Tasneem Mohammad contributed to this post and is a current Summer Associate at Fox Rothschild’s Princeton, NJ Office.

In April of 2024, the United States Food and Drug Administration (FDA) finalized new Guidance for Industry (GFI) #120: Veterinary Feed Directive Regulation Questions and Answers to inform industry stakeholders and small entities on how to comply with the final rule on Veterinary Feed Directives (VFDs) published in 2015. U.S. Food & Drug Admin., Small Entity Compliance Guide: CVM GFI #120 Veterinary Feed Directive Regulation Questions and Answers (2024).

A VFD is a statement issued by a veterinarian that allows for an animal caretaker to use VFD drugs in their animals’ feed. U.S. Food & Drug Admin., Veterinary Feed Directive Requirements for Veterinarians (2015), https://www.fda.gov/animal-veterinary/development-approval-process/veterinary-feed-directive-requirements-veterinarians (last visited July 8, 2024). VFD drugs are antimicrobial medications that are to be used in animal feeds to treat or prevent disease, while under the supervision of a licensed veterinarian. Id. Congress first recognized the need for VFD drugs in 1996 by passing the Animal Drug Availability Act (ADAA), which aimed to facilitate the usage of antimicrobials for food safety, and later control the usage of antimicrobials in animal feed to prevent the development of bacterial resistance to these medications, but the strict limitation of the control of antimicrobials in food animals by veterinary oversite did not begin in earnest until 2015. H.R. 2508, 104th Cong. (1996).; Veterinary feed directive (VFD) basics, American Veterinary Medical Ass’n, https://www.avma.org/resources-tools/one-health/antimicrobial-use-and-antimicrobial-resistance/veterinary-feed-directive-basics (last visited July 8, 2024).

The recently finalized guidance from the FDA guides veterinarians, distributors of medicated feed, and animal owners and caretakers in their roles and responsibilities in the VFD process, including the creation of a VFD, the manufacturing and distribution of feed that contains VFD drugs, and the effects of VFD requirements on animal owners. U.S. Food & Drug Admin., Small Entity Compliance Guide: CVM GFI #120 Veterinary Feed Directive Regulation Questions and Answers (2024). The FDA has stated that the updated language in the final guidance “better aligns with existing industry practices and clarifies flexibilities to reduce the burden on veterinarians, producers, and distributors.” FDA Finalizes Guidance to Provide Further Clarity on Veterinary Feed Directives, U.S. Food & Drug Admin., https://www.fda.gov/animal-veterinary/cvm-updates/fda-finalizes-guidance-provide-further-clarity-veterinary-feed-directives (last visited July 8, 2024).

Organizations representing different groups of stakeholders relevant to VFD regulation have reacted to the FDA’s regulatory path in distinct ways. For example, the American Veterinary Medical Association (AVMA), the “nation’s leading advocate for the veterinary profession” and largest veterinary medical association, commented in 2019 that it was in support of the proposed changes presented in the revised GFI #120. American Veterinary Medicine Ass’n, Comment Letter on Veterinary Feed Directive Regulation Questions and Answers; Small Entity Compliance Guide; Draft Guidance for Industry; Availability (Mar. 22, 2019), https://www.regulations.gov/comment/FDA-2010-N-0155-0248. The AVMA supported the “aim to put responsibility for [VFD] use into the hands of veterinarians,” who the AVMA believes are the best individuals to prescribe the type and amount of medications required to protect the health of the animal. Veterinary feed directive (VFD) basics, American Veterinary Medical Ass’n, https://www.avma.org/resources-tools/one-health/antimicrobial-use-and-antimicrobial-resistance/veterinary-feed-directive-basics (last visited July 8, 2024).

The Animal Health Institute (AHI), a trade association representing “manufacturers of animal health products — the pharmaceuticals, biological products and feed additives used in modern food production, and the medicines that keep livestock and pets healthy,” “fully aligned” itself in support of the FDA’s 2015 final VFD rules mandating increased veterinary involvement in the use of antimicrobial medications in food animals. Animal Health Community Collectively Redefines Antibiotic Use on the Farm, Animal Health Institute, (Jan. 3, 2017)  https://ahi.org/animal-health-community-collectively-redefines-antibiotic-use-farm/ (last visited July 8, 2024).

