Fact Sheet: FDA's Approval Process for Food Animal Antibiotics

This fact sheet discusses the animal antibiotic regulatory approval process, which ensures the safety of milk, meat and eggs from animals treated with antibiotics.  Human safety is a key component of the approval process and all antibiotics intended for use must pass a food safety test prior to approval. A more in depth overview of the safety assessment for meat and milk from animals treated with antibiotics is provided, including discussion of two additional aspects of this safety assessment related to antibiotic residues and antimicrobial resistance.  Furthermore, there is a link to a chart containing a visual depiction of the FDA Food Animal Antibiotic Approval Process available, as well as several informational resources pertaining to antibiotic use in animals, which can be found at the end of this fact sheet.

 


 

The Center for Veterinary Medicine (CVM), a branch of the Food and Drug Administration (FDA), is responsible for ensuring that animal drugs are safe, effective, and manufactured to the highest quality standards. While there are many aspects that go into the animal antibiotic approval process, human safety is a key component.  The standards and process for reviewing an antibiotic used in animals are similar to those for an antibiotic used in humans in most respects.  All drug evaluations include safety, efficacy and quality assessments.  Because livestock go into the human food chain, however, antibiotics intended for the use in these animals must pass food safety studies as well.  Also, an important part of the approval of new antibiotics in animals is the monitoring and surveillance after approval.  This fact sheet elaborates on how the CVM approval process works to ensure the safety of milk, meat and eggs from animals treated with antibiotics.

Human Safety

The safety assessment requires sponsors to submit data prior to approval showing not only that the proposed use of the antibiotic is safe for the animals in which it is to be used, but also that meat and milk from those animals is safe for humans to consume.

As explained below, the food safety assessment for antibiotics intended for food animals includes two additional considerations:

  • Drug Residues: The safety assessment for food animal antibiotics requires sponsors to submit food safety studies to ensure meat, milk and eggs from animals treated with the antibiotic will be safe for human consumption.  In addition, data from these studies are used to establish withdrawal periods specific to that antibiotic and the species of livestock.  The withdrawal period specifies the number of days that must pass after the last antibiotic treatment before the animal can enter the food supply.  FDA uses large margins of safety in establishing safe residue limits and withdrawal times to ensure that the antibiotic has sufficiently cleared the animal’s system before slaughter to ensure safe meat, milk and eggs.  Withdrawal times are clearly printed on an antibiotic’s label at the time of sale to a producer or veterinarian.  By law, any person who administers antibiotics must adhere to the specific antibiotic’s withdrawal time and is required to keep records verifying compliance to it.  Moreover, FDA and the U.S. Department of Agriculture have a coordinated surveillance program for meat and milk to help ensure that no violative residues are contaminating meat and milk.   
  • Antimicrobial Resistance: In 2003 FDA implemented Guidance 152, an additional safety measure that “outlines a comprehensive, evidence-based approach to preventing antimicrobial resistance that may result from the use of antimicrobial drugs in animals.”  Guidance 152 uses a science based, risk assessment approach for determining the level of risk to humans.  The guidance helps protect human health while providing safe tools for veterinarians and livestock producers to treat animals.  All new antibiotics must go through this qualitative risk assessment process, or the sponsor could conduct a more detailed quantitative risk assessment and submit the results to the agency.  CVM is also working with animal health companies to evaluate existing approved products.  If the risk assessment shows that the animal antibiotic might compromise the efficacy of drugs used to treat human diseases, then FDA can deny approval or require that the antibiotic be restricted in certain ways to minimize potential risk.  For example, FDA can deny its use in certain livestock species or deny its use for treating diseases not listed on the drug’s label.

FDA, in cooperation with the USDA and CDC, conducts the National Antimicrobial Resistance Monitoring System (NARMS) to collect data to monitor antimicrobial resistant foodborne pathogens in animal carcasses at slaughter, in retail meats, and in human clinical cases.  This information can provide useful insight about patterns of emerging resistance, which in turn can help guide treatment decisions in human and veterinary medicine.  Antimicrobial resistance patterns are useful in helping to identify the source and magnitude of resistance.  The data are important for developing public health recommendations for the use of drugs in humans and food animals and are also an asset to authorities who are investigating outbreaks of foodborne disease.

Chart: FDA Food Animal Antibiotic Approval Process

For more information regarding FDA’s approval process for animal antibiotics, see the following resources: