Compliance & Certification
FDA Food Facility Registration is a mandatory process for facilities that manufacture, process, pack, or hold food for consumption in the United States.
Full Definition
This registration is required by the U.S. Food and Drug Administration (FDA) under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act) and further strengthened by FSMA. It helps the FDA monitor the food supply chain and quickly respond to foodborne illness outbreaks or other emergencies. All domestic and foreign facilities involved in these activities must register, and the registration must be renewed biennially.
Why It Matters for CPG Brands
For CPG brand operators, failing to register can lead to severe penalties, including product detention, import refusal, and significant fines. Proper registration ensures your products can legally enter the market and demonstrates your commitment to food safety and regulatory compliance.
In CPG Operations
If your CPG brand produces its own products, such as snacks, beverages, or sauces, in a manufacturing facility, that facility must be registered with the FDA. Even if you use a co-packer, it's crucial to verify that their facility holds a current and valid FDA registration, as this impacts the legality of your product.
Example
A small batch artisanal jam brand, 'Berry Good Jams,' manufactures its products in a dedicated kitchen. Before selling their strawberry and blueberry jams nationwide, the owner must ensure their production facility is registered with the FDA. This involves submitting their facility name, address, contact information, and food product categories through the FDA's online system, and renewing it every two years.
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Frequently Asked Questions
Who needs to register with the FDA as a food facility?
Any domestic or foreign facility that manufactures, processes, packs, or holds food for human or animal consumption in the U.S. must register. This includes manufacturers, warehouses, and even some co-packers.
How often do I need to renew my FDA Food Facility Registration?
FDA Food Facility Registration must be renewed biennially (every two years) between October 1st and December 31st of even-numbered years. Failure to renew can lead to significant penalties.
What are the consequences if my CPG brand's facility isn't registered?
Unregistered facilities can face serious consequences, including product detention or refusal at import, injunctions, criminal prosecution, and significant fines. It can halt your ability to sell products in the U.S. market.