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.
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:
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: