Food and Drug Administration

nixiFLOR Injection Approved by the FDA for Bovine Respiratory Disease Treatment

Thu, 22 Jan 2026 19:37:10 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.

FDA Approves Exzolt Cattle-CA1 for Prevention and Treatment of New World Screwworm

Thu, 04 Dec 2025 18:42:23 GMT

On December 4, 2025, the U.S. Food and Drug Administration (FDA) granted conditional approval to Exzolt Cattle-CA1, a fluralaner topical solution from Merck Animal Health, for the use in beef cattle (≥ 2 months of age) and replacement dairy heifers (< 20 months of age). The approved uses include prevention and treatment of larval infestations by New World screwworm (NWS), and treatment and control of cattle fever tick.

“The FDA is leveraging every resource and authority at its disposal to ensure producers and veterinarians have the critical products they need to protect their livestock and safeguard our food supply against NWS and cattle fever tick,” said Timothy Schell, director of the FDA’s Center for Veterinary Medicine, in a press release . “We remain steadfast in our commitment to ensuring that animal drugs are safe and effective and that food from treated animals is safe to eat.”

While NWS has not yet been detected in the U.S., the threat persists just south of the border with a new case being reported yesterday. Cattle fever ticks, present along the U.S.-Mexico border in south Texas, are competent vectors of Babesia bovis and Babesia bigemina — agents of bovine babesiosis (Texas cattle fever).

“The threat of New World screwworm represents a growing concern to U.S. agriculture, potentially causing devastating economic losses for cattle producers that could reach hundreds of millions of dollars,” said Rick DeLuca, president of Merck Animal Health, in a news release . “We worked closely with the FDA to accelerate availability so that veterinarians and cattle producers will have access to a powerful new tool to protect cattle from these serious parasites, helping to safeguard the industry’s economic future and the nation’s beef supply.”

The conditional approval status reflects FDA’s determination that Exzolt Cattle-CA1 is safe for its labeled use and is reasonably expected to be effective, while requiring that its sponsor, Merck Animal Health, submit further data demonstrating its effectiveness over the next five years to support full approval.

Administration and Use Considerations

Exzolt Cattle-CA1 is a ready-to-use pour-on that delivers the active ingredient, fluralaner, to act systemically against infestations. Administration involves applying a narrow band of the solution from between the shoulder blades to the tailhead. It will be available in the first quarter of 2026 by prescription in 250 mL, 1 L or 5 L bottles.

After administration, there is a 98-day withdrawal period before slaughter to ensure meat from treated animals is free of drug residues. Use is prohibited in lactating dairy cattle, dairy calves, veal calves or bulls over one year of age that are intended for breeding.

This approval of Exzolt Cattle-CA1 complements that of Dectomax-CA1 , which was authorized in September 2025 for prevention and treatment of NWS infestations in cattle. Together, these two products give veterinarians and producers their first pharmacologic defenses against NWS.

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

Wed, 17 Sep 2025 13:58:13 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.

5 Reasons Consumer Distrust In Our Food Supply Is Rising

Mon, 03 Feb 2025 22:35:01 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 20:09:35 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)

FDA Releases Draft Guidance for Labeling Plant-Based Animal-Derived Foods

Tue, 07 Jan 2025 18:24:02 GMT

On Monday, Jan. 6, the U.S. Food and Drug Administration (FDA) released a draft guidance on labeling plant-based foods that are marketed and sold as alternatives to conventional animal products and a public comment period is open.

“Because definitions and standards of identity have not been established for plant-based alternatives, these foods are non-standardized foods and must be labeled with their common or usual names, or in the absence thereof, a statement of identity that accurately describes the food,” according to the draft guidelines.

According to the FDA, consumer demand for plant-based alternatives to animal products including eggs, seafood, poultry, meat, and dairy has increased over time. The total U.S. retail plant-based food dollar sales grew from $5.5 billion in 2019 to $8.1 billion in 2023.

“Consumers should be able to easily see and determine the particular plant source when looking at the name of the food on the label,” the document says.

