FDA Affirmation of Compliance Codes: A Practical Guide for Importers and Food Businesses
- Bustos Law Group
- Dec 29, 2025
- 6 min read
Key Takeaways:
Affirmation of Compliance (A of C) codes are three-letter codes used during FDA import entry to affirm regulatory compliance.
Some codes are mandatory; others are voluntary but can expedite FDA review.
Incorrect or missing codes trigger FDA holds, refusals, and increased scrutiny of future shipments.
Food importers face higher enforcement exposure due to complex registration, labeling, and safety requirements.
The importer of record is ultimately responsible for ensuring correct affirmations.
For importers and food businesses, FDA affirmation of compliance codes is a critical but often misunderstood part of the import process. These codes are not administrative formalities.
They are enforcement tools that the FDA uses to screen shipments, assess risk, and make admissibility decisions. A single incorrect code can delay your shipment, trigger a refusal, or place your products under heightened scrutiny for months.
This guide explains what affirmation of compliance codes are, which codes apply to food imports, and how to avoid costly mistakes.
What Are FDA Affirmation of Compliance Codes?
Affirmation of Compliance (A of C) codes are three-letter codes submitted to the FDA at the time of entry.
By using an A of C code, the entry filer affirms that the firm or product identified in an FDA line meets the requirements specific to that code.
These codes help the FDA conduct electronic screening of imports and make risk-based admissibility decisions.
Affirmations are different from documentation and certifications. An affirmation is a declaration that compliance requirements have been met.
It is not the same as submitting actual documentation or obtaining FDA certification.
However, the FDA expects that any affirmation you submit is backed by actual compliance and supporting records.
Where Affirmation of Compliance Codes Fit in the FDA Import Process
When a product arrives at a U.S. port of entry, the importer (or their customs broker) submits entry information to U.S. Customs and Border Protection (CBP).
This information is transmitted to the FDA through the Automated Commercial Environment (ACE) system.
FDA uses A of C codes, along with other entry data, to conduct automated screening and determine whether a shipment requires manual review, sampling, or field examination.
Affirmations play a key role in the FDA's risk-based approach to import admissibility.
Products with complete and accurate affirmations may proceed through initial screening more quickly. Products with missing, incorrect, or inconsistent affirmations are flagged for further review.
Who Is Responsible for Affirmation of Compliance Codes?
The importer of record is ultimately responsible for ensuring that the correct A of C codes are submitted. However, coordination failures are common. Foreign manufacturers and shippers may not understand U.S. requirements.
Customs brokers may submit codes based on incomplete information. The result is often a mismatch between what is affirmed and what is actually compliant.
Best practice is for the importer to work directly with regulatory affairs professionals to verify which codes apply before shipment, rather than relying solely on customs brokers to make these determinations.
Key FDA Affirmation of Compliance Codes for Food Imports
Several A of C codes are commonly used for food imports. Understanding when each applies is critical.
Code | Name | When It Applies |
|---|---|---|
REG | Facility Registration | Affirms that the food facility is properly registered with the FDA under the Food Facility Registration requirement. |
FCE | Food Canning Establishment Registration | Required for low-acid canned foods (LACF) and acidified foods. Indicates FDA registration of the canning establishment. |
SID | Process Filing (Scheduled Process) | Affirms that required process filings are on file with the FDA. Frequently required for shelf-stable food imports. |
LST | Product Listing | Used when the FDA requires product listing information. Often misunderstood or misapplied. |
ALC | Alcohol Content | |
NUT | Nutrition Labeling Compliance | Affirms compliance with FDA nutrition labeling requirements. A common source of errors for packaged foods. |
PNC | Prior Notice Confirmation | Affirms that prior notice requirements have been met. Required for most FDA-regulated food imports. |
Requirements vary by product and shipment context. Not every code applies to every shipment, and using an incorrect code can be as problematic as omitting a required one.
