Table of Contents

Guidance Documents
Other Information

Fumonisins are naturally occurring toxins produced by the molds Fusarium moniliforme (F. verticillioides), F. proliferatum, and other Fusarium species that are common natural contaminants of corn. Fumonisins can cause leukoencephalomalacia in horses and pulmonary edema in pigs and have been linked to a variety of significant adverse health effects in other livestock and experimental animals. When provided in the diet at levels of 50 ppm and above, purified fumonisin B1 induced kidney tumors in male rats and liver tumors in female mice. Although human epidemiological studies are inconclusive at this time, based on a wide variety of significant adverse animal health effects, the association between fumonisins and human disease is possible. Because the presence of fumonisins in animal feeds is of vital importance to CVM this page contains CVM and FDA information on the subject.

Guidance Documents

• Guidance For Industry 112 : Fumonisin Levels in Human Foods and Animal Feeds - Final Guidance 11/9/2001

Other Information

• CVM Updates

  • FDA Warns Horse Owners about Fumonisins in Horse Feed, November 29, 2006

  • Final Guidance Available on Fumonsin Levels in Human Food and Animal Feeds, November 15, 2001
    
    

• Federal Register Notices

  • Docket No. 00D-1277, CFSAN 200149. Guidance for Industry: Fumonisin Levels in Human Foods and Animal Feeds; Availability. Pages 56688--56689 [FR Doc. 01-28104] November 9, 2001
    | htm | | pdf |
    
    

  • Draft Guidance for Industry: Fumonisin Levels in Human Foods and Animal Feeds; Availability. FR Notice, Volume 65, Number 109, Page 35945, June 6, 2000
    | text | | pdf |
    
    

• CVM Background Document

  • CVM Background Paper - Background Paper in Support of Fumonisin Levels in Animal Feed, November 9, 2001
    
    

• CFSAN Background Document

  • CFSAN Background Paper - CFSAN Background Paper - Background Paper in Support of Fumonisin Levels in Corn and Corn Products Intended for Human Consumption, November 9, 2001

CVM A-Z Index | Contact CVM | About CVM | Site Map
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | Privacy | Accessibility | HHS Home Page