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- What the Center for Veterinary Medicine Does
- Who Regulates What: Navigating Federal Agencies
- How Animal Drugs Get Approved: From Lab to Market
- Animal Food Safety: Prevention Over Reaction
- Pet Food: What Your Label Really Means
- Hot Topics in Animal Health
- One Health: Connecting Animal and Human Well-being
- How to Stay Informed and Report Problems
- The Big Picture: Protecting Health Across Species
The health of your family dog, the safety of the nation’s milk and meat supply, and the development of life-saving medicines for backyard chickens all fall under one vital government body: the FDA’s Center for Veterinary Medicine (CVM). Though it may be one of the lesser-known FDA centers, CVM’s work is fundamental.
Its mission is protecting the health of both animals and people in the United States. This responsibility covers rigorous approval of new animal drugs, comprehensive regulation of all animal food – from pet kibble to livestock feed – and a critical, often unseen role in safeguarding the human food supply from drug residues and contaminants.
What the Center for Veterinary Medicine Does
At its core, the FDA’s Center for Veterinary Medicine is a high-performance, internationally recognized public health organization. It operates not just as a regulator but as a scientific body dedicated to a mission extending from the veterinarian’s office to the dinner table.
Mission and Values
CVM’s mission is powerfully stated as “Protecting Human and Animal Health.” This dual focus is the central theme of CVM’s identity and work. It acknowledges that animal health isn’t separate from the health of people who care for them and the environment they share.
The center’s vision is guided by three words: “Excellence. Innovation. Leadership.” These principles are supported by core values reflecting a modern, mission-driven organization:
We Serve: CVM defines itself as a public health regulatory center first and foremost, viewing safeguarding human and animal health as its primary duty while holding stakeholder trust – including consumers, veterinarians, and industry – in highest regard.
We Lead: The center fosters a culture where every employee, regardless of title, is empowered to contribute ideas and influence CVM’s direction.
We Learn: Continuous learning and professional growth are emphasized, recognizing that organizational expertise is built upon collective individual knowledge.
We Honor: CVM values its employees and celebrates diverse experiences and perspectives they bring, encouraging supportive and inspiring work environments.
Underpinning all of this is the foundational concept of “One Health.” CVM embraces the principle that people’s, animals’, and the environment’s health are inextricably linked. This isn’t an abstract idea but a practical approach to regulation.
For example, a medical breakthrough in treating human heart disease may offer insights for treating the same condition in animals, while environmental changes, such as emerging pathogens, can affect all living things. CVM puts this concept into practice in every facet of its work, from evaluating how animal drugs might impact the environment to tracking how antibiotic resistance can move between animals and humans.
How CVM is Organized
To accomplish its broad mission, CVM is organized into several distinct offices, each with specialized roles. This structure allows for focused expertise while ensuring all parts work together toward the common goal of protecting public health.
Office of the Director provides overall leadership for the entire center, directing CVM’s general activities, establishing mission-supporting policies, and leading educational outreach to pet owners, animal producers, veterinarians, and the animal health industry.
Office of New Animal Product Evaluation stands at the innovation forefront, managing rigorous approval processes for new animal drugs and other novel products. Its responsibilities include evaluating intentional genomic alterations (IGAs) in animals and cell- and tissue-based products. A key function is ensuring these new products are safe for target animals, effective for intended use, properly manufactured, and adequately labeled.
Office of Generic Animal Drugs manages approval processes for generic versions of already-approved brand-name animal drugs, ensuring generic drugs are bioequivalent to original products, meaning they work the same way in animals’ bodies.
Office of Surveillance and Compliance (OSC) acts as CVM’s “watchdog” after products reach markets. Its staff monitors animal drugs, devices, and food to ensure companies follow the law. When violations occur, OSC takes necessary enforcement actions, ranging from issuing warning letters to compelling companies to withdraw unsafe products through recalls.
Office of Applied Science is CVM’s scientific engine, using science to develop and support the center’s policies and regulatory decisions. Its researchers work to develop and apply state-of-the-art methods ensuring animal drugs and food are safe and effective.
Office of Minor Use and Minor Species (MUMS) addresses a unique veterinary medicine challenge. It works to make more animal drugs legally available for “minor species” (animals other than cattle, horses, swine, chickens, turkeys, dogs, and cats – such as sheep, goats, ferrets, or fish) and for “minor uses” (rare diseases in major species).
