American inventors and manufacturers are eager to bring new and better products to you, but they need to have a regulatory approval process—both at home and overseas—that enables their innovations to come to market.
Unfortunately, that’s not always the case when it comes to some of the new products that can help farmers and ranchers reduce their environmental footprint or improve nutrition.
For example, feed additives can reduce the greenhouse gas emissions from belching cattle.
Bovaer, a product developed by Royal DSM and licensed in the United States by Elanco Animal Health, consistently reduces enteric methane emissions by 30% in dairy cows and even higher percentages in beef cattle, according to the company. Methane emissions from belching cattle are one of the largest source of greenhouse gas emissions from agriculture.
The product has received approval in the European Union, but is under consideration at the Food and Drug Administration as an animal drug. Elanco is seeking regulatory approval for the product, but it has not yet been approved.
Ingredient suppliers and animal food manufacturers are regularly hitting costly roadblocks that prevent new products from reaching the marketplace, according to the American Feed Industry Association. Sometimes FDA approvals of non-drug feed ingredients take three to five years.
A study funded by the Institute for Feed Education and Research found that for every year of delay in the approval process, “submitting companies across the animal food manufacturing industry were losing an average $1.75 million annually in revenue per ingredient, diminishing their access to capital which could be used for further research and development in the field.” And, in some cases, the industry’s international counterparts have moved forward with ingredients approved in their home countries, leaving the U.S. industry behind.
Now, the FDA leadership has agreed to take a fresh look at its policy for approving animal feed ingredients.
In response to questions from Sen. Jerry Moran, R-KS, at a recent Senate agriculture appropriations subcommittee hearing, FDA Commissioner Robert Califf said he was “committed to reviewing” the agency’s policy on feed ingredients.
“The impact on emissions has got to be an important consideration,” Califf said. After the hearing, he noted that Moran has not been the only lawmaker to question him about FDA’s process, which has been criticized by feed manufacturers.
Also at the hearing, Califf and other officials responded to criticism of the agency’s food safety oversight, which has intensified as the nation has dealt with an infant formula shortage caused in part when a plant had to be shut down after FDA inspectors found numerous violations.
Califf noted that he plans a comprehensive review of the agency’s human foods programs, which will be completed within about three months after the contract details have been worked out. The agency is working with the Reagan-Udall Foundation to gather “external agency experts” for a review.
Califf was accompanied at the hearing by Susan Mayne, director of the Center for Food Safety and Applied Nutrition; Frank Yiannas, deputy commissioner for Food Policy and Response, and Michael Rogers, assistant commissioner for Human and Animal Food Operations.
Following the FDA panel, the subcommittee heard from Brian Ronholm, director of food policy at Consumer Reports, and Sarah Gallo, vice president for product policy at the Consumer Brands Association.
Gallo said, “The lack of a single, full-time, fully empowered, expert leader affects all aspects of the FDA’s food program. Inefficient decision making has slowed reviews, hindering progress and even rendering innovation obsolete. Inexperienced and undertrained inspectors are being sent into the field. A split and siloed food program undercuts communication and collaboration at the expense of efficiency and responsiveness.”
CBA and a broad range of business and public health groups called on Califf in April to “unify the FDA food program under a deputy commissioner for foods, with accountability to the commissioner and direct line authority over CFSAN, (the Center for Veterinary Medicine), and the food-related components and operations of (the Office of Regulatory Affairs.)
Members of Congress seem willing to allocate additional resources to the FDA so the agency can hire more help and hopefully, complete their regulatory reviews at a faster pace.
The U.S. House of Representative’s fiscal 2023 “minibus” package of six appropriations bills, includes a key amendment offered by Rep. Jim Baird, R-IN, and other bipartisan cosponsors to dedicate $8 million to the FDA’s Center for Veterinary Medicine to help with expediting reviews for new feed ingredients.
“Rep. Baird said it best when he shared that it is important for the United States to have a regulatory framework that offers a timely and predictable path to the marketplace for feed ingredients and that can keep pace with the evolving science of animal nutrition,” said AFIA President and CEO Constance Cullman. “The additional FDA funding for feed ingredient reviews in the House-passed spending bill is a huge win for the U.S. feed industry, putting us more on-par with other countries that continue to move forward with safe ingredients to enhance the safety, quality, environmental impact and nutrition of feed and pet food.
Baird was joined by Rep Jimmy Panetta, D-CA, David Rouzer, R-NC, Jim Costa, D-CA, Kim Schrier, D-WA, and Dusty Johnson, R-SD, in cosponsoring the amendment.
Editor’s note: Sara Wyant is publisher of Agri-Pulse Communications, Inc., www.Agri-Pulse.com.
