Magazine article FDA Consumer

Juice Maker Fined Record Amount for E. Coli-Tainted Product

Magazine article FDA Consumer

Juice Maker Fined Record Amount for E. Coli-Tainted Product

Article excerpt

A California juice company was fined $1.5 million after pleading guilty to 16 misdemeanor criminal charges related to a 1996 outbreak of dangerous Escherichia coli O157:H7 bacteria. One child died and 14 other children were seriously sickened after drinking the company's fresh, unpasteurized apple juice.

The fine is one of the largest ever imposed in FDA history for a food injury case, and the criminal conviction by federal prosecutors is one of the first ever obtained in a large-scale outbreak of infectious pathogens.

Odwalla Inc., of Half Moon Bay, agreed in a criminal plea bargain in July to pay the fine and serve five years of court-supervised probation. The plea agreement, filed in the U.S. District Court for the Eastern District of California, also requires Odwalla to implement a Hazard Analysis and Critical Control Point (HACCP) plan in its facility. HACCP is a food safety system that identifies potential food safety hazards and specifies controls for preventing these hazards.

A $250,000 portion of the fine will be divided between a charitable organization, Safe Tables Our Priority (STOP), and the food safety research centers of the University of Maryland and Pennsylvania State University. The funds will be used to raise consumer food safety awareness and research the safety of fresh produce.

The tainted juice affected consumers in Colorado, California, Washington state, and British Columbia. Fifteen children who drank the juice developed the life-threatening condition hemolytic uremic syndrome (HUS), a leading cause of kidney failure in children. One of the children, a 16-month-old Colorado girl, died from HUS-related multiple organ failure. At least 51 others were sickened, but to a lesser degree. Food safety experts say survivors of this strain of E. coli may have significant health problems for years.

In late October 1996, FDA received word that the health departments from the three affected states had identified an E. coli 0157:H7 outbreak. Washington state health officials also told FDA that using DNA "fingerprinting" methods, they had clustered 15 related cases of E. coli infection in which all the victims had reported drinking Odwalla apple juice.

When notified of these findings, Odwalla began a recall Oct. 31 of all its apple juice products. At the same time, FDA launched a 14-month investigation. An investigator with FDA's San Francisco district office, Helen Hamaoka, inspected the Odwalla plant and collected apple juice samples, which were shipped to FDA's analytical laboratory in Seattle. Tests showed the samples were negative for E. coli O157:H7. Hamaoka noted, however, that the company had ignored safety standards by centering its product testing more on shelf life than bacterial contamination.

On Nov. 5, 1996, FDA's Seattle district laboratory analyzed samples of juice found in an Odwalla warehouse in Washington state. …

Search by... Author
Show... All Results Primary Sources Peer-reviewed


An unknown error has occurred. Please click the button below to reload the page. If the problem persists, please try again in a little while.