Date: Saturday, July 4, 1998
FOR IMMEDIATE RELEASE
Contact: FDA Press Office (301) 827-6250

PRESIDENT CLINTON ANNOUNCES NEW MEASURE TO INCREASE SAFETY OF FRESH JUICES

President Clinton announced in his radio address today a new food safety regulation requiring a warning on packaged fresh fruit and vegetable juices that have not been processed to prevent, reduce or eliminate illness-causing microbes. The warning statements to be required by the Food and Drug Administration (FDA) will help inform consumers of the potential risks posed, particularly to children and the elderly, by unprocessed juices and will take effect in time for this year's apple cider season. This action is one in a series of steps the Clinton Administration has taken to improve the safety of foods Americans consume.

Unprocessed juices constitute only about 2 percent of the total juice sold in the U.S., but they have been linked to increasing numbers of foodborne disease outbreaks in the past few years. Unpasteurized apple cider and apple juice have been associated with E.coli 0157:H7 outbreaks which have caused severe illnesses and even death. A 1996 E.coli 0157:H7 outbreak associated with apple juice products sickened at least 66 people in the Western United States and Canada, including a child who died from the infection. Unpasteurized orange juice has been linked to salmonella outbreaks. In all, FDA estimates that up to 48,000 cases of foodborne illnesses each year may be attributable to the consumption of unprocessed juices.

These foodborne illnesses pose the greatest risk to children, the elderly, and those persons with suppressed immune systems resulting from cancer treatment, HIV infection or other significant health problems. While healthy persons may experience diarrhea, nausea, abdominal cramping, or fever for several days, those whose immune systems are not fully developed, or are impaired, may develop severe, life-threatening conditions if exposed to these foodborne pathogens.

"The growing number of foodborne outbreaks in recent years demonstrate the need for clear labeling that will alert parents and all consumers to the risks of unprocessed juices. Even though only a small percentage of juice products are not processed, it is critical that we spread the word so consumers most vulnerable to foodborne illnesses can make informed choices," said Secretary of Health and Human Services Donna Shalala.

The statement required to appear on unprocessed juice will read:

"WARNING: This product has not been pasteurized and, therefore, may contain harmful bacteria that can cause serious illness in children, the elderly, and persons with weakened immune systems."

Unpackaged juice, such as cups or glasses of juice sold in retail establishments, like restaurants or juice bars, are exempted from the warning statement.

Manufacturers may provide the warning statements as signs and placards to be used at the points of purchase for one year after the effective date of the rule (until September 1999 for apple juice and apple cider, and until November 1999 for other juices). This interim use of point-of-purchase labeling will provide manufacturers flexibility for a single juice season.

Under the new regulation, warning statements for unprocessed apple juice or apple cider will be in place by early September, in time for this fall's apple season. Warnings on all other unprocessed juice products will appear by November.

Today's action is part of a series of steps FDA is taking to enhance the safety of juices. In an earlier action, FDA proposed to require manufacturers of most packaged fruit and vegetable juices to implement hazard control programs in their plants to prevent microbiological, chemical and physical contamination of their products.

The required changes in the production process would consist of a scientifically designed program called Hazard Analysis and Critical Control Point, or HACCP. HACCP identifies the steps in food production where contamination is most likely to occur and then puts in place preventive controls.

Under the proposed HACCP system of control, juice products would be pasteurized or otherwise treated to achieve a proposed performance standard of a 5-log reduction (100,000 fold) in the numbers of harmful microbes as compared to levels that may be present in untreated juice. These reductions would apply to the shelf life of the juice. If HACCP becomes a final rule and is implemented by the manufacturer, the warning statement for packaged juices required in today's rule would not be necessary since reductions in pathogens would already be achieved.

"FDA is committed to ensuring that the nation's food supply remains the safest in the world," said Michael A. Friedman, M.D., Acting Commissioner of the Food and Drug Administration. "Today's action will be another step forward in our efforts to improve the safety of the foods Americans place on their tables each day."

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Note: Additional announcements on the President's July 4th food safety radio address [http://vm.cfsan.fda.gov/~lrd/press.html] are available at: http://vm.cfsan.fda.gov/~lrd/press.html. HHS press releases are available on the World Wide Web at: http://www.hhs.gov.