The FDA campus in Silver Spring, MD. Image source: Wikipedia
The Federal Food, Drug & Cosmetic Act, passed by the U.S. Congress in 1938, protects the heath of both humans and animals. The act gives authority to the FDA to oversee the safety of food, drugs and cosmetics. The act requires that a drug must be reviewed by the FDA for safety and effectiveness before a company can legally sell it. During this pre-market review, the agency evaluates information submitted by the company to make sure the drug is safe and effective for its intended use, and that the drug is properly manufactured and properly labeled.
A branch of the FDA called the Center for Veterinary Medicine (CVM) is charged with protecting public and animal health, ensuring that animal drugs are safe and effective. The CVM regulates drugs, devices, and food additives for 100 million companion animals.
So how does this work? Whenever a new prescription or over-the-counter drug is developed for use in animals, it has to be approved by the FDA before it can be sold and marketed to the public.
The drug approval process is complicated, and requires the drug sponsor to demonstrate that the new animal drug product is safe and effective when used as directed on the label.
Drug sponsors—usually the manufacturer of the product—submit a New Animal Drug Application to the FDA, along with supporting data, including all unexpected adverse side effects associated with the product’s use. The drug sponsor must show that it can manufacture the drug product so the product’s composition is consistent from batch to batch, that the product’s active ingredients come from reliable sources, and that the company follows good manufacturing practices while making the product.
It can be tricky for pet owners to know when a product has been manufactured according to FDA guidelines because manufacturers are not required to indicate this on the product label. Also, some products—particularly dietary supplements—don’t fall under the category of drugs or food, and so are not under the auspices of the FDA. To find out if a product has been approved by the FDA, email AskCVM@fda.hhs.gov with the name of the product. The CVM will respond with an answer.
Vetericyn Plus® products are manufactured in an FDA-cleared facility
The good news is that all products manufactured by Innovacyn®, makers of Vetericyn® for animals and Puracyn® for humans, are FDA-cleared. You can find evidence of this on our label, which states they are manufactured under strict FDA quality guidelines.
We’re proud to make Vetericyn Animal Wellness products here in U.S. and to the highest safety standards possible. Vetericyn is safe, non-toxic, effective, and produced in a facility that meets or exceeds FDA standards. When using Vetericyn for eye, ear, or skin care, you can be confident you are using the safest, most effective product to help your loveable pet.