Food and Drug Administration

nixiFLOR Injection Approved by the FDA for Bovine Respiratory Disease Treatment

Thu, 22 Jan 2026 19:37:11 GMT

The U.S. Food and Drug Administration (FDA) has approved nixiFLOR injectable solution by Parnell Technologies, marking the first FDA-approved generic version of Resflor GOLD by Merck Animal Health. This product is indicated for the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis, and for control of BRD-associated fever in beef and non-lactating dairy cattle.

nixiFLOR contains the same active ingredients as Resflor GOLD:

Florfenicol, a broad spectrum antibiotic effective against key bacterial pathogens involved in BRD
Flunixin meglumine, a non-steroidal anti-inflammatory drug (NSAID) that helps reduce fever and inflammation associated with respiratory infection

The FDA determined nixiFLOR is bioequivalent to the brand name product and that, when used according to the label, residues in edible tissues do not pose a public health concern. A withdrawal phase of 38 days must be observed before cattle treated with nixiFLOR enter the food supply.

Administered via subcutaneous injection in the neck, nixiFLOR is prescribed at 40 mg florfenicol/kg body weight and 2.2 mg flunixin/kg body weight (approximately 6 mL per 100lb. of body weight), with no more than 10 mL per injection site. This product is available by prescription only from licensed veterinarians, ensuring accurate diagnosis and responsible use.

Generic vs. Pioneer Drugs for Cattle: Should You Care?

Wed, 17 Sep 2025 13:58:12 GMT

Medication use is an essential part of maintaining health, productivity and welfare in dairy and beef cattle. From treating mastitis on a dairy to managing respiratory disease in a feedlot, veterinarians and producers rely on a range of pharmaceuticals to keep herds healthy. However, with many drugs available in both pioneer and generic forms, the question arises: Is there a meaningful difference between the two?

For veterinarians and producers, the decision involves more than just the label. Understanding the approval process, economics and practical considerations behind generic and pioneer drugs can help guide responsible choices that support animal health, food safety and economic sustainability.

What are Pioneer and Generic drugs?

Pioneer drugs are the original products developed by a pharmaceutical company that have an approved new animal drug application (NADA). They are protected by patents, which give the company exclusive marketing rights for a period of time. This exclusivity allowed the manufacturer to recoup the significant investment made in research, development and regulatory approval.

Generic drugs enter the market once those patents expire and have an approved abbreviated NADA (ANADA). A generic contains the same active ingredient, in the same dosage form and strength, and is administered through the same route as its brand name counterpart. In other words, a generic drug must deliver the same therapeutic effect as the brand name drug.

The key differences often lie in the inactive ingredients, such as stabilizers, preservatives or carriers, that can vary between products. These differences generally do not affect stability or efficacy, but may influence characteristics such as palatability or ease of administration.

Approval and Regulatory Oversight

Both pioneer and generic veterinary drugs are regulated by the FDA’s Center for Veterinary Medicine. However, the approval pathways differ:

Pioneer drug approval requires a company to submit an NADA. This includes extensive studies to prove the product’s safety for the target species, its effectiveness against the labeled condition, tolerance in the animal, food safety data (residue studies for milk and meat) and environmental impact. These studies often involve large clinical trials and can take years to complete.
Generic approval follows the ANADA process. Instead of repeating all of the brand name drug’s trials, the generic manufacturer must prove bioequivalence — that the drug behaves the same way in the animal’s body as the original product. Generics must also demonstrate consistent manufacturing practices and establish withdrawal times for milk and meat.

The result is that generics are held to rigorous standards of safety and efficacy. They are not weaker or inferior, they simply follow a more streamlined approval process as the groundwork has already been laid by the pioneer product.

Economics

One of the most notable differences between pioneer and generic drugs is cost. For producers, generic options can significantly reduce the cost of herd-level treatment, which is an important factor when treating dozens or hundreds of animals. For veterinarians, cost can influence prescribing practices and client satisfaction. Offering effective but more affordable treatment options might improve compliance and strengthen the veterinarian-producer relationship. In the long term, the availability of generics supports more sustainable herd health programs, particularly for common or recurring conditions.

Clinical and Practical Considerations

Does it work? vs. Did it work here?

When speaking on generic drugs, one of the key distinctions Dr. Nora Schrag, from Kansas State University, pointed out was the difference between whether a drug works and whether a drug worked in a specific production environment.

“‘Does the thing in the bottle work’ is a fundamentally very different question than ‘did it work,’ Schrag says. “‘Did it work’ includes the stuff in the bottle, but it also includes the people that are getting the stuff in the bottle into the critter, it includes the critters, it includes the weather, it includes everything else.”

