The U.S. Food and Drug Administration’s Center for Veterinary Medicine is providing additional information to beef cattle producers in preparation for implementing changes to the reimplantation of certain beef cattle ear implants. The FDA previously issued an update on December 10, 2021, that announced the target date of July 1, 2023, for the sponsors of beef cattle ear implants to update the labeling of their products regarding reimplantation within a production phase. Today’s communication also provides clarification on how FDA interprets beef cattle production phases, and the implications for use of beef cattle ear implants.
As a result of the labeling initiative, most cattle ear implants are now clearly labeled regarding reimplantation. Currently, there are some ear implants that are approved for reimplantation within a production phase and clearly state so on the labeling. Other implant products clearly state on labeling that reimplantation within a production phase is not permitted. The labeling of some cattle ear implants has not yet been updated. Unless a cattle ear implant clearly states on labeling that they are approved for reimplantation within a production phase, they are not approved for reimplantation.
FDA defines and describes beef cattle target animal subclasses in Appendix III of Guidance for Industry #191. The definitions are based on differences in physiological state and management of the animals at each phase and are reflective of the conditions of use that were used to demonstrate effectiveness of the product for FDA approval. Cattle producers should note that, although FDA does not define a change in production phase as a change in ownership or location, these changes may be accompanied by a change in production phase.
There are currently three beef target animal production phases (i.e., “variants”) that FDA describes in Appendix III and there are one or more cattle ear implants approved for use in each of these variants. FDA considers each of these variants as distinct production phases. These variants and definitions are listed and further described below:
|Beef calves 2 months of age and older1||Beef calves considered ruminating and nursing their dams from 2 months of age to weaning.|
While there are cattle ear implants approved for use in this production phase, no implants are approved for use in a reimplantation program in this production phase of cattle.
1Some products may have different age restrictions. Please see product labeling for more information.
|Growing Beef Steers and Heifers on Pasture (stocker, feeder, and slaughter)||Weaned growing beef steers and heifers (beef and dairy breeds) intended only for slaughter (i.e., not for reproductive purposes) maintained on pasture and receiving the majority of their diet from grazing. (See Appendix III of Guidance for Industry #191 for additional information.)|
While there are cattle ear implants approved for use in this production phase, no implants are currently approved for use in a reimplantation program in this production phase of cattle.
Cattle in this production phase may only receive one implant during this production phase regardless of whether they are considered part of the subclasses “stocker”, “feeder”, or “slaughter”.
|Growing Beef Steers and Heifers Fed in Confinement for Slaughter||Weaned growing and finishing beef steers and heifers (beef and dairy breeds) intended only for slaughter (i.e., not for reproductive purposes) and confined in group pens and fed a progressively high-energy diet ad libitum as their sole ration until slaughter. May also be referred to as feed yard or feedlot cattle in the industry. Includes growing beef steers and heifers in a grow yard.|
There are multiple implants currently approved for use in a reimplantation program in this production phase of beef cattle.
FDA defines growing beef steers and heifers in a grow yard as a subset population of the production phase “growing beef steers and heifers fed in confinement for slaughter”, regardless of whether they are co-located on a feedlot or are housed at a separate facility. The intent with defining this subclass of beef cattle is to allow for the appropriate use of drugs approved solely for use in grow yard cattle.
A change in ration (i.e., fed a progressively high-energy diet) is not a change in the production phase. There are no cattle ear implants approved only for use in grow yard cattle. Implants approved for use in growing beef steers and/or heifers fed in confinement for slaughter may be used in grow yard cattle, but cattle that receive an implant during the grow yard phase of production may not receive a subsequent implant, unless the implants used are approved and labeled for use in a reimplantation program for growing beef steers and/or heifers fed in confinement for slaughter.
Cattle continue to be permitted to receive more than one implant across different production phases, when using an implant approved for each specific phase. Within a production phase, cattle may only receive more than one implant if that implant is approved (as explicitly stated on the labeling) for use in a reimplantation program for that production phase. Beginning July 1, 2023, cattle ear implants that are not labeled for use in a reimplantation program for that production phase may not be used in a reimplantation program.
FDA acknowledges that beef cattle production industry nomenclature and terminology differs across the United States, and the terminology used by FDA for regulatory purposes does not always align with those terms. However, this does not permit creative interpretation of the cattle production phases for which implants are approved. Beef cattle producers are required to follow the phases as described in the approvals for implants and any other requirements in the Food, Drug, and Cosmetic Act (FD&C Act) and associated regulations in title 21 of the Code of Federal Regulations (CFR).
Under specified conditions, only veterinarians are legally allowed to prescribe approved human and animal drugs for extralabel uses in animals (21 CFR 530). When an approved human or animal drug is used in a way other than what is stated on the drug’s labeling, it is an extralabel use. This is sometimes referred by the public as an “off-label” use because the drug is used in a way that’s “off the label.” Non-veterinarians are not permitted to use drugs in an extralabel manner without the oversight of a veterinarian.
Veterinarians must follow all federal requirements addressing the extralabel use of drugs in animals, as detailed in FDA regulations. Use of a growth-promoting cattle ear implant in an extralabel manner, including those with an Rx marketing status, does not comply with these requirements, which limits extralabel use only to treatment situations when the health of an animal is threatened, it is suffering, or death may result from failure to treat. Extralabel use of a drug for growth-promotion purposes does not qualify for this permitted limited use. Illegal extralabel use may cause a drug to be adulterated under the FD&C Act and subject to possible enforcement action.