February 21, 1997
CVM POLICY ON COMPETITIVE EXCLUSION PRODUCTS
The Center for Veterinary Medicine (CVM) has recently evaluated the sale and use of competitive exclusion (CE) products in animals. Competitive exclusion products are products containing live microorganisms isolated from the gastro-intestinal tract of chickens and other animals. In addition, these products are labeled and/or promoted with therapeutic and/or structure/function claims which include statements about reduction in the level of salmonella and other enteric pathogens. Therefore, competitive exclusion products are classified as drugs under the Federal Food, Drug, and Cosmetic Act. Because these products are not generally recognized as safe and effective, they are considered unapproved new animal drugs when labeled with drug claims or misbranded if promoted for drug purposes. To continue to market these products they must be properly labeled and the subject of an approved New Animal Drug Application. Any previous opinions by the Center advising a different regulatory position are no longer valid.
Another class of products are the direct-fed microbial products which may be regulated as food under the provisions of Compliance Policy Guide (CPG) 689.100. These products consist of specific organisms listed in the Association of American Feed Control Officials (AAFCO) official publication and contain known quantities of the microbes (i.e. colony-forming units). In contrast, CE products consist of unquantified and/or unidentified microorganisms. CE products are not considered candidates for marketing under the provisions of the Direct-Fed Microbial CPG.
Unapproved microbial products are subject to immediate regulatory action, however, the Agency is prepared to work closely with any company actively seeking approval for their products. For information on obtaining approval for competitive exclusion products contact Dr. Steven Vaughn, Director of the Division of Therapeutic Drugs for Food Animals, Office of New Animal Drug Evaluation at (301) 594-1642. For information about the regulation of direct-fed microbial products, contact Dr. George Graber, Director of the Division of Animal Feeds, Office of Surveillance and Compliance at (301) 594-1724.
Issued by:
FDA, Center for Veterinary Medicine,
Communications Staff, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (240) 276-9300 FAX: (240) 276-9115
Internet Web Site: http://www.fda.gov/cvm
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