July 1, 2003

POSITION STATEMENT

For immediate release to United States customers only
Preparation instructions for powdered Neocate infant formula

(Rockville, MD. July 2003) In response to the recommendation issued by the FDA to Health Professionals on Enterobacter sakazakii ⁽¹⁾, and instructions from our parent company, Royal Numico, Nutricia changed the labelling of Neocate to indicate that it should be used immediately after preparation.  This action was initiated to protect infants against Enterobacter sakazakii and other opportunistic bacterial pathogens, which have been associated with the use of powdered infant formulas in neonatal units.

The FDA recommendation to Health Professionals states that the outbreaks of Enterobacter sakazakii infections have been related to the use of powdered milk-based infant formula products.  Neocate is based on synthetic amino acids, which are manufactured under highly controlled conditions, and the product undergoes extensive microbiological tests prior to release for commercial use (see Nutricia position statement dated May 2003). However, Neocate may be used in "vulnerable" groups of infants. Although the risk of contamination is minimal, this prompted us to take a very cautious approach.

We are confident that all possible measures are being taken to prevent contamination of Neocate powdered infant formula during processing.  Enterobacter Sakazakii is one of several opportunistic pathogens, which are generally present in the environment. Risk of contamination can increase during preparation, storage or administration of enteral formulas.

Please note that we have amended our label to reflect both the practicality of Neocate formula preparation and the vulnerability of a select patient population. Health Professionals may choose to recommend fresh preparation of Neocate and other powdered infant formulas for immune-compromised infants. When formula is prepared in advance, all steps in preparation must be followed to minimize the risk of contamination:

1. Wash hands prior to handling feeding equipment or formula. Clean preparation area.
2. All equipment (bottles, nipples, knives etc) should be clean and sterilized immediately prior to use.
3. Neocate should be reconstituted with cool, previously boiled water (boiled for 5 minutes and cooled for at least 30 minutes).
4. Reconstituted formula should be rapidly cooled to a temperature between 35^oF and 40^oF and stored in a refrigerator for a maximum of 24 hours from preparation.
5. If formula is warmed before feeding, the warming process should take no more than 15 minutes.
6. Unused formula remaining in the bottle one hour after the start of nipple feeding should be discarded. Feeds should not be re-warmed during feeding.
7. For tube feeding "hang-time" at room temperature should not exceed 4 hours.

For information on Nutricia products, please contact our Nutrition Support Department at: 1-800-NEOCATE or visit our website at www.shsna.com. For further information on safe preparation and handling of formula for infants, please refer to the American Dietetic Association guidelines "Preparation of Formula for Infants : Guidelines for Healthcare Facilities", 1991. Abbreviated version (revised 11/27/02) available at www.eatright.org/formulaguide.html.