The Food and Drug Administration, feed industry stakeholders and members of Congress see an upcoming reauthorization of the Animal Drug User Fee Act (ADUFA) as an ideal vehicle to make needed regulatory changes to allow for explanatory claims on feed labels.
ADUFA governs the animal drug approval process and funding for FDA to oversee the approvals. The law's authorization expires at the end of the month, and ag industry voices are hoping to tweak the handling of feed additives — which are currently treated as drugs under the law — through a change to FDA's regulatory authority.
Today, companies in the U.S. can only provide information regarding taste, nutrition and aroma on feed labels and can’t provide claims on improved feed efficiency, reduced emissions or improved animal health benefits.
“Honestly, in the U.S. it is extremely disappointing since our labels are mostly empty,” explained Daniela Solomon, animal health and nutrition regulatory affairs manager for Novozymes. “We are not even allowed to have production claims, which are the main claims that farmers want and need to have. Anything related to production is a drug claim.”
Animal drug approvals can easily take 10 years to work their way through the process, whereas an average food additive petition takes around three years, Solomon said.
Novozymes is not a feed manufacturer, but works with commercial partners to offer solutions that might include enzymes, microorganisms or both to provide improved animal digestion. These additives can lower feed costs through an improved feed conversion ratio, thus reducing production’s impact on the environment and reducing the use of antibiotics critical for human health.
Since 2019, Solomon has been part of the American Feed Industry Association’s claims working group and its efforts to improve the U.S. regulatory system. “The claims topic started to be discussed in the U.S. in the '90s. But discussions haven’t really progressed” until now, she said. That shift gives her hope feed additives could soon be regulated not as drugs, but as zootechnical ingredients.
The Innovative Feed Enhancement and Economic Development (Innovative FEED) Act — which advanced through the Senate Health Education. Labor and Pensions Committee this summer in a 19-2 vote — sets “zootechnical” as a new category of feed ingredients. In an interview with Agri-Pulse, Tracey Forfa, director of FDA's Center for Veterinary Medicine, said that change is needed to provide FDA the authority to modernize its regulatory framework and is a key component of CVM’s recently released innovation agenda.
Zootechnical terminology is already utilized by global competitors such as the European Union to recognize “animal food ingredients that act solely within the gut of an animal with scientifically substantiated claims related to the animal production, animal well-being, food safety and environment benefits,” Forfa said.
Historically, these products would fall into the traditional animal drug review process, but Forfa said CVM recognized that process is not the best option to review these types of products. The Innovative FEED Act takes the suggestions from CVM and industry stakeholders to harmonize feed label claims while still providing a “complete evaluation of safety and utility under ADUFA,” Forfa said.
Leah Wilkinson, AFIA
Europe established its zootechnical category in 2003; Canada and Brazil have done so more recently. The changes elsewhere in the world give foreign livestock producers access to the same products that could be available in the U.S. Stakeholders argue this puts U.S. farmers at a disadvantage, as they can’t be educated on what each feed ingredient offers.
The new category may not necessarily bring new ingredients faster into the market; Solomon said FDA will still need to verify the data provided by companies to uphold truthful claims. However, she hopes the process will take less time for claims of ingredients that are already approved.
“We’re behind the world in terms of approving these products in an agricultural society in America that is considered the most innovative and technologically advanced,” Chuck Conner, president and CEO of the Naitonal Council of Farmer Cooperatives, said at a recent Bipartisan Policy Center agricultural carbon markets event co-hosted by Agri-Pulse.
“In order for us to do our part, we need regulators to do their part as well. So, this is a joint action we need FDA to really have more clear regulations. We need to have a streamlined process for new ingredients in the U.S.,” Solomon said.
Jesse Sevcik, Elanco’s head of government affairs, said the current food additive process was created more than 60 years ago, a time frame that necessitates a modernization of the permissible categories for product approvals.
“From an innovative perspective, it adds predictability for innovators. It adds transparency of benefits for farmers. And it adds an element of confidence for consumers because of the FDA safety evaluation,” Sevcik said.
Solomon said the review process also disincentivizes some companies from even attempting to receive approval for their products in the U.S. because drug approvals do not always provide the return on investment for feed ingredients.
“We know there are several reputable companies in the U.S. in the animal health and nutrition space, including Novozymes, that already have new desired technologies that could be released anytime and could be helping farmers right now. However, we just have our hands tied, and we cannot do what we need to do because of the current regulatory scenario,” Solomon said.
Conner said this public-private partnership needs to start from the President on down, “demanding priority action on getting these products approved and in the hands of producers.” Conner said he knows there are many additives that farmers could be using today to realize environmental and animal health benefits.
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“I’ve been in government. I’ve seen the wheels of government turn as they have, and in this area, they are turning far too slowly. And I don’t think it’s on a path that we would find acceptable, or the American public find acceptable knowing the kind of progress that could be made literally tomorrow,” Conner said.
At the same BPC event, USDA Undersecretary for Farm Production and Conservation Robert Bonnie said USDA is also watching FDA and Congress’ actions and “thinking internally” of what it can do to incentivize and reward producers who use feed ingredients that may also have environmental benefits.
“Let’s make sure we’re ready to help producers scale those new products as they come along,” Bonnie said.
The Biden administration’s climate push is one reason former Florida Republican Rep. Ted Yoho is opposed to the inclusion of the Innovative FEED Act in an ADUFA package.
He told Agri-Pulse, “Some of the members of Congress think this is a push of the Biden administration for climate change, for methane reduction. And they’re using a vehicle in the agricultural industry that we know that supplements, that can reduce methane production.” He added the biggest concern is how these products may eventually be viewed by global trading partners, possibly creating new trade impediments similar to ractopamine and rBST.
Former Rep. Ted Yoho
However, a letter in support of the bill does include major producer groups including the National Milk Producers Federation, United Egg Producers, Dairy Farmers of America, Kansas Livestock Association and Oklahoma Cattlemen’s Association, among others. Several animal and feed industry groups also recently supported the passage of the Innovative FEED bill.
AFIA has members on Capitol Hill this week advocating for passage of the Innovative FEED Act as part of an ADUFA bill. Wilkinson told Agri-Pulse they’re pleased it came out of the Senate HELP Committee with strong support. The House version of ADUFA reauthorization did not include the Innovative FEED language when it advanced out of committee, but stakeholders have not heard widespread concerns about the inclusion as they head toward action on a potential continuing resolution or other must-pass bill.
The drug pathway “was the only pathway for these products and nobody was really pursuing it because it's cumbersome, burdensome and impractical for many feed ingredients,” Wilkinson said.
Yoho said he won’t be opposing ADUFA if it does end up including the Innovative FEED bill, but he is urging Congress to “tread lightly because if you pass this you may get some blowback that you weren’t anticipating, nor did you want.”
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