CVM’s organizational chart reveals thoughtful and deliberate design intended to ensure public health mission integrity. Responsibility for approving new drugs before sale resides primarily within the Office of New Animal Product Evaluation and Office of Generic Animal Drugs. However, responsibility for monitoring those same products for safety and compliance after they’re on the market falls to a completely separate office: the Office of Surveillance and Compliance.
This separation is a classic and essential feature of sound regulatory practice, designed to prevent potential conflicts of interest and ensure objective oversight. The scientist team that reviews initial data and approves drugs isn’t the same team that polices them once they’re being used by millions of animals in the real world.
Who Regulates What: Navigating Federal Agencies
For the average American, navigating federal consumer protection can be bewildering. It’s not always clear which agency is responsible for which product, especially regarding animal health and safety and the food they produce. The FDA, USDA, and EPA all have distinct but sometimes overlapping roles.
The Core Distinction: How Products Work
As a general rule, regulatory purview over veterinary products is determined by their primary mechanism of action – how they work in or on animals’ bodies.
FDA’s Center for Veterinary Medicine regulates products that achieve their effect primarily through chemical action or metabolism. This broad category includes most of what we think of as medicine. Its jurisdiction covers animal drugs (both prescription and over-the-counter pharmaceuticals), animal food (including pet food, treats, and livestock feed), and animal medical devices (such as thermometers, infusion pumps, or pacemakers). Oral and injectable flea and tick medications also fall under CVM authority as animal drugs.
USDA’s Center for Veterinary Biologics regulates products that work primarily by stimulating or modulating animals’ immune systems. These products are known as veterinary biologics. This is why USDA, not FDA, is responsible for regulating most animal vaccines, such as those protecting against rabies, distemper, or parvovirus.
Environmental Protection Agency regulates certain topical (spot-on) flea and tick products applied to animals’ skin. These products are classified as pesticides because they’re designed to kill pests and work on animal surfaces.
For consumers, the simplest way to identify the responsible agency is checking product labels. FDA-regulated drugs will have New Animal Drug Application (NADA) numbers or Abbreviated New Animal Drug Application (ANADA) numbers, often accompanied by statements like “Approved by FDA under NADA # XXX-XXX.” In contrast, EPA-regulated products display “EPA Registration Number” or “EPA Reg. No.” on packaging.
Food Regulation: The FDA vs. USDA Maze
Nowhere is jurisdictional complexity more apparent than in U.S. food supply regulation. Lines drawn between FDA and USDA’s Food Safety and Inspection Service (FSIS) can seem counterintuitive, but they’re critically important for food producers and consumers alike.
While FDA regulates the vast majority of the food supply – about 80% – USDA has specific and significant responsibilities:
| Food Category | Regulated by FDA | Regulated by USDA |
|---|---|---|
| Meat | Game meats (venison, bison, rabbit) | Domestic meats (beef, pork, lamb) |
| Poultry | Wild game birds (quail, pheasant) | Domestic poultry (chicken, turkey) |
| Eggs | Whole eggs in shell | Egg products (liquid, dried, frozen) |
| Seafood | Most fish and shellfish | Catfish |
| Dairy | All dairy products (milk, cheese, butter) | N/A |
| Produce | Processed fruits and vegetables | Raw fruits and vegetables |
| Mixed Products | Foods with <2% cooked meat (some soups, pizzas) | Foods with >2% cooked meat (meat-heavy frozen meals) |
This seemingly arbitrary and complex division isn’t the result of modern, logical design but rather historical artifact. USDA was established in 1862, with primary mission to support the nation’s agricultural economy, giving it early and foundational authority over livestock and the meatpacking industry. FDA was created decades later, in 1906, with broader mandate to protect consumers from unsafe foods and fraudulent drugs. Today’s confusing rules are legacy of these parallel historical paths.
How Animal Drugs Get Approved: From Lab to Market
The journey of an animal drug from laboratory concept to veterinary clinic medicine is long, rigorous, and meticulously regulated. CVM oversees every stage of this lifecycle, ensuring any drug sold in the United States is proven safe, effective, and manufactured to highest quality standards.
The New Animal Drug Application (NADA) Process
The path to approval for new, brand-name animal drugs is known as the New Animal Drug Application, or NADA, process. It’s systematic and comprehensive evaluation designed to leave no stone unturned regarding drug safety and effectiveness.
