First-Ever FDA Approval for Wild Quail

The U.S. Food and Drug Administration (FDA) has granted supplemental approval for Safe-Guard (fenbendazole) to treat and control gastrointestinal worms (Aulonocephalus spp.) in wild quail. This marks the first time an animal drug has been approved for use in wild quail, addressing a significant need for wildlife managers in controlling these parasites in quail populations. While there are existing FDA-approved drugs for farmed quail, this approval is unique in its application to wild quail.

FDA's Role in Protecting Minor Species

The FDA's mission encompasses the health protection and promotion of both humans and animals, including "minor species" such as wild quail. Minor species are defined as animals other than common livestock or companion animals, and can include sheep, goats, ferrets, zoo animals, and various wildlife. The approval of Safe-Guard for wild quail aligns with the FDA's commitment to supporting the health of these less common species.

Research and Collaboration

The studies supporting this approval were conducted by the Minor Use Animal Drug Program (formerly National Research Support Project-7), in partnership with researchers from Texas Tech Wildlife Toxicology Laboratory. This program, a collaborative effort between the FDA, USDA, and university researchers, focuses on generating scientific data to support FDA approval of new animal drugs for minor agricultural species. The program addresses four key technical sections for approval: effectiveness, target animal safety, human food safety, and environmental impact. The FDA provides technical and regulatory support to researchers, facilitating the approval process for safe and effective drugs for minor species.

Safety and Usage Guidelines

The FDA has determined that fenbendazole is both safe and effective for use in wild quail. Additionally, there is a reasonable certainty of no harm from residues of fenbendazole in the edible tissues of treated quail following human consumption, provided Safe-Guard is used according to labeling instructions. Wild quail should receive 90.7g of fenbendazole per ton of Type C medicated feed, administered over a period of 21 consecutive days.

Availability and Previous Approvals

Safe-Guard is available over-the-counter in 25-pound bags. Previously, it had been approved for treating certain intestinal parasites in other species, including cattle, swine, and turkeys. The current application for wild quail is sponsored by Intervet, Inc., based in Rahway, New Jersey.

Highlights

• FDA Approval: First animal drug approved for wild quail.
• Minor Species Focus: Aligns with FDA's mission to protect minor species.
• Collaborative Research: Supported by studies from the Minor Use Animal Drug Program and Texas Tech Wildlife Toxicology Laboratory.
• Safety and Efficacy: Fenbendazole deemed safe for human consumption following proper use.
• Administration: 90.7g of fenbendazole per ton of feed for 21 days.
• Availability: Over-the-counter, supplied in 25-pound bags.
• Previous Uses: Approved for cattle, swine, and turkeys.