FDA Requirements for Pet Food Manufacturers: What You Need to Know

How FDA Regulates Pet Food

Many pet food manufacturers are surprised to learn that their products fall under FDA's jurisdiction. FDA regulates pet food, animal feed, and pet treats as "food for animals" under the same statute that governs human food. This means pet food facilities face many of the same regulatory requirements as human food manufacturers.

There are also state-level regulations to consider. The Association of American Feed Control Officials (AAFCO) provides model regulations that most states adopt, covering ingredient definitions, nutritional adequacy statements, and feeding directions. However, AAFCO itself does not regulate pet food; individual states enforce their own feed laws.

Facility Registration Requirements

Every facility that manufactures, processes, packs, or holds pet food for distribution in the United States must register with FDA. This includes domestic and foreign facilities.

Key Registration Details

• Who must register: Manufacturers, processors, packers, and holders of pet food and animal feed intended for the US market, including contract manufacturers and co-packers.
• Biennial renewal: Food facility registrations (including pet food) must be renewed during even-numbered years between October 1 and December 31.
• No FDA fee: FDA does not charge a fee for food facility registration. The registration itself is free.
• US Agent required: Foreign pet food manufacturers must designate a US Agent for food facilities.

Assurentry's food facility registration service costs $199 (one-time) and includes guided registration, FEI number assistance, and compliance verification. See our pricing page for details.

Pet Food Labeling Requirements

Pet food labeling is one of the most heavily regulated aspects of the pet food business. Both FDA and AAFCO have specific requirements that must appear on every label:

Labeling mistakes are a leading cause of enforcement actions in the pet food industry. Use our Labeling Reviewer tool to check your labels for compliance issues before distribution.

cGMP and FSMA Requirements

The FDA Food Safety Modernization Act (FSMA) significantly expanded FDA's authority over animal food, including pet food. The key rule is the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (21 CFR Part 507).

What Part 507 Requires

• Current Good Manufacturing Practice (cGMP): Sanitation, equipment maintenance, personnel hygiene, and process controls applicable to all pet food facilities
• Hazard analysis: Identification of known or reasonably foreseeable hazards (biological, chemical, physical, radiological) in ingredients and the manufacturing process
• Preventive controls: Science-based controls to prevent or minimize identified hazards, including process controls, sanitation controls, supply-chain controls, and recall plans
• Monitoring and verification: Ongoing monitoring of preventive controls and verification that the food safety plan is working effectively
• Corrective actions: Procedures for handling deviations and ensuring affected products do not reach the market

Some small and very small businesses qualify for modified requirements under Part 507. However, cGMP requirements apply to all facilities regardless of size. For more on FSMA requirements, read our FSVP compliance guide.

Import Requirements for Foreign Manufacturers

Foreign pet food manufacturers face additional requirements when exporting to the United States. These requirements are enforced at the port of entry and failure to comply can result in detention and refusal of your shipment.

Recalls and Safety Reporting

Pet food recalls happen more frequently than many manufacturers expect. Common causes include Salmonella contamination, elevated vitamin D levels, foreign material contamination, and undeclared allergens. Understanding your reporting obligations is critical.

Reportable Events

• Voluntary recalls: If you discover a safety issue with your product, you should initiate a voluntary recall and notify FDA promptly. FDA can also request or mandate a recall.
• Adverse event reports: While there is no mandatory adverse event reporting requirement for conventional pet food, FDA encourages reporting through the Safety Reporting Portal. For medicated feeds, adverse event reporting is required.
• Reportable food registry: If you determine that there is a reasonable probability that your pet food product will cause serious adverse health consequences or death to animals, you must file a report with FDA within 24 hours.

Getting Started with Compliance

Whether you are launching a new pet food brand or ensuring an existing operation is fully compliant, here is your action plan:

1. Register your facility with FDA through the FDA Industry Systems portal. Assurentry can handle this for you for $199.
2. Designate a US Agent if your facility is located outside the United States.
3. Develop your food safety plan with hazard analysis and preventive controls as required by Part 507.
4. Review your labels for compliance with FDA and AAFCO requirements. Get your labels reviewed before printing.
5. Verify ingredient compliance to ensure all ingredients are approved for animal food use.
6. Set up a recall plan and adverse event monitoring process before you need them.
7. Monitor regulatory changes with a compliance dashboard to stay ahead of new requirements.

For a complete guide to food facility registration, visit our FDA food facility registration guide or explore our food industry services.