Currently there are no established guidelines for labeling plant-based alternative meat products and the draft of the guidelines aims to answer several questions including:

What should be included in the statement of identity for a plant-based alternative food that also includes the name of a food that has an established definition and standard of identity (e.g., “cheddar cheese”)?
What are important considerations when using “plant-based [animal derived food]” (e.g., “plant-based fish nuggets,” “plant-based sausage,” etc.) as part of the name for plant-based alternative foods?
How should plant-based alternative foods that are blends of different plant sources be labeled?
What are important considerations when using “[animal or meat]-free” or “non[animal or meat]” in the labeling of plant-based alternative foods?
What are important considerations when using a modified spelling, such as Chik’N, Be’f, Cheeze, as a name for plant-based alternative foods?
How should the statement of identity appear on the label?
What are important considerations when labeling plant-based alternative foods as “vegan” or “meat-free”?
Can vignettes or other statements be used to convey characterizing flavors?

Public comments are being accepted through May 5, 2025. Use this link to review document and comment.

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FDA Looks to Consolidate its Food Policy and Regulation Divisions

Wed, 01 Feb 2023 17:28:32 GMT

FDA wants to consolidate its food policy and regulation divisions in the wake of last year’s national baby-formula shortage. The agency was criticized for its slow response and other food safety concerns, as supply chain issues and a formula recall panicked parents and caregivers.

Abbott Laboratories, which makes Similac and other brands, halted production at its Sturgis, Mich., factory because of product safety concerns.

Read more: FDA Approves Lab-Grown Chicken for the First Time

“Today, I am announcing a new, transformative vision for the FDA Human Foods Program,” said Commissioner Robert Califf. “Creating a Human Foods Program under a single leader who reports directly to the Commissioner unifies and elevates the program while removing redundancies, enabling the agency to oversee human food in a more effective and efficient way.”

The revamped foods program would absorb the functions of Center for Food Safety and Applied Nutrition and the Office of Food Policy and Response, as well as some of the work of the Office of Regulatory Affairs.

How it Works

The Center for Veterinary Medicine (CVM) would continue as a separate office; “the relevant food safety activities will be closely coordinated” between the CVM director and the deputy commissioner for human foods, said Califf.

Read more: Conagra Recalls 2.5 Million Pounds of Canned Meat and Poultry Product

Under Califf’s proposal, the deputy commissioner for food “will have decision-making authority over policy, strategy and regulatory program activities within the Human Foods Program, as well as resource allocation and risk prioritization.”

An advisory committee of outside experts would look at “challenging and emerging issues in food safety, nutrition and innovative food technologies.”

Principal deputy commissioner Janet Woodcock said an “implementation and change” group of FDA managers already was laying the groundwork to make the reorganization a reality. “We look forward to sharing further details next month and in the future on our progress,” she said.

The deputy commissioner will be named by spring, Califf told the Associated Press.

FDA Approves Lab-Grown Chicken for the First Time

Fri, 18 Nov 2022 20:57:22 GMT

The FDA approved lab-grown chicken for the first time, greenlighting products from startup Upside Foods for human consumption. If Upside gets USDA approval next, the company said it could start pumping out 50,000 pounds of “no-kill” meat products every year.

The news follows Upside’s April announcement that it had secured $400 million in Series C funding, moving the company “from R&D to commercialization,” according to CEO Uma Valeti.

“Our team...continues to overcome seemingly insurmountable challenges in our mission to make our favorite food a force for good,” said Valeti.

Upside, with 140 employees, has now garnered over $600 million in funding from names like Bill Gates and meat companies Tyson and Cargill.

Brian Sikes, Cargill COO, stresses his team’s commitment to meatless meat:

“Our continued support for UPSIDE’s innovative work underscores Cargill’s commitment to an inclusive approach to wholesome, sustainable protein that will meet customer and consumer needs now and in the future.”

Meanwhile, Beyond Meat announced it would lay off 19% of staff last month, and retail sales in the plant-based meat industry overall have dropped 10% in the past year.

More on lab-grown meat :

Beyond Meat Faces Lawsuit Over False Protein Content and Quality Claims
Hoxton Farms Raises $22 Million for Cultivated Animal Fat

Pfizer Vaccine Receives Full FDA Approval: “Now is the Time to Get Vaccinated,” White House Says

Fri, 24 Sep 2021 14:50:48 GMT

Nearly nine months following the authorization of the first emergency use of a COVID-19 vaccine, the U.S. Food and Drug Administration (FDA) has granted a seal of approval for the Pfizer-BioNTech vaccine, Comirnaty.

