CURRENT MARKETING AND USE OF POWDERED INFANT FORMULA

**IN THE UNITED STATES**

**[Background]{.smallcaps}**

Infant formulas are products intended for use solely as a food for
infants (individuals not more than 12 months of age) because of their
simulation of human milk or their suitability as a complete or partial
substitute for human milk. Infant formulas are marketed in the United
States in three forms, as powdered, liquid concentrate, and liquid
ready-to-feed products. Powdered formulas for infant feedings have been
available since the late 1800s, with introduction of liquid concentrates
in the early 1950s and ready-to-feed products about 1960. Following
introduction of liquid formulas, the proportion of infant formula sold
in powdered form declined, with the lowest proportion of sales from
about 1970 to 1980; since 1980, the proportion of powdered infant
formula sales has increased (Fomon, 2001). Based on 1999 dollar sales
from Information Resources, Inc., powdered infant formula accounts for
approximately half (49%) of the infant formula market in the United
States. In most other countries, most infant formula is sold in powdered
form.

On a cost-per-feeding basis, powdered infant formulas are less expensive
than liquid formulas. Comparison of retail prices of a small,
convenience sample of powdered, concentrate, and ready-to-feed infant
formulas in the Washington, DC area in November 2002, suggests that
cost-per-feeding of powdered infant formula is about 67% of the cost of
ready-to-feed and 82% of the cost of concentrate.

The following sections of this paper describe types of infant formulas
currently marketed in the United States, preparation of powdered
products for feeding, and administration of infant formulas in health
care settings.

# 

# Currently Marketed Infant Formulas

Federal regulations (21 CFR 107.100) require minimum and, in some cases,
maximum levels of nutrients for infant formulas marketed in the United
States. These regulations do not specify ingredients to be used in
infant formulas but, like all foods, ingredients used in infant formulas
are generally recognized as safe (GRAS) food ingredients or approved
food additives.

Infant formulas are formulated to contain protein (nitrogen),
carbohydrate, and fat ingredients to provide for the energy and
macronutrient needs of infants. Micronutrients are added to formulations
either as individual ingredients or as ingredients of vitamin and
mineral premixes. Types and forms of infant formulas currently marketed
in the United States and macronutrient ingredients listed in product
label ingredient statements are described in the paragraphs that follow.

**Products for Term Infants**

The energy density of most formulas for term infants is 20 kcal/oz (670
kcal/L). Formulas with greater energy density (24 kcal/oz) have higher
levels of macronutrients but micronutrients are provided at the same
concentrations per 100 kcal as in the 20 kcal/oz formulas.

[Milk-based infant formulas]{.underline} are consumed by the majority of
term infants. These formulas are marketed in powdered, liquid
concentrate, and liquid ready-to-feed forms. Various cow milk-derived
products (e.g., nonfat milk, casein, combinations of casein and whey
proteins, or partially hydrolyzed whey protein concentrate) provide
protein for these formulas. Lactose, corn syrup solids, sucrose, or corn
maltodextrin provide carbohydrates and vegetable oil blends provide fat.

[Soy protein-based formulas]{.underline} are consumed by about 25% of
term infants in the United States. The soy protein is a specific protein
isolate fortified with L-methionine; combinations of corn maltodextrin,
sucrose, or corn syrup solids provide carbohydrate; and vegetable oil
blends provide fat. These formulas are marketed in powdered, liquid
concentrate, and liquid ready-to-feed forms.

[Protein hydrolysate-based formulas]{.underline} are often consumed by
infants with milk allergy or intolerance to intact protein. These
formulas are marketed in powdered, liquid concentrate, and liquid
ready-to-feed forms. Enzymatically hydrolyzed casein, fortified with
selected amino acids, provides nitrogen; combinations of corn syrup
solids, maltodextrin, or sucrose provide carbohydrate; and vegetable oil
blends provide fat. One protein hydrolysate-based product also includes
medium chain triglyceride (MCT) oils as a fat source.

[Amino acid-based formula]{.underline} may be consumed by infants who do
not tolerate formulas based on cow milk proteins, soy protein isolate,
or casein hydrolysates. One amino acid-based formula is currently
marketed in the United States and it is marketed only in powdered form.
This formula contains corn syrup solids, free amino acids, and a
vegetable oil blend as sources of macronutrients.

**Products for Preterm Infants**

[Premature infant formulas]{.underline} are consumed by many infants
born preterm. They are marketed only in ready-to-feed form. Energy
concentrations of these formulas are 24 kcal/oz and 20 kcal/oz. They
also contain higher concentrations of protein and certain micronutrients
to meet the needs of preterm infants. These formulas contain nonfat
milk, whey protein concentrate, corn syrup solids, lactose, vegetable
oil blends, or MCT as sources of macronutrients.