The Starting Point: The process begins not with FDA, but with drug sponsors – typically pharmaceutical companies – that have conducted initial research on promising new compounds. Before sponsors can conduct large-scale studies needed for approval, they must first open Investigational New Animal Drug (INAD) files with CVM.
Establishing INAD files is critical first step. It provides formal communication channels with FDA and allows sponsors to legally ship unapproved drugs across state lines to veterinarians and researchers who will conduct clinical trials. INAD provides frameworks for CVM to oversee research from earliest stages, ensuring studies are well-designed and that animal rights and welfare are protected.
Proving the Case: The burden of proof lies entirely with drug sponsors. It’s sponsors’ responsibility to conduct all necessary studies and collect extensive data required to convince CVM that drugs meet strict approval standards. Sponsors must provide substantial evidence in several key areas:
Target Animal Safety: Sponsors must demonstrate drugs are safe for specific animal species they’re intended to treat, at recommended doses. This involves studies to identify potential side effects, establish safety margins, and evaluate drugs’ effects over time.
Effectiveness: Sponsors must prove drugs consistently and reliably do what proposed labels claim they will do. This requires well-controlled clinical studies showing therapeutic benefits.
Human Food Safety: This is paramount concern for drugs intended for food-producing animals like cattle, swine, or chickens. Sponsors must conduct studies to understand how drugs are metabolized by animals and how long it takes for drug residues to leave animals’ tissues. Based on this data, CVM establishes scientifically-backed withdrawal periods – mandatory time that must pass between last time animals receive drugs and when their meat, milk, or eggs can enter human food supply.
Chemistry, Manufacturing, and Controls: Sponsors must provide detailed information proving they can consistently manufacture products that are pure, stable, and contain correct strength of active ingredients.
Environmental Impact: CVM requires assessments of drugs’ potential environmental impact, such as how drugs are excreted by animals and whether they could affect soil or water.
Labeling: Sponsors must develop comprehensive labels providing veterinarians and animal owners with all information needed to use drugs safely and effectively.
Special Approval Pathways
CVM recognizes that standard NADA processes, while thorough, can be barriers for drugs that are medically necessary but may not have large commercial markets. To address this, CVM has two alternative pathways to legal marketing status:
Conditional Approval (CNADA): This pathway is available for some drugs intended for minor species or for major species with serious or life-threatening conditions where unmet needs exist. Conditionally approved drugs have met all requirements for safety and manufacturing, but sponsors are still collecting final, substantial evidence of effectiveness. CNADA allows sponsors to legally sell drugs for up to five years while completing required effectiveness studies.
Indexing: This alternative pathway is available only for drugs intended for certain non-food-producing minor species (like ornamental fish, ferrets, or some zoo animals). Instead of full NADA reviews, indexing requests are reviewed by panels of qualified outside experts. If panels agree that drugs’ benefits outweigh risks for intended uses, FDA can add drugs to the “Index of Legally Marketed Unapproved New Animal Drugs for Minor Species.”
Generic Drug Approval: The ANADA Process
Once brand-name animal drugs have been on markets for several years, their patents and other marketing exclusivities may expire. This opens doors for other companies to produce generic versions, which are typically less expensive and increase competition.
The Generic Animal Drug and Patent Term Restoration Act (GADPTRA) of 1988 created streamlined pathways for approving these generic drugs through Abbreviated New Animal Drug Applications (ANADAs). They’re “abbreviated” because generic drug sponsors don’t have to repeat extensive and costly animal safety and effectiveness studies required for original brand-name drugs.
Instead, generic sponsors must prove their products are bioequivalent to original, approved drugs, known as Reference Listed New Animal Drugs (RLNADs). To demonstrate bioequivalence, generic sponsors must show their products:
- Contain the same active ingredient
- Are identical in strength and dosage form (tablet, injectable)
- Are administered by the same route (oral, topical)
- Are absorbed and utilized by animals’ bodies in the same way and to the same extent as brand-name drugs
To help generic drug manufacturers identify which brand-name drugs are eligible to be copied, FDA maintains a publication called “Approved Animal Drug Products,” known colloquially as the “Green Book.” This resource lists all FDA-approved animal drugs and provides key information about their patent and marketing exclusivity status.