When the FDA Requires Affirmation of Compliance Codes
Some A of C codes are mandatory for specific product types. For example, PNC (Prior Notice Confirmation) is required for most food imports.
FCE and SID codes are mandatory for low-acid canned foods and acidified foods. Other codes are optional but may expedite review.
The absence of a required code raises immediate red flags. FDA's automated system will detect the missing affirmation and may hold the shipment for manual review or refuse entry.
How FDA Reviews Affirmation of Compliance Codes
FDA's review process includes automated validation checks that cross-reference A of C codes against FDA databases.
For example, if you submit a REG code with a facility registration number, the FDA will verify that the number is valid and that the facility is currently registered.
If the affirmation does not match the FDA's records, the shipment may be escalated to document requests, sampling, or field examination.
Common Affirmation of Compliance Errors
Importers make several recurring mistakes with A of C codes:
Using incorrect or outdated codes: Codes change over time, and using an obsolete code can cause delays.
Submitting affirmations without underlying compliance: Affirming compliance when the facility is not actually registered, or the product does not meet labeling requirements.
Mismatch between product description and affirmation: For example, affirming LACF compliance for a product that is not actually a low-acid canned food.
Over-reliance on customs brokers: Brokers may not have the regulatory expertise to determine which codes apply.
Consequences of Incorrect or Missing Affirmation Codes
The consequences of A of C errors are significant:
Entry delays and holds: FDA may place the shipment on hold while it investigates.
FDA refusal of admission: The shipment may be refused entry and must be exported or destroyed.
Increased scrutiny of future shipments: FDA may flag the importer for heightened review on subsequent entries.
Potential placement on import alerts: Repeat violations can result in automatic detention of future shipments.
Affirmation of Compliance Codes for Food Imports
For food importers, affirmations intersect with food safety and labeling requirements. A facility must be registered, products must comply with preventive controls, and labels must meet FDA standards.
Affirmations are a way of declaring that these requirements have been met. However, the FDA will verify these declarations, and false affirmations can lead to enforcement action.
Repeat shipment risks are particularly high for food importers. If the FDA detects a pattern of incorrect affirmations or non-compliance, future shipments may be subject to automatic detention.
Best Practices for Managing Affirmation of Compliance Codes
To manage A of C codes effectively:
Establish internal verification procedures: Before each shipment, verify which codes apply and ensure that underlying compliance is in place.
Align affirmations with regulatory status and documentation: Make sure your facility registrations, process filings, and labeling are current.
Monitor regulatory changes: FDA periodically updates A of C codes and requirements. Stay informed.
Work with regulatory counsel: For complex products or high-value shipments, consult with an FDA compliance attorney before entry.
How Affirmation Codes Support FDA Enforcement Strategy
FDA uses affirmation data to identify trends and repeat violators. Patterns of incorrect affirmations signal to the FDA that an importer may not have adequate compliance systems in place. This information feeds into the FDA's risk profiling and enforcement prioritization.
How Bustos Law Group Assists with FDA Affirmation of Compliance Issues?
Bustos Law Group provides comprehensive support for importers and food businesses navigating FDA affirmation of compliance requirements:
Import Compliance Risk Review: Pre-entry evaluation of affirmation requirements and identification of compliance gaps before shipment.
FDA Import Issue Resolution: Assistance with FDA holds, refusals, and information requests, including regulatory strategy for admissibility disputes.
Food Industry Regulatory Support: Advising food manufacturers, importers, and brand owners on affirmation issues tied to labeling and safety compliance.
Regulatory Education and Resources: FDA news and insights on import enforcement trends and practical guidance for food import compliance.
Final Thoughts
Affirmation of compliance codes is are enforcement tool, not administrative checkboxes. Accuracy and documentation directly affect admissibility.
For importers and food businesses, proactive legal oversight reduces disruption and enforcement exposure. By integrating regulatory expertise into import operations, you can protect your supply chain and avoid costly delays.