Outcomes are influenced not just by the drug but also by management. Measuring whether a drug worked in a particular production setting requires keeping good records, monitoring success rates and comparing farm outcomes to peer benchmarks.

While generics and pioneer drugs are equivalent in active ingredient and expected efficacy, a few practical points deserve attention:

Perception: Some producers might be skeptical, perceiving pioneer products as more trustworthy. Veterinarians play a critical role in reassuring clients with evidence-based guidance.
Formulation differences: Rarely, a difference in inactive ingredients might influence animal tolerance or ease of use.
Compliance and stewardship: Regardless of whether pioneer or generic, observing label directions, withdrawal periods and judicious antimicrobial use principles remains essential.

Guidance for Decision-Making

The choice of what drug to use should be a collaborative effort between veterinarians and producers.

Veterinarians should evaluate both clinical needs and economic considerations. Recommending a generic is often appropriate, but being prepared to explain the science behind equivalency helps build producer confidence.
Producers should recognize withdrawal times and responsible use requirements apply equally to both drug types. Partnering with veterinarians ensures choices align with herd health goals and regulatory compliance.
Both parties must consider not only cost, but also judicious antimicrobial use, animal welfare and food safety when selecting products.

Both brand name and pioneer drugs are indispensable tools for managing cattle health. FDA’s rigorous approval process ensures generics are just as safe and effective as their pioneer counterparts. Generics offer producers significant cost savings that support sustainable operations. Working with their clients, veterinarians can help guide drug choices to ensure effective treatment while promoting stewardship and trust.

In the end, the decision is not about brand loyalty but using evidence-based judgment to balance animal health, food safety and economics. Together, these values benefit both the beef and dairy industry.

Senators Reintroduce DAIRY PRIDE Act to Crack Down on Misleading Dairy Labels

Wed, 30 Jul 2025 16:12:24 GMT

In a renewed effort to crack down on what dairy advocates call misleading and unfair labeling practices, a bipartisan group of U.S. senators has reintroduced legislation to prevent plant-based products from using dairy terms like milk, cheese and yogurt.

On Tuesday, Senators Tammy Baldwin, D-Wis., Jim Risch, R-Idaho, Susan Collins, R-Maine, and Peter Welch, D-Vt., announced the reintroduction of the Defending Against Imitations and Replacements of Yogurt, milk and cheese to Promote Regular Intake of Dairy Everyday Act, or DAIRY PRIDE Act, of 2025.

The bill requires the U.S. Food and Drug Administration (FDA) to enforce its own standards of identity for dairy products, which define milk and other dairy foods as being derived from cows, goats or sheep. Despite these standards, FDA’s 2023 draft guidance currently allows plant-based products made from nuts, seeds or grains to continue using dairy terms on their packaging.

“Wisconsin is known across the world as America’s Dairyland because our hardworking dairy farmers produce the best products with the highest nutritional value,” Baldwin says. “But for far too long, imitation dairy products made from plants and nuts have ridden the coattails of our dairy farmers. I’m proud to work with my Democratic and Republican colleagues to settle this once and for all.”

Risch adds, “Dairy comes from cows, goats and sheep, not almonds. Plant-based products’ misleading branding is a disservice to consumers and the farmers who dedicate their lives to making the nutritious dairy products Idahoans enjoy.”

The legislation would require FDA to issue updated guidance on enforcement within 90 days and report back to Congress within two years. It is widely supported by national and regional dairy groups, including the National Milk Producers Federation (NMPF), American Farm Bureau Federation, EDGE Dairy Farmer Cooperative, Wisconsin Cheese Makers Association, Midwest Dairy Coalition and Idaho Dairymen’s Association, among others.

Industry Applauds Legislative Action
Dairy organizations welcomed the bill as a move toward restoring fairness in the marketplace.

“When consumers buy products labeled as milk or cheese, they’re expecting delicious, nutritious foods made with the goodness of real dairy — not nuts, peas or beans,” says John Umhoefer, executive director of the Wisconsin Cheese Makers Association. “We applaud Senator Tammy Baldwin and the bipartisan Congressional coalition behind the DAIRY PRIDE Act.”

Gregg Doud, NMPF president and CEO, called FDA’s failure to enforce its own standards harmful to public health and confusing for consumers.

“It’s time to get rid of FDA’s 2023 guidance on labeling imitator beverages and replace it with straightforward policy that makes FDA enforce its own dairy standards of identity,” Doud says.

