Antibiotic Labels
Since the label lists a specific disease or pathogen against which the antibiotic works, FDA has stated they consider each of these claims to be prudent and judicious therapeutic claims for the use of antibiotics in food producing animals.
The label also contains information on the proper use of the product, such as the disease target, the dose needed for the specific animal according to its weight, and the route of administration. The label may contain restrictions or constraints on use. For example, the label will include withdrawal time, or period of time during which antibiotics may not be administered before the animal or animal products can enter the food supply. The withdrawal time is mandated to ensure the meat or milk does not contain residues above limits set by FDA.
The FDA & Judicious Use
Collaboration and continuous improvement contribute to strong animal health outcomes
Animal health companies and our trade associations worked collaboratively with the FDA to implement the agency’s Judicious Use Policy in 2017. Under this policy, companies voluntarily removed growth promotion claims from medically important antibiotic compounds, leaving only therapeutic claims. As a result, antibacterial agents medically important to humans are used in food animals only to fight disease.
Also, as part of Judicious Use policy, all the antibiotics products with therapeutic claims that are used in feed and water were brought under the supervision of a licensed veterinarian. All medically important antibiotics added to feed must be approved by a veterinarian by providing a Veterinary Feed Directive (VFD), written instructions to a feed mill on how to properly mix antibiotics in the feed. The veterinarian must have a Veterinary Client-Patient Relationship (VCPR) with the producer of the animals and must make the medical judgment that administration of the antibiotic is needed due to disease threats or outbreaks.
Animal health companies also worked successfully with FDA to bring all remaining medically important antibiotics that were marketed over-the-counter under prescription status. As a result, all medically important antibiotics used in animals are used under the supervision of a licensed veterinarian to address disease threats.
We continue to demonstrate our commitment by working with the FDA on the agency’s Five-Year Plan for Supporting Antimicrobial Stewardship in Veterinary Settings. This plan includes, among other things, ensuring labels on medically important compounds have appropriate duration of use instructions; collecting and analyzing data on the use of antibiotics in animals; and the development of a strategy to ensure antimicrobial stewardship in companion animals.