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          FDA Letter to Industry on Beef Cattle Ear ImplantsResources for You FDA Letter to Industry on Beef Cattle Ear Implants
  
  	
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    Print**FDA Letter to Industry – FDA updates information to beef cattle producers on use of cattle ear implants
(May 28, 2021 Letter)**

December 10, 2021

Dear Stakeholder,

The U.S. Food and Drug Administration’s Center for Veterinary Medicine is providing additional information to cattle producers on the use of beef cattle ear implants.

The FDA has recognized that the labeling for many cattle ear implants may not be clear to the end-user, particularly regarding reimplantation within a production phase. The FDA continues to work with sponsors of beef cattle ear implants to update the labeling of these products to clarify if or when a particular implant product may be used for reimplantation.

Currently, there are 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 focus of FDA’s initiative is to update the labeling of a third group of currently approved ear implant products that do not specify on the labeling as to whether reimplantation is approved.

The FDA has set June 2023 as the target date for the sponsors of this third group of ear implant products to begin introducing updated labeling regarding reimplantation within a production phase.

What to expect between now and June 2023:

With the exception of any new cattle implant approvals that may occur between now and June 2023, the labeling of currently approved cattle ear implant products is not expected to change with respect to language regarding reimplantation until June 2023.
	FDA recommends that beef cattle producers anticipate that, after June 2023, it will no longer be appropriate to reimplant ear implant products that do not clearly state on the labeling that reimplantation is permitted.  FDA is sharing this information now so that cattle producers can plan and begin to adjust their implant protocols and management practices accordingly.What to expect after June 2023:

FDA expects updated labeling for currently approved ear implant products to be introduced in June 2023.
	In the event that all product labels are not updated in June 2023, FDA expects that, after this date, cattle producers only reimplant products that explicitly state on the product labeling that reimplantation is permitted.It is important to note that reimplantation across production phases is not affected by these pending label changes. Beef cattle are and will still be allowed to receive multiple implants across *different*phases of production when using implants approved for that specific phase.  Cattle can also receive more than one implant within a production phase, but *only*if that implant is approved for repeated administration.

For reference: FDA Letter to Industry on Beef Cattle Implants (5/28/2021)
	Dear Stakeholder,

The FDA would like to take the opportunity to address recent inquiries from the beef cattle industry regarding beef cattle ear implants, and to reassure cattle producers that there are no changes to how they may be using these products at this time.

The FDA assures beef cattle producers that approved, over-the-counter implants will remain available for the beef cattle industry. These products have a variety of approved conditions of use and the FDA has recognized that the labeling for certain products may be unclear to the end-user, particularly with regard to repeat implantation. To address this issue, the FDA has initiated a process to work with the drug sponsors to clarify the labeling of the affected beef cattle ear implant products.

The FDA plans to continue to work closely with beef cattle producers to provide additional information as it becomes available, in order to minimize any confusion.

Additional Information

FDA Letter to Industry Provides Additional Information and Clarification on the Use of Beef Cattle Ear Implants
	FDA Answers Frequently Asked Questions Regarding Beef Cattle Production Phases and Reimplantation of Beef Cattle Ear Implants

                                                                                  Content current as of:
      05/12/2023Resources for You

          
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