Regulatory Aspects of Veterinary Nutraceuticals in the USA and Canada

Abstract

The Food and Drug Administration (FDA) in the US provides clarification, guidance, and regulatory oversight to protect human and animal health. The Center for Veterinary Medicine (CVM), a branch of FDA, ensures safety of veterinary medical products and animal feed including pet food. Nutraceuticals are neither food nor drugs and present a regulatory challenge. Although most nutraceuticals are generally regarded as safe, there is a growing concern about their safety, quality, and efficacy. To safeguard human health, the FDA has not provided any special provision to natural supplements intended to be included in animal feed. The FDA believes that there is insufficient information on the safe use of natural products in food animals to ensure human health from potential toxic residues. However, the use of oral natural supplements is not prohibited in pets if a product is harmless and not labeled to treat or cure an ailment. In Canada, veterinary nutraceuticals are defined as “natural supplements” and are regulated by Health Canada. Guidance includes information on permitted and excluded products, manufacturing, labeling, and adverse event reporting system. All products are required to obtain a notification number (NN) prior to sale in Canada. The objective of Canadian regulations is to facilitate the approval of safe products while keeping harmful supplements off the market to protect human and animal health.