Elanco announces FDA has completed review of Bovaer

Bovaer is a first-in-class methane-reducing feed ingredient for the U.S. dairy industry.

May 28, 2024

6 Min Read
Elanco Animal Health

Elanco Animal Health Inc. has announced the U.S. Food and Drug Administration has completed its comprehensive, multi-year review of Bovaer (3-NOP), a first-in-class methane-reducing feed ingredient, and determined the product meets safety and efficacy requirements for use in lactating dairy cattle.

“This monumental announcement has the ability to accelerate the opportunity for climate-neutral dairy farming while creating a new revenue stream for dairy farmers across the country,” said Jeff Simmons, President and CEO, Elanco Animal Health. “We appreciate FDA’s commitment to maintaining high standards for science-based review, while balancing the need to quickly bring solutions to the market. Bovaer represents another example of Elanco being a partner of choice in animal health, where the capabilities of our talented R&D, regulatory and commercial teams are delivering significant value.

Simmons continued: “As global temperatures breach new thresholds, consumers demand more sustainable products and the farm economy battles profitability challenges, we are excited to bring Bovaer to the market as a potential solution. Bovaer will create value for farmers, while helping food companies meet consumer demands and deliver on their sustainability commitments. As animal, human and now environmental health continue to converge, Bovaer is one of the most significant innovations that considers this intersection and provides consumers, farmers and society what they want for our future.”

Gregg Doud, President and CEO, of the National Milk Producers Federation (NPMF), said in a statement that, “FDA approval of Elanco’s Bovaer is another important step on U.S. dairy’s journey toward a net-zero future, one in which dairy farmers have already made great progress. Bovaer and other new technologies that reduce enteric emissions will help U.S. farmers be rewarded for participating in voluntary, producer-led sustainability initiatives, which is critical for the success of such efforts. 

“Consumers around the world are demanding lower-carbon foods. Innovations such as Bovaer will help U.S. dairy farmers remain globally competitive and maintain their role as leaders in more sustainable dairy production. We thank FDA for its recognition of and support for these efforts,” said Doud.

NMPF also commend Agriculture Secretary Tom Vilsack and his team at USDA for supporting dairy farmers as they prepare to use Bovaer on their own operations. “We are grateful to the department for awarding more than $90 million to dairy farmer-owned cooperatives and partner organizations for innovative feed management under the Regional Conservation Partnership Program for fiscal year 2023. FDA’s approval of Bovaer now enables these key resources to move forward and sets the stage for dairy to build on this first round in fiscal year 2024,” Doud said.

Bovaer represents another blockbuster potential innovation in Elanco’s portfolio and further accelerates livestock sustainability, the next billion-dollar plus market in animal health. This innovation is expected to accelerate market development and increase innovation in this space.

Bovaer works by suppressing the enzyme in the cow’s rumen that forms methane. Feeding one tablespoon of Bovaer per lactating dairy cow per day can reduce methane emissions about 30% or about 1.2 metric tons of carbon dioxide equivalent (CO2e) emissions annually, while creating opportunity for dairy farmers to be financially rewarded for reducing their dairy’s carbon footprint.

Expanding access across North America

Elanco and dsm-firmenich have agreed to expand Elanco’s commercialization of Bovaer across North America. In addition to the U.S., Elanco will also now have the right to market Bovaer in Canada and Mexico, where the product is already available for use in beef and dairy cattle. This expanded agreement can accelerate the opportunity to make climate-neutral cattle farming in North America a reality this decade, the companies said.

“We congratulate Elanco and the U.S. dairy sector, on this important milestone, and will support Elanco by providing initial supplies from Europe,” said Dimitri de Vreeze, CEO at dsm-firmenich. “This strategic collaboration exemplifies how we can accelerate the expansion and adoption of Bovaer in North America to significantly decrease methane emissions on a large scale, and thereby support global efforts to combat climate change. Bovaer holds the key to a transformative shift in the global dairy sector, and launching this feed ingredient in the U.S. after years of dedicated research, trials, and industry collaboration is a testament to its global potential.”

Simmons said, “We appreciate the work dsm-firmenich has invested in this revolutionary product and are pleased they’ve recognized Elanco as the global farm animal health leader and the right partner to bring this solution to farmers across North America.”

Why methane matters

This announcement comes at a pivotal time. According to the United Nations, the world's population has until the year 2030 to curb greenhouse gas emissions (GHG) or deal with irreversible impacts to the planet. In response, about two-thirds of all Fortune 500 companies have set significant climate commitment goals. Reducing enteric methane emissions from cattle—naturally generated through the enteric fermentation process—represents a key opportunity. Methane lasts about a decade in the atmosphere and is 27x more potent than carbon dioxide at trapping heat—so smaller reductions create greater impact on temperature. By mitigating methane, the livestock industry can reduce the rate of climate warming and allow food companies and retailers to make meaningful progress toward their Scope 3 emissions goals.

“Reducing enteric methane is critical if we are to reach our climate goals,” said Dr. Frank Mitloehner, CLEAR Center Director and University California Davis Professor and Cooperative Extension Air Quality Specialist. “It’s exciting our farmers will have an important tool to do that, in Bovaer.”

Creating new revenues streams for farmers

Feeding Bovaer to cows provides a scalable and credible way for dairy farmers to benefit from being good stewards of the environment by being financially rewarded for implementing on-farm sustainability interventions.

“At an added cost of a few cents a gallon of milk, Bovaer can help food companies meet their climate commitments and consumer desire for more sustainable dairy products,” said Katie Cook, Vice President, Livestock Sustainability and Farm Animal Marketing at Elanco. “Meanwhile, by engaging in voluntary carbon markets and securing USDA and state conservation programming, dairy producers have a scalable sustainability practice with the potential to create an annual return of $20 or more per lactating cow by feeding Bovaer. Our goal is to make this opportunity a reality starting this summer, while creating a self-sustaining carbon inset market for American agriculture.”

Dairy farmers incorporate Bovaer into their rations and quantify the effect using carbon market-friendly tools like UpLook by Elanco, an insights-based engine designed to quantify greenhouse gas emissions reductions. The tool utilizes on-farm data and peer-reviewed science to identify key drivers of an operation’s carbon footprint and track the progress of sustainability efforts. UpLook connects seamlessly to Athian, the first-of-its-kind livestock carbon inset marketplace. This seamless process allows farmers to quantify their emissions reduction efforts and certify carbon credits for sale. In addition to the carbon marketplace, the U.S. Department of Agriculture has awarded $89 million in funding to support farms using technologies like Bovaer to reduce their methane emissions.

“Products like Elanco’s Bovaer will allow U.S. farmers to be rewarded for participating in voluntary, producer-led sustainability efforts,” said Doud. “Consumers around the world are demanding lower-carbon foods. Bovaer is an innovation that can help U.S. dairy farmers remain globally competitive and maintain their role as leaders in more sustainable dairy production.”

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