oleic sunflower oil (14.5%), along with ARA and DHA from single cell oils (2.5%).
¶ Comparison based on fatty acid profile of typical mature U.S. breast milk.
Protein equivalents provide 13% of calories in Phenyl-Free 1. The product provides the essential amino acids (except phenylalanine) as well as nonessential amino acids (see Amino Acids table); 53% of the amino acids are essential amino acids. Tyrosine level is 1.6 g ⁄ 100 g powder. Since the product contains no phenylalanine, care must be taken to provide enough phenylalanine from breast milk, infant formula or other foods to support growth.
|Essential Amino Acids||Per 100 g Powder|
|Nonessential Amino Acids||Per 100 g Powder|
|Aspartic acid, mg||1280|
|Glutamic acid, mg||2600#|
# Added as glutamine.
Carbohydrate provides 40% of total calories in Phenyl-Free 1. The carbohydrate blend is corn syrup solids, modified corn starch and sucrose (table sugar). The sucrose in the product helps neutralize the taste of the amino acids. Phenyl-Free 1 is suitable for someone with lactose intolerance.
Vitamins and Minerals
Vitamin and mineral levels in Phenyl-Free 1 meet U.S. Food and Drug Administration requirements per 100 Calories for vitamins and minerals as mandated by the U.S. Infant Formula Act and the associated Code of Federal Regulations 21 C.F.R. part 107.1004. Amounts of B vitamins have been increased above levels in routine infant formulas for cofactor production. An increased level of choline, an essential nutrient important for brain development and the normal functioning of cells1-2, is provided. Calcium, iron, zinc, manganese, and copper levels are higher in order to help meet the needs for these minerals when low-protein solid foods are introduced.
1. Food and Nutrition Board, Institute of Medicine, Choline. In: Dietary References Intakes for Thiamin, Riboflavin, Niacin, Vitamin B6, Folate, Vitamin B12, Pantothenic Acid, Biotin, and Choline. Washington, DC: National Academy Press; 1998:390-422.
2. Zeisel SH, da Costa KA. Nutr Rev. 2009 Nov 67 (11):615-623.
3. Fomon SJ, Ziegler EE. Renal solute load and potential renal solute load in infancy. J Pediatr. 1999;134:11–14.
4. Nutrient Requirements for Infant Formulas. Code of Federal Regulations 21, C.F.R. 107.100.