Regulatory Brief

 Extralabel Use of Cephalosporins in Food-Producing Animals


Formal title: Docket Number [FDA-2008-N-0326] New Animal Drugs; Cephalosporin Drugs; Extralabel Animal Drug Use; Order of Prohibition

In the July 3, 2008 Federal Register the Food and Drug Administration (FDA) issued an order prohibiting the extralabel use of cephalosporin antimicrobial drugs in food-producing animals. The FDA stated that it was issuing the order based on evidence that extralabel use of these drugs in food-producing animals will likely cause an adverse event in humans and, as such, presents a risk to the public health.

On August 18th the FDA extended the deadline of the comment period from September 2, 2008 to November 3, 2008 and delayed the effective date of the Order of Prohibition to November 30, 2008.

Brief Description and AVMA Response:

The AVMA responded to the FDA's call for public input with an exhaustively researched and thoughtfully drafted letter. In that letter the AVMA states that it is committed to judicious use of antimicrobials, ensuring efficacy of antimicrobials and upholding animal and public health.

While the AVMA admires the FDA's intent, the organization has reached scientific conclusions that differ greatly from those offered by the FDA. The AVMA strongly recommends that the FDA postpone its final rule prohibiting all extralabel use of cephalosporin antimicrobials in food-producing animals, in order to perform a risk assessment characterizing the hazard, evaluating the risk, and ascertaining the impact of any risk management recommendations

The AVMA bases its recommendations on the following:

  • The lack of scientific evidence showing any significant risk to human health by extralabel use of cephalosporins in food producing animals
  • The lack of any demonstrated benefit of the rule to human health
  • The rule's potential for unintended consequences on animal health and welfare, on food safety, and on the practice of veterinary medicine
  • The misinterpretation of federal regulation

Background Documents:

View AVMA's full response to FDA (PDF)

View Federal Register document (PDF)

Status:

AVMA responded on October 30, 2008

FDA revokes prohibition, withdraws final rule (PDF)

AVMA Response to the FDA Extralabel Drug Use Order of Prohibition