After Approval: Ongoing Surveillance
CVM’s job doesn’t end once drugs are approved. In many ways, approval is just the beginning of drugs’ regulatory lifecycles. CVM’s Office of Surveillance and Compliance is responsible for continuously monitoring safety, quality, and effectiveness of all animal drugs on markets. This ongoing oversight is known as pharmacovigilance.
This system acknowledges fundamental drug development reality: pre-market clinical trials, no matter how thorough, are conducted on relatively small numbers of animals under controlled conditions. They can’t possibly predict every rare side effect or issue that might arise when drugs are used by millions of animals of different breeds, ages, and health statuses, often in combination with other medications.
Mandatory Sponsor Reporting: Drug sponsors are legally required to investigate and report problems with their products to CVM. Key required reports include:
- 3-Day Field Alert Reports: For any manufacturing defect or product quality issue that could potentially result in serious adverse health consequences
- 15-Day Alert Reports: For any adverse drug experience that is both serious (results in death, is life-threatening, or requires intervention to prevent permanent impairment) and unexpected (not listed on drug labels)
Public Reporting: CVM strongly encourages veterinarians, technicians, and animal owners to report any problems they observe with animal drugs or devices. This real-world data stream is invaluable for detecting potential safety signals that might otherwise be missed.
Animal Food Safety: Prevention Over Reaction
The FDA’s Center for Veterinary Medicine holds primary federal responsibility for ensuring food safety for all animals in the United States. This includes not only food we give our pets but also feed for millions of livestock animals that are part of the human food chain.
The Food Safety Modernization Act Revolution
Signed into law in 2011, the Food Safety Modernization Act (FSMA) represents the most sweeping reform of U.S. food safety laws in more than 70 years. The law applies to food for both humans and animals, and its core principle is fundamental paradigm shift: moving focus from reacting to foodborne illness outbreaks to proactively preventing them from happening in the first place.
Under FSMA, CVM implemented the Preventive Controls for Animal Food (PCAF) rule, which established new sets of modern, science-based standards for the animal food industry. This rule fundamentally shifted legal and operational responsibility for safety squarely onto manufacturers’ shoulders.
Key FSMA Requirements:
Food Facility Registration: Most facilities that manufacture, process, pack, or hold animal food are required to register with FDA.
Current Good Manufacturing Practices (CGMPs): For the first time, FSMA established mandatory, baseline safety and sanitation standards for all animal food production. These CGMPs cover all production aspects, including personnel health and hygiene, plant and equipment maintenance and cleaning, and pest control measures.
Hazard Analysis and Risk-Based Preventive Controls (HARPC): This is the heart of FSMA’s preventive approach. Covered facilities are now required to develop and implement written food safety plans. The plan must include:
- Hazard Analysis: Facilities must systematically identify potential biological, chemical (including radiological), and physical hazards that are known or reasonably foreseeable for each type of food they produce
- Preventive Controls: For any hazard requiring control to ensure safety, facilities must design, implement, and document preventive controls to significantly minimize or prevent that hazard
- Oversight and Management: Plans must include procedures for monitoring controls to ensure they’re working, taking corrective actions if problems arise, and verifying that entire systems are effective
Foreign Supplier Verification Program (FSVP): FSMA’s preventive mindset extends to global supply chains. The FSVP rule makes U.S. importers responsible for verifying that animal food and food ingredients they bring into the country are produced in manners meeting U.S. safety standards.
Pet Food: What Your Label Really Means
While FDA sets federal floors for pet food safety and regulation, ensuring all ingredients are safe and that labeling is truthful and not misleading, pet food labeling specifics are managed through unique dual systems.
At federal level, FDA requires all pet food be produced under sanitary conditions, be free of harmful substances, and be truthfully labeled. At state level, most states have adopted more detailed model regulations for pet food labeling developed by the Association of American Feed Control Officials (AAFCO).
AAFCO is a non-governmental organization composed of state and federal feed regulators. It doesn’t have direct regulatory power, but its model regulations become law when states adopt them. This partnership creates de facto national standards for pet food labels.
