Animal health regulation

The regulation of animal health and veterinary products, including animal feed, drugs, and pesticide spot-on products that protect animals against parasites such as fleas and ticks, varies by type of product involved. Different federal agencies including the Food and Drug Administration's (FDA) Center for Veterinary Medicine (CVM) and the U.S. Environmental Protection Agency's (EPA) Office of Pesticide Program (OPP) are tasked with regulating a given product’s registration, use, and sale.

Both companion animals, such as dogs and cats, and food animals meant for human consumption, including cattle, swine, and poultry, must be fed and treated with products that meet federal safety standards. This ensures their health and well-being, while also allowing for safe human interaction. The Association of American Feed Control Officials (AAFCO) is an independent organization that provides guidance to feed control regulators and the industry by developing uniform standards, laws, and enforcement policies in animal feed production, labeling, distribution, and sale across the states.

Specifically for animal feed:

  • Claims - Products that claim to improve, cure, treat, or mitigate any condition or disease in animals are classified as new animal drugs and subject to different federal and state regulations.
  • Ingredients - The FD&C Act requires that animal food be safe for consumption, prepared in sanitary conditions, be free of harmful substances and be properly labeled. These products include anything made for animal consumption, including meals, treats and snacks, nutrient supplements, nutrient-added waters, and edible chews. FDA fulfills its responsibilities for animal feed, including pet food, in part through an agreement with AAFCO, which manages the list of approved animal feed ingredients. Ingredients used in animal feed must either be listed by AAFCO, be generally recognized as safe (GRAS), or be FDA approved feed additives. New substances must either go through the AAFCO definition process, be recognized as GRAS or be approved by submitting a food additive petition to FDA.
  • Labeling - Animal feed labels are the primary source of informing consumers about products available for purchase. Each state has unique labeling and registration requirements. Once a label compliant in all state jurisdictions is developed, the product must be registered and approved by the states in which the product will be distributed and sold.

Companies must maintain products through licensing and registration renewal and tonnage reporting to ensure uninterrupted sales in states and territories where they wish to continue marketing their product.

TSG can help

  • Prepare and submit registrations and renewals
  • Prepare and submit New Animal Drug Applications (NADAs)
  • Indexing for minor uses and minor species
  • Prepare and submit GRAS notifications and self-affirmations
  • Develop labels and claims
  • Submit establishment registration
  • Advise on import and export issues
  • Report adverse events
  • Submit tonnage reporting
  • Prepare and submit feed additive petitions
  • Provide AAFCO new ingredient definition assistance
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