FDA Warns About Infant Formula Fraudulently Labeled as Nutramigen in Southern California

HHS NEWS

P99-23                                                     FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE                                      LA District: 949-798-7607
October 8, 1999                                            Print Media:  202-205-4144
		                                                                                                      
                                                           Consumer Inquiries:  888-SAFEFOOD
 

FDA WARNS ABOUT INFANT FORMULA FRAUDULENTLY
LABELED AS NUTRAMIGEN IN SOUTHERN CALIFORNIA

The Food and Drug Administration is warning parents in Southern California who feed their babies Mead Johnson's Nutramigen Powder infant formula to be aware of a potential counterfeit labeling fraud. FDA and the company have become aware of a small number of cases in the Southern California area in which cans of a milk or soy-based powder infant formula have been fraudulently labeled as Nutramigen. This has the potential to cause mild to severe allergic reactions to babies who must use a hypoallergenic infant formula.

Labels of Mead Johnson's Next Step Powdered milk or soy -based toddler formula were removed from certain cans and the Nutramigen label was substituted. FDA is warning parents to be aware of this potential fraud because babies who need hypoallergenic formula may be highly sensitized to protein and may have adverse reactions to the milk proteins in the Next Step formula. Such reactions could include severe gastrointestinal problems, skin rashes, fevers, or severe allergic reactions.

Parents are asked to check the letters embossed on the bottom of any cans of powdered infant formula with a Nutramigen label. The third line of the embossed copy on the bottom of the can should read NUTRAM. If it does not, the infant formula should not be fed to the baby, and parents should immediately notify Mead Johnson Nutritionals at 1-800-222-9123 for further instructions.

Mead Johnson Nutritionals notified stores and the media on Wednesday, October 6, 1999, as soon as the problem of the counterfeit labels was discovered. The counterfeit cans were purchased at several stores in southern California. Mead Johnson and the FDA are investigating this potential fraud.

Only cans of powdered infant formula labeled as Nutramigen that do not have NUTRAM embossed on the bottom of the can are involved in this FDA warning. Cans embossed with NUTRAM are not affected and are safe to use. Other forms of Nutramigen, both concentrate and ready-to-use, are not involved in this FDA warning.

Mead Johnson encourages parents who have any questions to call the Consumer Resource Center at 1-800-222-9123.