[Transitional formulas]{.underline} are consumed by many preterm infants
as they approach hospital discharge and after discharge. They are
provided in ready-to-feed and powdered forms for hospitals and powdered
form on the general market. The energy concentration of these formulas
is 22 kcal/oz and they contain higher concentrations of certain
nutrients than formulas for term infants. These formulas contain nonfat
milk, whey protein concentrate, maltodextrin, lactose, or vegetable oil
blends as sources of macronutrients.

[Human milk fortifiers]{.underline} are nutritional supplement products
that may be added to breast milk to supplement its nutrient content. One
human milk fortifier product is sold in liquid ready-to-feed form. It is
essentially the same in composition as 24 kcal/oz preterm formulas. Two
products are marketed in powdered form. These products contain corn
syrup solids and milk proteins with or without MCT as energy sources.
Addition of these powdered human milk fortifiers results in minimal
volume increment to the fluid volume consumed by the preterm infant.

**Products for Infants with Metabolic Disorders and Other Special
Populations**

[Metabolic infant formulas]{.underline} are formulated for use by
infants with disorders of amino acid metabolism such as phenylketonuria,
maple syrup urine disease, tyrosinemia, or other inherited metabolic
disorders. Metabolic infant formulas and other products for infants with
special nutritional needs are available only in powdered form. These
formulas contain corn syrup solids, blends of vegetable oils, and
selected balance of amino acids. Each is formulated without the primary
offending amino acid(s) for the specific disorders. Unlike other
formulas, these products are not intended to be fed as the sole source
of nutrition to infants with metabolic disorders.

**Products for Older Infants**

[Follow-up or follow-on formulas]{.underline} are iron-fortified, cow
milk-based or isolated soy protein-based products intended for use by
older infants (\>6 months) and toddlers consuming solid foods. These
formulas are marketed in powdered, liquid concentrate, and liquid
ready-to-feed forms. The nutrient concentrations of formulas for older
infants must meet the nutrient requirements for formulas fed to younger
infants. They typically contain higher levels of calcium and phosphorus
than formulas for younger infants.

**[Preparation of Powdered Infant Formulas]{.smallcaps}** **[for
Feeding]{.smallcaps}**

Like all powdered food products, powdered infant formulas are ***not***
sterile and contain bacteria. Good manufacturing practice is critical to
assure production of safe formulas. In addition, proper preparation,
storage, delivery, and disposal of infant formulas are also critical for
prevention of food-borne infections.

**Instructions on Product Labels**

Infant formula manufacturers are required by Federal regulation (21 CFR
107.20) to provide instructions for preparation and use on their product
labels. These regulations specify that product labels for powdered
products must include instructions for 1) storage of infant formula
before and after the container has been opened, 2) "sterilization" of
water, bottle, and nipples when necessary for preparing infant formula
for use, and 3) dilution of the formula, when appropriate (directions
for powdered infant formula must include the weight and volume of
powdered infant formula to be reconstituted). Statements 1) cautioning
against improper preparation or use of an infant formula and 2)
indicating that parents should consult their physicians about use of
infant formulas are also required.

Instructions for product storage before and after the powdered product
has been opened are similar to the following label statement.

1.  "Store unopened cans at room temperature. Cover opened can tightly
    with a plastic lid and store in a cool, dry place. Do not
    refrigerate or freeze. Use contents within 1 month of opening to
    ensure freshness."

Examples of instructions for preparation and use on labels of currently
marketed infant formulas include statements such as the following. A
single set of instructions is given for infants of all ages.

1.  "Bring water to a boil then cool to 100F (40C). Pour desired amount
    of water into bottle. . . . . . Feed immediately, or cover and
    refrigerate bottled formula to be used within 24 hours."

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1.  "Boil water for 5 minutes. Cool to a warm temperature (120-130F).
    Pour desired amount into feeding bottle. . . . . . Store in
    refrigerator until used. Use within 24 hours after mixing."

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1.  "Bring water for formula to a rolling boil (approximately 1 minute),
    then let cool to lukewarm temperature. . . . . . Feed immediately,
    or cover and refrigerate bottled formula until needed. Use within 48
    hours."

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1.  "Ask your baby's doctor about infant formula use, including the need
    to boil water for formula, bottle, and nipple assembly. Pour desired
    amount of warm water into bottle. . . . . . Feed immediately or
    cover and refrigerate prepared formula. Use within 48 hours. Throw
    away prepared formula left in feeding bottle or cup within one hour
    after feeding begins."

