FDA Approves First Animal Drug for Reduction of Manure Gas Emissions

A new drug for livestock has been approved by the U.S. Food and Drug Administration (FDA) and shows promising results to reduce ammonia gas in cattle.

FDA announced the approval of Experior (lubabegron Type A medicated article) on Nov. 6 after studies revealed that product was effective at reducing ammonia gas from manure after being fed to beef cattle.

There are several different sources of ammonia gas, including livestock manure. There are concerns when levels of ammonia are elevated because it can create atmospheric haze and noxious odors. Higher concentrations can cause irritation of the eyes, nose and throat in both humans and animals.

According to FDA, excess ammonia gas contributes to process called eutrophication, in which bodies of water become enriched with excess nutrients, especially nitrogen and phosphorous. Eutrophication has been blamed for algae blooms in water that block sunlight for plants causing lower levels of oxygen in water.

Research showed that Experior, a product developed by Elanco, partially reduces ammonia gas emissions from manure both in individually or group housed cattle in an enclosed facility. The study did not look at the product from an entire herd or farm level.

“We’re committed to supporting the development of novel animal drug products that are safe and effective, and we’re encouraged to see innovations that provide additional benefits to animals, people and the environment,” says Steven M. Solomon, M.P.H., D.V.M., director of the FDA’s Center for Veterinary Medicine.

A number of studies on Experior indicated the product is safe to feed to beef cattle. It also resulted in a safe meat product for consumers to eat. There are more than 4,000 cattle examined in the study. There were no differences in health events for animals fed Experior or the control group.

The Veterinary Drugs Directorate (VDD) of Health Canada conducted a separate review of Experior at the same time FDA was reviewing the drug. FDA says “This underscores the continued collaboration between the FDA’s Center for Veterinary Medicine and VDD, aimed at facilitating access to veterinary drugs across both countries.”

This development is also part of the larger One Health Initiative that has been advocating for “comprehensive approach to health and environmental problems and aims to promote, improve, and defend the health and well-being of all species.” One Health realizes that health of people, animals, and the environment are intertwined.

“Today we’re announcing the approval of the first animal drug that reduces ammonia gas emissions from an animal or its waste. These ammonia gasses can come from many sources and can affect the health of people, animals and the environment. Novel animal drug products such as these also support One Health approaches to public health,” Solomon says.

The FDA has granted approval of Experior to Elanco.