The American Farm Bureau Federation (AFBF), the “national advocate for farmers, ranchers and rural communities,” expressed concern over the direction of VFD regulations in 2016, stating that the “impact of removing important antimicrobials from the market [would] hinder efforts of veterinarians and livestock and poultry producers to assure animal health and protect our nation’s food supply.” Preserving Access to Antibiotics, American Farm Bureau Fed’n, (Oct. 2016) https://www.fb.org/files/antibiotics16.pdf. Given current VFD regulations, the AFBF has also urged caretakers of animals to forge closer relationships with veterinarians as required for access to antimicrobials via VFDs to protect the health of their animals. Elizabeth Quesnell Kohtz, Animal Health Top Concern for Farmers, Veterinarians, American Farm Bureau Fed’n, (May 10, 2016), https://www.fb.org/focus-on-agriculture/animal-health-top-concern-for-farmers-veterinarians. Though AFBF was critical of some aspects of the FDA regulations, it supports the national regulation of animal antimicrobials and accepts veterinarian oversight of antibiotic use. Preserving Access to Antibiotics, American Farm Bureau Fed’n, (Oct. 2016) https://www.fb.org/files/antibiotics16.pdf.

Though increased veterinary oversight over antibiotic usage in animals is hypothesized to decrease the prevalence of antimicrobial resistance, the impact of increased veterinary control can exacerbate the current shortage of food animal veterinarians (FAVs). Lisa M. Weltzien, The Livestock Veterinarian Shortage: Implications for Food Safety and Security, Johns Hopkins Center for a Livable Future Report, June 21, 2023 at 17. For example, in rural Colorado, there is reportedly only one veterinarian for every 85,000 food animals, making it difficult for veterinarians and producers to comply with VCPR requirements, since the average dairy cow herd size in Colorado was 1,845 cows in 2021. Kristen Browning-Blas, Rural relief: Governor signs veterinary debt assistance bill, Colo. State Univ. Source (Aug. 8, 2017), https://source.colostate.edu/rural-relief-governor-signs-veterinary-debt-assistance-bill/; Corey Geiger, Herd size keeps climbing, Hoard’s Dairyman (Jan. 10, 2023), https://hoards.com/article-33080-herd-size-keeps-climbing.html#dComments. A 2018 survey concluded that 728 of the surveyed counties (around 23%) across the country suffered from indicators of FAV shortages. Danielle M. Tack et al., Exploration of veterinary shortages in the wake of the Veterinary Feed Directive, J. of the American Veterinary Medical Ass’n at 1334 (2018). Bolstering the workforce of FAVs will be necessary to ensure that VFD regulations can be successfully implemented and the needs of animal owners are met. Lisa M. Weltzien, The Livestock Veterinarian Shortage: Implications for Food Safety and Security, Johns Hopkins Center for a Livable Future Report, June 21, 2023 at 17.

To help achieve that goal, passage of new federal or state legislation may be necessary. For example, the bipartisan Rural Veterinary Workforce Act, if passed, could provide tax benefits to veterinarians and veterinary students to encourage them to practice in rural communities and take care of local livestock. See News Release, Debbie Stabenow, Senator, Senators Stabenow, Crapo Lead Bipartisan Bill to Help Address Shortage of Veterinarians in Rural America (Sep. 18, 2023), https://www.stabenow.senate.gov/news/senators-stabenow-crapo-lead-bipartisan-bill-to-help-address-shortage-of-veterinarians-in-rural-america. This act would extend the current federal Veterinary Medicine Loan Repayment Program (VMLRP), which helps veterinarians set up practices in veterinary deserts by promising to pay off up to $75,000 of their student loans if they do so. Here’s one promising approach to address rural veterinary shortages, American Veterinary Medical Ass’n, (Nov. 21, 2023) https://www.avma.org/blog/heres-one-promising-approach-address-rural-veterinary-shortages. The proposed amendments to the existing VMLRP would remove required federal taxes from awards, allowing more of the program’s money to assist veterinarians directly. Id. The AVMA encourages those interested in supporting the bill to reach out to their members of congress. Id.

Some states have enacted similar laws. For example, the Kentucky Rural Veterinary Medicine Student Loan Repayment Program provides incentives to attract veterinarians to practice in an underserved rural area or shortage area for five years. Kentucky House Bill 553, 24RS (2024). The program is intended to address the “critical shortage of veterinary professionals in rural and underserved communities across Kentucky,” where only 1,160 of the state’s 2,571 active, licensed veterinarians are employed and working in the state. U.S. Bureau of Labor Statistics, Occupational Employment and Wages, May 2023: 29-1131 Veterinarians https://www.bls.gov/oes/current/oes291131.htm. The passage of similar state programs in addition to a national program will assist livestock producers in obtaining the veterinary partnerships needed to successfully achieve the goals of the federal VFD regulations.

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