Tag: dairy feed additives

FDA Moves Toward Improved Feed Ingredient Reviews

Posted on by Theresa Sweeney

In an important step to modernize its review and approval of animal feed ingredients, the Food and Drug Administration said Feb. 2 it’s withdrawing long-standing policy that classifies animal feed ingredients as animal drugs if making claims on production, environment, or food safety-related benefits.

NMPF has long advocated for FDA to rescind this policy to help pave the way for faster review and approval of animal feed ingredients that can reduce enteric methane emissions. A streamlined approval process, specifically one that would allow feed additives to be reviewed as foods rather than as drugs, is important for dairy farmers seeking to maintain global competitiveness as trade rivals adopt such ingredients, which currently are not allowed in the United States because of lengthy regulatory hurdles.

FDA also made clear that it supports the legislative authority embodied in the NMPF-backed Innovative FEED Act (H.R. 6687, S. 1842), which directs the agency to review enteric-reducing and other products using its Food Additive Petition process. That shift would represent an improvement over the current approach of reviewing such additives as drugs.

NMPF is urging dairy allies to write members of the House of Representatives to become sponsors for the Innovative FEED Act, which is critical to speeding FDA approval of Elanco’s 3-NOP (Bovaer) and similar future products. This NMPF call-to-action contains a pre-drafted message seeking House member endorsement of the legislation.

NMPF Secures Bipartisan Support for House Feed Additive Legislation

Posted on by Theresa Sweeney

NMPF built on its work to spur approval of enteric methane-reducing animal feed ingredients by securing bipartisan sponsors for the Innovative FEED Act in the House of Representatives. The House bill was introduced Dec. 7 by Representatives Greg Pence, R-IN, Kim Schrier, D-WA, Jim Baird, R-IN, and Angie Craig, D-MN.

Like its Senate counterpart, the House measure would give the U.S. Food and Drug Administration (FDA) the ability to review and approve animal feed ingredients using the agency’s Food Additive Petition pathway. This approach would allow FDA to review animal feed additives, which are not drugs, in a more efficient manner that would preserve animal, human, and environmental safety. Doing so would better position U.S. dairy farmers to act quickly and proactively to reduce enteric methane emissions and maintain global competitiveness. Products like Elanco’s Bovaer, or 3-NOP, can reduce enteric methane emissions by as much as 30 percent, making them poised to play a key role in dairy’s voluntary, producer-led sustainability efforts once approved.

The Innovative FEED Act was adopted by the Senate Health, Education, Labor, and Pensions Committee on June 15 by an overwhelming 19-2 vote. The House measure already has meaningful bipartisan support from members of the Energy & Commerce Committee, which oversees FDA-related policy. NMPF looks forward to working with its congressional champions and stakeholder partners to enact this bill into law early in 2024.

NMPF Urges Sped-Up FDA Approval of Climate Friendly Feed Additives

Posted on by Theresa Sweeney

NMPF called on the U.S. Food and Drug Administration on Nov. 16 to use existing legal authority to modernize its regulations allowing for faster approval of animal-feed additives that reduce greenhouse gas (GHG) emissions, submitting comments to the agency highlighting the need for urgent action to enhance dairy’s role as a climate solution.

Published in 1998, the FDA requested comment on its “Policy and Procedures Manual 1240.3605, Regulating Animal Foods with Drug Claims” to evaluate how the policy could be updated to reflect evolving scientific knowledge and promote innovation.

NMPF in its comments urged FDA to modernize the policy, which will allow for pre-market approval for important feed additive products like those which reduce enteric methane. Enteric emissions directly from cows currently account for roughly one-third of all GHG emissions from dairy farms and present an important area of opportunity for methane reductions. While animal-feed additives are a promising path toward a net-zero future for dairy as outlined in industry goals, their pace of approval lags that of competitors such as the European Union due to current FDA processes. Modernizing the process and allowing feed additives to be treated as foods rather than as drugs, can help the United States maintain and advance its global leadership in sustainability. Embracing new practices and technologies are key to making America’s dairy farmers an environmental solution while providing wholesome and nutritious dairy products to the U.S. and the world.

The feed additive comments were one of several NMPF submitted to federal agencies in November, with others including:

  • Comments to USDA Agricultural Marketing Service National Organic Program (USDA-AMS-NOP) on the proposed rule Organic Livestock and Poultry Standards, submitted Nov. 10 (USDA-AMS-NOP-21-0073-0001). USDA-AMS-NOP has proposed to amend the organic livestock and poultry production requirements by expanding and clarifying existing requirements covering livestock care and production practices and mammalian living conditions;and
  • Comments to the USDA Animal and Plant Health Inspection Service, submitted Nov.7, on the new approach to indemnity value determination and a new framework for the indemnity regulations.