In an AgriTalk interview on Tuesday with host Chip Flory, Dr. Bechara Choucair, White House vaccination coordinator, discussed the FDA’s approval of Pfizer’s vaccine.

“We know there are a lot of people who are still undecided about the vaccine. And there are many reasons why some of these folks are undecided about the vaccine. But for the subset of these folks, and according to the Kaiser Family foundation, up to three out 10 of these folks are waiting to get the full approval of the FDA before they get vaccinated,” Choucair says. “If you’ve been waiting for this approval before you get the vaccine, now is the time go ahead and get vaccinated.”

Many have questioned whether the FDA would push approval for the Pfizer vaccine because so many people have already received the jab. Choucair explains the FDA’s acceptance of the vaccine wasn’t a political move. The decision was based on fact and scientific data.

“The FDA has gone through a very complex process to ensure the safety, the effectiveness, and the quality production of this vaccine. They have reviewed literally hundreds of thousands of pages worth of preclinical data, clinical data, and information. They’re reviewed details of the manufacturing process,” Choucair says. “They’ve gone through inspections at the sites in which the vaccine is made. We know the FDA has worked around the clock and has said that this was one of their top priorities. And we know the FDA is the gold stand for safety in the world. So I think people should absolutely be confident in that this vaccine has met its high standards, is safe, and is effective.”

With Pfizer leading the FDA approval charge, it begs the question if or when Moderna and Johnson & Johnson will follow suit.

“We know from Moderna and Johnson & Johnson, both companies are still gathering final data and submitting their application materials. And the FDA has already said the COVID-19 vaccines are among their top priority,” Choucair told Flory. “Currently in the United States, we have three vaccines that are very safe and very effective. They’re effective at preventing you from getting the infection, but they are particularly effective in preventing you from getting more severe consequences after injection – like hospitalizations and deaths.”

Given that schools are reopening across the country with in-person classes, COVID-19 is likely to spike. However, Choucair says there is a spark of hope in the ongoing full approval of the Pfizer vaccine for teens and preteens.

“The vaccine has received full approval for 16 years old and older. Now, keep in mind that 12- to 15-year-olds will continue to receive the vaccine. Pfizer remains authorized for emergency use, and it is safe and effective, as we’ve heard from both the CDC and the FDA,” he says. “At this time, Pfizer has requested the full approval for the use of the vaccine and on individuals 16 and older. In July, Pfizer did say it would pursue separate approval for the 12-to-15-year age group once that additional six-month data comes out.”

Choucair told Flory the data attests to the effectiveness of the vaccine and the Pfizer option is working as anticipated.

“If you look at the overwhelming majority of hospitalizations related to COVID-19 in this country today, they are amongst those who are unvaccinated. You look at the overwhelming majority of people who are dying from COVID-19 today, they are by far unvaccinated. So the vaccines work. They’re effective; they’re safe. If you are still thinking about getting vaccinated, now is the time to roll up your sleeves and get that shot.”

An uptick in vaccinations seems likely with the FDA approving the Pfizer vaccine. However, it’s difficult to put into perspective how many Americans are vaccinated or unvaccinated. In his final thoughts, Choucair discussed the number of shots administered each day, as well as weekly averages.

“This is our path to getting this pandemic behind us. It all starts with more and more people getting vaccinated. And the fact remains that we’re seeing more and more people getting vaccinated every single day. We’ve averaged 800,000 doses per day over the last week or so. We have more than 470,000 people every single day, rolling-up their sleeves and getting that very first shot,” Choucair says. “We know people are realizing that this pandemic is not over. People are realizing this delta variant is much more contagious and they’re realizing there are more people in hospitals, more people dying, and we want to make sure they’re protecting themselves, and their communities.”

Listen to Chip Flory’s full interview with Dr. Bechara Choucair, White House vaccination coordinator, here.

What Does FDA’s Antibiotic Control Announcement Mean to Producers?

Fri, 20 Nov 2020 05:38:15 GMT

By: Dee Griffin, UNL-Great Plains Veterinary Educational Center

Perhaps the best description is the FDA announced the final step in a process that started almost two decades ago. The bottom line is this final step offers more for livestock producers than it is thought to take away.