Continued Consumer Confusion
The argument central to the bill is one of nutritional transparency. Dairy groups contend that allowing non-dairy alternatives to use traditional dairy terms implies a nutritional equivalency that doesn’t exist.

“Medical groups, including the American Academy of Pediatrics, agree that it’s a problem when products mislead consumers by using dairy terms to imply that they provide dairy’s unique nutritional profile, when nothing could be further from the truth,” according to NMPF.

Heidi Fischer, EDGE Dairy Farmer Cooperative president, echoed that sentiment, noting the bill protects consumer trust and supports the integrity of dairy labels.

“We encourage timely action on this bill to prevent further misleading product names on our grocery store coolers and shelves,” she says.

Broad Bipartisan Support
In addition to Baldwin, Risch, Collins and Welch, the 2025 DAIRY PRIDE Act is also cosponsored by Senators Pete Ricketts, R-Neb., Mike Crapo, R-Idaho, Angus King, I-Maine, Kirsten Gillibrand, D-N.Y., John Fetterman, D-Pa., Roger Marshall, R-Kan., Tina Smith, D-Minn., Amy Klobuchar, D-Minn., and Mike Rounds, R-S.D.

Supporters argue that this broad coalition reflects the widespread impact dairy farming has on rural economies and nutrition policy alike.

“Idaho dairy farmers have worked hard for generations to provide real, safe and wholesome dairy products,” says Rick Naerebout, CEO of the Idaho Dairymen’s Association. “Allowing plant-based alternatives to use dairy terms misleads consumers and undermines the work of our family farms.”

If passed, the DAIRY PRIDE Act would require FDA to enforce its own legal definitions for dairy terms and issue updated guidance within 90 days, formally reserving labels like milk, cheese and yogurt for animal-derived products. The agency would also need to report back to Congress within two years, outlining its enforcement progress and demonstrating accountability.

“Dairy-Free Butter” is a Crock: Butter Makers Urge for FDA Crackdown

Thu, 26 Jun 2025 18:03:15 GMT

The American Butter Institute (ABI) is calling on the U.S. Food and Drug Administration (FDA) to take swift action against what it says is misleading labeling by Country Crock, a brand now selling a product labeled as “dairy-free salted butter.” According to butter makers, it’s not butter - it’s a crock.

In a formal complaint sent to Claudine Kavanaugh, director of the FDA’s office of nutrition and food labeling, ABI alleges the plant-based spread violates the federal standard of identity for butter. While the product prominently features the word “butter” on its front label, the fine print reveals it’s actually a 79% plant-based oil spread.

“Dairy Free Butter”

(American Butter Institute)

Dairy-Free Salted Butter

(American Butter Institute)

“Country Crock is attempting to leverage the premium perception of real dairy butter maintained by consumers,” says Christopher Galen, executive director of ABI. “The manufacturer is clearly trying to confuse the consumer about what this product is: an ultra-processed seed oil concoction. This product may indeed be a crock from the country, but it’s certainly not butter.”

Under federal law, butter must be made from milk. ABI argues that letting companies label plant-based spreads as butter erodes consumer trust and the integrity of food labeling. Galen adds that with margarine and oil spreads facing declining sales, companies are trying to ride the coattails of butter’s growing popularity.

The complaint echoes a 2019 objection from the National Milk Producers Federation, which also pushed back on Country Crock’s use of “plant-based butter” in its marketing.

“Butter manufacturers are required to play by the rules,” Galen says. “The increasing number of fake butters on the market not only violates those rules, it misleads shoppers and undermines confidence in what they’re buying.”

The FDA has not yet responded to ABI’s complaint, but America’s butter makers are clear: If it’s not made from milk, don’t call it butter.

Your Next Read: A New Era for Nebraska: First Dairy Plant Breaks Ground in Over 60 Years

U.S. FDA Suspends Milk Quality Tests Amid Workforce Cuts

Tue, 22 Apr 2025 21:04:44 GMT

The Food and Drug Administration is suspending a quality control program for testing of fluid milk and other dairy products due to reduced capacity in its food safety and nutrition division, according to an internal email seen by Reuters.

The suspension is another disruption to the nation’s food safety programs after the termination and departure of 20,000 employees of the Department of Health and Human Services, which includes the FDA, as part of President Donald Trump’s effort to shrink the federal workforce.

The FDA this month also suspended existing and developing programs that ensured accurate testing for bird flu in milk and cheese and pathogens like the parasite Cyclospora in other food products.

