For The PET Pros: A Practical Policy Guide for Global Supply Chain Compliance

When you run a pet-industry business—whether you manufacture domestically in the United States or import pet food, treats, chews or other pet-related products into the U.S. market—it pays to know the full regulatory framework. At PetIn.ai, we empower pet-industry professionals (“For The PET Pros”) with the insight and structure needed to navigate the complex web of U.S. regulatory requirements, ensure smooth entry, minimize risk, and establish a strong, compliant supply chain.

Below is a detailed breakdown of how the Food and Drug Administration (FDA) and the United States Department of Agriculture (USDA) / Animal and Plant Health Inspection Service (APHIS) regulate pet-product manufacturing and importation in the U.S., what you need to prepare (qualifications, documentation), and the step-by-step process you should follow.

1. Regulatory Bodies & Scope

1.1 FDA – Animal Food, Pet Food & Treats

The FDA, via its Center for Veterinary Medicine (CVM), regulates animal food—including pet food, treats, chews, and ingredients destined for animals (dogs, cats, etc.). U.S. Food and Drug Administration+3U.S. Food and Drug Administration+3U.S. Food and Drug Administration+3
Key points:

• Pet food and treats are classified as “animal food” under the Federal Food, Drug, and Cosmetic Act (FD&C Act). U.S. Food and Drug Administration+1
• The FDA is responsible for ensuring that such foods are safe for their intended use, manufactured in sanitary conditions, free of harmful substances, properly labelled, and truthfully represented. U.S. Food and Drug Administration+1
• For domestic manufacturing and importation, the same fundamental food-safety and labelling requirements apply.

1.2 USDA / APHIS / FSIS – Animal Health, Animal-Derived Materials, Meat/ Poultry/ Eggs

When a pet-product contains animal-derived materials (meat, bone, offal, rendered material, hides, etc.), or when importing items that may pose animal-disease risks, the USDA / APHIS come into play.

• APHIS/VS (Veterinary Services) regulates imports of animal products, by-products, or those exposed to animal-source materials to prevent foreign animal disease introduction. APHIS
• The Food Safety and Inspection Service (FSIS) regulates imported meat, poultry and egg-products (including when those feed into pet-food chain) for safety, labelling, packaging. FSIS+1
• At U.S. ports of entry, the Customs and Border Protection (CBP) also collaborates with these agencies for enforcement.

2. Key Legal & Procedural Requirements

2.1 Domestic Manufacturing (U.S. Production)

If you manufacture pet food, treats or related pet supplies within the USA, here are the core obligations:

Facility Registration & Preventive Controls

Under the Food Safety Modernization Act (FSMA), facilities that manufacture, process, pack or hold animal food must register with the FDA (unless exempt) and implement preventive-controls, good manufacturing practices (CGMPs) and hazard-analysis plans. U.S. Food and Drug Administration+2U.S. Food and Drug Administration+2
What this means:

• Register facility with the FDA and renew every two years. U.S. Food and Drug Administration+1
• Develop and maintain a written food-safety plan: hazard analysis, preventive controls, monitoring, corrective actions, verification, and recordkeeping. U.S. Food and Drug Administration
• Ensure ingredient sourcing, production, packaging, storage, transport all meet sanitary and safety standards.

Labelling & Ingredient Claims

Your pet product label must meet FDA’s animal-food labelling rules: product identity, net quantity, manufacturer/distributor name & address, ingredient list (descending weight), nutritional adequacy statement (if claim made), and any claims must be truthful and not misleading. U.S. Food and Drug Administration+1
If you make structure/function claims (e.g., “supports joint health,” “hairball control”), these must be substantiated and acceptable under pet-food claims guidelines (often using model guidelines by Association of American Feed Control Officials – AAFCO). U.S. Food and Drug Administration+1

Quality Control & Traceability

Keep records of raw materials, production batches, ingredient analysis, finished-product testing, recall/tracking capability. While FDA does not formally approve every pet food brand, authorities may inspect and expect compliance. STAT+1

2.2 Importing Pet Products into the U.S.

If you import pet food, treats, chews, or pet-related products into the U.S., additional layers apply:

Prior Notice to FDA

If importing animal food (including pet food/treats), your shipment must be accompanied by a Prior Notice submitted to FDA before arrival. This applies even for imported feed/food for animals. U.S. Food and Drug Administration+1

USDA/APHis Permit or Exemption

When products contain animal-origin material (dairy, meat, rendered materials, “exposed to” animal-source), you often need a VS import permit via APHIS, and/or meet USDA import requirements. APHIS+1
Flow:

• Identify whether the commodity requires VS permit (use VS Permitting Assistant) APHIS
• If yes, file permit application electronically (via APHIS eFile) and receive permit before shipping. APHIS
• Some materials are exempt from VS permit but still subject to port-of-entry review. APHIS

FSIS Import Guidance (If Meat/Poultry/Egg Components)

If your product includes a meat/poultry/egg component regulated by FSIS, you must meet FSIS import protocols: establishment listing, inspection certificate, approved foreign country/establishment, label compliance etc. FSIS

Entry & Clearance at Port

When the shipment arrives, CBP identifies the shipment and refers to FDA/USDA for inspection/documentation. If docs or testing fail, shipment can be refused, detained, re-exported or destroyed. U.S. Food and Drug Administration

3. Step-by-Step Workflow for Manufacturing/Importation

3.1 Workflow for Domestic Production

1. Determine product classification (pet food vs pet supply vs animal drug).
2. Source ingredients, confirm compliance (especially animal-derived).
3. Ensure facility registration with FDA and renewal tracking.
4. Develop preventive-controls / GMP plan as required under FSMA.
5. Create label, ingredient list, claims, compliance check with FDA/AAFCO model rules.
6. Run quality control, keep traceability, batch records.
7. Launch product; monitor adverse events, complaints, and ensure recall plan.
8. Keep documentation ready for audits/inspections by FDA or state regulators.

