FDA Veterinary Products Compliance
Experienced Counsel Representing Veterinary Product Manufacturers and Other Companies in All FDA and Center for Veterinary Medicine (CVM) Compliance Matters
FDA Veterinary Products Compliance Team Lead
FDA Veterinary Products Compliance Team Lead
Former DOJ Attorney
FDA Veterinary Products Compliance Team Lead
Former Senior DOJ Trial Attorney
The U.S. Food and Drug Administration (FDA) and its Center for Veterinary Medicine (CVM) regulate most types of veterinary products sold in the United States. This includes not only products sold by veterinary clinics such as animal drugs, animal feed, and medical devices for animals, but also veterinary diagnostic tools, equipment, and machinery.
Different veterinary products are subject to varying levels of oversight by the FDA and CVM. While some products are subject to pre-market approval others are not. For example, as the FDA explains:
“Unlike animal drugs, animal feed does not have to be approved by FDA before it can be marketed. However, FDA makes sure the ingredients in the feed are safe and have an appropriate function, and many ingredients must be approved by FDA before they can be used in animal feed.”
But even when pre-market approval isn’t required, veterinary product manufacturers and other companies may still need to take several steps to establish compliance before bringing their products to market. As the FDA also explains, “[o]ne of the highest priorities of the FDA’s Center for Veterinary Medicine is our post-market activities. . . . We oversee the animal products industry for compliance by . . . pursuing regulatory and enforcement actions, as warranted, in collaboration with our federal and state regulatory partners.”
We Help Companies Establish and Maintain FDA Veterinary Products Compliance
Our lawyers and consultants help companies establish and maintain FDA veterinary products compliance. With prior experience working at the FDA and with the FDA’s federal regulatory partners, we are well-versed in all aspects of FDA compliance and enforcement. We know what it takes to help companies avoid scrutiny from the FDA and CVM, and we also have the capabilities required to defend companies that are facing scrutiny when necessary. We provide assistance with all aspects of FDA veterinary products compliance, including (but not limited to):
FDA Facility Registration
Certain veterinary product manufacturers, including many animal food manufacturers, are required to register their facilities with the FDA. We help our clients determine whether registration is required; and, if so, we guide them through the registration process while working with the FDA on their behalf. Our lawyers and consultants assist our clients with maintaining compliance with the FDA’s requirements for registered facilities as well, as noncompliance can lead to suspension of registration (among other penalties).
Animal Drug and Vaccine Compliance
Prescription animal drug and vaccine manufacturers are subject to the FDA’s drug approval process and compliance obligations, which are extensive. The same is true of research facilities, packagers, relabelers, and other companies involved in the veterinary medicine industry. Animal drugs and vaccines are subject to the FDA’s pre-market approval process; and, as the FDA makes clear, “[i]t’s illegal to market unapproved new animal drugs because they haven’t gone through the FDA pre-market review and obtained legal marketing status under the FD&C Act.”
The FDA also regulates flea and tick products in some cases. If a flea or tick product is not subject to the U.S. Environmental Protection Agency’s (EPA) oversight, then FDA compliance is most likely required. Like other animal drugs, flea and tick medications are subject to FDA approval, and manufacturers must have a New Animal Drug Application (NADA) or Abbreviated New Animal Drug Application (ANADA) number before they can sell these drugs to veterinary care providers.
Animal Food and Feed Compliance
Animal food and feed used in veterinary applications and sold by veterinary care providers are also subject to FDA compliance. However, unlike animal drugs and vaccines, they are not subject to FDA approval. As stated by the FDA, “[t]here is no requirement that pet food products have premarket approval . . . . However, the Federal Food, Drug, and Cosmetic Act (FFDCA) requires that pet foods, like human foods, be safe to eat, produced under sanitary conditions, contain no harmful substances, and be truthfully labeled.”
Veterinary Device Compliance
Veterinary devices are subject to the oversight of the FDA and CVM. While pre-market approval is not required, the FDA “does have regulatory oversight over devices intended for animal use and can take appropriate regulatory action if an animal device is misbranded or adulterated.” As a result veterinary device manufacturers (both in the U.S. and abroad) must ensure that their devices meet all applicable testing, safety, and labeling requirements—and they must be able to substantiate their safety and marketing claims when called upon to do so by the FDA or CVM.
Responding to Advisory Actions (Untitled Letters and Warning Letters)
The FDA issues Untitled Letters and Warning Letters to companies suspected of violating the FFDCA or the regulations that govern the manufacturing, marketing, or distribution of veterinary products. While these letters are advisory in nature, meaning that they do not immediately carry any penalties, failure to respond appropriately to an Untitled Letter or Warning Letter can lead to enforcement action by the FDA.
