Animal health regulation – USA
The regulation of animal health products, including animal feed, animal drugs, and pesticides, such as topical spot-ons, flea and tick collars, and other innovative products that protect animals against parasites such as fleas and ticks, varies by type of product involved and whether or not the product is considered a drug or pesticide.
Animal feed regulationBoth 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.
- Ingredients – The Federal Food, Drug, and Cosmetic Act (FD&C Act or FFDCA) requires that animal food is safe for consumption, is prepared in sanitary conditions, is free of harmful substances, and is 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 undergo the AAFCO definition process, be recognized as GRAS, or be approved after submission and review of a feed additive petition by FDA.
- Labeling – Animal feed labels are the primary source of information for 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 in all states where the product will be distributed and sold.
- Tonnage reporting and annual renewal – 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.
Animal drugsUnder the FD&C Act, new animal drugs are defined as articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals and articles (other than food) intended to affect the structure or any function of the body of animals. These products are classified as new animal drugs and subject to applicable federal regulations. The FDA’s CVM is charged with ensuring that animal drug products are both safe and effective through the review of New Animal Drug Applications (NADAs) or Generic New Animal Drug Applications (ANADA). Animal drug products are developed for both companion animals (including dogs, cats, and horses) and food-producing animals (including cattle, swine, and poultry). FDA’s CVM also ensures that food products such as meat, milk, and eggs are safe for human consumption. In addition to major species such as dogs, cats, horses, cattle, poultry, and swine, CVM also oversees drug products developed for minor species including fish, birds, and hamsters.
Pesticide products applied to animals for pest mitigationThe US EPA is charged with overseeing the sale and distribution of pesticide products under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and issues registrations following review of submitted applications containing data and draft product labeling. Data on product chemistry, toxicity, efficacy, companion animal safety, and residue chemistry (for food-producing animals) may be submitted to EPA for review in support of new pesticide applications. Like new animal drug products, a pesticide product can be used to treat or prevent a parasite infestation in animals, such as flea and tick infestations in dogs and cats. However, these products differ from new animal drugs in that they impart their effect on the outside of the animal, whereas new animal drugs must be absorbed into the animal’s circulation (i.e. become systemic) in order to impart their effect(s). Products such as flea and tick collars, topical spot-on products, livestock dips and sprays, as well as manure feed-through products, are regulated as pesticide products by EPA’s Office of Pesticide Programs if they impart their effect on the outside of the animal (often through contact with the pest). There are topical new animal drugs but they must be absorbed into the animal to work.
TSG can help
- Prepare and submit pesticide product registrations and renewals
- Determine the appropriate jurisdiction of a product either as a new animal drug submitted to FDA-CVM, or a pesticide product submitted to the US EPA
- Review feed formulations for compliance with federal requirements
- Prepare and submit applications for Type A medicated articles and feed additive petitions
- Prepare and submit New Animal Drug Applications (NADAs) and Abbreviated New Animal Drug Applications (ANADA) for generic drugs, and guide clients through the entire regulatory process to final product approval
- Review protocols and draft study reports
- Request Investigational New Animal Drug (INAD) files and Generic Investigational New Animal Drug (JINAD) files
- Lead CVM pre-submission conferences and meetings with EPA on behalf of clientele
- Act as US Agent for international companies
- Prepare Minor Use and Minor Species (MUMS) applications
- Prepare and submit GRAS notifications and self-affirmations
- Develop product labels and claims
- Submit establishment registration
- Advise on import and export issues
- Report adverse events
- Submit feed tonnage reporting
- Provide AAFCO new ingredient definition assistance
TSG provides companies with high-quality regulatory and scientific consulting services. We aim to understand our clients' goals and objectives, learn the scientific and technical aspects of projects and anticipate compliance challenges to plan a strategic path forward. TSG's team of experts is deadline-focused, responsive and committed to professionalism. We have the utmost respect for the confidentiality of our work, strong project management skills, and take great measure to cultivate long-term partnerships with clients.
Our team of animal health regulatory consultants help clients with all aspects of animal feed, animal drug and pesticide products. Leslie Patton is a senior scientific consultant who has more than a decade of experience in regulatory toxicology. Shannon Bryant-Spas specializes in the compliance of products including animal feed and pet food, at the state level. Pete Stevenson specializes in the compliance of animal feed and pet food products at the national and state levels, and previously worked as a regulatory affairs professional in the animal health industry. Tim Dotson has extensive experience achieving pesticide product registrations through the U.S. EPA and new animal drug product approvals through the FDA’s Center for Veterinary Medicine (FDA/CVM).
Frequently asked questions?
Companion animal New Animal Drug Applications (NADAs) typically take 3-5 years to complete, whereas production animal drug applications may take 5-8 years to complete.
The quality of the original submission is paramount, as is following process and maintaining good communication with the regulator. Delays may occur when applications of poor quality are submitted. At TSG we pride ourselves on being able to produce quality applications which help expedite the process for our clients.
As well as needing to comply with federal regulations, animal feed products are registered at the state level. Each state has its own procedure for registering products, overseeing their renewal, developing label requirements, and collecting tonnage fees based on sales. TSG can undertake state registrations, renewals and tonnage reporting on behalf of its clients – read more here. Animal drugs are regulated at the federal level and by some states while animal pesticide products are regulated by states and the federal government.
Determining the product classification upfront is a key part of the process. In this example, although your cat or dog may enjoy taking its medication – because many oral chewables are flavored and you can offer it to your pet as a ‘treat’ – these products are in fact drugs regulated by FDA. This is because they are systemically absorbed and kill the parasites after they take a blood meal from the animal; they are also administered orally rather than topically.
One label will work for the majority of states; however certain states will need additional information and therefore are likely to require a unique label. As animal health regulatory consultants, part of developing a regulatory compliance strategy is to help our clients devise the most expedient plan possible with as few label variations as possible.