FDA
TALK PAPER

Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857
FDA 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. 
 
T99-1                           Judith Foulke:       202-205-4144
January 5,1999                  
                                Consumer Inquiries:  888-INFO-FDA

EXPEDITED REVIEW GIVEN TO FOOD ADDITIVE PETITIONS
THAT PROVIDE FOOD SAFETY SOLUTIONS

Under new guidance published today by the FDA, top priority will be given to reviewing food additive petitions for products designed to decrease the risk of foodborne illness.

Specifically, expedited review will be given to food additives intended to significantly decrease pathogenic strains of E.coli, Salmonella, Campylobacter, Cyclospora, and Listeria or their toxins that may be present in food. According to statistics from the Centers for Disease Control and Prevention, Campylobacter bacteria causes the greatest number of foodborne illnesses and Salmonella ranks second. All five pathogens are capable of causing serious and even life-threatening illness. While America's food supply is among the safest in the world, every year millions of Americans become ill and thousands die as a result of infections caused by foodborne pathogens.

These expedited petitions will still have to meet the same approval standards that are applied to other food additive petitions, including the need for valid scientific evidence, the need to satisfy the safety standard, and the presentation of data to support the petitions.

Examples of petitions that could be designated for expedited review are those that propose the use of sources of radiation or chemicals such as chlorine dioxide intended to reduce harmful bacteria. This process of expedited review is designed to provide an incentive for manufacturers to develop these critical products and to ensure that such products are available for marketing as soon as possible, with the safety standard and process established by law for food additives.

"Food Additive Petition Expedited Review -- Guidance for Industry and Center for Food Safety and Applied Nutrition Staff" was published in the Federal Register on January 5, 1999. Written comments may be submitted at any time to the Dockets Management Branch, Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Comments will be considered when determining whether to amend the guidance.


More information on this subject is available at the Center for Food Safety and Applied Nutrition's Website.

This is a mirror of the page at HTTP://www.fda.gov/bbs/topics/ANSWERS/ANS00933.html

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