When did the FDA really start working with antibiotic resistance issues in livestock?
Two decades ago the FDA CVM (Center for Veterinary Medicine) recognized antibiotic resistance was making it harder to properly treat livestock. Drugs like Oxytet, PenG, Tylan, and Erythromycin had become less and less effective for treating diseases such as pneumonia. Working with congress, the FDA-CVM, livestock organizations and veterinary organization got legislation passed with a long legal name and hence goes by the more user friendly name of AMDUCA (Animal Medicinal Drug Use Clarification Act). This legislation, for the first time, allowed livestock to receive the proper dose of an animal drug regardless of the dose prescribed on the label and was referred to as “Extra Label Drug Use” (ELDU). It applied to over the counter (OTC) medications like Penicillin G. The label legally only allowed 1CC per 100 lbs (CWT). This is an ineffective dose, but doses higher than that would likely cause a violative drug residue. Causing a violative drug residue is a criminal offense; not a good situation for livestock producers or their vets! AMDUCA, in part provided a mechanism for better estimating the proper withdrawal if a drug required ELDU to be effective. AMDUCA has played an integral part in not only improving the proper antibiotic dosing in livestock, but also helped pave the way to better understanding of how to properly assign withdrawal times for drugs in which the ELDU applied. The statistically calculated random residue sampling program in the U.S. verifies we have a ZERO violative residue rate in all foods derived from meat, milk, and poultry.

What was the FDA’s next step on dealing with antibiotic resistance concerns?
AMDUCA was followed by almost a decade of work between the FDA and Center for Disease Control (CDC) trying to better understand the origin and trends of antibiotic resistance. The first part of this effort was CDC’s “National Antibiotic Resistance Monitoring System” (NARMS) which began in 1996. The system targeted enteric (coliform) bacteria such as Salmonella, E. coli, and Campylobacter. Of particular interest was the potential for antibiotic resistance in these bacteria that might be transferred from animals to humans via food. Yearly, thousands of samples of enteric bacteria from hundreds of laboratories across the U.S. (coast to coast and border to border) are submitted to the CDC NARMS laboratories for evaluation.

The evaluation led FDA and CDC scientists to develop a FDA CVM Guidance for Industry document (GFI) that would change the way antibiotics for animals would be approved in the future. The document was named GFI #152 and laid out a nine cell antibiotic resistance concern grid.

The grid ( figure 1 ) categorized antibiotics and their relationship to antibiotic resistance that could affect humans as; “critically important”, “important”, or “not important” to humans. Additionally, the grid categorized the potential for antibiotic resistance to develop based on the duration the bacteria would be exposed to an antibiotic. The document indicated there was minimal potential for bacteria to develop resistance if the exposure to the antibiotic was less than seven days. But indicated a serious concern for development of antimicrobial resistance if the bacteria were exposed to the antibiotic for longer than 21 days. Antibiotics fed to livestock often fit into the “bacteria exposed for greater than 21 days” category and were therefore of more concern.

Additionally, the decision was made to never approve an antibiotic in the future for “production purposes” such as “improved growth or gain” or for “improved feed efficiency” or for “improved reproductive efficiency”.

During this time frame many very effective antibiotics such as Draxxin, Excede, Resflor, Zactran, and Zuprevo have been approved for individual use in livestock. But new approvals for antibiotics that could be used in feed halted due to the concerns for potential antibiotic resistance of enteric bacteria such as Salmonella, E. coli, and Campylobacter that may be transferred to humans via food and potentially cause disease.

How to reopen the FDA approval process for antibiotics that can be fed to livestock for disease treatment, prevention, and/or control.
Livestock producers were stuck with the antibiotics that had been approved … nothing new was going to be available to help manage health problems in their livestock. It is important to remember we have very good products to control coccidia (Rumensin, Bovatec, and Deccox). We have chlortetracycline (CTC, Aureomycin) for treatment of scours caused by E. coli and pneumonia caused by Pasteurella multocida, and we have tylosin (Tylan) to control liver abscesses caused by Fusobacterium. But no new antibiotics for use in feed would be forth coming unless the FDA-CVM figured out a mechanism that the antibiotic will use WITHOUT jeopardizing the safe guards needed to protect humans.

In April 2012, the FDA-CVM announced a new Guidance for Industry named GFI #209. This document outlined the development of “Veterinary Feed Directives” (VFD) and represented a mechanism that could be used by the FDA to approve an antibiotic for use in livestock feed to “treat”, “prevent”, or “control” a “specific” disease causing bacteria in a “targeted” group of “affected animals” or a group of animals at a “high risk” of developing a disease caused by a “specific” bacteria.

