FDA Antibiotic Regulation Through the Decades

For more than 50 years, veterinarians and producers have administered antibiotics to food animals, primarily poultry, swine, and cattle, mostly to fight or prevent animal diseases. The FDA has provided a tightly regulated framework on how antibiotics can be used in the food supply.

  • 1980’s - All new medically important antibiotics have been approved with veterinary oversight.
  • 1996 - National Antimicrobial Resistance Monitoring System (NARMS) established.
  • 1997 - Extralabel use of fluoroquinolones and glycopeptides prohibited
  • 2003 - FDA established industry guidance for assessing antimicrobial resistance risks as part of the drug approval process
  • 2005 - Withdrawal of approval of fluoroquinolones for use in poultry
  • 2005 – Approach to evaluate the effect of antimicrobial residues on human intestinal flora into the pre-approval safety procedure enacted
  • 2010 - Initiated The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals
  • 2010 – First publication of annual summary report of antimicrobials sold for use in food-producing animals 
  • 2012 - Prohibited certain extralabel uses of cephalosporins 
  • 2012 - published final Guidance for Industry #209, draft Guidance for Industry #213,  and draft Veterinary Feed Directive proposed rule
    • Guidance for Industry #209 outlines the procedure for phasing out antibiotic use for growth promotion and phasing in veterinary oversight of these antibiotics.
  • 2012 & 2013 - Solicited public input on data collection and reporting related to antimicrobial use in food-producing animals.
  • 2013 - Published final Guidance for Industry #213 and proposed Veterinary Feed Directive rule.
  • 2013 - FDA revised its animal sampling structure in the National Antimicrobial Resistance Monitoring System (NARMS) to get more representative animal data on all four target organisms under surveillance.
    • NARMS partners at CDC and USDA have published over 150 peer-reviewed research articles examining the nature and magnitude of antimicrobial resistance hazards associated with antibiotic use in food producing animals
  • 2013 - FDA partnered with three State public health laboratories to collect more data on resistance in bacteria from retail meats.
  • 2014 - FDA is working with USDA and CDC to explore mechanisms for gathering representative antibiotic use information for food producing animals.
  • 2014 - First publication of annual summary report of antimicrobials sold for use in food-producing animals in expanded format
  • 2015 - FDA issued the Veterinary Feed Directive final rule
    • This rule lays out what veterinarians must do when they need to authorize the use of antimicrobials in feed to protect the animals they serve.
  • 2016 – Implementation of Gudiance for Industry #213 is anticipated to be completed.