Under the Federal Food, Drug and Cosmetic Act (FFDCA), any article intended to be fed to an animal is considered a food, and subject to extensive FDA regulatory requirements. It does not matter whether the article will become a component of pet food or animal feed – both are governed by the very same regulations, with minor regulatory differences.
Unique to the pet food/animal feed industries is the FDA’s relationship with the Association of American Feed Control Officials (AAFCO). The FDA and the AAFCO have a memorandum of understanding in which the AAFCO assists the FDA in safeguarding the health of animals, while ensuring consumer protection. While the AAFCO has no regulatory authority, it helps federal and state authorities regulate the sale and distribution of pet food/animal feed, as well as the ingredients and additives used. Any actor in the pet food/animal feed industries should pay close attention to the AFFCO and its extensive guidance and reach.
Finally, while there is no premarket requirement to bring pet food/animal feed to market (absent some state licensing requirements), federal and state laws do impose certain conditions. They require pet food/animal feed to be pure, safe to eat, produced under sanitary conditions, contain no harmful substances, not contain misleading claims or claims that would render the product an unapproved new animal drug, and be truthfully labelled. Further, each state has rules related to licenses, registration, annual update requirements, renewal dates, inspection fees, tonnage reporting and fees for various actors in the supply chain.
Armstrong Teasdale attorneys have significant experience advising the pet food and animal feed industries. Our attorneys serve as close advisors, guiding companies of all sizes, from startups to Fortune 100 companies, step-by-step through the complex regulatory regime. Our ultimate goal is to help our clients grow market share while managing the increasing regulatory burdens and judicial actions impacting the pet food/animal feed industries.
Our pet food/animal feed advisors assist with:
- New animal food additive petitions;
- Ingredient and additive reviews;
- Implementation of Pet Food/Animal Feed Standard Operating Procedures (SOPs);
- Adverse event reporting and liability management;
- Compliance with current good manufacturing practices and best practices;
- Label and labeling reviews, including assistance with advertisements, internet marketing and social media networks;
- Medicated feed requirements;
- Association of American Feed Control Officials (AAFCO) guidance;
- State regulatory requirements;
- Audits of operations and associated risk assessment related to noncompliance;
- Defense against FDA and FTC enforcement actions such as product recalls, FDA detentions and refusals, warning letters, 483s, adulteration and misbranding charges, import alerts, or claims brought by state or federal prosecutors for violation of safety regulations, and for false labeling and advertising;
- U.S. Customs matters such as Form 28s, liquidated damages, criminal investigations, seizures, HTS classifications, free trade agreements, country of origin issues, import/export guidance and supply chain management;
- Analysis and advocacy with respect to relevant legislation and pet food/animal feed regulatory matters; and
- Obtaining patents and trademarks, and gray market protection strategies.
For more information, please contact Ryan Fournier.