Effective Monday, the agency suspended its proficiency testing program for Grade “A” raw milk and finished products, according to the email sent in the morning from the FDA’s Division of Dairy Safety and addressed to “Network Laboratories.”

Grade “A” milk, or fluid milk, meets the highest sanitary standards.

The testing program was suspended because FDA’s Moffett Center Proficiency Testing Laboratory, part of its division overseeing food safety, “is no longer able to provide laboratory support for proficiency testing and data analysis,” the email said.

An HHS spokesperson said the laboratory was already set to be decommissioned before the staff cuts and though proficiency testing would be paused during the transition to a new laboratory, dairy product testing will continue.

The Trump administration has proposed cutting $40 billion from the agency.

The FDA’s proficiency testing programs ensure consistency and accuracy across the nation’s network of food safety laboratories. Laboratories also rely on those quality control tests to meet standards for accreditation.

“The FDA is actively evaluating alternative approaches for the upcoming fiscal year and will keep all participating laboratories informed as new information becomes available,” the email said.

Your Next Read: Chobani Breaks Ground on $1.2B New York Plant

5 Reasons Consumer Distrust In Our Food Supply Is Rising

Tue, 28 Jan 2025 20:49:59 GMT

Bread, check. Blueberries, check. As I wheel my grocery cart alongside the deli case, I’m taken aback at what I see. Rather, it is what I don’t see that has me wondering, “What in the world?” This section of my favorite grocery store is now almost completely empty, except for a couple of ham loaves and a renegade block of cheese.

In a slightly distraught tone I ask the worker behind the counter, “What’s going on?” He hesitates for a moment, then replies, “The store is in the process of changing suppliers for our deli products. We should have more of a selection next week.” Then it dawns on me: my favorite brand of deli meat and cheese, Boar’s Head, has officially been blacklisted by my go-to grocery store.

I should not have been surprised. Boar’s Head began its fall from public grace on July 26, 2024, when the company issued a recall for more than 207,528 lb. of product due to potential listeria contamination. The CDC linked the contamination to 61 illnesses and, tragically, 10 deaths. It was the worst listeria outbreak in the U.S. in over a decade.

The outbreak was ultimately traced to a production line at the company’s Jarratt, Va., plant. According to USDA inspection reports, which USA Today had to obtain through a Freedom of Information Act request, 69 reports of non-compliance were recorded at the Jarratt plant between 2023 and 2024. What was in those reports was unsettling. Documentation of insects live and dead, black and green mold, mildew, dripping and standing water, as well as other unsanitary conditions within the plant in the weeks leading up to the July recall. In a move that was too little too late, Boar’s Head announced on Sept. 13, 2024 that the Jarratt plant would be closed permanently.

In 1906, Upton Sinclair published his famous novel “The Jungle,” which exposed the horrific conditions in the meatpacking industry at the time. The writer’s work proved to be an instant bestseller to the masses. The irony is that nearly 120 years later, one might find it hard to discern whether they’re reading a current USDA Food Safety and Inspection Service (FSIS) report or a chapter straight out of “The Jungle.”

Just One Of Many
The Boar’s Head case was only one the high profile food recalls last year. Remember the E. coli contaminated onions on McDonald’s quarter pounders? Then, Costco issued a massive recall on their Kirkland Signature brand of organic eggs because of a threat of Salmonella. And to cap off the year with the scariest illness yet, on Dec. 18, 2024, the CDC confirmed a patient in Louisiana had been hospitalized with the nation’s first severe case of avian influenza A (H5N1) virus, aka the “bird flu.”

If it seems that the number of food recalls are coming at us at a more fast and furious pace than ever, then your gut instinct is spot on. The Food and Drug Administration, which reports food and cosmetics together, says 1,908 such products were recalled in the fiscal year that ended in September. That’s the highest number since 2019. Such a constant barrage of warnings is having a serious affect on consumers’ overall psyche — and not in a positive way. According to a September 2024 Gallup report, only 57% of Americans say they have a “great deal” or “fair amount” of confidence in the government to keep food safe. This number is a 27 point decrease since 2019, and is a record low for the Gallup Consumption Habits Poll since its inception in 1999.

This explosion of 20th century foodborne illnesses has me asking the same question I asked the worker behind the deli counter: “What’s going on?”

5 Reasons To Be Skeptical
There are multiple reasons consumers have good reason to be less confident in the safety of their food.

First, there’s the government. Second, more and more of our food is imported, which makes it harder to inspect. Third, you have a growing quest for more natural food, which sometimes circumvents traditional inspection channels. Fourth, industry consolidation means only a handful of players control both the production and processing. That’s not inherently a bad thing, but if something goes wrong, it’s probably going to be big. Finally, we now have the ability, through more technology and data, to find, detect and isolate the specific source of contamination and document it.