Eight Required Label Elements
Pet food labels are legal documents. Under AAFCO models, every pet food label must contain eight required items:
- Brand and Product Name: Names themselves are regulated by specific rules based on percentages of named ingredients
- Name of Species: Labels must clearly state whether food is for dogs, cats, or another species
- Net Quantity Statement: This tells you how much food is in packages by weight or volume
- Guaranteed Analysis: This section provides nutrient content information, listing minimum percentages of crude protein and crude fat, and maximum percentages of crude fiber and moisture
- Ingredient List: Ingredients must be listed in descending order by their weight in product formulations. All ingredients must be either Generally Recognized as Safe (GRAS) for intended use or be approved food additives
- Nutritional Adequacy Statement: This critically important statement tells you if food is “complete and balanced” for particular life stages, such as “adult maintenance,” “growth” (for puppies or kittens), or “all life stages”
- Feeding Directions: Labels must provide instructions on how much to feed animals, typically based on their weight
- Manufacturer or Distributor Information: Labels must list names and addresses of parties responsible for products
Decoding Product Names
Pet food naming conventions are common sources of consumer confusion. AAFCO rules ensure product names accurately reflect their contents:
| The Rule | Example Name | What It Means |
|---|---|---|
| The 95% Rule | “Beef for Dogs” | Named ingredient (beef) must make up at least 95% of product’s total weight, excluding water added for processing |
| The 25% or “Dinner” Rule | “Beef Dinner for Dogs” | Named ingredient (beef) must make up at least 25% of product’s weight (but less than 95%), excluding water. Qualifying terms like “Dinner,” “Entrée,” or “Formula” must be used |
| The 3% or “With” Rule | “Dog Food with Beef” | Product must contain at least 3% of named ingredient (beef). The word “with” is key trigger for this rule |
| The “Flavor” Rule | “Beef Flavor Dog Food” | Product must contain amount of ingredient sufficient for its flavor to be detectable by animal. No specific percentage required |
Hot Topics in Animal Health
CVM’s work often intersects with issues of high public interest and scientific debate. In these situations, the agency must navigate complex science, communicate with concerned public, and uphold its regulatory mission, often facing incomplete information.
The Raw Pet Food Debate
The feeding of raw meat-based diets to pets has grown in popularity, but it’s an area where FDA has expressed significant and consistent safety concerns.
FDA’s Official Stance: The agency’s position is unambiguous. FDA “does not believe raw meat foods for animals are consistent with the goal of protecting the public from significant health risks.” This stance is rooted in the “precautionary principle” that guides much food and drug law: in the face of documented risk, the agency defaults to restriction positions until safety can be affirmatively demonstrated through rigorous scientific processes.
The Identified Risks: The primary risk is microbiological contamination. FDA’s own surveillance studies, as well as peer-reviewed research, have repeatedly found harmful bacteria like Salmonella, Listeria monocytogenes, and pathogenic E. coli in commercially available raw pet foods. These pathogens pose risks not only to pets consuming food but also to humans in households.
Pets can consume contaminated food, show no illness signs, and yet become carriers, shedding bacteria into home environments through feces or saliva, potentially contaminating surfaces and leading to human illness.
Recent Concerns (H5N1 Avian Influenza): The emergence of H5N1 virus in U.S. dairy cattle has added new layers of concern. Because the virus can be transmitted through unpasteurized milk or uncooked meat from infected animals, FDA has determined that H5N1 is a new, reasonably foreseeable hazard. As results, the agency has formally required manufacturers of pet food containing uncooked or unpasteurized poultry or cattle ingredients to reanalyze their food safety plans under FSMA.
Grain-Free Diets and Canine Heart Disease
Beginning in 2018, CVM found itself at the center of complex and concerning scientific mystery involving potential links between certain popular pet foods and serious heart conditions in dogs.
The Investigation: In July 2018, FDA announced it was investigating reports of non-hereditary canine dilated cardiomyopathy (DCM) in dogs. A striking number of these reports involved dogs eating diets labeled as “grain-free” and containing high proportions of peas, lentils, other legume seeds (collectively known as pulses), and/or potatoes as main ingredients.
DCM is a disease of heart muscle that can lead to congestive heart failure and death. The reports were particularly concerning because they involved breeds not typically known to have genetic predispositions to the disease.
Key Findings and Complexity: CVM, in collaboration with the Veterinary Laboratory Investigation and Response Network (Vet-LIRN), launched multi-faceted investigation. Despite extensive product testing, the agency didn’t find any single nutritional deficiency (such as low taurine levels) or contaminant across reported diets that would explain the cases.