The idea was not new. Veterinary Feed Directives had been successfully used in swine operations. The expansion of the VFD to include cattle had many obstacles to overcome. Not the least of which is how to make a medication readily available when and where the medication is needed when a disease event occurs. And additionally, how can the public be assured the medications are being used in accordance with FDA legal regulations?

The first VFD medication approved was Pulmotil for the treatment of pneumonia in swine and cattle. The pharmaceutical company that makes Pulmotil has worked hard through their network of distributors to insure the medication has been available when and where it is needed. Public assurance of the responsible use of the medication comes through the documentation required by the FDA when the medication is used. Yes, the paper work is a hassle, but in the first year of VFD availability the FDA has streamlined some required documentation. Additionally, through free enterprise, a company stepped up and now offers electronic management of the documentation. Their service, now unwritten by the pharmaceutical company, improves speed, accuracy, and decreases errors.

What is next?
The success of the FDA-CVM VFD effort to make available an antibiotic for livestock disease management AND document the ability to safe guard the public’s interest in decreasing the risk of antibiotic resistance development has led the FDA-CVM to the final step in eliminating unwarranted “production use” (improved growth, gain, efficiency) of antibiotics in livestock in which “bacteria are exposed for greater than 21 days” to the antibiotic and for which there is no medically warranted need.

On December 11, 2013 the FDA-CVM announced the GFI #213. This document is directed to pharmaceutical companies that have antibiotics that currently have “production use” labeling (improved growth, gain, efficiency). On December 12, 2013 an additional VFD document, 21CFR 514 and 558, was published in the Federal Register. This document outlines the specific steps pharmaceutical companies will take to have their antibiotic considered for being approved for use under the VFD requirement.

The FDA-CVM has made GFI #213 and associated VFD requirements available for evaluation and comment since early 2012 and therefore come as no surprise to pharmaceutical companies. On the same day GFI #213 was announced, two major pharmaceutical companies enthusiastically endorsed GFI #213. Companies that currently have antibiotics with “production use” have three years to follow the 21CFR 514 and 558 requirements to gain approved VFD labeling. In three years all production use labels will expire. Here is an example of a current label with GFI #213 indicated changes http://go.unl.edu/7iwo .

Why would a pharmaceutical company or livestock owner “enthusiastically endorse” the FDA-CVM announcement of GFI #213?
With the expiration of “production use” (improved growth, gain, efficiency) labeling, comes the opportunity for FDA approval of several new VFD medications. The one VFD made available thus far is superior for treatment of pneumonia than any antibiotic that has been available in the past and it seems very realistic that other, even more effective VFD antibiotics currently exist and are only an approval process away from being available for use under VFD requirements.

Livestock owners get the potential for new more effective medications that can be used in the feed to manage disease events and give up nothing. The “production use” (improved growth, gain, efficiency) labeling is decades out of date. There are long lists of theories about how antibiotics improved growth, gain, and efficiency, but nothing has ever stood the test of time and scrutiny better than “good health” as the mechanism for improved growth, gain, and efficiency. The data is lacking to support the use of antibiotics in feed for improved growth, gain, efficiency, so much so the National Cattlemen’s Beef Association (NCBA) technical and scientific advisor group in 2001 recommended the addition of an additional item on the NCBA’s “Antibiotic Prudent Use Guidelines” that read, “Sub-therapeutic Antibiotic Use is Discouraged: Antibiotics should be limited to prevent or control disease and should not be used if the principle intent is to improve performance.”

Bottom line
The downside is there will be paper work involved for using VFD medications. In time we will learn how to streamline the paperwork. Already, an enterprising company this last year figured out how to make managing VFD paperwork much easier.

A decade from now, if the antibiotic resistance has decreased we will all be glad we participated in helping the effort. If antibiotic resistance doesn’t change, the world will know the problem they blamed on us wasn’t of our making and we will likely have gotten a few new feed usage antibiotics that are much more effective than what we currently have available. It seems to me, perhaps a win-win for us.