3.2 Workflow for Importing into USA

1. Classify the product: pet food/treats vs supply vs animal drug; determine if animal-derived materials included.
2. If importing from overseas: ensure foreign manufacturer/facility meets equivalent standards and you (importer) have paperwork.
3. If product includes animal-origin material → check APHIS VS permit requirement; file permit application via VS eFile and await approval.
4. Submit FDA Prior Notice for the shipment, specifying the product, quantity, port of entry.
5. If meat/poultry/egg components exist → check FSIS import guidelines: foreign establishment list, certificate, label compliance.
6. Prepare documentation: commercial invoice, packing list, HS codes, certificate of origin, sanitary certificate (if needed), APHIS permit.
7. On arrival, CBP channels to FDA/USDA inspection; if selected, present documents, samples may be taken.
8. If approved, release shipment; if issues arise, cooperate with authority for corrective action, possible re-export or destruction.
9. Maintain records of each shipment for regulatory retention period, monitor imported batches in market, be ready for recall or alert.

4. Qualifications & Documentation Checklist

Facility Qualification (Domestic)

• FDA registration number, renewal proof.
• Written food-safety plan: hazard analysis, preventive controls, monitoring/corrective action procedures.
• GMP documentation: sanitation, training records, equipment maintenance.
• Ingredient supplier verification & traceability.
• Finished product test results (nutritional adequacy, contaminants, ingredients).
• Label samples, claim substantiation, statement of nutritional adequacy (if applies).

Importer Qualification (for U.S. entry)

• Importer’s registration/identification with U.S. authorities (as needed).
• For animal-origin material: APHIS VS import permit or documented exemption.
• For meat/poultry/egg component: FSIS import eligibility, foreign establishment listing, certified export certificate.
• Prior Notice submission evidence (FDA).
• Bill of lading, commercial invoice, packing list.
• Label compliant with U.S. labelling law.
• Records of foreign manufacturer’s compliance (audit reports, certifications).
• Traceability and recall plan for imported batches.

5. Common Pitfalls & Practical Tips

• Mis-classification: If you treat a product as “pet supply” whereas it contains animal-derived material, you may inadvertently trigger APHIS/USDA policies.
• Labelling claims: Unsubstantiated health claims (e.g., “cures arthritis in dogs”) may raise the product into the definition of a drug/animal-drug, invoking stricter regulation.
• Foreign facility oversight: U.S. importers must ensure foreign facilities meet standards; ignorance is not a defence.
• Prior Notice omission: Failing to file FDA Prior Notice will likely result in detention or refusal of entry.
• Record keeping: U.S. authorities expect ready access to batch records, ingredient records, supplier verification. Incomplete records can delay clearance or lead to corrective action.
• Animal disease risk: Products with animal-origin ingredients face greater scrutiny to prevent introduction of foreign animal diseases; APHIS may impose testing, quarantine or disallow entry.
• State-level registration: Even after federal clearance, many U.S. states require pet-food product registration and review of labels. Consumer Products Law Blog

6. Summary Table: Domestic vs Import Compliance

7. Why This Matters for Your Pet Industry Business

As a member of the pet supply chain—whether you are a manufacturer, wholesaler, distributor, importer or retailer—compliance with U.S. regulatory standards is not optional. Mis-steps can lead to shipment refusal, costly delays, product recalls, reputational damage, or even legal enforcement. At PetIn.ai we serve pet industry professionals (“For The PET Pros”) with up-to-date policy guidance and actionable workflows to help you navigate supply chains globally and enter the U.S. market confidently and compliantly.

8. Next Steps & Action Plan

1. Map your product portfolio and flag each item: Is it pet food/ treat? Does it include animal‐derived materials? Will you import?
2. Develop a compliance checklist based on the above workflows.
3. Confirm your foreign manufacturing partners meet equivalent standards and maintain necessary documentation.
4. Build a record-keeping system: ingredient sourcing, batch records, labels, certifications, import/export documentation.
5. Train your team and set internal audit schedule.
6. Monitor regulatory updates – both FDA and USDA/APHIS publish changes and you must stay current.
7. Leverage PetIn.ai for ongoing updates, trend insights and sector-specific regulation summaries.

Disclaimer

This overview is provided for informational purposes only and does not constitute legal advice. The regulatory requirements of the United States (including those of the FDA and USDA/APHIS) may be updated or interpreted differently over time. While we have made every effort to ensure accuracy, PetIn.ai disclaims liability for any errors or omissions herein. If you identify any data inaccuracies or potential infringement issues, please contact us at info@petin.ai for correction or removal.