ROCKVILLE, Md., Jan. 6 /PRNewswire/ -- 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.
SOURCE Food and Drug Administration
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Related links:
http://www.fda.gov
CONTACT:
Judith Foulke of the FDA, 202-205-4144;
Broadcast Media, 301-827-3434; or Consumer Inquiries,
888-INFO-FDA
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