FDA Logo--links to FDA home page
U.S. Food and Drug Administration
HHS Log--links to Department of Health and Human Services website

FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA

horizonal rule

FDA News

FOR IMMEDIATE RELEASE
P03-62
August 22, 2003

Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA


Lactoferrin Considered Safe to Fight E. Coli

FDA today announced that aLF Ventures, Salt Lake City, Utah, has consulted with the agency about aLF Ventures' plans to market lactoferrin, a component of an anti-microbial spray. This spray can be applied to uncooked beef carcasses to fight E.coli 0157:H7, an organism that can cause severe gastrointestinal disease in humans. FDA informed aLf Ventures today that it does not question their decision to market lactoferrin, an anti-microbial protein found in cow's milk and beef.

Although aLF Ventures was not required to seek approval from FDA before it marketed lactoferrin, aLF Ventures provided FDA scientific data supporting the firm's conclusion that lactoferrin is "generally recognized as safe" (GRAS) and safe for the general population as well as for individuals who are allergic to milk.

"Innovative technology is a critical building block in preserving the strong foundation of the U.S. food supply," said Dr. Lester Crawford, Deputy Commissioner of the Food and Drug Administration. "We must continue to encourage scientific research and new technology to maintain this nation's safe food supply."

A substance used in food can be GRAS if its safety has been established by generally available scientific data and information that lead qualified experts to conclude that the use of the ingredient is safe for its proposed use.

In its notice submitted to FDA, aLF Ventures noted that the amount of added lactoferrin that remains on the beef after spraying is comparable to the amount of lactoferrin that is naturally occurring in the beef.

aLF Ventures also submitted data to the U.S. Department of Agriculture (USDA) regarding the effectiveness of lactoferrin against E.coli 0157:H7. USDA is the agency responsible for addressing labeling issues with lactoferrin-treated beef.

####

rule