Farmers, Brewers Await Grain Fate Under FDA Rule

Fri, 13 Nov 2020 01:59:29 GMT

Farmers and brewers are still waiting to hear a final ruling from the FDA on the use of spent grains in cattle rations.
By: Josie Sexton, The Coloradoan

FORT COLLINS, Colo. (AP) — After months of panic by brewers and farmers and their representatives in Congress, the U.S. Food and Drug Administration has announced it will amend a rule that, in its initial form, could have cost both industries millions of dollars.

The Food Safety Modernization Act, the largest reform of food safety laws in 70 years, passed through Congress in 2011, and as a result, in late 2013, the FDA proposed a rule to monitor U.S. animal feed production more closely in order to prevent food-borne illnesses such as salmonella.

But in the fine print of the administration’s 100-page document, published last October, breweries were included in the new animal feed regulations. The reason? For centuries, they have been donating or selling their “spent” grains, leftover after sugar is extracted from malt during the mashing process, to farmers who use it to feed their cattle.

It’s an old tradition of “one local industry helping another local industry,” said Chris Thorne, vice president of communications for the Washington-based Beer Institute, which has been working with the FDA to amend the proposal.

“This is the kind of recycling story we want to see continue.”

The only reason it couldn’t continue, Thorne said, is the cost for a brewery to comply with new FDA standards. In regulating breweries also as animal feed producers, the FDA would require more cleaning, monitoring and sampling of the grain before its transfer to farmers. This would translate to manpower and machinery for a brewery and, on average, an investment of $13.6 million annually, according to a study by the Beer Institute and the American Malting Barley Association.

Both organizations say these costs are unnecessary.

In a letter to the FDA commissioner late last month, Sen. Mark Udall, D-Colo., echoed their sentiment.

“Brewers operate in a highly regulated environment currently which demands sterile practices and inputs...” Udall said in the letter. "... the U.S. Department of Agriculture has decades worth of data that ... does not reveal to my knowledge any evidence that dedicating spent brewers grains for agricultural use has ever compromised food safety to humans or animals.”

“The (FDA) had a solution in hand, but they didn’t have a problem,” Thorne agreed. “The issue is that there would be greater costs, and if you didn’t want to pay those costs, if you couldn’t absorb them, then you’d probably landfill the grain.”

On Thursday, the FDA said it would take another look at the rule and clarify it. It said it considers livestock feed generally safe but wants to ensure brewers’ grain is handled properly during transfer from breweries to farms.

When asked what they would do if forced to comply with the FDA rule, New Belgium Brewing and Odell Brewing Co. spokespeople said they likely would send the grain to a landfill. New Belgium produced 64 million pounds of spent grain in 2013 that it sold to one farm for animal feed. Odell produced just more than 5 million pounds that the brewery donated to one farmer.

Lugene Sas, owner of Taft Hill Dairy, started feeding his cattle with Odell’s spent grain 20 years ago. Now he is a fixture at the brewery; Odell even has a chocolate milk stout named after him.

He drives a pickup truck twice daily, five days a week, to collect more than four tons at a time of the still slightly sweet, fibrous and protein-rich feed. He said the fiber in the brewer’s grain is highly digestible, which helps his cows’ gut movement. They like the taste, so they eat more and, in turn, they produce more milk. He has never had a problem with food-borne illness.

“Everything is fresh fresh fresh. You give them good, quality feed, they’re happier cows,” Sas said. “I’m in business today because of the feed, otherwise I would be out of something that I love to do.”

He was worried about the FDA legislation being cost-prohibitive to brewers. Specifically, he mentioned a requirement to dry the spent grain, which is still wet when he gets it out of Odell’s holding silo, less than 24 hours after the malt’s mash.

But Thorne said this drying requirement is one of the biggest misconceptions that has spread across his industry in the panic since October. On the FDA website’s open comment page, which closed at the end of March, more than 2,000 concerned parties took issue with some or all of the proposed brewery regulations, among them, drying out the grain.

But that wasn’t even part of the FDA’s proposal, Thorne said.

“I just don’t know where that ever came from,” said Dan McChesney, director of FDA’s Office of Surveillance and Compliance, in an article published April 17 in Food Safety News. “What’s expected of (brewers) is really not much more than what they’re currently doing. ...”

As McChesney’s comments indicate, the FDA is now responding to the beer community, first by dispelling any myths, and then by amending the proposal, which will happen this summer.