Responding to FDA Administrative Actions (Inspections, Recalls, and Import Refusals)
Veterinary product manufacturers and other companies facing FDA inspections must engage experienced defense counsel to help them navigate the process. After conducting an inspection, the FDA issues an FDA Form 483 to the targeted entity identifying any and all apparent violations, though the FDA makes clear that, “[t]hese reports are not an all-inclusive list of every possible legal violation and only capture what FDA investigators saw during the course of a single inspection.”
Manufacturers and other companies must respond appropriately to recall letters and import refusals as well. These have the potential to substantially impair companies’ revenue derived from their veterinary products—in addition to leading to FDA enforcement in the event of non-compliance. At Oberheiden P.C., we have extensive experience handling all types of FDA administrative actions on behalf of our clients.
Along with advisory actions and administrative actions, the FDA pursues various other means of enforcement to ensure the safety of animal drugs and vaccines, animal devices, and other veterinary products. Along with mandatory recalls and import refusals, FDA enforcement actions can lead to other consequences ranging from civil fines to criminal prosecution depending on the circumstances involved. As former FDA personnel and U.S. Department of Justice (DOJ) prosecutors, our lawyers and consultants are well-versed in all aspects of FDA civil and criminal enforcement.
Put our highly experienced team on your side
Dr. Nick Oberheiden
Founder
Attorney-at-Law
Lynette S. Byrd
Former DOJ Trial Attorney
Partner
Brian J. Kuester
Former U.S. Attorney
Hon. Kevin McCarthy
55th Speaker, U.S. House of Representatives (ret.)
Government Consultant
Mike Pompeo
Of Counsel
Former U.S. Secretary of State
John W. Sellers
Former Senior DOJ Trial Attorney
Linda Julin McNamara
Federal Appeals Attorney
Nicholas B. Johnson
Former Prosecutor
Roger Bach
Former Special Agent (DOJ)
Chris J. Quick
Former Special Agent (FBI & IRS-CI)
Michael S. Koslow
Former Supervisory Special Agent (DOD-OIG)
Ray Yuen
Former Supervisory Special Agent (FBI)
FAQs: What Companies Need to Know About FDA Veterinary Products Compliance
Does the FDA Issue Mandatory Recalls for Veterinary Products?
Yes, the FDA has authority to issue mandatory recalls for veterinary products, including animal drugs and medical devices. While the FDA typically issues voluntary recall requests and attempts to work with manufacturers to resolve product safety-related issues first, it does not hesitate to exercise its mandatory recall authority when necessary.
What Federal Laws Govern Animal Drugs and Vaccines?
Several federal laws govern the manufacture, marketing, and distribution of animal drugs and vaccines in the United States. These include, but are not limited to, the Animal Drug Availability Act (ADAA), Animal Medicinal Drug Use Certification Act (AMDUCA), Animal Drug User Fee Act (ADUFA), and Food Safety Modernization Act (FSMA), among many others. For animal drug and vaccine manufacturers, effectively managing federal compliance is a complex and resource-intensive process, and it is critical to work with experienced compliance counsel to avoid unnecessary scrutiny from the FDA.
Are Animal Drugs and Vaccines Subject to FDA Approval?
Yes, just like drugs and vaccines for human use, drugs and vaccines for veterinary use are subject to FDA approval. Animal drug and vaccine manufacturers must go through the appropriate pre-market submission process and obtain either an approved new animal drug application (NADA), abbreviated new animal drug application (ANADA), or conditional approval (CNADA), or else they must obtain alternate approval from the FDA such as an investigational exemption or emergency use authorization (EUA).
What Are the Risks of FDA Noncompliance for Veterinary Product Manufacturers?
For veterinary product manufacturers, the risks of FDA noncompliance range from receiving an Untitled Letter or Warning Letter that provides notice of noncompliance to facing a civil or criminal law enforcement investigation. In between, manufacturers can face invasive inspections, mandatory recalls, import refusals, and other administrative penalties. At Oberheiden P.C., we help veterinary product manufacturers carefully navigate all aspects of FDA compliance so that they can avoid these penalties.
Do I Need to Engage a Law Firm for FDA Veterinary Products Compliance?
Veterinary product manufacturers, importers, distributors, and other companies should all engage experienced counsel to assist them with FDA compliance. There are numerous laws and regulations that potentially apply, and these laws and regulations can impose different requirements for different companies. Our lawyers and consultants have experience with all aspects of FDA compliance in the veterinary products industry, and we rely on this experience to help our clients implement and manage effective compliance programs.
Schedule an Appointment with an FDA Veterinary Products Compliance Lawyer at Oberheiden P.C.
The lawyers and consultants on our FDA compliance team advise companies in the veterinary products industry throughout the United States and worldwide. To speak with a member of our team in confidence, please call 888-680-1745 or request a complimentary consultation online today.