**Preparation of Formula in Infant Health Care Facilities**

Physical facilities and practices for preparation of infant formulas
vary widely among intensive health care facilities treating ill infants.
The American Dietetic Association (ADA) published guidelines in 1991 for
preparation, storage, and administration of safe infant formulas in
health care facilities (The American Dietetic Association, 1991). This
reference is currently being updated; an abbreviated version with a
revision date of November 2002 is available at
<http://www.eatright.org/formulaguide.html>.

The ADA guidelines specify that all infant formulas should be prepared
by trained, healthy personnel using aseptic technique in a specific
location devoted to infant formula preparation (preferably a separate
room with little risk of microbial or chemical contamination). The
guidelines present detailed information for minimizing the potential for
microbial contamination and growth during infant formula preparation,
storage and use in health care facilities.

Enteral Administration of Infant Formulas in General Health Care And
Neonatal Intensive Care Settings

Infants will often need to be fed by more than one route or method
during hospitalization. While many in-hospital settings have developed
guidelines for general enteral feedings, it remains particularly
difficult to determine optimal introduction and advancing of enteral
feedings in preterm infants and in seriously ill infants.

General enteral feeding approaches and indications for their use are
discussed by Wessel (1994). Guidelines for enteral delivery of infant
feedings are suggested by The American Dietetic Association (1991,
revised 2002).

**Nipple Feeding**

Nipple feeding from breast or bottle requires an infant to have a
coordinated gastrointestinal tract response, including established
sucking and swallowing reflexes and efficient gastric emptying and
motility. The suck-swallow reflex develops generally at 34 to 36 weeks
of gestational age and stable preterm infants can begin nipple feeding
around this time. Formulas for preterm infants or fortified human milk
are the most common feedings although other formulas may be indicated
for certain medical conditions and for older, ill infants (Wessel,
1994).

Facility-prepared feedings must be fed within four hours of preparation,
or covered and stored under refrigeration for not more than 24 hours
after preparation. Any warming before feeding should be accomplished in
less than 15 minutes. For infants being nipple fed, any product
remaining in the bottle one hour after the start of nipple feeding
should be discarded (The American Dietetic Association, 1991, revised
2002).

**Tube Feeding**

Infants without adequate physiologic function to undertake nipple feeds
(infants generally younger than 34 weeks gestational age, very sick
infants, or infants requiring mechanical ventilation) will require
either parenteral or tube feeding regimens. Decisions to use the
infant's intestinal tract for nutrient absorption will generally
encompass products fed via tube, by continuous or intermittent (bolus)
delivery through the nasogastric, orogastric, or transpyloric routes.
Less often, gastrostomy feeding tubes inserted trans-abdominally
directly into the stomach may be used. The choice will depend on the
gastrointestinal development and the health/disease status of the
infant. Continuous delivery is commonly used for very small infants and
infants who have difficulty with bolus feedings or intermittent
placement of feeding tubes. It is generally used with transpyloric
feedings, as well as with some gastrostomy feedings. Rates of delivery
may be very slow (a few ml/hr) for very small or very sick infants
(Wessel, 1994).

Facility-prepared feedings must be fed within four hours of preparation,
or covered and stored under refrigeration for not more than 24 hours
after preparation. For intermittent (bolus) enteral tube feeding,
facility-prepared formula should be packaged in amounts needed for one
feeding or for a four-hour period. For continuous enteral tube feeding,
hang-time for facility-prepared infant formula should not exceed four
hours. (The American Dietetic Association, 1991, revised 2002).

**[Summary]{.smallcaps}**

At present, powdered infant formulas account for 49% of the infant
formula market in this country. Many infant formulas are available in
multiple forms (powdered, liquid concentrate, and liquid ready-to-feed);
however, amino acid-based formula and formulas for infants with
metabolic disorders and other special infant populations are available
only in powdered form. Although human milk fortifiers are available in
both ready-to-feed and powdered forms, use of the powdered form adds
less to the volume that the infant must consume. General preparation
instructions and guidelines for preparation of powdered infant formulas
in health care facilities are presented. Approaches and guidelines for
administration of enteral feedings in health care settings are also
presented.

**[References]{.smallcaps}**

The American Dietetic Association. 1991. Preparation of formula for
infants: guidelines for health care facilities. Chicago: The American
Dietetic Association. 100p. An abbreviated on-line revision \[November
2002\] is available at <http://www.eatright.org/formulaguide.html>.

Fomon, SJ. 2001. Infant feeding in the 20^th^ century: formula and
beikost. Journal of Nutrition. 131:409S-420S.

Information Resources, Inc. 1999. Infoscan 1999 Annual Data. Chicago,
Illinois: Information Resources Inc.

Wessel, JJ. 1994. Feeding methodologies. In: Nutritional care for
high-risk newborns (Rev. Ed.). S Groh-Wargo, M Thompson, J Cox, editors.
Chicago: Precept Press. p. 206-219.