Equine supplements may be beneficial to horses and may be used as a dietary supplement. Horse owners may purchase supplements from veterinarians, Internet retailers or pet supply stores. Equine supplements are not intended to treat disease and may not have undergone the stringent testing for safety and efficacy that federal law requires for new animal drugs. Congress has authorized the Food and Drug Administration (FDA) to regulate animal food and drugs. This authority includes equine supplements that are regulated by the FDA's Center for Veterinary Medicine (CVM).
Animal Drug Regulation
For regulatory purposes, a drug is considered a substance that is designed or intended for disease treatment or prevention or a substance that alters the structure or function of an animal's body. In some instances, equine supplements may be considered drugs under the Federal Food Drug & Cosmetic Act (FFDCA), the law authorizing FDA to regulate food, drugs and cosmetics. For example, an equine supplement manufacturer is not allowed to make claims of disease treatment or prevention that would make it a drug and subject to prior FDA approval. A new animal drug must be approved by the submission of a new animal drug application (NADA) to the CVM.
Nutrition Labeling and Education Act of 1990
The Nutrition Labeling and Education Act of 1990 mandated the FDA permit certain health claims on human food. CVM encompassed many of these policies to permit certain labeling and health claims on animal food products. Prior to marketing of an animal food additive as known safe and effective, with certain labeling and health claims, CVM asks a manufacturer to submit scientific data or studies demonstrating a basis for the claim.
NASC Guidelines and Adverse Event Reporting
The National Animal Supplement Council (NASC) is a nonprofit organization created by a group of animal supplement manufacturers to regulate the animal supplement industry, including equine supplements. NASC has developed good manufacturing practice guidelines for manufacturers. NASC members must undergo a facility inspection to ensure they are in compliance with the guidelines. NASC members must also report and investigate adverse events involving their dietary supplements to the NASC. This information is available to other NASC members and the FDA.
Dietary Supplement and Health Education Act
The Dietary Supplement and Health Education Act, commonly known as DSHEA, amended the FFDCA to define dietary supplements and allow certain labeling claims by dietary supplement manufacturers. In an April 22, 1996 Federal Register Notice, CVM indicated the law applied to human food products and not to animal food products. In the April 1996 notice, CVM noted that DSHEA's legislative history did not suggest the Act was intended to encompass animal food products. In contrast to many human dietary supplements, CVM noted that little testing has been conducted on dietary supplements for animals to determine their safety and efficacy.
Tags: animal food, dietary supplements, food products, animal food products, certain labeling
