Building Bridges to Ease Paths to Market

By CH4 Global
July 2, 2024

Many elements contribute to innovation. Creativity, a sense of urgency or necessity, knowledge sharing, and perseverance come to mind. But regulatory support for market entry is just as critical. In some cases, the latter is a matter of governments providing a pathway for products to reach market. In the case of feed additives, the bipartisan Innovative Feed Enhancement and Economic Development (FEED) Act is a critical enabler in the U.S. This important legislation is designed to make it possible for the Food and Drug Administration (FDA) to create a third pathway for approving products that deliver non-nutritive benefits to animals. Equally important is that these products provide support for farmers.

Paving a Third Pathway for Product Approval

Today, the FDA can approve animal products as foods if they supply nutritional value. If they do not provide nutritional value, the only alternative for market entry is to go the drug regulatory route. That said, drugs are generally defined as products that treat or manage a disease. However, many products, such as probiotics, are not treating a disease, but still help manage some aspect of an animal’s body.

For products designed for humans, the FDA has the three regulatory pathways: A product can be classified as a food, drug, or dietary supplement. The FDA does not review and approve dietary supplements for safety and effectiveness or their labeling for accuracy before these products are sold to the public for human consumption, though the products must comply with safety requirements. Dietary supplement companies are responsible for ensuring that their products are safe and accurately labeled. Should a company make false claims surrounding health, the FDA can mandate that it cease and desist. In other words, companies must meet predefined criteria and can be fined or worse if their dietary supplement does not meet requirements.

By regulating any non-food animal product as a drug – or not providing an apt category for products like our Methane TamerTM Beef Feedlot additive – the industry is limited in quickly bringing to market innovative solutions. The purpose of the Innovative FEED Act is to address this shortcoming by providing a pathway for products that are not a food or a drug. Human-targeted products such as supplements are already regulated by the FDA. The Act would provide a similar path to market when it comes to products designed for animals and providing farmers a cost-effective way to implement feed-efficient products that will meet new regulatory requirements to reduce methane emissions. Notably, it would create a new category for animal feed additives, enabling manufacturers to more efficiently make substantiated claims about production and well-being benefits.

Streamlining Passage of the Bill

As part of CH4 Global’s commitment to helping the world achieve Gigatonne-level reductions of enteric methane through our innovative product and production means, we believe in driving innovation in other ways. Specifically, we believe we have a role to play in advocating for government action that helps more products like our Methane Tamer get into the hands of farmers and food producers. And it’s safe for consumption. Humans have consumed seaweed by humans for thousands of years, and ruminants have been known to graze on seaweed on beaches.

Underscoring Innovation

To that end, a CH4 Global representative recently traveled to Washington, D.C to meet with aides to Congress members including August Pfluger from Texas, Diane Harshbarger from Tennessee, Rick Allen from Georgia, Russ Fulcher from Indiana, and Jeff Duncan of South Carolina. Some members hadn’t heard about the bill. Still others had heard of it but had misinterpreted the bill’s intent. Our focus was helping them understand how crucial this bill is for innovation. After we educated these aides about the true and full purpose of the Innovative FEED Act, a few additional members of the House signed on as co-sponsors of the bill.

In addition to being a form of deregulation, the Innovative FEED Act will enable the agricultural industry in the U.S. to remain competitive on the global market. Other governments are already allowing these products to be sold. That means farmers and food producers in Australia can take advantage of products that help reduce enteric methane, which also helps reduce animal feed energy loss, among other benefits.

Australia allows companies to sell products such as ours as feed additives, though they must meet all feed regulations. Should a company make a claim that isn’t supportable, the Australian government’s equivalent to the FTC takes action. Understanding that other countries with respected regulatory frameworks have made this decision can help state senators and members of the House confirm that they are on the right track in their thinking.

Supporting a Framework For the Future

Unfortunately, this promising Act has gotten tangled in some DC red tape. The Act could be considered by the Agricultural Committees for review since the bill has to do with farm animals, or by the Energy and Health Committees as that is tied to the FDA. Though both paths are valid, a unified approach would streamline the approval process.

Since our discussions in Washington, D.C., Senator John Boozman – who is on the Senate Agriculture Committee – has proposed the Innovative FEED Act be an amendment to the farm bill currently in the Senate for review. As the Senator said, “Farmers, ranchers and foresters have diverse conservation needs and our framework reflects that, providing equity across practices to address drought, water quality, wildlife habitat biodiversity, soil erosion and climate resiliency while continuing to provide for carbon sequestrating and greenhouse gas reducing practices.” We are pleased to see bipartisan support for this bill and will continue to monitor its movement in DC and do all we can to help drive its passage sooner than later.

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