“We are working to develop regulations that are responsive to the concerns expressed, practical for businesses, and that also help ensure that food for animals is safe and will not cause injury to animals or humans,” Juli Putnam said on behalf of FDA in an email statement.

With that, Thorne said he and the Beer Institute are “cautiously optimistic.”

“It is our understanding that the amended rule will allow brewers to continue marketing spent grains in the same manner that we have been,” he said.

“Brewers have demonstrated that we can market these grains in a safe, swift and sanitary process. The grain already exceeds human consumption standards, let alone those for animals.”

Spent grain, by the numbers:

64 million: pounds of spent grain that New Belgium produced in 2013, which was 74 percent of the brewery’s total waste stream.
64 million: pounds of spent grain that New Belgium sold in 2013, to one farm.
5.1 million: pounds of spent grain that Odell Brewing created in 2013.
90,000: pounds of spent grain donated by Odell Brewing to Lugene Sas, weekly.
20: years that Sas has been getting his cattle feed from Odell Brewing.

Brewers Fear Proposed FDA Rule Would Spike Costs

Fri, 13 Nov 2020 01:59:20 GMT

Northwest beer brewers have joined a national outcry over a proposed rule from the Food and Drug Administration which they say would make it prohibitively expensive for them to recycle spent grain by providing it to dairy farmers.

The FDA is trying to tighten the country’s food safety network. The proposal would classify companies that distribute spent grain to farms as animal feed manufacturers, imposing new sanitation requirements and possibly forcing them to dry and package the material before distribution, The Oregonian reported .

“This proposed regulation would help prevent foodborne illness in both animals and people,” the agency said in a statement last month.

But brewers say the new requirements could cost millions and force them to raise beer prices.

“That would be cost prohibitive,” said Scott Mennen, vice president of brewery operations at Widmer Brothers brewery in Portland, Ore. “Most brewers would have to put this material in a landfill.”

For centuries, brewers have provided spent grain to dairy farmers, giving the farmers a low-cost or free source of high-protein, high-fiber feed for their cows. That means farmers don’t like the proposal either.

One gallon of beer yields about a pound of spent malted barley husks. It’s a food-grade product and heated to about 170 degrees Fahrenheit during brewing, which would kill any contaminants.

Most big brewers — like Widmer and Full Sail — ship the spent grain in bulk. Nationwide, brewers ship nearly 3 million tons a year, and about 90 percent goes to livestock, according to the Beer Institute, a trade industry group.

“It’s a premium product,” said Jerome Rosa, an organic farmer in Gervais who fetches about 20 tons a week from a brewer in Portland to feed his 300 cows. “I pay virtually nothing. But it’s like putting honey on your cereal. It makes the cows want to eat more and we notice it in their production.”

Without the spent grain, Rosa said, his feed costs would go up — adding to the cost of his milk.

Another farmer, Tim Hutton of Yacolt, Wash., said he’d have to abandon his hobby of raising cows and pigs. He relies almost entirely on spent grain from Gigantic Brewing Co., to feed his animals.

“It’s one of those rare things that’s been a win-win for livestock producers and the beverage industry,” said Tami Kerr, director of the Oregon Dairy Farmers Association.

Under current rules, breweries and distillers are exempt from animal feed requirements. The FDA’s proposal would end that exemption. The proposed rule is one of seven pillars of the Food Safety Modernization Act, signed by President Obama in 2011 to stem food poisoning, which sickens 48 million people a year in the United States and kills 3,000.

Daniel McChesney, director of surveillance and compliance in the FDA’s Center for Veterinary Medicine, said the agency isn’t aware of cases where the practice has led to food-borne illnesses. “But we’re trying to get to a preventative mode,” he said.

He said the FDA has been surprised by the reaction and is reconsidering the rule. The FDA will open up the rule to comments again this summer and then revise the proposal, which is due to be finalized by August 2015.

Among the critics are several Northwest lawmakers. Sen. Ron Wyden, D-Ore., co-chair of the craft brewers caucus in the Senate, wrote a letter to the FDA with the other chair, Sen. Lisa Murkowski, R-Alaska, asking it to reconsider.

Rep. Peter DeFazio, D-Ore., and co-chair of the craft brewers caucus in the House, called the proposal “absurd.”

“This is the kind of stuff that makes government look bad,” DeFazio said. “It would mark a huge setback . adding tons of waste to our landfills.”