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Specializing in FDA Regulatory Matters

Veterinary Services

Just as with products intended for human use, FDA’s Center for Veterinary Medicine (CVM) regulates products, sold in the US and intended for use with animals and in animal feed. Animal food includes both livestock feed and pet food. The term food additive is also defined in the Federal Food, Drug, and Cosmetic Act (section 201(s)) as any substance that directly or indirectly becomes a component of a food or that affects a food’s characteristics.

In the case of animal food, CVM’s responsibilities are vast. For instance CVM manages the FDA medicated feed and pet food programs and monitors and establishes standards for animal food additives. Approval of drugs for use in food-producing animals includes assurance that any residue of the drug remaining in edible tissue is safe for human consumption. The term Generally Recognized as Safe or GRAS that has become so familiar in the human food industry also applies to products covered by CVM. Firms producing animal food and feed should submit a GRAS notification or a food additive petition before that substance can be added to animal food.

In order for a drug product to be sold in the U.S., companies must receive FDA premarket approval to substantiate safety and effectiveness under the conditions of its intended use.   In the case of drugs for use in animals, CVM approval also indicates the drug’s strength, quality, and purity are consistent from batch to batch, and that the drug’s labeling is accurate and makes no false or misleading claims. Applying for and receiving CVM approval for drug products is a complex and technically challenging process.

EAS Consulting Group, LLC. assists clients in navigating the CVM regulatory process and provides US Agent and Registration services. Our toxicologists which specialize in animal products, can answer questions such as whether certain antibiotics are safe in food-producing animals as well as the safety of pet food and animal feed products as well as the acceptability and safety of animal food/feed ingredients.  EAS can assist in the design protocol of safety studies and premarket approval process as well as file submissions on behalf of your company.

EAS can help with:

  • NADA (New Animal Drug Application)
  • ANADA (Abbreviated New Animal Drug Application or generic drug)
  • Freedom of Information Act requests
  • Medicated Feed Mill Licensing assistance
  • Regulatory review of proposed product labeling
  • Food Additive Petitions
  • Audits of pet food/feed and animal drug manufacturers and distributors

EAS Consulting Group is proud to have expert consultants who have lead the food field in the U.S. marketplace.  View a sampling of some former positions held by our consultants prior to joining EAS.