1. Rescission of Label Approvals
   An FSIS review of recently approved labels bearing “Raised without Antibiotics (RWA)” or similar claims revealed that some labels for poultry products have been approved in error.
   
   Specifically, the RWA claim is present on the labeling of some poultry products that were produced from poultry that were fed a diet that included ionophores, e.g. salinomycin, narasin, and monesin. The term “antibiotics” is defined by the American Veterinary Medical Association (AVMA) as “a chemical substance produced by a microorganism, which has the capacity, in dilute solutions, to inhibit the growth of or to kill other microorganisms.” It is longstanding FSIS policy that ionophores are antibiotics because they meet the AVMA definition. The Food and Drug Administration (FDA) agrees that by strict definition, ionophores are antibiotics thus; poultry meat from birds to which ionophores have been administered is not eligible to bear a “RWA” claim.
   
   Effective immediately, all poultry product labels bearing a RWA or similar claim for birds administered ionophores are rescinded. Any company using ionophores in the feed formulations of poultry that are labeled with a RWA claim needs to 1) remove the claim from its labeling, 2) remove ionophores from the feed formulation of such poultry, or 3) submit a new label application with appropriate supporting documentation, for approval of a revised claim regarding ionophores.
   
   The company may submit a request for temporary approval consistent with 9 CFR 381.132(f) (PDF Only) while it removes the RWA claim from its label, removes ionophores from feed formulations for poultry that is to be labeled with such a claim, or awaits FSIS approval of a revised claim.
   
   Companies may petition FSIS to initiate a public process to consider the use of ionophores in the feed formulations of poultry that are used to make products labeled with a RWA or similar claims.
   
   
2. Parameters for the Use of a Claim about Antibiotics when Ionophores Are Used
   FSIS will consider approving claims about antibiotic use in poultry fed ionophores. Such claims should be consistent with the following parameters:
   
   
   1. The claim should not assert that the poultry was raised strictly without antibiotics, e.g., the unqualified claim “Raised without Antibiotics” would not be acceptable.
   2. The claim, specifically the term “antibiotics,” would need to be qualified to reflect the characteristics of ionophores, e.g., “Raised without Antibiotics that impact antibiotic resistance in humans.”
   3. The claim should be a single statement.
   4. The type size of the words that qualify the term “antibiotics” needs to be at least ½ the size of the smallest letters (including any highlighting or outlining) of the largest letter in the words “Raised without Antibiotics” or similar terms and should be in the same color type and provide for easy readability. The entire claim must be prominent and conspicuous.
   5. Such labeling should be submitted to the Labeling and Program Delivery Division for sketch approval including supporting documentation detailing the feed formulation.
      

Last Modified:  March 19, 2008