FDA concluded that potential association between these diets and DCM is “complex scientific issue that may involve multiple factors,” including interaction between dogs’ individual genetics and metabolism with specific ingredients and formulations in diets.
Current Status: After initial surge, the number of DCM reports submitted to FDA has declined significantly since 2020. In late 2022, FDA announced it would no longer provide routine public updates on investigation unless meaningful new scientific information becomes available.
CBD in Animal Products
The explosive growth in popularity of cannabis-derived products, particularly cannabidiol (CBD), has created significant regulatory challenge for CVM. Despite widespread marketing of CBD products for pets, FDA’s position is legally and scientifically straightforward.
The Legal Landscape: FDA’s stance is clear: CBD is an unapproved animal drug. Under the Federal Food, Drug, and Cosmetic Act, any product marketed with claims that it can diagnose, cure, mitigate, treat, or prevent disease in animals is a drug. Since no CBD products have gone through rigorous NADA processes to prove they’re safe and effective, it’s illegal to sell them with such therapeutic claims.
Furthermore, because CBD is the active ingredient in approved prescription drugs for humans, the FD&C Act’s “exclusionary clause” prohibits it from being legally added to food for humans or animals. This means edible pet treats and foods containing CBD are considered adulterated under law.
Safety Concerns: CVM has numerous significant safety concerns about unregulated CBD markets. The burden of proof for safety rests with manufacturers, and for CBD, that proof is absent. Key concerns include:
- Lack of Data: There is lack of scientific data on long-term effects of CBD in animals and what constitutes safe and effective doses
- Drug Interactions: Potential for CBD to interact with other medications animals may be taking is unknown
- Manufacturing and Contaminants: Unregulated products may not be manufactured to quality standards and could contain harmful contaminants like pesticides or heavy metals
- Human Food Safety: For food-producing animals, there is complete absence of data on how CBD residues might accumulate in meat, milk, and eggs and what levels, if any, would be safe for human consumption
One Health: Connecting Animal and Human Well-being
The concept of “One Health” is a cornerstone of CVM’s modern mission, recognizing that people’s, animals’, and the environment’s health are deeply interconnected. This philosophy isn’t just a talking point; it’s practical framework guiding CVM’s most critical public health functions.
Protecting the Human Food Supply
One of CVM’s most fundamental responsibilities under the One Health umbrella is ensuring that drug use in food-producing animals doesn’t pose risks to people. When drugs are developed for use in animals like cattle, swine, poultry, or fish, major parts of CVM’s pre-market approval reviews are dedicated to human food safety.
Scientists at CVM meticulously review data from drug sponsors to understand how drugs are absorbed, distributed, and metabolized by animals, and how long it takes for drug residues to be eliminated from animals’ bodies. Based on this data, CVM establishes legally-enforceable withdrawal periods – mandatory time that must pass between last drug doses and when animals can be slaughtered for meat or their milk or eggs can be collected for human consumption.
Combating Antimicrobial Resistance
Perhaps no issue better illustrates the One Health concept than the global crisis of antimicrobial resistance (AMR). AMR is the process by which bacteria and other microorganisms evolve to resist effects of drugs designed to kill them, leading to rise of “superbugs.” This is quintessential One Health problem because antibiotic use in any population – human or animal – can contribute to development of resistant bacteria that can then spread through ecosystems, threatening health of all.
CVM is a key federal partner in the fight against AMR. Its work in this area isn’t just a domestic issue but critical component of global public health strategy.
The cornerstone of CVM’s AMR efforts is its participation in the National Antimicrobial Resistance Monitoring System (NARMS). Established in 1996, NARMS is collaborative public health surveillance system involving FDA, Centers for Disease Control and Prevention, and USDA.
This partnership allows for comprehensive, One Health approaches to tracking resistance by monitoring bacteria isolated from three key areas:
- Ill people (monitored by CDC)
- Retail meats (monitored by FDA)
- Food-producing animals on farms (monitored by USDA)
By collecting and analyzing data from all three sectors, NARMS can provide unique and powerful pictures of how resistant bacteria are emerging and moving between animals, food supply, and humans.
How to Stay Informed and Report Problems
The FDA’s Center for Veterinary Medicine relies on partnership with the public to fulfill its public health mission. Veterinarians, pet owners, and livestock producers are eyes and ears on the ground, and their reports of problems with animal drugs and food are vital sources of real-world safety information.
