Yes! No! Maybe So! – What FDA Does and Does Not Regulate
by Ashley Steel, Center for Veterinary Medicine, FDA
Each week, FDA’s Center for Veterinary Medicine (CVM) receives a variety of
phone calls and e-mails from consumers asking questions like, “Who regulates
flea and tick products?” and “How do I treat my cat’s urinary tract infection?”
While CVM’s Communications Staff is happy to direct consumers to the appropriate
resources, it may be helpful to know that FDA is not the only organization
responsible for protecting animal health. FDA regulates the drugs, devices, and
feed given to or used on over one hundred million companion and food-producing
animals in the U.S. Several other government and non-government organizations
also play a role in animal health.
Yes!
Animal Drugs – The Federal Food, Drug, and Cosmetic Act
gives FDA the legal authority to approve and regulate drugs for animals. Before
a drug company can market an animal drug, the company must get the drug approved
by FDA. To get FDA approval, the drug company must prove that:
- the drug is safe and effective for a specific use in a specific animal species. If the drug is for use in food-producing animals, the drug company must also prove that food products made from treated animals are safe for people to eat;
- the manufacturing process is adequate to preserve the drug’s identity, strength, quality, and purity. The drug company must show that the drug can be consistently produced from batch to batch; and
- the labeling is appropriate and truthful. The drug company must make sure that the labeling contains all necessary information to use the drug safely and effectively, including the risks associated with the drug.
FDA’s role does not stop after an animal drug is approved. As long as the
animal drug is marketed in the U.S., FDA continues to monitor:
- the drug’s safety and effectiveness;
- the drug’s manufacturing process to make sure quality and consistency are maintained from batch to batch; and
- how the drug is marketed to make sure the advertisements are truthful and not misleading.
Besides the standard approval process, two additional pathways to the
marketplace are available for some animal drugs for minor species or minor uses
in a major species. These two pathways are conditional approval and
indexing.
| For the complete definition of the term “drug,”
please see the Federal Food, Drug, and Cosmetic Act at Section 201(g) [21 U.S.C. 321]3.
For more information about the animal drug approval
process, please visit:
From an Idea to the Marketplace: The Journey of an Animal Drug through the Approval Process4
For an online database of FDA-approved animal drugs,
please see Animal Drugs @ FDA6
For more information about minor species, minor uses, conditional approval,
and indexing, please visit: |
Animal Devices – The key difference between an animal device
and an animal drug is how the product works. If it relies on a chemical action
occurring in or on the animal’s body to work, the product is a drug, not a
device. If it needs to be metabolized by the animal’s body to work, the product
is a drug, not a device.
Antibiotics, anesthetics, and insulin are examples of drugs. Needles,
syringes, surgical instruments, X-ray equipment, certain diagnostic test kits,
and dental appliances are examples of devices.
Unlike animal drugs, animal devices do not have to be approved by FDA before
they can be marketed. Manufacturers and distributers of animal devices are
responsible for making sure they are safe, effective, and properly labeled. FDA
has the authority to take regulatory action if an animal device is adulterated
or misbranded.
| For the complete definition of the term “device,”
please see the Federal Food, Drug, and Cosmetic Act at Section 201(h) [21 U.S.C. 321]10.
For more information about animal devices, please
visit: How
FDA Regulates Veterinary Devices11
|
Animal Feed – The Federal Food, Drug, and Cosmetic Act
requires food for both people and animals to be:
- safe;
- produced under sanitary conditions; and
- truthfully labeled.
Animal feed includes pet food and pet treats, as well as feed for
food-producing animals, such as cattle, pigs, chickens, and farmed-raised fish.
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. FDA also evaluates the human food safety
aspect of animal feed for food-producing animals. That is, FDA makes sure it’s
safe for people to eat food products made from animals that ate the feed.
| For more information about animal feed, please visit: Animal Food & Feeds12 |
Turtles Under 4 Inches – Under federal law, FDA banned the
sale of turtles less than 4 inches long in 1975 because of human health
concerns. Small turtles may seem like fun additions to the home, but they carry
dangerous bacteria called Salmonella.
| For more information about turtle safety, please visit: Pet Turtles - A Common Source of Salmonella13 |
No!
Vaccines for Animal Diseases – FDA does not regulate
vaccines for animal diseases. Veterinary biologics, including vaccines for
animal diseases, are regulated by the U.S. Department of Agriculture.
| For more information about vaccines for animal disease, please visit: Veterinary Biologics (USDA)14 |
Maybe So!
Pharmacies – Pharmacists are licensed by their state board
of pharmacy and must follow the rules and regulations of that state board. FDA
is responsible for approving and regulating the drugs sold in pharmacies. Some
pharmacies also compound drugs. FDA has rules and policies about compounding
drugs that apply to those pharmacies.
|
For more information about boards of pharmacy and
for contact information for each state board of pharmacy, please visit the
website of the National Association
of Boards of Pharmacy (NABP)15
For more information about the compounding of animal
drugs, please visit: Compounding of
Animal Drugs16
Please refer questions about a specific drug for your animal or drug pricing
to your veterinarian or pharmacist. |
Practice of Veterinary Medicine – Veterinarians are licensed
by their state veterinary licensing board and must meet the requirements of the
licensing board to practice in that state. FDA regulates the devices and drugs
that veterinarians use, and the conditions under which veterinarians may
prescribe drugs for extra-label uses.
| What does “extra-label” mean?When an approved drug is used in a manner other than what is stated on the label, it is an extra-label use. This is commonly called an “off-label” use because the drug is used in a way that is “off the label.” |
| For more information about veterinary licensing
boards and for contact information for each state veterinary licensing board,
please visit the website of the American Association of Veterinary State Boards (AAVSB)17 .
For more information about extra-label drug use in animals, please visit: Please refer specific questions about your animal’s health to your veterinarian. |
Flea and Tick Products – FDA regulates some flea and tick
products for animals while the Environmental Protection Agency (EPA) regulates
others. If a product is regulated by EPA, it will have an EPA Registration
Number (sometimes written as “EPA Reg. No.”) on the label. If a product is
regulated by FDA, it will typically have the statement “Approved by FDA”
followed by a six-digit New Animal Drug Application (NADA) or Abbreviated New
Animal Drug Application (ANADA) number on the label.
|
For more information about flea and tick products, please visit: |
Milk, Eggs, Meat, Poultry, and Catfish – The responsibility
of food safety is shared by FDA and the U.S. Department of Agriculture (USDA).
FDA regulates milk and milk products, such as cheese, cream, and ice cream. FDA
also regulates “shell eggs” which, as the name implies, are eggs still inside
their shells. USDA regulates “egg products” which are eggs that have been
removed from their shells for processing. In general, USDA regulates meat,
poultry, and catfish.
|
For more information about food and food safety, please visit: |
Not on the Regulatory
RadarSome products on the market for animals don’t fall under the
regulatory authority of any government or non-government organization,
including:
|
For questions or concerns about FDA-regulated animal products, contact CVM’s
Communications Staff at:
Phone: 240-276-9300
Fax: 240-276-9115
E-mail: AskCVM@fda.hhs.gov
Address: 7519 Standish Place
Rockville, MD 20855
Fax: 240-276-9115
E-mail: AskCVM@fda.hhs.gov
Address: 7519 Standish Place
Rockville, MD 20855
-
-
No comments:
Post a Comment