The FDA has recently stepped up its enforcement activity with respect to animal and pet food manufacturing. On February 8, 2023, the FDA announced an expansion of a voluntary recall for a Nestlé Purina dog food product. On March 10, 2023, the FDA announced a voluntary recall of cat and dog supplements distributed by Stratford Care USA due to elevated levels of vitamin A found in the supplements. And on March 14, 2023, the FDA published a warning letter issued to Primal Pet Foods, Inc. in relation to the company’s recall of its dog food product, stating the company had not taken sufficient steps to address operational and manufacturing deficiencies found during an FDA inspection of the manufacturing facility.
In light of the recent spate of warning letters and product recalls, manufacturers, distributors and marketers should understand the scope of the FDA’s authority, regulations and guidelines related to the manufacturing of animal and pet food products.
FDA and State Regulatory Authority over Animal and Pet Food Products
The FDA categorizes food for animals as either animal food or pet food—a distinction that recognizes how food for domesticated animals is often stored, sold and produced similarly to human food. Animal and pet food manufacturing and labeling are regulated at both the federal and state levels. The FDA establishes manufacturing and labeling requirements for animal and pet food products under the Food, Drugs and Cosmetics (FD&C) Act.[1] Individual states have adopted their own quality control and labeling regulations, with the majority of states modeling their regulations after or otherwise directly adopting the model regulations crafted by the Association of American Feed Control Officials (AAFCO).
In 2011, Congress passed the Food Safety and Modernization Act (FSMA), which requires the FDA to regulate animal and pet food production practices and monitor the production facilities for adulterated products. Under FSMA, FDA-registered animal and pet food manufacturers must adhere to formal baseline standards and practices for the safety, sanitation, production and operation of animal and pet food manufacturing facilities.
The FDA has stated that its primary goal is to ensure that ingredients included in animal and pet food products are safe and have an appropriate function, and labeling requirements are an important means of ensuring that manufacturers adhere to safety standards. Additionally, in cooperation with the FTC (which oversees marketing claims), the FDA reviews specific health claims made about pet food products, such as “maintains urinary tract health,” “low magnesium” and “hairball control.”
FDA Manufacturing Guidance
The FDA has published a number of guidance documents to help animal and pet food manufacturers better understand the FDA’s current thinking on various animal and pet-food-related topics. Topics covered include hazard and risk-based preventative controls for manufacturers, evaluations of specific substances and additives, and best practices for storage, labeling and transportation of animal and pet food products. While guidance documents do not generally establish legally enforceable responsibilities upon manufacturers, they do provide insights into factors the FDA considers in determining whether to take regulatory action.
In addition to the published guidance documents, the FDA provides a list of guidance documents currently in development that it plans to publish as drafts or final guidance documents by the end of the calendar year. While the listed topics are non-binding and not comprehensive, they reveal FDA’s plans to address additional consumer safety issues for animal and pet food products. Proposed guidance document topics include utility studies for specific additives and increased guidance on ingredient labeling and nomenclature.
FDA Enforcement Takeaways
The recently reported recalls and warning letters indicate that the FDA is becoming increasingly active in addressing potential contamination or adulteration of animal and pet food products. This is in line with the FDA’s commitment to increasing on-site facility inspections, instead of the fully remote or hybrid inspections conducted during the COVID-19 pandemic. Through such on-site inspections, the FDA regularly identified deficiencies in manufacturing conditions and appropriate standard operating procedures for animal and pet food facilities, which subsequently led to consumer complaints and product contamination. As such, animal and pet food manufacturing facilities should ensure that they have implemented adequate quality controls, can correct any deficiencies or violations found in a timely and comprehensive manner, and appropriately conduct any product recalls as needed.
[1] See 21 C.F.R Parts 500 – 99 for regulations concerning animal drugs, feeds and related products.