Finding Recall Information
When companies remove animal drugs or food products from markets due to safety concerns, these are known as recalls. FDA ensures this information is publicly available.
The primary resource for information on recalls of animal drugs, pet food, and livestock feed is the “Recalls & Withdrawals” page on FDA’s Animal & Veterinary section website. This page features searchable tables of recent and past recalls.
The recall table provides dates of recalls, brand names, product descriptions, reasons for recalls (Salmonella contamination, elevated nutrient levels), and names of companies issuing recalls.
A broader government portal, Recalls.gov, consolidates recall information from various federal agencies and is another useful resource for food recalls from both FDA and USDA.
How to Report Animal Drug Problems
If you’re a veterinarian or animal owner and you suspect an animal has had side effects or other problems with animal drugs or medical devices, reporting it is crucial step in post-market safety monitoring.
Who to Contact First: FDA recommends you first try calling drug companies to report adverse events. Company phone numbers can almost always be found on product labels or packaging. Drug manufacturers are legally required to record and investigate these reports and submit them to FDA.
Reporting Directly to FDA: You also have options to report problems directly to CVM. This is done by completing and submitting FORM FDA 1932a, titled “Veterinary Adverse Experience, Lack of Effectiveness or Product Defect Report.” This form can be used for any problem with any animal drug (approved or unapproved) or animal device.
How to Submit: Download and save the blank form to your computer, then open it, fill it out completely, save the completed version, and email it as attachment to [email protected].
What to Include: Your report should be as detailed as possible. Include information about products (name, NADA number if available), animals (species, breed, age, pre-existing conditions), descriptions of adverse events, and any diagnostic tests or treatments provided by veterinarians.
For Questions: If you have questions about reporting or need assistance, contact CVM by phone at 1-888-FDA-VETS (1-888-332-8387) or by email at [email protected].
How to Report Pet Food Problems
If you believe pet food or treats have made your pet sick or are otherwise contaminated or mislabeled, you can report it to FDA.
The Safety Reporting Portal: The primary method for submitting pet food complaints is through FDA’s electronic Safety Reporting Portal. The portal will guide you through the process of submitting your complaint.
Information You’ll Need: Before beginning your report, gather all relevant information:
- Product Details: Exact brand name, product name, type of container, net weight, and UPC code (barcode)
- Lot Number and Dates: Lot number and “Best By” or expiration date. Lot number is series of letters and numbers stamped on bags or cans and is the single most important piece of information for FDA investigation, as it allows them to trace products back to specific manufacturing plants and production runs
- Pet Information: Details about your pet, including species, age, weight, health status, symptoms they experienced, and any diagnosis or medical records from your veterinarian
What Happens Next: FDA reviews every complaint it receives. While not every individual report will lead to full investigation or product testing, information becomes part of the agency’s larger surveillance database. This data helps FDA identify trends, detect potential widespread contamination events, and ultimately prevent future problems.
The Big Picture: Protecting Health Across Species
The FDA’s Center for Veterinary Medicine operates at the intersection of animal health, human safety, and environmental protection. Its work touches virtually every aspect of our relationship with animals – from the medicines that keep our pets healthy to the safety of the milk we drink and the meat we eat.
Understanding CVM’s role helps us appreciate the complex web of regulations and safeguards that protect both our animal companions and our food supply. The agency’s commitment to science-based decision making, transparent communication, and continuous monitoring creates multiple layers of protection that have served the public well for decades.
Whether you’re a pet owner curious about what’s in your dog’s food, a livestock producer ensuring animal welfare, or simply a consumer who wants to understand how government protects food safety, CVM’s work affects you. By staying informed about recalls, understanding how to report problems, and appreciating the scientific rigor behind regulatory decisions, we all become partners in maintaining the health and safety of animals and the people who care for them.
The One Health concept that guides CVM’s mission reminds us that our health and our animals’ health are fundamentally connected. When we protect animals, we protect ourselves. When we ensure safe animal food, we help ensure safe human food. And when we use medicines responsibly in animals, we help preserve their effectiveness for future generations of both animals and people.
Our articles make government information more accessible. Please consult a qualified professional for financial, legal, or health advice specific to your circumstances.