FROM OUR CORPORATE PARTNERS Don’t Take for Granted “FDA-APPROVED” he United States enjoys one of the safest sup-plies of food and drugs in the world. Since the early 1900s, the US government has been regulating that supply to minimize misrepresen-tations and major abuses in the food and drug industries. While the Food and Drug Administra-tion (FDA) creates a sense of security by prohibit-ing misbranding and adulteration of foods and drugs, security can breed carelessness. While the regulations and enforcement of those regulations still keep America’s food and drugs safe, there are a lot of animal health prod-ucts on the market that aren’t approved by the FDA. Just because you can buy it for your horse, doesn’t mean its FDA-approved or safe. “A lot of people believe what’s on the bottle,” says Dr. Joe Bertone, a Professor of Equine Med-icine at the Western University of Health Sci-ences. “That has to do with the U.S. having an FDA for more than 70 years. Back at the turn of the century, people always questioned what was in the bottle because there was no one there to tell them the bottle actually contained what was on the label.” Some companies are using loopholes to pro-mote substances that aren’t FDA-approved. This is creating some confusion for consumers. What are veterinary medical devices and compounded drugs? What are they supposed to be used for? WHAT ARE DEVICES? “Look for an NADA number, a package insert with “FDA-ap-proved” claims and a label that says FDA-approved,” Dr. Bertone says. T A human medical device must go through the Center for Disease Control (CDC) and is essentially an object or substance not intended to change in the body. Screws for surgery, contact lenses and x-ray machines are examples of devices. Vet-erinary devices don’t have to go through the CDC. The Center for Veterinary Medicine (CVM) regulates those, but has chosen to not enforce the regulation. In other words, no one polices veterinary devices in anyway. “If I take a nail and say this is a veterinary medical device, the CVM FDA doesn’t bother to regulate it,” says Dr. Bertone, who was a Veteri-nary Medical Officer at the Center for Veterinary Medicine in the FDA for five years. “That’s why there are ultrasound machines that don’t have the specifications necessary to be a cardiac ma-chine, but are being sold to veterinarians as car-diac machines. The sellers just call it that, knowing the public, including veterinarians, don’t understand the issue. They are calling it a veterinary device so that no one will oversee them. As long as they don’t say they are a drug the FDA won’t enforce the regulations.” Another example is Polyglycan® Sterile Solu-tion. It is a veterinary medical device and is la-beled as a post-surgical lavage. If used properly, it should only be used to wash out an opening after surgery; instead it is being used to replace Adequan® (polysulfated glycosaminoglycan), and Legend® (hyaluronate sodium) Injectable Solution. Adequan® and Legend® are FDA-ap-proved drugs that have been shown to be safe and effective and have the substances within them that the label says they do, by FDA en-forcement of manufacturing. Polyglycan® Ster-ile Solution has never been shown to meet the standards of an FDA drug and they have never been approved for content of the bottle nor manufacturing because they are marketed as a veterinary medical device. In other words, there is no one that assures you what’s in the bottle, from batch to batch, or if the product is safe and effective. You are using it on the manufac-turer’s word.