FDA TALK PAPER Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available.
T98-77 Print Media: 301-827-6242
October 23, 1998
Consumer Inquiries: 800-532-4440
FRESH CITRUS JUICE MANUFACTURERS CAN ASK FOR EXTRA TIME
BEFORE WARNING LABELS ARE REQUIRED FDA announced today that the agency will consider giving citrus juice manufacturers who agree to meet specific conditions towards ensuring the safety of their products, up to an additional eight months to comply with new requirements for carrying warning labels on packaged fresh citrus juices.Earlier this summer, FDA established a requirement that packaged juice products that are not pasteurized or otherwise processed to prevent, reduce or eliminate illness-causing microbes (pathogens) must carry a warning statement to inform consumers of the risk of food borne illness to children, the elderly and persons with weakened immune systems. The effective date for displaying the warning was September 8, 1998, for apple juice and cider, and will be November 5, 1998, for all other juices. Today's action responds to citrus industry requests for additional time to develop a process that will achieve the FDA-required reduction in pathogens (100,000 fold or 5-log). If such a process is in place, the manufacturer is not required to use a warning statement on their juice products. Under today's approach, the agency will grant an 8-month extension to a manufacturer who agrees to: - Use the time granted to develop, adapt, and validate procedures that achieve a 5-log reduction in the pertinent pathogens.
- Establish interim protection measures using Hazard Analysis Critical Control Point (HAACP) principles to identify and correct production procedures where there is the potential for a food safety hazard to occur. The interim measures should include, at a minimum, strict controls for chemical washing and brushing fruit, sanitizing fruit, culling damaged fruit, and using only those types of fruit with skins that are sufficiently smooth and durable to be cleanable and to remain intact after cleaning.
- Use the warning label on their products no later than July 8, 1999 unless by that date the firm can achieve the 5-log reduction in pathogens using a validated process.
In addition to meeting the criteria outlined above, a manufacturer must register a request for an extension with the FDA by December 19, 1998.FDA also announced today that the agency will sponsor technical scientific workshops in Florida and California to discuss methods developed by the citrus industry to reduce pathogens in fresh citrus juice and the methods for measuring and validating such systems. Several major fresh citrus juice producers have already developed and are using such production methods. The technical workshops will be held Nov. 12, 1998, in Lake Alfred, Florida, and Nov. 19, 1998, in Irvine, California.
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