An Overview of the FDA Final Guidance 213 and Proposed Veterinary Feed Directive (VFD)

An Overview of the FDA Final Guidance 213 and Proposed Veterinary Feed Directive (VFD)

By Dr. Kathy Simmons, DVM, NCBA Chief Veterinarian

On Dec. 12, the Food and Drug Administration (FDA) published their final Guidance #213 and a proposal for revisions to the current Veterinary Feed Directive (VFD). These revisions proposed for the VFD are in response to complaints from stakeholders that the current VFD process can be burdensome. This current guidance is part of FDA’s larger strategy for judicious use of the antibiotics that are most important for use in human medicine and are currently used in feed and water for food-producing animals. Guidance #213 is directed toward the use of these products in feed and water and pertains to the medically important antibiotic classes listed in Appendix A of Guidance 152. The specific drugs or product applications affected by Guidance #213 can be found in a list on the FDA website here.

Guidance #213 does not pertain to the ionophores, such as monensin, unless used in a combination product with a medically important antibiotic.

Guidance #213 is a follow up to final Guidance #209, which states that the antibiotics important to human health should only be used in animal agriculture in ways that are necessary to maintain animal health and with veterinary oversight. Guidance #213 establishes the roadmap for the animal drug manufacturers to phase out the growth promotion use of these products in feed and water over the next three years and revise product labels as needed for use indications of control, prevention and therapy. All medically important antibiotics used in feed and water will require a veterinary prescription or a VFD in order to obtain these products for control, prevention and treatment use.

What is the objective of this FDA guidance? Doubtless, most everyone is aware of the global concern for increasing antibiotic resistance and the problems that antibiotic resistance creates for effectively treating infections in humans and animals. FDA has responsibly chosen to address the concern of antibiotic resistance and its threat to public health. FDA guidance seeks to eliminate the subtherapeutic use of medically important antibiotics in feed and water for growth promotion. The cattle industry, through the Beef Quality Assurance program, also supports this stance by stating in the Judicious Antibiotic Use Guidelines that, “Subtherapeutic Antibiotic Use is Discouraged: Antibiotic use should be limited to prevent or control disease and should not be used if the principle intent is to improve performance.”

So, what does this guidance really mean for cattlemen and women? The loss of the medically important antibiotics for growth promotion has only a minimal impact as there are really very few of these products used for growth promotion in the cattle industry. Our current use of antibiotics in feed is primarily for the prevention and control of conditions/diseases such as liver abscesses, coccidiosis and anaplasmosis. The use of these products will still be available in feed and water for control, treatment and prevention through the oversight of the veterinarian by Rx or VFD. It is extremely important to cattlemen and women to have an efficient and dtreamlined VFD process in order to facilitate the timely and uninterrupted access to these