Tag: FDA

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

Posted on by Alan Bjerga

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

“Innovative and voluntary solutions are needed to reduce greenhouse gas (GHG) emissions, including methane,” said Dr. Jamie Jonker, NMPF’s chief science officer, in the comments submitted today. “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. Feed composition changes can directly or indirectly reduce enteric emissions resulting from livestock.”

While animal-feed additives are a promising path toward a net-zero future for dairy as outlined in industry goals, the pace of their approval lags that of competitors such as the European Union due to current FDA processes. By streamlining bureaucracy and allowing feed-additives to be treated as foods rather than as drugs, the United States can maintain and advance its global leadership in sustainability, Jonker wrote.

Through the U.S. Dairy Net Zero Initiative, a collaboration across dairy organizations, dairy-farm research is advancing new technology and new market development opportunities to make sustainability practices more accessible and affordable to farms of all sizes, including enteric methane reduction.

“One of the greatest opportunities that exists for U.S. dairy farmers is their ability to provide real solutions to many of today’s biggest environmental challenges like GHG emissions,” Jonker wrote. “Embracing new practices and technologies is key to making America’s dairy farmers an environmental solution while providing wholesome and nutritious dairy products to the U.S. and the world.”

For more on how dairy is advancing its stewardship and best practices, visit the National Dairy FARM (Farmers Assuring Responsible Management) Program’s Environmental Stewardship page.

NMPF Pushes Back on FDA Over Proposed Traceability Rule

Posted on by Theresa Sweeney

NMPF filed comments Feb. 22 urging FDA to withdraw a proposed traceability rule that identifies what foods are high-risk and would warrant additional recordkeeping requirements to improve their traceability.

FDA proposed that all cheeses other than hard cheese should be considered high-risk foods.  FDA’s risk-ranking model, under the proposal, would place “pasteurized cheese, other than hard” as the riskiest of all foods in the marketplace — even above cheese made from raw milk, a finding NMPF thought was absurd.

This questionable ranking was partly caused by FDA adding a new criterion to its risk ranking model beyond what Congress had instructed it to do in the Food Safety Modernization Act, landmark food-safety legislation that became law in 2011. FDA added consumption data to the model, which had the effect of increasing a food’s risk rating due to its popularity. NMPF stated in its comments that popularity and risk do not go hand-in-hand — nor can FDA override what Congress has directed.

The comments also took issue with the agency’s interpretation that cheese made with pasteurized milk is not a food that has been subjected to a kill step, and therefore that full recordkeeping provisions should apply. Food subjected to a kill step has significantly fewer recordkeeping requirements, according to the proposed rule.

This rule, if put into effect, would increase consumer confusion, as FDA has long told consumers to choose pasteurized cheeses over raw-milk cheeses based on food safety concerns.

NMPF reviewed comments filed by the International Dairy Foods Association and supported their filing in its comments.

FDA Must Enforce Fake-Dairy Rules, NMPF Tells Agency Ombudsman in New Advocacy Phase

Posted on by Theresa Sweeney

With FDA giving little indication of promised action on proper labeling of imitation dairy products, the National Milk Producers Federation today asked the agency’s ombudsman to ensure that rules are properly enforced.

“Allowing unlawfully labeled ‘plant-based’ imitation dairy foods to proliferate poses an immediate and growing risk to public health; it is a clear dereliction of the FDA’s duty to enforce federal law and agency regulations,” wrote NMPF President and CEO Jim Mulhern in the letter, sent to Dr. Laurie Lenkel, ombudsman for the U.S. Food and Drug Administration. “The FDA’s Office of the Ombudsman must intervene to break the bureaucratic logjam that is adversely affecting consumers. Doing so would fit squarely within the Office’s own mission to ensure even-handed application of FDA policy and procedures.”

The FDA ombudsman, based in the agency commissioner’s office, “serves as a neutral and independent resource for members of FDA-regulated industries when they experience problems with the regulatory process,” according to the agency. NMPF is urging the ombudsman’s office to take appropriate action to remedy the FDA’s lax approach to enforcing its own rules on the use of dairy terms on products containing no dairy ingredients, which have proven impacts on public health – a new phase of advocacy brought about by the agency’s regrettable inaction. The American Academy of Pediatrics and other organizations have offered evidence of nutritional deficiencies caused by confusion over the contents of plant-based versus dairy beverages.

NMPF last year released its own road map offering solutions to how public health, product integrity and free speech could be protected through updated regulations. NMPF also supports the DAIRY PRIDE Act, a potential legislative prod for FDA action, and has asked FDA commissioner Dr. Stephen Hahn to follow up on the pledge he made nearly one year ago to make fake-dairy labeling a high-priority issue at FDA.

U.S. Dairy Exports to Benefit from New USDA-FDA Partnership

Posted on by Theresa Sweeney

The U.S. Department of Agriculture (USDA) and Food and Drug Administration (FDA) today signed a Memorandum of Understanding (MOU) that will establish an interagency process to further support exports of U.S. dairy products. Both agencies play critical roles in facilitating foreign sales of American-made dairy products, which is recognized and appreciated by the U.S. dairy industry. This MOU will draw upon the expertise of FDA as well as USDA’s Agricultural Marketing Service (AMS) and Foreign Agricultural Service (FAS) to deepen and streamline their work together on the issues facing dairy exports to the benefit of U.S. dairy farmers and manufacturers.

The U.S. Dairy Export Council (USDEC) and the National Milk Producers Federation (NMPF) worked with both agencies to advance this new approach to dairy export collaboration. NMPF and USDEC deeply appreciate the USDA and FDA’s dedication to drafting this new MOU to facilitate U.S. dairy exports and their ongoing collaboration with the dairy industry. Foreign competitors are making advances in international markets, making efforts to expand overseas opportunities for U.S. dairy critical to the long-term health of U.S. dairy farmers and processors.

“Today’s announcement of an interagency MOU on dairy trade between USDA and FDA is the result of years of conversation and efforts between stakeholders within the U.S. dairy industry and the U.S. government to establish consistent guidance on tackling the rising number of export challenges facing our industry. This MOU will help our industry continue to grow in an increasingly competitive global environment,” said Tom Vilsack, president and CEO of USDEC.

“This new partnership ensures that the staff at USDA and FDA are working together in the most efficient way possible to lower barriers for our farmer’s dairy exports. Increasing U.S. dairy exports will strengthen the health of our farmers and rural communities, which is more important than ever as America’s dairy industry faces new and unprecedented challenges. We appreciate all of the hard work from both agencies and stand ready to support the USDA and FDA’s commitment to open new doors for U.S. dairy exports,” said Jim Mulhern, president and CEO of NMPF.