Time For An Overhaul
Food safety policy and implementation at the government level is in need of a serious overhaul. There is a chance it could actually happen. In 2018, the previous Trump administration proposed consolidating federal food oversight into a single agency with USDA.

There are so many common sense things that a fully functioning food agency could do. For one, start with better and more noticeable country of origin labeling (COOL) on imported foods. It should be prominent, displaying the country’s flag as the primary indicator of origin. If nothing else, we’ll all get better at geography. Next, companies that embrace new technologies that prevent contamination should be rewarded with tax credits. We do it for electric cars. Why not for safer food?

Finally, the most important change needs to come in the form of accountability and transparency both from the food industry itself and the government that regulates it. That didn’t happen in the case of Boar’s Head, and 10 people lost their lives because of it. In the age of AI and social media, those FSIS plant inspection reports should be posted on platforms such as X and Facebook for the public to see in real time. Without such transparency, we’re no better off than we were back in 1906.

FDA Proposes New Front-of-Package Food Labeling to Help Consumers Make Healthier Food Choices

Tue, 14 Jan 2025 17:17:52 GMT

The Food and Drug Administration (FDA) has proposed a new front-of-package (FOP) labeling rule aimed at helping consumers make healthier food choices quickly and easily. This “Nutrition Info box,” a black-and-white design, will display levels of saturated fat, sodium, and added sugars, categorized as “Low,” “Med,” or “High,” along with the percent Daily Value for each nutrient.

Based on extensive research involving nearly 10,000 U.S. adults, this initiative seeks to complement the existing Nutrition Facts label and simplify decision-making for shoppers. If finalized, large manufacturers would have three years to comply, while smaller businesses (less than $10 million in annual food sales) would have four.

Example of Proposed Info Box

(FDA )

The FDA anticipates this measure will empower consumers, encourage healthier product formulations, and contribute to reducing chronic diseases like heart disease, diabetes, and obesity.

“For example, when comparing yogurt, the Nutrition Info box could help them identify a yogurt that is lower in added sugars,” said FDA in a statement.

Public comments on the proposal are open until May 16, 2025.

This new label is designed to complement the existing Nutrition Facts label found on the back of food packages, providing a more accessible and quick-reference guide for consumers.

FDA Commissioner Robert M. Califf, M.D., emphasized the importance of this proposal, stating, “It is time we make it easier for consumers to glance, grab and go. Adding front-of-package nutrition labeling to most packaged foods would do that.”

FDA also says that by displaying simplified, at-a-glance, nutrition information that details and interprets the saturated fat, sodium, and added sugar content of a food as “Low,” “Med,” or “High” on the front of food packages would provide consumers with an accessible description of the numerical information found in the Nutrition Facts label.

What are other examples of what the nutrition info boxes could look like? FDA provided the examples below.

Examples of nutrition box info.

(FDA)

New Federal Feed Additive Legislation Proposed

Wed, 10 Jan 2024 18:54:35 GMT

A bi-partisan coalition of U.S. representatives has proposed new legislation to streamline FDA approval of some feed additives.

The Innovative Feed Enhancement and Economic Development Act of 2023 (“ Innovative FEED Act ”) is intended to de-regulate the approval of new animal feed additives and encourage innovation by:

Creating a new category of animal feeds called “zootechnical animal food substances” and defining them as substances that only act within the gastro-intestinal tract of the animal to lower food pathogens, reduce byproducts for animals, or affect its gut microbiome.
Making it clear that zootechnical animal food substances would be regulated within FDA’s existing Food Additive Petition process for market approval, saving innovators time and money.
Providing farmers with more voluntary tools to help nourish their animals and support farmers’ profitability.
Leveling the playing field for American farmers and innovators.

Congressman Greg Pence (R-Indiana), lead sponsor of the bill , said “…it is critical that our nation’s farmers have access to these feed additives in a timely and affordable manner.” He added the new policy would shorten FDA review times of feed additives by several years, and that many other countries already have such expedited procedures for evaluating and approving new feed additives.

An extensive list of industry leadership groups – including the National Milk Producers Federation (NMPF) and American Feed Industry Association (AFIA) also support the bill. In addition to Pence, its primary sponsors are Congressman Jim Baird (R-Indiana); Congresswoman Kim Schrier (D-Washington); and Congresswoman Angie Craig (D-Minnesota), along with 8 other congressional members as co-sponsors.

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